Infanrix Hexa

Infanrix Hexa

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, HBsAg 10 mcg; inactivated poliomyelitis virus 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
Primary & booster vaccination against DPT, hepatitis B, poliomyelitis & HIB in infants & toddlers.
Dosage/Direction for Use
Deep IM inj Full-term infant 3-dose primary vaccination Three 0.5-mL doses w/ at least 1 mth interval between primary doses. Give booster dose at least 6 mth after the last priming dose, preferably before 18 mth of age. Full-term infant 2-dose primary vaccination Two 0.5-mL doses w/ at least 1 mth interval between primary doses. Give booster dose at least 6 mth after the last priming dose, preferably between 11 & 13 mth of age. Preterm infant born after at least 24 wk of gestational age 3-dose primary vaccination Three 0.5-mL doses w/ at least 1 mth interval between primary doses. Give booster dose at least 6 mth after the last priming dose, preferably before 18 mth of age. Where a dose of hepatitis B vaccine is given at birth, Infanrix Hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of 6 wk.
Contraindications
Hypersensitivity; after previous administration of DPT, hepatitis B, polio or HIB vaccines. Encephalopathy of unknown etiology occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine.
Special Precautions
Do not administer intravascularly/intradermally. Postpone vaccination in patients w/ acute severe febrile illness. Will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or HIB. Subsequent dose of vaccine should be carefully considered if any of the following occur: 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 including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Thrombocytopenia or bleeding disorders. Syncope may occur. Consider risk of apnea & resp monitoring for 48-72 hr in very preterm infants (≤28 wk of gestation) & those w/ history of resp immaturity. +ve urine test can be observed w/in 2 wk following vaccination, perform other tests to confirm HIB infection. Not intended for use in adults. Pregnancy & lactation.
Adverse Reactions
Appetite loss; irritability, abnormal crying, restlessness; somnolence; inj site pain, redness, local swelling (≤50 mm), fever ≥38°C. Nervousness; vomiting, diarrhoea; pruritus; local swelling at the inj site (>50 mm), fever >39.5°C, inj site reactions including induration.
Drug Interactions
Higher rate of febrile reactions w/ pneumococcal conjugate vaccine. More frequent occurrence of fever, pain at inj site, appetite loss & irritability w/ MenB vaccine & 7-valent pneumococcal conjugate vaccine. Adequate response may not be achieved in patients receiving immunosuppressive therapy.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Infanrix Hexa susp for inj
Packing/Price
0.5 mL x 2's
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