RYSTIGGO 140 mg /Ml Injectable Solution

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About the medicine

Інструкція із застосування RYSTIGGO

Зміст інструкції

  1. Rystiggo 140 mg/mL injectable solution
    1. What is Rystiggo and what is it used for
    2. What you need to know before you use Rystiggo
    3. How to use Rystiggo
    4. Possible side effects
    5. How to store Rystiggo
    6. Package Contents and Other Information
    7. Preparation
    8. Preparation of the vial(s) and syringe
    9. Preparation of the infusion
    10. Infusion and Completion

Rystiggo 140 mg/mL injectable solution

rozanolixizumab

Stylized black triangle with the tip pointing downwards on a white background

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 using 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, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
  • If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

  • 1. What Rystiggo is and what it is used for
  • 2. What you need to know before you use Rystiggo
  • 3. How to use Rystiggo
  • 4. Possible side effects
  • 5. How to store Rystiggo
  • 6. Contents of the pack and other information

1. What is Rystiggo and what is it used for

What is Rystiggo
Rystiggo contains the active substance rozanolixizumab. Rozanolixizumab is a monoclonal antibody
(a type of protein) designed to recognize and bind to FcRn, a protein that causes antibodies
of the immunoglobulin G (IgG) class to remain in the body for longer.
In adults, Rystiggo is used in combination with standard therapy for the treatment of generalized Myasthenia
Gravis (gMG), an autoimmune disease that causes muscle weakness and can
involve multiple muscle groups throughout the body. This condition can also cause shortness of
breath, extreme fatigue and difficulty swallowing. Rystiggo is used in adults with
gMG who produce IgG autoantibodies against acetylcholine receptors or muscle-specific
kinase.
In generalized Myasthenia Gravis (gMG), IgG autoantibodies (proteins of the immune system
that attack parts of one's own body) attack and damage the proteins involved in
communication between nerves and muscles, called acetylcholine receptors or muscle-specific
kinase.
By binding to FcRn, Rystiggo reduces the level of IgG antibodies, including IgG autoantibodies,
thus helping to improve the symptoms of the disease.

2. What you need to know before you use Rystiggo

Do not use Rystiggo

  • if you are allergic to rozanolixizumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine if you fall into any of the
following categories:
Myasthenic crisis
Your doctor may not prescribe this medicine if you are using or may need to use a ventilator due to
muscle weakness caused by gMG (myasthenic crisis).
Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
Cases of aseptic meningitis associated with this medicine have been observed. If you develop symptoms of
aseptic meningitis, including severe headache, fever, stiff neck, nausea, vomiting and/or
sensitivity to bright light, contact a doctor immediately.
Infections
This medicine may reduce your natural resistance to infections. Before starting or during
treatment with this medicine, tell your doctor about any symptoms of infection (feeling of
warmth, fever, chills or tremors, cough, sore throat or fever on the lips, these can be signs of
an infection).
Hypersensitivity (allergic reactions)
This medicine contains a protein that, in some people, may cause reactions such as skin rash, swelling or
itching. You will be monitored for any signs of an infusion reaction during treatment and for 15 minutes
afterwards.
Immunizations (vaccinations)
Tell your doctor if you have received a vaccine in the last 4 weeks or if you have a vaccination planned in
the near future.

Children and adolescents
Do not give this medicine to children under 18 years of age because the use of Rystiggo
has not been studied in this age group.

Other medicines and Rystiggo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Taking Rystiggo together with other medicines may reduce the effectiveness of those medicines, including
therapies with antibodies (such as rituximab) or immunoglobulins subcutaneously or intravenously. Other
medicines, including immunoglobulins subcutaneously or intravenously, or procedures such as
plasmapheresis (a process in which the liquid part of the blood, or plasma, is separated from the blood
taken from a person), may compromise the effect of Rystiggo. Tell your doctor if you are
taking or plan to take any other medicines.
Tell your doctor about your treatment with Rystiggo before getting a vaccination. This
medicine may compromise the effect of vaccines. Vaccination with so-called live attenuated or live
vaccines is not recommended during treatment with Rystiggo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
The effects of this medicine in pregnancy are unknown. You should not use this medicine if you are
pregnant or suspect you are pregnant, unless your doctor specifically recommends it.
It is not known whether this medicine passes into breast milk. Your doctor will help you decide whether to
breastfeed and use Rystiggo.

