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Ritemvia (rituximab) – Labelling - L01XC02

Updated on site: 10-Oct-2017

Medication nameRitemvia
ATC CodeL01XC02
Substancerituximab
ManufacturerCelltrion Healthcare Hungary Kft.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ritemvia 500 mg concentrate for solution for infusion

Rituximab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 500 mg of rituximab

1 mL contains 10 mg of rituximab

3.LIST OF EXCIPIENTS

Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 500 mg / 50 mL

1 vial

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

Celltrion Healthcare Hungary Kft. 1051 Budapest

Bajcsy-Zsilinszky út 12., 4. em. 410. Hungary

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1207/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

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

Ritemvia 500 mg concentrate for solution for infusion

Rituximab

Intravenous use

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

(10 mg/mL)

500 mg / 50 mL

6.OTHER

PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS

Ritemvia 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 Ritemvia

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 Ritemvia.

Keep this card with you for 2 years after your last dose of Ritemvia.

This is because side effects can develop several months after you have had treatment.

When should I not have Ritemvia?

Do not have Ritemvia 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 else do I need to know?

Rarely Ritemvia 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 Ritemvia treatment.

Where can I get more information?

See the Ritemvia 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.

What are the signs of getting an infection?

Look out for the following possible

signs of infection:

Fever or cough all the time

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 Ritemvia treatment.

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