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ANTIMANIA

Meglumine antimonate · Fatro S.p.A.

1 form: solution. In force in Georgia: 1 of 1 (veterinary register).

Forms and doses1 of 1 in force in Georgia

The dose from the product's label, by species and weight. Check the label of the pack you use.

Form Species Dose Frequency Georgia
Solution · Dog Dog Canine Leishmaniosis · Subcutaneous: 0.33 ml/kg - Georgia Yes, veterinary
Veterinary (National Food Agency)
In the register: ანტიმანია 300 მგ/მლ, 5 x 5 მლ
№ 17-11
Verified on: 23 Oct 2026
Details: pack, label wording, sources, registration

ANTIMANIA, Solution

Meglumine antimonate 300 mg/ml solution for injection for dogs
vetman assessment
vetman’s 10-point assessment brings together a product’s regulatory credibility, clinical efficacy, safety and practicality. Cost-effectiveness is assessed only when reliable data are available. It is informational and does not replace a veterinarian’s clinical judgment for an individual patient.
Dog
5.6/10
Weak evidence support
vetman assessment

ANTIMANIA

Meglumine antimonate 300 mg/ml solution for injection for dogs
Assessed clinical scopeDog · Complete authorised dog label: symptomatic subcutaneous monotherapy of canine leishmaniosis · Subcutaneous
Care settingVeterinary-supervised multiweek injection course after confirmed active canine leishmaniosis and staging, with intensive clinical, renal, hepatic, cardiac, urine/protein and parasitological monitoring
vetman score 5.6/10 Weak evidence support
Evidence confidence: Medium Georgia: Yes, veterinary · № 17-11 · Verified on 23 Oct 2026

An authorised antileishmanial with real symptomatic activity, but the exact monotherapy label is materially behind current combination evidence: relapse is frequent, cure is not parasitological, organ monitoring is intensive and the injection/vial burden is high.

Regulatory and scientific credibility7.5/10

The exact product has current transparent Georgian and Italian/EU prescription authorisations, a valid generic legal basis and detailed label. Credibility is limited by no public exact-product outcome dossier and a major conflict between its monotherapy/no-coadministration label and current first-line combination guidance.

Clinical efficacy5.0/10

Meglumine antimoniate 100 mg/kg can produce substantial clinical remission, but monotherapy had 74.3% relapse within one year in a randomized trial and current WAVD guidance strongly does not recommend it. The well-supported antimoniate-allopurinol combination is not the exact authorised ANTIMANIA regimen and cannot be credited as if it were.

Safety and tolerability5.5/10

GI illness, prostration, musculoskeletal pain, injection reactions and renal/cardiac injury are material, especially with prolonged or repeated use. Hepatic/cardiac insufficiency are contraindications; renal disease needs stabilisation, dose titration and repeated organ monitoring, while overdose and interaction evidence is limited.

Clinical practicality3.5/10

Daily or preferably q12h SC injections for 3-4 weeks, 0.33 ml/kg/day volume, single-use 5 ml vials and extensive staging/monitoring create a high clinic, owner and patient burden. A 20 kg dog needs 6.6 ml/day and at least 28 five-ml vials for 21 days before wastage.

Full-course cost-effectiveness-

Current Georgian full-course price was unavailable; price is excluded from the denominator.

