Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
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
ETHICA INDUSTRI FARMASI (SITE JABABEKA) - Indonesia
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
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
KAPLET SALUT SELAPUT
DUS, 10 STRIP @ 10 KAPLET SALUT SELAPUT
FRESENIUS KABI COMBIPHAR - Indonesia
2022-04-23
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 Lue koko asiakirja