ALAMYCIN AEROSOL VETERINARY

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

OXYTETRACYCLINE HYDROCHLORIDE

Tilgjengelig fra:

COMEX LTD

ATC-kode:

J01AA06

Legemiddelform:

SPRAY

Sammensetning:

OXYTETRACYCLINE HYDROCHLORIDE 32.1 MG/ML

Administreringsrute:

TOPICAL

Resept typen:

Required

Produsert av:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

Terapeutisk gruppe:

OXYTETRACYCLINE

Terapeutisk område:

OXYTETRACYCLINE

Indikasjoner:

For the treatment of foot rot and topical infections caused by Oxytetracycline-sensitive organisms in sheep.

Autorisasjon dato:

2020-06-30

Informasjon til brukeren

_THIS LEAFLET HAS BEEN REVIEWED AND APPROVED BY THE MOH: 6.2010 _
_ _
_SUMMARY OF PRODUCT CHARACTERISTICS _
_VETERINARIAN PRESCRIPTION ONLY MEDICINE _
_FOR ANIMAL USE ONLY _
1.
NAME FORM AND STRENGTH OF THE VETERINARY MEDICIN
Alamycin Aerosol Veterinary, topical spray
2.
ACTIVE INGREDIENTS
Oxytetracycline Hydrochloride 32.1 Mg/Ml
Each 140g aerosol can contain:
Oxytetracycline Hydrochloride 5 gr (3.6% w/w)
For a full list of excipients, see section 13 “further
information”
3.
INDICATIONS FOR USE
Oxytrycycline in indicated for the treatment in wide range of gram
positive and gram
negative bacterial pathogens. Alamycin Aerosol is indicated for the
treatment of foot rot
and topical infections caused by organisms sensitive to
oxytetracycline in sheep.
THERAPEUTIC GROUP:
Tetracyclin
antibiotic
4.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance.
5.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
Side effects can be reported to the Ministry of Health by clicking on
the link "Reporting
adverse events due to drug treatment" found on the home page of the
Ministry of
Health website (www.health.gov.il) which refers to the online form for
reporting
adverse events, or by entering the link:
_https://sideeffects.health.gov.il/_
_ _
6.
TARGET SPECIES:
Sheep
7.
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For Topical use.
Foot rot: Before spraying, the infected area should be cleaned and
hooves should
be pared.
8.
HOW TO USE THE PREPARATION:
Holding the can upright, spray at a distance of 15-20 cm away for a
few seconds or
until the area is covered.
Treated sheep should be allowed to stand on dry ground for one hour
before
returning to pasture.
9.
WITHDRAWAL PERIOD
Meat: 0 days.
Milk: 0 days.
In the case of forced slaughter, the treated area should be removed
and not used for
human consumption.
10.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
•
Special precautions for use in animals:
Keep away from the animal eyes.
For external use only.
•
Special precautions to be t

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alamycin Aerosol 3.58% w/w cutaneous spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE _
Each 140g aerosol can contains 5g Oxytetracycline Hydrochloride
(equivalent
to 3.58% w/w).
_EXCIPIENTS _
Patent Blue V (E 131) 0.33% w/w as a marker dye
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous spray solution
A blue opaque solution.
4.
CLINICAL PARTICULARS
4.1
_TARGET SPECIES_
:
Cattle, sheep and pigs
4.2
_INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:_
Alamycin Aerosol is indicated for the treatment of foot rot in sheep
and
topical infections caused by organisms sensitive to oxytetracycline in
cattle,
sheep and pigs.
4.3
_CONTRAINDICATIONS:_
None.
4.4
_SPECIAL WARNINGS FOR EACH TARGET SPECIES:_
None.
4.5
_SPECIAL PRECAUTIONS FOR USE:_
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Keep away from the animal’s eyes
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT
TO THE ANIMALS:
Keep away from eyes.
Avoid contact with skin.
Avoid inhaling vapours.
Wash hands after use.
Do not spray on a naked flame or any incandescent material.
Highly flammable.
Must be used in a well ventilated area.
Do not smoke when using this product.
4.6
_ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS):_
None.
4.7
_USE DURING PREGNANCY, LACTATION OR LAY:_
The product can be safely administered to pregnant and lactating
animals.
4.8
_INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION:_
None.
4.9
_AMOUNT TO BE ADMINISTERED AND ADMINISTRATION ROUTE:_
For the treatment of foot rot, the hooves should be cleaned and pared
prior to
administration. Wounds should be cleaned prior to administration.
Shake the
can before use. Spray for a few seconds or until the lesion is
adequately
covered.
Treated sheep should be allowed to stand on dry ground for one hour
before
returning to pasture.
4.10
_OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES) (IF NECESSARY):_
Not applicable.
4.