REKAMBYS 600 mg Prolonged-Release Injectable Suspension
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Інструкція із застосування REKAMBYS
Зміст інструкції
- REKAMBYS 600 mg injectable suspension with prolonged release
- What is REKAMBYS and what is it used for
- What you need to know before using REKAMBYS
- How REKAMBYS is administered
- Possible side effects
- How to store REKAMBYS
- Package contents and other information
- Inspect the vial
- Wait 15 minutes
- Shake vigorously
- Inspect the suspension
- Remove the vial cap
- Open the vial adapter container
- Apply the adapter to the vial
- Lift the container
- Prepare the syringe
- Connect the syringe
- Press the plunger
- Slowly draw up the dose
- Unscrew the syringe
- Connect the needle
- Prepare the injection site
- Remove the cap
- Remove excess liquid
- Stretch the skin
- 5 cm
- Insert the needle
- Inject the dose
- Examine the injection site
- Avoid needle stick injuries
- Dispose of safely
- For how long can the medicine be left out of the refrigerator?
- For how long can the medicine be left in the syringe?
- Why is it necessary to inject air into the vial?
- Is the order of administration of the two drugs important?
- Why is the ventrogluteal site recommended for administration?
- REKAMBYS 900 mg prolonged-release injectable suspension
- What is REKAMBYS and what is it used for
- What you need to know before using REKAMBYS
- How REKAMBYS is administered
- Possible side effects
- How to store REKAMBYS
- Contents of the pack and other information
- Inspect the vial
- Wait 15 minutes
- Shake vigorously
- Inspect the suspension
- Remove the vial cap
- Open the vial adapter container
- Apply the adapter to the vial
- Lift the container
- Prepare the syringe
- Connect the syringe
- Press the plunger
- Slowly draw up the dose
- Unscrew the syringe
- Connect the needle
- Prepare the injection site
- Remove the cap
- Remove excess liquid
- Stretch the skin
- Insert the needle
- Inject the dose
- Examine the injection site
- Avoid needle stick injuries
- Dispose of safely
- How long can the medicine be left out of the refrigerator?
- How long can the medicine be left in the syringe?
- Why is it necessary to inject air into the vial?
- Is the order of administration of the two medications important?
- Why is the ventrogluteal site recommended for administration?
REKAMBYS 600 mg injectable suspension with prolonged release
rilpivirine
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What REKAMBYS is and what it is used for
- 2. What you need to know before you use REKAMBYS
- 3. How REKAMBYS is administered
- 4. Possible side effects
- 5. How to store REKAMBYS
- 6. Contents of the pack and other information
1. What is REKAMBYS and what is it used for
REKAMBYS contains the active substance rilpivirine. It belongs to a group of medicines called
non-nucleoside reverse transcriptase inhibitors (NNRTIs), which are used for the treatment
of infection with the human immunodeficiency virus type 1 (HIV-1).
REKAMBYS works together with other medicines against HIV to block the virus's ability to create
more copies of itself. REKAMBYS injections do not cure HIV infection, but help to
reduce the amount of HIV in the body and keep it at a low level. This keeps away damage
to the immune system and the development of infections and diseases associated with AIDS.
REKAMBYS is always administered with another medicine against HIV called
cabotegravir injectable. They are used together in adults and adolescents (at least 12 years of age and weighing
at least 35 kg) with HIV-1 infection already under control.
2. What you need to know before using REKAMBYS
Do not use REKAMBYSif you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Do not use REKAMBYS if you are taking any of the following medicines, as they may affect the activity of REKAMBYS or the other medicine:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for the treatment of epilepsy and prevention of seizures)
- rifabutin, rifampicin, rifapentine (medicines for the treatment of some bacterial infections, such as tuberculosis)
- dexamethasone (a corticosteroid used for various conditions, such as inflammation and allergic reactions) when taken orally or by injection
- products containing St. John's wort ( Hypericum perforatum, a herbal remedy for depression).
If you are taking any of these medicines, talk to your doctor for information about alternative medicines.
Warnings and precautions
Talk to your doctor or pharmacist before using REKAMBYS.
Tell your doctor about your condition
Check the following points and tell your doctor if you fall into any of these conditions.
- Tell your doctor if you suffer from or have suffered from liver problems,including hepatitis B or C, or kidney problems. Your doctor may check the function of your liver or kidneys to decide if you can use REKAMBYS. See “Uncommon side effects” in section 4
- Immediately tell your doctor if you notice the appearance of any symptoms of infection(for example, fever, chills, sweating). In some patients with HIV, inflammation caused by previous infections may appear shortly after starting HIV treatment. These symptoms are believed to be due to an improvement in the body's immune response, allowing it to fight infections that were previously present but did not cause obvious symptoms.
- Immediately tell your doctor if you notice any symptoms, such as muscle weakness, weakness starting in the hands and feet and progressing to the trunk, palpitations, tremor, or hyperactivity. This is because autoimmune diseases (disorders in which the immune system mistakenly attacks the body's healthy tissues) may develop even after you have started taking medicines to treat HIV infection. Autoimmune diseases can occur many months after starting treatment.
