Alamycin LA 200 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytetracycline dihydrate

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QJ01AA06

INN (International Name):

Oxytetracycline dihydrate

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

oxytetracycline

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Alamycin‐LA‐SPC‐IE‐tracked
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 2 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.
Alamycin‐LA‐SPC‐IE‐tracked
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
In case of contact with eyes or skin, wash immediately with water as
irritation may occur.
Wash hands after use.
Take care to avoid accidental injection.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Although well tolerated, occasionally a slight local reaction of a
transient nature has been observed.
Hypersensitivity reactions, including anaphylaxis (sometimes fatal),
have been reported very rarely.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The use of tetracycline during the period of tooth and bone
development, including late pregnancy may
lead to tooth discoloration. Alamycin LA can be safely ad