Driving and using machines
It is unlikely that Rystiggo will affect your ability to drive and use machines.

Rystiggo contains proline
Each mL of this medicine contains 29 mg of proline.
Proline may be harmful to patients who suffer from hyperprolinemia, a rare genetic disorder in
which an excess of an amino acid, proline, accumulates in the body.
If you suffer from hyperprolinemia, tell your doctor and do not use this medicine unless your doctor has
recommended it.

Rystiggo contains polysorbate 80
This medicine contains 0.3 mg of polysorbate 80 per mL. Polysorbates can cause
allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Rystiggo

Treatment with Rystiggo will be initiated and supervised by a specialist doctor experienced in the
management of neuromuscular or neuroinflammatory disorders.

How much Rystiggo is given and for how long
You will receive Rystiggo in cycles of 1 infusion per week for 6 weeks.
The doctor will calculate the correct dose for you based on your weight:

  • if you weigh at least 100 kg, the recommended dose is 840 mg per each infusion (6 mL per administration)
  • if you weigh from 70 kg to less than 100 kg, the recommended dose is 560 mg per each infusion (4 mL per administration)
  • if you weigh from 50 kg to less than 70 kg, the recommended dose is 420 mg per each infusion (3 mL per administration)
  • if you weigh from 35 kg to less than 50 kg, the recommended dose is 280 mg per each infusion (2 mL per administration)

The frequency of treatment cycles varies for each patient and the doctor will assess whether and when it is
appropriate to administer a new cycle of treatment.
The doctor will advise you on the duration of treatment with this medicine.

How Rystiggo is given
Rystiggo will be administered by a doctor or nurse.
You may also inject Rystiggo yourself. Together with your doctor or nurse you will decide whether, after
training by a healthcare professional, you will be able to inject the medicine yourself. Another
person can also give you the injections after being trained. Do not administer Rystiggo to yourself or
to others before receiving adequate training.
If you or your caregiver injects Rystiggo, you must read and follow the instructions for
You will receive the medicine in the form of an infusion under the skin (subcutaneous use). The injection is
usually performed in the lower part of the abdomen, below the navel. Injections should not
be performed in areas where the skin is painful, bruised, red or hardened.
Administration is performed using an infusion pump set to a flow rate
up to 20 mL/h.
Administration can also be performed manually (with manual push, i.e. without an infusion pump), at the flow rate most comfortable for you.

If you receive more Rystiggo than you should
If you suspect that you have accidentally received a dose of Rystiggo higher than prescribed, contact
your doctor for advice.

If you forget or miss an appointment for Rystiggo therapy
If you miss a dose, contact your doctor immediately for advice and to schedule another
appointment for a new administration of Rystiggo within 4 days. The next
dose should then be administered according to the original dosing schedule until
completion of the treatment cycle.

If you stop treatment with Rystiggo
Do not stop treatment with this medicine without first talking to your doctor.
Stopping or discontinuing treatment with Rystiggo may cause the reappearance of symptoms of
Generalized Myasthenia Gravis.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Rystiggo the following side effects have been observed, presented in order of decreasing
frequency:

Very common:may affect more than 1 in 10 people

  • Headache (including migraine)
  • Diarrhoea
  • Fever (pyrexia)

Common:may affect up to 1 in 10 people

  • Rapid swelling under the skin in areas such as the face, throat, arms and legs (angioedema)
  • Joint pain (arthralgia)
  • Skin rash, sometimes with red bumps (papular rash)
  • Reaction at the injection site, including rash at the injection site, redness of the skin (erythema), inflammation, discomfort and pain at the infusion site
  • Infections of the nose and throat

Not known(frequency cannot be estimated from available data)

  • reversible non-infectious inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis):
  • headache
  • fever
  • stiff neck
  • nausea
  • vomiting
  • and/or intolerance to bright light

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Rystiggo

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 label of the vial and on the
outer packaging after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Each vial of injectable solution must be used only once (single-use). The unused medicine and waste
derived from such medicine must be disposed of in accordance with local regulations.
Do not use this medicine if you notice that the liquid appears cloudy, contains foreign particles or has
changed colour.
Do not dispose of any medicine in wastewater 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 Rystiggo contains

  • The active substanceis rozanolixizumab. Each mL of solution contains 140 mg of rozanolixizumab. Each vial of 2 mL contains 280 mg of rozanolixizumab. Each vial of 3 mL contains 420 mg of rozanolixizumab. Each vial of 4 mL contains 560 mg of rozanolixizumab. Each vial of 6 mL contains 840 mg of rozanolixizumab.
  • The other ingredientsare: histidine, histidine hydrochloride monohydrate, proline, polysorbate 80 and water for injections. See section 2 Rystiggo contains proline and Rystiggo contains polysorbate 80.

