


Ask a doctor about a prescription for ROTARIX ORAL SUSPENSION IN A DOSING TUBE. LIVE ANTI-ROTAVIRUS VACCINE
Rotarix oral suspension in dosing tube
live rotavirus vaccine
Read all of this leaflet carefully before your child is given this vaccine because it contains important information for you.
Contents of the pack
Rotarix is a vaccine that contains live, attenuated human rotaviruses, which helps to protect your child from 6 weeks of age against gastroenteritis (diarrhea and vomiting) caused by rotavirus infection.
How Rotarix works
Rotavirus infection is the most common cause of severe diarrhea in infants and young children. Rotavirus is easily spread by hand-to-mouth contact with the feces of an infected person. Most children with rotavirus diarrhea recover on their own. However, some children become very ill with a severe case of vomiting, diarrhea, and fluid loss that can be life-threatening and require hospitalization.
When the vaccine is given to a person, the immune system (the body's natural defense) will produce antibodies against the types of rotavirus that occur most frequently. These antibodies protect against disease caused by these types of rotavirus.
Like all vaccines, Rotarix may not completely prevent all vaccinated individuals from rotavirus infections it is intended to protect against.
Rotarix must not be given
Warnings and precautions
Consult your doctor/healthcare professional before your child is given Rotarix if:
If your child experiences severe stomach pain, persistent vomiting, blood in the stool, abdominal swelling, and/or high fever after receiving Rotarix, contact a doctor/healthcare professional immediately (see also section 4 "Possible side effects").
As always, please take the precaution of washing your hands thoroughly after changing used diapers.
Using Rotarix with other medicines
Tell your doctor if your child is using or has recently used or may need to use any other medicine or has recently received any other vaccine.
Rotarix can be given at the same time as your child is given other recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough) vaccine, Haemophilus influenzaetype b vaccine, oral or inactivated poliomyelitis vaccine, hepatitis B vaccine, as well as conjugated pneumococcal and meningococcal serogroup C vaccines.
Using Rotarix with food and drinks
There are no restrictions on the intake of food or liquids by your child, including breastfeeding, before or after vaccination.
Breastfeeding
Based on evidence from clinical trials, breastfeeding does not reduce the protection against rotavirus gastroenteritis provided by Rotarix. Therefore, breastfeeding can continue during the vaccination period.
Rotarix contains sucrose, glucose, phenylalanine, and sodium
If your doctor has told you that your child has an intolerance to some sugars, talk to your doctor before your child is given this vaccine.
This vaccine contains 0.15 micrograms of phenylalanine per dose. Phenylalanine may be harmful if your child has phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body cannot eliminate it properly.
This vaccine contains 34 mg of sodium (main component of table/cooking salt) per dose.
The doctor or nurse will give your child the recommended dose of Rotarix. The vaccine (1.5 ml of liquid) will be given orally. Under no circumstances should this vaccine be given by injection.
Your child will receive two doses of the vaccine. Each dose will be given separately with an interval of at least 4 weeks between the two doses. The first dose will be given from 6 weeks of age. Both doses of the vaccine must have been given by 24 weeks of age, although they should preferably be given before 16 weeks of age.
Rotarix can be given to premature infants following the same vaccination schedule as the rest of infants, provided that gestation has lasted at least 27 weeks.
In the event that your child spits or regurgitates most of the vaccine dose, a single replacement dose can be given at the same visit.
When your child is given a first dose with Rotarix, it is recommended that your child also receive a second dose of Rotarix (and not another rotavirus vaccine).
It is important that you follow the instructions given by your doctor or nurse regarding follow-up visits. If you forget to return to your doctor at the scheduled appointment, talk to your doctor.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects may occur with this vaccine:
Side effects that have been reported during the marketing of Rotarix include:
Reporting of side effects
If your child experiences 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 through the Spanish Medicines Agency's online platform, www.notificaRAM.es. 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 is the last day of the month stated.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Store in the original package to protect from light.
Once opened, the vaccine should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Composition of Rotarix
Human rotavirus strain RIX4414 (live, attenuated)* at least 10^6.0 CCID50
Appearance of the Productand Container Size
Oral suspension
Rotarix is supplied as a clear, colorless liquid in a single-dose oral dispenser tube (1.5 ml).
Rotarix is available in packs of 1, 10, or 50.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For further information, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00 Bulgaria GlaxoSmithKline Biologicals SA Tel: +359 80018205 | Lietuva GlaxoSmithKline Biologicals SA Tel: +370 80000334 Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00 |
Ceská republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 | Magyarország GlaxoSmithKline Biologicals SA Tel.: +36 80088309 |
Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta GlaxoSmithKline Biologicals SA Tel: +356 80065004 |
Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701 | Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100 |
Eesti GlaxoSmithKline Biologicals SA Tel:+372 8002640 Ελλάδα GlaxoSmithKline Μονοπρ?σωπη A.E.B.E Tηλ: + 30 210 68 82 100 | Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 Österreich GlaxoSmithKline Pharma GmbH. Tel: + 43 (0)1 97075 0 |
España GlaxoSmithKline, S.A. Tel: + 34 900 202 700 | Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000 |
France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 | Portugal Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00 |
Hrvatska GlaxoSmithKline Biologicals SA Tel.: + 385 800787089 | România GlaxoSmithKline Biologicals SA Tel: +40 800672524 |
Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000 | Slovenija GlaxoSmithKline Biologicals SA Tel: + 386 80688869 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika GlaxoSmithKline Biologicals SA Tel: + 421 800500589 |
Italia GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 7741 111 | Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 |
Κ?προς GlaxoSmithKline Biologicals SA Τηλ: + 357 80070017 | Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvija GlaxoSmithKline Biologicals SA Tel: + 371 80205045 | United Kingdom(Northern Ireland) GlaxoSmithKline UK Tel: + 44 (0)800 221 441 |
Date of Last Revision of this Leaflet: 01/2022
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu
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This information is intended solely for healthcare professionals:
The vaccine is presented as a clear, colorless liquid, free from visible particles, for oral administration.
The vaccine is ready to use (no reconstitution or dissolution is required).
The vaccine is administered orally without being mixed with other vaccines or solutions.
The vaccine should be visually inspected for any foreign particles and/or changes in physical appearance. If any of these circumstances are observed, the vaccine should be discarded.
The disposal of unused vaccines and all materials that have come into contact with them should be carried out in accordance with local regulations.
Instructions for vaccine administration:
Read the instructions for use completely before starting to administer the vaccine
Do not use the vaccine if you observe anything abnormal.
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D Administer the vaccine
Do not use the vaccine if you observe anything abnormal.
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Discard the empty tube and cap in approved biological waste containers in accordance with local regulations.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for ROTARIX ORAL SUSPENSION IN A DOSING TUBE. LIVE ANTI-ROTAVIRUS VACCINE – subject to medical assessment and local rules.