Esmeron 50 mg/5ml

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Rocuronium Bromide 50 mg/5ml

Available from:

مستودع أدوية أداتكو - Adatco Drug Store

ATC code:

M03AC09

INN (International Name):

Rocuronium Bromide 50 mg/5ml

Dosage:

50 mg/5ml

Units in package:

10 Vial X 5ml

Manufactured by:

Siegfried Hameln GmbH/GERMANY (المانيا)

Patient Information leaflet

BS 12_336
03
200912
485 x 435.5
MSD ARTWORK
402290571-0021
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Technical Info
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SGK IS A MATTHEWS INTERNATIONAL CORPORATION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Esmeron
®
10 mg/ml, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml Esmeron contains 10 mg rocuronium bromide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
pH 3.8 – 4.2
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esmeron is indicated in adult and pediatric patients (from term
neonates to adolescents [0 to 18 years]) as
an adjunct to general anesthesia_ _to facilitate tracheal intubation
during routine induction and to provide
skeletal muscle relaxation during surgery. In adults, Esmeron is also
indicated to facilitate tracheal
intubation during rapid sequence induction and as an adjuvant in the
Intensive Care Unit (ICU) to facilitate
tracheal intubation and mechanical ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Like other neuromuscular blocking agents, Esmeron should only be
administered by, or under the supervision
of, an experienced physician who is familiar with the action and use
of these agents.
Posology
As with other neuromuscular blocking agents, the dosage of Esmeron
should be individualized for each
patient. The method of anesthesia_ _and_ _the expected duration of
surgery_, _the method of sedation and the
expected duration of mechanical ventilation, possible interaction with
other drugs that are administered
concomitantly_,_ and the condition of the patient should be taken into
account when determining the dose.
The use of an appropriate neuromuscular monitoring technique is
recommended for the evaluation of
neuromuscular block and recovery of neuromuscular function.
Inhalational anesthetics potentiate the neuromuscular blocking effects
of Esmeron. This potentiation
only becomes clinically relevant during the course of the anesthesia,
when the inhalational anesthetics
have reache