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Indications:

Indicated for the active immunisation of infants and children from 6 weeks to 9 years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae. active against Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F

Contraindications:

•Hypersensitivity to any component of the vaccine, including diphtheria toxoid. •The occurrence of an allergic reaction, or anaphylactoid reaction following prior administration

Adverse reactions:

Administration site conditions: Erythema, induration/ swelling, pain/ tenderness. Induration/ swelling or erythema >2.4cm. Tenderness interfering with movement. - - Injection site dermatitis, injection site urticaria, injection site pruritus. General disorders: Fever ≥ 38 °C. Fever > 39 °C. - - - Gastrointestinal disorders: Decreased appetite, vomiting, diarrhoea. - - - - Nervous system disorders: Drowsiness, restless sleep. - - Seizures (including febrile seizures), hypotonic-hyporesponsive episode. - Psychiatric disorders: Crying, irritability. - - - - Skin & subcutaneous tissue disorders: - Rash, urticaria or urticaria-like rash. - Angioneurotic oedema, erythema multiforme. Immune system disorders: - - - - Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, anaphylactic/ anaphylactoid reaction including shock. Blood and lymphatic system disorders: - - - - Lymphadeno-pathy localised to the region of the injection site

Interactions:

During clinical studies, administered simultaneously with diphtheria-tetanus-pertussis vaccine (DTP) or diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus Influenzae type B vaccine (Hib), oral polio vaccine (OPV) or inactivated polio vaccine (IPV), hepatitis B vaccines, meningococcal serogroup C conjugate vaccine, measles-mumps-rubella vaccine (MMR) and varicella vaccine. Thus, the safety experience reflects the use of this product as part of the routine immunisation schedule. In some studies, differences in antibody response to some of the antigens have been inconsistently found, however, this is not anticipated to be of any clinical relevance. Data on concomitant administration with Meningitec (meningococcal serogroup C conjugate vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as primary series vaccinations Immunogenicity data from controlled clinical trials with concurrent administration are not available for Hib (PRP-OMP), Hib (PRP-OMP)-HepB and Tripacel brand DTPa (see Australian Standard Vaccine Schedule).

Warnings:

•Not recommended for use in adult populations. •Do not administer intravenously. •As with any vaccine, may not protect 100% of individuals receiving the vaccine. will not protect against Streptococcus pneumoniae serotypes other than those included in the vaccine, nor against other micro-organisms that cause invasive disease or otitis media.

Form:

Suspension for injection in a vial.

Dosage and Administration

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Consultants Corner

Dr. Tahsin Martini

Dr. Tahsin Martini Degree status: M.D. in Ophthalmology

Yaser Habrawi , F.R.C.S.Ed

Yaser Habrawi , F.R.C.S.Ed Consultant Ophthalmologist

Samir Moussa M.D.

Samir Moussa M.D. ENT Specialist

Dr. Faisal Dibsi

Dr. Faisal Dibsi Specialist of Otolaryngology - Head and Neck Surgery

Dr . Dirar Abboud

Dr . Dirar Abboud Hepatologist – Gastroenterologist

Dr. Hani Najjar

Dr. Hani Najjar Pediatrics, Neurology

Dr. Talal Sabouni

Dr. Talal Sabouni UROLOGY AND KIDNEY TRANSPLANT

Dr. Samer Al-Jneidy

Dr. Samer Al-Jneidy Pediatrician
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