CRYPTOFOR 140000 IUML VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PAROMOMYCIN AS SULFATE

متاح من:

M.P.VET LTD

الشكل الصيدلاني:

ORAL SOLUTION

تركيب:

PAROMOMYCIN AS SULFATE 140,000 IU/ML

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BIOVET JSC, BULGARIA

الخصائص العلاجية:

For sheep (pre-ruminant lambs) and goats (preruminant kids): Reduction of the severity and the duration of diarrhoea associated with Cryptosporidium parvum in individual animals confirmed to have cryptosporidial oocyst in their faeces. Paromomycin reduces faecal oocyst shedding

تاريخ الترخيص:

2023-07-27

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:
CRYPTOFOR 140,000 IU/ML VETERINARY
Oral solution for sheep and goats
2.
COMPOSITION:
EACH ML CONTAINS:
ACTIVE SUBSTANCE:
140,000 IU of paromomycin activity.
EXCIPIENTS:
Sodium metabisulfite (E223)
4.0 mg
Methyl parahydroxybenzoate (E218)
1.0 mg
Propyl parahydroxybenzoate
0.1 mg
For the full list of
excipients, see section 13 “Other Information”.
3.
WHAT IS THE MEDICINE INTENDED FOR?
Reduction of the severity and the duration of diarrhoea associated
with _ Cryptosporidium _
_parvum_ in individual animals confirmed to have cryptosporidial
oocyst in their faeces.
Paromomycin reduces faecal oocyst shedding.
Therapeutic group: other antiprotozoal agents
4.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to paromomycin,
other
aminoglycosides or any of the excipients.
Do not use in cases with impaired function of the kidneys or liver.
Do not use in ruminating animals
.
5.
ADVERSE REACTIONS
Aminoglycoside antibiotics such as paromomycin can cause oto- and
nephrotoxicity.
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.
Alternatively you can report via your national reporting system
{national system
details}.
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
6. TARGET SPECIES
Sheep (pre-ruminant lambs) and goats (pre-ruminant kids).
7.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For oral use.
Dose rate: 35 000 IU of paromomycin /kg BW /day for 7 consecutive
days, i.e. 0.25
ml of product

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cryptofor 140 000 IU/ml Veterinary
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
paromomycin activity (as paromomycin sulfate)
140 000 IU/ml
Excipients:
Sodium metabisulfite (E223) 4.0 mg
Methyl parahydroxybenzoate (E218) 1.0 mg
Propyl parahydroxybenzoate 0.1 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
A clear yellow to amber solution.
4. CLINICAL PARTICULARS
4.1 Target species
Sheep (pre-ruminant lambs)
goats (pre-ruminant kids).
4.2 Indications for use, specifying the target species
Reduction of the severity and the duration of diarrhoea associated
with
Cryptosporidium parvum
in individual animals confirmed to have cryptosporidial
oocysts in their faeces.
Paromomycin reduces faecal oocyst shedding.
4.3 Contraindications
Do not use in animals with known hypersensitivity to paromomycin,
other
aminoglycosides or any of the excipients listed in section 6.1.
Do not use in cases with impaired function of the kidneys or liver.
Do not use in ruminating animals.
4.4 Special warnings for each target species
Lambs and goat kids should only receive the treatment upon
confirmation of
cryptosporidial oocysts in their faeces and as soon as possible after
the onset of
diarrhoea (see section 4.5i).
In field studies investigating the effect of the product on diarrhoea
associated with
cryptosporidiosis, the median duration of clinically relevant
diarrhoea was 3 days for
treated lambs compared to 6 days for untreated lambs and 4 days in
treated kid
goats compared to 7 days for the untreated goats, during the 7-day
treatment period.
4.5 Special precautions for use
Special precautions for use in animals
Since the product is potentially ototoxic and nephrotoxic, it is
recommended to
assess kidney function, especially when considering administration of
the product to
newborn animals due to the known higher gastrointestinal absorption of
paromomycin in neonates. This higher abso