Linspec 50/100 mg/ml Solution for injection for dogs, cats, pigs and pre-ruminant calves

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lincomycin hydrochloride; Spectinomycin sulfate tetrahydrate

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QJ01FF52

INN (International Name):

Lincomycin hydrochloride; Spectinomycin sulfate tetrahydrate

Dosage:

50, 100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Cattle, Dogs, Pigs

Therapeutic area:

lincomycin, combinations

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2010-07-29

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Linspec 50/100 mg/ml Solution for injection for dogs, cats, pigs and
pre-ruminant calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (pre-ruminating calves), Pigs, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory infections, intestinal infections, urinary
tract infections, skin infections (including wounds and
abscess) and arthritis caused by organisms sensitive to lincomycin and
/ or spectinomycin including:
_Actinobacillus_ spp.
_Pasteurella_ spp.
_Brachyspira hyodysenteriae_
_Escherichia coli_
_Salmonella_ spp.
_Campylobacter_ spp.
_Bacteroides_ spp.
_Clostridium_ spp.
_Fusobacterium_ spp.
_Actinomyces_ spp.
_Staphylococcus_ spp.
_Streptococcus_ spp.
_Mycoplasma_ spp.
4.3 CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active substances
or to any of the excipients.
Do not
administer to rabbits,
hamsters,
guinea pigs,
chinchillas,
horses or ruminants as this could result
in severe
gastro-intestinal disturbance.
Each ml contains:
ACTIVE SUBSTANCE
Lincomycin (as lincomycin hydrochloride)
50
mg
Spectinomycin (as spectinomycin sulfate tetrahydrate) 100 mg
EXCIPIENTS
Benzyl alcohol (E1519)
9
mg
For the full list of excipients, see section 6.1.
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