- Tell your doctor if you are taking medicines that, you have been told, may cause a life-threatening irregular heartbeat (torsade de pointes).
Reactions to injections
In some people, symptoms of a post-injection reaction have occurred within a few minutes after the injection of rilpivirine. Most symptoms resolved within a few minutes after the injection.
Symptoms of post-injection reactions may include: difficulty breathing, stomach cramps, rash, sweating, numbness of the mouth, feeling of anxiety, feeling of heat, feeling dizzy or feeling faint, changes in blood pressure, and pain (e.g., back and chest). Tell the healthcare professional if you experience these symptoms after receiving the injections.
It is important to keep your appointments
It is important to attend all scheduled appointmentsfor the administration of REKAMBYS, in order to monitor the status of your HIV infection and prevent the disease from worsening. Do not miss any visits, it is very important for the success of the treatment. If you cannot attend a scheduled visit, inform your doctor as soon as possible. Talk to your doctor if you are thinking of stopping treatment. If you have not attended the appointment on the scheduled day for the REKAMBYS injection or if you have stopped REKAMBYS therapy, you will need to take other medicines to treat your HIV infection and to reduce the risk that the virus becomes resistant when drug levels in your body are too low to treat the HIV infection.
Children
The use of REKAMBYS is not intended for children under 12 years of age or adolescents weighing less than 35 kg, because it has not been studied in these patients.
Other medicines and REKAMBYS
Tell the healthcare professional if you are taking, have recently taken, or might take any other medicines. Some medicines can affect the levels of REKAMBYS in the blood if you are taking these medicines while being treated with REKAMBYS, or REKAMBYS may affect how other medicines work.
REKAMBYS must not be administered with certain medicines (see "Do not use REKAMBYS" in section 2).
The effects of REKAMBYS or other medicines may changeif you use REKAMBYS together with any of the following medicines:
- clarithromycin, erythromycin (antibiotics)
- methadone (used to treat narcotic dependence and withdrawal)
If you are taking any of these medicines, talk to your doctor for information about alternative medicines.
Pregnancy and breastfeeding
If you are pregnant or planning a pregnancy, tell your doctor immediately.
The doctor will consider the benefit and risk for you and your baby resulting from the use of REKAMBYS during pregnancy. If you are planning a pregnancy, talk to your doctor beforehand, because rilpivirine may remain in the body for up to 4 years after the last REKAMBYS injection.
Breastfeeding is not recommended for HIV-positive women as HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or thinking about breastfeeding, you should talk to your doctor as soon as possible.
Driving and operating machinery
Some patients may experience fatigue, dizziness, or drowsiness during treatment with REKAMBYS. Do not drive vehicles or operate machinery if you experience any of these side effects.
REKAMBYS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. essentially “sodium-free”.
3. How REKAMBYS is administered
REKAMBYS will be administered to you by a doctor or nurse as an injection into the
muscle of the buttock (intramuscular or i.m. injection).
The injection will be given to you once every month or once every 2 months,together with another
injectable medicine called cabotegravir. Your doctor will explain how often you will be
administered the medicine.
When you start treatment with REKAMBYS, you and your doctor may decide to start
with daily treatment of a 25 mg rilpivirine tablet with a meal and a 30 mg cabotegravir tablet for one monthbefore the first REKAMBYS injection. This period
is called induction period- taking these tablets before the administration of the
REKAMBYS and cabotegravir injections will allow the doctor to assess how suitable these
medicines are for you.
As another option, you and your doctor may decide to start directly with REKAMBYS injections.
If you receive REKAMBYS every month, the treatment will be as follows:
When
MedicineFirst injectionFrom the second injection onwards, every month
Rilpivirina Single 900 mg injection 600 mg via injection every month
Cabotegravir Single 600 mg injection 400 mg via injection every month
If you receive REKAMBYS every 2 months, your treatment will be as follows:
When
MedicineFirst and second injection, one
month apart
From the third injection onwards, every two
months
Rilpivirina Single 900 mg injection 900 mg via injection, every 2 months
Cabotegravir Single 600 mg injection 600 mg via injection, every 2 months
If you miss a REKAMBYS injection
It is important to keep your scheduled appointments to receive the injection. If you miss an
appointment, contact your doctor immediately to schedule a new appointment.
Talk to your doctorif you think you will not be able to attend an appointment to receive the
REKAMBYS injection on the scheduled date. Your doctor may advise you to take tablets until you are
able to receive the REKAMBYS injection again.
If you are given too much REKAMBYS
This is unlikely to happen, because this medicine will be administered to you by a doctor or
a nurse. If you have any concerns, contact your doctor or nurse.
Do not stop using REKAMBYS without first consulting your doctor.
REKAMBYS should be used for the entire period recommended by your doctor. Do not stop this
treatment unless your doctor tells you to.
Low levels of rilpivirine (the active ingredient of REKAMBYS) may remain in the body for up to
4 years after stopping treatment. However, when you have received the last REKAMBYS injection, the low levels of rilpivirine that remain will not act sufficiently against the
virus, which may then become resistant. To keep the HIV-1 infection under control and prevent the
virus from becoming resistant, you must start a different anti-HIV treatment until the
next REKAMBYS injection is due.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following is a list of side effects that have been reported when REKAMBYS is used together with cabotegravir injection.
