Mycoflor Injectable, Florfenicol (D:C.I) 30 % Soluton for Injection
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
23-03-2012
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Active ingredient:
florfenicol 30 %
Available from:
SP Veterinaria S.A
ATC code:
QJ01BA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
florfenicol
Therapeutic area:
Cattle, Pigs
Authorization date:
2011-10-26
Summary of Product characteristics
Issued: December 2011
AN: 00749/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mycoflor 300 mg/ml solution for injection for pigs
Florfenicol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance:
Florfenicol. 300mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear, light yellow to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: Treatment of acute outbreaks of respiratory disease caused by strains of
_Actinobacillus pleuropneumoniae _and_ Pasteurella multocida_ _susceptible to _
_florfenicol_
4.3
CONTRAINDICATIONS
Do not use in adult boars intended for breeding purposes.
Do not administer to animals with known hypersensitivity to florfenicol or to any
of the excipients of the product
Do not use in case of known resistance to florfenicol
Do not administer intravenously
Refer to section 4.11
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the recommended treatment dose or the recommended duration
of treatment
Issued: December 2011
AN: 00749/2010
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product should only be used in piglets of less than 2kg after a benefit:risk
assessment by a veterin
ary surgeon’.
The product should be used in conjunction with susceptibility testing and take
into account official and local a
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