Baclofen Sintetica

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Baclofen 0.05 mg/mL

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Baclofen 0.05 mg/mL

Dosage:

0.05 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Baclofen 0.05 mg/mL Excipient: Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

Polpharma Pharmaceuticals Works SA

Therapeutic indications:

Intrathecal baclofen is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I glass with score-break and blue ring marker, 1 mL - 10 dose units - 60 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate. Do not freeze.

Authorization date:

2015-05-25

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.1 March 2017
Page 1 of 20
1 PRODUCT NAME
Baclofen Sintetica 0.05 mg/mL, solution for injection
Baclofen Sintetica 0.5 mg/mL, solution for infusion
Baclofen Sintetica, 2 mg/mL, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is baclofen
((RS)-4-amino-3-(4-chlorophenyl)butanoic acid).
The chemical structure of baclofen (CAS number: 1134-47-0) is:
Baclofen is a chemical analogue of the inhibitory neurotransmitter
gamma-aminobutyric acid
(GABA).
Baclofen Sintetica is a solution for intrathecal injection and
intrathecal infusion. It contains no
preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ampoules containing 0.05 mg in1 mL are available for administering
low-dose bolus injections during
the screening phase.
Ampoules containing 10 mg in 5 mL, 10 mg in 20 mL and 40 mg in 20 mL,
are available for use with
infusion pumps. The concentration chosen for use depends upon the
total daily dose required as
well as the delivery rate of the pump. Please consult the pump
manufacturer's manual for specific
recommendations.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intrathecal baclofen is indicated in patients with severe chronic
spasticity of spinal origin (associated
with injury, multiple sclerosis, or other spinal cord diseases) or of
cerebral origin who are
unresponsive to orally administered antispastics (including oral
baclofen) and/or who experience
unacceptable side effects at effective oral doses.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.1 March 2017
Page 2 of 20
4.2
DOSE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
Intrathecal administration of baclofen through an implanted delivery
system should only be
undertaken by physicians with the necessary knowledge and experience.
Specific instructions for
implanting, programming and/or refilling the implantable pump are
given by the pump
manufacturers, and must be strictly adhered to.
_ _
_DOSAGE _
Intrat