View drug registration information details.
Items | Registration information |
ID | 535 |
No | 535 |
Brand Name | KETOSTERIL |
Ingredients | TYROSINE 30 MG, HISTIDINE 38 MG, THREONINE 53 MG, TRYPTOPHAN 23 MG, LYSINE ACETATE 105 MG, CALCIUM-4-METHYL-2-OXO-VALERATE(KETO-ANALOGUE LEUCINE, CALCIUM SALT) 101 MG, CALCIUM -2-OXO-3-PHENYL-PROPIONATE (KETO-ANALOGUE PHENYLALANINE, CALCIUM SALT) 68 MG, CALCIUM-3-METHYL-2-OXO-BUTYRATE (KETO-ANALOGUE VALINE, CALCIUM SALT) 86 MG, CALCIUM-3-METHYL-2-OXO-VALERATE (KETO-ANALOGUE ISOLEUCINE, CALCIUM SALT) 67 MG, CALCIUM-DL-2-HYDROXY-4-METHYLTHIO-BUTYRATE (HYDROXY-ANALOGUE METHIONINE, CALCIUM SALT) 59 MG |
Dosage Form | FILM COATED TABLET |
Primary Packaging | PLASTIC/ALU FOIL BLISTERPACK |
Storage | STORE AT TEMPERATURE NOT EXCEEDING 25 C |
Shelf Life | 3 YEARS |
Pack Size | BOX OF 5 X 20'S |
Dispensing Category | Prescription only |
ATC Classification | V06DD |
Pharmaceutical Class | AMINO ACIDS |
Indications | PREVENTION AND THERAPY OF DAMAGES DUE TO FAULTY OR DEFICIENT PROTEIN METABOLISM IN CHRONIC RENAL INSUFFICIENCY IN CONNECTION WITH LIMITED PROTEIN IN FOOD OF 40 G PER DAY (FOR ADULTS) AND LESS; I.E. GENERALLY IN PATIENTS WITH A GLOMERULAR FILTRATION RATE (GFR) BELOW 25 ML/MIN |
Contraindications | HYPERCALCEMIA, DISTURBED AMINO AND METABOLISM, IN CASE OF HEREDITARY PHENYLKETONURIE |
Side Effects | HYPERCALCAEMIA |
Unit Price | |
EDL |
No |
Description | AN OBLONG, YELLOW FILM COATED TABLET |
Note | |
License Owner | DKSH LAOS COMPANY LIMITED |
Manufacturer | LABESFAL-LABORATORIOS ALMIRO S.A. |
Country | PORTUGAL |
Import Registration No | 2398188 |
Import Registration Date | 1996-05-11 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2022-05-27 |
FDD Registration No | 06 I 5542/23 |
FDD Registration Date | 2023-06-26 |
Expiry Date | 2026-06-25 |
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