StructoKabiven

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

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Patient Information leaflet (PIL)

07-08-2009

Summary of Product characteristics (SPC)

07-08-2009

Active ingredient:

(Amino acid solution) Calcium chloride dihydrate corresp. to Calcium chloride 0.56g; (Amino acid solution) Glycine (Aminoacetic acid); (Amino acid solution) L- Histidine; (Amino acid solution) L- Isoleucine; (Amino acid solution) L- Leucine; (Amino acid solution) L- Methionine; (Amino acid solution) L- Serine; (Amino acid solution) L- Threonine; (Amino acid solution) L- Valine; (Amino acid solution) L-Alanine; (Amino acid solution) L-Arginine; (Amino acid solution) L-Lysine acetate corresp. to L-Lysine 6.6g

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

B05BA10

Dosage:

0.740g per 1000ml

Pharmaceutical form:

EMULSION

Composition:

(Amino acid solution) Calcium chloride dihydrate corresp. to Calcium chloride 0.56g 0.740g per 1000ml; (Amino acid solution) Glycine (Aminoacetic acid) 11.0g per 1000ml; (Amino acid solution) L- Histidine 3.0g per 1000ml; (Amino acid solution) L- Isoleucine 5.0g per 1000ml; (Amino acid solution) L- Leucine 7.4g per 1000ml; (Amino acid solution) L- Methionine 4.3g per 1000ml; (Amino acid solution) L- Serine 6.5g per 1000ml; (Amino acid solution) L- Threonine 4.4g per 1000ml; (Amino acid solution) L- Valine 6.2g per 1000ml; (Amino acid solution) L-Alanine 14.0g per 1000ml; (Amino acid solution) L-Arginine 12.0g per 1000ml; (Amino acid solution) L-Lysine acetate corresp. to L-Lysine 6.6g 9.3g per 1000ml; (Amino acid solution) L-Phenylalanine 5.1g per 1000ml; (Amino acid solution) L-Proline 11.2g per 1000ml; (Amino acid solution) L-Tryptophan 2.0g per 1000ml; (Amino acid solution) L-Tyrosine 0.40g per 1000ml; (Amino acid solution) Magnesium sulphate heptahydrate corresp. to Magnesium sulphate 1.2g 2.47g per 1000m

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Fresenius Kabi AB

Authorization status:

ACTIVE

Authorization date:

2007-04-12

Patient Information leaflet

XXX XXX
Bipacksedel
StructoKabiven Leaﬂ et Singapore Bioﬁ ne
(ersätter 330 313 )
Tryckspeciﬁ kation
Format:
420 x 630 mm
Färger:
PMS svart
Utskrift:
anpassat till A3
4:e korr. 09-07-16
C Eriksson, 018-64 40 91
1.  Name of the Medicinal Product
StructoKabiven emulsion for infusion
2.  Qualitative and Quantitative Composition
StructoKabiven consists of a three chamber bag system. Each
bag contains the following partial volumes depending on the
three pack sizes.

986 ml 1477 ml 1970 ml  Per  1000ml
Amino acid solution
with electrolytes.
500 ml  750 ml 1000 ml
508 ml
Glucose 42%
298 ml  446 ml  595 ml
302 ml
Fat emulsion
188 ml  281 ml  375 ml
190 ml
This corresponds to the following total compositions:
Active ingredients
986 ml  1477ml  1970 ml  Per 1000 ml
Puriﬁ ed structured triglyceride  38 g
56 g
75 g
38.5 g
Glucose (as monohydrate)  125 g
187 g
250 g
127 g
Alanine
7.0 g  10.5 g  14.0 g
7.1  g
Arginine
6.0 g
9.0 g  12.0 g
6.1  g
Glycine
5.5 g
8.2 g  11.0 g
5.6  g
Histidine
1.5 g
2.2 g
3.0 g
1.5  g
Isoleucine
2.5 g
3.8 g
5.0 g
2.5  g
Leucine
3.7g 5.6
g 7.4
g
3.8
g
Lysine (as acetate)
3.3 g
5.0 g
6.6 g
3.4  g
Methionine
2.2 g
3.2 g
4.3 g
2.2  g
Phenylalanine
2.6 g
3.8 g
5.1 g
2.6  g
Proline
5.6 g
8.4 g  11.2 g
5.7  g
Serine
3.2 g
4.9 g
6.5 g
3.3  g
Taurine
0.50 g  0.75 g
1.0 g
0.5  g
Threonine
2.2 g
3.3 g
4.4 g
2.2  g
Tryptophan
1.0 g
1.5 g
2.0 g
1.0  g
Tyrosine
0.20 g  0.30 g  0.40 g
0.20  g
Valine
3.1 g
4.6 g
6.2 g
3.1  g
Calcium chloride (as Calcium
chloride dihydrate)
0.28 g  0.42 g  0.56 g
0.28  g
Sodium glycerophosphate
(as hydrate)
2.1 g
3.1 g
4.2 g
2.13  g
Magnesium sulphate (as
Magnesium sulphate
heptahydrate)
0.60 g  0.90 g
1.2 g
0.61  g
Potassium chloride
2.2 g

