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Eliquis (apixaban) – Labelling - B01AF02

Updated on site: 06-Oct-2017

Medication nameEliquis
ATC CodeB01AF02
Substanceapixaban
ManufacturerBristol-Myers Squibb / Pfizer EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON 2.5 mg

1.NAME OF THE MEDICINAL PRODUCT

Eliquis 2.5 mg film-coated tablets apixaban

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 2.5 mg apixaban.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

20 film-coated tablets

60 film-coated tablets

60 x 1 film-coated tablets

100 x 1 film-coated tablets

168 film-coated tablets

200 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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

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

Bristol-Myers Squibb/Pfizer EEIG, Bristol-Myers Squibb House,

Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex

UB8 1DH

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/691/001

EU/1/11/691/002

EU/1/11/691/003

EU/1/11/691/004

EU/1/11/691/005

EU/1/11/691/013

EU/1/11/691/015

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Eliquis 2.5 mg

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 BLISTERS OR STRIPS BLISTER 2.5 mg

1. NAME OF THE MEDICINAL PRODUCT

Eliquis 2.5 mg tablets apixaban

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb/Pfizer EEIG

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 2.5 mg (Symbol)

1. NAME OF THE MEDICINAL PRODUCT

Eliquis 2.5 mg tablets apixaban

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb/Pfizer EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

sun as symbol moon as symbol

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON 5 mg

1. NAME OF THE MEDICINAL PRODUCT

Eliquis 5 mg film-coated tablets apixaban

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg apixaban.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

20 film-coated tablets

28 film-coated tablets

56 film-coated tablets

60 film-coated tablets

100x 1 film-coated tablets

168 film-coated tablets

200 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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

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

Bristol-Myers Squibb/Pfizer EEIG, Bristol-Myers Squibb House,

Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex

UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/691/006

EU/1/11/691/007

EU/1/11/691/008

EU/1/11/691/009

EU/1/11/691/010

EU/1/11/691/011

EU/1/11/691/012

EU/1/11/691/014

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Eliquis 5 mg

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 BLISTERS OR STRIPS BLISTER 5 mg

1. NAME OF THE MEDICINAL PRODUCT

Eliquis 5 mg tablets apixaban

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb/Pfizer EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PATIENT ALERT CARD

Eliquis (apixaban)

Patient Alert Card

Carry this card with you at all times

Show this card to your pharmacist, dentist and any other healthcare professionals that treat you. I am under anticoagulation treatment with Eliquis (apixaban) to prevent blood clots

Please complete this section or ask your doctor to do it

Name:

Birth Date:

Indication:

Dose: mg twice daily

Doctor's Name:

Doctor's telephone:

Information for patients

Take Eliquis regularly as instructed. If you miss a dose, take it as soon as you remember and continue to follow your dosing schedule.

Do not stop taking Eliquis without talking to your doctor, as you are at risk of suffering from a stroke or other complications.

Eliquis helps to thin your blood. However, this may increase your risk of bleeding.

Signs and symptoms of bleeding include bruising or bleeding under the skin, tar-coloured stools, blood in urine, nose-bleed, dizziness, tiredness, paleness or weakness, sudden severe headache, coughing up blood or vomiting blood.

If the bleeding does not stop on its own, seek medical attention immediately.

If you need surgery, inform your doctor that you are taking Eliquis.

Information for healthcare professionals

Eliquis (apixaban) is an oral anticoagulant acting by direct selective inhibition of factor Xa.

Eliquis may increase the risk of bleeding. In case of major bleeding events, it should be stopped immediately.

Treatment with Eliquis does not require routine monitoring of exposure. A calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations, e.g., overdose and emergency surgery (prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) clotting tests are not recommended) – see SmPC.

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