Rotarix Dosage & Drug Information

Concise Prescribing Info Bahasa 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 Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Per 1.5 mL Live attenuated human rotavirus RIX4414 strain not <10⁶ CCID₅₀

Indications/Uses

Prevention of gastroenteritis caused by rotavirus.

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Dosage/Direction for Use

Oral vaccination course consists of 2 doses. The 1^st dose may be administered from 6 wk. There should be an interval of at least 4 wk between doses. The vaccination course should be completed by 24 wk.

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Overdosage

View Rotarix overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity after previous administration or to any component of Rotarix. History of intussusception, uncorrected congenital malformation of the GIT eg, Meckel's diverticulum, severe combined immunodeficiency disorder (SCID).

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Special Precautions

For oral use only & do not inj. Postpone vaccination in patients w/ acute severe febrile illness, diarrhea or vomiting. Infants w/ GI illnesses; symptoms indicative of intussusception; immunosuppressed infant, patients w/ immunodeficient close contacts eg, individuals w/ malignancies, immunocompromised or on immunosuppressive therapy. Protective immune response may not be elicited in all vaccinees. Does not protect against gastroenteritis due to other pathogens than rotavirus. Not for use in adults.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhoea; irritability.

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Drug Interactions

Concomitant use of oral polio vaccine (OPV) may slightly reduce the immune response to rotavirus vaccine.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Rotarix detailed prescribing information

Storage

View Rotarix storage conditions for details to ensure optimal shelf-life.

Description

View Rotarix description for details of the chemical structure and excipients (inactive components).

Action

View Rotarix mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.

Regulatory Classification

Presentation/Packing

Form

Rotarix vaccine oral susp

Packing/Price

((oral applicator)) 1's; ((squeezable tube)) 10 × 1's; ((squeezable tube)) 1's; ((squeezable tube)) 50 × 1's

Rotarix

rotavirus vaccine

Manufacturer:

GlaxoSmithKline Indonesia