GALLIFEN VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FENBENDAZOLE

متاح من:

G.W. ORACEL INTERNAT. LTD

الشكل الصيدلاني:

SUSPENSION

تركيب:

FENBENDAZOLE 200 MG / 1 ML

طريقة التعاطي:

PER OS IN DRINKING WATER

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BIOVET JSC, BULGARIA

الخصائص العلاجية:

Treatment of chicken infected with Heterakis gallinarum (adult stages) or Ascardia galli (adult stages)

تاريخ الترخيص:

2023-05-23

نشرة المعلومات

PACKAGE LEAFLET FOR VETERINARY MEDICINAL PRODUCT
This medicine is dispensed with a veterinarian’s prescription only
For veterinary use only
1. NAME OF THE MEDICINE, ITS FORM AND STRENGTH:
GALLIFEN VETERINARY
Suspension for use in drinking water for chickens.
2. ACTIVE INGREDIENT AND OTHER INGREDIENTS
1 ml suspension contains:
Fenbendazole 200 mg
For the full list of excipients, see section 13 “Other
Information”.
3.
WHAT IS THE MEDICINE INTENDED FOR
Treatment of chicken infected with Heterakis gallinarum (adult stages)
or Ascardia galli
(adult stages)
.
4 .
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
5.
ADVERSE REACTIONS
None known.
You can report side effects to the Ministry of Health by clicking on
the link “Report side effects
resulting from medicinal treatment” found on the homepage of the
Ministry of Health website
(www.health.gov.il), which will direct you to the online form for
reporting side effects, or by entering
the link: https://sideeffects.health.gov.il
If you notice any side effects, or you think that the medicine has not
worked, please inform your
veterinary surgeon.
6
. TARGET SPECIES
Chickens
7. DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
In drinking water use.
Shake well before use.
The dose is 1.0 mg fenbendazole per kg body
weight per day (equivalent to 0.005 ml of the product). This dose has
to be
administered on 5 consecutive days.
Dose calculation:
The required daily amount of product is calculated from the total
estimated body
weight (kg) of the entire group of chickens to be treated. Please use
the
following formula:
ml product/day = total estimated body weight (kg) of
chickens to be treated x 0.005 ml
8. HOW TO USE THE MEDICINAL PRODUCT
To ensure administration of the correct dose, body weight should be
determined as
accurately as possible.
Before allowing animals to have access to the medicated water, the
water delivery
system should be drained, if possible, and flushed with the medicated
water to ensure
accurac

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallifen Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Fenbendazole 200 mg
EXCIPIENTS:
Sodium benzoate (E211) 3 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for use in drinking water.
White to almost white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of chickens infected with _Heterakis gallinarum _(adult
stages)_ _or_ Ascaridia _
_galli _(adult stages),
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk of
development of resistance and could ultimately result in ineffective
therapy:
•
Too frequent and repeated use of anthelmintics from the same class,
over an
extended period of time.
•
Under dosing, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration of the dosing
device (if
any).
Suspected clinical cases of resistance to anthelmintics should be
further investigated
using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where
the results of
the test(s) strongly suggest resistance to a particular anthelmintic,
an anthelmintic
belonging to another pharmacological class and having a different mode
of action
should be used. 4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The safety of the product at overdose has not been evaluated in
chickens less than
3 weeks old .
Use of the product deviating from the instructions in the SPC may
increase the risk of
development of resistance.
Special precautions to be taken by the person administering the
medicinal product to
animals
- Embryotoxic effects cannot be excluded. Pregnant women must take
extra
precautions when handling this veterinary medic