Hepa-Merz infusion concentrate 0.5g/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

L, ORNITHINE, ASPARTATE

Available from:

Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany

ATC code:

A05BA

INN (International Name):

L-ORNITHINE 5 g/ml L-ASPARTATE 5 g/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

L-ORNITHINE 5 g/ml L-ASPARTATE 5 g/ml

Prescription type:

POM

Therapeutic area:

BILE AND LIVER THERAPY

Authorization status:

Withdrawn

Authorization date:

2006-11-08

Patient Information leaflet

Instructions for use, please read carefully!
Composition:
1 ampoule of 10 ml contains: L-ornithine-L-aspartate 5.0 g
This application form of Hepa-Merz 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 and the energy balance
improved. Liver
dysfunctions are favourably influenced, and the regeneration of the
liver cells is
promoted.
Indications:
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 conciousness (pre-coma) or neurological complications
(hepatic
encephalopathy).
Contraindications:
Severe renal insufficiency (a serum creatinine value exceeding 3
mg/100 ml can be
regarded as a reference value).
Side effects:
In isolated cases, transient gastrointestinal complaints such as
nausea and vomiting
were observed which did not require discontinuation of the treatment,
and dis-
appeared after reduction of the dose.
Dosage and mode of application:
Unless otherwise prescribed, up to 4 ampoules daily.
With incipient disturbance of consciousness (pre-coma) and clouding of
conscious-
ness (coma) up to 8 ampoules during 24 hours, depending on the
severity of the
condition.
Maximum infusion rate: 5 g/h.
Hepa-Merz may be added to all conventional infusion solutions.
However, for 
reasons of venous tolerance the dose should not exceed 6 ampoules per
500 ml
infusion.
Note:
Administration of high doses of Hepa-Merz requires monitoring of serum
and urinary
urea levels.
Presentation:
5 ampoules of 10 ml infusion concentrate
Special storage conditions:
Do not store above 25°C.
Keep all drugs out of the reach of children!
Marketing Authorisation Holder:
Merz Pharmaceuticals GmbH, 60318 Frankfurt am Main, Germany.
Manufacturer:
Merz Pharma GmbH & Co. KGaA, 60318 Frankfurt am

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
Hepa-Merz infusion concentrate 0.5 g/ml 
Concentrate for solution for infusion 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active substance: L-ornithine L-aspartate. 
One ampoule of 10 ml contains 5.00 g L-ornithine L-aspartate. 

For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL 
FORM 
Concentrate for solution for infusion. 
Hepa-Merz infusion concentrate is a clear solution. 

4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Latent and manifest hepatic encephalopathy.  
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Intravenous use: The ampoules are added
to an infusion solution before use, and infused in this 
form.  

Unless otherwise prescribed, patients may be given up to 4 ampoules
per day. 

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. 

Hepa-Merz infusion concentrate can be mixed with the usual
infusion solutions without any 
problem. 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.  

Hepa-Merz infusion concentrate must not be administered into an
artery.  

Page 2 of 4 
4.3 CONTRAINDICATIONS 
Severe renal impairment (renal failure). A serum creatinine
level in excess of 3 mg/100 ml can be 
taken as a guide. 
Hypersensitivity to L-ornithine L-aspartate or to any of the
excipients. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
At high doses of Hepa-Merz infusion concentrate, serum and urine
urea levels should be monitored.  
If liver function is substantially impaired, the infusion rate
must be adjusted to the individu