DOUVISTOME Oxiclozanid 34mg oral suspension for cattle and sheep

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PRODUCT NAME
DUOVISTOME 34 mg/ml

Oral suspension for bovine animals and sheep

DECLARATION (SUBSTANCE) OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS (INGREDIENTS)
Composition for 1 ml:

Active substance:
Oxyclazandid 34 mg.

FARMACEUTIC FORM:
Oral suspension. Cream-coloured suspension, homogeneous after shaking.

CLINICAL PARTICULARITIES

Target species
Cattle and sheep.

Indications for use, specifying target species
In bovine and ovine animals:
- Treatment and control of Fasciolosis (Fasciola hepatica, Fasciola gigantica) Paraphystomosis (Paraphistomum spp.)
- Removal of cestode segments.

Contraindications
Do not use in animals with known hypersensitivity to the active substance or any of the excipients.

Special warnings for target species
Certain precautions should be taken to avoid the following practices, as they may increase the risk of developing resistance and thus to inefficiency of treatment:
- too frequent and repeated use of antiheimiths of the same class for an extended period of time;
- underdosing, which may be due to an underestimation of body mass, misadministration of the product or non-calibration of the dosing device (if any).
All suspected cases of antihelmintic resistance should be further investigated using appropriate tests (e.g. fecal egg count test). Where tests clearly suggest resistance to a particular antihelmintic, another of another pharmacological class whose mode of action is different shall be used.

Special precautions for use
Special precautions for use in animals
Before calculating the dose, the weight of the animals should be assessed as accurately as possible.

Adverse reactions (frequency and severity)
The side effects generally observed are: anorexia, diarrhea or prostration.

Use during gestation, lactation or laying period
During the studies carried out in target species at different reproductive stages, no fetotoxic, teratogenic or negative effects on fertility were observed.
The product can be administered during the gestation period.

Interactions with other medicinal products or other forms of interaction
They don't know each other.

Quantities to be administered and route of administration:
Cattle: 10 mg oxyclozanid / kg body weight, which corresponds to 3 ml Douvistome / 10 kg body weight, administered orally. The maximum dose of 3,5 g oxyclozanid per animal, i.e. 100 ml Douvistome/animal, should not be exceeded.

Sheep: 15 mg oxyclozanid / kg body weight, which corresponds to 4.5 ml Douvistome / 10 kg body weight, administered orally. The maximum dose of 0,68 g oxyclosandid per animal, i.e. 20 ml Douvistome/animal, should not be exceeded.
In order to ensure the correct dose, it is recommended to correctly estimate body weight to avoid overdose or underdosing, the accuracy of the measuring device should also be checked.

Overdose (symptoms, emergency procedures, antidotes), as appropriate
If the dose of 15 mg/kg is exceeded, anorexia, diarrhoea, prostration may be observed.
Cases of mortality may occur if the dose exceeds 50 mg/kg.

Waiting time:
Cattle:
Cams and organs: 13 days.
Milk: 108 hours (4.5 days)

Sheep:
Meat and organs: 14 days.
Milk: 7 days.

FARMACOLOGICAL PROPERTY
Pharmacotherapeutic group: antihelmintics, phenol derivatives including salicylanilide, oxyclozanide.

Pharmacodynamic properties
Oxyclozanide was used for its fasciolicactionde action in 1966. It is a white non-hygroscopic crystalline powder and virtually insoluble in water. Animals are usually treated with an aqueous solution containing 34 mg oxyclozanid / ml.
The main indications of oxyclozanide are: treatment and control of faciolose, paraphystomosis and cestoses (removal of proglots) in cattle and sheep. The primary action of salicylates has generally been associated with the release of oxidative phosphorylation. Salicylanids are 1000 to 10 000 times more active than dinitrophenol, a previous compound known as an inhibitor of oxidative phosphorylation.
Pharmacodynamic properties
Oxyclozanide was used for its fasciolicactionde action in 1966. It is a white non-hygroscopic crystalline powder and virtually insoluble in water. Animals are usually treated with an aqueous solution containing 34 mg oxyclozanid / ml.
The main indications of oxyclozanide are: treatment and control of faciolose, paraphystomosis and cestoses (removal of proglots) in cattle and sheep. The primary action of salicylates has generally been associated with the release of oxidative phosphorylation. Salicylanids are 1000 to 10 000 times more active than dinitrophenol, a previous compound known as an inhibitor of oxidative phosphorylation.

Pharmacokinetic peculiarities:
After oral administration to ruminants, the maximum plasma concentration (Cmax) is reached 24 hours later indicating a very rapid absorption process. The rate of gastrointestinal absorption is slow in sheep, most likely due to slower transit. The limit and rate of absorption of oxyclozanide are dose dependent. A linear increase in the plasma concentration of oxyclozanide is observed in cattle at doses between 10 and 15 mg/kg body weight.
Oxyclozanide and halogenated salicylates are extensively palsmatically bound and little distributed in tissues. This extensive plasma binding is responsible for the long half-life of elimination. Oxyclozanid is very little metabolized and is eliminated mainly unmodified.
A glucuronide metabolite of oxyclozanide has been identified. This active antihelmintic glucuronid is excreted by bile in high concentrations near adult fascioles. This bile excretion is an important pathway for active fasciolicids against adult parasites in the bile ducts.

FARMACEUTIC PARTICULARITIES
List of excipients:
Methylparahydroxybenzoate, propylparahydroxybenzoate, sodium melibisulphite, magnesium and aluminium silicate, sodium carmelose, sodium lauri sulphate, sodium citrate, purified water.

Incompatibilities
They don't know each other.

Shelf life:
Shelf life as packaged for sale: 3 years.
Shelf life after the first opening of the primary packaging: 3 months.

Special storage precautions:
It does not require special storage conditions.