Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nuvaxovid

Document Subject

Generated Narrative: MedicinalProductDefinition mp0b2c64f281f8a04082b537d7d8030a6f

identifier: http://ema.europa.eu/identifier/EU/1/21/1618/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Nuvaxovid dispersion for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0b2c64f281f8a04082b537d7d8030a6f

identifier: http://ema.europa.eu/identifier/EU/1/21/1618/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - nuvaxovid

Attesters

What is in this leaflet

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

Nuvaxovid is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus.

Nuvaxovid is given to individuals 12 years of age and older.

The vaccine causes the immune system (the body s natural defences) to produce antibodies and specialised white blood cells that work against the virus, to give protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.

Nuvaxovid should not be given
if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid if: you have ever had a severe or life-threatening allergic reaction after receiving any other vaccine injection or after you were given Nuvaxovid in the past, you have ever fainted following any needle injection, you have a high fever (over 38 C) or severe infection. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold, you have bleeding problems, you bruise easily or you use a medicine to prevent blood clots, your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or cancer medicines).

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Nuvaxovid (see section 4).
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days.
Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.

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

As with any vaccine, the 2-dose vaccination course of Nuvaxovid may not fully protect all those who receive it and it is not known how long you will be protected.

Children

Nuvaxovid is not recommended for children aged below 12 years. Currently, there is no information available on the use of Nuvaxovid in children younger than 12 years of age.

Other medicines and Nuvaxovid

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 Nuvaxovid listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines (for example, feeling faint or lightheaded or feeling very tired).

Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

Nuvaxovid contains sodium and potassium

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

This vaccine contains less than 1 mmol potassium (39 milligrams) per dose, that is to say, essentially potassium-free .

Individuals 12 years of age and older
Nuvaxovid will be given to you as two separate 0.5 mL injections.

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

It is recommended that you receive the second dose of Nuvaxovid 3 weeks after your first dose to receive the full course of this vaccine.

A booster dose of Nuvaxovid may be given approximately 3 months after the second dose in individuals 12 years of age and older.

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

If you miss an appointment for your second injection of Nuvaxovid ask your doctor or nurse for advice. If you miss a scheduled injection, you may not be fully protected against COVID-19.

Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects go away within a few days of appearing. If symptoms persist, contact your doctor, pharmacist or nurse.

As with other vaccines, you may feel pain or discomfort at the injection site, or you may see some redness and swelling at this site. However, these reactions usually clear up within a few days.

Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:

• feeling faint or light-headed
• changes in your heartbeat
• shortness of breath
• wheezing
• swelling of your lips, face, or throat
• hives or rash
• nausea or vomiting
• stomach pain

Talk to your doctor or nurse if you develop any other side effects. These can include:

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

• headache
• feeling sick (nausea) or getting sick (vomiting)
• muscle ache
• joint pain
• tenderness or pain where the injection is given
• feeling very tired (fatigue)
• generally feeling unwell

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

• redness where the injection is given
• swelling where the injection is given
• fever (>38 C)
• pain or discomfort in the arm, hand, leg and/or foot (pain in the extremity)

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

• enlarged lymph nodes
• high blood pressure
• itchy skin, rash or hives
• redness of the skin
• itchy skin where the injection is given
• chills

Rare (may affect up to 1 in 1000 people):

• warmth where the injection is given

Not known (cannot be estimated from available data):

• severe allergic reaction
• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), which can result in breathlessness, palpitations or chest pain

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 and include batch/Lot number if available. By reporting side effects, you can help provide more information on the safety of this vaccine.

Keep this medicine out of the sight and reach of children.

Your doctor, pharmacist, or nurse is responsible for storing this vaccine and disposing of any unused product correctly.

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

What Nuvaxovid contains

One dose (0.5 mL) Nuvaxovid contains 5 micrograms of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M.

*produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.

Matrix-M is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve, and/or prolong the protective effects of the vaccine. Matrix-M adjuvant contains Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract per 0.5 mL dose.

The other ingredients (excipients) included in Nuvaxovid are:
Disodium hydrogen phosphate heptahydrate
Sodium dihydrogen phosphate monohydrate
Disodium hydrogen phosphate dihydrate Sodium chloride
Polysorbate Cholesterol Phosphatidylcholine (including all-rac- -Tocopherol) Potassium dihydrogen phosphate Potassium chloride Sodium hydroxide (for the adjustment of pH)
Hydrochloric acid (for the adjustment of pH)
Water for Injections What Nuvaxovid looks like and contents of the pack

The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2).

5-dose vial

• 2.5 mL of dispersion for injection in a vial with a rubber stopper and a blue flip-off top.
• Pack size: 2 multidose vials or 10 multidose vials. Each vial contains 5 doses of 0.5 mL.

10-dose vial

• 5 mL of dispersion for injection in a vial with a rubber stopper and a blue flip-off top.

•     Pack size: 2 multidose vials or 10 multidose vials. Each vial contains 10 doses of 0.5 mL. 

Not all pack sizes may be marketed.

Marketing Authorisation Holder Novavax CZ a.s. Bohumil Jevany, 28Czechia

Manufacturer Novavax CZ a.s. Bohumil Jevany, 28Czechia

This leaflet was last revised in.

Scan the code with a mobile device to get the package leaflet in different languages.

Or visit the URL: https://www.NovavaxCovidVaccine.com

Other sources of information

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