Description of Rystiggo and package contents
Rystiggo is an injectable solution. Each pack contains 1 vial of 2 mL, 3 mL, 4 mL or
6 mL of injectable solution.
Not all vial sizes may be marketed.
The solution ranges from colourless to pale yellow-brown, from clear to slightly opalescent (pearly white).
The devices used for administration must be purchased separately.

Marketing Authorisation Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium

Manufacturer
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00

Lietuva
UAB Medfiles
Tel: + 370 5 246 16 40

България
Ю СИ БИ България ЕООД
Teл.: +359 (0) 2 962 30 49

Luxembourg/Luxemburg
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: +420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: +36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: +45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: +356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: +49 / (0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel: +31 / (0)76-573 11 40

Eesti
OÜ Medfiles
Tel: + 372 730 5415

Norge
UCB Nordic A/S
Tlf: +47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: +30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: +43-(0)1 291 80 00

España
UCB Pharma, S.A.
Tel: +34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: +48 22 696 99 20

France
UCB Pharma S.A.
Tél: +33 / (0)1 47 29 44 35

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: +351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: +40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: +353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: +386 1 589 69 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
UCB s.r.o., organizačná zložka
Tel: +421 (0) 2 5920 2020

Italia
UCB Pharma S.p.A.
Tel: +39 / 02 300 791

Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: +358 9 2514 4221

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 056300

Sverige
UCB Nordic A/S
Tel: +46 / (0) 40 294 900

Latvija
Medfiles SIA
Tel: + 371 67 370 250

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: https://www.ema.europa.eu. Also, links to other websites on rare diseases and related therapeutic
treatments are provided.
--------------------------------------------------------------------------------------------------------------------------

INSTRUCTIONS FOR USE
Rystiggo (rozanolixizumab)
Rystiggo 140 mg/mL solution, for subcutaneous use
Single-dose vial

Before using Rystiggo, read all of the following instructions. Before you use it for the first time, a
doctor or nurse will show you how you can administer Rystiggo to yourself. Another person
may also administer the infusions to you after receiving the necessary training. Do not administer
Rystiggo to yourself or others until you have been shown how to do it. This information
does not replace discussion with your doctor regarding your medical condition or your
treatment.
If you are using an infusion pump (also known as a syringe pump) to administer Rystiggo,
read the instructions provided by your doctor or nurse on how to set up the pump.

Important information you must know before
administering Rystiggo to yourself or others

Medicine vial with cap and a stylized eye on the left observing the vial
  • For subcutaneous use only.
  • Use each vial only once.
  • Check your dose - you may need more than 1 vial to prepare the prescribed dose.
  • Donot use Rystiggo if the expiry date has passed.
  • Before using Rystiggo, check that the dose on the pack (or packs) is the same as the prescribed dose. Donot use if the dose is not the same as the prescription. Contact your doctor or nurse for further steps.
Medicine vial with cap and seal indicated by blue lines and dots to illustrate the components
  • Donot use the vial if the liquid contains visible particles. The medicine should be from colourless to pale yellow-brown, from clear to slightly opalescent (pearly white).
  • Donot shake the vial.
  • Donot use if the vial’s protective cap is missing or damaged. If any of the vials are defective or are without a cap, report it and return it to the pharmacy.
  • If you are using a non-programmable pump, refer to the manufacturer’s instructions for use and your nurse’s information on how to fill the infusion line and set the dose.

How to store Rystiggo

  • Store in a refrigerator (2 °C - 8 °C).
  • Donot freeze.
Medicine vial with cap and hourglass-shaped timer indicating the waiting time for
  • Keep Rystiggo in the original packaging to protect it from light.
  • Remove the pack from the refrigerator before infusion. To make infusion more comfortable, before using this medicine, allow the vial to reach room temperature. This may take 30 to 120 minutes. Do not heat it in any other way.

