Infanrix-IPV+Hib

Infanrix-IPV+Hib

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid not <30 IU, tetanus toxoid not <40 IU, pertussis toxoid 25 mcg, filamentous hemagglutinin 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; HIB polysaccharide 10 mcg
Indications/Uses
Active immunisation in infants ≥2 mth against DPT, poliomyelitis & HIB. Booster dose for childn who have previously been immunised w/ DPT, polio & HIB antigens.
Dosage/Direction for Use
Deep IM inj (anterolateral thigh) Primary vaccination Three 0.5-mL doses in the 1st 6 mth of life starting from 2 mth of age w/ at least 1-mth interval between subsequent doses. Booster vaccination Recommended in the 2nd yr of life, w/ an interval of at least 6 mth after completion of primary vaccination schedule.
Contraindications
Hypersensitivity to any component of the vaccine, or after previous administration of DPT, inactivated polio or HIB vaccines. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine.
Special Precautions
Do not administer IV. Does not protect against diseases caused by other types of H. influenzae nor against meningitis caused by other organisms. Hypersensitivity to neomycin & polymyxin. Postpone vaccination in patients w/ acute severe febrile illness. Thrombocytopenia or bleeding disorders. Syncope as psychogenic response to the needle inj. Subsequent dose of vaccine should be carefully considered if any of the following occur: Rectal temp ≥40°C w/in 48 hr of unidentifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) w/in 48 hr of vaccination; persistent, inconsolable crying lasting ≥3 hr w/in 48 hr of vaccination; convulsion w/ or w/o fever w/in 3 days of vaccination. Progressive neurological disorders in childn including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Consider risk of apnea & resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) & those w/ history of resp immaturity. Not recommended in adults, adolescent or childn >5 yr. Pregnancy & lactation.
Adverse Reactions
Appetite loss; irritability, abnormal crying, restlessness; somnolence; inj site reactions eg, pain & redness, local swelling (≤50 mm), fever (≥38°C). Diarrhoea, vomiting; inj site reaction including induration, local swelling at inj site (>50 mm).
Drug Interactions
Different inj vaccines should always be administered at different inj sites. Adequate response may not be achieved in patients receiving immunosuppressive therapy.
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 susp for inj
Packing/Price
0.5 mL x 2's (P2,061/box)
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