Draxxin Plus 100 mg/ml + 120 mg/ml Solution for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoprofen, Tulathromycin

Available from:

Zoetis UK Limited

ATC code:

QJ01FA99

INN (International Name):

Ketoprofen, Tulathromycin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial; Anti Inflammatory

Authorization status:

Authorized

Authorization date:

2020-09-01

Summary of Product characteristics

Revised: March 2023
AN: 00640/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Draxxin Plus 100 mg/ml + 120 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Tulathromycin
100 mg
Ketoprofen
120 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION
OF
EXCIPIENTS AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION
IS
ESSENTIAL
FOR
PROPER
ADMINISTRATION
OF
THE
VETERINARY MEDICINAL PRODUCt
Monothioglycerol
5 mg
Propylene glycol
Citric acid (E-330)
Hydrochloric
acid,
concentrated
_(for pH adjustment)_
Sodium hydroxide _(for pH adjustment)_
Pyrrolidone
Water for injections
Clear colourless to yellow / green-yellow solution. Free from visible
particles
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of bovine respiratory disease (BRD) associated with pyrexia
due to
_Mannheimia _
_haemolytica_,
_Pasteurella _
_multocida, _
_Histophilus _
_somni_
and
_Mycoplasma bovis_ susceptible to tulathromycin.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of
the excipients.
Revised: March 2023
AN: 00640/2022
Page 2 of 8
Do not use simultaneously with other macrolides or lincosamides (see
section
3.4).
Do
not
administer
to
animals
suffering
from
gastrointestinal
lesions,
haemorrhagic
diathesis,
blood
dyscrasia
or
hepatic,
renal
or
cardiac
conditions.
3.4
SPECIAL WARNINGS
Cross
resistance
occurs
with
other
macrolides.
Do
not
administer
simultaneously with antimicrobials with a similar mode of action such
as other
macrolides or lincosamides.
3.5
SPECIAL PRECAUTIONS FOR USE
This
veterinary
medicinal
product
does
not
contain
any
antimicrobial
preservative.
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on
identification and
susceptibility testing of the target pathogen(s). If this is not
possible, therapy
should
be
based
on
epidemiological
informat