Nauzene

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Cyclizine hydrochloride 50mg

Saadav alates:

Teva Pharma (New Zealand) Limited

INN (Rahvusvaheline Nimetus):

Cyclizine hydrochloride 50 mg

Annus:

50 mg

Ravimvorm:

Tablet

Koostis:

Active: Cyclizine hydrochloride 50mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Povidone Pregelatinised maize starch

Ühikuid pakis:

Blister pack, PVC/PVDC/ Aluminium foil blister, 20 tablets

Klass:

Restricted

Retsepti tüüp:

Prescription

Valmistatud:

Micro Labs Ltd

Näidustused:

Nauzene is indicated for the prevention and treatment of nausea and vomiting including motion sickness, nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period, and radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels. Nauzene may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/ Aluminium foil blister - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, Polypropylene container with polypropylene cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2011-04-29

Toote omadused

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME (STRENGTH PHARMACEUTICAL FORM)
NAUZENE (cyclizine hydrochloride tablets 50 mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cyclizine hydrochloride 50 mg.
Excipient with known effect:
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, circular, biconvex, uncoated tablet with a scoreline on one
side and plain on the other.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NAUZENE is indicated for the prevention and treatment of nausea and
vomiting including:
•
motion sickness
•
nausea and vomiting caused by narcotic analgesics and by general
anaesthetics in the post-
operative period
•
radiotherapy, especially for breast cancer since cyclizine does not
elevate prolactin levels.
NAUZENE may be of value in relieving vomiting and attacks of vertigo
associated with Meniere's
disease and other forms of vestibular disturbance.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and children over 12 years: One tablet up to three times daily.
Children 6 to 12 years: Half a tablet up to three times daily.
Children under 6 years: Not recommended.
_SPECIAL POPULATIONS _
Use in the Elderly: There have been no specific studies of cyclizine
in the elderly. Experience has
indicated that normal adult dosage is appropriate.
To prevent travel sickness, NAUZENE should be taken 30 minutes before
departure.
4.3
CONTRAINDICATIONS
NAUZENE should not be given to individuals with known hypersensitivity
to cyclizine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As
with
other
anticholinergic
agents,
cyclizine
should
be
used
with
caution
and
appropriate
monitoring in patients with glaucoma, obstructive disease of the
gastrointestinal tract and in males
with possible prostatic hypertrophy.
Cyclizine should be used with caution in patients with severe heart
failure. In such patients, cyclizine
may cause a fall in cardiac output associated with increases in heart
rate, mean arteri