Very common side effects (affect at least 1 in 10 people)
- headache
- reactions at the injection site: these reactions are generally mild to moderate and have become less frequent over time. Symptoms may include: pain and discomfort, formation of a nodule or hardened mass
- feeling hot/fever (pyrexia), which can occur within a week after the injections.
Common side effects (affect less than 1 in 10 people)
- depression
- anxiety
- abnormal dreams
- difficulty sleeping (insomnia)
- dizziness
- nausea
- vomiting
- stomach pain (abdominal pain)
- abdominal gas (flatulence)
- diarrhoea
- skin rash
- muscle pain (myalgia)
- tiredness (fatigue)
- feeling weak (asthenia)
- feeling generally unwell
- weight gain
- reactions at the injection site - are generally mild to moderate and subside over time. Symptoms may include: redness, itching, swelling, feeling of warmth or bruising (which may include changes in skin colour or a build-up of blood under the skin).
Uncommon side effects (affect less than 1 in 100 people)
- drowsiness
- feeling faint, during or after an injection, with possible fainting
- liver damage (signs may include yellowing of the skin and the white of the eyes, loss of appetite, itching, tenderness to the abdomen, pale stools or unusually dark urine)
- altered liver function test values (increased transaminases)
- increased bilirubin(a substance produced by the liver) in the blood
- reactions at the injection site - are generally mild to moderate and subside over time. Symptoms may include: numbness, minor bleeding, abscess (collection of pus) or cellulitis (feeling of warmth, swelling or redness of the skin).
Other side effects
- severe abdominal pain caused by inflammation of the pancreas (pancreatitis).
The following side effects that can occur with rilpivirine tablets may also occur with REKAMBYS injections.
Very common side effects (affect at least 1 in 10 people)
- increased cholesterol and/or pancreatic amylase in the blood
Common side effects (affect less than 1 in 10 people)
- loss of appetite
- sleep disorders
- depressed mood
- stomach discomfort
- dry mouth
- low number of white blood cells and/or platelets, decrease in hemoglobin values in the blood, increased triglycerides and/or lipase in the blood
Uncommon side effects (affect less than 1 in 100 people)
- signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome, see section 2 for more details)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store REKAMBYS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What REKAMBYS contains
- The active ingredient is rilpivirine. Each 2 mL vial contains 600 mg of rilpivirine.
- The excipients are poloxamer 338, citric acid monohydrate (E330), glucose monohydrate, disodium hydrogen phosphate monohydrate, sodium hydroxide (E524) for pH adjustment and maintaining isotonicity, and water for injections.
Description of the appearance of REKAMBYS and package contents
Long-acting injectable suspension. REKAMBYS is contained in a glass vial. The
package also contains 1 syringe, 1 vial adapter and 1 injection needle.
Marketing authorization holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:
België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0) 10 85 65 00
Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88
[email protected]
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]
Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10
[email protected]
Nederland
ViiV Healthcare BV
Tel: + 31 (0) 33 2081199
Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel: +372 617 7410
[email protected]
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
[email protected]
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
[email protected]
Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA
Tel: + 351 21 094 08 01
[email protected]
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]
România
Johnson & Johnson Rom ânia SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]
Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
ViiV Healthcare S.r.l
Tel: +39 045 7741600
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]
Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.
The following information is intended exclusively for healthcare professionals:
Instructions for use for the injection of REKAMBYS 2 mL:
General description
A complete dose requires two injections:
2 mL of cabotegravir and 2 mL of rilpivirine.
Cabotegravir and rilpivirine are suspensions that do not require further dilution or
reconstitution operations. The preparation procedure is identical for both medicinal products. Follow these
instructions carefully when preparing the suspension for injection to avoid liquid leakage.
Cabotegravir and rilpivirine are for intramuscular use only. Both injections must
be administered in separate injection sites in the gluteal muscles.
Note:the ventrogluteal site is recommended. The order of administration is not
important.
Storage information
- Store in a refrigerator at a temperature between 2 °C and 8 °C. Do notfreeze.
Package contents
- 1 vial of rilpivirine
- 1 vial adapter
- 1 syringe
- 1 syringe needle (23 G, 1½ inches)
Consider the patient's body type and, based on your clinical judgment, select an injection needle of the appropriate length.
Rilpivirine vialVial adapter
Vial
capsule
(rubber stopper
under the
capsule)
SyringeInjection needle
Plunger
Needle cap
Needle cap
Additional materials required
- Non-sterile gloves
- 2 alcohol swabs
- 2 gauze pads
- A suitable sharps container
1 x 2 mL cabotegravir pack
Make sure you have the closed cabotegravir pack on hand before you start.
Preparation
1. Inspect the vial
- Check that the expiry date has not been exceeded.
- Inspect the vial immediately. If any foreign particulate matter is visible, do not use the medicine.
Check the
expiry date and
the medicine
Do notuse if the expiry date has been exceeded.
2. Wait 15 minutes
- Wait at least 15 minutes before proceeding with the injection, to allow the medicine to reach room temperature.
