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NeuroBloc (botulinum toxin type B) – Package leaflet - M03AX01

Updated on site: 08-Oct-2017

Medication nameNeuroBloc
ATC CodeM03AX01
Substancebotulinum toxin type B
ManufacturerEisai Ltd.

Package leaflet: Information for the user

NeuroBloc 5000 U/ml Solution for Injection

Botulinum Toxin Type B

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have further questions, please ask your doctor or pharmacist.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What NeuroBloc is and what it is used for

2.What you need to know before you use NeuroBloc

3.How to use NeuroBloc

4.Possible side effects

5.How to store NeuroBloc

6.Contents of the pack and other information

1.What NeuroBloc is and what it is used for

NeuroBloc injection works by reducing or stopping muscle contractions. It contains the active ingredient ‘Botulinum Toxin Type B’.

NeuroBloc is used to treat an illness called cervical dystonia (torticollis). This is where you have contractions of your neck or shoulder muscles that you cannot control.

2. What you need to know before you use NeuroBloc

Do not use NeuroBloc:

-if you are allergic to Botulinum Toxin Type B or any of the other ingredients of NeuroBloc (listed in section 6)

-if you have other problems with your nerves or muscles, such as amyotrophic lateral sclerosis (Lou Gehrig's disease), peripheral neuropathy, myasthenia gravis or Lambert-Eaton syndrome (muscle weakness or numbness or pain)

-if you have been experiencing shortness of breath or difficulty swallowing

You must not be given NeuroBloc if any of the above applies to you. If you are not sure talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before using NeuroBloc:

-if you have a bleeding problem such as haemophilia

-if you have lung problems

-if you have difficulty swallowing. This is because swallowing problems could make you breathe food or liquids into your lungs, which could then cause very serious pneumonia

General precaution:

NeuroBloc has been approved for the treatment of cervical dystonia only and should not be used to treat anything else. The safety of NeuroBloc when used to treat other conditions is not known: some side effects may be fatal.

Children and adolescents

NeuroBloc is not to be used in children aged 0-18 years.

Other medicines and NeuroBloc

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because NeuroBloc can affect the way some medicines work and other medicines can also affect the way NeuroBloc works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

-aminoglycoside antibiotics for an infection

-medicines to stop blood clotting, such as warfarin

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are given NeuroBloc.

Before having an operation

If you are going to have an operation, please tell your doctor that you have been given NeuroBloc. This is because NeuroBloc can affect the medicines you may be given before a general anaesthetic.

Pregnancy, breast feeding and fertility

-you will not normally be given NeuroBloc if you are pregnant or breast-feeding. This is because it is not known how NeuroBloc affects patients who are pregnant and it is not known if NeuroBloc passes into a nursing mother’s breast milk

-if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Driving and using machines

You may have muscle weakness or eye problems such as blurred vision or eyelid drooping after being given NeuroBloc. If this happens, do not drive or use any tools or machines.

NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc. This means it is essentially “sodium free”.

3.How to use NeuroBloc

NeuroBloc will be given to you by a doctor with specialist experience in the treatment of cervical dystonia and in the use of botulinum toxins.

How much will be given

-your doctor will decide how much NeuroBloc to give you

-the usual dose is 10,000 units, however, it can be higher or lower

-if you have had NeuroBloc injections before, your doctor will take into account how well it worked the other times

How NeuroBloc is given

-NeuroBloc will be injected into your neck or shoulder muscles, depending on which ones are causing the problem

-your doctor may inject part of the dose into different places in your muscles

Having more injections of NeuroBloc

-the effects of NeuroBloc will usually last about 12 to 16 weeks

-your doctor will decide if you need another injection and how much to give you

If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.

If you are given more NeuroBloc than you should

-if you have been given more NeuroBloc than you need, some of your muscles that were not injected may feel weak or you may develop symptoms away from the injected muscles, like difficulty in swallowing or breathing. This may occur when higher doses of up to 15,000 units are given

-if you have difficulty breathing or you are worried by any symptoms you develop away from the place of the injection, talk to your doctor immediately. If he/she is unavailable seek emergency assistance. You may need urgent medical treatment

A serious condition called “botulism” which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body. If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored. Recovery usually takes place over a period of time.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They may happen days to weeks after you have had the injection. You may feel pain at the place where you had the injection, but this should wear off after a few minutes.

You may get a dry mouth and it might become difficult to swallow. In rare cases difficulty in swallowing may be severe and choking is possible. If your swallowing difficulty gets worse or you have choking or breathing problems, see a doctor immediately. You may need urgent medical treatment.

Aspiration pneumonia caused by food particles or vomit entering into the lungs, and respiratory disease, have been reported after treatment with botulinum toxins (Type A and Type B). These side effects have sometimes resulted in death and are possibly related to the spread of botulinum toxin to body parts away from the place where the injection is given.

Other side effects include:

Very common (may affect more than 1 in 10 people)

-dry mouth

-difficulty swallowing

-headache

Common (may affect up to 1 in 10 people)

-blurred vision or drooping of your upper eyelid

-indigestion or being sick (vomiting)

-constipation

-neck pain

-feeling weak, pain or stiff muscles around your body

-loss of strength or energy

-changes in the taste of your food and drink

-changes in the sound of your voice

-flu-like symptoms

Skin allergies such as rash with or without paleness, redness, patches, severe itching; and skin eruptions such as welts or hives have also been reported after receiving NeuroBloc. The frequency of these side effects is not known.

