SOMAVERT 10 mg Powder And Solvent For Injectable Solution

Зміст інструкції

1. SOMAVERT 10 mg powder and solvent for injectable solution, 15 mg powder and solvent for injectable solution, 20 mg powder and solvent for injectable solution, 25 mg powder and solvent for injectable solution, 30 mg powder and solvent for injectable solution
   1. What is SOMAVERT and what is it used for
   2. What you need to know before using SOMAVERT
   3. How to use SOMAVERT
   4. Possible side effects
   5. How to store SOMAVERT
   6. Package contents and other information
   7. You will need
   8. Preparation
   9. Choose the injection area
   10. Remove the vial cap
   11. Remove the syringe cap
   12. Insert the safety needle
   13. Remove the needle cover
   14. Insert the needle
   15. Add the liquid
   16. Rotate the vial
   17. Check the medicine
   18. Reposition the needle
   19. Aspirate the dose
   20. Insert the needle
   21. Inject the medication
   22. Secure the needle
   23. Disposal
   24. After the Injection

SOMAVERT 10 mg powder and solvent for injectable solution, 15 mg powder and solvent for injectable solution, 20 mg powder and solvent for injectable solution, 25 mg powder and solvent for injectable solution, 30 mg powder and solvent for injectable solution

pegvisomant
Read this leaflet carefully before you start 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is SOMAVERT and what is it used for

SOMAVERT is used for the treatment of acromegaly, a hormonal disorder caused by increased
secretion of growth hormone (GH) and IGF-I (insulin-like growth factors), which is
characterized by excessive bone growth, swelling of soft tissues, heart disease and related
disorders.
The active ingredient of SOMAVERT, pegvisomant, is known as a growth hormone receptor antagonist. These substances reduce the action of GH and levels of IGF-1 in the bloodstream.

2. What you need to know before using SOMAVERT

Do not use SOMAVERT

• If you are allergic to pegvisomant 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 SOMAVERT.

• If you experience vision disturbances or headache, you should contact your doctor immediately.
• The doctor or nurse will monitor the levels of IGF-I (insulin-like growth factors) in your blood and, if necessary, will adjust the dose of SOMAVERT.
• The doctor must also monitor your adenoma (benign tumor).
• The doctor will perform tests of your liver function before starting and during treatment with SOMAVERT. If the results of these tests are abnormal, the doctor will discuss treatment options with you. After starting treatment, the doctor or nurse will check the level of liver enzymes in the blood every 4-6 weeks for the first 6 months of treatment with SOMAVERT. The administration of SOMAVERT must be stopped if signs of liver disease persist.
• If you have diabetes, your doctor may need to adjust the amount of insulin or other medicines you are taking.
• In patients, fertility may increase as the disease improves. The use of this medicine is not recommended in pregnant women and women of childbearing potential should be informed of the need to use a contraceptive method. See also below the section on Pregnancy.

Other medicines and SOMAVERT
Tell your doctor if you have previously used other medicines for the treatment
of acromegaly or diabetes.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
During treatment, you may be given other medicines. It is important to continue to
use all medicines, as well as SOMAVERT, unless otherwise advised by your doctor, pharmacist
or nurse.

Pregnancy, breastfeeding and fertility
The use of SOMAVERT in pregnant women is not recommended. Women of childbearing potential should
use a contraceptive method during treatment.
It is not known whether pegvisomant is excreted in breast milk. Do not breastfeed while you are being treated
with SOMAVERT unless you have discussed this with your doctor first.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
No studies have been conducted on the ability to drive vehicles and operate machinery.

SOMAVERT contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to use SOMAVERT

Inject this medicine always following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
An initial dose of 80 mg of pegvisomant will be administered subcutaneously (just under the
skin) by the doctor. Subsequently, the usual daily dose of pegvisomant, which is injected
subcutaneously (just under the skin) is 10 mg.
Every four to six weeks, based on the serum IGF-1 level, the doctor must make appropriate
dose adjustments in increments of 5 mg of pegvisomant/day, to maintain an optimal
therapeutic response.

Method and route of administration
SOMAVERT is injected under the skin. The injection can be self-administered or performed by
another person, for example your doctor or your assistant. Detailed
treatment with this medicine must be followed as instructed by your doctor.
This medicine must be dissolved before use. The solution to be injected must not be
mixed in the same syringe or vial with other medicines.
Skin fatty tissue may accumulate at the injection site. To avoid this, a slightly different
area should be used for each injection, as described in Phase 2 of
SOMAVERT”. This will ensure that the skin and underlying area have the necessary recovery time between
injections.
If you feel that the effect of this medicine is too strong or too weak, contact your
doctor, pharmacist or nurse.

