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Hepa-Merz

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L-Ornithine-L-Aspartate · Merz Pharmaceuticals GmbH

1 form: solution. In force in Georgia: 1 of 1 (human 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.

Choose species and weight; the matching row will be highlighted.
Form Species Dose Frequency Georgia
Solution · Cat Cat No dose for this species
No feline IV dose, exact-product clinical efficacy study or target-animal safety cohort was located. Do not copy the exploratory canine regimen or a human ampoule count into a cat.
 - Georgia Yes, human
In force until 17 Jun 2029
Human (Ministry of Health, RAMA)
№ რ-041313
Verified on: 15 Oct 2026
Solution · Dog Dog 616 mg/kg
Mild HE only in one non-randomised 17-dog case series. This is not an established standard dose. Convert through 500 mg/ml only for preparation, dilute before use, and reconcile the calculated plan with the exact-product 5 g/hour ceiling and fluid tolerance.
 · over one day; exact infusion profile not reported		 over one day; exact infusion profile not reported Georgia Yes, human
In force until 17 Jun 2029
Human (Ministry of Health, RAMA)
№ რ-041313
Verified on: 15 Oct 2026
Solution · Dog Dog 154 mg/kg
Exploratory severe-HE initial phase. At 500 mg/ml this is 0.308 ml/kg/hour of concentrate before dilution. Above about 32.5 kg it exceeds the exact human-label absolute ceiling of 5 g/hour; no validated canine reconciliation rule exists.
 · every hour for the first 4 hours of the severe-HE study protocol		 every hour for the first 4 hours of the severe-HE study protocol Georgia Yes, human
In force until 17 Jun 2029
Human (Ministry of Health, RAMA)
№ რ-041313
Verified on: 15 Oct 2026
Solution · Dog Dog 30 mg/kg
Exploratory severe-HE continuation phase. At 500 mg/ml this is 0.060 ml/kg/hour of concentrate before dilution. Printed phases calculate to 1,216 mg/kg/day; do not substitute the internally inconsistent paper-stated 1,232 mg/kg/day total.
 · every hour for the next 20 hours after the initial 4-hour phase		 every hour for the next 20 hours after the initial 4-hour phase Georgia Yes, human
In force until 17 Jun 2029
Human (Ministry of Health, RAMA)
№ რ-041313
Verified on: 15 Oct 2026
Details: pack, label wording, sources, registration

Hepa-Merz, Solution

infusion concentrate 500 mg/ml (5 g/10 ml ampoule), human medicine
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 Intravenous LOLA as a hospital rescue adjunct for diagnosed hyperammonaemic hepatic encephalopathy refractory to conventional cause-directed and supportive treatment
4.5/10
Weak evidence support
vetman assessment

Hepa-Merz

infusion concentrate 500 mg/ml (5 g/10 ml ampoule), human medicine
Assessed clinical scopeDog · Intravenous LOLA as a hospital rescue adjunct for diagnosed hyperammonaemic hepatic encephalopathy refractory to conventional cause-directed and supportive treatment · Intravenous
Care settingSpecialist hospital use with pharmacy-reviewed dilution, infusion pump, dedicated line/compatibility review and serial neurologic, ammonia, renal, urea, fluid and electrolyte monitoring.
vetman score 4.5/10 Weak evidence support
Evidence confidence: Low Georgia: Yes, human · № რ-041313 · Verified on 15 Oct 2026 Off-label use

A biologically plausible salvage adjunct with one encouraging but methodologically weak canine series; exact dilution, renal screening and rate arithmetic are essential, and it is not a first-line replacement.

Regulatory and scientific credibility4.0/10

Exact human identity and current Georgian/Lithuanian authorisations are verifiable, but veterinary use has no authorisation and the sole old canine report used a differently described Hepa-Merz market product; the PLAYBOOK formulation/evidence gate caps this axis.

Clinical efficacy4.0/10

Fifteen of 17 dogs improved with falling ammonia, but owner-selected treatment, a three-dog non-equivalent control, mixed diseases/severity, no blinding and a 24-hour before-after analysis cannot establish comparative efficacy or an optimal regimen.

Safety and tolerability5.5/10

No obvious adverse effects were reported in 17 dogs and the exact human label is transparent, but this was not a safety study; high exploratory doses, severe renal contraindication, rate-related nausea/vomiting and reproduction gaps remain important.

Clinical practicality4.5/10

A 24-hour two-rate infusion is feasible in intensive care but requires exact dilution, pump programming, continuous venous access and reconciliation of weight-based study rates with a 5 g/hour absolute label ceiling and patient fluid tolerance.

Full-course cost-effectiveness-

A current Georgian exact-pack price and patient-specific full hospital-course cost were not verified, so cost is excluded.

