ALAMYCIN LA 200MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-01-2016
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Active ingredient:
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Available from:
Norbrook Laboratories Limited
ATC code:
QJ01AA06
INN (International Name):
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Dosage:
Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Ovine, Porcine
Therapeutic area:
Oxytetracycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1988-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alamycin LA 200mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Oxytetracycline (as Oxytetracycline Dihydrate)
200
mg
Excipient
Sodium Formaldehyde Sulphoxylate
4
mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs and piglets.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Oxytetracycline is active against a wide range of Gram-positive and Gram-negative pathogenic bacteria, certain
rickettsia and the larger viruses. Alamycin LA is indicated in the treatment of a wide range of common systemic,
respiratory and local infections caused by or associated with organisms sensitive to oxytetracycline in cattle, sheep and
pigs.
4.3 CONTRAINDICATIONS
Do not use in animals suffering from hepatic or renal damage.
Do not use in animals with known hypersensitivity to Oxytetracycline.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/12/2015_
_CRN 7022548_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not dilute Alamycin LA.
If concurrent treatment is administered, use a separate injection site.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
None known.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Although well tolerated, occasionally a slight local reaction of a transient nature has been observed.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The use of tetracycline during the period of tooth and bo
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