Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bimervax

Document Subject

Generated Narrative: MedicinalProductDefinition mp0b425a6e45767f61f6d3b4247eda39d0

identifier: http://ema.europa.eu/identifier/EU/1/22/1709/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: BIMERVAX 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-0b425a6e45767f61f6d3b4247eda39d0

identifier: http://ema.europa.eu/identifier/EU/1/22/1709/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - bimervax

Attesters

What is in this leaflet

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

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

BIMERVAX is given to individuals 16 years of age and older who have previously received a mRNA 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.

BIMERVAX 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 receiving BIMERVAX if:

• you have ever had a severe or life-threatening allergic reaction after receiving any other vaccine injection;
• you have ever fainted following any needle injection;
• you have a high temperature (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 (anticoagulant medicine);
• 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).

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

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

Children and adolescents BIMERVAX is not recommended for children aged below 16 years. Currently, there is no information available on the use of BIMERVAX in children younger than 16 years of age.

Other medicines and BIMERVAX 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 BIMERVAX listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines. Wait until any effects of the vaccine have worn off before you drive or use machines.

BIMERVAX 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 0.5 mL dose, that is to say, essentially potassium-free .

BIMERVAX will be given to you as 0.5 mL injection into a muscle of your upper arm.

It is recommended that you receive BIMERVAX as a single dose at least 6 months after a previous vaccination series with mRNA 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 BIMERVAX, ask your doctor, pharmacist or nurse.

Like all medicines, this vaccine 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 BIMERVAX:

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

• headache
• pain where the injection is given
• feeling very tired (fatigue)
• muscle pain

Common (may affect up to 1 in 10 people)

• redness, swelling or tenderness where the injection is given
• feeling sick (nausea) or getting sick (vomiting)
• diarrhoea
• fever
• enlarged lymph nodes
• axillary pain

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

• chills or feeling feverish
• insomnia
• dizziness
• itching where the injection is given
• hipersensitivity where the injection is given
• joint pain
• feeling weak or lack of energy
• feeling sleepy
• abdominal pain
• itchy skin
• pain when swallowing
• generally feeling unwell

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

• Cold sweating
• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
• allergic reactions such as hives, rash or itching
• Back pain
• Bruise where the injection is given

Not known (cannot be estimated from available data, based on a single case during clinical trials):

• Inflammation of the lining outside the heart (pericarditis), which can result in breathless, 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. The following information about storage, expiry, use and handling as well as disposal is intended for healthcare professionals. Do not use this vaccine after the expiry date which is stated on the label after EXP. Store in a refrigerator (2 C 8 C). Do not freeze. Keep vials in outer carton in order to protect from light.
After first puncture, store at 2 C 8 C, use within 6 hours. Information on handling are described in the section intended for healthcare professionals at the end of the package leaflet. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

What BIMERVAX contains

One dose (0.5 mL) contains 40 micrograms of selvacovatein adjuvanted with SQBA.

Selvacovatein is SARS-CoV-2 virus recombinant spike (S) protein RBD fusion heterodimer B.1.351 and B.1.1.7 strains) produced by recombinant DNA technology.

SQBA is included in this vaccine as an adjuvant to accelerate and improve the protective effects of the vaccine. SQBA contains per 0.5 mL dose: squalene (9.75 mg), polysorbate (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injections.

The other ingredients (excipients) are: disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, potassium chloride and water for injections. BIMERVAX contains potassium and sodium (see section 2). What BIMERVAX looks like and contents of the pack The vaccine is a white homogeneous emulsion for injection. 5 mL of emulsion is provided in a vial with a rubber stopper and a plastic flip-off top. Each vial contains 10 doses of 0.5 mL.
Pack size: 10 multidose vials. Marketing Authorisation Holder

Hipra Human Health, S.L.U. Avda. la Selva, 17170 Amer (Girona) SPAIN

Manufacturer

Laboratorios Hipra, S.A. Avda. la Selva, 17170 Amer (Girona) SPAIN

This leaflet was last revised in

Other sources of information

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