ESMERON 10 Mg/Ml Solution for Inj/Inf

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

ROCURONIUM BROMIDE

제공처:

NV Organon

ATC 코드:

M03AC09

INN (국제 이름):

ROCURONIUM BROMIDE

복용량:

10 Mg/Ml

약제 형태:

Solution for Inj/Inf

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Other quaternary ammonium compounds

승인 상태:

Authorised

승인 날짜:

1996-08-07

환자 정보 전단

1
ESMERON®
10 MG/ML
SOLUTION FOR INJECTION/INFUSION
ROCURONIUM BROMIDE
INFORMATION FOR THE DOCTOR
1.
NAME OF THE MEDICINAL PRODUCT
Esmeron 10mg/ml Solution for injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 10 mg rocuronium bromide.
Each 2.5 ml vial contains 25 mg rocuronium bromide.
Each 5 ml vial contains 50 mg rocuronium bromide.
Each 10 ml vial contains 100 mg rocuronium bromide
Excipients:
Each ml of solution contains 1.64 mg of sodium
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless to slightly yellow/brown, sterile, aqueous solution.
pH: 3.8 – 4.2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esmeron is indicated in adult and paediatric patients (from term
neonates to adolescents [0 to <18
years]) as an adjunct to general anaesthesia to facilitate tracheal
intubation during routine sequence
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 adjunct in the
intensive care unit (ICU) to facilitate intubation and mechanical
ventilation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Like other neuromuscular blocking agents, Esmeron should only be
administered by, or under
supervision of, experienced clinicians who are familiar with the
action and use of these drugs.
As with other neuromuscular blocking agents, the dosage of Esmeron
should be individualised in
each patient. The method of anesthesia and the expected duration of
surgery, the method of sedation
and the expected duration of mechanical ventilation, the 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.
2
Inhalational
anaesthetics
do
potentiate
the
neuromuscular

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esmeron 10 mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 10 mg rocuronium bromide.
Each 2.5 ml vial contains 25 mg rocuronium bromide.
Each 5 ml vial contains 50 mg rocuronium bromide.
Each 10 ml vial contains 100 mg rocuronium bromide.
Excipients:
Each ml of solution contains 1.64 mg of sodium.
For full list of excipients,_ see section 6.1._
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless to slightly yellow/brown, sterile aqueous solution
pH 3.8 - 4.2
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esmeron is indicated in adult and paediatric patients (from term
neonates to adolescents [0 to <18 years]) as an adjunct
to general anaesthesia to facilitate tracheal intubation during
routine sequence 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 adjunct in the intensive care unit (ICU) to
facilitate intubation and mechanical ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Like other
neuromuscular
blocking agents,
Esmeron should only be administered by,
or
under
supervision of,
experienced clinicians who are familiar with the action and use of
these drugs.
As with other neuromuscular blocking agents,
the dosage of Esmeron should be individualised in each patient.
The
method of
anesthesia and the expected duration of
surgery,
the method of
sedation and the expected duration of
mechanical ventilation, the 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.
Inhalational anaesthetics do potentiate the neuromuscular blocking
effects of Esmeron. This potentiation, however,
only becomes cli