Wait
15 minutes
3. Shake vigorously
- Holding the vial firmly, shake it vigorously for 10 seconds, as illustrated in the figure.
10
sec.
4. Inspect the suspension
- Turn the vial upside down and check the resuspension, which should have a uniform appearance. If the suspension is not uniform, shake the vial again.
- It is normal to see small air bubbles.
Note:the order of preparation of the vials
is not important.
5. Remove the vial cap
- Remove the cap from the vial.
- Wipe the rubber stopper with an alcohol-soaked swab.
Avoidany contact with the rubber stopper
after disinfection.
6. Open the vial adapter container
- Remove the protective paper from the vial adapter container.
Note: do notremove the adapter from its
container for the next step. The adapter
does notfall out if the container is inverted.
7. Apply the adapter to the vial
- Place the vial on a flat surface.
- Press the adapter against the vial, as illustrated in the figure.
- The adapter should connect to the vial with a snap (“click”).
click
8. Lift the container
- Lift the adapter vial container, as shown.
9. Prepare the syringe
- Remove the syringe from its packaging.
- Draw 1 mL of air into the syringe. This operation will facilitate the aspiration of the liquid in the next step.
10. Connect the syringe
- Hold the vial and its adapter firmly, as illustrated in the figure.
- Screw the syringe onto the vial adapter tightly.
11. Press the plunger
- Press the plunger all the way down, introducing air into the vial.
12. Slowly draw up the dose
- Invert the syringe and vial, then slowly draw up as much liquid as possible into the syringe. The liquid contained in the vial may be greater than the prescribed dose.
Note:keep the syringe in a vertical position
to avoid liquid leakage.
13. Unscrew the syringe
- Hold the syringe plunger firmly in position as shown to prevent leakage of liquid. It is normal to feel some back pressure.
- Detach the syringe by unscrewing it from the vial adapter and holding the adapter as illustrated in the figure.
Note:check that the suspension has a
uniform appearance and a milky white
color.
14. Connect the needle
- Partially open the packaging containing the needle so as to expose only the base.
- Holding the syringe in a vertical position, firmly insert it into the needle with a rotating movement.
- Remove the packaging from the needle.
Injection
15. Prepare the injection site
Injections must be performed in the
gluteal site. Choose one of the following areas where
to perform the injection:
- ventrogluteal (recommended site)
- dorsogluteal (upper outer quadrant)
Note:perform the injection exclusively
by the intramuscular route in the gluteal site.
Do notinject intravenously.
Dorsogluteal
Ventrogluteal
16. Remove the cap
- Fold the needle cover outwards, away from the needle.
- Remove the cap from the injection needle.
17. Remove excess liquid
- Hold the syringe with the needle pointing upwards. Press the plunger up to the 2 mL dose mark to remove excess liquid and any air bubbles.
Note:disinfect the injection site with a
swab soaked in alcohol. Allow the
skin to air dry before proceeding.
2 ml
18. Stretch the skin
Adopt the z-track injection technique to
minimize the risk of medication leakage from the injection site.
2.5 cm
- Firmly stretch the skin covering the injection site, shifting it by approximately 2.5 cm.
- Keep the skin in this position to administer the injection.
19. Insert the needle
- Insert the needle to its full length or to a depth sufficient to reach the muscle.
20. Inject the dose
- Continuing to hold the skin taut, slowly press the plunger all the way down.
- Ensure that the syringe is empty.
- Withdraw the needle and immediately release the skin.
21. Examine the injection site
- Apply pressure to the injection site with a gauze pad.
- In case of bleeding, a bandage may be applied.
Do notmassage the area.
22. Avoid needle stick injuries
- Fold the needle cover over the needle.
- Apply gentle pressure to the needle cover, pushing it against a hard surface, to lock it into position.
- The needle cover locks with a “click”.
click
After the injection
23. Dispose of safely
- Dispose of used needles, syringes, vials and adapters in accordance with local health and safety regulations.
Repeat the procedure for the second medicine
If cabotegravir has not yet been injected,
follow the relevant specific instructions for use
for the preparation and injection of the medicine.
Repeat all the
steps for the
second
medicine
Questions and Answers
1. For how long can the medicine be left out of the refrigerator?
The best thing to do is to inject the medicine as soon as it has reached room temperature. However, the vial can still remain in its packaging at room temperature (maximum 25 °C) for up to 6 hours.
Do not return it to the refrigerator. If not used within 6 hours, the vial must be discarded.
2. For how long can the medicine be left in the syringe?
The best thing to do is to inject the medicine (at room temperature) as soon as possible after drawing it up from the vial. However, the medicine can remain in the syringe for up to 2 hours before performing the injection.
If the 2-hour period is exceeded, the medicine, syringe and needle must be discarded.
3. Why is it necessary to inject air into the vial?
Introducing 1 mL of air into the vial facilitates the subsequent aspiration of the dose into the syringe.
Without air, some of the liquid could unintentionally flow back into the vial, leaving in the syringe
a quantity of liquid less than necessary.
4. Is the order of administration of the two drugs important?
No, the order is not important.
