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

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Chlortetracycline hydrochloride

Dostępny od:

Le Vet Beheer B.V.

Kod ATC:

QS01AA02

INN (International Nazwa):

Chlortetracycline hydrochloride

Dawkowanie:

10 milligram(s)/gram

Forma farmaceutyczna:

Eye ointment

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Cats, Dogs, Horses

Dziedzina terapeutyczna:

chlortetracycline

Wskazania:

Antibiotics

Status autoryzacji:

Authorised

Data autoryzacji:

2017-09-01

Charakterystyka produktu

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