DRAXXIN INJECTABLE SOLUTION VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TULATHROMYCIN

متاح من:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

TULATHROMYCIN 100 MG / 1 ML

طريقة التعاطي:

I.M, S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ZOETIS MANUFACTURING & RESEARCH SPAIN, S.L

الخصائص العلاجية:

Cattle : treatment and prevention of bovine respiratory disease associated with mannheimia ( pasteurella) haemolytica pasteurella multocida haemophilus somnus and mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment. Pigs : treatment of swine respiratory disease associated with actinobacillus pleuropneumoniae pasteurella multocida and mycoplasma hyopneumoniae sensitive to tulathromycin.

تاريخ الترخيص:

2019-03-31

نشرة المعلومات

• Overdose
In
cattle,
in
administration
of
3,
5
or
10 times the recommended dose, transient
signs attributed to injection site discomfort
were
observed
and
included
restlessness,
headshaking, pawing the ground, and brief
decrease
in
feed
intake.
Mild
myocardial
degeneration has been observed in cattle
receiving
5-6
times
the
recommended
dosage.
In
young
pigs
weighing
approximately
10 kg given 3 or 5 times the therapeutic
dose transient signs attributed to injection
site
discomfort
were
observed,
including
excessive vocalisation and restlessness.
Lameness was observed when the hind leg
was used as the injection site.
• Incompatibility
Given that compatibility studies have not
been conducted, do not mix Draxxin with
other veterinary medicinal products.
11.
STORAGE INSTRUCTIONS
Prevent
poisoning!
To
prevent
poisoning,
keep this, and all other medicines, in a closed
place, out of the reach and sight of children
and/or infants.
Do not use the medicine after the expiry date
(exp. date) which is stated on the package.
The expiry date refers to the last day of that
month.
• Storage conditions
Store below 30°C
• Shelf-life after opening the bottle
28 days.
12. INSTRUCTIONS FOR THE DISPOSAL
OF
THE
UNUSED
PRODUCT
OR
WASTE MATERIALS
Dispose of any remaining veterinary medicine
or waste obtained from using a veterinary
medicine in the same manner as toxic waste;
do not discard into a sewer.
13.
ADDITIONAL INFORMATION
• IN ADDITION TO THE ACTIVE INGREDIENT, THIS
MEDICINE ALSO CONTAINS
Citric Acid, anhydrous
Hydrochloric Acid (for pH adjustment)
Sodium Hydroxide (for pH adjustment)
Propylene Glycol
Monothioglycerol
Water for Injections
• WHAT THE MEDICINE LOOKS LIKE AND CONTENTS
OF THE PACK
A vial with a clear, colourless to yellowish
solution.
• PACK SIZES
Glass vial with volume of 20, 50, 100, 250 and
500 ml.
Not all volumes may be marketed.
The 500 ml vials must not be used for pigs.
• REGISTRATION HOLDER
Zoetis Israel Holding B.V.,
5 Atir Yeda Street, Kfar Saba
• MANUFACTURER’S NAME
FAREVA AMBOISE, FRAN

خصائص المنتج

Draxxin LPD
05.10.2021
1
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Draxxin Injectable Solution Veterinary
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tulathromycin 100 mg/ml
EXCIPIENT:
Monothioglycerol 5 mg/ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Treatment and prevention of bovine respiratory disease associated with
mannheimia (pasteurella)
haemolytica pasteurella multocida haemophilus somnus and mycoplasma
bovis sensitive to
tulathromycin. The presence of the disease in the herd should be
established before preventative
treatment.
Pigs
Treatment of swine respiratory disease associated with actinobacillus
pleuropneumoniae pasteurella
multocida and mycoplasma hyopneumoniae sensitive to tulathromycin.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity of the target animals to
macrolide antibiotics.
Do not use simultaneously with other macrolides or lincosamides (see
section 4.8).
Do not use in lactating animals producing milk for human consumption.
Do not use in pregnant animals, which are intended to produce milk for
human consumption, within 2
months of expected parturition.
Draxxin LPD
05.10.2021
2
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If
this is not possible, therapy should be based on local (regional, farm
level) epidemiological information
about susceptibility of the target bacteria.
If a hypersensitivity reaction occurs appropriate treatment should be
administered without delay.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Tulathromycin is irritating to eyes. In case of accidental eye
exposure, flush the eyes immediate