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

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.
IRISH MEDICINES BOARD
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_Date Printed 10/01/2014_
_CRN 7016312_
_page number: 1_
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 been formulated specifically for pigs. It should not be administered to other species as severe adverse
reactions, including fatalities in dogs, may occur. Do not use in case of hypersensitivity to the active substance or any
of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to