If you inject more SOMAVERT than you should
If you have accidentally injected a dose of SOMAVERT greater than that prescribed by your doctor
it is probably not serious, but you should contact your doctor, pharmacist or nurse immediately.

If you forget to use SOMAVERT
If you forget to have the injection, you should inject the next dose as soon as you remember and continue
to inject SOMAVERT as prescribed by your doctor. Do not inject a double dose to
make up for the missed single dose.
If you have any further questions on 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.
Allergic reactions (anaphylactic), from moderate to severe, have been reported in some patients undergoing treatment with SOMAVERT. Symptoms of a severe allergic reaction may include one or more of the following: swelling of the face, tongue, lips or throat; wheezing or difficulty breathing
(laryngeal spasm); widespread rash, hives or itching; or dizziness. Inform
your doctor immediately if you notice any of these symptoms.
Very common (may affect more than 1 in 10 people)

• Headache
• Diarrhoea
• Joint pain

Common (may affect up to 1 in 10 people)

• Shortness of breath.
• Increased levels of substances that measure liver function. These increases can be observed from blood test results.
• Blood in urine.
• Increased blood pressure.
• Constipation, nausea, vomiting, feeling of fullness, indigestion, gas in the intestines.
• Dizziness, drowsiness, uncontrolled tremor, reduced sensitivity to touch.
• Bruising or bleeding at the injection site, pain or swelling at the injection site, accumulation of fat in the area under the skin where the injection was given, swelling of the extremities, weakness, fever.
• Sweating, itching, rash, tendency to bruise.
• Muscle pain, arthritis.
• Increased cholesterol in the blood, weight gain, increased glucose in the blood, decreased glucose in the blood.
• Flu-like syndrome, fatigue.
• Altered dreams.
• Eye pain.

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction after administration (fever, rash, itching and, in severe cases, difficulty breathing, rapid swelling of the skin requiring urgent medical attention). These can occur immediately or several days after administration.
• Protein in urine, increased urine, kidney problems.
• Loss of interest, feeling of confusion, increased sexual drive, panic attacks, memory loss, sleep problems.
• Decreased platelets in the blood, increased or decreased white blood cells in the blood, tendency to bleed.
• Abnormal sensations, impaired healing.
• Eye fatigue, inner ear problems.
• Swelling of the face, dry skin, night sweats, redness of the skin (erythema), raised itchy welts on the skin (urticaria).
• Increased fatty acids in the blood, increased appetite.
• Dry mouth, increased salivation, dental problems, haemorrhoids.
• Altered sense of taste, migraine.

Not known (frequency cannot be estimated from available data)

• Anger.
• Severe dyspnoea (laryngospasm).
• Tendency to rapid swelling of the skin and underlying tissue and the inner lining (mucosa) of organs (angioedema).

Approximately 17% of patients during treatment will develop antibodies to the growth hormone.
It appears that the antibodies do not interrupt the activity of this medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 provide more information on the safety of this medicine.

5. How to store SOMAVERT

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 vial and the packaging
after the wording Exp. The expiry date refers to the last day of that month.
Store the vials of powder in a refrigerator (2°C – 8°C) in their packaging to protect the
medicine from light. Do not freeze.
Packages containing the vials of SOMAVERT powder can be stored at room temperature
up to a maximum of 25°C for a period of no more than 30 days. Write the date
of limited use of the vials on the packaging indicating day/month/year, calculating 30 days from
the date of removal from the refrigerator. The vials must be protected from light. Do not put
this medicine back in the refrigerator.
Dispose of this medicine if you do not use it within the use-by date of the vials or within
the expiry date printed on the packaging, if the latter is earlier.
Store the pre-filled syringes at a temperature below 30°C or store in a refrigerator (2°C–8°C).
Do not freeze.
After preparation, the SOMAVERT solution must be used immediately.
Do not use this medicine if you notice that the solution is cloudy or contains particles of material.
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 SOMAVERT contains

• The active ingredient is pegvisomant.
• SOMAVERT 10 mg: one vial of powder contains 10 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of the solution contains 10 mg of pegvisomant.
• SOMAVERT 15 mg: one vial of powder contains 15 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of the solution contains 15 mg of pegvisomant.
• SOMAVERT 20 mg: one vial of powder contains 20 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of the solution contains 20 mg of pegvisomant.
• SOMAVERT 25 mg: one vial of powder contains 25 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of the solution contains 25 mg of pegvisomant.
• SOMAVERT 30 mg: one vial of powder contains 30 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of the solution contains 30 mg of pegvisomant.
• The other ingredients are: glycine, mannitol (E421), disodium phosphate anhydrous and monosodium phosphate monohydrate (see section 2 “SOMAVERT contains sodium”).
• The solvent is water for injections.

