oral suspension in a squeeze tube
rotavirus vaccine, live
What Rotarix is and what it is used for
Rotarix is a viral vaccine, containing live attenuated human rotavirus, that helps protect your baby, 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 from hand to mouth through contact with feces from an infected child. Most children with rotavirus-induced diarrhea recover without treatment. However, some children can become very ill with severe vomiting, diarrhea, and life-threatening fluid loss that requires hospitalization.
When a person receives the vaccine, the immune system (the body’s natural defense) will make antibodies against the most common types of rotavirus. The antibodies protect against diseases caused by these types of rotavirus.
Like all vaccines, Rotarix may not completely protect all vaccinated people against the rotavirus infections that are intended to be prevented.
What you need to know before your child receives Rotarix
Rotarix should not be given
- if your child has previously had an allergic reaction to the rotavirus vaccine 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 invagination (blockage of the intestinal passage that occurs when one segment of the intestine is folded into another segment)
- if your baby is born with a malformation of the gut that can lead to invagination
- if your child has an unusual hereditary disease that affects the child’s immune system called Severe Combined Immunodeficiency (SCID)
- if your child has a serious infection with a high fever. It may be necessary to postpone vaccination until the child has recovered. A minor infection such as a cold should not be a problem but talk to your doctor first
- if your child has diarrhea or vomiting. It may be necessary to postpone vaccination until the child has recovered.
Warnings and cautions
Talk to your doctor/healthcare professional before giving your child Rotarix
- he/she has close contact with a person, for example, a family member, who has weakened the immune system, for example, due to cancer, or who is taking drugs that weaken the immune system
- he/she has a gastrointestinal disease
- he/she has not gained weight or grown as expected
- he/she has an illness or is taking any medication that reduces his / her resistance to infection, or if his / her mother took any medication during pregnancy that may have weakened the immune system.
If your child develops severe abdominal pain, persistent vomiting, blood in the stool, bloated stomach, and/or fever after taking Rotarix, contact a doctor/healthcare professional immediately (see also section 4 “Possible side effects”).
As always, be sure to wash your hands thoroughly after changing diapers.
Other medicines and Rotarix
Tell your doctor if your child is taking, has recently taken, or might take other medicines, or if the child has recently been vaccinated with another vaccine.
Rotarix can be given at the same time as your child receives other commonly recommended vaccines such as vaccines against diphtheria, tetanus, pertussis (pertussis), Haemophilus influenzae type b, polio (oral or inactivated), hepatitis B as well as conjugated pneumococcal and meningococcal serogroup C vaccines
Rotarix with food and drink
There are no restrictions on your child’s intake of food and drink, either before or after vaccination.
Breast-feeding
Based on the results of clinical trials, breastfeeding does not reduce the protection that Rotarix provides against gastroenteritis caused by rotavirus. Breast-feeding can therefore continue independently of the vaccination.
Rotarix contains sucrose, glucose, phenylalanine, and sodium
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving your child this vaccine.
This vaccine contains 0.15 micrograms of phenylalanine per dose. Phenylalanine can 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 34 mg of sodium (the main component of cooking/table salt) per dose.
How Rotarix is given
Your doctor or nurse will give the recommended dose of Rotarix to your child. The vaccine (1.5 ml liquid) should be given orally (orally). Under no circumstances may the vaccine be injected.
Your child will receive two doses of the vaccine. The doses are given at different times with an interval of at least 4 weeks between the two doses. The first dose can be given from 6 weeks of age. Both vaccine doses must be given before 24 weeks of age, and should preferably be given before 16 weeks of age.
Rotarix can be given according to the same vaccination schedule to infants born prematurely, provided the pregnancy lasts for at least 27 weeks.
If your child spits out or vomits most of the vaccine dose, a new vaccine dose can be given on the same vaccination occasion.
When Rotarix is given to your child as the first dose, it is recommended that your child also receive Rotarix (and not another rotavirus vaccine) as the second dose.