Important safety and use flags

  • Human infusion concentrate. Current Georgian and Lithuanian human authorisations do not establish veterinary approval; all assessed use is off-label, and no authorised veterinary LOLA infusion was identified.
  • CONCENTRATE: never infuse the 500 mg/ml ampoule neat. Add to a compatible infusion solution; the exact human label allows no more than six ampoules per 500 ml and a maximum absolute rate of 5 g/hour.
  • The severe-dog paper prints 154 mg/kg/hour for 4 hours then 30 mg/kg/hour for 20 hours: arithmetic gives 1,216 mg/kg/day, not its stated 1,232 mg/kg/day. Use the phase rates only under specialist review.
  • The canine study regimen was converted from humans, tested in only 17 non-randomly selected dogs and used a differently described Korean Hepa-Merz product. It is exploratory, not an established standard dose or comparative first-line therapy.
  • Severe renal impairment is an exact-label contraindication. The human creatinine >3 mg/dl guide is not a validated canine/feline threshold; review renal function, urine output, hydration, acid-base/electrolytes and serum/urine urea.
  • Never administer intra-arterially. Use a pump, verified venous access and line/solution compatibility; inspect the clear solution and prepare immediately before use according to local sterile-infusion policy.
  • Nausea and vomiting can be dose/rate related. Slow or stop the infusion and reassess if they occur; do not assume absent adverse events in 17 dogs establishes safety at the exact regimen.
  • Treat HE causes and precipitants and provide standard supportive management. MSD describes LOLA as salvage for chronic hyperammonaemic HE refractory to conventional interventions, not a replacement for definitive shunt/liver care or first-line enteric ammonia control.
  • The 154 mg/kg/hour canine initial rate reaches the exact human-label 5 g/hour ceiling at about 32.5 kg. No validated canine rule reconciles the weight-based study rate with that absolute product limit; obtain specialist/pharmacy review.
  • Pregnancy, lactation, breeding-animal and paediatric veterinary safety are not established; human information advises avoidance unless benefit clearly outweighs risk.
Assessment sources
  1. Hepa-Merz exact SPC2008
  2. GE Hepa-Merz audit2026
  3. LT Hepa-Merz register2026
  4. Canine IV LOLA report2016
  5. MSD small-animal HE2024
  6. Dog-cat HE review2016
Assessed: 22 Oct 2026The overall score uses 25/25/25/15/10 weights. An unassessed price is excluded and the remaining weights are proportionally renormalised.
Cat Intravenous LOLA as a hospital rescue adjunct for diagnosed hyperammonaemic hepatic encephalopathy refractory to conventional cause-directed and supportive treatment
Not rateable
No numerical score assigned
vetman assessment

Hepa-Merz

infusion concentrate 500 mg/ml (5 g/10 ml ampoule), human medicine
Assessed clinical scopeCat · Intravenous LOLA as a hospital rescue adjunct for diagnosed hyperammonaemic hepatic encephalopathy refractory to conventional cause-directed and supportive treatment · Intravenous
Care settingSpecialist hospital use with pharmacy-reviewed dilution, infusion pump, dedicated line/compatibility review and serial neurologic, ammonia, renal, urea, fluid and electrolyte monitoring.
vetman score Not rateable No numerical score assigned
Evidence confidence: Low Georgia: Yes, human · № რ-041313 · Verified on 15 Oct 2026 Off-label use
Not rateable

No defensible feline IV dose, exact-product efficacy study or target-animal safety cohort was located. Canine exploratory rates and human fixed ampoule counts cannot be transferred responsibly to a cat.

Exact product identity is known, but feline dose, benefit and target-animal safety are not; a numerical score would imply evidence that does not exist.

