oral solution
Rotavirus vaccine (live)
What RotaTeq is and what it is used for
RotaTeq is an oral vaccine that helps protect infants and toddlers from gastroenteritis (diarrhea and vomiting) caused by rotavirus infection and can be given to infants from 6 to 32 weeks of age (see section 3). The vaccine contains 5 types of live rotavirus strains. When an infant receives the vaccine, the immune system (the body’s defenses) produces antibodies against the most common types of rotavirus. The antibodies help protect against gastroenteritis caused by these types of rotavirus.
What you need to know before your child receives RotaTeq
Do not use RotaTeq
- if your child is allergic to any of the ingredients of this vaccine (see section 6). Contents of the package and other information).
- if your child has developed an allergic reaction after receiving a dose of RotaTeq or any other rotavirus vaccine.
- if your child has had an intestinal invasion (a bowel obstruction where one section of the intestine encloses another section).
- if your baby was born with a malformation of the gastrointestinal tract that could lead to susceptibility to intestinal invasion.
- if your child has a disease that reduces his / her resistance to infection.
- if your child has a serious infection and a high fever. It may be necessary to postpone vaccination until after recovery. A milder infection, such as a cold, should not be a problem, however, talk to your doctor first.
- if your child has diarrhea or vomiting. It may be necessary to postpone vaccination until after recovery.
Warnings and cautions
Talk to your doctor or pharmacist before your child receives RotaTeq about your child:
- have undergone a blood transfusion or received immunoglobulin in the last 6 weeks.
- has close contact with, for example, a family member who has a weakened immune system, e.g. a person who has cancer or who is taking medications that may weaken the immune system.
- have any disturbance in the gastrointestinal tract.
- has not increased in weight and height as can be expected.
- or if the mother has taken a medicine during pregnancy that weakens the immune system.
Contact your doctor or healthcare professional immediately if your child experiences severe abdominal pain, persistent vomiting, blood in the stool, bloated stomach, and/or high fever after receiving RotaTeq (see also section 4 “Possible side effects”).
As usual, be sure to wash your hands thoroughly when changing dirty diapers.
Like all vaccines, RotaTeq may not completely protect all children who are vaccinated, even when all three doses have been taken.
If your child has already been infected with rotavirus but is not yet ill at the time of vaccination, RotaTeq may not be able to prevent the disease.
RotaTeq does not protect against diarrhea and vomiting due to causes other than rotavirus.
Other medicines and RotaTeq
RotaTeq can be given at the same time as your child receives other commonly recommended vaccinations, such as vaccine against diphtheria, tetanus, pertussis (pertussis), Haemophilus influenzae type b, inactivated or oral poliomyelitis vaccine, hepatitis B vaccine, a conjugate vaccine against pneumococcal infections and group C meningococcal infection.
Tell your doctor or pharmacist if your child is taking, has recently taken, or might receive any other medicines (or other vaccines).
RotaTeq with food and drink
There are no restrictions on food or fluid intake, including breast milk, either before or after vaccination with RotaTeq.
RotaTeq contains sucrose
If you have been told by your child that you have an intolerance to some sugars, tell your doctor/nurse before taking the vaccine.
RotaTeq contains sodium
This vaccine contains 37.6 mg sodium (the main ingredient in common salt/table salt) per dose. This corresponds to 1.88% of the maximum recommended daily sodium intake for adults.
How to use RotaTeq
RotaTeq is for oral use only.
A doctor or nurse will give the recommended dose of RotaTeq to your child. The vaccine is given by gently squeezing the tube and pouring the vaccine into your child’s mouth. The vaccine can be given independently of food, liquid, or breast milk. If the child spits out or vomits most of the vaccine dose, a single dose can be given as a replacement during the same vaccination visit.
The vaccine must not be injected under any circumstances.
The first dose of one (2 ml) RotaTeq can be given from 6 weeks of age and should be given before 12 weeks of age (about 3 months). RotaTeq may be given to premature infants provided the pregnancy lasts at least 25 weeks. These infants should receive the first dose of a vaccine between 6 and 12 weeks after birth.
Your child will receive 3 doses of RotaTeq at least four weeks apart. Your child must receive all 3 doses of the rotavirus protection vaccine. It is recommended that all three doses be given at 20-22 weeks of age. All three doses must have been taken at 32 weeks of age.
When RotaTeq is given to your child at the first dose, it is recommended that your child also receive RotaTeq (and not any other rotavirus vaccine) to complete the vaccine regimen.
If you forgot a visit for RotaTeq
You must follow your doctor’s instructions on your child’s return visit for the follow-up doses. If you forget or can not return to the doctor at the agreed time, consult the doctor.
Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Contact your doctor or healthcare professional immediately if your child has any of the following symptoms:
- Allergic reactions (occurring in an unknown number of infants) may be severe ( anaphylaxis ) and may include: allergic swelling that may affect the face, lips, tongue, or throat.
- Tracheal spasm (bronchial spasm) (rare, may affect up to 1 in 1,000 babies). This may occur as wheezing, coughing, or difficulty breathing.
- Severe abdominal pain, persistent vomiting, blood in the stool, swollen stomach, and/or high fever. These can be symptoms of a very rare (can occur in up to 1 in 10,000 infants) but serious side effect called intestinal invagination (a bowel obstruction where one part of the intestine encloses another part).
Other side effects reported with RotaTeq are the following:
- Very common (may affect more than 1 in 10 people): fever, diarrhea, vomiting
- Common (may affect up to 1 in 10 babies): upper respiratory tract infections
- Uncommon (may affect up to 1 in 100 people): abdominal pain (see also above for signs of the very rare side effect an intestinal invasion), runny nose and sore throat, ear infection, rash, blood in the stool
- Rare (may affect up to 1 in 1,000 babies): hives
- Has been reported (occurs in an unknown number of infants): irritability
In very premature babies (born in or before the 28th week of pregnancy), longer than normal breaks between breaths can occur for 2-3 days after vaccination.
Contact your doctor/nurse for more information on the side effects of RotaTeq.
How to store RotaTeq
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 label after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 o C-8 o C). Store the dosing tube in the outer carton. Sensitive to light.
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 for RotaTeq
| G1 | 2.2 x 10 6 infectious devices |
| G2 | 2.8 x 10 6 infectious devices |
| G3 | 2.2 x 10 6 infectious devices |
| G4 | 2.0 x 10 6 infectious devices |
| P1A [8] | 2.3 x 10 6 infectious devices |
The other ingredients in RotaTeq are sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids, and vitamins ), and purified water.
What the medicine looks like and the contents of the pack
Oral solution.
This vaccine is found in an end stub and is a pale yellow clear liquid that may have a pink tint.
RotaTeq is available in packs of 1 or 10 dosing tubes. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Merck Sharp & Dohme, BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
Manufacturer responsible for batch release: Merck Sharp & Dohme, BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
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