ABRYSVO 0.5 ml Powder and solvent for injectable solution

Зміст інструкції

1. Abrysvo powder and solvent for injectable solution
   1. What is Abrysvo and what is it used for
   2. What you need to know before you receive Abrysvo
   3. How Abrysvo is administered
   4. Possible side effects
   5. How to store Abrysvo
   6. Content of the pack and other information

Abrysvo powder and solvent for injectable solution

Vaccine for the respiratory syncytial virus (bivalent, recombinant)

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 medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before receiving this vaccine 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.
• If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Abrysvo and what is it used for

Abrysvo is a vaccine to prevent lung (respiratory tract) disease caused by a virus
called respiratory syncytial virus (RSV). Abrysvo is administered to:

• pregnant women to protect their newborns from birth up to 6 months of age or
• individuals aged 18 years and older.

RSV is a common virus that, in most cases, causes mild, flu-like symptoms,
such as sore throat, cough, or stuffy nose. However, in young children, RSV can cause serious
lung problems. In the elderly and individuals with chronic diseases, RSV can worsen
diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure
(CHF). In the most severe cases, RSV may require hospitalization and, in some cases, can be fatal.

How Abrysvo works
This vaccine helps the immune system (the body's natural defenses) produce antibodies
(substances in the blood that help the body fight infections) that protect against lung disease
caused by RSV. In pregnant women who have been vaccinated between the 24th and 36th
week of pregnancy, these antibodies are transmitted to the newborn through the placenta before
birth, which protects them when they are at highest risk for RSV.

2. What you need to know before you receive Abrysvo

Abrysvo should not be given to you

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive this vaccine

• if you have previously had a severe allergic reaction or breathing problems after receiving an injection of any other vaccine or after you were given Abrysvo in the past;
• if the idea of receiving the vaccine makes you feel nervous or if you have previously fainted after an injection. Fainting can occur before or after any injection;
• if you have an infection with a high fever. In this case, vaccination will be postponed. You do not need to postpone vaccination for a minor infection, such as a cold, however, it is advisable to consult your doctor;
• if you suffer from bleeding problems or if you bruise easily;
• if your immune system is weakened, which may prevent you from getting the maximum benefit from Abrysvo;
• if you are less than 24 weeks pregnant.

If any of the above conditions apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before receiving Abrysvo.
As with all vaccines, Abrysvo may not fully protect all vaccinated people.

Children and adolescents
Abrysvo is not recommended in children and young people under 18 years of age, except for adolescents during pregnancy (see “Pregnancy” section below).

Other medicines and Abrysvo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine or if you have recently received another vaccine.
Abrysvo can be given at the same time as an influenza vaccine or a COVID-19 vaccine. An interval of at least two weeks is recommended between vaccination with Abrysvo and vaccination with a tetanus, diphtheria and acellular pertussis (pertussis) vaccine.

Pregnancy and breastfeeding
Pregnant women can receive this vaccine in the late second or third trimester (weeks 24 to 36). If you are breastfeeding, ask your doctor or nurse for advice before you receive this vaccine.

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

Abrysvo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

Abrysvo contains polysorbate 80
A dose of Abrysvo contains 0.08 mg of polysorbate 80. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Abrysvo is administered

You will be given an injection of 0.5 mL into a muscle in the upper arm.
If you have any questions about the use of Abrysvo, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everyone will experience them.

Serious side effects
Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions: signs of a severe allergic reaction include swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, and dizziness. See also section 2.
• Guillain-Barré syndrome (a neurological disorder that usually begins with tingling and weakness in the limbs and can progress to paralysis of part or all of the body).

Tell your doctor immediately if you notice signs of these serious side effects.

The following side effects have been reported in pregnant women
Very common(may affect more than 1 in 10 people)

• pain at the injection site
• headache
• muscle pain (myalgia)

Common(may affect up to 1 in 10 people)

• redness at the injection site
• swelling at the injection site

Rare(may affect up to 1 in 1,000 people)

• allergic reactions such as rash or hives
• swelling of the glands (lymphadenopathy)

No side effects have been reported in infants born to vaccinated mothers.

The following side effects have been reported in subjects aged 18 years and over
Very common(may affect more than 1 in 10 people)

• fatigue
• headache
• pain at the injection site
• muscle pain (myalgia)

Common(may affect up to 1 in 10 people)

• joint pain (arthralgia)
• redness at the injection site
• swelling at the injection site

Uncommon(may affect up to 1 in 100 people)

• fever (pyrexia)

Rare(may affect up to 1 in 1,000 people)

• allergic reactions such as rash or hives
• swelling of the glands (lymphadenopathy)
• bruising at the injection site (hematoma)
• itching at the injection site (pruritus)

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions (see above “Serious side effects”)
• Guillain-Barré syndrome (see above “Serious side effects”).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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 Abrysvo

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 package and label after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ºC–8 ºC).
Do not freeze. Discard if the package has been frozen.
After reconstitution Abrysvo must be administered immediately or within 4 hours if
stored at a temperature between 15 °C and 30 °C. Do not freeze.

