RotaTeq

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RotaTeq uses


1 INDICATIONS AND USAGE

RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age .

RotaTeq® is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9. (1)

RotaTeq is approved for use in infants 6 weeks to 32 weeks of age. (1)

2 DOSAGE AND ADMINISTRATION

FOR ORAL USE ONLY. NOT FOR INJECTION.

The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age .

There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.

Do not mix the RotaTeq vaccine with any other vaccines or solutions. Do not reconstitute or dilute .

For storage instructions .

Each dose is supplied in a container consisting of a squeezable plastic dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch .

2.1 Use with Other Vaccines

In clinical trials, RotaTeq was administered concomitantly with other licensed pediatric vaccines .

2.2 Instructions for Use

To administer the vaccine:

What do I do if my child misses a dose of RotaTeq?

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your doctor will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your doctor for advice.

What else should I know about RotaTeq?

This leaflet gives a summary of certain information about the vaccine. If you have any questions or concerns about RotaTeq, talk to your doctor.

What are the ingredients in RotaTeq?

5 live rotavirus strains (G1, G2, G3, G4, and P1).

Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.

Parts of porcine circovirus (a virus that infects pigs) types 1 and 2 have been found in RotaTeq. Porcine circovirus type 1 (PCV-1) and porcine circovirus type 2 (PCV-2) are not known to cause disease in humans.

Rx only

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Copyright © 2008, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

Revised: 06/2013

USPPI-OS-V2601306R019


PRINCIPAL DISPLAY PANEL - Carton 10 Single-Dose 2 mL Tubes

Manuf. and Dist. by:

Merck Sharp & Dohme Corp., a sub. of

MERCK & CO., INC.

Whitehouse Station, NJ 08889, USA

NDC 0006-4047-41

10 Single-Dose

2 mL Tubes

Rotavirus Vaccine, Live,

Oral, Pentavalent

RotaTeq®

FOR ORAL USE ONLY. NOT FOR INJECTION.

Administer orally without mixing with any

other vaccines or solutions.

Each 2 mL oral dose contains 5 rotavirus reassortants that have been propagated

in Vero cells. The minimum dose levels (infectious units, IU) are as follows:

G1 (2.2 x 106) IU; G2 (2.8 x 106) IU; G3 (2.2 x 106) IU; G4 (2.0 x 106) IU and P1 (2.3 x 106) IU.

RotaTeq contains no preservatives.

Rx only

PRINCIPAL DISPLAY PANEL - Carton 10 Single-Dose 2 mL Tubes

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RotaTeq pharmaceutical active ingredients containing related brand and generic drugs:


RotaTeq available forms, composition, doses:


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Frequently asked Questions

Can i drive or operate heavy machine after consuming RotaTeq?

Depending on the reaction of the RotaTeq after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider RotaTeq not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is RotaTeq addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on RotaTeq, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of RotaTeq consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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