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Summary of Product characteristics

XXX XXX
Bipacksedel
StructoKabiven Leaﬂ et Singapore Excel
(ersätter 330 313 )
Tryckspeciﬁ kation
Format:
420 x 630 mm
Färger:
PMS svart
Utskrift:
anpassat till A3
4:e korr. 09-07-16
C Eriksson, 018-64 40 91
1.
Name of the Medicinal Product
StructoKabiven emulsion for infusion
2.
Qualitative and Quantitative Composition
StructoKabiven consists of a three chamber bag system. Each
bag contains the following partial volumes depending on the
three pack sizes.
986 ml 1477 ml 1970 ml Per 1000ml
Amino acid solution
with electrolytes.
500 ml
750 ml 1000 ml
508 ml
Glucose 42%
298 ml
446 ml
595 ml
302 ml
Fat emulsion
188 ml
281 ml
375 ml
190 ml
This corresponds to the following total compositions:
Active ingredients
986 ml
1477ml 1970 ml Per 1000 ml
Puriﬁ ed structured triglyceride 38 g
56 g
75 g
38.5 g
Glucose (as monohydrate)
125 g
187 g
250 g
127 g
Alanine
7.0 g
10.5 g
14.0 g
7.1 g
Arginine
6.0 g
9.0 g
12.0 g
6.1 g
Glycine
5.5 g
8.2 g
11.0 g
5.6 g
Histidine
1.5 g
2.2 g
3.0 g
1.5 g
Isoleucine
2.5 g
3.8 g
5.0 g
2.5 g
Leucine
3.7g
5.6 g
7.4 g
3.8 g
Lysine (as acetate)
3.3 g
5.0 g
6.6 g
3.4 g
Methionine
2.2 g
3.2 g
4.3 g
2.2 g
Phenylalanine
2.6 g
3.8 g
5.1 g
2.6 g
Proline
5.6 g
8.4 g
11.2 g
5.7 g
Serine
3.2 g
4.9 g
6.5 g
3.3 g
Taurine
0.50 g
0.75 g
1.0 g
0.5 g
Threonine
2.2 g
3.3 g
4.4 g
2.2 g
Tryptophan
1.0 g
1.5 g
2.0 g
1.0 g
Tyrosine
0.20 g
0.30 g
0.40 g
0.20 g
Valine
3.1 g
4.6 g
6.2 g
3.1 g
Calcium chloride (as Calcium
chloride dihydrate)
0.28 g
0.42 g
0.56 g
0.28 g
Sodium glycerophosphate
(as hydrate)
2.1 g
3.1 g
4.2 g
2.13 g
Magnesium sulphate (as
Magnesium sulphate
heptahydrate)
0.60 g
0.90 g
1.2 g
0.61 g
Potassium chloride
2.2 g
3.4 g
4.5 g
2.3 g
Sodium acetate (as Sodium
acetate trihydrate)
1.7 g
2.6 g
3.4 g
1.7 g
Zinc sulphate (as Zinc
sulphate heptahydrate)
0.0065 g 0.0097 g
0.013 g
0.0066 g
Corresponding to
986 ml
1477 ml
1970 ml Per 1000 ml
• Amino acids
50 g
75 g
100 g
51 g
• Nitrogen
8 g
12 g
16 g
8 g
• Fat
38 g
56 g
75 g
38 g
• Carbohydrates
- Glucose
(anhydrous)
125 g
187 g
250 g
127 g
• E

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