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Nervous System

Isotoran (Liquid for Inhalation)
(Isoflurane)



CONTENT

Fluid for inhalation. 100 ml of the preparation contain isoflurane 99,9 g.

PHARMACOLOGIC PROPERTIES

PHARMACODYNAMICS
Isotoran is a medication for inhalation anesthesia. It induces a rapid induction of general anesthesia, diminishing of pharyngeal and laryngeal reflexes and moderate muscle relaxation.

Muscle relaxation may be adequate for some surgical operations at normal levels of general anesthesia, but should greater muscle relaxation be required small doses of muscle relaxants may be used. A depth of anesthesia change rapidly with isoflurane. Although slight pungency may limit the rate of Isotoran induction, excessive secretion of salivary and tracheobronchial glands are not stimulated.

pharmacokinetics
Relatively little metabolism of isoflurane occurs in the human body. In the post operative period only 0.17% of isoflurane can be found as urinary metabolites. Inorganic fluoride Cmax value in blood serum averages less than 5 umol/l and it is determined during 4 hours after anesthesia, returning to normal levels within the following 24 hours. 

therapeutic indicationS
- for inhalation anesthesia in combination with oxygen or with oxygen + nitrous oxide mixture.

DOSAGE AND ADMINISTRATION
Vaporizers specially calibrated should be used
so that the concentration of isoflurane delivered can be accurately controlled.
Minimum alveolar concentration (MAC) for isoflurane depends on the age

Age

100% oxygen

N2O (60%) + O2

N2O (70%) + O2

0 - 1 month (prematurely borns)

1.60%

-

-

1 - 6 months

1.87%

-

-

7 - 11 months

1.80%

-

-

1 - 2 years

1.60%

-

-

3 - 5 years

1.62%

-

-

6 - 10 years

1.40%

0.58%

-

10 - 15 years

1.16%

0.53%

-

26 +/- 4 years

1.28%

-

0.56%

44 +/- 7 years

1.15%

-

0.50%

64 +/- 5 years

1.05%

-

0.37%

Premedication. Drugs used for premedication should be selected for individual patient bearing in mind the respiratory depressant effect of isoflurane. In case of need anticholinergic drugs can be used.
Induction. It is recommended that inhalational induction with Isotoran be initiated at a concentration of 0.5%. Concentrations of 1.5 to 3.0% usually produce surgical anesthesia in 7 to 10 minutes.
Maintenance. Surgical levels of anesthesia may be maintained with 1-2.5% isoflurane in oxygen/nitrous oxide mixture. An additional 0.5-1% isoflurane may be required when given with oxygen alone.
For caesarean section, 0.5-0.75% isoflurane in a mixture of oxygen/nitrous oxide is suitable to maintain general anesthesia for this procedure.

CONTRAINDICATIONS
- malignant hyperthermiain anamnesis

- sensitivity to isoflurane.

SIDE EFFECTS
Cardiovascular system
: heart rhythm disturbances and arterial hypotension can occur.
Laboratory indices: elevation leukocytes count even in the absence of surgical stress.
Respiration system: respiratory depression can occur.
During recovery:
in rare cases - tremor, nausea, vomiting.

PACKAGING
100 ml of liquid for inhalation anesthesia in umber vial with adapter for vaporizer.
1 vial together with instruction on drug administration in a carton box.

 
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