L-Ornithine-L-Aspartate Injection 5 g/10 ml, each ml contains : L-Ornithine-L-Aspartate 500 mg.
L-Ornithine-L-Aspartate with L-Ornithine-L-Aspartate as active ingredient is available in injection 5 g/10 ml.
- Treatment of hyperammonemia due to acute or chronic liver disease, e.g., liver cirrhosis, fatty liver and hepatitis.
- Treatment of precoma of hepatic encephalopathy.
DOSAGE AND ADMINISTRATIONS :
- Unless otherwise indicated, patients may be given up to 4 ampoules per day.
- Patients with incipient clouding of consciousness (precoma) or clouding of consciousness (coma), up to 8 ampoules may be given in 24 hours, depending on the severity of the condition.
- The ampoules are added to an infusion solution before use and infused in this form.
- L-Ornithine-L-Aspartate infusion can be mixed with the usual infusion solutions. So far, no peculiarities have been observed with regards to miscibility. However, the ampoules should be admixed to the infusion solution only immediately before application. For venous tolerability, however no more than 6 ampoules should be dissolved per 500 ml infusion.
- The maximum infusion rate is 5 g L-Ornithine-L-Aspartate (corresponding to the content of 1 ampoule) per hour. L-Ornithine-L-Aspartate infusion must not be administered into an artery.
- Experience in children is limited.
In use stability :
- 0.9% Sodium chloride, 5% Dextrose dan Ringer’s lactate as a carrier solutions are compatible with L-Ornithine-L-Aspartate 500 mg/ml.
- The solution mixtures were stable up to 24 hours.
Signs of intoxication have not been observed following an overdose of L-Ornithine-L-Aspartate. Cases of overdose require symptomatic treatment.
- Hypersensitivity to L-Ornithine-L-Aspartate.
- Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guidance value.
WARNINGS AND PRECAUTIONS :
- At high doses of L-Ornithine-L-Aspartate infusion, serum and urine urea levels should be monitored. If liver function is substantially impaired, the infusion rate must be adjusted to the individual patient in order to prevent nausea and vomiting. No data are available on the use of the drug in children.
- Pregnancy and lactation : There are no clinical data available on the use of L-Ornithine-L-Aspartate infusion in pregnancy. L-Ornithine-L-Aspartate has been investigated for reproduction toxicity only to a limited extent in experimental animal studies. Therefore, the administration of L-Ornithine-L-Aspartate infusion in pregnancy should be avoided. If treatment with L-Ornithine-L-Aspartate is nevertheless thought to be necessary, the benefits and risks should be carefully assessed. It is not known whether L-Ornithine-L-Aspartate secreted into breast milk. Therefore, administration of L-Ornithine-L-Aspartate should be avoided during lactation. If treatment with L-Ornithine-L-Aspartate is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.
- Effects on ability to drive and use machinery : Depending on the underlying disease, the ability to drive and operate machines may also be impaired on treatment with L-Ornithine-L-Aspartate.
DRUG INTERACTIONS :
No interaction studies have been performed. Up to now, interactions are not known.
ADVERSE REACTIONS :
Nausea, vomiting, sensation of heat and palpitation. Generally, these symptoms are transient and do not necessitate discontinuation of treatment with L-Ornithine-L-Aspartate. The symptoms disappear on reduction of the dose or infusion rate.
L-Ornithine-L-Aspartate Injection 5 g/10 ml Box, 10 ampoules @ 10 ml
Reg. No. GKL1802357243A1
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia