Lioresal Intrathecal 10mg/20ml solution for infusion ampoules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Baclofen

Beschikbaar vanaf:

Novartis Pharmaceuticals UK Ltd

ATC-code:

M03BX01

INN (Algemene Internationale Benaming):

Baclofen

Dosering:

500microgram/1ml

farmaceutische vorm:

Solution for infusion

Toedieningsweg:

Intrathecal

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 10020200; GTIN: 5010678530308

Bijsluiter

LIORESAL
® INTRATHECAL INJECTION 50 MICROGRAMS/1 ML
LIORESAL
® INTRATHECAL INFUSION 10 MG/5 ML
LIORESAL
® INTRATHECAL INFUSION 10 MG/20 ML
(BACLOFEN)
PATIENT INFORMATION LEAFLET
The product will be called Lioresal Intrathecal in this leaflet
WHAT YOU NEED TO KNOW ABOUT LIORESAL INTRATHECAL
Your doctor has decided that you or your child needs this medicine to
help treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TREATMENT. IT
CONTAINS IMPORTANT
INFORMATION.
Keep the leaflet in a safe place because you may want to read it
again.
If you have any other questions, or if there is something you don’t
understand, please ask your
doctor or nurse.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Lioresal Intrathecal is and what it’s used for
2.
Things to consider before you have Lioresal Intrathecal
3.
Having Lioresal Intrathecal
4.
Possible side effects
5.
How to store Lioresal Intrathecal
6.
Further information
1.
WHAT LIORESAL INTRATHECAL IS AND WHAT IT’S USED FOR
Lioresal Intrathecal contains the active ingredient, baclofen. It is
administered by intrathecal
injection directly into the spinal fluid. It is available in three
different sizes and strengths
containing either 50 micrograms in 1 ml, 10 mg in 5 ml or 10 mg in 20
ml of baclofen.
Baclofen is a muscle-relaxant drug. Lioresal Intrathecal is intended
for adults and children of 4
years and above and is used to reduce and relieve the excessive
tension in your muscles (spasms)
occurring in various illnesses such as cerebral palsy, multiple
sclerosis, spinal cord diseases,
cerebrovascular accidents, and other nervous system disorders.This
injection is used in people
who haven’t responded to oral medicines or who get unacceptable side
effects when they take
baclofen by mouth.
2.
THINGS TO CONSIDER BEFORE YOU HAVE LIORESAL INTRATHECAL
SOME PEOPLE MUST NOT HAVE LIORESAL INTRATHECAL. TALK TO YOUR DOCTOR
IF:

you thin

Productkenmerken

OBJECT 1
LIORESAL INTRATHECAL INFUSION 10MG/20ML
Summary of Product Characteristics Updated 11-Jul-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Lioresal
®
Intrathecal Injection 50micrograms/1ml
Lioresal
®
Intrathecal Infusion 10mg/5ml
Lioresal
®
Intrathecal Infusion 10mg/20ml
2. Qualitative and quantitative composition
Active substance
b-(Aminomethyl)-p-chlorohydrocinnamic acid (= baclofen), a racemic
mixture of the R, (-) and S, (+)
isomers
One ampoule of 1 ml contains 50 micrograms baclofen, (50
micrograms/ml).
One ampoule of 5 ml contains 10 mg baclofen, (2000 micrograms/ml).
One ampoule of 20 ml contains 10 mg baclofen, (500 micrograms/ml).
For excipients see section 6.1 List of excipients.
3. Pharmaceutical form
Solutions for intrathecal injection and intrathecal infusion.
4. Clinical particulars
4.1 Therapeutic indications
Lioresal Intrathecal is indicated in patients with severe chronic
spasticity of spinal or cerebral origin
(associated with injury, multiple sclerosis, cerebral palsy) who are
unresponsive to oral baclofen or other
orally administered antispastic agents and/or those patients who
experience unacceptable side-effects at
effective oral doses.
In patients with spasticity due to head injury a delay of at least one
year before treatment with Lioresal
Intrathecal is recommended, to allow the symptoms of spasticity to
stabilise.
Lioresal Intrathecal may be considered as an alternative to ablative
neurosurgical procedures.
_Paediatric population _
Lioresal Intrathecal is indicated in patients aged 4 to <18 years with
severe chronic spasticity of cerebral
origin or of spinal origin (associated with injury, multiple
sclerosis, or other spinal cord diseases) who are
unresponsive to orally administered antispastics (including oral
baclofen) and/or who experience
unacceptable side effects at effective oral doses.
4.2 Posology and method of administration
Intrathecal administration of Lioresal through an implanted delivery
system should only be undertaken by
physicians with