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Ganfort (bimatoprost / timolol) – Labelling - S01ED51

Updated on site: 07-Oct-2017

Medication nameGanfort
ATC CodeS01ED51
Substancebimatoprost / timolol
ManufacturerAllergan Pharmaceuticals Ireland

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR SINGLE BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution bimatoprost/timolol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).

3.LIST OF EXCIPIENTS

Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution, 3 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Remove contact lenses before use.

8.EXPIRY DATE

EXP

Discard four weeks after first opening.

Opened:

9.SPECIAL STORAGE CONDITIONS

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/340/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

GANFORT

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING THREE BOTTLES

1.NAME OF THE MEDICINAL PRODUCT

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution bimatoprost/timolol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)

3.LIST OF EXCIPIENTS

Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution, 3 x 3 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Remove contact lenses before use.

8.EXPIRY DATE

EXP

Discard four weeks after first opening.

Opened (1)

Opened (2)

Opened (3)

9.SPECIAL STORAGE CONDITIONS

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/340/002

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

GANFORT

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE

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

GANFORT 0.3 mg /ml + 5 mg/ml eye drops, solution bimatoprost/timolol

Ocular use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS

1.NAME OF THE MEDICINAL PRODUCT

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).

3.LIST OF EXCIPIENTS

Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 5 x 0.4 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Once the pouch is opened, use the single-dose containers within 7 days.

9.SPECIAL STORAGE CONDITIONS

Keep single-dose containers in the pouch in order to protect from light and moisture.

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

Discard the opened single-dose container immediately after use.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/340/003-005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

For single use only

16.INFORMATION IN BRAILLE

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS

1.NAME OF THE MEDICINAL PRODUCT

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).

3.LIST OF EXCIPIENTS

Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 5 x 0.4 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Keep single-dose containers in the pouch in order to protect from light and moisture.

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

Discard the opened single-dose container immediately after use.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/340/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

For single use only

16.INFORMATION IN BRAILLE

GANFORT single-dose

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 6 POUCHES, EACH CONTAINING 5 SINGLE-DOSE CONTAINERS)

1.NAME OF THE MEDICINAL PRODUCT

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).

3.LIST OF EXCIPIENTS

Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 30 x 0.4 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Keep single-dose containers in the pouch in order to protect from light and moisture.

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

Discard the opened single-dose container immediately after use.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/340/004

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

For single use only

16.INFORMATION IN BRAILLE

GANFORT single-dose

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS (PROVIDED IN 18 POUCHES, EACH CONTAINING 5 SINGLE-DOSE CONTAINERS)

1.NAME OF THE MEDICINAL PRODUCT

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).

3.LIST OF EXCIPIENTS

Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 90 x 0.4 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular 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

Keep single-dose containers in the pouch in order to protect from light and moisture.

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

Discard the opened single-dose container immediately after use.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/340/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

For single use only

16.INFORMATION IN BRAILLE

GANFORT single-dose

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SINGLE-DOSE CONTAINER

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

GANFORT bimatoprost/timolol

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6.OTHER

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