ULTIVA 5 mg (INJECTION)

Land: Sydafrika

Sprog: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgængelig fra:

Pharmacare Limited û Woodmead

Dosering:

See ingredients

Lægemiddelform:

INJECTION

Sammensætning:

EACH 1,0 ml CONTAINS REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 5,0 mg

Autorisation status:

Registered

Autorisation dato:

1999-03-05

Produktets egenskaber

_ZA_ULTIINJ_1212_00 Page 1 of 21 _
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS:
S6
PROPRIETARY NAME AND DOSAGE FORM:
ULTIVA
 1 MG Injection
ULTIVA

2 MG Injection
ULTIVA

5 MG Injection
COMPOSITION:
Each ULTIVA 1 mg vial contains remifentanil hydrochloride equivalent
to 1 mg remifentanil base
Each ULTIVA 2 mg vial contains remifentanil hydrochloride equivalent
to 2 mg remifentanil base
Each ULTIVA 5 mg vial contains remifentanil hydrochloride equivalent
to 5 mg remifentanil base
_Excipients _
Glycine
PHARMACOLOGICAL CLASSIFICATION:
A 2.9 Other analgesics
PHARMACOLOGICAL ACTION:
Remifentanil is a selective µ-opioid agonist with a rapid onset and
very short duration of
action. The µ-opioid activity of remifentanil is partially
antagonized by narcotic antagonists
such as naloxone.
_ZA_ULTIINJ_1212_00 Page 2 of 21 _
PHARMACOKINETIC PROPERTIES:
Following administration of the recommended doses of remifentanil, the
effective biological
half-life is 3-10 minutes. The average clearance of remifentanil in
young healthy adults is
40 ml/min/kg. Blood concentrations of remifentanil are proportional to
the dose administered
throughout the recommended dose range. For every 0,1 µg/kg/min
increase in infusion rate,
the blood concentration of remifentanil will rise 2,5 ng/ml.
Remifentanil is approximately
70 % bound to plasma proteins.
_METABOLISM: _
Remifentanil
is
an
Esterase
Metabolised
Opioid
that
is
susceptible
to
metabolism by non-specific blood and tissue esterases. The metabolism
of remifentanil
results in the formation of an essentially inactive carboxylic acid
metabolite (1/4600
th
as
potent
as remifentanil).
The
half-life of
the
metabolite in healthy adults is 2 hours.
Approximately
95
%
of
remifentanil
is
recovered
in
the
urine
as
the
carboxylic
acid
metabolite.
Remifentanil is not a substrate for plasma cholinesterase.
_PLACENTAL AND MILK TRANSFER: _Remifentanil crosses the placenta and
appears in breast milk.
In a human clinical trial, the concentration of remifentanil