NEOMAY 500 000 IU/g powder for use in drinking water/milk replacer

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Neomycin

متاح من:

Laboratorios Maymó, S.A.

ATC رمز:

QA07AA01

INN (الاسم الدولي):

Neomycin

جرعة:

500,000 international unit(s)/gram

الشكل الصيدلاني:

Powder for use in drinking water/milk

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجموعة العلاجية:

Cattle, Chickens, Ducks, Other Birds, Pigs, Turkeys

المجال العلاجي:

neomycin

الخصائص العلاجية:

Antibacterial

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-12-23

خصائص المنتج

Health Products Regulatory Authority
11 August 2020
CRN009P77
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NEOMAY 500 000 IU/g powder for use in drinking water/milk replacer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains
ACTIVE SUBSTANCE:
Neomycin (as Neomycin sulphate) 500 000 IU
​
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water/milk replacer.
White or almost white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves), pigs (weaned and fattening pigs), chickens (including
laying hens), ducks, turkeys (including turkey hens), geese,
quail and partridges.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of gastrointestinal infections caused by _E. coli_
susceptible to neomycin.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to aminoglycosides or to any of the excipients.
Do not use in cases of intestinal obstruction.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medicated drinking water intake can be affected by the severity of the
disease. In case of insufficient intake of water/milk
replacer, calves and pigs should be treated parenterally.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Powder for oral solution that is to be dissolved in water and cannot
be used as it is.
Special care should be taken when considering administration of the
product to the newborn calf due to the known higher
gastrointestinal absorption of neomycin in neonates. This higher
absorption could lead to an increased risk of oto- and
nephrotoxicity. The use of the product in neonates should be based on
the benefit/risk determination from the attending
veterinarian.
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
bacteri