Ronaxan 100 mg Tablets for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Doxycycline

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QJ01AA02

INN (International Name):

Doxycycline

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1991-06-27

Summary of Product characteristics

Revised: January 2022
AN: 01406/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ronaxan 100 mg tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Doxycycline (as doxycycline hyclate)
...........................................100 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Light yellow to yellow, biconvex, round, scored tablets.
The tablets can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs
For the treatment of respiratory tract infections including rhinitis,
tonsillitis and
bronchopneumonia caused by _Bordetella bronchiseptica _and_
Pasteurella _spp.
susceptible to doxycycline.
For the treatment of canine ehrlichiosis caused by _Ehrlichia canis_.
Cats
For the treatment of respiratory tract infections including rhinitis,
tonsillitis and
bronchopneumonia caused by _Bordetella bronchiseptica_ and
_Pasteurella _spp.
susceptible to doxycycline.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in animals with renal or hepatic insufficiency.
Revised: January 2022
AN: 01406/2021
Page 2 of 7
Do not use in animals with diseases associated with vomiting or
dysphagia (see also
section 4.6).
Do not use in animals with known photosensitivity (see also section
4.6).
Do not use in puppies and kittens before completion of teeth enamel
formation.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
_Ehrlichia canis_ infection: treatment should be initiated at the
onset of clinical signs.
Complete eradication of the pathogen is not always achieved, but
treatment for 28
days generally leads to a resolution of the clinical signs and a
reduction of the
bacterial load. A longer duration of treatment, based on a
benefit/risk assessment by
the responsible veterinarian, may be required particularly in severe
or chronic
ehr