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Iasibon (ibandronic acid) – Labelling - M05BA06

Updated on site: 07-Oct-2017

Medication nameIasibon
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerPharmathen S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Iasibon 1 mg concentrate for solution for infusion ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (sodium monohydrate).

3. LIST OF EXCIPIENTS

Sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion. 1 ampoule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, for infusion 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

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any special storage conditions prior to reconstitution. After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)

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

Pharmathen S.A. 6, Dervenakion str.

Pallini 15351, Attiki Greece

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/659/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Iasibon 1 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Ampoule

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

Iasibon 1 mg concentrate for solution for infusion ibandronic acid

I.V. 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

1 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Iasibon 2 mg concentrate for solution for infusion ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

Sodium acetate trihydrate sodium chloride, glacial acetic acid and water for injections.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 ampoule

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, for infusion 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

9. SPECIAL STORAGE CONDITIONS

This medicinal product does not require any special storage conditions prior to reconstitution.After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)

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

Pharmathen S.A. 6, Dervenakion str.

15351 Pallini, Attiki Greece

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/659/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Iasibon 2 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Ampoule

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

Iasibon 2 mg concentrate for solution for infusion ibandronic acid

I.V. 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

2 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Iasibon 6 mg concentrate for solution for infusion ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

Sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial

5 vials 10vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, for infusion 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

9. SPECIAL STORAGE CONDITIONS

This medicinal product does not require any special storage conditions prior to reconstitution. After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)

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

Pharmathen S.A. 6, Dervenakion str.

15351 Pallini, Attiki Greece

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/659/005

EU/1/10/659/006

EU/1/10/659/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Iasibon 6 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

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

Iasibon 6 mg concentrate for solution for infusion ibandronic acid

I.V. 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

6 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Iasibon 50 mg film-coated tablets ibandronic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).

3. LIST OF EXCIPIENTS

The tablets also contain lactose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets 3 film-coated tablets 6 film-coated tablets 9 film-coated tablets

28 film-coated tablets

84 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Do not suck, chew or crush tablets

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

Store in the original package in order to protect from moisture

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

Pharmathen S.A. 6, Dervenakion str

15351 Pallini, Attiki Greece

Tel.: +302106604300

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/659/001

EU/1/10/659/002

EU/1/10/659/008

EU/1/10/659/009

EU/1/10/659/0010

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Iasibon 50 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil

1. NAME OF THE MEDICINAL PRODUCT

Iasibon 50 mg film-coated tablets ibandronic acid

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.OTHER

Mon

Tue

Wed

Thu

Fri

Sat

Sun

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