NIMBEX cisatracurium (as besilate) 20mg/10mL injection ampoule

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

cisatracurium besilate, Quantity: 2.68 mg/mL (Equivalent: cisatracurium, Qty 2 mg/mL)

זמין מ:

Aspen Pharmacare Australia Pty Ltd

טופס פרצבטיות:

Injection, solution

הרכב:

Excipient Ingredients: benzenesulfonic acid; water for injections

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

5 X 10mL

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Nimbex injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the Intensive Care Unit.

leaflet_short:

Visual Identification: Colourless to pale yellow or greenish yellow solution, practically free from visible particulate matter.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

1996-09-13

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION
NIMBEX (CISATRACURIUM BESILATE)
INJECTION
1
NAME OF THE MEDICINE
Cisatracurium besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimbex injection is supplied in two strengths, either 2 mg or 5 mg of
cisatracurium besilate
per mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Nimbex injection is a colourless to pale yellow or greenish solution,
practically free from
visible particulate matter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Nimbex injection is indicated for use during surgical and other
procedures and in intensive
care to relax skeletal muscles, and to facilitate tracheal intubation
and mechanical ventilation.
It is used as an adjunct to general anaesthesia, or sedation in the
intensive care unit.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Nimbex injection contains no antimicrobial preservative and is
intended for single patient use.
_ _
USE BY INTRAVENOUS BOLUS INJECTION
DOSAGE IN ADULTS
_Tracheal intubation_. The recommended intubation dose of Nimbex
injection for adults is 0.15
mg/kg bodyweight. This dose produces good to excellent conditions for
tracheal intubation
120 seconds following injection.
Higher doses will shorten the time to onset of neuromuscular block.
The following table, Table
1, summarises mean pharmacodynamic data when Nimbex injection was
administered at
doses
of
0.1
to
0.4
mg/kg
bodyweight
to
healthy
adult
patients
during
opioid
(thiopentone/fentanyl/midazolam) or propofol anaesthesia.
2
TABLE 1
INITIAL NIMBEX
INJECTION DOSE
(MG/KG
BODYWEIGHT)
ANAESTHETIC
BACKGROUND
TIME TO 90%
T
1
®
SUPPRESSION
(MIN)
TIME TO
MAXIMUM T
1
®
SUPPRESSION
(MIN)
TIME TO
SPONTANEOUS
T
1
®
RECOVERY
(MIN)
0.1
Opioid
3.4
4.8
45
0.15
Propofol
2.6
3.5
55
0.2
Opioid
2.4
2.9
65
0.4
Opioid
1.5
1.9
91
®
Single twitch response as well as the first component of the
Train-of-Four response of
the adductor pollicis muscle following the supramaximal electrical
stimulation of the ulnar
nerve
Enflurane or isoflurane anaesthesia may