Description of the appearance of SOMAVERT and contents of the pack
SOMAVERT consists of a white powder and a solvent for injectable solution (10 mg, 15
mg, 20 mg, 25 mg or 30 mg of pegvisomant in a vial and 1 mL of solvent in a
prefilled syringe). Packs of 1 and/or 30 are available. Not all pack sizes may be
marketed. The powder is white and the solvent is clear and colourless.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: + 36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς Α.Ε.
Τηλ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Ísland
Icepharma hf.
Sími: +354 540 8000

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0)1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/. Also, links to other websites on rare diseases and related therapeutic treatments are provided.
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INSTRUCTIONS FOR USE
SOMAVERT powder in a vial with solvent in a prefilled syringe
pegvisomant for injection
for subcutaneous use only
single-dose vial
SOMAVERT is supplied in a vial as a white layer of powder. Before use,
SOMAVERT must be mixed with a liquid (diluent).
The liquid is supplied in a prefilled syringe labelled “Solvent for SOMAVERT”.
Do not mix SOMAVERT with any other liquid.
It is important that you or someone else administer the injections, unless you have been
adequately instructed by the healthcare professional.
Store the pack of vials in a refrigerator, at a temperature between 2°C and
8°C and protected from direct sunlight. Packs containing vials of SOMAVERT
powder can be stored at room temperature up to a maximum of 25°C for a period
of no more than 30 days. Write the expiry date of the vials on the pack
indicating day/month/year, calculating 30 days from the date of removal from the refrigerator. The vials
must be protected from light. Do not return this medicine to the refrigerator.
Dispose of this medicine if you do not use it within the new expiry date of the vials or
within the expiry date printed on the pack, if the latter is earlier.
The prefilled syringes can be stored at room temperature. Keep out of the reach
of children.

1. You will need

A single pack of SOMAVERT containing:

• a vial of SOMAVERT powder
• a pre-filled syringe with solvent
• a safety needle You will also need:
• a cotton ball
• an alcohol swab
• a needle container

VialVial

Syringe

Safety needle

2. Preparation

Before starting:

• Mix SOMAVERT and the solvent only when you are ready to inject the dose.
• Remove one pack of SOMAVERT from the refrigerator and allow it to reach room temperature naturally in a safe place.
• Wash your hands with soap and water and dry them thoroughly.
• Open the packaging of the syringe and safety needle so that they are easier to take while you prepare for the injection.
• Do not use the syringe or vial if: o they are damaged or defective; o the expiry date has been exceeded. o it has been frozen, even if it is now thawed (syringe only).

3. Choose the injection area

Choose the injection area
3

• For each injection, choose a different point within the area.
• Avoid bruised, reddened, painful or hardened areas and areas with scars or skin diseases.
• Clean the injection area with a swab soaked in alcohol according to the instructions of the healthcare professional.
• Allow the injection area to dry.

4. Remove the vial cap

Remove the cap
of the vial
4

• Remove the cap from the vial.
• Discard the cap, it will no longer be needed. Caution:avoid touching the rubber stopper of the vial.

5. Remove the syringe cap

Remove the
syringe cap
5

• Break the syringe cap. This may require more force than expected.
• Discard the syringe cap, it will no longer be needed.
• Hold the syringe in an upright position to avoid leakage. Caution:avoid touching the end of the syringe once the cap has been removed.

6. Insert the safety needle

Insert the safety needle
6

• Firmly screw the safety needle onto the syringe until it locks into place.

7. Remove the needle cover

Remove the
needle cover
7

• Bend the needle protection to release the needle cover.
• Carefully remove the needle cover.
• Dispose of the needle cover, it will no longer be needed. Caution:avoid contact of the needle with anything.

8. Insert the needle

Insert the needle
8

• Insert the needle through the center of the rubber stopper of the vial as shown in the figure.
• Hold the syringe while the needle is inserted into the rubber stopper of the vial to prevent it from bending.

