Ronaxan 100 mg tablets for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxycycline hyclate

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QJ01AA02

INN (International Name):

Doxycycline hyclate

Dosage:

100 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

doxycycline

Authorization status:

Authorised

Authorization date:

1990-10-12

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2022
CRN00CRW2
Page 1 of 5
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.
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 ehrlichiosis. All treated