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RotaTeq (rotavirus serotype G1, serotype G2,...) – Labelling - J07BH02

Updated on site: 10-Oct-2017

Medication nameRotaTeq
ATC CodeJ07BH02
Substancerotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1
ManufacturerMSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

RotaTeq – Pack size of 1 single-dose(2ml) Tube

RotaTeq – Pack size of 10 single-dose(2ml) Tubes

1.NAME OF THE MEDICINAL PRODUCT

RotaTeq, oral solution

Rotavirus vaccine, live

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (2 ml) contains rotavirus type*:

2.2 x 106 IU1

G1

G2

2.8 x 106

IU1

G3

2.2 x 106

IU1

G4

2.0 x 106

IU1

P1A[8]

2.3 x 106

IU1

* human-bovine rotavirus reassortants (live), produced in Vero cell.

1Infectious Units

3.LIST OF EXCIPIENTS

Sucrose

4.PHARMACEUTICAL FORM AND CONTENTS

2 ml oral solution in a tube pack size of 1 tube

pack size of 10 tubes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

FOR ORAL USE ONLY

Read the package leaflet before use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Keep the dosing tube in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Please read the package leaflet for disposal of medicines no longer required

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/348/001 pack of 1 tube

EU/1/06/348/002 pack of 10 tubes

13.MANUFACTURER’S BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Text for the protective bag

1. NAME OF THE MEDICINAL PRODUCT

RotaTeq, oral solution

Rotavirus vaccine, live

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

1 dose

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

tube label

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

RotaTeq

Oral solution

Oral use

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (2 ml)

6.OTHER

MSD VACCINS

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