Infanrix-IPV+Hib

Infanrix-IPV+Hib

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Per 0.5 mL Adsorbed diphtheria toxoid not <30 IU, adsorbed tetanus toxoid not <40 IU, pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, pertactin 8 mcg, inactivated poliovirus type 1 (Mahoney) 40 D-antigen U, type 2 (MEF-1) 8 D-antigen U & type 3 (Saukett) 32 D-antigen U, H. influenzae type b polysaccharide 10 mcg (conjugated to tetanus toxoid approx 25 mcg), adsorbed on Al hydroxide hydrated (Al(OH)3 0.5 mg Al3+
Indications/Uses
Active immunization in infants from 2 mth against DTP, poliomyelitis & HIB. Booster dose for childn previously immunized w/ DTP, polio & HIB antigens.
Dosage/Direction for Use
Deep IM inj in anterolateral thigh Primary vaccination 3 doses of 0.5 mL in the 1st 6 mth of life, starting from age 2 mth w/ at least 1 mth interval between subsequent doses. Booster dose Given in the 2nd yr of life w/ at least 6 mth interval after completion of primary vaccination schedule.
Contraindications
Hypersensitivity to any components of Infanrix-IPV+Hib. Hypersensitivity after previous administration of DTP, inactivated polio or HIB vaccines. Encephalopathy of unknown etiology occurring w/in 7 days following previous vaccination w/ pertussis containing vaccine.
Special Precautions
Hypersensitivity to neomycin & polymyxin. Does not protect against diseases caused by other types of H. influenzae nor against meningitis caused by other organisms. Postpone vaccination in patients w/ acute severe febrile illness. Do not administer IV. Thrombocytopenia or bleeding disorder. Syncope (fainting) may occur. Patients receiving immunosuppressive therapy. Rectal temp ≥40°C, collapse or shock-like state (hypotonic-hyporesponsive episode), persistent & inconsolable crying lasting ≥3 hr, occurring w/in 48 hr of vaccination; convulsion w/ or w/o fever w/in 3 days of vaccination. In childn w/ progressive neurological disorders eg, infantile spasms, uncontrolled epilepsy or progressive encephalopathy. History of febrile convulsions, family history of convulsions, Sudden Infant Death syndrome or adverse event following DTP, IPV &/or HIB vaccination. Excretion of capsular polysaccharide antigen in the urine. Consider risk of apnoea & monitor resp for 48-72 hr in very premature infants (≤28 wk of gestation) & those w/ history of resp immaturity. Not recommended in adults, adolescents & childn >5 yr.
Adverse Reactions
Appetite loss; irritability, crying abnormal, restlessness; somnolence; pain & redness, local swelling (≤50 mm) at the inj site, fever (≥38°C). Diarrhoea, vomiting; inj site reactions eg, induration, local swelling (>50 mm).
Drug Interactions
Adequate response may not be achieved w/ immunosuppressive therapy or patients w/ immunodeficiency.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Infanrix-IPV+Hib vaccine (inj)
Packing/Price
(pre-filled syringe + 1 dose vial) 0.5 mL x 2's
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