NEOCLOSANTEL

Description

NEOCLOSANTEL (CURRENTLY IN REGISTRATION PROCESS)

COMPOSITION:
Active substance
Closantel 50 miligrams

Excipients:
Glycerol
Propylene glycol
Disodium edetate
Sodium hydroxide
Water for injection

 

INDICATION

Bovine:

– Treatment and control of fasciolosis caused by adult forms and larvae of Fasciola hepatica.

– Treatment of gastrointestinal nematodosis caused by adult forms and larvae of the following nematodes: Bunostomum phlebotomum, Haemonchus contortus, Haemonchus placei and Oesophagostomum radiatum.
-Treatment of hypodermosis caused by subcutaneous larvae of Hypoderma spp.

Sheep:

– Treatment and control of fasciolosis caused by adult forms and larvae of Fasciola hepatica.

– Treatment of gastrointestinal nematodosis caused by adult forms and larvae of the following nematodes: Bunostomum phlebotomum, Haemonchus contortus, Haemonchus placei, Oesophagostomum radiatum and Chabertia ovis.

– Treatment of oestrosis caused by larvae Oestrus ovis.

CONTRAINDICATION
Do not use in case of known hypersensitivity to the active substance and/or excipient.

TARGET SPECIES
Bovine, sheep

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

Subcutaneous administration .
Dose:
Bovine:
– Fasciolosis and gastrointestinal nematodosis: 2.5 mg of closantel / kg of body weight (equivalent to 0.05 ml / kg bw) in a single dose.
– Hypodermosis: 5 mg of closantel / kg of body weight (equivalent to 0.1 ml / kg b.w. ) in a single dose.
Sheep:
– Gastrointestinal estrosis and nematodosis: 2.5 mg of closantel / kg of body weight (equivalent to 0.05 ml / kg bw) in a single dose.
– Fasciolosis: 5 mg of closantel / kg of body weight (equivalent to 0.1 ml / kg b.w.) in a single dose.

ADVICE ON CORRECT ADMINISTRATION
A maximum volume per injection site is
Bovine: 15 ml.
Sheep: 3 ml.
To ensure administration of a correct dose, body-weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Provide sufficient separation between injection sites when multiple administration sites are required. Give a light massage at the injection site.
The treatment schedule should be based on epidemiological factors and be personalized for each farm. The treatment program should be established by the licensed veterinarian.

WITHDRAWAL PERIOD

Bovine:
Meat: 54 days.
Milk: Not authorised for use in cattle producing milk for human consumption including during the dry period. Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption.

Ovine:
Meat: 107 days.
Milk: Not authorised for use in sheep producing milk for human consumption including during the dry period. Do not use within 1 year before the first calving in sheep which are intended to produce milk for human consumption.

SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
It does not require any special storage conditions.
Shelf life after first opening the container: 28 days.

SPECIAL WARNING(S)

Special warnings for each target species
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 Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Special precautions for use in animals
This medicine does not contain any antimicrobial preservative.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to closantel should avoid all contact with the veterinary medicinal product.
Handle the medicine carefully to avoid accidental self-injection, as well as contact with the skin and eyes, taking specific precautions:
– Wear gloves and wash your hands after using the medicine.
– If exposure of the skin or eyes accidentally occurs, wash immediately with plenty of water.
– Do not smoke, eat or drink while handling the medicine.

Use during pregnancy/ lactation
No contraindications have been described during pregnancy.
Use in accordance with the benefit / risk assessment by the responsible veterinarian.

Overdose (symptoms, emergency procedures, antidotes), if necessary
The margin of safety is wide and both cattle and sheep tolerate doses up to 4 times higher than the therapeutic ones. The symptoms of toxicity are: ataxia, incoordination, weakness and vision disturbances.

Incompatibilites
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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

The drug should not be disposed of in waste water and household waste.
Ask your veterinarian or pharmacist how to dispose of medicines no longer required. These measures are intended to protect the environment.

Nature and composition of packaging: Type II amber glass vials of 100 ml. The vials are closed with a bromobutyl stopper and an aluminum cap.

Conditions or restrictions regarding supply and use: On veterinary prescription only.

ATC-vet code: QP52AG09

Reviews

There are no reviews yet.

Be the first to review “NEOCLOSANTEL”