It is possible that cervical dystonia could become worse after you have had your injection.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store NeuroBloc

-keep this medicine out of the sight and reach of children

-do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP

-store in a refrigerator (2°C-8°C). Do not freeze

-keep the vial in the outer carton in order to protect from light

-Within its shelf-life, NeuroBloc may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25oC. At the end of this period, the product should not be put back in the refrigerator and should be disposed of

-the date at which the medicine was taken out from the refrigerator will be put on the outer carton

-if the medicine is diluted, the doctor will use it immediately

-before using the medicine the doctor will check that the solution is clear and colourless/light yellow. If there are any visible signs of deterioration, the medicine should not be used, but discarded

-any unused solution should be discarded

-due to the special nature of NeuroBloc, the doctor will ensure that all used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements

6.Contents of the pack and other information

What NeuroBloc contains

The active substance is Botulinum Toxin Type B. One millilitre (ml) contains 5000 U.

One vial of 0.5 ml contains 2500 U of Botulinum Toxin Type B.

One vial of 1 ml contains 5000 U of Botulinum Toxin Type B.

One vial of 2 ml contains 10,000 U of Botulinum Toxin Type B.

The other ingredients are disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid (for pH adjustment) and water for injections.

What NeuroBloc looks like and contents of the pack

NeuroBloc is presented as a solution for injection in a vial that contains 0.5 ml (2500 Units), 1.0 ml (5000 Units) or 2.0 ml (10,000 Units). The solution is clear and colourless to pale yellow.

Pack size of 1.

Marketing Authorisation holder

Eisai Limited

Mosquito Way

Hatfield

Herts

AL10 9SN

United Kingdom

Manufacturer

Eisai Manufacturing Limited

Mosquito Way

Hatfield

Herts

AL10 9SN

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Eisai Europe Ltd.

Eisai Ltd.

Tél/Tel: + 32 (0) 2 502 58 04

Tel. + 44 (0) 208 600 1400

 

(Jungtinė Karalystė)

България

Luxembourg/Luxemburg

Eisai Ltd.

Eisai Europe Ltd.

Teл.: + 44 (0) 208 600 1400

Tél/Tel: + 32 (0) 2 502 58 04

Обединено кралство

(Belgique/Belgien)

 

Česká republika

Magyarország

Eisai GesmbH organizační složka

Valeant Pharma Hungary

Tel: + 420 242 485 839

Tel.: + 36 1 230 43 20

Danmark

Malta

Eisai AB

Associated Drug Company Ltd

Tlf: +46 (0) 8 501 01 600

Tel: +356 2277 8000

(Sverige)

 

Deutschland

Nederland

Eisai GmbH

Eisai B.V.

Tel: + 49 (0) 69 66 58 50

Tél/Tel: + 31 (0) 900 575 3340

Eesti

Norge

Eisai Ltd.

Eisai AB

Tel: + 44 (0) 208 600 1400

Tlf: + 46 (0) 8 501 01 600

(Ühendkuningriik)

(Sverige)

Ελλάδα

Österreich

Arriani Pharmaceuticals S.A.

Eisai GesmbH

Τηλ: + 30 210 668 3000

España

Polska

Eisai Farmacéutica, S.A.

Eisai Ltd.

Tel: +(34) 91 455 94 55

Tel.: + 44 (0) 208 600 1400

 

(Wielka Brytania)

France

Portugal

Eisai SAS

Eisai Farmacêutica,Unipessoal Lda

Tél: + (33) 1 47 67 00 05

Tel: +351 214 875 540

Hrvatska

România

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(Marea Britanie)

(Velika Britanija)

 

Ireland

Slovenija

Eisai Ltd.

Eisai Ltd.

Tel: + 44 (0) 208 600 1400

Tel: + 44 (0) 208 600 1400

(United Kingdom)

(Velika Britanija)

Ísland

Slovenská republika

Eisai AB

Eisai GesmbH organizační složka

Sími: + 46 (0) 8 501 01 600

Tel: + 420 242 485 839

(Svíþjóð)

(Česká republika)

Italia

Suomi/Finland

Eisai S.r.l.

Eisai AB

Tel: + 39 02 5181401

Puh/Tel: + 46 (0) 8 501 01 600

 

(Ruotsi/Sverige)

Κύπρος

Sverige

 

 

Arriani Pharmaceuticals S.A.

Eisai AB

 

 

Τηλ: +30 210 668 3000

Tel: + 46

(0)

8 501 01 600

Latvija

United Kingdom

Eisai Ltd.

Eisai Ltd.

 

Tel: + 44 (0) 208 600 1400

Tel: + 44

(0)

208 600 1400

(Lielbritānija)

 

 

 

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

-------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

NeuroBloc is provided in vials for single use only.

The medicinal product is ready to use and no reconstitution is required. Do not shake.

To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2 of Summary of Product Characteristics). Such dilutions with sodium chloride should be done in a syringe, pulling out the desired amount of NeuroBloc into the syringe first, and then adding sodium chloride to the syringe. In non clinical experiments, NeuroBloc solution has been diluted up to 6-fold without any resulting change in potency. Once diluted, the medicinal product must be used immediately as the formulation does not contain a preservative.

Any unused solution, all vials of expired NeuroBloc and equipment used in the administration of the medicinal product should be carefully discarded as Medical Bioharzardous Waste in accordance with local requirements. Vials should be visually inspected prior to use. If the NeuroBloc solution is not clear and colourless/light yellow or if the vial appears damaged, the product should not be used, but discarded as Medical Biohazardous Waste in accordance with local requirements.

Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach –2 ml (0.5%): 1 litre water) solution. Wear waterproof gloves and soak up the liquid with an appropriate absorbent. Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.

Do not use after the expiration date stamped on the vial.

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