Gabbrovet Multi 140 mg/ml Solution for Use in Drinking Water/Milk for Pre-ruminant Cattle and Pigs

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Paromomycin Sulfate

可用日期:

Ceva Animal Health Ltd

ATC代码:

QA07AA06

INN（国际名称）:

Paromomycin Sulfate

药物剂型:

Solution for use in drinking water/milk

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Cattle, Pigs

治疗领域:

Antimicrobial

授权状态:

Authorized

授权日期:

2018-04-10

产品特点

Unlimited Renewal: February 2023
AN: 03222/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gabbrovet Multi 140 mg/ml Solution for Use in Drinking Water/Milk for
Pre-ruminant
Cattle and Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Paromomycin (as sulfate)
140 mg
(equivalent to 140 000 IU of paromomycin activity)
(equivalent to approximately 200 mg of paromomycin sulfate)
EXCIPIENTS:
Benzyl alcohol
(E1519)
7.5 mg
Sodium metabisulfite
(E223)
3.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for use in drinking water, milk or milk replacer
Pale yellow to yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pre-ruminant cattle and new-born calves), pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PRE-RUMINANT CATTLE:
_Colibacillosis_
Treatment of gastro-intestinal infections caused by _Escherichia coli_
susceptible to
paromomycin.
_Cryptosporidiosis_
Treatment of infections caused by diagnosed _Cryptosporidium
parvum_, by reduction
of diarrhoea and reduction of faecal oocyst shedding. Administration
has to start
within 24 hours after the onset of diarrhoea.
Unlimited Renewal: February 2023
AN: 03222/2022
Page 2 of 8
PIGS:
_Colibacillosis_
Treatment of gastro-intestinal infections caused by _Escherichia coli
_susceptible to
paromomycin.
4.3
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.
Do not use in turkeys due to the risk of selection for antimicrobial
resistance in
intestinal bacteria.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross-resistance has been shown between paromomycin and neomycin in
Enterobacterales. Use of the product should be carefully considered
when
susceptibility testing has shown resistance to aminoglycosides because
its
effectiveness may be reduced.”
Treatm