You must follow the instructions from your doctor and nurse regarding return visits. If you miss an appointment, ask your doctor for advice.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects may occur with this vaccine:
- Common (these may occur in up to 1 in 10 vaccine doses):
- diarrhea
- irritability
- Uncommon (these may occur in up to 1 in 100 vaccine doses):
- abdominal pain (see also below for signs of intestinal invagination, which is a very rare side effect )
- gases
- dermatitis
Side effects reported after the launch of Rotarix:
- Very rare: hives ( urticaria )
- Very rare: intestinal invasion (part of the intestine is twisted and thus blocked). Signs of this can be severe abdominal pain, repeated and persistent vomiting, blood in the stool, swollen stomach, and/or high fever. Contact your doctor/healthcare professional immediately if your child experiences any of these symptoms
- blood in the stool
- in children born prematurely (born week 28 or earlier in pregnancy), there may be longer than usual respiratory arrest for 2-3 days after vaccination
- Children with an unusual hereditary disease called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or intestine ( gastroenteritis ), which causes the vaccine virus to pass out with the feces. Signs of gastroenteritis may include nausea, vomiting, stomach cramps, or diarrhea.
How to store Rotarix
Keep this vaccine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
The vaccine should be used immediately after opening the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is:
Human rotavirus strain RIX4414 (live attenuated) * not less than 6.0 CCID 50
* produced on Vero cells - The other ingredients in Rotarix are sucrose, disodium Adipate, and Dulbecco’s Modified Eagle Medium (DMEM) (which contains phenylalanine, sodium, glucose, and other substances), sterile water, (see also section 2, “Rotarix contains sucrose, glucose, phenylalanine, and sodium” ). )
What Rotarix looks like and the contents of the pack
Oral suspension
Rotarix is supplied as a clear colorless liquid in a single-dose tube (1.5 ml).
Rotarix is supplied in packs of 1, 10, or 50.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals SA / NVTel: + 32 10 85 52 00 | LithuaniaGlaxoSmithKline Biologicals SATel: +370 80000334 |
| BulgariaGlaxoSmithKline Biologicals SATel. +359 80018205 | Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals SA / NVTel / + .: + 32 10 85 52 00 |
| Czech RepublicGlaxoSmithKline sroTel: + 420 2 22 00 11 11cz.info@gsk.com | HungaryGlaxoSmithKline Biologicals SATel .: +36 80088309 |
| DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com | MaltaGlaxoSmithKline Biologicals SATel: +356 80065004 |
| GermanyGlaxoSmithKline GmbH & Co. KGTel: + 49 (0) 89 360448701produkt.info@gsk.com | The NetherlandsGlaxoSmithKline BVTel: + 31 (0) 33 2081100nlinfo@gsk.com |
| EestiGlaxoSmithKline Biologicals SATel: +372 8002640 | NorwayGlaxoSmithKline ASTel: + 437 22 70 20 00 |
| GreeceGlaxoSmithKlineAEBE ActingTηλ: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbH.Tel .: + 43 (0) 1 97075 0at.info@gsk.com |
| SpainGlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com | PolandGSK Services Sp. z ooTel: + 48 (22) 576 9000 |
| FranceGlaxoSmithKline LaboratoryTel: + 33 (0) 1 39 17 84 44diam@gsk.com | PortugalSmith Kline & French Portuguesa – ProductsTel: + 351 21 412 95 00 FI.PT@gsk.com |
| CroatiaGlaxoSmithKline Biologicals SATel .: +385 800787089 | Romania GlaxoSmithKline Biologicals SATel: +40 800672524 |
| IrelandGlaxoSmithKline (Ireland) LtdTel: + 353 (0) 1 4955000 | SloveniaGlaxoSmithKline Biologicals SATel: +386 80688869 |
| IcelandVistor hf.Phone: +354 530 3700 | Slovak RepublicGlaxoSmithKline Slovakia SATel: +421 800500589recepcia.sk@gsk.com |
| ItalyGlaxoSmithKline SpATel: + 39 (0) 45 7741 111 | Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 10 30 30 30 |
| ΚύπροςGlaxoSmithKline Biologicals SA:Ηλ: +357 80070017 | SwedenGlaxoSmithKline ABTel: + 46 (0) 8 638 93 00info.produkt@gsk.com |
| LatviaGlaxoSmithKline Biologicals SATel: +371 80205045 | United Kingdom (Northern Ireland)GlaxoSmithKline Biologicals SATel: + 44 (0) 800 221 441customercontactuk@gsk.com |