Fentadon 50 Microgram/ml, Solution for Injection for Dogs

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Fentanyl

Διαθέσιμο από:

Eurovet Animal Health B.V.

Φαρμακολογική κατηγορία (ATC):

QN02AB03

INN (Διεθνής Όνομα):

Fentanyl

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Dogs

Θεραπευτική περιοχή:

Neurological Agent analgesic

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2012-02-27

Αρχείο Π.Χ.Π.

Revised: March 2017
AN: 00451/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fentadon 50 microgram/ml solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each1 ml solution contains:
ACTIVE SUBSTANCE:
Fentanyl 50 microgram
(equivalent to fentanyl citrate 78.5 microgram)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.6 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For intra-operative analgesia during surgical procedures such as soft
tissue and
orthopaedic surgery.
For the control of post-operative pain associated with major
orthopaedic and soft
tissue surgery.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, or to
any of the
excipients.
Do not use in dogs with cardiac failure, hypotension, hypovolaemia,
obstructive
airway disease, respiratory depression, hypertension or with a history
of epilepsy.
Do not use in animals with severe liver or renal dysfunction.
Refer to sections 4.7 and 4.8.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: March 2017
AN: 00451/2016
Page 2 of 7
The use of this veterinary medicinal product must be preceded by a
thorough clinical
examination. Atropine may be used to block the vagal effects.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This veterinary medicinal product should be titrated for the
individual animal to an
effective dose that provides adequate analgesia and minimises
undesirable effects.
Animals should be carefully monitored until an effective dose is
reached. Due to
individual differences in pain sensitivity, the effects of fentanyl
may be variable. Older
animals may tend to titrate to a lower effective dose than younger
animals.
It is important when estimating the required dose for intra-operative
analgesia to
assess t