Limoxin-25 Spray spray

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

oxytetracycline (oxytetracycline hydrochloride)

Prieinama:

Interchemie werken De Adelaar Eesti AS

ATC kodas:

QD06AA03

INN (Tarptautinis Pavadinimas):

oxytetracycline (oxytetracycline hydrochloride)

Dozė:

25mg/ml

Vaisto forma:

spray

Vienetai pakuotėje:

200ml spray can

Recepto tipas:

Prescription

Autorizacija statusas:

Registered

Leidimo data:

2018-10-03

Pakuotės lapelis

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Marketing authorisation holder:
Manufacturer and batch releaser:
Interchemie werken “De Adelaar” B.V.
Interchemie werken “De Adelaar” Eesti AS
Metaalweg 8
Vanapere tee 14
5804 CG Venray
Viimsi, Harju county
The Netherlands
Estonia
NAME PRODUCT:
Limoxin-25 spray.
PHARMACEUTICAL FORM:
A blue solution for external administration; antiseptic spray for
external (topical) administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
oxytetracycline hydrochloride
25.0 mg.
INDICATIONS:
External skin, teat, hoof and paw infections caused by oxytetracycline
sensitive micro-organisms, like _Bordetella_,
_Campylobacter_,
_Chlamydia_,
_E_.
_coli_,
_Haemophilus_,
_Mycoplasma_,
_Pasteurella_,
_Rickettsia_,
_Salmonella_,
_Staphylococcus_ and _Streptococcus_ spp.
CONTRA-INDICATIONS:
Hypersensitivity to tetracyclines.
Administration to animals with a seriously impaired renal and/or
hepatic function.
Concurrent administration of penicillins, cephalosporins, quinolones
and cycloserine.
TARGET SPECIES:
Calves, cattle, goats, sheep and swine.
ADVERSE REACTIONS:
Hypersensitivity reactions.
DOSAGE AND ADMINISTRATION:
Spray one or two times a day from a distance of 15 - 20 cm.
SPECIAL WARNINGS
Pressurized container. Protect from direct sunlight and do not expose
to temperatures exceeding 50 ºC. do not
spray towards or close to the eyes. Do not pierce or burn before or
after use.
WITHDRAWAL TIMES:
None.
PACKAGING:
Spraycan of 200 ml.
SHELF LIFE AND STORAGE INSTRUCTIONS:
Limoxin-25 spray has a 3-year shelf life when stored dark at 15 - 25

C.
KEEP OUT OF REACH AND SIGHT OF CHILDREN!
LEGAL STATUS FOR SUPPLY:
Prescription only medicine (POM-V).

Prekės savybės

PART I: SUMMARY OF DOSSIER
I SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Limoxin-25 spray
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Oxytetracycline hydrochloride
25 mg/ml
3. PHARMACEUTICAL FORM
Limoxin-25 spray is an antiseptic spray for external administration.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves, cattle, goats, sheep and swine.
4.2 INDICATIONS
External skin, teat, hoof and paw infections caused by oxytetracycline
sensitive micro-
organisms,
like
_Bordetella_,
_Campylobacter_,
_Chlamydia_,
_E. _
_coli_,
_Haemophilus_,
_Mycoplasma_, _ Pasteurella_, _ Rickettsia_, _ Salmonella_, _
Staphylococcus_ and _ Streptococcus_
spp.
4.3 CONTRA-INDICATIONS
Hypersensitivity to tetracyclines.
Administration to animals with a seriously impaired renal and/or
hepatic function.
Concurrent administration of penicillins, cephalosporins, quinolones
and cycloserine.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special pecautions for use in animals
Do not spray in or around the eyes.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Because of possible sensitisation and contact dermatitis, direct skin
contact has to be
avoided during administration.
Do not incinerate or puncture the spraycan.
Do not expose to temperatures above 50 °C.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Hypersensitivity reactions may occur.
4.7
USE DURING PREGNANCY AND LACTATION
No restrictions.
4.8 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Do not combine Limoxin-25 Spray with other external formulations.
4.9 AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Spray one or two times a day from a distance of 15 - 20 cm.
4.10
OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY
Not relevant for this external formulation.
4.11 WITHDRAWAL PERIODS
None.
5. PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Oxytetracycline belongs