QUADROSOL 10 %, injectable solution
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorization holder
Prodivet pharmaceuticals sa, Hagbenden 39c, B-4731 EYNATTEN
Manufacturer responsible for batch release
aniMedica Herstellungs GmbH, Im Südfeld 9, D-48308 Senden-Bösensell
Produlab Pharma bv, Forellenweg 16, NL-4941 Raamsdonksveer
NAME OF THE VETERINARY MEDICINAL PRODUCT
QUADROSOL 10 %, injectable solution
Levamisolum 100 mg/ml
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per ml :
Active substance: Levamisole chlorhydrate118 mg equiv. to 100 mg of levamisole base.
Excipients: Methyl parahydroxybenzoate 1.5mg - Propyl parahydroxybenzoate 0.2mg - sodium metabisulfite 2.0 mg – citric acid - sodium hydroxide – water for injection.
Treatment of internal parasitosis in bovines and pigs (gastro-intestinal and pulmonary strongylosis).
QUADROSOL 10 %, injectable solution is active on worms including:
Dictyocaulus viviparus: adults
Bunostomum phlebotomum: adults
Cooperia oncophora.: adults
Haemonchus spp.: adults
Nematodirus battus: adults
Ostertagia ostertagi.: adults
Oesophagostomum spp.: adults
Trichostrongylus colubriformis: adults
Resistances were reported towards Ostertagia ostertag.
Metastrongylus spp.: adults
Ascaris suum: adults
Oesophagostomum spp.: adults
Resistances were reported towards Oesophagostomum spp.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not administer to milk cows whose milk is intended for human consumption.
Levamisole appears to have few adverse effects in target animals when administered at the recommended doses.
The possible interaction with the receptors of the cells of the animal explain the undesirable effects, even the cases of intoxication.
These effects include: hypersalivation, tremor, abdominal pain, anorexia, and inflammation at the injection site as well as seizures, excitement, irritability, rapid breathing, dyspnea, frequent urination and defecation, collapse.
Inhibition of acetylcholinesterase may also cause muscarinic manifestations (constriction of pupils, acceleration of gastrointestinal motility and bradycardia).
This product is to be used with caution in animals severely debilitated or with significant renal or hepatic disorders.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Bovine and porcine
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Each treatment is constituted of a single administration of the drug. For a correct dosage, the body weight of the animal should be determined as accurately as possible; the accuracy of the dosing device should be checked.
If the animals are treated collectively rather than individually, they should be grouped and treated according to their body weight to avoid under or overdose
Usual dosage: 5 mg/kg bw = 1 ml/20 kg bw IM. The dosage is the same for adults and calves.
Usual dosage: 5 mg/kg bw = 1 ml/20 kg bw i.m.
Way of administration:
ADVICE ON CORRECT ADMINISTRATION
Avoid to inject in the innerved areas of the shoulder or the leg.
Bovine: Meat and offals: 32 days. Milk: Do not administer to milk cows whose milk is intended for human consumption.
Porcine: Meat and offals: 34 days
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children. Do not store above 25 °C. Keep the bottle in the outer carton, to be protected from light. Do not refrigerate or freeze. Protect from frost.
Shelf life after first opening the container: 28 days, below 25 °C, protect from light, after the date of the first withdrawal.
Special precautions for use in animals
Frequent and repeated use can induce resistance.
Special precautions to be taken by the person administering the medicinal product to animals:
Avoid self-injection. Single oral doses are generally well tolerated. Chronic ingestion can lead to haematological complications, agranulocytosis and others. Accidental self-injection may trigger a mild local reaction. Levamisole rarely causes symptoms in humans after a single exposure.
The following practices should be avoided as they increase the risk of developing resistance, which can ultimately lead to treatment inefficiency:
- the frequent and repeated use of anthelmintics of the same class for a long time
- the underdosing, which may result from underestimation of the weight of the animals, incorrect administration of the product or lack of calibration of the dosing device (if applicable)
Suspected clinical cases of anthelmintic resistance should be investigated further by appropriate tests (eg Faecal Egg Count Reduction Test). Where test results strongly suggest resistance to a particular anthelmintic, an anthelmintic of another pharmacological class with a different mode of action should be used.
Levamisole resistance has been reported for Ostertagia ostertagi in cattle. Therefore, the use of this product should be based on local (regional, farm) epidemiological information on the susceptibility of these helminths and on recommendations on how to limit the selection of anthelmintic resistance.
Levamisole resistance has been reported for Oesophagostomum spp. In pigs. Therefore, the use of this product should be based on local (regional, farm) epidemiological information on the susceptibility of these helminths and on recommendations on how to limit the selection of anthelmintic resistance
Use during pregnancy or lactation
- QUADROSOL 10 % injectable solution can be used for gestating or lactating females.
- Do not administer to milk cows whose milk is intended for human consumption.
Interaction with other medicinal products and other forms of interaction
- Levamisole can be simultaneously administered with Azaperone in piglets.
- Simultaneous administration of tetrahydropyrimidines (pyrantel, morantel, methyridine, diethylcarbamazine) and other cholinergic compounds must be avoided (because of the similarity of their mode of action with that of the levamisole).
Overdose (symptoms, emergency procedures, antidotes), if necessary
The accidental injection of the double dose induces overdose symptoms after half an hour; they disappear spontaneously.
Symptoms of overdose: excitability, salivation, watering of the eyes, hyperesthesia, colic and nervous disorders.
Treatment: In case of overdose, atropine, as a symptomatic treatment, can be recommended
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
For the doctor
Levamisole has a muscarinic and a nicotinic action which is expressed by agitation, salivation, tear production, hyperesthesia, colics and nervous disorders. According to the gravity of the symptoms, a treatment with atropine should immediately be initiated.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
For any information about this veterinary medicinal product, please contact local representative of the Marketing Authorization Holder:
PRODIVET Pharmaceuticals S.A./N.V.
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
e-mail : email@example.com
Bottles in clear glass class I Ph. Eur. - bromobutyl stoppers - capsules in natural aluminum or aluminum-polypropylene. 100 and 250 ml.
Not all pack sizes may be marketed.
Available on prescription only.