SevoFlo
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
29-03-2021
Vara einkenni
(SPC)
29-03-2021
Opinber matsskýrsla
(PAR)
18-01-2018
Virkt innihaldsefni:
sevoflurane
Fáanlegur frá:
Zoetis Belgium SA
ATC númer:
QN01AB08
INN (Alþjóðlegt nafn):
sevoflurane
Meðferðarhópur:
Dogs; Cats
Lækningarsvæði:
Anesthetics, general
Ábendingar:
For the induction and maintenance of anaesthesia in dogs and cats.
Vörulýsing:
Revision: 18
Leyfisstaða:
Authorised
Leyfisdagur:
2002-12-11
Upplýsingar fylgiseðill
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
SEVOFLO 100% INHALATION VAPOUR, LIQUID FOR DOGS AND CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
AbbVie S.r.l.
S.R. 148 Pontina Km 52 snc
04011 Campoverde di Aprilia (LT)
ITALY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SevoFlo 100% Inhalation vapour, liquid for dogs and cats.
sevoflurane
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
100% 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 as very common adverse reactions, 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.
20
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
with the use of other halogenated anaesthetic agents. In cats,
transient
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SevoFlo 100% Inhalation vapour, liquid for dogs and cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each bottle contains 250 ml sevoflurane (100%).
EXCIPIENT(S)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation vapour, 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,
SevoFlo 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 ch
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