6. Content of the pack and other information

What Abrysvo contains
The active ingredients are:
RSV subgroup A prefusion stabilized F antigen 60 micrograms
RSV subgroup B prefusion stabilized F antigen 60 micrograms
(RSV Antigens)
Prefusion-stabilized F glycoprotein
produced in Chinese hamster ovary cells using recombinant DNA technology.
The other ingredients are:
Powder

• trometamol
• trometamol hydrochloride
• sucrose
• mannitol (E421)
• polysorbate 80 (E433)
• sodium chloride
• hydrochloric acid Solvent
• water for injections

Description of the appearance of Abrysvo and contents of the pack
Abrysvo is supplied in the form of:

• a white powder in a glass vial
• a solvent to dissolve the powder contained in a pre-filled syringe or in a vial

After dissolving the powder in the solvent, the solution is clear and colourless.
Abrysvo is available in the following pack sizes:

• a box containing 1 vial of powder, 1 pre-filled syringe of solvent and 1 vial adapter, with 1 needle or without needles (pack of 1 dose).
• A box containing 5 vials of powder, 5 pre-filled syringes of solvent and 5 vial adapters, with 5 needles or without needles (pack of 5 doses).
• A box containing 10 vials of powder, 10 pre-filled syringes of solvent and 10 vial adapters, with 10 needles or without needles (pack of 10 doses).
• A box containing 5 vials of powder and 5 vials of solvent (pack of 5 doses).
• A box containing 10 vials of powder and 10 vials of solvent (pack of 10 doses).

Not all pack sizes may be marketed.

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
Pfizer Ireland Pharmaceuticals
Grange Castle Business Park
Clondalkin, Dublin 22
Ireland
For further information on this medicine, contact the local representative of the marketing authorisation
holder:

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

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

България
Пфайзер Люксембург САРЛ,
Клон България
Teл: +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 A.E.
Τηλ.: +30 210 6785800

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

España
Pfizer, S.L.
Télf: +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

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

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

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

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

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

Ísland
Icepharma hf.
Simi: + 354 540 8000

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

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

Kύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Tηλ: +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 website of the European Medicines
Agency, https://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
medicine administered must be clearly recorded.
Administration
Abrysvo is for intramuscular use only.
The unopened vial is stable for 5 days if stored at temperatures between 8 °C and 30 °C.
After this period Abrysvo must be used or discarded. This information
constitutes guidelines for healthcare professionals only in case of temporary temperature excursions.
Reconstituted vaccine storage
Abrysvo must be used immediately after reconstitution or within 4 hours. Store the
reconstituted vaccine at a temperature between 15 ºC and 30 ºC. Do not freeze the
reconstituted vaccine.
Chemical and physical stability during use has been demonstrated for 4 hours at a temperature between
15 °C and 30 °C. From a microbiological point of view, the product should be used immediately.
If not, the storage times and conditions before use are the responsibility
of the user.
Preparation for administration

For use of the antigen vial for Abrysvo (powder), pre-filled solvent syringe and vial
adapter

for vial
The powder must only be reconstituted with the solvent supplied in the pre-filled syringe
using the vial adapter.

Vial containing the
antigens for Abrysvo
(powder)
Adapter
for
vial
Pre-filled syringe containing the solvent for
Abrysvo

Syringe
cap
Luer Lock adapter Vial cap (with removable
cap removed)

Step 1. Connect the vial adapter

• Remove the top cover from the vial adapter packaging and remove the removable cap from the vial.
• Keeping the vial adapter in its packaging, center it on the vial cap and connect it by pushing down. Do not push the vial adapter at an angle as this may cause leaks. Remove the packaging.

Step 2. Reconstitute the powder component (antigens) to prepare Abrysvo

• For all syringe assembly steps, hold the syringe only by the Luer Lock adapter to prevent it from detaching during use.
• Rotate the syringe cap to remove it, then continue to rotate to connect the syringe to the vial adapter. Stop rotating when you feel resistance.
• Inject the entire contents of the syringe into the vial. Hold the plunger down and gently rotate the vial until the powder is completely dissolved. Do not shake.

Step 3. Draw up the reconstituted vaccine

• Completely invert the vial and slowly draw up the entire contents into the syringe to ensure a dose of 0.5 mL of Abrysvo.
• Rotate to disconnect the syringe from the vial adapter.
• Attach a sterile needle suitable for intramuscular injection.

The prepared vaccine appears as a clear and colourless solution. Visually inspect the vaccine for
large particulate matter and colour changes before administration. Do not use if any of these
characteristics are observed.

For use of the Abrysvo (powder) antigen vial and solvent vial
The powder must only be reconstituted with the supplied solvent vial.

• 1. Using a sterile needle and syringe, draw up the entire contents of the solvent vial and inject the entire contents of the syringe into the vial containing the powder.
• 2. Gently rotate the vial in a circular motion until the powder is completely dissolved. Do not shake.
• 3. Draw up 0.5 mL from the vial containing the reconstituted vaccine.

The prepared vaccine appears as a clear and colourless solution. Visually inspect the vaccine for
large particulate matter and colour changes before administration. Do not use if any of these
characteristics are observed.
Disposal
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.

ANNEX IV
CONCLUSIONS RELATING TO THE REQUEST FOR ANNUAL PROTECTION OF
COMMERCIAL PROPERTY PRESENTED BY THE EUROPEAN MEDICINES
AGENCY
Conclusions presented by the European Medicines Agency on:

• one-year protection of commercial property

In view of the provisions contained in Article 14(11) of Regulation 726/2004/EC, the
Committee for Human Medicinal Products (Committee for Human Medicinal Products,CHMP) has
examined the data submitted by the marketing authorisation holder, and considers that
the new therapeutic indication provides a clinically relevant benefit compared to existing therapies,
as further described in the European Public Assessment Report (European

Public Assessment Report, EPAR).