Ketosteril film-coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

HISTIDINE; THREONINE; TRYPTOPHAN; TYROSINE__; LYSINE ACETATE; ALPHA-HYDROXYMETHIONINE, CALCIUM SALT; ALPHA-KETOISOLEUCINE, CALCIUM SALT; ALPHA-KETOLEUCINE, CALCIUM SALT; ALPHA-KETOPHENYLALANINE, CALCIUM SALT; ALPHA-KETOVALINE, CALCIUM SALT

Boleh didapati daripada:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Nama Antarabangsa):

HISTIDINE; THREONINE; TRYPTOPHAN; TYROSINE__; LYSINE ACETATE; ALPHA-HYDROXYMETHIONINE, CALCIUM SALT; ALPHA-KETOISOLEUCINE, CALCIUM SALT; ALPHA-KETOLEUCINE, CALCIUM SALT; ALPHA-KETOPHENYLALANINE, CALCIUM SALT; ALPHA-KETOVALINE, CALCIUM SALT

Unit dalam pakej:

20tablet Tablets; 5 foils X 20tablet Tablets

Dikeluarkan oleh:

LABESFAL LABORATORIOS ALMIRO S.A.

Ciri produk

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LIT.KETOSTERIL COM REV MY
798519
José Duarte
17 Abr.2015
02
1:1
798519
Black
_Cut_
INSTRUCTIONS FOR USE - READ CAREFULLY!
FRESENIUS KABI DEUTSCHLAND GMBH
D-61346 Bad Homburg v.d.H.
KETOSTERIL TABLETS
Film-coated tablets
Calcium-3-methyl-2-oxo-valerate
(
a
-Ketoanalogue to Isoleucine, Calcium salt)
Calcium-4-methyl-2-oxo-valerate
101 mg
(
a
-Ketoanalogue to Leucine, Calcium salt)
Calcium-2-oxo-3-phenyl- propionate
68 mg
(
a
-Ketoanalogue to Phenylalanine, Calcium salt)
Calcium-3-methyl-2-oxo-butyrate
86 mg
(
a
-Ketoanalogue to Valine, Calcium salt)
Calcium-DL-2-hydroxy-4-(methyl- thio) butyrate
59 mg
(
a
-Hydroxyanalogue to Methionine, Calcium salt)
L-Lysine-acetate
(≡ 75 mg L-Lysine)
105 mg
L -Threonine
53 mg
L -Tryptophan
23 mg
L-Histidine
38 mg
L-Tyrosine
30 mg
Total nitrogen content/tablet
36 mg
Calcium/tablet
1.25 mmol
50mg
Oblong, yellow film-coated tablet
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)
between 5 and about 15 ml/minutes.
For oral use.
If not otherwise prescribed, take 4 to 8 tablets three times a day
during meals. Swallow whole.
This dosage applies to adults (70 kg/BW).
-Hypersensitivity to the active substances or to any of the
67 mg
COMPOSITION
ONE FILM-COATED TABLET
CONTAINS: INDICATIONS
APPLICATION
AND DOSAGE
PRODUCT DESCRIPTION:
CONTRAINDICATIONS
excipients
-Hypercalcaemia
-Disturbed amino acid metabolism
Hypercalcemia may develop. In this case it is recommended to
decrease vitamin D intake. If the hypercalcaemia persists, reduce
the dosage of Ketosteril as well as other source of calcium.
The serum calcium level should be monitored regularly.
Ensure sufficient calorie intake.
No experience has been gained so far with the administration in
paediatric patients.
In the presence of hereditary phenylketonuria, attention should be
®
given to the fact that Ketosteril
contains