Duphacycline XL Oxytetracycline 30% w/v Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline Dihydrate

Available from:

Zoetis UK Limited

ATC code:

QD06AA03

INN (International Name):

Oxytetracycline Dihydrate

Authorization status:

Expired

Summary of Product characteristics

Revised: July 2014
AN: 00423/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphacycline XL Oxytetracycline 30% w/v Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances:
Per ml
Oxytetracycline Dihydrate
300mg
Excipients:
Sodium Formaldehyde Sulphoxylate
0.4% w/v
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
A clear dark amber liquid
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle
Pigs
Sheep
4.2.
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
For the treatment of conditions caused by or associated with organisms
sensitive to oxytetracycline including:
_Bordetella bronchiseptica_
_Actinomyces pyogenes_
_Erysipelothrix rhusiopathiae_
_Pasteurella _spp
_Staphylococcus _spp
_Streptococcus _spp
Certain mycoplasma, rickettsia, protozoa and chlamydia
The product is indicated for the treatment of pasteurellosis,
pneumonia,
atrophic rhinitis, erysipelas, joint-ill, navel-ill and summer
mastitis in
cows, ovine kerato conjunctivitis (pink-eye) and the control of
enzootic
abortion in sheep.
4.3.
CONTRAINDICATIONS
Not for use in horses, dogs or cats.
Revised: July 2014
AN: 00423/2014
Page 2 of 5
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
This product does not contain an antimicrobial preservative.
Swab the septum before removing each dose. Use a sterile
needle and syringe.
Do not dilute the product.
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
Avoid accidental self-injection.
Wash hands after use.
In case of contact with eyes or skin, wash off immediately with
water as irritation may occur.
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Although the product is well tolerated, occasionally a slight local
reaction
of a transient nature may be observed.
4.7.
USE DURING PREGNANCY,