Keep this medicine out of the sight and reach of
children.
What is in the pack

  • 1 vial of Rystiggo: 2 mL, 3 mL, 4 mL or 6 mL depending on the prescribed dose.

use.

Step-by-step instructions

1. Preparation

Step 1:Gather all necessary materials on a flat and clean work surface:

  • Includedin the Rystiggo package(s): o Rystiggo vial.

Check the dose – you may need more than 1 vial to prepare the prescribed dose.

Package contents: syringe, vial, waste container, patches, cap, needle, connector and protection device for the
  • Not includedin the Rystiggo package:

o Syringe (5-10 mL depending on the prescribed dose).

Prefilled syringe with needle protected by a transparent safety cap

o Transfer needle with an 18G or larger diameter needle or vented vial adapter.
o Infusion line with a 26G or larger diameter needle. The infusion line must be 61 cm or less in length.

Prefilled syringe with needle protected by a transparent safety capPrefilled syringe with needle protected by a transparent safety cap on a white background

o Alcohol-soaked wipes.

Transparent infusion connector with two side openings and a visible locking mechanism

o Adhesive tape or transparent dressing.

Transparent prefilled syringe with visible plunger and metal needle attachedPrefilled syringe with white plunger and metal needle protected by a transparent safety cap

o Plaster.

Prefilled syringe with needle protected by a transparent safety capPrefilled syringe with needle protected by a transparent safety cap

o Sharps container.

Prefilled syringe with needle protected by a transparent safety cap on a white background

o Bowl or paper towel to collect excess liquid when filling the infusion line.
do

o Syringe pump – if using a pump.

The materials shown above are for illustrative purposes only. Specific materials may appear
different.
Step 2:
Clean the work surface and hands

  • Clean the work surface with a disinfectant and wash your hands thoroughly with soap and water or use a hand disinfectant. Dry them with a clean cloth.

2. Preparation of the vial(s) and syringe

Check the dose – more than 1
vial may be needed to prepare the prescribed dose.
Step
3:Remove the protective cap from the
vial(s)

Hand holding a medicinal vial with a grey cap and removing the circular top protectorHand holding a glass vial with a rubber stopper and a transparent plastic adapter for the
  • Remove the protective cap from the vial(s) by holding the edge and lifting it.
  • Clean the rubber stopper with a swab soaked in alcohol. Allow to air dry.
  • Leave the aluminum protection in place.
  • Check the dose - if more than one vial is needed to prepare the prescribed dose, remove all caps and clean the stoppers.

If you are using a vented vial adapter instead of a
transfer needle, you can skip directly to
step 7.

Transparent syringe with a graduated scale from 1 to 5 ml, plunger and metal needle to

Step 4: Attach the transfer needle to the syringe

  • Remove the plastic covers from the syringe and the transfer needle. Do not touch the tip of the syringe or the base of the needle to avoid contamination from germs.
  • With the needle cap still inserted, press or gently rotate the transfer needle onto the syringe until it is firmly connected.
Hand holding a syringe and connecting a needle, with a blue arrow indicating the direction of movement forHand grasping a transparent syringe with needle inserted, blue arrow indicates direction of subcutaneous injection

Step 5: Draw air into the syringe

  • Slowly pull down on the syringe plunger to draw air into the syringe.
  • Fill the syringe with approximately the same amount of air as the amount of medicine contained in the vial.
  • Keep the needle cap inserted during this operation.

Step 6: Remove the needle cap from the transfer
needle

Hand holding a prefilled syringe with needle pointing to
  • Hold the syringe with one hand.
  • With the other hand, hold the needle cap of the transfer needle and pull it off the needle
  • Place the cap on the table to discard it later.
  • Do nottouch the tip of the needle.
  • Do notlet the tip of the needle touch anything after removing the cap.

Step7: Insert the transfer needle or the vented adapter
directly into the vial
Follow the instructions depending on the infusion method you are
using:

Hand holding a syringe above a medicinal vial with needle pointing downwards and blue arrow indicating the direction

Using the transfer needle

  • Place the vial on the table and insert the transfer needle directly through the rubber stopper.

