AMINORAL 1.5

Country: Indónesía

Tungumál: indónesíska

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

Virkt innihaldsefni:

ALPHA-KETO-ISOLEUCIN CALCIUM, ALPHA-KETO-LEUCINE CALCIUM, ALPHA-KETO-PHENYLALANINE CALCIUM, ALPHA-KETO-VALINE CALCIUM, ALPHA-HYDROXY METHIONINE CALCIUM, LYSINE ACETATE, THREONINE, TRYPTOPHAN, HISTIDINE, TYROSINE

Fáanlegur frá:

ETHICA INDUSTRI FARMASI (SITE JABABEKA) - Indonesia

INN (Alþjóðlegt nafn):

ALPHA-KETO-ISOLEUCIN CALCIUM, ALPHA-KETO-LEUCINE CALCIUM, ALPHA-KETO-PHENYLALANINE CALCIUM, ALPHA-KETO-VALINE CALCIUM, ALPHA-HYDROXY METHIONINE CALCIUM, LYSINE ACETATE, THREONINE, TRYPTOPHAN, HISTIDINE, TYROSINE

Skammtar:

100.50 MG /151.50 MG /102.00 MG /129.00 MG /88.50 MG /157.50 MG /79.50 MG /34.50 MG /57.00 MG /45.00

Lyfjaform:

KAPLET SALUT SELAPUT

Einingar í pakka:

DUS, 10 STRIP @ 10 KAPLET SALUT SELAPUT

Framleitt af:

FRESENIUS KABI COMBIPHAR - Indonesia

Leyfisdagur:

2022-04-23

Vara einkenni

SUMMARY OF PRODUCT CHARATERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AMINORAL 1.5 Film-Coated Caplet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated caplet contains:

-Ketoisoleucine, Calcium salt
100.5 mg

-Ketoleucine, Calcium salt
151.5 mg

-Ketophenylalanine, Calcium salt
102
mg

-Ketovaline, Calcium salt
129
mg

-Hydroxymethionine, Calcium salt
88.5 mg
Lysine Acetate
157.5 mg
Threonine
79.5 mg
Tryptophan
34.5 mg
Histidine
57
mg
Tyrosine
45
mg
3.
PHARMACEUTICAL FORM
Film-coated caplet; yellow with thin glossy coating; plain
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy of chronic renal insufficiency in connection with high
calory-low protein diet 40 g/day or less
in compensated or decompensated retention i.e generally in patients
with a glomerular filtration rate
(GFR) between 5 and 50 ml/minutes
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
If not otherwise prescribed, 8 – 16 caplets in total per day during
meals divided into three times.
Swallow whole.
This dosage applies to adults (70 kg/body weight)
Aminoral 1.5 film-coated caplets are given as long as the glomerular
filtration rate is between 5 and
50 ml/minute, and concomitantly, dietary should contain 40 g/day
protein or less (adults).
4.3
CONTRAINDICATIONS
Hypercalcaemia, disturbances of amino acid metabolism.
Hypersensivity to the active substances or to any of the excipients
listed in section 6.1
4.4
SPECIAL WARNING AND PRECAUTIONS FOR USE
DISETUJUI OLEH BPOM : 31/03/2022
ID : EREG10040712100013
-
It is important to ensure sufficient calories provided to the patient
-
Precautions shall be taken in case of concomittant administration of
calcium preparations which
may cause hypercalcaemia. The serum calcium level should be monitored
regularly.
-
In the presence of hereditary phenylketonuria, attention should be
given to the fact that Aminoral
1.5 contains phenylalanine.
-
Monitoring of the serum phosphate levels is needed in case of
concomitant administration of
aluminium hydroxide
-
There is no expe