5000 U / ml solution for injection
Botulinum toxin type
What NeuroBloc is and what it is used for
Injection with NeuroBloc works by reducing or stopping muscle contractions. The drug contains the active ingredient “botulinum toxin type B”.
NeuroBloc is used to treat a condition called cervical dystonia ( torticollis ). This is when you have contractions in the muscles of the neck or shoulders that you can not control.
What you need to know before using NeuroBloc
Do not use NeuroBloc:
- if you are allergic to botulinum toxin type B or any of the other ingredients of this medicine (listed in section 6)
- if you have other nerve or muscle problems such as amyotrophic lateral sclerosis (Lou Gehrig’s disease), peripheral neuropathy , myasthenia gravis or Lambert-Eaton syndrome (muscle weakness, muscle numbness or muscle pain)
- if you have experienced shortness of breath or difficulty swallowing.
You must not take NeuroBloc if any of the above apply to you. Ask your doctor or pharmacist if you are unsure.
Warnings and cautions
Talk to your doctor or pharmacist before using NeuroBloc:
- if you suffer from a bleeding disorder, e.g. haemophilia
- if you have lung problems
- if you have difficulty swallowing because difficulty swallowing can cause food or fluid to breathe into your lungs which can then cause very severe pneumonia .
General precaution:
NeuroBloc has only been approved for the treatment of cervical dystonia and must not be used to treat anything else. The safety of NeuroBloc is unknown when used to treat other conditions: some side effects can be fatal.
Children and young people
NeuroBloc should not be used in children under 18 years of age.
Other medicines and NeuroBloc
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. NeuroBloc may affect the way some medicines work and other medicines may also affect the way NeuroBloc works.
It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:
- aminoglycoside antibiotics for infection
- drugs that prevent blood clots e.g. warfarin .
Ask your doctor or pharmacist for advice before taking NeuroBloc if you are not sure if any of the above applies to you.
Before an operation
If you are going to have an operation, tell your doctor that you have received NeuroBloc, as NeuroBloc may affect the medicines you may receive before anesthesia.
Pregnancy, breastfeeding and fertility
- NeuroBloc is not normally used 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 the breast milk of a breast-feeding mother.
- 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, e.g. blurred vision or drooping eyelids, after taking NeuroBloc. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units NeuroBloc, ie. is almost sodium-free.
How to use NeuroBloc
NeuroBloc will be given to you by a doctor with specialist knowledge and experience in the treatment of cervical dystonia and the use of botulinum toxins.
How much will be given
- your doctor will decide how much NeuroBloc you should receive
- the usual dose is 10,000 units but it can be higher or lower
- if you have received NeuroBloc before, your doctor will take into account how well it worked.
How NeuroBloc is given
- NeuroBloc will be injected into your neck or shoulder muscles depending on the causes of the problems
- your doctor may inject parts of dose one into different places in your muscles.
Getting more injections of NeuroBloc
- The effect of NeuroBlock usually lasts about 12 to 16 weeks
- Your doctor will decide if you need additional injections and how much to take.
If you have the impression that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
If you take more NeuroBloc than you should
- if you have received more NeuroBloc than you need, some of the muscles that have not been injected may feel weak or you may have symptoms far from the injected muscles, such as difficulty swallowing or difficulty breathing. This can occur when a higher dose is given to you, up to 15,000 units.
- If you have difficulty breathing or are worried about any of your symptoms far from the injection site, contact your doctor immediately. Seek emergency help if he / she is not available. You may need urgent drug treatment.
A serious condition, called “botulism”, which causes muscle paralysis and respiratory failure can occur if too much of the active ingredient (botulinum toxin) is injected. If your doctor suspects that botulism may have occurred, you will be hospitalized and your breathing (lung function) will be monitored. Recovery usually occurs after a while.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. They can occur days to weeks after you received your injection. You may feel pain in the place where you received the injection, but it should go away after a few minutes.
You may become dry in the mouth and it may be difficult to swallow. In rare cases, the difficulty in swallowing can be severe and there may be a risk of suffocation. If the difficulty in swallowing becomes worse or if you have a choking attack or breathing problems, you must seek medical attention immediately. You may need urgent drug treatment.
Pneumonia caused by food particles or vomiting entering the lungs and diseases of the respiratory tract have been reported after treatment with botulinum toxin (type A and type B). These side effects have sometimes been fatal and may be due to the spread of botulinum toxin to body parts far from the injection site.
Other side effects include:
Very common (may affect more than 1 user in 10)
- dry mouth
- difficulty swallowing
- headache.
Common (may affect up to 1 in 10 people)
- blurred vision or drooping eyelids
- indigestion or nausea (vomiting)
- constipation
- neck pain
- weakness, ache or muscle stiffness around the body
- powerlessness or energy loss
- changes in the taste of what you eat and drink
- change in how your voice sounds
- flu-like symptoms .
Skin allergies such as rash with or without pallor, redness, blemishes, severe itching, and raised skin rashes, e.g. streaks and hives, have been reported after treatment with NeuroBloc. The frequency of these side effects is unknown.
It is possible that the cervical dystonia could get worse after you receive your injection .
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 vial after EXP.
- Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
- Keep the vial in the outer carton. Sensitive to light.
- During the shelf life, NeuroBloc can be stored outside the refrigerator for a single period of up to 3 months, at a maximum of 25 ° C. At the end of this period, the product must not be put back in the refrigerator but must be discarded.
- The date when the product was taken out of the refrigerator must be stated on the outer packaging.
- If the medicine is ready for use, your doctor will use it immediately.
- Before using the medicine, check that the solution is clear and colorless or light yellow. If there are any visible signs of deterioration, the medicine should not be used but discarded.
- Any unused solution must be discarded.
- Due to the special nature of NeuroBlock’s, your doctor will make sure that all used vials, needles and syringes are treated as medical hazardous waste according to current regulations.
Contents of the package and other information
Content declaration
The active substance is botulinum toxin type B. One milliliter (ml) contains 5000 E.
A 0.5 ml vial 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 the medicine looks like and contents of the pack
NeuroBloc is a solution for injection in a vial containing 0.5 ml (2500 units), 1.0 ml (5000 units) or 2.0 ml (10,000 units).
The solution is clear and colorless to light yellow.
Pack size 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sloan Pharma S.à.rl
33, Rue du Puits Romain
8070 Bertrange
Luxembourg
Manufacturer
Almac Pharma Services Limited
Seagoe Industrial Estate
Portadown
Craigavon
BT63 5UA
UK
and
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland