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Zaltrap (aflibercept) – Labelling - L01XX44

Updated on site: 11-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

ZALTRAP 25 mg/ml concentrate for solution for infusion aflibercept

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of 4 ml contains 100 mg of aflibercept (25 mg/ml).

One vial of 8 ml contains 200 mg of aflibercept (25 mg/ml).

3.LIST OF EXCIPIENTS

Also contains sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

100 mg/4 ml

1 vial

3 vials

200 mg/8 ml

1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Single-dose vial

Read the package leaflet before use.

For intravenous use only. Use only after dilution.

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

Shelf life after dilution: see package leaflet.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Store in the original package 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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe 54, rue La Boétie 75008 Paris

France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/814/001 1 vial (100 mg/4 ml)

EU/1/12/814/002 3 vials (100 mg/4 ml)

EU/1/12/814/003 1 vial (200 mg/8 ml)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

ZALTRAP 25 mg/ml sterile concentrate aflibercept

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg/4 ml

200 mg/8 ml

6.OTHER

For intravenous use only.

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