HALOCUR VETERINARY

Երկիր: Իսրայել

Լեզու: անգլերեն

Աղբյուրը: Ministry of Health

Ակտիվ բաղադրիչ:

HALOFUGINONE AS LACTATE

Հասանելի է:

INTERVET ( ISRAEL) LTD

Դեղագործական ձեւ:

SOLUTION (ORAL)

Կազմը:

HALOFUGINONE AS LACTATE 0.50 MG/ML

Կառավարման երթուղին:

PER OS

Ռեկվիզորի տեսակը:

Required

Պատրաստված է:

INTERVET PRODUCTIONS SA., FRANCE

Թերապեւտիկ ցուցումներ:

In new born Calves: Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, In farms with history of cryptosporidiosis.Administration should start in the first 24 to 48 hours of age. Reduction of diarrhoea due to diagnosed Cryptosporidium parvum. Administration should start within 24 hours after the onset of diarrhoea.In both cases, the reduction of ocysts excretion has been demonstrated.

Հաստատման ամսաթիվը:

2020-12-31

Տեղեկատվական թերթիկ

CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL PRODUCT
The medicine is dispensed with a veterinarian's prescription only
For animal use only
1. NAME OF THE MEDICINAL PRODUCT AND ITS FORM:
HALOCUR VETERINARY
Oral Solution
2. COMPOSITION:
Active substance
Halofuginone base (as lactate salt) 0.50 mg/ml
Inactive substances
Benzoic acid 1.00 mg/ml
Tartrazine (E 102) 0.03 mg/ml
The full list of excipients is detailed in section 13 –
“Additional information”.
3. WHAT IS THE MEDICINAL PRODUCT INTENDED FOR:
In new born calves:

Prevention of diarrhea due to diagnosed _ Cryptosporidium parvum_, in
farms with
history of cryptosporidiosis infection
Administration should start in the first 24 to 48 hours of age.

For reduction of diarrhea due to diagnosed _ Cryptosporidium parvum.
_Administration
should start within 24 hours after the onset of diarrhea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
THERAPEUTIC GROUP: Quinazolinone derivate
4. CONTRAINDICATIONS:
Do not administer on an empty stomach.
Do not administer in cases where diarrhea persists for more than 24
hours and in
weak calves.
Do not administer to cows producing milk for human consumption.
5. SIDE EFFECTS:
In very rare cases (less than 1 animal in 10,000 animals treated,
including isolated
reports), an increase in the level of diarrhea has been observed in
treated animals.
If you notice any side effects, even those not already listed in this
package leaflet or
you think that the medicine has not worked, please inform your
veterinary surgeon.
Side effects can be reported to the Ministry of Health by clicking on
the link
“Reporting Side Effects due to Drug Treatment” found on the
Ministry of Health
homepage (www.health.gov.il) that directs you to the online form for
reporting side
effects, or by entering the link:
https://sideeffects.health.gov.il
6. TARGET SPECIES:
New born calves
7. METHOD OF ADMINISTRATION AND DOSAGE:
For oral use in calves after feeding.
The dosage is 100 μg of Halofuginone / kg body weight / once

Ապրանքի հատկությունները

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HALOCUR VETERINARY
Oral solution for calves
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Halofuginone base
0.50 mg/ml
(as lactate salt)
EXCIPIENTS:
Benzoic acid 1.00 mg/ml
Tartrazine (E 102) 0.03 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
Canary yellow homogenous clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
New born calves.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention of diarrhoea due to diagnosed
_Cryptosporidium parvum_
, in farms with history of
cryptosporidiosis.
Administration should start in the first 24 to 48 hours of age.
Reduction of diarrhoea due to diagnosed
_Cryptosporidium parvum_
.
Administration should start within 24 hours after the onset of
diarrhoea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
4.3
CONTRAINDICATIONS
Do not use on an empty stomach.
Do not use in case of diarrhoea established for more than 24 hours and
in weak animals.
Not for use in cows producing milk for human consumption.
4.4
SPECIAL WARNINGS
2
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Administer after colostrum feeding, or after milk or milk replacer
feeding only, using either a
syringe or any appropriate device for oral administration. Do not use
on an empty stomac h. For
treatment of anorexic calves, the product should be administered in
half a litre of an electrolyte
solution. The animals should receive enough colostrum according to
good breeding practice.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Repetitive contact with the product may lead to skin allergies. Avoid
skin, eye or mucosal contact
with the product. Wear protective gloves while handling the product.
In case of skin and eye contact wash the exposed area thoroughly with
clean water. If eye irritation
persists, seek medical advice.
Wash hands after use.
4.6
ADVERS