Orbax Oral Suspension 3%
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
19-02-2013
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Active ingredient:
orbifloxacin 30 mg/ml
Available from:
Schering-Plough Limited
ATC code:
QJ01MA95
Pharmaceutical form:
Oral suspension
Therapeutic group:
Orbifloxacin
Therapeutic area:
Cats, Dogs
Authorization date:
2011-04-21
Summary of Product characteristics
Revised: October 2012
AN: 00697/2012
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav 500 mg Palatable Tablets for Dogs
Noroclav Tablets 400mg/100mg for Dogs (Sweden)
Noroclav Comprimés 400mg/100mg pour Chiens (France)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active Ingredients:
Amoxicillin (as amoxicillin trihydrate)
400 mg
Clavulanic acid (as potassium clavulanate)
100 mg
Colouring Agent:
Carmoisine Lake (E122)
2.45mg
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Tablet. Pink divisible circular tablet with score line on one face and figure 500
embossed on opposing face. The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of the following infections caused by beta-lactamase producing strains of
bacteria sensitive to amoxicillin in combination with clavulanic acid:
- Skin infections (including superficial and deep pyodermas) caused by
susceptible _Staphylococci_.
- Urinary tract infections caused by susceptible _Staphylococci_ or _Escherichia coli_.
- Respiratory infections caused by susceptible _Staphylococci_.
- Enteritis caused by susceptible _Escherichia coli_.
It is recommended to carry out suitable tests for sensitivity when initiating the
treatment. The treatment should only proceed if sensitivity is proven to the
combination.
Revised: October 2012
AN: 00697/2012
Pa
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