SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Premadex Pour-On Solution for Cattle 5 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Ivermectin 5.0 mg/ml
Excipient(s):
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pour-on solution.
Clear, colourless to pale yellow solution.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle.
4.2 Indications for use, specifying the target species
Premadex Pour-On Solution for Cattle 5 mg/ml is indicated for the treatment of gastro-intestinal nematodes, lungworms, warbles, chorioptic and sarcoptic mange mites, sucking and biting lice of beef and non-lactating dairy cattle.
Gastro-intestinal roundworms
Ostertagia ostertagi (L4, adults and inhibited stages)
Haemonchus placei (L4, adults)
Trichostrongylus axei (L4, adults)
Trichostrongylus colubriformis (L4, adults)
Cooperia spp. (adults)
Cooperia punctata (adults)
Cooperia oncophora (adults)
Oesophagostomum radiatum (L4, adults)
Strongyloides papillosus (adults)
Trichuris spp. (adults)
Lungworms (adults and 4th-stage larvae)
Dictyocaulus viviparus
Warbles (parasitic stages)
Hypoderma bovis
Hypoderma lineatum
Mites
Sarcoptes scabiei var. bovis
Chorioptes bovis
Lice
- Sucking lice
Linognathus vituli
Haematopinus eurysternus
- Biting lice
Damalinia bovis
The product, at the recommended use level of 500 μg/kg of ivermectin, has a persistent activity on:
Dictyocaulus viviparus: for up to 28 days
Ostertagia spp.: for up to 21 days
Oesophagostomum radiatum: for up to 21 days
Cooperia spp.: for up to 14 days
Trichostrongylus axei: for up to 14 days.
The product helps in the control of the mange mite Chorioptes bovis but complete elimination may not occur.
The product has also a persistent activity on the horn fly (Haematobia irritans) for 28 days; partial efficacy may last for up to 35 days post application.
Occasionally, variable activity may be observed against Haemonchus placei (L4), Cooperia spp., Trichostrongylus axei and Trichostrongylus colubriformis.
To obtain optimal benefit of Premadex Pour On Solution for Cattle 5 mg/ml, the product is recommended to be used as part of treatment programs, based on the epidemiology of the parasites in question.
4.3 Contra-indications
Do not use in animals known to be hypersensitive to the active substance or to any of the ingredients.
Do not inject or give orally. This product is for application to skin surface only.
Do not use in dairy cows during lactation or the dry period and in beef cows during the lactation period when milk is intended for human consumption.
Do not use in pregnant dairy heifers within 60 days prior to calving.
4.4 Special warnings for each target species
Assess bodyweight as accurately as possible before calculating the dosage.
Cattle should not be treated when the hair or hide is wet. Rain falling on animals less than two hours after dosing may result in reduced efficacy. However, under such conditions, efficacy of the product against infections of Ostertagia ostertagi or Dictyocaulus viviparus in cattle may be maintained. The influence of extreme weather conditions on the long-term performance (persistent activity) of the product is not known.
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
* Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
* Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal
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