Using the vial adapter

  • Place the vial on the table and insert the vial adapterdirectly through the rubber stopper.
Hand holding a syringe above a vial with needle inserted and blue arrow indicating the downward direction
  • Attach the syringe to the vented vial adapter.

Step 8: Rotate the vial and syringe

Medicinal vial connected to a prefilled syringe with a blue arrow indicating the rotational movement for
  • Now turn the vial and syringe upside down.
  • Keep the transfer needle or vented adapter inside the vial.

If you are using a vented vial adapter, you can
skip directly to step 11.
Step 9: Push the air from the syringe into the vial

Syringe drawing medicine from transparent vial with needle inserted and hand pulling the plunger towards
  • Check that the transfer needle is now pointing upwards and make sure the tip of the needle is in the space above the medicine.
  • Slowly push the syringe plunger upwards to push all the air from the syringe into the vial. Keep your thumb on the syringe plunger at all times - so as not to let air into the syringe.
Prefilled transparent syringe with needle connected and liquid to
  • Keep the tip of the needle in the space above the medicine at all times.
  • Do notintroduce air into the medicine as this could create bubbles.
Hand holding a syringe connected to a medicinal vial with a blue arrow indicating the extraction movement

Step 10: Prepare tofill the syringe

  • Keep your thumb pressed on the syringe plunger. With your other hand, slowly and carefully pull the vial slowly and carefullyupwards so that the tip of the needle is completely covered by the liquid.

Step 11:Fill the syringe with as much
medicine as possible
Check the dose – more than 1 vial may be needed to prepare the
prescribed dose.

  • Now slowly pull the syringe plunger down and fill the syringe with the medicine.

If you are using a
transfer needle to fill the syringe, proceed as follows:

Hand holding a syringe with needle inserted in a medicinal vial with a detailed enlargement of the needle-vial connection and directional arrow

or Continue to slowly and carefully pull the
vial upwards to keep the tip
of the needle completely covered by the liquid.
or Adjust the tip of the needle to keep it in
the liquid. This will allow you to extract as much
medicine as possible from the vial(s).

Prefilled syringe with plunger partially pressed and needle protected by transparent safety cap
  • You should now have more medicine in the syringe than the prescribed dose. This will be adjusted later.

A very small amount of medicine will also remain
that will not be possible to extract from the vial. This will be
discarded with the vial later.
If you are using a vented vial adapter, disconnect the syringe from the vented vial adapter.
Leave the vented adapter in the vial. It can be
discarded at the end of the infusion. You can now skip
directly to step 14.
Step 12: Remove the air from the syringe

Hand holding a syringe ready for
  • If there is space between the liquid in the syringe and the top of the syringe, slowly push the plunger to push the air back into the vial.
  • If you notice air bubbles in the syringe, you can remove them by gently tapping the syringe with your index finger. Now slowly push the plunger to push the air back into the vial.
Hand holding a syringe full of transparent liquid with a graduated scale and needle connected

Step13: Remove the transfer needle from the vial and
from the syringe

Hand holding a syringe with needle inserted in a medicinal vial, blue arrow indicates direction of aspiration
  • Turn the vial and syringe over and place the vial on the work surface.
  • Remove the transfer needle and syringe from the vial by pulling the syringe upwards.
  • Remove the transfer needle from the syringe by pulling or rotating the base of the needle carefully.
Syringe with needle pointing towards a sharps container with a circular opening and blue lid
  • Do nottouch the needle. Do notput the needle cap back on.
  • Dispose of the needle in a sharps container.
  • If you are using a vented vial adapter instead of the needle, you do not need to remove the vented adapter from the vial before discarding it.

Step 14: Recheck the dose

  • If you need to use another vial to prepare the prescribed dose and in order to avoid contamination, repeat steps 4-13 with the same syringe and a new transfer needle or vented adapter.

3. Preparation of the infusion

Step15: Attach the infusion line to the syringe

Syringe with separate needle and transparent extension connected, blue arrow indicates the direction of drug flow
  • During preparation of the infusion line, place the syringe on a clean work surface.
  • Remove the infusion line from the protective bag.
  • Remove the cap from the end of the infusion line by twisting it. Place the cap on the work surface to dispose of it later.
  • Attach the infusion line to the syringe until it is securely connected. Do nottouch the tip of the syringe or the base of the infusion line to avoid contamination from germs.
  • Do notremove the needle cover cap from the needle of the infusion line.

