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LABELLING AND PACKAGE LEAFLET
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A. LABELLING
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{OUTER CARTON/5/10/20/25/30/50/100 ML}
{LABEL/100 ML}
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fentadon 50 microgram/ml, solution for injection for dogs
SE, DK: Fentadon Vet. 50 microgram/ml, solution for injection for dogs
NO: Fentadon vet 50 microgram/ml, solution for injection for dogs
Fentanyl
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
ACTIVE SUBSTANCE:
Fentanyl 50 microgram (equivalent to fentanyl citrate 78.5 microgram)
EXCIPIENT(S):
Methyl parahydroxybenzoate (E218) 1.6 mg
Propyl parahydroxybenzoate (E216) 0.2 mg
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless
4.
PACKAGE SIZE
5/10/20/25/30/50/100 ml
5.
TARGET SPECIES
Dogs
6.
INDICATION(S)
---
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
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Accidental injection is dangerous. Read the package leaflet before use.
10.
EXPIRY DATE
EXP {month/year}
Once broached, use by ..
11.
SPECIAL STORAGE CONDITIONS
Do not freeze.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials should be disposed of in accordance with local requirements.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUP
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製品の特徴
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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fentadon 50 microgram/ml, solution for injection for dogs
SE, DK: Fentadon Vet. 50 microgram/ml, solution for injection for dogs
NO: Fentadon vet 50 microgram/ml, solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml solution:
ACTIVE SUBSTANCE:
Fentanyl 50 microgram
(equivalent to fentanyl citrate 78.5 microgram)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) 1.6 mg
Propyl parahydroxybenzoate(E 216)
0.2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless
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 and renal dysfunction.
Refer to section 4.7. and 4.8.
4.4
SPECIAL WARNINGS
The use of this 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
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