TRACRIUM INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ATRACURIUM BESYLATE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

M03AC04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ATRACURIUM BESYLATE 10 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GLAXOSMITHKLINE MANUFACTURING S.P.A, ITALY

Therapeutic group:

ATRACURIUM

Therapeutic area:

ATRACURIUM

Therapeutic indications:

Atracurium is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation.

Authorization date:

2013-02-28

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
09/06/2013
םש
רישכת
תילגנאב
רפסמו
םושירה
047-24-22759
;
T RACRIUM INJECTION
םש
לעב
םושירה
GLAXOSMITHKLINE (ISRAEL) LTD :
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
אפורל ןולעב
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יחכונ טסקט
שדח טסקט
4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
Caution should also be
exercised when administering
atracurium to patients who
have shown hypersensitivity to
other neuromuscular blocking
agents since a high rate of
cross-sensitivity (greater than
50%) between neuromuscular
blocking agents has been
reported (see
_Contraindications_).
--------------------------------
High rates of cross-sensitivity_ _between
neuromuscular blocking agents have been
reported. Therefore, where possible,
before administering atracurium,
hypersensitivity to other neuromuscular
blocking agents should be excluded.
Atracurium should only be used when
absolutely essential in susceptible patients.
Patients who experience a hypersensitivity
reaction under general anaesthesia should
be tested subsequently for hypersensitivity
to other neuromuscular blockers.
Monitoring of serial creatinine phosphate
(cpk) values should be considered in
asthmatic patients receiving high dose
corticosteroids and neuromuscular blocking
agents in ICU.

Summary of Product characteristics

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1
of
9
TRACRIUM
TM INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Tracrium
TM
Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atracurium Besilate 10 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atracurium is a highly selective, competitive or non-depolarising
neuromuscular blocking agent which
is used as an adjunct to general anaesthesia to enable tracheal
intubation to be performed and to relax
skeletal muscles during surgery or controlled ventilation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Intravenous injection or continuous infusion.
_ _
_Used by injection in adults_
: Tracrium is administered by intravenous injection.
The dosage range recommended for adults is 0.3 to 0.6 mg/kg (depending
on the duration of full block
required) and will provide adequate relaxation for about 15 to 35
minutes.
Endotracheal intubation can usually be accomplished within 90 seconds
from the intravenous injection
of 0.5 to 0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.1 to 0.2
mg/kg as required. Successive
supplementary dosing does not give rise to accumulation of
neuromuscular blocking effect.
Spontaneous recovery from the end of full block occurs in about 35
minutes as measured by the
restoration of the tetanic response to 95% of normal neuromuscular
function.
The neuromuscular block produced by Tracrium can be rapidly reversed
by standard doses of
anticholinesterase agents, such as neostigmine and edrophonium,
accompanied or preceded by
atropine, with no evidence of recurarisation.
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2
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_Use as an infusion in adults_
: After an initial bolus dose of 0.3 to 0.6 mg/kg, Tracrium can be
used to
maintain neuromuscular block during long surgical procedures by
administration as a continuous
infusion at rates of 0.3 to 0.6 mg/kg/hour.
Tracrium can be administered by infusion during cardiopulmonary bypass
surgery at the recommended
infusion rates. Induced hypothermia to