Pfizer (Australia) MIDAZOLAM INJECTION midazolam 15mg/3mL injection ampoule

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

midazolam, Quantity: 5 mg/mL

Pieejams no:

Pfizer Australia Pty Ltd

Zāļu forma:

Injection, solution

Kompozīcija:

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

Ievadīšanas:

Intravenous, Intramuscular

Vienības iepakojumā:

5 x 3mL ampoules

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Intravenously as an agent for: conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy,coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid. Induction of anaesthesia preliminary to administration of other anaesthetic agents. With the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. Intermittent intravenous administration or continuous infusion for: sedation in intensive care units. Intramuscularly for: preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Produktu pārskats:

Visual Identification: Clear colourless to pale yellow solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

1999-12-24

Produkta apraksts

Version: pfpmidai21118
Supersedes: pfpmidai10218
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AUSTRALIAN PRODUCT INFORMATION –
MIDAZOLAM INJECTION (MIDAZOLAM)
1.
NAME OF THE MEDICINE
Midazolam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam Injection contains 1 mg/mL or 5 mg/mL midazolam (as
hydrochloride)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Midazolam Injection is a clear, colourless to pale yellow solution for
injection. Midazolam
Injection is adjusted to pH 3.3.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INTRAVENOUSLY AS AN AGENT FOR:
•
conscious sedation prior to short surgical, diagnostic, therapeutic or
endoscopic
procedures such as bronchoscopy, gastroscopy, cystoscopy, coronary
angiography and
cardiac catheterisation, either alone or in conjunction with an
opioid.
•
induction of anaesthesia preliminary to administration of other
anaesthetic agents. With
the use of an opioid premedicant, induction of anaesthesia can be
obtained with a
narrower dose range and in a shorter period of time.
INTERMITTENT INTRAVENOUS ADMINISTRATION OR CONTINUOUS INFUSION FOR:
•
sedation in intensive care units.
INTRAMUSCULARLY FOR:
•
preoperative sedation (induction of sleepiness or drowsiness and
relief of apprehension)
and to impair memory of perioperative events.
4.2 DOSE AND METHOD OF ADMINISTRATION
THIS PRODUCT IS FOR SINGLE PATIENT USE ONLY. USE ONCE AND DISCARD ANY
RESIDUE.
Dosage should be individualised and drug should be administered
slowly.
Lower doses may be required in elderly or debilitated patients or in
patients with hepatic or
renal insufficiency. Because serious and life-threatening
cardiorespiratory adverse events have
been reported, provision for monitoring, detection and correction of
these reactions must be
Version: pfpmidai21118
Supersedes: pfpmidai10218
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made for every patient to whom midazolam is administered, regardless
of age or health status.
The dosage of midazolam administered should be adjusted according to
the type and amount
of premedica