Pcv Suspension

PCV - 10 CIPLA is a vaccine that contains ten polysaccharide serotypes from the bacterium, Streptococcus pneumoniae, as antigens or active substances of the medicine. PCV - 10 CIPLA is used to immunise (or in the prevention of) children, aged 6 weeks to 24 months, against diseases caused by Streptococcus pneumoniae, which include meningitis (inflammation around the brain), sepsis or bacteraemia (bacteria in the blood stream), pneumonia (lung infection) and ear infections.

PCV - 10 CIPLA should not be given to you or your child if the following applies to you or your child:

• Allergic to the active substances or to any of the other ingredients in this medicine (listed in section 6.1) or to any other vaccine that contains diphtheria toxoid.

Warnings and precautions:

Tell your health care professional if you have or your child has any of the following conditions:

• An allergic reaction in the previous vaccination schedule.
• An existing infection, signs include having a fever and a general feeling of being unwell.
• Blood clotting disorders and you or your child are receiving treatment for these disorders, e.g., being prone to bleeding or bruising easily.
• A weak immune system, e.g., if your baby was born prematurely or having HIV disease.
• Breathing problems in premature infants.
• If your child was born very prematurely (at or before 28 weeks of gestation), particularly if your child has a history of breathing problems, as longer gaps than normal between breaths may occur for 2 - 3 days after vaccination with PCV - 10 CIPLA.

Other medicines and PCV - 10 CIPLA:

Always tell your health care provider if you or your child is receiving any other medicine. This includes all complementary or traditional medicines.

Driving and using machines:

Data on “Effects on ability to drive and use machines” are not available.

You will not be expected to give your child or yourself PCV - 10 CIPLA. It will be given to you by a person who is qualified to do so. The doctor or nurse will inject the recommended dose of PCV - 10 CIPLA preferably into the thigh in infants or upper arm in young children.

Babies less than 6 months of age: typically, your child should receive an initial course of three injections followed by a booster dose:

• The first injection may be given from the age of six weeks or two months of age.
• Each injection will be given one month to two months apart.
• A fourth injection (booster) will be given between 9 to 10 months or 12 to 15 months of age.
• You will be told when your child should come back for the next injection.

Babies who missed PCV - 10 CIPLA vaccination in the first 6 months of life will receive PCV - 10 CIPLA doses as follows:

• Catch-up schedule for children aged 7 to 11 months: two primary doses with an interval of at least 1 month between doses. A third or booster dose will be given in the second year of life, at least 2 months after the last primary dose.
• Catch-up schedule for children aged 12 to 24 months: two doses with an interval of at least 2 months between doses.

Since a health care provider will administer PCV - 10 CIPLA, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Since a health care provider will administer PCV - 10 CIPLA, it is unlikely that the dose will be missed. If you or your child misses an appointment date, visit the health care provider as soon as you remember.

PCV - 10 CIPLA can have side effects. Not all side effects reported for PCV - 10 CIPLA are included in this leaflet. Should your/your child’s general health worsen or if he/she experiences any untoward effects while taking PCV - 10 CIPLA, please consult your health care provider for advice. If any of the following happens, tell your doctor immediately and go to the casualty department at your nearest hospital:

• Anaphylaxis, a life-threatening allergic reaction and may be indicated by swollen face, throat or mouth causing breathing/eating difficulties, itchy and/or painful skin rash.

These are all very serious side effects. If you/your child has them, you/your child may have had a serious reaction to PCV - 10 CIPLA. You/your child may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following:

Frequent side effects:

• Flu-like illness
• Decreased appetite
• Irritability
• Rash
• Fever
• Reddening at the injection site
• Drowsiness
• Pain

Less frequent side effects:

• Diarrhoea (runny tummy)

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

Reporting of suspected adverse reactions: If you get 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. By reporting side effects, you can help provide more information on the safety of PCV - 10 CIPLA.

PCV-10 CIPLA must be stored at 2 °C to 8 °C, in the refrigerator. Shake well. Do not freeze. Discard if the vaccine has been frozen. A fine white deposit with clear colourless supernatant may be observed upon storage of the vial. The does not constitute a sign of deterioration.