Halothane liquid for inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

halothane

Available from:

Piramal Pharma Limited

ATC code:

N01AB01

INN (International Name):

halothane

Dosage:

100%

Pharmaceutical form:

liquid for inhalation

Units in package:

250ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-06-29

Patient Information leaflet

IN/PI/0039/19/01
PROFESSIONAL USER LEAFLET
HALOTHANE 100% INHALATION VAPOUR, LIQUID
NAME OF MEDICINAL PRODUCT
Halothane
ACTIVE INGREDIENT
Halothane 100% v/v.
PHARMACEUTICAL FORM
CONTENTS BY WEIGHT, VOLUME OR DOSAGE UNIT
Halothane is supplied in 250 ml amber glass bottles.
PHARMACOTHERAPEUTIC GROUP
General anaesthetic.
INDICATIONS
Induction and maintenance of general anaesthesia in adults and
children. Use of halothane
in paediatric dental anaesthesia should be restricted to hospitals
only.
CONTRAINDICATIONS
History of unexplained jaundice or pyrexia after a previous exposure
to halothane is an
absolute contra-indication to its future use in that patient.
Halothane is contraindicated in patients with known, or suspected,
genetic predisposition to
malignant hyperpyrexia.
Children under 18 years undergoing dental procedures outside hospital.
100% Inhalation Vapour, Liquid
Inhalation Vapour, Liquid.
PRECAUTIONS FOR USE
Halothane can induce liver damage. Minor changes in serum
amino-transferase activity have
been reported to occur in up to 30% of patients. The incidence of
severe liver damage
(jaundice, which may lead to hepatic failure as a consequence of
massive hepatic cell necrosis)
is much rarer but cases requiring liver transplants and fatalities
have been reported. The risk of
developing hepatic failure appears to be greatly increased by repeated
exposure to halothane.
Although short intervals of time between exposures are likely to
increase the risk of
hepatotoxicity, even long intervals between exposure may not reduce
the risks, since some
patients have developed severe reactions to halothane given many years
after the previous
exposure.
_Other _
risk factors for hepatotoxicity include female gender, obesity, middle
age and
a history of drug allergy. On present available information, the
following precautions should be
taken:
1.
A careful anaesthetic history is to be taken from patients due to
undergo anaesthesia in
order to determine whether exposure to halothane took place and the
nature of any adverse
reac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Halothane 100% Inhalation Vapour, Liquid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Halothane 100% v/v active.
3.
PHARMACEUTICAL FORM
Inhalation Vapour, Liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Induction and maintenance of general anaesthesia in adults and
children. Use of halothane in
paediatric dental anaesthesia should be restricted to hospitals only.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Induction: Anaesthesia may be induced with 2 to 4% v/v of halothane in
oxygen or mixtures of nitrous
oxide and oxygen. Induction may also be started at a concentration of
0.5% v/v and increased
gradually to the required level.
Maintenance: Anaesthesia is maintained with concentrations of 0.5 Lo
2% depending on the tlow rate
used; the lower concentration is usually suitable for the elderly.
Children:
For induction in children a concentration of 1.5 to 2% v/v has been
used.
Elderly:
Elderly patients tend to require less halothane than adults but the
actual dose is dependent on the
patient's physical state
4.3.
CONTRAINDICATIONS
History of unexplained jaundice or pyrexia after a previous exposure
to halothane is an absolute
contra-indication to its future use in that patient. Halothane is
contraindicated in patients with known,
or suspected, genetic predisposition to malignant hyperpyrexia.
Children under 18 years undergoing
dental procedures outside hospital
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Halothane can induce liver damage. Minor changes in serum
amino-transferascactivity have been
reported to occur in up to 30% of patients. The incidence ofsevere
liver damage Uaundice, which may
lead to hepatic failure as a consequenceof massive hepatic cell
necrosis) is much rarer but cases
requiring liver transplantsand fatalities have been reported. The risk
of developing hepatic failure
appears tobe greatly increased by repeated exposure to halothane.
Although short intervals
of time between exposures are likely to increase th