Norflex

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Orphenadrine citrate 30 mg/mL

Prieinama:

iNova Pharmaceuticals (New Zealand) Limited

INN (Tarptautinis Pavadinimas):

Orphenadrine citrate 30 mg/mL

Dozė:

30 mg/mL

Vaisto forma:

Solution for injection

Sudėtis:

Active: Orphenadrine citrate 30 mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection

Vienetai pakuotėje:

Ampoule, glass, 3 x 2mL, 6 mL

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Albemarle Corporation

Produkto santrauka:

Package - Contents - Shelf Life: Ampoule, glass, 3 x 2mL - 6 mL - 36 months from date of manufacture stored at or below 25°C

Leidimo data:

1969-12-31

Prekės savybės

NEW ZEALAND DATA SHEET
NORFLEX
TM
NORFLEX
Page 1 of 5
1
1 PRODUCT NAME
NORFLEX 100 mg slow release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each slow release tablet contains orphenadrine citrate 100 mg.
Excipient with known effect:
Lactose monohydrate
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Slow release tablet
White, round, biconvex tablets marked N/X on one face and no markings
on the other face.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
For the relief of stiffness and pain resulting from skeletal muscle
spasm in sprains and strains, local
muscle injury, prolapsed intervertebral disc, lumbago, fibrositis,
non-articular rheumatism, acute
torticollis, surgery, fractures, anxiety and tension.
Orphenadrine citrate has also been shown to be effective for treatment
of tension headache and
persistent hiccoughs.
4.2
Dose and method of administration
Adults
Two tablets per day; one in the morning and one in the evening.
Children
Safety and effectiveness in children have not been established.
NORFLEX is not recommended for
children under 12 years.
Special Populations
_Elderly _
The elderly may be more susceptible to anticholinergic side effects
and should be given a reduced
dosage.
4.3
Contraindications
x
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
x
Glaucoma
x
Paralytic ileus
x
Pyloric or duodenal obstruction
NEW ZEALAND DATA SHEET
NORFLEX
TM
NORFLEX
Page 2 of 5
x
Stenosing peptic ulcers
x
Prostatic hypertrophy or obstruction of the prostate or bladder neck
x
Oesophageal spasm (megaesophagus)
x
Myasthenia gravis.
44.4
Special warnings and precautions for use
Orphenadrine citrate should be used with caution in patients with
impaired kidney or liver function,
tachycardia, cardiac decompensation, coronary insufficiency or cardiac
arrhythmias.
Safety of continuous long-term therapy with orphenadrine has not been
established. Therefore,
periodic monitoring of blood, urine and liver function values is
recommended if orphenadrine is
pre