- 5.Is there anything you can do to warm the vial to room temperature more quickly?The best thing to do is to let the vial reach room temperature spontaneously. To speed up the warming process, you can use the heat of your hands, ensuring however that the temperature of the vial does not exceed 25 °C. Do not use any other heating method.
6. Why is the ventrogluteal site recommended for administration?
The ventrogluteal approach, in the gluteus medius muscle, is recommended because this area is located
away from major nerves and blood vessels. The dorsogluteal approach, in the gluteus maximus muscle, is
acceptable, if preferred by the healthcare professional. The injection must not be performed in any other
site.
REKAMBYS 900 mg prolonged-release injectable suspension
rilpivirine
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you get any side effects, see your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What REKAMBYS is and what it is used for
- 2. What you need to know before you use REKAMBYS
- 3. How REKAMBYS is administered
- 4. Possible side effects
- 5. How to store REKAMBYS
- 6. Contents of the pack and other information
1. What is REKAMBYS and what is it used for
REKAMBYS contains the active substance rilpivirine. It belongs to a group of medicines called
non-nucleoside reverse transcriptase inhibitors (NNRTIs), which are used for the treatment
of infection with the human immunodeficiency virus type 1 (HIV-1).
REKAMBYS works together with other medicines against HIV to block the virus's ability to create
more copies of itself. REKAMBYS injections do not cure HIV infection, but help to
reduce the amount of HIV in the body and keep it at a low level. This keeps the damage
to the immune system at bay and prevents the development of infections and diseases associated with AIDS.
REKAMBYS is always administered with another medicine against HIV called
cabotegravir injectable. They are used together in adults and in adolescents (at least 12 years of age and at least
35 kg in weight) with HIV-1 infection already under control.
2. What you need to know before using REKAMBYS
Do not use REKAMBYSif you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Do not use REKAMBYS if you are taking any of the following medicines, as they may affect the activity of REKAMBYS or the other medicine:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for the treatment of epilepsy and prevention of seizures)
- rifabutin, rifampicin, rifapentine (medicines for the treatment of some bacterial infections, such as tuberculosis)
- dexamethasone (a corticosteroid used for various conditions, such as inflammation and allergic reactions) when taken orally or by injection
- products containing St. John's wort ( Hypericum perforatum, a herbal remedy for depression).
If you are taking any of these medicines, talk to your doctor for information about alternative medicines.
Warnings and precautions
Talk to your doctor or pharmacist before using REKAMBYS.
Tell your doctor about your condition
Check the following points and tell your doctor if you fall into any of these conditions.
- Tell your doctor if you suffer from or have suffered from liver problems,including hepatitis B or C, or kidney problems. Your doctor may check the function of your liver or kidneys to decide if you can use REKAMBYS. See “Uncommon side effects” in section 4
- Immediately tell your doctor if you notice the appearance of any symptoms of infection(for example, fever, chills, sweating). In some patients with HIV, inflammation caused by previous infections may appear shortly after starting HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, allowing it to fight infections that were previously present but did not cause obvious symptoms.
- Immediately tell your doctor if you notice any symptoms, such as muscle weakness, weakness starting in the hands and feet and progressing to the trunk, palpitations, tremor, or hyperactivity. This is because autoimmune diseases (disorders in which the immune system mistakenly attacks healthy tissues of the body) may occur even after you have started taking medicines to treat HIV infection. Autoimmune diseases can occur many months after starting treatment.
- Tell your doctor if you are taking medicines that, you have been told, may cause a life-threatening irregular heartbeat (torsade de pointes).
Reactions to injections
In some people, post-injection reaction symptoms have occurred within a few minutes after the injection of rilpivirine. Most symptoms resolved within a few minutes after the injection.
Symptoms of post-injection reactions may include: difficulty breathing, stomach cramps, rash, sweating, numbness of the mouth, feeling of anxiety, feeling of warmth, feeling dizzy or feeling faint, changes in blood pressure, and pain (e.g. back and chest). Tell the healthcare provider if you experience these symptoms after receiving the injections.
It is important to keep your appointments
It is important to attend all scheduled appointmentsfor the administration of REKAMBYS, in order to monitor the status of your HIV infection and prevent the disease from worsening. Do not miss any visits, it is very important for the success of the treatment. If you cannot attend a scheduled visit, inform your doctor as soon as possible. Talk to your doctor if you are thinking of stopping treatment. If you have not attended the appointment on the scheduled day for the REKAMBYS injection or if you have stopped REKAMBYS therapy, you will need to take other medicines to treat the HIV infection and to reduce the risk that the virus becomes resistant when the levels of the drug in your body are too low to treat the HIV infection.
Children
The use of REKAMBYS is not intended for children under 12 years of age or adolescents weighing less than 35 kg, because it has not been studied in these patients.
Other medicines and REKAMBYS
Tell the healthcare professional if you are taking, have recently taken, or might take any other medicines. Some medicines may affect the levels of REKAMBYS in the blood if you are taking these medicines while being treated with REKAMBYS, or REKAMBYS may affect how other medicines work.
REKAMBYS must not be administered with certain medicines (see "Do not use REKAMBYS” in section 2).
The effects of REKAMBYS or other medicines may changeif you use REKAMBYS together with any of the following medicines:
- clarithromycin, erythromycin (antibiotics)
- methadone (used to treat narcotic dependence and withdrawal)
If you are taking any of these medicines, talk to your doctor for information about alternative medicines.
Pregnancy and breastfeeding
If you are pregnant or planning a pregnancy, tell your doctor immediately.
The doctor will consider the benefit and risk for you and your baby from using REKAMBYS during pregnancy. If you are planning a pregnancy, talk to your doctor first, because rilpivirine may remain in the body for up to 4 years after the last REKAMBYS injection.
Breastfeeding is not recommended for women with HIV because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or planning to do so, it is good to talk to your doctor as soon as possible.
Driving and operating machinery
Some patients may experience fatigue, dizziness, or drowsiness during treatment with REKAMBYS. Do not drive vehicles and do not use machinery if you experience any of these side effects.
REKAMBYS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. essentially “sodium-free”
3. How REKAMBYS is administered
REKAMBYS will be administered to you by a doctor or nurse as an injection into the
muscle of the buttock ( intramuscular or i.m. injection).
The injection will be administered once every month or once every 2 months, together with another
injectable medicine called cabotegravir. Your doctor will explain how often you will be
administered the medicine.
When you start treatment with REKAMBYS, you and your doctor may decide to start
with a daily treatment of one 25 mg rilpivirine tablet with a meal and one 30 mg cabotegravir tablet for one monthbefore the first REKAMBYS injection. This period
is called induction period- taking these tablets before the administration of the
REKAMBYS and cabotegravir injections will allow the doctor to assess how well these
medicines are suitable for you.
As another option, you and your doctor may decide to start directly with REKAMBYS injections.
If you receive REKAMBYS every month, the treatment will be as follows:
When
MedicineFirst injectionFrom the second injection onwards, every month
Rilpivirine Single 900 mg injection 600 mg via injection every month
Cabotegravir Single 600 mg injection 400 mg via injection every month
If you receive REKAMBYS every 2 months, your treatment will be as follows:
When
MedicineFirst and second injection, one
month apart
From the third injection onwards, every two
months
Rilpivirine Single 900 mg injection 900 mg via injection, every 2 months
Cabotegravir Single 600 mg injection 600 mg via injection, every 2 months
If you miss an REKAMBYS injection
It is important to keep your scheduled appointments to receive the injection. If you miss an
appointment, contact your doctor immediately to schedule a new appointment.
Talk to your doctorif you think you will not be able to attend an appointment to receive the
REKAMBYS injection on the scheduled date. Your doctor may advise you to take the tablets until
you are able to receive the REKAMBYS injection again.
If you are given too much REKAMBYS
This is unlikely to happen, because this medicine will be administered to you by a doctor or
a nurse. If you have any doubts, contact your doctor or nurse.
Do not stop using REKAMBYS without first consulting your doctor.
REKAMBYS should be used for the entire period recommended by your doctor. Do not stop this
treatment unless your doctor tells you to.
Low levels of rilpivirine (the active ingredient of REKAMBYS) may remain in the body for up to
4 years after stopping treatment. However, when you have received the last REKAMBYS injection, the low levels of rilpivirine that remain will not act sufficiently against
the virus, which may then become resistant. To keep the HIV-1 infection under control and prevent the
virus from becoming resistant, you must start a different anti-HIV treatment until the
next REKAMBYS injection is scheduled.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following is a list of side effects that have been reported when REKAMBYS is used together with cabotegravir injection.
Very common side effects (affecting at least 1 in 10 people)
- headache
- reactions at the injection site: these reactions are generally mild to moderate and become less frequent over time. Symptoms may include: pain and discomfort, formation of a nodule or hardened mass
- feeling hot/fever (pyrexia), which can occur within a week after the injections.
Common side effects (affecting less than 1 in 10 people)
- depression
- anxiety
- abnormal dreams
- difficulty falling asleep (insomnia)
- dizziness
- nausea
- vomiting
- stomach pain (abdominal pain)
- abdominal gas (flatulence)
- diarrhea
- skin rash
- muscle pain (myalgia)
- tiredness (fatigue)
- feeling weak (asthenia)
- general feeling of discomfort
- weight gain
- reactions at the injection site - are generally mild to moderate and subside over time. Symptoms may include: redness, itching, swelling, feeling of warmth, or bruising (which may include changes in skin color or a collection of blood under the skin).
Uncommon side effects (affecting less than 1 in 100 people)
- drowsiness
- feeling faint, during or after an injection, with possible fainting
- liver damage (signs may include yellowing of the skin and the white of the eyes, loss of appetite, itching, tenderness to the abdomen, pale stools, or unusually dark urine)
- altered liver function test values (increased transaminases)
- increased bilirubin(a substance produced by the liver) in the blood
- reactions at the injection site - are generally mild to moderate and subside over time. Symptoms may include: numbness, minor bleeding, abscess (collection of pus), or cellulitis (warmth, swelling, or redness of the skin).
