ENGEMYCIN SPRAY VETERINARY

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

OXYTETRACYCLINE HYDROCHLORIDE

Disponible desde:

INTERVET ( ISRAEL) LTD

formulario farmacéutico:

CUTANEOUS SPRAY

Composición:

OXYTETRACYCLINE HYDROCHLORIDE 25 MG/ML

Vía de administración:

CUTANEOUS

tipo de receta:

Required

Fabricado por:

INTERVET PRODUCTIOND SRL, ITALY

indicaciones terapéuticas:

For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs:*Treatment of foot infections caused in particular by: Dichelobacter nodosus, Fusobacterium necrophorum and other Fusobacterium spp., and Bacteroides spp. *Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions.

Fecha de autorización:

2021-09-30

Información para el usuario

The format of this leaflet was determined by the Ministry of Health
and its content
checked and approved in October 2016.
CONSUMER PACKAGE INSERT FOR A VETERINARY MEDICINAL PRODUCT
The medicine is dispensed with a veterinarian’s prescription only
For veterinary use only
1.
NAME OF THE MEDICINE:
ENGEMYCIN SPRAY VETERINARY
CUTANEOUS SPRAY
2.
COMPOSITION:
Active ingredients
Oxytetracycline hydrochloride 25.00 mg/ml
(equivalent to oxytetracycline 23.15 mg/ml)
Inactive ingredients
Patent blue V (E131) 1.25 mg/ml
A list of inactive ingredients is detailed in the section “Further
Information”.
3.
WHAT IS THE MEDICINE INTENDED FOR:
For the treatment of the following infections caused by or associated
with organisms
sensitive to oxytetracycline in cattle, sheep and pigs.
Foot infections caused in particular by: _Dichelobacter nodosus_,
_Fusobacterium _
_necrophorum_, and other _Fusobacterium_ ssp., and _Bacteroides_ spp.
Supporting treatment of superficial wound infections following surgery
or physical
injuries, e.g., tail biting in pigs, scratches and abrasions.
Pharmacotherapeutic group: antibiotics for topical use, tetracyclines.
4. CONTRAINIDICATIONS:
Do not spray on the udder of the treated animal in order to prevent
traces of the
active ingredient in the milk.
Do not use in the case of hypersensitivity to oxytetracycline or to
any of the inactive
ingredients.
5. SIDE EFFECTS
None.
Side effects can be reported to the Ministry of Health by clicking on
the link “Report
Side Effects of Drug Treatment” found on the Ministry of Health
homepage
(www.health.gov.il) that directs you to the online form for reporting
side effects, or by
entering the link:
https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe
[e-mail]
6.
TARGET ANIMALS:
Cattle, sheep and pigs.
7.
METHOD OF ADMINISTRATION AND DOSAGE:
A suspension in the form of a cutaneous spray.
FOR TOPICAL USE ONLY.
8. ADMINISTRATION OF MEDICINAL PRODUCT:
Shake well before use. The spray container is designed for use in
either the

Ficha técnica

_The format of this leaflet was determined by the Ministry of Health
and its content was checked and _
_approved in _
October 2016
_ _
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Engemycin Spray Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains
Active substance:
Oxytetracycline hydrochloride
25.00 mg
(equivalent to oxytetracycline
23.15 mg
Excipients:
Patent blue V (E131)
1.25 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray, suspension
Green to green-blue suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following infections caused by, or associated
with,
organisms sensitive to oxytetracycline in cattle, sheep and pigs:

Treatment of foot infections caused in particular by: _Dichelobacter
nodosus_,
_Fusobacterium _
_necrophorum_
and
other
_Fusobacterium_
spp.,
and
_Bacteroides_ spp.

Supporting treatment of superficial wound infections following surgery
or
physical injuries, e.g., tail biting in pigs, scratches and abrasions.
4.3
CONTRAINDICATIONS
Do not use for treatment of teats in order to prevent the product from
getting
into milk.
Do not use in animals in cases of hypersensitivity to oxytetracycline
or to any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The animals should be treated in a well ventilated area.
Do not spray in or near the eyes.
Use of the product should be based on susceptibility testing of the
bacteria
isolated from the animal. If this is not possible, therapy should be
based on
local (regional, farm level) epidemiological information about
susceptibility of the
target bacteria.
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Because of the risk of sensitisation and contact dermatitis, the user
should
avoid skin contact. Wear appropriate impermeable gloves whil