Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - abrysvo

Document Subject

Generated Narrative: MedicinalProductDefinition mp0e4b0f32f27cd3409c6b65f9b73ff49f

identifier: http://ema.europa.eu/identifier/EU/1/23/1752/001 – 1 vial, 1 vial adaptor, 1 pre-filled syringe, 1 needle

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Abrysvo powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0e4b0f32f27cd3409c6b65f9b73ff49f

identifier: http://ema.europa.eu/identifier/EU/1/23/1752/001 – 1 vial, 1 vial adaptor, 1 pre-filled syringe, 1 needle

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - abrysvo

Attesters

What is in 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 given
4. Possible side effects
5. How to store Abrysvo
6. Contents of the pack and other information

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

• pregnant individuals to protect their infants from birth through 6 months of age or
• individuals 60 years of age and older.

RSV is a common virus which, in most cases, causes mild, cold-like symptoms such as a sore throat, cough or a blocked nose. However, in young infants RSV can cause serious lung problems. In older adults and people with chronic medical conditions, RSV can worsen illnesses such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). RSV can lead to hospitalisation in severe cases and in some cases it can be fatal.

How Abrysvo works This vaccine helps the immune system (the body s natural defences) to make antibodies (substances in the blood that help the body fight infections) which protect against lung disease caused by RSV. In pregnant individuals who are vaccinated between weeks 24 and 36 of pregnancy, these antibodies are passed to the infant through the placenta before birth which protects infants when they are at most risk from RSV.

Abrysvo should not be given

• if you are allergic to the active substances 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 are given this vaccine

• if you have ever had a severe allergic reaction or breathing problems after you received any other vaccine injection or after you were given Abrysvo in the past.
• if you are feeling nervous about getting the vaccine or have ever fainted after any injection. Fainting can happen before or after any injection
• if you have an infection with a high fever. If this is the case, then vaccination will be postponed. There is no need to delay vaccination for a minor infection, such as a cold, but talk to your doctor first.
• if you have a bleeding problem or bruise easily.
• if you have a weakened immune system which may prevent you from getting the full benefit from Abrysvo.
• if you are less than 24 weeks pregnant.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Abrysvo.

As with any vaccine, Abrysvo may not fully protect all those who receive it.

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

Other medicines and Abrysvo Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.

Abrysvo may be given at the same time as a flu vaccine. A gap of at least two weeks is recommended between administration of Abrysvo and administration of a vaccine against tetanus, diphtheria and acellular pertussis (whooping cough).

Pregnancy and breast-feeding Pregnant individuals can be given this vaccine in the late second or third trimester (weeks 24 to 36). Talk to your doctor or nurse for advice before getting this vaccine if you are breast-feeding.

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

Abrysvo contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

You will be given one injection of 0.5 mL into a muscle of your upper arm.

If you have any questions on the use of Abrysvo, ask your doctor, pharmacist or nurse.

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

Serious side effects

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

• Guillain-Barr syndrome (a neurological disorder that usually starts with pins and needles and weakness of the limbs and may progress up to paralysis of part or all of the body).

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

• allergic reactions - signs of an allergic reaction include swelling of the face, lips, tongue or throat, hives, difficulty breathing or swallowing and dizziness. See also section 2. Tell your doctor immediately if you notice signs of these serious side effects.

The following side effects were reported in pregnant individuals

Very common (may affect more than 1 in 10 people)

• pain where the injection is given
• headache
• muscle pain (myalgia).

Common (may affect up to 1 in 10 people)

• redness where the injection is given
• swelling where the injection is given.

No side effects were reported in infants born to vaccinated mothers.

The following side effects were reported in individuals 60 years of age and older

Very common (may affect more than 1 in 10 people)

• pain where the injection is given

Common (may affect up to 1 in 10 people)

• redness where the injection is given
• swelling where the injection is given.

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

• Guillain-Barr syndrome (see Serious side effects, above).

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

• allergic reactions (see Serious side effects, above).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C).

Do not freeze. Discard if the carton has been frozen.

After reconstitution Abrysvo should be administered immediately or within 4 hours if stored between 15 C and 30 C. Do not freeze.

What Abrysvo contains

The active substances are: RSV subgroup A stabilised prefusion F antigen1,2 60 micrograms RSV subgroup B stabilised prefusion F antigen1,2 60 micrograms (RSV antigens) 1glycoprotein F stabilised in the prefusion conformation 2produced in Chinese Hamster Ovary cells by recombinant DNA technology.

The other ingredients are: Powder

• trometamol
• trometamol hydrochloride
• sucrose
• mannitol
• polysorbate * sodium chloride
• hydrochloric acid Solvent
• water for injections

What Abrysvo looks like and contents of the pack

Abrysvo is provided as

• a white powder in a glass vial
• a solvent in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear and colourless. Abrysvo is available in
• a carton containing 1 vial of powder, 1 pre-filled syringe of solvent, 1 vial adaptor, with 1 needle or without needles.
• a carton containing 5 vials of powder, 5 pre-filled syringes of solvent, 5 vial adaptors, with 5 needles or without needles.
• a carton containing 10 vials of powder, 10 pre-filled syringes of solvent, 10 vial adaptors, with 10 needles or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles
Belgium

Manufacturer Pfizer Manufacturing Belgium NV Rijksweg 2870 Puurs-Sint-Amands Belgium

Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin, Dublin Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: + 32 (0)2 554 62 Latvija Pfizer Luxembourg SARL fili le Latvij
Tel.: + 371 670 35
,
Te : +359 2 970 4Magyarorsz g Pfizer Kft Tel: + 36 1 488 37 esk republika Pfizer, spol. s r.o.
Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: + 356 21344Danmark Pfizer ApS Tlf: + 45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15-0

Pfizer A.E. .: +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. T lf: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel.: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. Simi: + 354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l.
Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520 K
Pfizer . . (Cyprus Branch) T : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: + 44 (0) 1304 616This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: