HEPA-MERZ

Država: Indonezija

Jezik: indonezijski

Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivni sastojci:

ORNITHINE ASPARTATE

Dostupno od:

COMBIPHAR - Indonesia

INN (International ime):

ORNITHINE ASPARTATE

Doziranje:

3 G

Farmaceutski oblik:

GRANULA

Jedinice u paketu:

DUS, 10 SACHET @ 5 G

Proizveden od:

MERZ - Germany

Datum autorizacije:

2017-07-25

Svojstava lijeka

HEPA-MERZ
® _GRANULATE_
L-ORNITHINE -
L-ASPARTATE
3 g/5 g, Granules for oral solution
COMPOSITION
Each sachet with 5 g contains 3.0 g L-ornithine-L-as-
partate.
Excipients: Citric acid, saccharin sodium, sodium
cyclamate, povidone 25, fructose, flavourings, orange
yellow S (E110).
INDICATIONS
Treatment of concomitant disease and sequelae due to
impaired hepatic detoxification activity (e.g.in cirrhosis
of the liver) with the symptoms of latent and manifest
hepatic encephalopathy.
POSOLOGY AND METHOD OF ADMINISTRATION
Granules for oral solution.
The dissolved contents of 1–2 sachets of Hepa-Merz
granules are taken up to 3 times daily.
Hepa-Merz granules are dissolved in plenty of fluid
(e.g. a glass of water, tea or juice) and taken with or
after meals.
The experiences on the use of the drug in children are
limited.
CONTRAINDICATIONS
Severely impaired renal function (renal insufficiency). A
serum creatinine value over 3 mg/100 ml can be used
as a guideline value.
Hepa-Merz granules must not be taken by patients
with known hypersensitivity to L-ornithine-L-aspartate,
orange yellow S or any of the excipients.
WARNINGS AND PRECAUTIONS
Hepa-Merz granules contain fructose. Patients with rare
hereditary problems of fructose intolerance should not
take this medicine.
Hepa-Merz granules contain 1.13 g fructose per sachet
(equivalent to 0.11CEU). This should be taken into
account in patients with diabetes mellitus.
Any possible fructose intolerabilities should be checked
by the attending physician before treatment.
Hepa-Merz granules may be harmful to the teeth (cari
-
es) in long-term use.
No data are so far available on the use of the drug in
children.
INTERACTION
None known
PREGNANCY AND LACTATION
_Pregnancy:_
No clinical data are available relating to intake of
Hepa-Merz granules during pregnancy. No exhaustive
animal studies have been performed for L-ornithi
-
ne-L-aspartate, to investigate its toxicity in relation to
reproduction. Administration of Hepa-Merz granules
during pregnancy should therefore be avoided. I