5 gm/10 ml
For the use of a Registered Medical Practitioner or a Hospital or a Institution only.
L-Ornithine-L-Aspartate is a combination amino acids. Chemically, L-Ornithine-L-Aspartate is (S)-2,5-Diaminopentanoic acid L-Aspartate salt. The molecular formula is C9H19N3O6 and molecular weight is 265.27.
STRUCTURAL FORMULA :
Its structural formula is :
SOLHEPA is a clear yellow coloured solution filled in 10 ml amber glass ampoules.
Each ml contains :
L-Ornithine-L-Aspartate 500 mg
Water for Injections I.P. q.s.
Contains no preservatives.
It is well known that both ornithine and aspartic acid play a key role in the liver metabolism. In fact, ornithine is the starting point of which ammonia is converted into urea, a non-toxic substance. The other component of the drug, aspartic acid, not only represents as important stage in the reaction sequence involved in the urea cycle, but also features in the tricarboxylic acid cycle as oxaloacetate formed by transamination, thereby improving the energy balance of the diseased liver. Furthermore, aspartic acids promote natural regeneration of the liver cells by taking part in pyrimidine biosynthesis.
For the treatment of hyperammonemia as a result of acute and chronic liver diseases such as liver cirrhosis, fatty liver, hepatitis; especially for the treatment of incipient disturbances of consciousness (pre-coma) or neurological complications (hepatic encephalopathy). This application form of SOLHEPA is especially effective in severe cases of liver disease. As ornithine aspartate exerts its action in the metabolic cycles of the liver, elevated blood ammonia levels are rapidly lowered. The capacity of detoxification, particularly of the urea cycle, is enhanced.
1. SOLHEPA can be added to any of the conventional intravenous fluids (saline or dextrose etc.)
2. The normal dilution rate is a 1 ampoule per 100 ml of I.V. fluid. However for the reason of venous tolerance, the dose should not exceed 6 ampoules per 500 ml infusion. Maximum infusion rate : 5 g/hr.
INSTRUCTION FOR USE OF AMPOULE :
The ampoule used in this product is equipped with O.P.C (One Point Cut) opening system. No ampoule file is needed to open the ampoule. The neck of the ampoule is prescored at the point of constriction. A coloured dot on the ampoule head helps to orientate the ampoule. Take the ampoule and face the coloured dot. Let the solution at the head of the ampoule to flow down by shaking or a gentle stroke. The ampoule opens easily by placing the thumb on the coloured dot and gently pressing downwards as shown.
a. On the first day : Depending on severity of the condition between 8 to 20 ampoules in divided doses. Satisfactory results were obtained when 8 ampoules were used in the first quarter of the day followed by 4 ampoules in each of next three quarters.
b. From 2nd day onwards : 8 ampoules per day. The duration of administration is dependent on the course of the disease.
SOLHEPA is contraindicated in severe renal insufficiency (a serum creatinine value exceeding 3 mg/100 ml.)
Administration of high doses of SOLHEPA requires monitoring of serum and urinary urea levels.
SOLHEPA should be used during pregnancy only if the potential benefits out-weigh the potential risk to the foetus.
SIDE EFFECTS :
In isolated cases, transient gastrointestinal complaints such as nausea and vomiting were observed which did not require discontinuation of the treatment, and disappeared after reduction of the dose.
PHARMACEUTICAL PRECAUTIONS :
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Store below 30°C (86°F), protected from light.
Do not refrigerate.
SHELF LIFE :
36 months from the date of manufacture.
SOLHEPA contains L-Ornithine-L-Aspartate 500 mg filled in 10 ml amber ampoules.
5 ampoules are packed in a carton with package insert.
Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.