Ronaxan 100 mg tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

doxycycline hyclate

Available from:

Merial Animal Health Limited

ATC code:

QJ01AA02

Dosage:

100 mg/tablet

Pharmaceutical form:

Tablets

Therapeutic group:

Canine

Therapeutic area:

Antibacterial

Authorization status:

Authorised

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ronaxan 100 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
ACTIVE SUBSTANCE :
Doxycycline
100 mg
(as doxycycline hyclate)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Round, biconvex, light yellow to yellow scored tablet. The tablets can be divided into equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia in dogs due to organisms
sensitive to doxycycline including: _Pasteurella _spp., _Bordetella bronchiseptica_, _Staphylococcus aureus _and other
_Staphylococcus _spp, and _Streptococcus _spp.
Treatment of arthropod-borne _Ehrlichia canis _infection.
4.3 CONTRAINDICATIONS
Do not use in pregnant animals.
Do not use in known cases of hypersensitivity to the active ingredient.
Vomiting, oesophagitis and oesophageal ulcerations have been reported as side effects following doxycycline therapy,
and Ronaxan should not therefore be administered to patients with dysphagia or diseases accompanied by vomiting.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/03/2014_
_CRN 7013952_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the recommended dosage.
Tablets should be administered at feeding time.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands thoroughly after use. Handle the tablets with care if you know you are hypersensitive (allergic) to
tetracycline. In case of
                                
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