Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - foclivia

Document Subject

Generated Narrative: MedicinalProductDefinition mp81e7ff6268dfde3de233f5f0af119c35

identifier: http://ema.europa.eu/identifier/EU/1/09/577/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Foclivia suspension for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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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-81e7ff6268dfde3de233f5f0af119c35

identifier: http://ema.europa.eu/identifier/EU/1/09/577/001-002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - foclivia

Attesters

What is in this leaflet:

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

Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic.

Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

It is for use in to prevent flu caused by the H5N1 type of the virus.

When a person is given the vaccine, the body s natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.

As with all vaccines, Foclivia may not fully protect all persons who are vaccinated.

Foclivia should not be given if you:

• have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia,
• are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia,
• are allergic to eggs, chicken protein, ovalbumin,
• are allergic to kanamycin sulphate and neomycin sulphate (antibiotics), formaldehyde, hydrocortisone, cetyltrimethylammonium bromide (CTAB).
• Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• However, in a pandemic situation, you may still be given the vaccine. This is as long as medical treatment is available straight away, in case you have an allergic reaction.

Warnings and precautions

Talk to your doctor or nurse before having this vaccine:

• if you feel feverish,
• if you have any illness or infection,
• if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions).

Please inform your doctor or nurse if you have a bleeding problem or bruise easily.

The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.

Fainting can occur following, or even before, any needle injection. Therefore, tell the doctor or nurse if you fainted with a previous injection.

Foclivia may not fully protect everyone who is vaccinated, especially elderly subjects and those with weakened immune systems, such as HIV patients, or those with underlying long term medical problems, such as diabetes, lung disease or heart problems. Tell your doctor if you have a weak immune system or an underlying long term medical problem.

In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.

Other medicines and Foclivia Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine. Foclivia can be given at the same time as non-adjuvanted seasonal influenza vaccines. There is no information on administration of Foclivia with non-influenza vaccines. If administration of Foclivia with other vaccines cannot be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware that the side effects may be more intense.

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 or nurse for advice before taking this vaccine. Your doctor needs to assess the benefits and potential risks of giving you the vaccine.

Driving and using machines Some side effects listed in Section 4. Possible side effects may affect your ability to drive or use tools or machines.

Foclivia contains sodium and potassium Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It is essentially sodium- and potassium-free.

Your doctor or nurse administers the vaccine in accordance with official recommendations. A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass.

A second dose of vaccine should be given after an interval of at least 3 weeks.

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect you may need urgent medical attention or hospitalisation:

difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

The side effects listed below have occurred with Foclivia in clinical studies:

Very common (affects more than 1 user in 10): Pain/tenderness at the site of injection Hardening of the skin at the injection site Injection site redness
Injection site swelling Bruising of the skin at the injection site* Aching muscles Headache Fatigue Generally feeling unwell Shivering Sweating* Nausea* Change in eating habits** Diarrhoea Vomiting Sweating and unusual sweating** Sleepiness** Iritability** Unusual crying** Fever*** *Reported as, Common, in adults and elderly ** Reported only in infants and young children 6-35 months of age ***Reported as Very common only in children 6 months-8 years. Reported as Common in adolescents and adults 9-60 years of age and Uncommon in eldery (over 61 years)

Common (affects 1 to 10 users in 100): Aching joints
Injection site bleeding Loss of appetite

Uncommon (affects 1 to 10 users in 1000) Hives (Urticaria)

These side effects are usually mild and disappear within 3 days without treatment. If they persist, CONSULT YOUR DOCTOR.

Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients Nausea, aching joints, diarrhoea and loss of appetite were reported very commonly in this population. In addition, vomiting was commonly reported.

Other rare side effects observed after routine use The additional side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to Foclivia and with the same adjuvant. These side effects may occur with Foclivia.

• Generalised skin reactions including

• Itching

• Rash or swelling of the skin and mucous membranes

• Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction).

• Disorders of the gut such as

• Abdominal pain

• Dizziness, drowsiness.

• Neurological disorders such as

• Severe stabbing or throbbing pain along one or more nerves

• Tingling

• Fits

• Neuritis (inflammation of nerves)

• Syncope or presyncope (fainting or feeling about to faint)

• Swollen lymph nodes, palpitations (irregular or forceful heart beat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).

• Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.

In addition side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and not-adjuvanted vaccines given routinely every year to prevent seasonal flu. These side effects may occur with Foclivia.

• Low blood platelet count which can result in bleeding or bruising.
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems).
• Erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness).
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barr Syndrome.
• Swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction).
• Extensive swelling of injected limb lasting more than one week.

Reporting of side effects If you get any side effects, talk to your doctor 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.

Do not use Foclivia after the expiry date which is stated on the carton and the 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 vaccine has been frozen. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Foclivia contains

• Active substance: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase). They are isolated from the surface of influenza virus particles, which are grown in fertilised hen s eggs from healthy chicken flocks and inactivated with formaldehyde. These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.

One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:

A/Vietnam/1194/2004 (H5N1)

• Adjuvant: The vaccine contains an adjuvant (a compound containing squalene) to stimulate a better response. The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).

• Other ingredients: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.

What Foclivia looks like and contents of the pack Foclivia is a milky-white liquid. It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, in box of 1 or 10, with or without needle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Seqirus S.r.l. Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy

Manufacturer Seqirus Netherlands B.V. Paasheuvelweg 1105BJ Amsterdam Netherlands

This leaflet was last revised in {MM/YYYY}.

Foclivia has been authorised under Exceptional Circumstances . This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.

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