Robinul 0.2mg/1mL injection

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

glycopyrronium bromide, Quantity: 0.2 mg/mL

Prieinama:

Aspen Pharmacare Australia Pty Ltd

INN (Tarptautinis Pavadinimas):

glycopyrronium bromide (glycopyrrolate)

Vaisto forma:

Injection, solution

Sudėtis:

Excipient Ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid

Vartojimo būdas:

Intravenous, Intramuscular

Vienetai pakuotėje:

25 x 1ml vials, 5 X 1mL

Klasė:

Medicine Registered

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

1. As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents. 2. As a preoperative or intra-operative antimuscarinic to attenuate or prevent intraoperative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes. 3. To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants.

Produkto santrauka:

Visual Identification: Clear colourless solution free of visible suspended particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2011-10-06

Prekės savybės

1
AUSTRALIAN PRODUCT INFORMATION
ROBINUL (GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE))
INJECTION
1
NAME OF THE MEDICINE
Glycopyrronium bromide (glycopyrrolate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ROBINUL 1 mL ampoule and 1 mL vial contains glycopyrronium bromide
(glycopyrrolate)
bromide (glycopyrronium bromide (glycopyrrolate)) 0.2 mg as the active
ingredient.
ROBINUL 2 mL vial contains glycopyrronium bromide (glycopyrrolate)
bromide
(glycopyrronium bromide (glycopyrrolate)) 0.2 mg as the active
ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Injection, solution
4 CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1.
As a preoperative antimuscarinic to reduce salivary, tracheobronchial
and pharyngeal
secretions, and to reduce the acidity and volume of the gastric
contents.
2.
As a preoperative or intra-operative antimuscarinic to attenuate or
prevent intra-
operative bradycardia associated with the use of suxamethonium or due
to cardiac
vagal reflexes.
3.
To protect against the peripheral muscarinic actions (e.g. bradycardia
and excessive
secretions) of anticholinesterases such as neostigmine or
pyridostigmine given to
reverse neuromuscular blockade produced by non-depolarising muscle
relaxants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For intramuscular or intravenous administration.
PRE-ANAESTHETIC USE
Adults
2
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 (see Section 3.3 – 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 t