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Revatio (sildenafil) – Labelling - G04BE03

Updated on site: 09-Oct-2017

Medication nameRevatio
ATC CodeG04BE03
Substancesildenafil
ManufacturerPfizer Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER PACKAGING/CARTON

1.NAME OF THE MEDICINAL PRODUCT

Revatio 20 mg film-coated tablets

Sildenafil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg of sildenafil (as citrate).

3.LIST OF EXCIPIENTS

Contains lactose monohydrate.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

90 film-coated tablets

90 x 1 film-coated tablets

300 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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

Do not store above 30oC. 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

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/05/318/001

EU/1/05/318/004

EU/1/05/318/005

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Revatio 20 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

VIAL CARTONAND VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Revatio 0.8 mg/ml solution for injection

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains 0.8 mg of sildenafil (as citrate). Each 20 ml vial contains 12.5 ml (10 mg sildenafil, as citrate).

3. LIST OF EXCIPIENTS

Contains glucose and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 vial 10 mg/12.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous 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

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

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/318/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Revatio 0.8 mg/ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS IMMEDIATE PACKAGING/BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Revatio 20 mg tablets

Sildenafil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer

3.EXPIRY DATE

EXP

4.BATCH NUMBER

LOT

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Revatio 10 mg/ml powder for oral suspension

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution each ml of the suspension contains 10 mg of sildenafil (as citrate). One bottle of reconstituted suspension (112 ml) contains 1.12 g of sildenafil (as citrate).

3. LIST OF EXCIPIENTS

Contains sorbitol.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension 1 bottle

1 press-in bottle adapter, 1 measuring cup and 1 oral dosing syringe

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake bottle well before use.

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

Powder: Do not store above 30oC. Store in the original package in order to protect from moisture.

After reconstitution: Store below 30°C or in refrigerator at 2°C to 8°C. Do not freeze. Discard any remaining oral suspension 30 days after constitution.

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

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/318/003

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Revatio 10 mg/ml

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Revatio 10 mg/ml powder for oral suspension

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One bottle of reconstituted suspension (112 ml) contains 1.12 g of sildenafil (as citrate). After reconstitution 1 ml contains 10 mg of sildenafil (as citrate).

3. LIST OF EXCIPIENTS

Contains sorbitol.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake bottle well before use.

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

Powder: Do not store above 30oC. Store in the original package in order to protect from moisture.

After reconstitution: Store below 30°C or in refrigerator at 2°C to 8°C. Do not freeze. Discard any remaining suspension30 days after constitution.

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

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/318/003

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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