Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vidprevtyn

Document Subject

Generated Narrative: MedicinalProductDefinition mp70fa014e07592e69938a0c03f0ec3015

identifier: http://ema.europa.eu/identifier/EU/1/21/1580/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VidPrevtyn Beta solution and emulsion for emulsion 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

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-70fa014e07592e69938a0c03f0ec3015

identifier: http://ema.europa.eu/identifier/EU/1/21/1580/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - vidprevtyn

Attesters

What is in this leaflet

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

VidPrevtyn Beta is a vaccine used for preventing COVID-19. VidPrevtyn Beta is given to adults who previously received either mRNA or adenoviral vector COVID-19 vaccine.

The vaccine stimulates the immune system (the body s natural defences) to produce specific antibodies that work against the virus, giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.

Do not use VidPrevtyn Beta:
If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
If you are allergic to octylphenol ethoxylate, a substance that is used in the manufacturing process. Small amounts of this substance may remain after manufacturing.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given the vaccine if:

• you have ever had a severe allergic reaction after any other vaccine injection or after you were given VidPrevtyn Beta in the past;
• you have ever fainted following any needle injection;
• you have a severe illness or infection with a high temperature (over 38 C). However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
• you have a bleeding problem, you bruise easily or you use a medicine to prevent blood clots.
• you have a weakened immune system (immunodeficiency) or you are using medicines that weaken the immune system (such as high-dose corticosteroids or cancer medicines).

As with any vaccine, VidPrevtyn Beta may not fully protect all those who receive it. It is not known how long you will be protected.

Children and adolescents VidPrevtyn Beta is not recommended for children aged under 18 years. Currently there is no information available on the use of VidPrevtyn Beta in children and adolescents younger than years of age.

Other medicines and VidPrevtyn Beta Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines or vaccines.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine.

Driving and using machines
Some of the side effects of VidPrevtyn Beta mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.

VidPrevtyn Beta contains sodium and potassium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .
This medicine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially potassium-free .

Your doctor, pharmacist or nurse will inject the vaccine into a muscle, usually in your upper arm.

You will receive one injection. It is recommended that you receive VidPrevtyn Beta once as a booster dose at minimum 4 months following the prior vaccination series with either mRNA or adenoviral vector COVID-19 vaccine.

After the injection, your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the side effects occur within 3 days of getting the vaccine and go away within a few days of appearing. If symptoms persist, contact your doctor, pharmacist or nurse.

Get urgent medical attention if you get symptoms of a severe allergic reaction shortly after vaccination. Such symptoms may include:

• feeling faint or light-headed
• changes in your heartbeat
• shortness of breath
• wheezing
• swelling of your lips, face, or throat
• itchy swelling under the skin (hives) or rash
• feeling sick (nausea) or vomiting
• stomach pain.

The following side effects may occur with VidPrevtyn Beta: Side effects which may affect up to 1 in 100 people may not have all been detected in the clinical studies done to date.

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

• Headache
• Muscle pain
• Joint pain
• Feeling unwell
• Chills
• Pain where the vaccine is injected

Common (may affect up to 1 in 10 people):

• Fever ( 38.0 C)
• Tiredness
• Feeling sick (nausea)
• Diarrhoea
• Redness or swelling where the vaccine is injected

Uncommon (may affect up to 1 in 100 people):

• Enlarged lymph nodes
• Itching, bruising or warmth where the vaccine is injected.

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

• Dizziness

Not known (cannot be estimated from available data):

• Allergic reactions such as rash or hives or swelling of the face
• Severe allergic reactions (anaphylaxis)

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 vaccine out of the sight and reach of children.

Information about storage, use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.

What VidPrevtyn Beta contains

• There are two multidose vials (antigen vial and adjuvant vial) that must be mixed before use. After mixing, the vaccine vial contains 10 doses of 0.5 mL.
• One dose (0.5 mL) contains 5 micrograms of recombinant SARS-CoV-2 spike protein antigen (B.1.351 strain).
• AS03 is included in this vaccine as an adjuvant to enhance production of specific antibodies. This adjuvant contains squalene (10.69 milligrams), DL- -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
• The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium chloride, polysorbate 20, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections.

What VidPrevtyn Beta looks like and contents of the pack

• The antigen solution is a colourless, clear liquid.
• The adjuvant emulsion is a whitish to yellowish homogeneous milky liquid.
• Prior to administration, the two components should be mixed. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.

Each pack contains 10 multidose antigen vials and 10 multidose adjuvant vials.

• Each antigen vial contains 2.5 mL antigen solution in a multidose vial (type 1 glass) with a stopper (chlorobutyl) and an aluminium seal with a green plastic flip-off cap
• Each adjuvant vial contains 2.5 mL adjuvant emulsion in a multidose vial (type 1 glass) with a stopper (chlorobutyl) and an aluminium seal with a yellow plastic flip-off cap.

After mixing the antigen solution with the adjuvant emulsion, the vial contains 10 doses of 0.5 mL.

Marketing Authorisation Holder
Sanofi Pasteur - 14 Espace Henry Vall e - 69007 Lyon France

Manufacturer Sanofi Pasteur - 1541 avenue Marcel M rieux - 69280 Marcy l'Etoile France

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

Belgi / Belgique /Belgien Sanofi Belgium tel.: +32 2 710.54.Lietuva Swixx Biopharma UAB Tel.: +370 5 236 91
Swixx Biopharma EOOD
Te .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium tel.: +32 2 710.54. esk republika Sanofi s.r.o. Tel: +420 233 086 Magyarorsz g sanofi-aventis zrt Tel.: +36 1 505 0Danmark Sanofi A/S Tel: +45 4516 7Malta Sanofi S.r.l. Tel: +39 02 39394 Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 54 54 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel.: +372 640 10 Norge Sanofi-aventis Norge AS Tel: + 47 67 10 71
. .
: +30.210.8009 sterreich sanofi-aventis GmbH Tel: +43 1 80 185-0. Espa a sanofi-aventis, S.A.
Tel: +34 93 485 94 Polska Sanofi Pasteur Sp. z o.o. Tel.: + 48 22 280 00 France Sanofi Pasteur Europe T l: 0800 222 Appel depuis l tranger : +33 1 57 63 23 Portugal Sanofi Produtos Farmac uticos, Lda. Tel: + 351 21 35 89 Hrvatska Swixx Biopharma d.o.o Tel.: +385 1 2078 Ireland sanofi-aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 Rom nia Sanofi Romania SRL Tel.: +40(21) 317 31 Slovenija Swixx Biopharma d.o.o. Tel.: +386 1 235 51 sland Vistor Tel : +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel.: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800536Suomi/Finland Sanofi Oy Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. .: +357 22 741Sverige Sanofi AB Tel: +46 8-634 50 Latvija Swixx Biopharma SIA Tel.: +371 6 616 4United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in

Other sources of information

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