Important safety and use flags

  • Scope boundary: this score covers the complete authorised ANTIMANIA dog label—symptomatic SC monotherapy of active canine leishmaniosis. It does not cover prophylaxis, subclinical infection, cats, human disease or the guideline-preferred antimoniate-allopurinol combination as if that combination were on-label.
  • Confirm and stage disease: compatible clinical/clinicopathologic findings, exclusion of differentials, demonstration of infection and quantitative serology are required. Do not expose a merely seropositive subclinical dog to a direct anti-Leishmania drug.
  • Exact label regimen: 100 mg/kg/day = 0.33 ml/kg/day SC, preferably divided as 50 mg/kg every 12 hours. Start at half the daily dose and titrate, especially with renal impairment. Initial course is 3 weeks; extend only one week for insufficient clinical improvement.
  • Critical evidence conflict: 2025 WAVD guidance strongly does not recommend meglumine-antimoniate monotherapy because relapse and repeated-course resistance are frequent; it recommends antimoniate plus long-course allopurinol first-line. ANTIMANIA says not to administer with other veterinary medicines—do not silently rewrite the exact label as the combination protocol.
  • Clinical remission is not parasitological cure. In a randomized monotherapy study 85.4% initially remitted but 74.3% relapsed within one year. The dog can remain infected and potentially infectious to vectors; maintain sand-fly prevention and structured long-term follow-up.
  • Before and during treatment monitor clinical score, CBC, biochemistry, protein electrophoresis, urinalysis/UPC and renal function; monitor hepatic and cardiac function and use quantitative serology plus microscopy/qPCR when indicated. Stabilise diagnosed renal disease before starting.
  • Do not use in hepatic or cardiac insufficiency. Stop intolerance; any lower-dose restart is veterinarian-directed. Watch for vomiting, diarrhoea, anorexia, prostration, myalgia/arthralgia, injection swelling and renal/cardiac injury, especially with longer or repeated courses.
  • Do not mix with saline or another veterinary medicine; compatibility and interaction data are unavailable. The label permits pregnancy/lactation, but no robust exact-product reproductive outcomes establish zero fetal or neonatal risk—make and document a patient-specific benefit-risk decision.
  • Plan volume and supplies before starting: a 20 kg dog needs 6.6 ml/day, so a three-week course uses 138.6 ml—at least 28 single-use 5 ml vials before wastage. Opened vials must be used immediately; rotate SC sites and record every dose.
  • Resistance and zoonotic control: investigate absent response with adherence/dose-duration audit, repeat staging and parasitic burden—not automatic serial courses. Avoid unnecessary extension/repetition, use effective sand-fly repellency and never equate treatment with elimination of public-health transmission risk.
Assessment sources
Assessed: 23 Oct 2026The overall score uses 25/25/25/15/10 weights. An unassessed price is excluded and the remaining weights are proportionally renormalised.
Composition / strength
Meglumine antimonate300 mg/ml
Formulation Type
Solution
Administration route
Subcutaneous
Manufacturer
Fatro S.p.A. · Italy
Registration
Georgia Yes, veterinary
Veterinary (National Food Agency)
In the register: ანტიმანია 300 მგ/მლ, 5 x 5 მლ
№ 17-11
Verified on: 23 Oct 2026
EU Yes, veterinary
№ AIC 104601012; 104601024
Verified on: 23 Oct 2026
UK No
US No
Controlled in Georgia
Unknown
Information not fully verified Exact label: symptomatic SC treatment of canine leishmaniosis, 100 mg/kg/day (=0.33 ml/kg/day), preferably split as 50 mg/kg every 12 hours. Start at half the daily dose and titrate, especially with renal impairment. Initial course 3 weeks; extend only one week if clinical improvement is insufficient. Clinical improvement is not parasitological cure and repeated courses can select resistance. Current 2025 evidence recommends meglumine antimoniate with long-course allopurinol as first-line and strongly rejects monotherapy; the exact label says not to administer with other veterinary medicines, so do not present the combination as on-label for this product.
Dog
WeightCanine Leishmaniosis · Subcutaneous
Any weight 0.33 ml/kg
  • Canine Leishmaniosis · Subcutaneous (daily, preferably split into two equal injections 12 hours apart): Symptomatic treatment only: clinical improvement does not mean parasitological cure. Initial course is 3 weeks and may be extended by one week if improvement is insufficient. Start at half the daily dose and titrate, particularly with renal impairment; stabilise diagnosed renal disease first and monitor renal, hepatic and cardiac function. Do not use in hepatic or cardiac insufficiency and do not administer with other veterinary medicines. Pregnancy and lactation use is permitted by the label.
Source:
EU SPC 2023
Official product label (SPC)
Approved by a medicines regulator as part of the product's authorisation. It applies to that product as authorised there.
ANTIMANIA 300 mg/ml solution for injection for dogs - Official Product Information
EU Veterinary Medicines Information, 2023

All of this shows in vetman as you prescribe

The dose for the patient's weight, registration in Georgia and controlled status, right on the prescription.