Important safety and use flags

  • Human infusion concentrate. Current Georgian and Lithuanian human authorisations do not establish veterinary approval; all assessed use is off-label, and no authorised veterinary LOLA infusion was identified.
  • CONCENTRATE: never infuse the 500 mg/ml ampoule neat. Add to a compatible infusion solution; the exact human label allows no more than six ampoules per 500 ml and a maximum absolute rate of 5 g/hour.
  • No feline dose is established. Do not copy the 17-dog exploratory protocol, convert a human ampoule count by body weight or use the historical 2 ml patient-chart exposure as a dose rule.
  • The canine study regimen was converted from humans, tested in only 17 non-randomly selected dogs and used a differently described Korean Hepa-Merz product. It is exploratory, not an established standard dose or comparative first-line therapy.
  • Severe renal impairment is an exact-label contraindication. The human creatinine >3 mg/dl guide is not a validated canine/feline threshold; review renal function, urine output, hydration, acid-base/electrolytes and serum/urine urea.
  • Never administer intra-arterially. Use a pump, verified venous access and line/solution compatibility; inspect the clear solution and prepare immediately before use according to local sterile-infusion policy.
  • Nausea and vomiting can be dose/rate related. Slow or stop the infusion and reassess if they occur; do not assume absent adverse events in 17 dogs establishes safety at the exact regimen.
  • Treat HE causes and precipitants and provide standard supportive management. MSD describes LOLA as salvage for chronic hyperammonaemic HE refractory to conventional interventions, not a replacement for definitive shunt/liver care or first-line enteric ammonia control.
  • The 154 mg/kg/hour canine initial rate reaches the exact human-label 5 g/hour ceiling at about 32.5 kg. No validated canine rule reconciles the weight-based study rate with that absolute product limit; obtain specialist/pharmacy review.
  • Pregnancy, lactation, breeding-animal and paediatric veterinary safety are not established; human information advises avoidance unless benefit clearly outweighs risk.
Assessment sources
  1. Hepa-Merz exact SPC2008
  2. GE Hepa-Merz audit2026
  3. LT Hepa-Merz register2026
  4. Canine IV LOLA report2016
  5. MSD small-animal HE2024
  6. Dog-cat HE review2016
Assessed: 22 Oct 2026No axis or overall score is shown when the available evidence does not support a responsible numerical assessment.
Composition / strength
L-Ornithine-L-Aspartate500 mg/ml
Formulation Type
Solution
Administration route
Intravenous
Manufacturer
Merz Pharmaceuticals GmbH · Germany
Registration
Georgia Yes, human
In force until 17 Jun 2029
Human (Ministry of Health, RAMA)
№ რ-041313
Verified on: 15 Oct 2026
 EU Yes, human
№ LT/1/94/0572/001
Verified on: 22 Oct 2026
 UK No
Verified on: 16 Oct 2026
 US No
Verified on: 16 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 16 Oct 2026
Information not fully verified Human IV concentrate; all veterinary use is off-label. Do not administer neat: add to a compatible infusion solution. Exact human label: no more than six ampoules per 500 ml and maximum 5 g/hour. One weak canine study used 616 mg/kg/day IV for mild HE; for severe HE it printed 154 mg/kg/hour for 4 hours then 30 mg/kg/hour for 20 hours. Those phases total 1,216 mg/kg/day, not the paper-stated 1,232 mg/kg/day. No defensible feline dose is established.
DoseSpeciesWeightRouteFrequencySource
No dose for this species
No feline IV dose, exact-product clinical efficacy study or target-animal safety cohort was located. Do not copy the exploratory canine regimen or a human ampoule count into a cat.
 Cat Any weight Intravenous dose not established
Dog-cat HE review
Scientific article
A study or review published in a scientific journal. Its findings apply to the animals and conditions it studied.
Hepatic encephalopathy in dogs and cats
Journal of Veterinary Emergency and Critical Care, 2016
616 mg/kg
Mild HE only in one non-randomised 17-dog case series. This is not an established standard dose. Convert through 500 mg/ml only for preparation, dilute before use, and reconcile the calculated plan with the exact-product 5 g/hour ceiling and fluid tolerance.
 Dog Any weight Intravenous over one day; exact infusion profile not reported
Canine IV LOLA report
Scientific article
A study or review published in a scientific journal. Its findings apply to the animals and conditions it studied.
Hyperammonemic hepatic encephalopathy management through L-ornithine-L-aspartate administration in dogs
Journal of Veterinary Science, 2016
154 mg/kg
Exploratory severe-HE initial phase. At 500 mg/ml this is 0.308 ml/kg/hour of concentrate before dilution. Above about 32.5 kg it exceeds the exact human-label absolute ceiling of 5 g/hour; no validated canine reconciliation rule exists.
 Dog Any weight Intravenous every hour for the first 4 hours of the severe-HE study protocol
Canine IV LOLA report
Scientific article
A study or review published in a scientific journal. Its findings apply to the animals and conditions it studied.
Hyperammonemic hepatic encephalopathy management through L-ornithine-L-aspartate administration in dogs
Journal of Veterinary Science, 2016
30 mg/kg
Exploratory severe-HE continuation phase. At 500 mg/ml this is 0.060 ml/kg/hour of concentrate before dilution. Printed phases calculate to 1,216 mg/kg/day; do not substitute the internally inconsistent paper-stated 1,232 mg/kg/day total.
 Dog Any weight Intravenous every hour for the next 20 hours after the initial 4-hour phase
Canine IV LOLA report
Scientific article
A study or review published in a scientific journal. Its findings apply to the animals and conditions it studied.
Hyperammonemic hepatic encephalopathy management through L-ornithine-L-aspartate administration in dogs
Journal of Veterinary Science, 2016

Known Contraindications

  • Critical
    if you suffer from severely impaired kidney function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guideline value.
    Sources: Product label
  • Critical
    Known hypersensitivity to L-ornithine L-aspartate is a contraindication.
    Sources: Product label
  • Warning (Cat)
    No dose has been established for cats. The only identified veterinary publication concerns dogs, and even that dose was extrapolated from human medicine. Use in cats therefore requires an individual veterinary decision.
  • Caution
    Do not administer ornithine aspartate infusion concentrate intra-arterially.
    Sources: Product label

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