ZEARL 10 MG/ML SOLUTION FOR INJECTION FOR PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DORAMECTIN

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QP54AA03

INN (International Name):

DORAMECTIN

Dosage:

10 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Porcine

Therapeutic area:

doramectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2011-12-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zearl 10 mg/ml Solution for Injection for Pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Zearl 10 mg/ml Solution for Injection contains the following:
ACTIVE SUBSTANCE:
Doramectin
10 mg
(1)
EXCIPIENT(S):
Butylhydroxyanisole (E320)
0.1 mg
(1)
Contains no overage and assumes a potency of 100 percent.
The actual
amount
of doramectin added will
depend on the potency of the ingoing drug substance.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Colourless to pale yellow sterile oily solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
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4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of mange mites, gastrointestinal roundworms, lungworms,
kidney worms and sucking lice in pigs.
Gastrointestinal nematodes (adults and fourth stage larvae)
_Hyostrongylus rubidus_
_Ascaris suum_
_Strongyloides ransomi (adults only)_
_Oesophagostomum dentatum_
_Oesophagostomum quadrispinulatum_
Lungworms
_Metastrongylus spp. (adults only)_
Kidney worms
_Stephanurus dentatus (adults only)_
Sucking Lice
_Haematopinus suis_
Mange Mites
_Sarcoptes scabiei_
Zearl injection for pigs protects pigs against infection or
reinfection with_ Sarcoptes scabiei_ for 18 days.
4.3 CONTRAINDICATIONS
The product has be