Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - twinrix

Document Subject

Generated Narrative: MedicinalProductDefinition mpc3bcf9603926d754cd4924142c795340

identifier: http://ema.europa.eu/identifier/EU/1/97/029/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Twinrix Paediatric, suspension for injection in pre-filled syringe

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-c3bcf9603926d754cd4924142c795340

identifier: http://ema.europa.eu/identifier/EU/1/97/029/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - twinrix

Attesters

What is in this leaflet

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

Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month.

• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.

Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.

Twinrix Paediatric should not be given if

• you are allergic to:

• the active substances, or any of the ingredients of this medicine (listed in section 6).
• neomycin.
  Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

• you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
• you have a severe infection with a high temperature (over 38 C). A minor infection such as a cold should not be a problem, but talk to your doctor first.

Warnings and precautions Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:

• you have experienced any health problems after previous administration of a vaccine.
• you have a poor immune system due to illness or drug treatment.
• you have a bleeding problem or bruise/ bruises easily.

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

Other medicines and Twinrix Paediatric
Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.

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

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before you are given this vaccine. It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.

Twinrix Paediatric contains neomycin and sodium Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic). This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

You will receive a total of three injections over 6 months. Each injection is given on a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month, and six months after the first dose.

• First dose: at an elected date
• Second dose: 1 month later
• Third dose: 6 months after the first dose

Your doctor will advise on the possible need for extra doses, and future booster dosing.

If you miss a scheduled injection, talk to your doctor and arrange another visit.

Make sure you finish the complete vaccination course of three injections. If not, you may not be fully protected against the diseases.

The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.

The vaccine should never be given into a vein.

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

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

Side effects that may occur are the following:

Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.

Very common (these may occur with more than 1 in 10 doses of the vaccine): pain and redness at the injection site.

Common (these may occur with up to 1 in 10 doses of the vaccine): drowsiness, headache, nausea, loss of appetite, swelling or bruising at the injection site, generally feeling unwell, tiredness, fever equal to or greater than 37.5 C, irritability.

Uncommon (these may occur with up to 1 in 100 doses of the vaccine): diarrhoea, vomiting, stomach pain, rash, aching muscles, upper respiratory tract infection.

Rare (these may occur with up to 1 in 1,000 doses of the vaccine): swollen glands in the neck armpit or groin (lymphadenopathy), dizziness, loss of skin sensitivity to pain or touch (hypoaesthesia), feeling of pins and needles (paraesthesia), hives, itching, joint pain, low blood pressure, flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills.

Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia), purple or red brown spots visible through the skin (thrombocytopenic purpura), swelling or infection of the brain (encephalitis), degenerative disease of the brain (encephalopathy), inflammation of nerves (neuritis), numbness or weakness of the arms and legs (neuropathy), paralysis, fits or seizures, swelling of the face, mouth or throat (angioneurotic oedema), purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), joint swelling, muscular weakness, infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis), inflammation of some blood vessels (vasculitis), abnormal laboratory liver test results, multiple sclerosis, swelling of the spinal cord (myelitis), drooping eyelid and sagging muscles on one side of the face (facial palsy), a temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barr syndrome), a disease of the nerves of the eye (optic neuritis), immediate injection site pain, stinging and burning feeling.
Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness) may also occur very rarely (with up to 1 in 10,000 doses of the vaccine).
Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. Such reactions may occur before leaving the doctor s surgery. However, if you get any of these symptoms you should contact a doctor urgently.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.

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 protect the environment.

What Twinrix Paediatric contains

• The active substances are:
  Hepatitis A virus (inactivated)1,2 360 ELISA Units Hepatitis B surface antigen3,4 10 micrograms

1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 0.2 milligrams Al3+

• The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.

What Twinrix Paediatric looks like and contents of the pack

Suspension for injection in pre-filled syringe.

Twinrix Paediatric is a white, slightly milky liquid.

Twinrix Paediatric is available in 1-dose pre-filled syringe with or without separate needles, pack sizes of 1, 10 and 50. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a. Rue de l Institut B-1330 Rixensart Belgium

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

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 Lietuva GlaxoSmithKline Biologicals SA Tel. +370 80000
GlaxoSmithKline Biologicals SA .: +359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 Magyarorsz g GlaxoSmithKline Biologicals SA Tel.: +36 80088cz.info@gsk.com

Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline Biologicals SA Tel: +356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline Biologicals SA Tel: +372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. T : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0) 1 39 17 84 diam@gsk.com

Hrvatska GlaxoSmithKline Biologicals SA Tel.: +385 800787Portugal Smith Kline & French Portuguesa - Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com

Rom nia GlaxoSmithKline Biologicals SA Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5Slovenija GlaxoSmithKline Biologicals SA Tel: +386 80688 sland Vistor hf.
S mi: +354 535 7Slovensk republika GlaxoSmithKline Biologicals SA Tel.: +421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30
GlaxoSmithKline Biologicals SA : +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija GlaxoSmithKline Biologicals SA Tel: +371 80205United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA Tel: +44(0)800 221customercontactuk@gsk.com This leaflet was last revised in

Other sources of information

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