Duphacycline LA 20% Solution for Injection

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Oxytetracycline

Disponibil de la:

Zoetis UK Limited

Codul ATC:

QD06AA03

INN (nume internaţional):

Oxytetracycline

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Cattle, Pigs, Sheep

Zonă Terapeutică:

Antimicrobial

Statutul autorizaţiei:

Expired

Data de autorizare:

1994-04-07

Caracteristicilor produsului

Revised: April 2014
AN: 01718/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphacycline LA 20% Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances:
Per ml
Oxytetracycline
200mg
(equivalent to 216mg Oxytetracycline dehydrate per ml)
Excipients:
Sodium Formaldehyde Sulphoxylate (antioxidant)
4mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear amber liquid, free from visible particles
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs.
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
Oxytetracycline is active against a wide range of Gram-positive and
Gram-negative pathogenic bacteria and certain rickettsia. The product
is indicated for the treatment of a wide range of common systemic,
respiratory and local infections caused by or associated with
organisms
sensitive to Oxytetracycline in cattle, sheep and pigs. These include:
_Bordetella _
_bronchiseptica_,_ _
_Actinomyces _
_pyogenes_,_ _
_Erysipelothrix _
_rhusiopathiae_,_ _
_Escherichia _
_coli_,_ _
_Haemophilus _
_somnus_,_ _
_Mannheimia _
_haemolytica_,_ Pasteurella multocida_,_ Salmonella dublin_,_
Staphylococcus _
_aureus_,_ _
_Streptococcus _
_agalactiae_,_ _
_Streptococcus _
_faecalis_,_ _
_Streptococcus pyogenes _and_ Streptococcus uberis_.
4.3
CONTRAINDICATIONS
Not recommended for use in horses, dogs or cats. Contraindicated in
animals suffering from hepatic or renal damage and in animals with
known hypersensitivity to Oxytetracycline.
4.4
SPECIAL WARNINGS
None
Revised: April 2014
AN: 01718/2013
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Do not dilute. If concurrent treatment is administered use a
separate injection site.
ii)
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
Wash hands after use.
In case of contact with eyes or skin, wash immediately with
water as irritation may occur.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOU