Glycopyrronium Bromide 200 micrograms/ml Solution for Injection

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Glycopyrronium bromide 0.2 mg/mL

Dostępny od:

Max Health Limited

INN (International Nazwa):

Glycopyrronium bromide 0.2 mg/mL

Dawkowanie:

0.2 mg/mL

Forma farmaceutyczna:

Solution for injection

Skład:

Active: Glycopyrronium bromide 0.2 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

Sztuk w opakowaniu:

Ampoule, glass, Type 1 glass, colourless with one point cut 3mL, 10 dose units

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Harman Finochem Limited

Wskazania:

Glycopyrrolate is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions: to reduce the volume and free acidity of gastric secretions and to block cardiac vagal inhibitory reflexes during induction of anaesthesia and intubation when indicated. Glycopyrronium bromide 200 micrograms per mL solution for injection may be used intraoperatively to counteract drug-induced or vagal traction reflexes with the associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g. bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarising muscle relaxants. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

Podsumowanie produktu:

Package - Contents - Shelf Life: Ampoule, glass, Type 1 glass, colourless with one point cut 3mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, glass, Type 1 glass, colourless with one point cut 1mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Data autoryzacji:

2013-02-07

Charakterystyka produktu

Page 1 of 8
1
PRODUCT NAME
Glycopyrronium Bromide 200 micrograms/ml Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains glycopyrronium bromide (glycopyrrolate) 0.2
mg.
For full list of excipients, see section 6.1.
_ _
3
PHARMACEUTICAL FORM
Solution for Injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In _Anaesthesia: _Glycopyrronium bromide
is indicated
for use as a preoperative
antimuscarinic
to reduce salivary, tracheobronchial and pharyngeal secretions; to
reduce the volume and free
acidity of gastric secretions, and to block cardiac vagal inhibitory
reflexes during induction of
anaesthesia
and
intubation
when
indicated.
Glycopyrronium
bromide
may
be
used
intraoperatively
to
counteract drug-induced
or
vagal
traction
reflexes
with
the
associated
arrhythmias.
Glycopyrronium bromide protects
against
the peripheral muscarinic
effects (e.g.
bradycardia
and
excessive
secretions)
of
cholinergic
agents
such
as
neostigmine
and
pyridostigmine
given to reverse the neuromuscular blockade
due to non-depolarising muscle
relaxants.
_In Peptic Ulcer_: For use in adults as adjunctive therapy for the
treatment of peptic ulcer when
rapid anticholinergic effect is desired or when oral medication is not
tolerated.
4.2
DOSE AND METHOD OF ADMINISTRATION
For intramuscular or intravenous administration.
PRE-ANAESTHETIC USE
Adults - 0.2 mg to 0.4 mg intravenously or intramuscularly before the
induction of anaesthesia.
Alternatively, a dose of 0.004 to
0.005
mg/kg
up
to
a
maximum
of
0.4
mg
may
be used.
Larger
doses
may
result
in
profound
and
prolonged
antisialogogue
effect,
which
may
be
unpleasant for the patient.
Children (Read Contraindications) -
1
month
to
12
years
of
age
0.004
to
0.008 mg/kg
up
to
a
maximum
of
0.2
mg
intravenously
or
intramuscularly
before
the
induction
of
anaesthesia. Larger doses may result in profound and prolonged
antisialogogue
effect which
may be unpleasant for the patient.
INTRAOPERATIVE USE
When used
to treat
arrhythmias
associated
with traction
reflexes,