Stemetil

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Prochlorperazine mesilate 25mg

Διαθέσιμο από:

sanofi-aventis new zealand limited

INN (Διεθνής Όνομα):

Prochlorperazine mesilate 25 mg

Δοσολογία:

25 mg

Φαρμακοτεχνική μορφή:

Suppository

Σύνθεση:

Active: Prochlorperazine mesilate 25mg

Μονάδες σε πακέτο:

Blister pack, 1x10, 10 suppositories

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Sanofi Chimie

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, 1x10 - 10 suppositories - 60 months from date of manufacture stored at or below 25°C

Ημερομηνία της άδειας:

1969-12-31

Αρχείο Π.Χ.Π.

ste-ccdsv6-dsv14-23nov22
Page 1
NEW ZEALAND DATA SHEET
1
STEMETIL
Stemetil 12.5mg/mL solution for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stemetil solution for injection contains 12.5 mg/mL prochlorperazine
mesilate. Each ampoule
contains 1 mL.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Stemetil solution for injection is clean, bright and not more than
very pale yellow.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prochlorperazine is used for nausea and vomiting from whatever cause.
It may also be used for
migraine, schizophrenia (particularly in the chronic stage) and acute
mania.
4.2
DOSE AND METHOD OF ADMINISTRATION
NAUSEA AND VOMITING
Adults
_Intramuscular _
_Treatment of nausea and vomiting _
12.5 mg by deep intramuscular injection, followed by oral
prochlorperazine six hours later, if
necessary.
ste-ccdsv6-dsv14-23nov22
Page 2
SCHIZOPHRENIA AND OTHER PSYCHOTIC DISORDERS
Adults
_Intramuscular _
12.5 mg to 25 mg two or three times a day by deep intramuscular
injection until oral treatment
becomes possible.
Children
Intramuscular prochlorperazine should not be given to children.
Elderly
Prochlorperazine should be used cautiously in this group in psychotic
disorders. Elderly patients
susceptible to centrally-acting medicines hence lower initial dosage
is recommended. There is an
increased risk of drug-induced Parkinsonism in the elderly,
particularly after prolonged use.
Correct initial diagnosis of the disorder is important. Care should
also be taken not to confuse
adverse effects of prochlorperazine, e.g. orthostatic hypotension with
effects due to the primary
disorder.
4.3
CONTRAINDICATION
Circulatory collapse, central nervous system depression (coma or drug
intoxication), previous
history of a hypersensitivity reaction (e.g. jaundice or blood
dyscrasia) to phenothiazines
especially to prochlorperazine, bone marrow depression.
Hypersensitivity to prochlorperazine, other phenothiazines, or to any
of the other ingredients of
Stemetil.
The use of prochlorperazine