ESMERON INJECTION 50 mg5ml

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

ROCURONIUM BROMIDE

Διαθέσιμο από:

MSD PHARMA (SINGAPORE) PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

M03AC09

Δοσολογία:

10 mg/ml

Φαρμακοτεχνική μορφή:

INJECTION

Σύνθεση:

ROCURONIUM BROMIDE 10 mg/ml

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

N V ORGANON

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1997-08-19

Φύλλο οδηγιών χρήσης

S-CCDS-MK8085-SOi-072018
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 a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
pH: 3.8-4.2
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Esmeron
is
indicated
as
an
adjunct
to
general
anesthesia
to
facilitate
endotracheal intubation, to provide skeletal muscle relaxation and to
facilitate
mechanical ventilation in adults, children and infants from one month
of age.
Esmeron is also indicated as an adjunct in the intensive care unit
(ICU) to
facilitate
mechanical
ventilation
as
part
of
Rapid
Sequence
Induction,
however, this has not been studied in infants and children.
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 individualized 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 anesthetics do potentiate the neuromuscular blocking
effects of
Esmeron. This potentiation however, becomes clinically relevant in the
course
of
anesthesia,
when
the
volatile
agents
have
reached
the
tissue
concentrations required for this interaction. Consequently,
adjustments with
Esmeron should be made by administering smaller maintenance doses at
less frequent intervals or by using lower infusion rates of Esmeron
during long
lasting procedures (longer than 1 hour)

Αρχείο Π.Χ.Π.

S-CCDS-MK8085-SOi-022022
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 a 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
as
an
adjunct
to
general
anesthesia
to
facilitate
endotracheal intubation, to provide skeletal muscle relaxation and to
facilitate
mechanical ventilation in adults, children and infants from one month
of age.
Esmeron is also indicated as an adjunct in the intensive care unit
(ICU) to
facilitate
mechanical
ventilation
as
part
of
Rapid
Sequence
Induction,
however, this has not been studied in infants and children.
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 individualized 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 anesthetics do potentiate the neuromuscular blocking
effects of
Esmeron. This potentiation however, becomes clinically relevant in the
course
of
anesthesia,
when
the
volatile
agents
have
reached
the
tissue
concentrations required for this interaction. Consequently,
adjustments with
Esmeron should be made by administering smaller maintenance doses at
less frequent intervals or by using lower infusion rates of Esmeron
during long
lasting procedures (longer than 1