Sevohale (previously known as Sevocalm)
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
05-05-2021
Produktets egenskaber
(SPC)
05-05-2021
Offentlige vurderingsrapport
(PAR)
25-06-2018
Aktiv bestanddel:
sevoflurane
Tilgængelig fra:
Chanelle Pharmaceuticals Manufacturing Limited
ATC-kode:
QN01AB08
INN (International Name):
sevoflurane
Terapeutisk gruppe:
Dogs; Cats
Terapeutisk område:
Anesthetics, general
Terapeutiske indikationer:
For the induction and maintenance of anaesthesia.
Produkt oversigt:
Revision: 5
Autorisation status:
Authorised
Autorisation dato:
2016-06-21
Indlægsseddel
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
SEVOHALE
INHALATION VAPOUR, LIQUID FOR DOGS AND CATS, 100% V/V SEVOFLURANE
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
IRELAND
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sevohale 100% v/v Inhalation vapour, liquid for dogs and cats.
sevoflurane
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
100% v/v sevoflurane.
4.
INDICATION(S)
For the induction and maintenance of anaesthesia.
5.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to sevoflurane or
other halogenated anaesthetic
agents.
Do not use in animals with a known or suspected genetic susceptibility
to malignant hyperthermia.
6.
ADVERSE REACTIONS
Hypotension, tachypnoea, muscle tenseness, excitation, apnoea, muscle
fasciculations and emesis
have been reported very commonly, based on post-authorisation
spontaneous reporting experience.
Dose-dependent respiratory depression is commonly observed while using
sevoflurane, therefore
respiration should be closely monitored during sevoflurane anaesthesia
and the inspired concentration
of sevoflurane adjusted accordingly. Anaesthetic-induced bradycardia
is commonly observed during
sevoflurane anaesthesia. It may be reversed by administration of
anticholinergics.
Paddling, retching, salivation, cyanosis, premature ventricular
contractions and excessive
cardiopulmonary depression have been reported very rarely, based on
post-authorisation spontaneous
reporting experience.
In dogs, transient elevations in aspartate aminotransferase (AST),
alanine aminotransferase (ALT),
lactate dehydrogenase (LDH), bilirubin and white blood cell counts may
occur with sevoflurane, as
20
with the use of other halogenated anaesthetic agents. In cats,
transient increases in AST and ALT may
occur with sevoflurane, howev
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Produktets egenskaber
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sevohale 100% v/v Inhalation vapour, liquid for dogs and cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Sevoflurane
100% v/v.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation vapour, liquid.
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the induction and maintenance of anaesthesia.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to sevoflurane or
other halogenated anaesthetic
agents.
Do not use in animals with a known or suspected genetic susceptibility
to malignant hyperthermia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Halogenated volatile anaesthetics can react with dry carbon dioxide
(CO
2
) absorbents to produce
carbon monoxide (CO) that may result in elevated levels of
carboxyhaemoglobin in some dogs. In
order to minimise this reaction in rebreathing anaesthetic circuits,
Sevohale should not be passed
through soda lime or barium hydroxide that has been allowed to dry
out.
The exothermic reaction that occurs between inhalation agents
(including sevoflurane) and CO
2
absorbents is increased when the CO
2
absorbent becomes desiccated, such as after an extended period
of dry gas flow through the CO
2
absorbent canisters. Rare cases of excessive heat production, smoke
and/or fire in the anaesthetic machine have been reported during the
use of a desiccated CO
2
absorbent and sevoflurane. An unusual decrease in the expected depth
of anaesthesia compared to the
vaporiser setting may indicate excessive heating of the CO
2
absorbent canister.
If it is suspected that the CO
2
absorbent may be desiccated, it must be replaced. The colour indicator
of most CO
2
absorbents does not necessarily change as a result of desiccation.
Therefore, the lack of
3
significant colour change shou
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