Uni 5: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Per 0.5 mL Diphtheria toxoid 25 Lf (not <30 IU), tetanus toxoid 5.5 Lf (not <60 IU), B. pertussis (whole cell) 16 IOU (not <4 IU), r-HBsAg 12.5 mcg, purified capsular polysaccharide of Hib (PRP) covalently linked to 20-36.7 mcg of tetanus toxoid 11 mcg, Al phosphate not >1.25 mg

Indications/Uses

Active immunization against diphtheria, tetanus, pertussis, hepatitis B & HIB disease in infants from 6 wk.

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Dosage/Direction for Use

Administer as deep IM inj, preferably in the anterolateral aspect of the thigh. Primary vaccination 3 doses of 0.5 mL each w/in the 1st 6 mth. 3 doses at 6-10-14-wk of age must be administered at intervals of at least 4 wk. For Thailand, infants should receive 3 doses at 2, 4, & 6 mth of age.

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Overdosage

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Contraindications

Hypersensitivity. Severe reaction to previous dose. Convulsions/seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormalities.

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Special Precautions

Do not inj IV. Rare anaphylactic event. Postpone vaccination in patients w/ acute severe febrile illness. Monitor patient for at least 30 min after immunization. Not to be used for treatment of diphtheria, tetanus, pertussis, hepatitis-B or HIB infection. Temp ≥40°C w/in 48 hr not due to another identifiable cause, collapse or shock-like state (hypotonic-hyporesponsive episode) w/in 48 hr, persistent crying lasting ≥3 hr occurring w/in 48 hr, convulsions w/ or w/o fever occurring w/in 3 days. High incidence of pertussis. Immunosuppressed patients or those on immunosuppressive therapy. Patients w/ thrombocytopenia or bleeding disorder. History of febrile convulsions, family history of convulsions & sudden infant death syndrome. Review medical history especially w/ regard to previous vaccination & possible occurrence of undesirable events.

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Use In Pregnancy & Lactation

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Adverse Reactions

Pain, swelling, fever.

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Drug Interactions

Concomitant use w/ anticoagulant therapy. May reduce immune response to vaccines w/ immunosuppressive therapies including irradiations, anti-metabolites, alkylating agents, cytotoxic drugs & corticosteroids (used in greater than physiological doses).

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07AG52 - haemophilus influenzae B, combinations with pertussis and toxoids ; Belongs to the class of hemophilus influenzae B vaccines.

Thai FDA Category

Presentation/Packing

Form

Uni 5 susp for inj

Packing/Price

0.5 mL x 10 × 1's

Uni 5

Manufacturer:

Biological E. Limited

Distributor:

Biogenetech