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Aloxi (palonosetron hydrochloride) – Labelling - A04AA05

Updated on site: 05-Oct-2017

Medication nameAloxi
ATC CodeA04AA05
Substancepalonosetron hydrochloride
ManufacturerHelsinn Birex Pharmaceuticals Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Aloxi 250 micrograms solution for injection

Palonosetron (as hydrochloride)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).

Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).

3.LIST OF EXCIPIENTS

Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 x 5 ml vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intravenous use

Single use only

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

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/306/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL

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

Aloxi 250 micrograms solution for injection

Palonosetron

IV use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aloxi 500 micrograms soft capsules

Palonosetron

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 500 micrograms palonosetron. (as hydrochloride).

3. LIST OF EXCIPIENTS

Also contains sorbitol. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 soft capsule.

5 soft capsules.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Republic of Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/306/002

EU/1/04/306/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aloxi 500 micrograms

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Aloxi 500 micrograms soft capsules

Palonosetron

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Helsinn

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.OTHER

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