Isofane 100% w/w Inhalation Vapour, Liquid

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
20-09-2023

Viambatanisho vya kazi:

Isoflurane

Inapatikana kutoka:

Piramal Critical Care Limited

INN (Jina la Kimataifa):

Isoflurane

Dawa fomu:

Inhalation vapour, solution

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cats, Dogs, Horses, Mouse, Ornamental Birds, Rabbits, Rat, Reptiles

Eneo la matibabu:

Neurological Agent general anaesthetic

Idhini hali ya:

Authorized

Idhini ya tarehe:

1999-06-28

Tabia za bidhaa

                                Revised: February 2022
AN: 01412/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Isofane 100% _wlw _Inhalation vapour, liquid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Isoflurane 100% w/w
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Inhalation vapour, liquid
A clear colourless liquid with a characteristic odour.
4.
CLINICAL PARTICULARS
Summary presentation of the active substance: Isoflurane is a volatile
liquid
halogenated hydrocarbon. Although the exact mode of action is poorly
understood
it is thought that, in common with other general anaesthetics,
isoflurane acts by
competing with endogenous ligands for binding to specific
neuroreceptors.
4.1
TARGET SPECIES
Horses, dogs, cats, small mammals, ornamental birds and reptiles.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To induce and maintain anaesthesia in all types of veterinary surgery.
4.3
CONTRAINDICATIONS
Do not use in animals sensitive to isoflurane or other halogenated or
inhalation
anaesthetic agents. Do not use in animals with a known susceptibility
to malignant
hyperthermia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Horses: Recovery from isoflurane anaesthesia is generally smooth and
rapid.
However, one report suggests that horses recovering from isoflurane
anaesthesia
may appear un-coordinated. It is important to provide adequate
post-anaesthetic
analgesia since isoflurane anaesthetised horses may become aware of
their
surroundings more rapidly than horses recovering from halothane
anaesthesia.
Other species: none
Revised: February 2022
AN: 01412/2021
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals None known
ii.
Special precautions for the person administering the veterinary
medicinal
product to animals
Do not breathe the vapour. The Occupational Exposure Standard (OES)
for
isoflurane has been set at 50 ppm on an 8-hour weighted average.
Operating rooms and recovery areas should be provided with adequate
ve
                                
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