Hepa-merz
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Hepa-Merz, 5 g/10 ml, concentrate for solution for infusion
Ornithini aspartas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
- Please keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Hepa-Merz is and what it is used for
- Important information before using Hepa-Merz
- How to use Hepa-Merz
- Possible side effects
- How to store Hepa-Merz
- Contents of the pack and other information
1. What Hepa-Merz is and what it is used for
Hepa-Merz is a medicine that enhances the removal of ammonia from the body by stimulating urea synthesis in the liver. Hepa-Merz also supports ammonia elimination from tissues other than the liver. Hepa-Merz is used in the treatment of hepatic encephalopathy associated with acute and chronic liver diseases, such as fatty liver, cirrhosis, and in hyperammonaemia.
2. Important information before using Hepa-Merz
When not to use Hepa-Merz
Do not use Hepa-Merz in patients with the following conditions:
- hypersensitivity to L-ornithine L-aspartate;
- severe renal insufficiency (serum creatinine concentration above 3 mg/100 ml);
- disorders of amino acid metabolism involved in the urea cycle, e.g. due to enzymatic defects.
Warnings and precautions
Before starting treatment with Hepa-Merz, discuss it with your doctor or pharmacist.
When high doses are administered, serum and urinary urea concentrations should be monitored.
In patients with severe liver function impairment, the infusion rate should be individually adjusted to avoid gastrointestinal disturbances such as nausea and vomiting.
Children
There is a lack of data regarding the use of Hepa-Merz in children.
Hepa-Merz and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines planned for future use.
No interactions between Hepa-Merz and other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
There are insufficient data on the safety of Hepa-Merz during pregnancy; therefore, the use of this medicine should be avoided during pregnancy. However, if administration of Hepa-Merz in a pregnant woman is necessary, the physician should weigh the potential benefit against the possible risk before deciding to administer the drug.
Breastfeeding
It is not known whether L-ornithine L-aspartate (the active substance of Hepa-Merz) passes into human milk. The use of Hepa-Merz during breastfeeding should be avoided. However, if administration of the medicine in a breastfeeding woman is necessary, the physician should weigh the potential benefit against the possible risk before deciding to administer the drug.
Driving and operating machinery
The ability to drive vehicles and operate machinery may be impaired due to the underlying disease for which Hepa-Merz is used in treatment.
3. How to use Hepa-Merz
Dosage:
This medicinal product should always be used as directed by the physician. In case of doubt, consult the
physician or pharmacist.
The usual dose is up to 20 g (4 ampoules) per day.
In pre-comatose and comatose states, up to 40 g (8 ampoules) per day, depending on the patient's condition.
If the patient feels that the effect of the medicine is too strong or too weak, they should contact the physician
or pharmacist.
Route of administration
Intravenous administration.
Before administration, the contents of the ampoule should be dissolved in an infusion fluid. Hepa-Merz may be administered in all commonly used infusion solutions. Incompatibilities related to dissolution have not been observed to date.
It is recommended to prepare the infusion solution immediately before administration.
Due to the risk of vein damage, no more than 6 ampoules should be administered in 500 ml of fluid. Infusion rate: maximum 5 g (1 ampoule) per hour.
Do not administer intra-arterially.
Use of higher than recommended dose of Hepa-Merz
Symptoms of poisoning following overdose of Hepa-Merz have not been observed to date.
In the event of overdose, symptomatic treatment should be administered.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Uncommon adverse reactions (occurring in fewer than 1 in 100 people):
nausea.
Rare adverse reactions (occurring in fewer than 1 in 1,000 people):
vomiting.
Frequency not known (cannot be estimated from available data):
hypersensitivity, allergic reactions (anaphylactic reactions).
Nausea and vomiting are usually transient and do not require discontinuation of the medicine. They resolve after
reducing the dose or infusion rate of the medicine.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
5. How to store Hepa-Merz
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Hepa-Merz contains
The active substance in this medicine is L-ornithine L-aspartate.
Each vial (10 ml) of concentrate for solution for infusion contains 5 g of L-ornithine L-aspartate.
The other ingredient (excipient) is water for injections.
What Hepa-Merz looks like and contents of the pack
Hepa-Merz, concentrate for solution for infusion, is a clear solution.
The pack contains 10 vials of 10 ml each.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100, 60318 Frankfurt am Main, Germany
Manufacturer:
Merz Pharma GmbH & Co. KGaA, Eckenheimer Landstr. 100, 60318 Frankfurt am Main, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Bulgaria, country of export Marketing Authorisation Number: 20000705
Parallel Import Licence Number: 139/23