Betamox Palatable Drops Powder for Oral Suspension

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

קנה את זה

הורד מאפייני מוצר (SPC)
12-06-2017

מרכיב פעיל:

Amoxicillin trihydrate

זמין מ:

Norbrook Laboratories Limited

קוד ATC:

QJ01CA04

INN (שם בינלאומי):

Amoxicillin trihydrate

כמות:

114.8 milligram(s)/gram

טופס פרצבטיות:

Powder for oral suspension

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Cats, Dogs

איזור תרפויטי:

amoxicillin

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

1987-10-01

מאפייני מוצר

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox Palatable Drops Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Each bottle contains the equivalent of 750 mg Amoxicillin (as the
Trihydrate) and when reconstituted with 12 ml water
gives a 15 ml suspension containing Amoxicillin at a concentration of
50 mg/ml.
Excipients:
Erythrosine (E127)
0.312 mg.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
A pale red powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Amoxycillin is a broad spectrum semi-synthetic penicillin bactericidal
in action.
In vitro it is effective against a wide
range of
Gram-positive and Gram-negative bacteria found in dogs and cats
including:
_Bacillus cereus,_
_Bordetella_
_bronchiseptica,_
_Corynebacterium spp,_
_Citrobacter freundii_,
_Chromobacter spp,_
_Flavobacter spp,_
_Pasteurella spp_
(including P._ multocida), Salmonella_ spp, Staphylococci (penicillin
sensitive strains), Streptococci.
Some effect has been observed against_ Escherichia coli._
Betamox Palatable Drops are suitable for the control of infections
caused by susceptible organisms including:
infections of the alimentary tract, respiratory tract and urogenital
tract, eye and ear infections and skin and wound
infections
4.3 CONTRAINDICATIONS
Betamox Palatable Drops should not be given to penicillin sensitive
animals.
As with other penicillins,
amoxycillin should not
be used orally or parenterally in rabbits,
guinea pigs,
hamsters or
gerbils.
Caution is advised when used in any other very small herbivores.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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