Step 16: Fill the infusion line with the
medication

Hand holding an injection device with a needle and drops of liquid falling into a cylindrical container
  • Make sure you have a bowl or paper towel in front of you that can be used to collect any medication from the infusion line that is not needed.
  • Hold the cap on the needle of the infusion line and keep it above the bowl. Now hold the syringe in a vertical position and fill the infusion line with the medication by gently pushing the syringe plunger.
  • The amount of liquid remaining in the syringe mustcorrespond to the prescribed dose.
  • If using a syringe pump, read the manufacturer's instructions on how to set up and use the pump and fill the infusion line.

Step 17: Choose and prepare the infusion site

Stylized abdomen with belt and buckle, two oval areas highlighted on the flanks and a small circle on the
  • Choose an infusion site: lower right or lower left quadrant of the abdomen, below the navel. or Do notuse an area of skin that:
    • is sore, bruised, red, or hard
    • has scars or stretch marks.
  • Preparation of the infusion site: o Clean the infusion area with an alcohol-soaked wipe and let it air dry.

Step 18: Insert the needle of the infusion line

Hand holding a syringe tilted at 45 degrees while injecting the drug into the skin with a subcutaneous needle enlarged in a circle
  • Carefully remove the needle cover cap from the needle of the infusion line.
  • Fold together the wings of the butterfly and hold them with the thumb and index finger of one hand.
  • With the other hand, pinch the skin between 2 fingers to form a fold.
  • Push the needle into the middle of the skin and push it under the skin.
  • The needle should enter easily. If it resists, you can pull it out slightly.
  • You may use an infusion line without a butterfly needle at the end. The nurse or doctor will explain how to insert the needle.
Rectangular medicinal patch applied to the skin with a small device connected via wires and a side button

Step 19: Secure the needle of the infusion line

  • Use a transparent dressing to keep the needle in place. Some infusion sets include an adhesive.
Gray horizontal line on a white background representing a trace or a straight path
  • You can use adhesive tape to hold the infusion line to the skin.
Black horizontal line on a white background representing a cross-section or schematic diagram

4. Infusion and Completion

Step 20:Start the infusion
Follow the instructions for the infusion method you are
using:
Manual push

or Sit comfortably and press firmly
on the syringe plunger to administer the
medicine.
o The medicine should be administered at a
comfortable rate. Continue to
push until no medicine remains
in the syringe.
o Before and during the infusion, make sure the
infusion line does not twist or kink. If this happens,
the flow of medicine may be interrupted. In
this case, correct the kink in the infusion line and try
again.
o If you experience discomfort or if some of the medicine
flows back into the infusion line, you can push more
slowly.

Syringe pump

  • Before using a syringe pump, make sure you understand the following:

o How to set up the syringe pump (set an
infusion rate of up to 20 mL per hour).
o How to set the occlusion alarm to the maximum
value.
o How to start the syringe pump.
o What the various sounds and alarms of the syringe
pump mean and how to manage them.
o How to stop the syringe pump.

  • When you are ready for the infusion: o Place the syringe in the syringe holder and start the pump following the pump's instructions. o Sit comfortably while the pump administers the medicine. o Before and during the infusion, make sure the infusion line does not twist or kink. If this happens, the flow of medicine may be interrupted. In this case, correct the kink in the infusion line and try again. o At the end, stop the pump following the pump's instructions. o Remove the syringe from the syringe pump.

Note: some medicine will remain in the infusion line. This is normal and can be discarded
in a sharps container.
Step 21: End the infusion and clean up

Vial of medicine, syringe with needle and sharps container with disposal indication via arrow
  • Once the infusion is complete, do nottry to remove the dressing from the needle. Remove them both from the skin and discard them with the syringe in a sharps container.
  • After removing the needle, there may be a drop or two of liquid at the infusion site. This is normal.
  • Dispose of any vials and remaining medicine used in a sharps container.
  • Cover the infusion site with a clean dressing, such as a bandage.
  • Dispose of any other materials used in household waste.

Always keep the sharps container out of sight and reach of children.

Doctor consultation

Не впевнені, чи підходить вам цей лікарський засіб?

