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MabThera (rituximab) – Labelling - L01XC02

Updated on site: 08-Oct-2017

Medication nameMabThera
ATC CodeL01XC02
Substancerituximab
ManufacturerRoche Registration Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

MabThera 100 mg concentrate for solution for infusion

Rituximab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 10 mg/mL rituximab.

3.LIST OF EXCIPIENTS

Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 100 mg / 10 mL

2 vials of 10 mL

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after dilution

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

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Keep the container in the outer carton, in order to protect from light

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/98/067/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

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

VIAL LABEL

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

MabThera 100 mg concentrate for solution for infusion

Rituximab

IV

2.METHOD OF ADMINISTRATION

For intravenous use after dilution

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Vial of 10 mL (10 mg/mL) 100 mg / 10 mL

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

MabThera 500 mg concentrate for solution for infusion

Rituximab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 10 mg/mL rituximab.

3. LIST OF EXCIPIENTS

Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 500 mg / 50 mL

1 vial of 50 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after dilution

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

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Keep the container in the outer carton, in order to protect from light

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/067/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

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

VIAL LABEL

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

MabThera 500 mg concentrate for solution for infusion

Rituximab

IV

2. METHOD OF ADMINISTRATION

For intravenous use after dilution

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Vial of 50 mL (10 mg/mL) 500 mg / 50 mL

6. OTHER

PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS

MabThera Alert Card for patients with non-oncology diseases

Why have I been given this card?

This medicine may make you more likely to get infections. This card tells you:

What you need to know before having MabThera

What the signs of an infection are

What to do if you think you might be getting an infection.

It also includes your name and

doctor’s name and phone number on the back.

What should I do with this card?

Keep this card with you all the time - such as in your wallet or purse.

Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your MabThera.

Keep this card with you for 2 years after your last dose of MabThera. This is because side effects can develop several months after you have had treatment.

When should I not have MabThera?

Do not have MabThera if you have an active infection or a serious problem with your immune system.

Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.

What are the signs of getting an infection?

Look out for the following possible signs of infection:

Fever or cough all the time

What else do I need to know?

Rarely MabThera can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML. This can be fatal.

Signs of PML include:

-Confusion, memory loss or problems thinking

-Loss of balance or a change in the way you walk or talk

-Decreased strength or weakness on one side of your body

-Blurred vision or loss of vision.

If you get any of these, tell a doctor or nurse straight away. You should also tell them about your MabThera treatment.

Where can I get more information?

See the MabThera package leaflet for more information.

Treatment start date and contact details

Date of most recent infusion: ____________

Date of first infusion: ___________________

Patient’s Name:________________________

Doctor’s Name:________________________

Doctor’s contact details:_________________

Make sure you have a list of all your medicines when you see a health care professional.

Please talk to your doctor or nurse if you have any questions about the information in this card.

Weight loss

Pain without injuring yourself

Feeling generally unwell or listless.

If you get any of these, tell a doctor or nurse straight away.

You should also tell them about your MabThera treatment.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

MabThera 1400 mg solution for subcutaneous injection

rituximab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 1400 mg/11.7 mL rituximab.

3. LIST OF EXCIPIENTS

Recombinant human hyaluronidase (rHuPH20) L-histidine

L-histidine hydrochloride monohydrate, -trehalose dehydrate

L-methionine

Polysorbate 80 Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1400 mg/11.7 mL

1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use only

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

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Keep the vial in the outer carton, in order to protect from light.

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/067/003

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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

VIAL LABEL

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

MabThera 1400 mg solution for subcutaneous injection

rituximab

subcutaneous

2. METHOD OF ADMINISTRATION

Only for subcutaneous use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1400 mg/11.7 mL

6. OTHER

Information to appear on Peel-off sticker

MabThera 1400 mg rituximab

1400 mg/11.7 mL

SC for Non-Hodgkin’s Lymphoma

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

MabThera 1600 mg solution for subcutaneous injection

rituximab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 1600 mg/13.4 mL rituximab.

3. LIST OF EXCIPIENTS

Recombinant human hyaluronidase (rHuPH20) L-histidine

L-histidine hydrochloride monohydrate, -trehalose dehydrate

L-methionine

Polysorbate 80 Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1600 mg/13.4 mL

1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use only

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

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Keep the vial in the outer carton, in order to protect from light.

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/067/004

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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

VIAL LABEL

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

MabThera 1600 mg solution for subcutaneous injection

rituximab

subcutaneous

2. METHOD OF ADMINISTRATION

Only for subcutaneous use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1600 mg/13.4 mL

6. OTHER

Information to appear on Peel-off sticker

MabThera 1600 mg rituximab

1600 mg/13.4 mL

SC for Chronic Lymphocytic Leukaemia

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