KETOPROSOL VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

KETOPROFEN

متاح من:

HACHAKLAIT LTD

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

KETOPROFEN 100 MG / 1 ML

طريقة التعاطي:

I.V, I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CP-PHARMA HANDELSGESELLSCHAFT MBH, GERMANY

الخصائص العلاجية:

Horses: The alleviation of inflammation and pain associated with musculoskeletal disorders .The alleviation of visceral pain associated with colic.Cattle: The supportive treatment of parturient paresis associated with calving. Reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with an antimicrobial therapy as appropriate. Improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative microorganisms, in conjunction with antimicrobial therapy. Reducing oedema of the udder associated with calving.

تاريخ الترخيص:

2021-10-19

نشرة المعلومات

PATIENT LEAFLET FOR A VETERINARY PRODUCT
The medicine is marketed according to a Veterinary Doctor prescription
only
For Animal use only
1. NAME OF THE VETERINARY MEDICINAL PRODUCT, DOSAGE FORM AND STRENGTH
Ketoprosol Veterinary, solution for injection
2. ACTIVE SUBSTANCE and its quantity per unit dose: Ketoprofen 100
mg/ml
Excipients: Benzyl alcohol 10 mg/ml.
For the full list of excipients, see section 13 of this leaflet.
3. WHAT IS THIS MEDICINE USED FOR
HORSES:
- the alleviation of inflammation and pain associated with
musculoskeletal disorders.
- the alleviation of visceral pain associated with colic.
CATTLE:
- the supportive treatment of parturient paresis associated with
calving.
- reducing the pyrexia and distress associated with bacterial
respiratory disease when used in
conjunction with an antimicrobial therapy as appropriate.
- improving the recovery rate in acute clinical mastitis, including
acute endotoxin mastitis, caused by
Gram-negative micro-organisms, in conjunction with antimicrobial
therapy.
- reducing oedema of the udder associated with calving.
Therapeutic group: Non-Steroidal Anti Inflammatory Drugs (NSAID)
4. CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substances or to any of the
excipients.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within 24
hours of each other, corticosteroids, diuretics and anticoagulants.
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is the possibility
of gastro-intestinal ulceration or bleeding, or where there is
evidence of blood dyscrasia.
5. SIDE EFFECTS
In very rare cases (less than 1 animal in 10,000 animals), due to the
action of inhibition of
prostaglandin synthesis, there can be the possibility in certain
individuals of gastric or renal
intolerance.
In very rare cases (less than I animal in 10,000 animals), allergic
reactions may occur.
Side effects can be reported to the Ministry of Health by clicking on
the link "Adverse Drug Reactions
Rep

خصائص المنتج

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketoprosol Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml
ACTIVE SUBSTANCE:
Ketoprofen 100 mg
EXCIPIENTS:
Benzyl alcohol 10 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horse
-
the alleviation
of inflammation and pain associated with musculoskeletal
disorders;
-
the alleviation of visceral pain associated with colic.
Cattle
-
the supportive treatment of parturient paresis associated with
calving;
-
reducing the pyrexia and distress associated with bacterial
respiratory disease
when used in conjunction with an antimicrobial therapy as appropriate;
-
improving the recovery rate in acute clinical mastitis, including
acute endotoxin
mastitis,
caused
by
Gram-negative
micro-organisms,
in
conjunction
with
antimicrobial therapy;
-
reducing oedema of the udder associated with calving.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substances or to
any of the excipients listed in section 6.1.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently
Page 2 of 5
or within 24 hours of each other, corticosteroids, diuretics and
anticoagulants.
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is
the possibility of gastro-intestinal ulceration or bleeding, or where
there is evidence of
blood dyscrasia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The use of ketoprofen is not recommended in foals under the age of 15
days.
Use in any animal less than 6 weeks of age or in aged animals may
involve
additional
risk. If such use cannot be avoided animals may require a reduced
dosage and careful management.
Avoid use in any dehydrated,
hypovolaemic or hypotensive an