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Stayveer (bosentan monohydrate) – Labelling - C02KX01

Updated on site: 10-Oct-2017

Medication nameStayveer
ATC CodeC02KX01
Substancebosentan monohydrate
ManufacturerMarklas Nederlands BV   

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON WITH 56 AND 112 TABLETS

OUTER CARTON/BLISTERS

1.NAME OF THE MEDICINAL PRODUCT

STAYVEER 62.5 mg film-coated tablets

bosentan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

112 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

9.SPECIAL STORAGE CONDITIONS

Do not store above 30 °C

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

Marklas Nederland BV

Beneluxlaan 2b

3446 GR Woerden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/832/001

EU/1/13/832/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

STAYVEER 62.5 mg

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 WITH 56 AND 112 TABLETS

OUTER CARTON/BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

STAYVEER 125 mg film-coated tablets

bosentan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 125 mg bosentan (as monohydrate)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

112 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C

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

Marklas Nederland BV

Beneluxlaan 2b

3446 GR Woerden

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/832/002

EU/1/13/832/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

STAYVEER 125 mg

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 AND THE IMMEDIATE

PACKAGING

CARTON WITH 56 TABLETS

OUTER CARTON & BOTTLE LABEL/ BOTTLES

1. NAME OF THE MEDICINAL PRODUCT

STAYVEER 62.5 mg film-coated tablets

bosentan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Do not swallow the desiccant

8. EXPIRY DATE

Use within 30 days after the first opening

Open date:

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

Marklas Nederland BV

Beneluxlaan 2b

3446 GR Woerden

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/832/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

STAYVEER 62.5 mg

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 AND THE IMMEDIATE

PACKAGING

CARTON WITH 56 TABLETS

OUTER CARTON & BOTTLE LABEL/ BOTTLES

1. NAME OF THE MEDICINAL PRODUCT

STAYVEER 125 mg film-coated tablets

bosentan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 125 mg bosentan (as monohydrate)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Do not swallow the desiccant

8. EXPIRY DATE

Use within 30 days after the first opening

Open date:

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

Marklas Nederland BV

Beneluxlaan 2b

3446 GR Woerden

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/832/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

STAYVEER 125 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

STAYVEER 62.5 mg tablets

bosentan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Marklas Nederland BV

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

STAYVEER 125 mg tablets

bosentan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Marklas Nederland BV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PATIENT ALERT CARD

((Front cover))

((Back cover))

Important Safety Alerts for Patients taking

Contraception

 

 

STAYVEER (bosentan)

 

Do you currently use or take contraceptives?

This card contains important information about STAYVEER. Please read this

 

Yes

 

No

 

 

 

 

card carefully before starting your treatment with STAYVEER.

 

If Yes, write the names of these here:

Your name: __________________________________________________

 

______________________________________

Prescribing doctor: ________________________________________

 

______________________________________

If you have questions about STAYVEER ask your doctor.

Take this card to your doctor or your gynaecologist at your next visit and

Marklas Nederland BV

he/she will be able to advise you on whether you need to use additional or

alternative contraceptive methods.

 

 

 

 

 

 

 

 

 

 

((Inside 1))

((Inside 2))

 

 

 

If you are a woman of childbearing age read this page carefully

Blood Test for Liver Function

 

 

Pregnancy

Some patients taking STAYVEER were found to have abnormal liver function

STAYVEER may harm the development of the foetus. Therefore, you must not

tests. During treatment with STAYVEER, your doctor will arrange for regular

take STAYVEER if you are pregnant and you must also not become pregnant

blood tests to check for changes in your liver function.

while taking STAYVEER.

Remember to have your liver blood test every month.

 

Moreover, if you are suffering from pulmonary hypertension disease, the

After an increase in dose, an additional test will be done after 2 weeks.

occurrence of a pregnancy can severely deteriorate the symptoms of your

Date of first monthly test: _________________________________

disease. If you suspect you may be pregnant, tell your doctor or gynaecologist.

 

Your monthly liver blood test schedule:

Contraception

 

 

 

 

 

Birth control based on hormones – such as oral contraceptives or birth control

 

 

 

 

pills, hormone injections, implants, or birth control skin patches don’t reliably

Jan ______

May ______

Sep _____

prevent pregnancy in women who are taking STAYVEER. You need to use a

 

 

 

 

barrier form of birth control – like a condom, diaphragm or vaginal sponge – in

Feb ______

Jun

______

Oct _____

addition to any of these kinds of hormonal birth control. Be sure to discuss any

questions you may have with your doctor or your gynaecologist – complete the

Mar ______

Jul

______

Nov _____

details on the back of this card and take it to your doctor or gynaecologist at

your next visit.

Apr ______

Aug ______

Dec _____

You should have a pregnancy test before initiation of STAYVEER and every

 

 

 

 

month during the treatment even if you think that you are not pregnant.

 

 

 

 

Date of first monthly test: _________________________________

 

 

 

 

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