Limoxin-200LA solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

oxytetracycline (oxytetracycline dihydrate)

Available from:

Interchemie werken "De Adelaar" Eesti AS

ATC code:

QJ01AA06

INN (International Name):

oxytetracycline (oxytetracycline dihydrate)

Dosage:

200mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(1) glass bottle 50ml, (1) glass bottle 100ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-30

Patient Information leaflet

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-200 LA.
PHARMACEUTICAL FORM: Solution for parenteral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
oxytetracycline (as dihydrate)
200.0 mg.
- EXCIPIENTS:
benzyl alcohol
10.5 mg.
INDICATIONS:
Oxytetracycline belongs to the group of tetracyclines and acts
bacteriostatic against many Gram-positive and
Gram-negative
bacteria
like
Bordetella,
Campylobacter,
Chlamydia,
E.
coli,
Haemophilus,
Mycoplasma,
Pasteurella, Rickettsia, Salmonella, Staphylococcus and Streptococcus
spp. The action of oxytetracycline is
based on inhibition of bacterial protein synthesis. Oxytetracycline is
mainly excreted in urine, for a small part in
bile and in lactating animals in milk. One injection acts for two
days.
Limoxin-200 LA solution for parenteral administration is indicated for
arthritis, gastrointestinal and respiratory
infections caused by oxytetracycline sensitive micro-organisms like
Bordetella, Campylobacter, Chlamydia, E.
coli, Haemophilus, Mycoplasma, Pasteurella, Rickettsia, Salmonella,
Staphylococcus and Streptococcus spp. in
calves, cattle, goats, sheep and swine.
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:
After intramuscular administration local reactions can occur, which
disappear in a few days.
Discoloration of teeth in young animals and hypersensitivity reactions
may happen.
Overdoses may result in re

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME LIMOXIN-200 LA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
CONTENT
SPECIFICATION
Oxytetracycline base
(as dihydrate)
200.0 mg/ml
Ph. Eur.
OTHER INGREDIENTS
CONTENT
SPECIFICATION
Magnesium chloride hexahydrate
88.8 mg/ml
Ph. Eur.
Polyvidone
50.0 mg/ml
Manufacturer’s specifications
N-Methyl-2-pyrrolidone
0.36 ml/ml
Manufacturer’s specifications
Benzyl alcohol
0.01 ml/ml
Ph. Eur.
Monoethanolamine
ad pH = 9.2
BP
Water for injections
ad 1 ml
Ph. Eur.
3.
PHARMACEUTICAL FORM
Solution for parenteral administration.
4.
PHARMACOLOGICAL PROPERTIES
OXYTETRACYCLINE belongs to the group of tetracyclines and acts
bacteriostatically against
many Gram-positive and Gram-negative bacteria like Bordetella,
Campylobacter, Chlamydia,
E. coli, Haemophilus, Mycoplasma, Pasteurella, Rickettsia, Salmonella,
Staphylococcus and
Streptococcus spp. The action of oxytetracycline is based on
inhibition of bacterial protein
synthesis. Oxytetracycline is mainly excreted in urine, for a small
part in bile and in lactating
animals in milk.
5. CLINICAL PARTICULARS
5.0
Target species: Calves, cattle, goats, sheep and swine.
5.1
Indications.
Arthritis, gastrointestinal and respiratory infections and arthritis
caused by oxytetracycline
sensitive micro-organisms, like Bordetella, Campylobacter, Chlamydia,
E. coli, Haemophilus,
Mycoplasma, Pasteurella, Rickettsia, Salmonella, Staphylococcus and
Streptococcus spp.
5.2
Contra-indications.
•
Hypersensitivity to tetracyclines.
•
Administration to animals with a seriously impaired renal and/or
hepatic function.
•
Concurrent administration of penicillins, cephalosporines, quinolones
and cycloserine.
5.3
Undesirable effects.
•
After intramuscular administration local reactions can occur, which
disappear in a few
days.
•
Discoloration of teeth in young animals.
•
Hypersensitivity reactions.
5.4
Special precautions for use.
None.
5.5
Use during pregnancy and lactation.
No restrictions.
5.6
Interactions.
Do not combine LIMOXIN-200 LA with