Sevoflurane 100% Inhalation Vapour, liquid

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sevoflurane

Available from:

Piramal Critical Care Limited

ATC code:

N01AB; N01AB08

INN (International Name):

Sevoflurane

Dosage:

100 percent volume/volume

Pharmaceutical form:

Inhalation vapour, liquid

Prescription type:

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

Therapeutic area:

Halogenated hydrocarbons; sevoflurane

Authorization status:

Not marketed

Authorization date:

2012-01-13

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevoflurane 100% Inhalation Vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevoflurane 100%.
Excipient with known effect:
None
The finished product is comprised only of the active ingredient, see
section 6.1.
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Clear, colourless, volatile liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction and maintenance of
general
anaesthesia in adult
and paediatric patients of
all
ages,
including full
term
neonates (see section 4.2 for age details).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Premedication should be selected according to the need of the
individual patient, and at the discretion of the
anaesthetist.
SURGICAL ANAESTHESIA:
Sevoflurane should be delivered via a vaporizer specifically
calibrated for use with Sevoflurane so that the
concentration delivered can be accurately controlled. Sevoflurane
bottles fitted with an integrated adaptor are
specifically designed to work with a Dräger-Vapor2000 vaporiser with
a Dräger Fill or Piramal Fill port.
MAC (minimum alveolar concentration) values for sevoflurane decrease
with age and with the addition of nitrous
oxide. Dosage should be individualised and titrated to the desired
effect according to the patient’s age and clinical
status. The table below indicates average MAC values for different age
groups.
Table 1: MAC values for Adults and Paediatric patients
according to age
Age of Patient
(years)
Sevoflurane 100%
Inhalation Vapour,
liquid in Oxygen
Sevoflurane
100% Inhalation
Vapour, liquid in
65% N O/35%
O
0 – 1 months*
3.3%
2.0%**
1 - < 6 months
3.0%
6 months - < 3
2.8%
2
2
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