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Elonva (corifollitropin alfa) – Labelling - G03GA09

Updated on site: 06-Oct-2017

Medication nameElonva
ATC CodeG03GA09
Substancecorifollitropin alfa
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Elonva 100 micrograms solution for injection corifollitropin alfa

2.STATEMENT OF ACTIVE SUBSTANCE

Each pre-filled syringe contains 100 micrograms of corifollitropin alfa in 0.5 mL solution for injection.

3.LIST OF EXCIPIENTS

Other ingredients: sodium citrate, sucrose, polysorbate 20, methionine, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pre-filled syringe with an automatic safety (needle injury prevention) system and a sterile injection needle. 0.5 mL

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Subcutaneous use (SC)

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

Storage by the pharmacist

Store in a refrigerator. Do not freeze

Storage by the patient

There are two options:

1.Store in a refrigerator. Do not freeze.

2.Store at or below 25°C for a period of not more than 1 month.

Keep the syringe 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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBERS

EU/1/09/609/001

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

PRE-FILLED SYRINGE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Elonva 100 micrograms injection corifollitropin alfa

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 mL

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Elonva 150 micrograms solution for injection corifollitropin alfa

2. STATEMENT OF ACTIVE SUBSTANCE

Each pre-filled syringe contains 150 micrograms of corifollitropin alfa in 0.5 mL solution for injection.

3. LIST OF EXCIPIENTS

Other ingredients: sodium citrate, sucrose, polysorbate 20, methionine, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pre-filled syringe with an automatic safety (needle injury prevention) system and a sterile injection needle. 0.5 mL.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Subcutaneous use (SC)

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

Storage by the pharmacist

Store in a refrigerator. Do not freeze.

Storage by the patient

There are two options:

1.Store in a refrigerator. Do not freeze.

2.Store at or below 25°C for a period of not more than 1 month.

Keep the syringe 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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBERS

EU/1/09/609/002

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

PRE-FILLED SYRINGE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Elonva 150 micrograms injection corifollitropin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 mL

6. OTHER

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