QUADROSOL<sup>®</sup> pour-on

QUADROSOL® pour-on

  • Levamisole 200 mg/ml
  • Topical solution
  • Bottles of 500 ml
Cattle

PACKAGE LEAFLET

QUADROSOL Pour-on, 200 mg/ml, solution for pour-on

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Prodivet pharmaceuticals sa/nv
Hagbenden 39C
B -4731 EYNATTEN

Manufacturer responsible for batch release:

aniMedica Herstellungs GmbH
Im Südfeld 9
D-48308 Senden-Bösensell

NAME OF THE VETERINARY MEDICINAL PRODUCT

QUADROSOL Pour-on, 200 mg/ml, solution for pour-on

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Active substance: Levamisole 200 mg/ml
Excipients: Butyldiethylene glycol ad 1 ml 

INDICATION(S)

Treatment of internal parasitosis in cattle (gastro-intestinal and pulmonary strongylosis).
Levamisole is in general inactive against inhibited larval stages L4.
QUADROSOL® pour-on is active on:
 
Pulmonary worms :
Dictyocaulus viviparus: adults – larval stage L4
 
Gastro-intestinal worms :
Bunostomum phlebotomum: adults
Cooperia oncophora.: adults - larval stage L4
Haemonchus spp.: adults - larval stage L4
Nematodirus battus: adults
Ostertagia ostertagi.: adults
Trichostrongylus spp.: adults
 
Resistances were reported towards Ostertagia ostertagi.

CONTRAINDICATIONS

Do not administer to milk cows whose milk is intended for human consumption.
Do not use in case of hypersensitivity to the active substance, or to any of the excipients.

ADVERSE REACTIONS

In some cases, a superficial desquamation of the cutaneous surface without any harmful secondary  effect may be observed within 15 days following the application of the product.
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 explains the undesirable effects, even the cases of poisoning.
These effects include: hypersalivation, tremors, abdominal pain, anorexia as well as convulsions, excitement, irritability, rapid breathing, dyspnea, frequent urination and defecation, collapse.
Inhibition of acetylcholinesterase may also cause muscarinic manifestations (constriction of the pupils, acceleration of gastrointestinal motility and bradycardia).
This product must be used with caution in severely debilitated animals or in animals with severe renal or hepatic impairment.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

TARGET SPECIES

Bovine

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Young and adult animals:

Each treatment is constituted of a single administration of the drug by pouring along the backbone of the animal.

Usual dosis:

5 ml for 100 kg BW, means 10 mg Levamisole per Kg BW
Do not exceed 30 ml for a bovine of more than 600 kg.

Way of administration

For external use (pour on method), QUADROSOL® pour on must be poured with the recommended dose in dorso-lumbar area, on the skin of the animals to be treated without rubbing or brushing, the point of application.
An important risk of overdose is present, especially in calves. To reduce this risk of overdose, the body weight of the animal should be determined as accurately as possible prior to  the application of the product and the accuracy of the metering device should be checked.
If the animals are treated collectively rather than individually, they should be grouped and treated according to their body weight in order to avoid under- or overdose

ADVICE ON CORRECT ADMINISTRATION

  • For each anthelmintic treatment, it is recommended to deworm all animals exposed to the same conditions of stabulation.
  • The product penetrates spontaneously through the skin, do not rub, nor brush, the point of application.

WITHDRAWAL PERIOD

Meat and offals: 42 days
Milk: Do not administer to milk cows whose milk is intended for human consumption.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.
Do not store above 25 °C.
Store in the original packaging protected from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf-life after first opening the container: the solution remains stable until the expiry date appearing after the initials EXP.

SPECIAL WARNING(S)

The following practices should be avoided as they increase the risk of developing resistance, which may ultimately lead to ineffective treatment:

  • - frequent and repeated use of anthelmintics from the same class over a long period
  • - under-dosage, which may result from under-estimation of the weight of the animals, incorrect administration of the product or lack of calibration of the dosing device (if any)

Suspected clinical cases of resistance to anthelmintics should be investigated further by appropriate tests (eg Faecal Egg Count Reduction Test). When the results of the tests strongly suggest a resistance to a particular anthelmintic, an anthelmintic of another pharmacological class and with a different mode of action should be used.
Levamisole resistance has been reported for Ostertagia ostertagi in cattle. Therefore, use of this product should be based on local (regional, farm) epidemiological information on the susceptibility of these helminths andon  recommendations on how to limit anthelmintic resistance selection.

Special precautions for use in animals

  • Use the product outside or in well ventilated areas
  • Do not open the bottle or throw the product near an open flame or a incandescent body 

Special precautions to be taken by the person who administers the veterinary medicinal product to the animals

  • Avoid any application of the product on the skin of the person who uses the product.
  • it is recommended to wear rubber hand gloves when manipulating the product. In case of contact of the product with the skin or eyes of a person, rinse immediately and abundantly with water.
  • Levamisole can cause idiosyncratic reactions and severe blood disturbances by very few people. When symptoms such as dizziness, nauseas or vomiting appear during the handling of the product, or if fever or throat pain appears little of time afterwards, it is advised to ask immediately a medical opinion.

Use during pregnancy, lactation

QUADROSOL® pour-on 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:

Do not administer simultaneously with tetrahydropyrimidines and other compounds with cholinergic action.

Overdose (symptoms, emergency procedures, antidotes), if necessary

excitability, salivation, watering of the eyes, hyperesthesia, colic and nervous troubles
In case of overdose, atropine, as a symptomatic treatment, can be recommended
Warn immediately the veterinarian surgeon.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTEMATERIAL, IF ANY

Medicines should not be disposed of via wastewater or household waste

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

December 2015

OTHER INFORMATION

Translucent polyethylene bottles of 500 or 1000 ml.
Not all pack sizes may be marketed.

For any additional information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
PRODIVET Pharmaceuticals S.A./N.V.
Hagbenden 39c
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
e-mail : info@prodivet.com
 
Available on prescription only.
 
QUADROSOL PO-NOT-GB-V2.8-20151216