Обговоріть симптоми та можливі варіанти лікування з лікарем онлайн.

Medicine questions

Виникли питання під час прийому ліків?

Обговоріть свої симптоми та лікування з лікарем онлайн.

Аналоги RYSTIGGO в інших країнах

Препарати з тією самою діючою речовиною, доступні в інших країнах.

Аналог RYSTIGGO у Іспанія

Лікарська форма: РОЗЧИН ДЛЯ ІН'ЄКЦІЙ, 140 мг/мл
Діюча речовина: rozanolixizumab
Виробник: Ucb Pharma
Потрібен рецепт
Лікарська форма: РОЗЧИН ДЛЯ ІНФУЗІЙ, ЩО ВВОДИТЬСЯ ІН'ЄКЦІЙНО, 10 мг/мл
Діюча речовина: inebilizumab
Виробник: Amgen Europe B.V.
Потрібен рецепт
Лікарська форма: РОЗЧИН ДЛЯ ІН'ЄКЦІЙ, 150 мг
Діюча речовина: natalizumab
Виробник: Biogen Netherlands B.V.
Потрібен рецепт
Лікарська форма: РОЗЧИН ДЛЯ ІНФУЗІЙ, ЩО ВВОДИТЬСЯ ІН'ЄКЦІЙНО, 300 мг
Діюча речовина: ocrelizumab
Виробник: Roche Registration Gmbh
Потрібен рецепт
Лікарська форма: РОЗЧИН ДЛЯ ІНФУЗІЙ, ЩО ВВОДИТЬСЯ ІН'ЄКЦІЙНО, 12 мг
Діюча речовина: alemtuzumab
Виробник: Sanofi Belgium
Потрібен рецепт
Лікарська форма: РОЗЧИН ДЛЯ ІН'ЄКЦІЙ, 20 мг
Діюча речовина: ofatumumab
Виробник: Novartis Europharm Limited
Потрібен рецепт

Лікарі онлайн щодо RYSTIGGO

Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.

Лікар
5.0(2)

Наталія Бессоліцина

Ревматологія26 років досвіду

Наталія Бессоліцина — лікарка-ревматолог вищої категорії з великим клінічним досвідом. Вона спеціалізується на діагностиці, лікуванні та довгостроковому супроводі пацієнтів із захворюваннями суглобів, хребта та системними аутоімунними порушеннями. Проводить онлайн-консультації відповідно до міжнародних стандартів і принципів доказової медицини.

З якими симптомами та діагнозами звертаються:

  • Біль у суглобах (гострий, хронічний, рецидивний).
  • Запальні артрити: ревматоїдний артрит, псоріатичний артрит, поліартрит.
  • Обмінні порушення: подагра, подагричний артрит.
  • Захворювання хребта: анкілозуючий спондиліт (хвороба Бехтерєва).
  • Дегенеративні зміни: остеоартроз, гонартроз, коксартроз, плечолопатковий періартрит.
  • Системні захворювання: червоний вовчак, склеродермія, васкуліти.
  • Остеопороз та підвищена ламкість кісток.

Лікарка надає розгорнуті рекомендації щодо лікування, обстежень та профілактики загострень. У своїй практиці Наталія Бессоліцина поєднує доказову медицину з персоналізованим підходом — враховуючи перебіг захворювання, спосіб життя пацієнта та його цілі щодо якості життя.

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Отримайте рецепт на RYSTIGGO онлайн

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Часті запитання

Чи потрібен рецепт для RYSTIGGO?

RYSTIGGO потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.

Яка діюча речовина у RYSTIGGO?

Діюча речовина у RYSTIGGO — Розаноликсизумаб. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.

Хто виробляє RYSTIGGO?

RYSTIGGO виробляється компанією UCB PHARMA S.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.

Які лікарі можуть оцінити застосування RYSTIGGO онлайн?

Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування RYSTIGGO з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.

Як купити RYSTIGGO у Польщі?

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 RYSTIGGO у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.

Щоб отримати рецепт, ви можете скористатися Oladoctor:

Які є альтернативи RYSTIGGO?

Інші препарати з тією самою діючою речовиною (Розаноликсизумаб) включають BENLYSTA, BRIUMVI, ENTYVIO. 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.

Будьте в курсі новин Oladoctor

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