Supemtek - patient leaflet, side effects, dosage

Patient leaflet - Supemtek

B. PACKAGE LEAFLET

Package Leaflet – Information for the User

Supemtek

Solution for injection

Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side affects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, nurse or pharmacist.
– This vaccine has been prescribed for you only. Do not pass it on to others.
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

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

1. What Supemtek is and what it is used for

Supemtek is a vaccine for adults who are 18 years of age and older. This vaccine helps to protect you against flu (influenza). Supemtek is egg-free because of the technology used to produce it.

How Supemtek works

When a person is given Supemtek, the body’s natural defence (the immune system) produces protection against the influenza virus. None of the ingredients in the vaccine can cause flu. As with all vaccines, Supemtek may not fully protect all persons who are vaccinated.

When to have a flu vaccine

Flu can spread very fast.

It is caused by different types of flu virus that can change every year. This is why you might need to be vaccinated every year.
The greatest risk of catching flu is during the cold months between October and March.
If you were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring

since you run the risk of catching flu until then.

Your doctor will be able to recommend the best time to be vaccinated.

2. What you need to know before you receive Supemtek

Do not use Supemtek if you are allergic to :

the active ingredients or any of the other ingredients of this medicine (listed in section 6).
octylphenol ethoxylate, a trace residual from the manufacturing process.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before receiving Supemtek.

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

Before receiving the vaccine, tell your doctor, nurse or pharmacist if:

you have a short-term illness with fever. Vaccination may need to be delayed until your fever has gone.
you have a weakened immune system (immunodeficiency or you are taking medicines that affect the immune system such as cancer medicine (chemotherapy) or corticosteroid medicines).
you have a bleeding problem or bruise easily.
you have fainted with an injection before. Fainting can happen after, or even before an injection.

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

Other medicines and Supemtek

Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.

Supemtek may be given at the same time as other vaccines by using separate limbs.

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 pharmacist for advice before using this vaccine. Your doctor or pharmacist will help you to decide if you should receive Supemtek.

Driving and using machines

Supemtek has no or negligible effect on your ability to drive and use machine.

Supemtek contains sodium

This vaccine contains less than 1 mmol sodium (23 mg) per dose, this means that it’s essentially ‘sodium free’.

3. How Supemtek is given

Supemtek is given to you by your doctor, nurse or pharmacist as an injection into the muscle at the top of the upper arm (deltoid muscle).

Adults from 18 years of age and older:

One dose of 0.5 mL.

4. Possible side effects

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

Severe allergic reactions

Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. It can be life-threatening.

Symptoms include:

difficulty breathing, shortness of breath
swelling of the face, lips, throat or tongue
cold, clammy skin
palpitations
feeling dizzy, feeling weak, fainting
rash or itching

The following side effects have been reported with Supemtek:

Other side effects

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

pain at the injection site
feeling tired (fatigue)
headache
muscle pain and joint pain

Muscle pain and joint pain are common in adults aged 50 years and older.

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

feeling sick (nausea)
redness, swelling, hardening around the area where the vaccine is injected
fever, shivering

Fever is rare in adults aged 50 years and older.

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

diarrhoea
itching, skin irritation, rash
flu-like symptoms
cough, mouth and throat pain
itching where the vaccine is injected

Itching is rare in adults aged 50 years and older.

Skin irritation and rash have not been reported in adults aged 50 years and older.

Flu-like symptoms has not been reported in adults aged 18–49 years.

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

feeling dizzy
hives

Feeling dizzy and hives have not been reported in adults aged 18–49 years.

Not known (cannot be estimated from the available data):

neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (Guillain-Barre syndrome).

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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Supemtek

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

Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.

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

6. Contents of the pack and other information

What Supemtek contains

One dose (0.5 mL) contains:

The active substances are influenza virus haemagglutinin (HA) proteins, of the following strains*:

A/xxxxxx (H1N1) -like virus.........................................45 micrograms HA

A/xxxxxx (H3N2) -like virus.........................................45 micrograms HA

B/xxxxxx- like virus.......................................................45 micrograms HA

B/xxxxxx – like virus......................................................45 micrograms HA

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

What Supemtek looks like and contents of the pack

Supemtek is a solution for injection in a pre-filled syringe (ready to use syringe).

Supemtek is a clear and colourless solution.

A single syringe contains 0.5 mL of solution for injection.

Supemtek is available in packs containing 1, 5 or 10 pre-filled syringes without needle or with separate needle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Pasteur

14 Espace Henry Vallée

69007 Lyon

France

Manufacturer

Sanofi Pasteur

Parc Industriel d'Incarville

27100 Val de Reuil

France

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

België/ Belgique /Belgien

Sanofi Belgium

Tél/Tel.: +32 2 710.54.00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

Efc^rapufl

Swixx Biopharma EOOD

Ten.: +359 (0) 2 4942 480

Luxembourg/Luxemburg

Sanofi Belgium tel.: +32 2 710.54.00

Česká republika sanofi-aventis, s.r.o.

Tel: +420 233 086 111

Magyarország sanofi-aventis zrt Tel.: +36 1 505 0055

Danmark

Sanofi A/S

Tel: +45 4516 7OOO

Malta

Sanofi S.r.l.

Tel: +39 02 39394983

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel.: 0800 54 54 010

Tel. aus dem Ausland: +49 69 305 21 130

Nederland

Genzyme Europe B.V. Tel: +31 20 245 4000

Eesti

Swixx Biopharma OÜ

Tel: +372 640 10 30

Norge

Sanofi-aventis Norge AS

Tel: + 47 67 10 71 00

EXÀàôa

BLANES A.E.

Tip.: +30.210.8009111

Österreich

Sanofi-Aventis GmbH Tel: +43 (1) 80185–0.

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Polska

Sanofi Pasteur Sp. z o. o.

Tel.: +48 22 280 00 00

France

Sanofi Pasteur Europe

Tél: O8OO 42 43 46

Appel depuis l’étranger : +33 1 57 63 67 97

Portugal

Sanofi – Produtos Farmacéuticos, Lda.

Tel: + 351 21 35 89 400

Hrvatska

Swixx Biopharma d.o.o.

Tel: +385 1 2078 500

Romania

Sanofi Romania SRL

Tel.: +40(21) 317 31 36

Ireland

sanofi-aventis Ireland T/A SANOFI

Tel: + 353 (0) 1 4035 600

Slovenija

Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00

Island

Vistor

Tel : +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600

Italia

Sanofi S.r.l.

Tel: 800536389

Tel dall'estero: +39 02 39394983

Suomi/Finland

Sanofi Oy

Tel: +358 (0) 201 200 300

Kùnpoç

C.A. Papaellinas Ltd.

Tip.: +357 22 741741

Sverige

Sanofi AB

Tel: +46 8–634 50 00

Latvija

Swixx Biopharma SIA

Tel: +371 6 616 47 50

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

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

Other sources of information

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

The following information is intended for healthcare professionals only:

Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.