LINCOCIN SOLUBLE POWDER

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LINCOMYCIN (AS LINCOMYCIN HYDROCHLORIDE PH. EUR.)

Available from:

Zoetis Ireland Limited

ATC code:

QJ01FF02

INN (International Name):

LINCOMYCIN (AS LINCOMYCIN HYDROCHLORIDE PH. EUR.)

Dosage:

400 mg/g

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

POM

Therapeutic group:

Porcine

Therapeutic area:

Lincomycin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2014-09-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Lincocin Soluble Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
_Active Substance:_
Lincomycin
(as lincomycin hydrochloride)
400 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
White to off-white free-flowing powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of swine dysentery.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to active ingredient.
Do not treat animals with lincomycin and erythromycin concurrently.
Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-
intestinal disturbance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/12/2016_
_CRN 7023836_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS:
Avoid inhaling dust and contact with skin.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS:
Avoid skin contact and inhalation of dust. Wash hands and exposed skin after use.
Persons known to be hypersensitive to the active ingredient should handle the product with care.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Occasionally, pigs given lincomycin-medicated water may, within the first 2 days after onset of treatment, develop soft
stools and/or mild swelling of the anus. On rare occasions some pigs may show reddening of the skin and mild irritable
behaviour. These conditions are usually self-correcting within