Antishmania 10 x 5 ml

ANTISHMANIA

300 mg/ml solution for injection for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION (ES, EL)
Each ml contains:
Active substance:
Meglumine antimonate ……………………… 300 mg
equivalent to antimony …………………………… 81 mg
Excipients:
Potassium metabisulfite ………………………….. 1,6 mg
Anhydrous sodium sulfite ………………………… 0,18 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injectable solution.
Pale yellow clear solution.
4. CLINICAL DATA
4.1. target species
Dogs.
4.2. Indications for use, specifying the target species
Treatment of canine leishmaniasis.
4.3. contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs with hepatic, renal or cardiac insufficiency.
4.4. Special warnings for each target species
If after 4 weeks of treatment there is no response, it is considered that the
Leishmania strain is resistant and alternative treatment should be investigated.

4.5. Special precautions for use
Special precautions for use in animals
Treatment must be accompanied by serological and etiological monitoring that
indicate the prognosis of the disease and, consequently, the fate of the animal.
Start treatment by administering half the dose, especially in case of
decreased renal permeability; gradually increase the dose until reaching
the recommended one.
In cases of intolerance, suspend the treatment and start it at lower doses.
Renal function should be monitored before and during treatment.
Monitoring of liver and heart function is also recommended during
the treatment.
In case of renal insufficiency and/or ocular pathologies (such as keratitis, uveitis,
conjunctivitis) associated clinical signs should be stabilized or treated before
start treatment.
In cases of diagnosed renal insufficiency, the symptoms should be stabilized or treated.
associated symptoms before the start of treatment with the veterinary medicinal product.
Special precautions to be taken by the person administering the medicinal product
vet to animals
People with a known hypersensitivity to the active substance should avoid all
contact with the veterinary medicinal product.
Avoid contact with skin, eyes and mouth.
If the veterinary medicinal product accidentally gets into the eyes or in case of
accidental spillage on the skin, wash thoroughly with plenty of water.
In case of accidental self-injection, consult a doctor immediately and
show him the package insert or label.
Wash hands after use.
Do not eat, drink or smoke during application. .
4.6. Adverse reactions (frequency and seriousness)
A painful reaction may be observed during injection. The toxicity of this compound can sometimes cause symptoms characterized by fever, tachycardia, vomiting, weakness, prostration, myalgia, and arthralgia.
The signs usually subside with discontinuation of treatment. Its prolonged use can cause kidney and heart damage.
4.7. Use during pregnancy and lactation
The safety of the veterinary medicinal product has not been established during
pregnancy or lactation. Use only according to evaluation
benefit/risk carried out by the responsible veterinarian.
4.8. Interaction with other medicinal products and other forms of interaction
There is no information available.
See section 4.9.

4.9. Dosage and route of administration
Route of administration: subcutaneous.
The recommended daily dose of meglumine antimonate is 100 mg/kg bw.
(body weight) (equivalent to 0,33 ml of veterinary medicinal product / kg bw / day). Yeah
administration of several injections per day is possible, it is recommended to administer the
daily dose divided into two injections of 50 mg meglumine antimonate/kg
pc separated from each other by an interval of 12 h.
Volumes greater than 10 mL should be divided and administered at 2 points of
different injection.
The initial duration of treatment is 3 weeks. This can last 1
another week, if sufficient clinical improvement is not observed.
To eliminate parasites, repeated treatments may be necessary. Therefore,
monitoring of the clinical evolution of the animal is recommended.

4.10. Overdosage (symptoms, emergency measures, antidotes), if necessary

Both in the literature and in clinical experience, data on overdose
that have been reported are limited, therefore the signs and symptoms of
overdosage have not been characterized.
In case of overdose, the patient should be monitored and treated.
symptomatically. Special attention should be paid to potential toxic effects
in the liver, heart and kidney.
There is no known antidote. After subcutaneous injection of 200 mg/kg of
meglumine antimonate (double the recommended dose), may be observed
reactions at the injection site (edema, hardness).
4.11. Waiting time
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiprotozoals. Antimony compounds.
ATCvet code: QP51AB01

6. PHARMACEUTICAL DATA
6.1. List of excipients
Potassium metabisulfite (E224)
Anhydrous sodium sulphite (E221)
Sodium hydroxide (to adjust pH)
Water for injections
6.2. incompatibilities
Do not administer together with normal saline. In the absence of studies of
compatibility, this veterinary medicinal product must not be mixed with other
Veterinary medicines.
6.3. Period of validity
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: immediate use.
6.4. Special storage precautions
Store at a temperature below 25°C.
6.5. Nature and composition of the immediate packaging
5 ml colorless type I glass vials closed with a chlorobutyl rubber stopper
type I and an aluminum collar with a polypropylene security seal.
Cardboard box with 5 or 10 vials.
Not all formats may be marketed.
6.6. Special precautions for disposal of the veterinary medicinal product
used or, where appropriate, the residues derived from its use

Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.

ANTISHMANIA

See technical sheet