9. Add the liquid

9Add the liquid

• Tilt the vial and syringe as shown in the figure.
• Push the plunger slowlyuntil all the liquid has been emptied into the vial.
• Caution:do not spray the liquid directly onto the powder as this forms foam. Foam makes the medicine unusable.
• Do not remove the needle yet.

10. Rotate the vial

10Rotate the vial

• Hold the syringe and the vial with one hand as shown in the figure.
• Gently move the liquid with a rotating motion by moving the vial in a circular motion on a flat surface.
• Continue to move the liquid with a rotating motion until the powder has completely dissolved. Note:this may take up to 5 minutes.

11. Check the medicine

11Check the medicine

• With the needle inserted into the vial, carefully check the medicine. It must be clear and free of particles.
• Do not use if: o the medicine is cloudy or not clear; o the medicine has any color; o there are particles or a layer of foam in the vial.

12. Reposition the needle

12Reposition the needle

• Rotate the vial so that the space of the rubber stopper is visible, as shown in the figure.
• Pull the needle down so that the tip is at the lowest point of the liquid. This will help to aspirate as much liquid as possible.
• Check that the plunger has not moved; if so, push it back down to the end of the syringe. This ensures that all air is expelled from the syringe before aspirating the dose.

13. Aspirate the dose

Aspirate the dose
13

• Slowly pull the plunger to aspirate as much medicine as possible from the vial. Note:if air is visible in the syringe, tap the cylinder to allow the air bubbles to rise to the surface and then gently push them into the vial.
• Remove the needle from the vial.

14. Insert the needle

Insert the needle
14

• Gently pinch the skin at the injection site.
• Insert the needle completely into the skin.

15. Inject the medication

15Inject the medication

• Push the plunger slowly until the syringe is empty. Note:make sure the needle is always fully inserted.
• Release the skin and remove the needle.

16. Secure the needle

Secure the needle
16

• Fold the needle shield over the needle.
• Apply gentlepressure using a hard surface to close the needle shield. Note:You will hear a click when the needle shield is closed.

17. Disposal

Disposal
17

• The syringe and needle must NEVERbe reused. Dispose of the needle and syringe according to the instructions of your doctor, nurse, or pharmacist and in accordance with local health and safety regulations.

18. After the Injection

After the Injection
18

• If necessary, use a clean cotton ball and gently press on the injection area.
• Do not rub the area.

QUESTIONS AND ANSWERS
What should I do if I accidentally touch the rubber stopper of the vial?

• Clean the rubber stopper of the vial with a new alcohol wipe and allow it to dry completely. If you are unable to clean the rubber stopper, do not use the vial.

What should I do if the syringe has fallen?

• Do not use it, even if it does not appear damaged. Dispose of the syringe as you would a used syringe. You will need another syringe.

How many times can I insert the needle into the rubber stopper of the vial?

• Only once. Removing and reinserting the needle greatly increases the risk of damaging it. This can cause discomfort and increases the risk of damaging and infecting the skin. There is also a risk of losing some of the medicine.

Can I shake the vial if the powder does not dissolve?

• No, do not shake the vial under any circumstances. Shaking it can destroy the medicine and create foam. It may take a few minutes for the powder to dissolve completely. Continue to gently move the vial with a rotating motion until the liquid is completely clear.

How can I tell if there is foam in the vial?

• Foam is a mass of small bubbles that form a floating layer on the surface of the liquid. Do not inject SOMAVERT if it is foamy.

How can I prevent foam from forming?

• Press the plunger very slowly so that the liquid gently penetrates inside the vial. Do not spray the liquid directly onto the powder, as this creates foam. This technique will also reduce the rotation time and allow you to draw up more medicine.

Is there air visible in the syringe? Can I use it anyway?

• Tiny air bubbles in the liquid are normal and you can give the injection without problems. However, you may accidentally draw air into the syringe, which must be removed before giving the injection. Bubbles and air that may form on the surface of the liquid must be pushed back into the vial.

Why can't I draw up all the medicine from the vial?

• The vial is shaped in such a way that a very small amount of medicine will remain inside. This is normal. To ensure that only traces of medicine remain, make sure that the tip of the needle is at the lowest point inside the vial while drawing up the dose.

What should I do if I have any doubts about my medicine?

• For any questions, ask your doctor, nurse, or pharmacist who is knowledgeable about SOMAVERT.