Ophtocycline 10 mg/g eye ointment for dogs, cats and horses

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Chlortetracycline hydrochloride

Prieinama:

Le Vet Beheer B.V.

ATC kodas:

QS01AA02

INN (Tarptautinis Pavadinimas):

Chlortetracycline hydrochloride

Dozė:

10 milligram(s)/gram

Vaisto forma:

Eye ointment

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Cats, Dogs, Horses

Gydymo sritis:

chlortetracycline

Terapinės indikacijos:

Antibiotics

Autorizacija statusas:

Authorised

Leidimo data:

2017-09-01

Prekės savybės

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ophtocycline 10 mg/g eye ointment for dogs, cats and horses (AT, BE,
BG, CY, CZ, DE, EL, ES,
HR, HU, IE, IT, LU, NL, PT, RO, SI, SK, UK)
Ophtaclin vet 10 mg/g eye ointment for dogs, cats and horses (DK, EE,
FI, LT, LV, IS, NO, PL, SE)
Ophtocycline eye ointment for dogs, cats and horses (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCES:
Chlortetracycline hydrochloride
10.0 mg
(equivalent to 9.3 mg chlortetracycline)
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment.
Yellowish to yellow homogenous ointment
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats and horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of keratitis, conjunctivitis and blepharitis caused by
_Staphylococcus _
spp.,
_ Streptococcus _
spp.
_, Proteus _
spp.
_ _
and/or
_ Pseudomonas _
spp
_._
.
_ _
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
other tetracyclines or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the veterinary medicinal product should be based on
identification and susceptibility testing of
the target pathogen(s). If this is not possible, therapy should be
based on epidemiological information
and knowledge of susceptibility of the target pathogens at farm level,
or at local/regional level.
Use of the product should be in accordance with official, national and
regional antimicrobial policies.
Use of the veterinary medicinal product deviating from the
instructions given in the SPC may increase
the prevalence of bacteria resistant to chlortetracycline and may
decrease the effectiveness of
treatment with other tetracyclines due to the potential for
cross-resistance.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
This veterinary me