Baclofen 50micrograms/1ml solution for injection ampoules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Baclofen

Tilgængelig fra:

Aguettant Ltd

ATC-kode:

M03BX01

INN (International Name):

Baclofen

Dosering:

50microgram/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Intrathecal

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 10020200; GTIN: 5060238380072

Indlægsseddel

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Baclofen Aguettant 0.05 mg/ml
solution for injection
{baclofen}
PLEASE READ THIS PRODUCT INFORMATION CAREFULLY
BEFORE YOU OR YOUR CHILD IS GIVEN BACLOFEN
SINCE IT CONTAINS IMPORTANT INFORMATION.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.
The name of this medicinal product is BACLOFEN
AGUETTANT 0.05 MG/ML SOLUTION FOR INJECTION, but
will be referred as Baclofen throughout the whole
leaflet.
IN THIS LEAFLET:
1. What Baclofen is and what it is used for
2. Before you take Baclofen
3. How to use Baclofen
4. Possible side effects
5. How to store Baclofen
6. Further information
1. WHAT BACLOFEN IS AND WHAT IT IS
USED FOR
Your doctor has decided that you or your child
needs this medicine to help treat your condition.
Baclofen 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. BEFORE YOU TAKE BACLOFEN
CHILDREN AND ADOLESCENTS:
Baclofen formulation is intended for children of
4 years and above.
DO NOT USE BACLOFEN
• if you are allergic to baclofen or to any of the
other ingredients of Baclofen. (These are listed
at the end of the leaflet)
• if you suffer from epilepsy refractory to therapy
• Baclofen should not be administered by any
route other than intrathecal (into the spinal
canal)
TAKE SPECIAL CARE WITH BACLOFEN
• if you are having an

Produktets egenskaber

OBJECT 1
BACLOFEN 0.05MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 08-May-2015 | Aguettant Ltd
1. Name of the medicinal product
Baclofen Aguettant 0.05mg/ml solution for injection
2. Qualitative and quantitative composition
_Baclofen Aguettant 0.05 mg/ml solution for injection_
1 ml of solution for injection contains 0.05 mg (50 micrograms)
baclofen, 3.5mg sodium.
1 ampoule contains 0.05 mg (50 micrograms) baclofen, 3.5 mg sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear and colourless solution in ampoules.
The pH of the solution is comprised between 5.5 and 6.8.
The osmolarity of the solution is comprised between 270 - 300 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Baclofen Aguettant is indicated in patients with severe chronic
spasticity resulting from trauma, multiple
sclerosis or other spinal cord disorders, 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.
Baclofen Aguettant is effective in adult patients with severe chronic
spasticity of cerebral origin, resulting
e.g. from cerebral palsy, brain trauma or cerebrovascular accident;
however, clinical experience is
limited.
_Paediatric population _
Baclofen Aguettant 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
Baclofen Aguettant is intended for administration in single bolus test
doses (via spinal catheter or lumbar
puncture) and, for chronic use, in implantable pumps suitable for
continuous administration of Baclofen
Aguettant into the intrathecal space (EU certified pumps).
Establishment of the