Other side effects
- severe abdominal pain caused by inflammation of the pancreas (pancreatitis).
The following side effects that can occur with rilpivirine tablets may also occur with REKAMBYS injections.
Very common side effects (affecting at least 1 in 10 people)
- increased cholesterol and/or pancreatic amylase in the blood
Common side effects (affecting less than 1 in 10 people)
- loss of appetite
- sleep disorders
- depressed mood
- stomach discomfort
- dry mouth
- low number of white blood cells and/or platelets, decreased hemoglobin levels in the blood, increased triglycerides and/or lipase in the blood
Uncommon side effects (affecting less than 1 in 100 people)
- signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome, see section 2 for more details)
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store REKAMBYS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What REKAMBYS contains
- The active ingredient is rilpivirine. Each 3 mL vial contains 900 mg of rilpivirine.
- The excipients are poloxamer 338, citric acid monohydrate (E330), glucose monohydrate, disodium hydrogen phosphate monohydrate, sodium hydroxide (E524) for pH adjustment and maintaining isotonicity, and water for injections.
Description of the appearance of REKAMBYS and contents of the pack
Prolonged-release injectable suspension. REKAMBYS is contained in a glass vial. The
pack also contains 1 syringe, 1 vial adapter and 1 injection needle.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0) 10 85 65 00
Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88
[email protected]
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]
Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10
[email protected]
Nederland
ViiV Healthcare BV
Tel: +31 (0) 33 2081199
Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel: +372 617 7410
[email protected]
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
[email protected]
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
[email protected]
Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA
Tel: +351 21 094 08 01
[email protected]
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]
România
Johnson & Johnson Rom ânia SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]
Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
ViiV Healthcare S.r.l
Tel: +39 045 7741600
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]
Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, https://www.ema.europa.eu
The following information is intended exclusively for healthcare professionals:
Instructions for use for the injection of REKAMBYS 3 mL:
General description
A complete dose requires two injections:
3 mL of cabotegravir and 3 mL of rilpivirine.
Cabotegravir and rilpivirine are suspensions that do not require further dilution or
reconstitution operations. The preparation procedure is identical for both medicinal products. Follow these
instructions carefully when preparing the suspension for injection to avoid liquid leakage.
Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be
administered in separate injection sites in the gluteal muscles.
Note:the ventrogluteal site is recommended. The order of administration is not
important.
Information for storage
- Store in a refrigerator at a temperature between 2 °C and 8 °C. Do notfreeze.
Contents of the pack
- 1 vial of rilpivirine
- 1 vial adapter
- 1 syringe
- 1 syringe needle (23 G, 1½ inches) Consider the patient's body weight and, based on your clinical judgment, select an injection needle of appropriate length.
Vial adapter
Rilpivirine vial
Vial
cap
(rubber stopper
under the cap)
Syringe
Injection needle
Plunger
Needle cover
Additional materials required
- Non-sterile gloves
- 2 alcohol-soaked swabs
- 2 gauze pads
- A suitable container for sharps
1 pack of 3 mL cabotegravir
Make sure you have the closed pack of cabotegravir at hand before starting.
Preparation
1. Inspect the vial
- Check that the expiry date has not been exceeded.
- Immediately inspect the vial. If any foreign particulate matter is visible, do not use the medicine.
Check the
expiry date and
the medicine
Do notuse if the expiry date has been exceeded.
2. Wait 15 minutes
- Wait at least 15 minutes before proceeding with the injection, to allow the medicine to reach room temperature.
Wait 15 minutes
3. Shake vigorously
- Holding the vial firmly, shake it vigorously for 10 seconds, as illustrated in the figure.
10
sec
4. Inspect the suspension
- Turn the vial upside down and check the resuspension, which should have a uniform appearance. If the suspension is not uniform, shake the vial again.
- It is normal to see small air bubbles.
Note:the order of preparation of the vials
is not important.
5. Remove the vial cap
- Remove the cap from the vial.
- Wipe the rubber stopper with an alcohol-soaked swab.
Avoidany contact with the rubber stopper
after disinfection.
6. Open the vial adapter container
- Remove the protective paper from the vial adapter container.
Note: do notremove the adapter from its
container for the next step. The adapter
does notfall out if the container is inverted.
7. Apply the adapter to the vial
- Place the vial on a flat surface.
- Press the adapter against the vial, as shown in the figure.
- The adapter should connect to the vial with a snap (“click”).
click
8. Lift the container
- Lift the adapter vial container, as shown.
9. Prepare the syringe
- Remove the syringe from its packaging.
- Draw 1 mL of air into the syringe. This operation will facilitate the aspiration of the liquid in the next step.
10. Connect the syringe
- Hold the vial and its adapter firmly, as illustrated in the figure.
- Screw the syringe onto the vial adapter tightly.
11. Press the plunger
- Press the plunger all the way down, introducing air into the vial.
12. Slowly draw up the dose
- Invert the syringe and vial, then slowly draw up as much liquid as possible into the syringe. The liquid contained in the vial may be greater than the prescribed dose.
Note:keep the syringe in a vertical position
to avoid liquid leakage.
13. Unscrew the syringe
- Hold the syringe plunger firmly in position as shown to prevent leakage of liquid. It is normal to feel some back pressure.
- Detach the syringe by unscrewing it from the vial adapter and holding the adapter as illustrated in the figure.
Note:check that the suspension has a uniform appearance and a milky white color.
14. Connect the needle
- Partially open the packaging containing the needle, exposing only the base.
- Holding the syringe in a vertical position, firmly insert it into the needle with a rotating movement.
- Remove the packaging from the needle.
Injection
15. Prepare the injection site
Injections must be performed in the
gluteal area. Choose one of the following areas where
to administer the injection:
- ventrogluteal (recommended site)
- dorso-gluteal (upper outer quadrant)
Note:administer the injection exclusively
intramuscularly in the gluteal area.
Do notinject intravenously.
VentroglutealDorsogluteal
16. Remove the cap
- Fold the needle cover outwards, away from the needle.
- Remove the cap from the injection needle.
17. Remove excess liquid
- Hold the syringe with the needle pointing upwards. Press the plunger up to the 3 mL dose marking to remove excess liquid and any air bubbles.
Note:disinfect the injection site with a
swab soaked in alcohol. Allow
the skin to air dry before proceeding.
3 ml
18. Stretch the skin
Adopt the z-track injection technique to
minimize the risk of medication leakage from the injection site.
2.5 cm
- Firmly stretch the skin covering the injection site, displacing it by approximately 2.5 cm.
- Keep the skin in this position to administer the injection.
19. Insert the needle
- Insert the needle to its full length or to a depth sufficient to reach the muscle.
20. Inject the dose
- While continuing to hold the skin taut, slowly press the plunger all the way down.
- Make sure the syringe is empty.
- Withdraw the needle and immediately release the skin.
21. Examine the injection site
- Apply pressure to the injection site with a gauze pad.
- In case of bleeding, a bandage may be applied.
Do notmassage the area.
22. Avoid needle stick injuries
- Fold the needle cover over the needle.
- Apply slight pressure on the needle cover, pushing it against a hard surface, in order to lock it into position.
- The needle cover locks with a “click”.
click
After the injection
23. Dispose of safely
- Dispose of used needles, syringes, vials and adapters in accordance with local health and safety regulations.
Repeat the procedure for the second medicine
If cabotegravir has not yet been injected,
follow the relevant specific instructions for use
for the preparation and injection of the medicine.
Repeat all the
steps for the
second
medicine
Questions and Answers
1. How long can the medicine be left out of the refrigerator?
The best thing to do is to inject the medicine as soon as it has reached room temperature. However, the
vial can still remain in its packaging at room temperature (maximum 25 °C) for up to 6 hours.
Do not return it to the refrigerator. If not used within 6 hours, the vial must be discarded.
2. How long can the medicine be left in the syringe?
The best thing to do is to inject the medicine (at room temperature) as soon as possible after drawing it
from the vial. The medicine can still remain in the syringe for up to 2 hours before performing
the injection.
If the 2-hour period is exceeded, the medicine, syringe and needle must be discarded.
3. Why is it necessary to inject air into the vial?
Introducing 1 mL of air into the vial facilitates the subsequent aspiration of the dose into the syringe.
Without air, some of the liquid could unintentionally flow back into the vial, leaving in the syringe
a quantity of liquid less than necessary.
4. Is the order of administration of the two medications important?
No, the order is not important.
- 5.Can anything be done to warm the vial to room temperature more quickly?The best thing to do is to let the vial reach room temperature spontaneously. To speed up the warming process, you can use the heat of your hands, ensuring however that the temperature of the vial does not exceed 25 °C.
Do not use any other heating method.
6. Why is the ventrogluteal site recommended for administration?
The ventrogluteal approach, into the gluteus medius muscle, is recommended because this area is located
away from major nerves and blood vessels. The dorsogluteal approach, into the gluteus maximus muscle, is
acceptable, if preferred by the healthcare professional. The injection should not be performed in any other
site.
Не впевнені, чи підходить вам цей лікарський засіб?
Обговоріть симптоми та можливі варіанти лікування з лікарем онлайн.
Виникли питання під час прийому ліків?
Обговоріть свої симптоми та лікування з лікарем онлайн.
- Країна реєстрації
- Лікарська формаProlonged-release injectable suspension, 600 MG
- Код АТХJ05AG05
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до REKAMBYSЛікарська форма: Film-coated tablet, 25 MGДіюча речовина: РилпивиринВиробник: JANSSEN-CILAG INTERNATIONAL N.V.Потрібен рецептЛікарська форма: Film-coated tablet, 600 MGДіюча речовина: ЭфавирензВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецепт
Аналоги REKAMBYS в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог REKAMBYS у Іспанія
Лікарі онлайн щодо REKAMBYS
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на REKAMBYS онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
REKAMBYS не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у REKAMBYS — Рилпивирин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
REKAMBYS виробляється компанією JANSSEN-CILAG INTERNATIONAL N.V.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування REKAMBYS з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати REKAMBYS у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Рилпивирин) включають EDURANT, EFAVIRENTS AUROBINDO, EFAVIRENTS TEVA. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
