Rhemox 500 mg/g powder for use in drinking water for pigs, chicken broilers, duck broilers and turkeys for meat production

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate

Available from:

Industrial Veterinaria S.A.

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin trihydrate

Dosage:

500 milligram(s)/gram

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Ducks, Pigs, Turkeys

Therapeutic area:

amoxicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-10-16

Summary of Product characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Rhemox 500 mg/g powder for use in drinking water for pigs, chicken
broilers, duck
broilers and turkeys for meat production
Rhemox 500 mg/g powder for use in drinking water for pigs, chickens,
ducks and turkeys
Rhemox 435.6 mg/g powder for use in drinking water for pigs, chicken
broilers, duck
broilers and turkeys for meat production
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Amoxicillin trihydrate
500 mg
(Equivalent to 435.6 mg Amoxicillin)
“Only for France:”
Amoxicillin (as trihydrate)
435.6 mg
(Equivalent to 500 mg of Amoxicillin trihydrate)
EXCIPIENT:
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder for use in drinking water.
Fine and homogeneous white to cream white powder.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
Chicken (broiler), duck (duck broiler) and turkey (turkey for meat
production).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: Treatment of infections caused by strains of
_Streptococcus suis _
susceptible to amoxicillin
_._
Chicken broilers, duck broilers and turkeys for meat production:
Treatment of pasteurellosis
and colibacillosis caused by strains of
_Pasteurella_
spp. and
_Escherichia coli_
susceptible to
amoxicillin.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to penicillins, to other
beta-lactams or to any of the
excipients.
Do not use orally in rabbits, guinea pigs, hamsters or other small
herbivores, given that
amoxicillin, as for all aminopenicillins, has deleterious effects on
caecal bacteria.
Do not use in horse given that amoxicillin, as all aminopenicillins,
has an important effect on
caecal bacteria.
Do not use orally in animals with functional rumen.
Do not use in animals with renal disease, including anuria and
oliguria.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The use of the product should be combined with good management
practices, i.e. good
hygiene, proper ventilation, no overstocking.
The uptake of medication by animals