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Components of
Rotavirus Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

Prevention of Rotavirus Gastroenteritis

Proprietary Name

RotaTeq

Rotarix

Manufacturer

Merck

GlaxoSmith Kline

Viability

Live

Live

Microorganism

Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7) from the bovine rotavirus parent strain

The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain

Derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells.

After reconstitution, the final formulation (1 mL) contains at least 106 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.

Dose

2 mL

1 mL
Recommended Age 6-32 weeks 6-24 weeks

Route

Oral

Oral

Dose form

Liquid

Liquid

Appearance

Pale yellow clear liquid that may have a pink tint

White and turbid

Concentration

2.0 - 2.8 x 106 infectious units of each reassortant

≥ 106 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus

Preservatives

None

None

Adjuvant

None

None

Excipients

Fetal bovine serum (trace)

Polysorbate 80

Sodium citrate

Sodium phosphate monobasic monohydrate

Sodium hydroxide

Sucrose

Amino Acids
Calcium carbonate
Calcium chloride
Concentrated Vitamin solution
Dextran
D-glucose
Dulbecco's Modified Eagle Medium (DMEM)
Ferric nitrate
L-cystine
L-glutamine
L-tyrosine
Magnesium Sulfate
Phenol red
Sodium chloride
Sodium phosphate
Sodium pyruvate
Solidum hydrogenocarbonate
Sorbitol
Sucrose
Xanthan

Allergens

Fetal bovine serum (trace) Latex, contained in the oral applicator

Media

Cell culture

Dulbeccos Modified Eagle Medium (DMEM)

Packaging

1 individually pouched single-dose tube

10-pack of individually pouched single-dose tubes

ROTARIX is available as a vial of lyophilized vaccine, a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution.

Routine Storage

Store and transport refrigerated at 2-8C (36-46F). RotaTeq should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.

Protect from light

May be stored refrigerated at 2 to 8C (36 to 46F) or at room temperature up to 25C (77F), after reconstitution.

Discard the reconstituted vaccine if not used within 24 hours in biological waste container. Do not freeze.

Discard if the vaccine has been frozen.

Package Insert last updated June 2013 September 2012

updated June 2013

This page was last updated on February 12, 2014

2014 Institute for Vaccine Safety