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Palonosetron Accord (palonosetron) – Labelling - A04AA05

Updated on site: 09-Oct-2017

Medication namePalonosetron Accord
ATC CodeA04AA05
Substancepalonosetron
ManufacturerAccord Healthcare Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 250 micrograms of palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml).

3.LIST OF EXCIPIENTS

Excipients: mannitol, citric acid monohydrate, sodium citrate ,disodium edetate, sodium hydroxide, hydrochloric acid concentrated, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 x 5 ml vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Single use only.

Read the package leaflet before use.

Intravenous 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

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

Any unused solution should be discarded.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1104/001

13.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 SMALL IMMEDIATE PACKAGING UNITS

LABEL

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

Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride)

I.V. use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 mcg/5 ml

6.OTHER

Comments

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