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NutropinAq (somatropin) – Labelling - H01AC01

Updated on site: 08-Oct-2017

Medication nameNutropinAq
ATC CodeH01AC01
Substancesomatropin
ManufacturerIpsen Pharma

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

{CARTON - 1 CARTRIDGE}

1.NAME OF THE MEDICINAL PRODUCT

NutropinAq 10 mg/2 ml (30 IU), solution for injection

Somatropin

2.STATEMENT OF ACTIVE SUBSTANCE

One ml contains 5 mg of somatropin

One cartridge contains 10 mg (30 IU) of somatropin

3.LIST OF EXCIPIENTS

Other ingredients: sodium chloride, liquefied phenol, polysorbate 20, sodium citrate, citric acid anhydrous and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

1 cartridge containing 2 ml solution for injection

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before use.

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

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP: {date}

After first opening, use before 28 days at 2°C – 8°C.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the blister in the outer carton.

Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C.

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

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/164/003

13.BATCH NUMBER

Lot: {number}

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

NutropinAq 10 mg/2 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

{CARTON - 3 CARTRIDGES}

1. NAME OF THE MEDICINAL PRODUCT

NutropinAq 10 mg/2 ml (30 IU), solution for injection

Somatropin

2. STATEMENT OF ACTIVE SUBSTANCE

One ml contains 5 mg of somatropin

One cartridge contains 10 mg (30 IU) of somatropin

3. LIST OF EXCIPIENTS

Other ingredients: sodium chloride, liquefied phenol, polysorbate 20, sodium citrate, citric acid anhydrous and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

3 cartridges containing 2 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP: {date}

After first opening, use before 28 days at 2°C – 8°C.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the blister in the outer carton.

Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C.

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

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/164/004

13. BATCH NUMBER

Lot: {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NutropinAq 10 mg/2 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

{CARTON - 6 CARTRIDGES}

1. NAME OF THE MEDICINAL PRODUCT

NutropinAq 10 mg/2 ml (30 IU), solution for injection

Somatropin

2. STATEMENT OF ACTIVE SUBSTANCE

One ml contains 5 mg of somatropin

One cartridge contains 10 mg (30 IU) of somatropin

3. LIST OF EXCIPIENTS

Other ingredients: sodium chloride, liquefied phenol, polysorbate 20, sodium citrate, citric acid anhydrous and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

6 cartridges containing 2 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP: {date}

After first opening, use before 28 days at 2°C – 8°C.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the blister in the outer carton.

Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C.

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

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/164/005

13. BATCH NUMBER

Lot: {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NutropinAq 10 mg/2 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {BLISTER}

1. NAME OF THE MEDICINAL PRODUCT

NutropinAq 10 mg/2 ml (30 IU) solution for injection

Somatropin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma.

3.EXPIRY DATE

EXP: {date}

4.BATCH NUMBER

Lot: {number}

5.OTHER

Subcutaneous use.

Read the package leaflet before use.

Store in a refrigerator.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {CARTRIDGE}

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NutropinAq 10 mg/2 ml

SC

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP: {date}

4. BATCH NUMBER

Lot: {number}

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6.OTHER

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