COGENTIN Solution for Injection 1 mg Milligram

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

BENZATROPINE MESILATE

זמין מ:

Merck Sharp and Dohme Limited

כמות:

1 mg Milligram

טופס פרצבטיות:

Solution for Injection

תאריך אישור:

1979-04-01

מאפייני מוצר

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cogentin 1mg/ml Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sterile injection of ‘Cogentin’ contains 1.0
mg/ml benzatropine mesilate. (2mg per 2ml ampoule)
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear, colourless, sterile solution for injection.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
‘Cogentin’ is an anti-parkinsonian agent with
powerful anticholinergic effects.
It is indicated
for symptomatic treatment of all types of ‘classical’ parkinsonism including
arteriosclerotic, 
post-encephalitic, and idiopathic parkinsonism, and
of extrapyramidal reactions induced by phenothiazines or 
reserpine. It is not recommended for use in tardive dyskinesia
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
‘Cogentin’ Injection is only to be used in an emergency
or when a patient is unable to swallow tablets.
As ‘Cogentin’ is cumulative in action, treatment should begin
with a low dosage, which can be increased by amounts of 
0.5 mg at intervals of five to six days, to
the smallest dosage necessary
for optimal relief without excessive 
side-effects. Maximum dosage, 6 mg a day.
‘Cogentin’ Injection may be used intramuscularly
or intravenously in emergencies, or for patients unable to
swallow 
tablets. (As there is no significant difference in
time of onset of effect between intramuscular and intravenous 
administration, the intravenous route is not usually necessary.)
In emergencies, 1-2 ml (1-2 mg) of ‘Cogentin’ Injection
will normally provide quick relief. If signs of parkinsonism 
begin to return, the dose can be repeated.
‘_Classical’ parkinsonism: Usual dosage_: 1-2 mg a day, with
a range of 0.5-6 mg a day. Dosage must be adjusted on 
an individual basis, taking into consideration the age and
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