Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rotarix

Document Subject

Generated Narrative: MedicinalProductDefinition mp12c8a969675c3f7a6a3764899fb6a5f5

identifier: http://ema.europa.eu/identifier/EU/1/05/330/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rotarix powder and solvent for oral suspension

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-12c8a969675c3f7a6a3764899fb6a5f5

identifier: http://ema.europa.eu/identifier/EU/1/05/330/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - rotarix

Attesters

What is in this leaflet

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

Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.

How Rotarix works

Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. Most children with rotavirus diarrhoea recover on their own. However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.

When a person is given the vaccine, the immune system (the body s natural defences) will make antibodies against the most commonly occurring types of rotavirus. These antibodies protect against disease caused by these types of rotavirus.

As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.

Rotarix should not be given

• if your child has previously had any allergic reaction to rotavirus vaccines or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
• if your child was born with a malformation of the gut that could lead to intussusception.
• if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).
• if your child has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
• if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until recovery.

Warnings and precautions Talk to your doctor/health care professional before your child receives Rotarix if:

• he/she has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system.
• he/she has any disorder of the gastrointestinal system.
• he/she has not been gaining weight and growing as expected.
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken during pregnancy any medicine that may weaken the immune system.

After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 Possible side effects ).

As always, please take care to wash your hands thoroughly after changing soiled nappies.

Other medicines and Rotarix Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine.

Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.

Rotarix with food and drink There are no restrictions on your child s consumption of food or liquids, either before or after vaccination.

Breast-feeding Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule.

Rotarix contains sorbitol, sucrose, glucose, phenylalanine and sodium This vaccine contains 13.5 mg sorbitol in each dose.

If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before your child receives this vaccine.

This vaccine contains 0.15 microgram phenylalanine in each dose. Phenylalanine may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. This vaccine contains less than 1 mmol sodium (23 mg) in each dose, that is to say essentially sodium-free .

The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1 mL liquid) will be given orally. Under no circumstance should this vaccine be administered by injection.

Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.

Rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks.

In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.

It is important that you follow the instructions of your doctor or nurse regarding return visits. If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.

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

The following side effects may happen with this vaccine:

Common (These may occur with up to 1 in 10 doses of the vaccine):
diarrhoea
irritability

Uncommon (These may occur with up to 1 in 100 doses of the vaccine): abdominal pain (see also below for signs of very rare side effects of intussusception) flatulence inflammation of the skin

Side effects that have been reported during marketed use of Rotarix include: Very rare: hives (urticaria) Very rare: intussusception (part of the intestine gets blocked or twisted). The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. Contact a doctor/health care professional right away if your child experiences one of these symptoms. blood in stools in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea.

Reporting of side effects
If your child gets any of the 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 vaccine out of the sight and reach of children.

Do not use this vaccine 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). Do not freeze. Store in the original package in order to protect from light.

After reconstitution, the vaccine contained in the oral applicator should be administered promptly. If the reconstituted vaccine is not used within 24 hours, it should be discarded.

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

What Rotarix contains

• The active substances are:

Human rotavirus RIX4414 strain (live, attenuated)*
not less than 106.0 CCID*Produced on Vero cells

• The other ingredients in Rotarix are:
  Powder: dextran, sucrose, sorbitol (E420), amino acids (including phenylalanine), Dulbecco s Modified Eagle Medium (DMEM) (containing phenylalanine, sodium, glucose and other substances), (see also section 2, Rotarix contains sorbitol, sucrose, glucose, phenylalanine and sodium ) Solvent: calcium carbonate, xanthan gum, sterile water

What Rotarix looks like and contents of the pack

Powder and solvent for oral suspension

Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant. There is also a transfer adapter which allows easy transfer of the solvent into the glass container containing the powder for mixing the different components of the vaccine.

Both components must be mixed together before your child receives the vaccine. The mixed vaccine will appear more turbid than the solvent alone.

Rotarix is available in a pack of 1, 5, 10 or 25. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals SA 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 cz.info@gsk.com

Magyarorsz g GlaxoSmithKline Biologicals SA Tel.: +36 80088Danmark 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 Suomi/Finland GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 7741 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)800 221 customercontactuk@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: