Isotroy liquid for inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

isoflurane

Available from:

Troikaa Pharmaceuticals Ltd

ATC code:

N01AB06

INN (International Name):

isoflurane

Dosage:

100%

Pharmaceutical form:

liquid for inhalation

Units in package:

100ml and 250ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-09-26

Patient Information leaflet

Prescribing Information
For the use of Registered Medical
Practitioner or Hospital or Laboratory Only.
ISOTROY
Isoflurane 100 ml & 250 ml
Inhalation Vapour, Liquid
FRONT
Manufactured by :
Troikaa Pharmaceuticals Ltd.
Sanand - Kadi Road, Thol - 382 728, Dist. Mehsana,
Gujarat State, India
I.IS.ARM.E-01
DESCRIPTION :
Isoflurane 100 ml & 250 ml
Levels of anaesthesia change rapidly with isoflurane. Heart rhythm
remains stable. Spontaneous respiration becomesdepressed as depth of
anaesthesia increases and should be closely monitored.
CLINICAL PHARMACOLOGY :
Isoflurane appears to sensitize the myocardium to adrenaline to an
even
lesser extent than enflurane. Limited data suggests that subcutaneous
infiltration of upto 50ml in 1:2,00,000 adrenaline does not induce
ventricular arrhythmias, in patients anaesthetised with isoflurane.
COMPOSITION :
ISOTROY (isoflurane), a non-flammable liquid, is a general inhalation
anesthetic drug.
Each bottle contains :
Pharmacodynamic properties :
Induction and particularly recovery are rapid. Although slight
pungency
may limit the rate of induction, excessivesalivation and
tracheo-bronchial
secretions are not stimulated. Pharyngeal and laryngeal reflexes are
diminished quickly.
Cerebral blood flow remains unchanged during light anaesthesia but
tends to rise at deeper level. Increase in cerebrospinal fluid
pressure can
be prevented or reversed by hyperventilating the patient before or
during
anaesthesia.
Electro-encephalographic
changes and convulsion are
extremely rare with isoflurane.
During induction there is a decrease in blood pressure which returns
towards normal with surgery stimulation. Blood pressure tends to fall
during maintenance in direct relation to the depth of anaesthesia due
to
peripheral vasodilation but cardiac rhythm remains normal. With
controlled respiration and normal PACO2, cardiac output tends to be
maintained despite increasing depth of anaesthesia, primarily through
a
rise in heart rate. With spontaneous respiration, the resulting
hypercapnia may increase the

Summary of Product characteristics

THE SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
A)
PRODUCT NAME
:
Isotroy (Isoflurane )
B)
STRENGTH
:
Each bottle contains:
Isoflurane ………..…100 ml
2.
QUALITY AND QUANTITATIVE COMPOSITION
A)
QUALITATIVE DECLARATION:
Each bottle contains:
Isoflurane ……..…100 ml
B)
QUANTITATIVE DECLARATION:
SR.
NO.
NAME OF INGREDIENT
QUANTITY/BOTTLE
PURPOSE OF
INGREDIENTS
1.
Isoflurane
100.00 ml
Active
3.
PHARMACEUTICAL FORM:
Inhalation Vapour, Liquid
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
Isoflurane is indicated as a general anaesthetic by inhalation.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION:
Vaporisers specially calibrated for isoflurane must be used so that
the concentration of anaesthetic can
be accurately controlled.
MAC (minimum alveolar concentration)values for isoflurane vary with
age. The table below indicates
average MAC values for different age groups.
ADULTS
AGE
AVERAGE MAC VALUES IN 100% OXYGEN
70% N
2
O
26 ± 4
1.28
0.56
44 ± 7
1.15
0.50
64 ± 5
1.05
0.37
PAEDIATRIC POPULATION
AGE
AVERAGE MAC VALUES IN 100% OXYGEN
Preterm neonates < 32 weeks gestationalage
1.28%
Preterm neonates 32-45 weeks gestational
1.41%
age
0– 1 month
1.60%
1– 6 month
1.80%
6 – 12 month
1.87%
1 – 5 years
1.60%
PREMEDICATION
Drugs used for premedication should be selected for individual patient
bearing in mind the respiratory
depressant effect of isoflurane. The use of anti-cholinergic is a
matter of choice but may be advisable for
inhalation induction in paediatrics.
Induction of anaesthesia in adults
A
short
acting
barbiturate
or
other
intravenous
induction
agent
is
usually
administered
followed
by
inhalation of isoflurane mixture. Alternatively, isoflurane with
oxygen or with an oxygen/nitrous oxide
mixture may be used.
It is recommended that induction with isoflurane be initiated at a
concentration of 0.5%. Concentrations
of 1.5 to 3.0% usually produce surgical anaesthesia in 7 to 10
minutes.
Induction of anaesthesia in children
Isoflurane is not recommended for use as an in