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Zypadhera (olanzapine pamoate) – Labelling - N05AH03

Updated on site: 11-Oct-2017

Medication nameZypadhera
ATC CodeN05AH03
Substanceolanzapine pamoate
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection

1.NAME OF THE MEDICINAL PRODUCT

ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine. After reconstitution: 150 mg/ml olanzapine.

3.LIST OF EXCIPIENTS

The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.

4.PHARMACEUTICAL FORM AND CONTENTS

One vial of powder for prolonged release suspension for injection.

One vial of 3 ml solvent.

One Hypodermic syringe and safety needle.

Three Hypodermic safety needles.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use.

Do not administer intravenously or subcutaneously.

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

Vial of suspension after reconstitution: 24 hours.

Once withdrawn from vial into syringe, suspension should be used immediately.

9.SPECIAL STORAGE CONDITIONS

Do not refrigerate or freeze.

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12.MARKETING AUTHORISATION NUMBER (S)

EU/1/08/479/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to restricted medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial Label ZYPADHERA 210 mg powder for prolonged release suspension for injection

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

ZYPADHERA 210 mg powder for prolonged release injection olanzapine

IM

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

210 mg

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection

1. NAME OF THE MEDICINAL PRODUCT

ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine. After reconstitution: 150 mg/ml olanzapine.

3. LIST OF EXCIPIENTS

The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

One vial of powder for prolonged release suspension for injection.

One vial of 3 ml solvent.

One Hypodermic syringe and safety needle.

Three Hypodermic safety needles.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use.

Do not administer intravenously or subcutaneously.

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

Vial of suspension after reconstitution: 24 hours.

Once withdrawn from vial into syringe, suspension should be used immediately.

9. SPECIAL STORAGE CONDITIONS

Do not refrigerate or freeze.

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER (S)

EU/1/08/479/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to restricted medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial Label ZYPADHERA 300 mg powder for prolonged release suspension for injection

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

ZYPADHERA 300 mg powder for prolonged release injection olanzapine

IM

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

300 mg

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection

1. NAME OF THE MEDICINAL PRODUCT

ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine. After reconstitution: 150 mg/ml olanzapine.

3. LIST OF EXCIPIENTS

The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

One vial of powder for prolonged release suspension for injection.

One vial of 3 ml solvent.

One Hypodermic syringe and safety needle.

Three Hypodermic safety needles.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intramuscular use.

Do not administer intravenously or subcutaneously.

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.

8.OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

Vial of suspension after reconstitution: 24 hours.

Once withdrawn from vial into syringe, suspension should be used immediately.

9. SPECIAL STORAGE CONDITIONS

Do not refrigerate or freeze.

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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER (S)

EU/1/08/479/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to restricted medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial Label ZYPADHER 405 mg powder for prolonged release suspension for injection

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

ZYPADHERA 405 mg powder for prolonged release injection olanzapine

IM

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

405 mg

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial Label

Solvent for ZYPADHERA

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

Solvent for ZYPADHERA

IM

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

3 ml

6. OTHER

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