Rotavac 5D, Oral liquid

ROTAVAC 5D is a rotavirus vaccine used to protect your child against gastroenteritis (gut infection causing diarrhoea and vomiting) caused by rotavirus infection. It is given to infants from the age of 6 weeks as a 3-dose series.

ROTAVAC 5D should not be given:

• If your child has had a previous allergic reaction to rotavirus vaccine or any other ingredient in ROTAVAC 5D. Including neomycin and kanamycin which are antibiotics.
• If your child has a rare inherited illness called Severe Combined Immunodeficiency Disease (SCID) which affects his/her immunity.
• If your child has previously had intussusception (IS) (a bowel obstruction in which one part of the bowel becomes enfolded within another part); or has a history of gut malformation that could lead to IS.
• If your child has a history of inherited or genetic gut disorders.
• If your child has ongoing diarrhoea and vomiting.
• If your child has a severe infection with a high fever the vaccination must be postponed.

Warnings and precautions

Tell your doctor or healthcare provider before your child receives ROTAVAC 5D:

• If your child has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken any medicine during pregnancy that may weaken the immune system.
• If your baby has been diagnosed with human immunodeficiency virus (HIV) infection.
• If your child has any disorder of the gastrointestinal system.
• If your child has not been gaining weight and growing as expected.
• If your baby has any infection, including chest infections, or severe or mild fever.
• If your child 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.

Take special care with ROTAVAC 5D: After your child has received ROTAVAC 5D, contact your doctor or healthcare provider immediately if your child has persistent vomiting, blood in the stools, a swollen belly, or a lump in the belly. As always, please take care to wash your hands thoroughly with soap and water after changing soiled nappies. AS with all vaccines, ROTAVAC 5D may not completely protect all children who were vaccinated against gastroenteritis (diarrhoea and vomiting).

Other medicines and ROTAVAC 5D:

Always tell your health care provider if your child is taking any other medicine or has recently received any other vaccine. (This includes all complementary or traditional medicines.) Your child may be given ROTAVAC 5D at the same time he/she receives other routine childhood vaccines such as the oral or inactivated polio, diphtheria-tetanus-pertussis (whooping cough), hepatitis B, and Haemophilus influenzae type B vaccines as well as pneumococcal vaccines.

ROTAVAC 5D with food and drink

There are no restrictions to your baby's liquid consumption including breast milk, either before or after vaccination with ROTAVAC 5D.

Pregnancy and breastfeeding

ROTAVAC 5D is a paediatric vaccine and should not be administered to adults, including pregnant women. Breast feeding may be continued during the immunisation schedule.

You will not be expected to give your child ROTAVAC 5D. Your doctor, nurse or healthcare provider will give the recommended dose of ROTAVAC 5D to your child. The vaccine is always given into the child’s mouth. ROTAVAC 5D should under no circumstances be injected.

Below is a representation for ROTAVAC 5D Vial.

Your child will receive 3 doses of the vaccine. The first dose (0,5 ml or 5 drops) will be given at the age of 6 weeks followed by the second dose 4 weeks later then the third and final dose 4 weeks later. ROTAVAC 5D should be given to your child before the age of 34 weeks (8 months) If your child spits out or brings the vaccine dose back up, a single replacement dose may be given at the same vaccination visit. Your child may continue to receive the remaining doses according to the vaccination schedule. If ROTAVAC 5D is given to your child as the first dose, it is recommended that your child also receives ROTAVAC 5D and not another rotavirus vaccine for the second and third doses.

ROTAVAC 5D can have side effects. Not all side effects reported for ROTAVAC 5D are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effects while taking ROTAVAC5D, please consult your healthcare provider for advice. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following side effects:

• Less frequent: Continuous vomiting, blood in stools and an abdominal (belly) lump, or if the abdomen is bloated, swollen, or inflated. These are all very serious side effects. Your child may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects: Cough, running nose, diarrhoea, fever, vomiting and irritability (crying).
• Side effects with frequency unknown: Tiredness, middle ear infection (otitis media), common cold (nasopharyngitis) and cough with wheezing (bronchospasm).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If your child gets side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by reporting to the Holder of The Registration Certificate using the email address [email protected]. By reporting side effects, you can help provide more information on the safety of ROTAVAC 5D.

Store all medicines out of reach of children. Store the vaccine between 2 °C to 8 °C (in a refrigerator). The multi-dose vial must be used in the same immunisation session or within a maximum of 6 hours. DO NOT FREEZE. Store in the original package and container. Do not use after the expiry date stated on the label. Return all unused vaccine to your pharmacist. Do not dispose of unused vaccine in drains or sewerage systems (e.g., toilets). Safely dispose of the empty vial, cap, and oral applicator in an approved biological waste container according to local regulations.

When not to use ROTAVAC 5D ROTAVAC 5D contains a vaccine vial monitor (VVM). A VVM contains a heat-sensitive material that is printed on the label to register cumulative heat exposure over time. Healthcare providers must compare the colour of the heat sensitive square to a reference circle to determine whether or not the vaccine has been exposed to too much heat and should be discarded.