SmofKabiven Central emulsion for infusion, Excel bags

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

L-alanine; L-arginine; GLYCINE; L-histidine; L-isoleucine; L-leucine; L-lysine; L-methionine; L-phenylalanine; L-proline; L-serine; Taurine; L-threonine; L-tryptophan; L-tyrosine; L-valine; Calcium chloride; Sodium glycerophophate hydrate; Magnesium sulphate heptahydrate; Potassium chloride; Sodium acetate trihydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya bean oil, refined; Triglycerides, medium chain; Olive oil, refined; Fish oil, rich in omega-3 acids

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA10

INN (International Name):

L-alanine; L-arginine; GLYCINE; L-histidine; L-isoleucine; L-leucine; L-lysine; L-methionine; L-phenylalanine; L-proline; L-serine; Taurine; L-threonine; L-tryptophan; L-tyrosine; L-valine; Calcium chloride; Sodium glycerophophate hydrate; Magnesium sulphate heptahydrate; Potassium chloride; Sodium acetate trihydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya bean oil, refined; Triglycerides, medium chain; Olive oil, refined; Fish oil, rich in omega-3 acids

Dosage:

0 gram(s)

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2009-08-28

Patient Information leaflet

-
if you have fluid in the lungs (acute pulmonary oedema)
-
if you have too much body fluid (hyperhydration)
-
if you have heart failure that is not treated
-
if
you
have
a
defect
in
your
blood
clotting
system
(haemophagocytotic syndrome)
-
if you are in an unstable condition, such as after serious trauma,
uncontrolled diabetes, acute heart attack, stroke, blood clot
(embolism), metabolic acidosis (a disturbance resulting in too
much acid in the blood), serious infection (severe sepsis),
coma and if you don’t have enough body fluid (hypotonic
dehydration).
-
in children under 2 years of age
Warnings and precautions:
Talk to your doctor before using SmofKabiven Central if you have:
-
kidney problems
-
diabetes mellitus
-
pancreatitis (inflammation of the pancreas)
-
liver problems
-
hypothyrodism (thyroid problems)
-
sepsis (serious infection)
If during the infusion you get fever, rash, swelling, difficulty in
breathing, chills, sweating, nausea or vomiting, tell the healthcare
professional immediately because these symptoms might be
caused by an allergic reaction or that you have been given too
much of the medicine.
Your doctor may regularly need to check your blood for liver
function tests and other values.
Children and adolescents
SmofKabiven Central is not meant for newborn babies or children
younger than 2 years old. SmofKabiven can be given to children
from 2 to 16/18 years old.
Other medicines and SmofKabiven Central
Tell your doctor if you are taking, have recently taken or might take
any other medicines, even without prescription.
Pregnancy and breast-feeding
Data from using SmofKabiven Central during pregnancy or breast-
feeding is lacking. SmofKabiven Central should therefore be given
to pregnant or breast-feeding women only if the doctor finds it
necessary. The use of SmofKabiven Central may be considered
during pregnancy and breastfeeding, as advised by your doctor
Driving and using machines
Not relevant as the medicine is given at the hospital.
3. How to use SmofKabiven Central
Always use this medi

Summary of Product characteristics

Health Products Regulatory Authority
08 January 2020
CRN008JV4
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Central emulsion for infusion, Excel bags
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven consists of a three chamber bag system. Each bag contains
the following partial volumes depending on the five
pack sizes.
493 ML
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML
Amino acid solution with electrolytes
250 ml
500 ml
750 ml
1000 ml
1250 ml
508 ml
Glucose 42%
149 ml
298 ml
446 ml
595 ml
744 ml
302 ml
Lipid emulsion
94 ml
188 ml
281 ml
375 ml
469 ml
190 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
493 ML
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Alanine
3.5 g
7.0 g
10.5 g
14.0 g
17.5 g
7.1 g
Arginine
3.0 g
6.0 g
9.0 g
12.0 g
15.0 g
6.1 g
Glycine
2.8 g
5.5 g
8.2 g
11.0 g
13.8 g
5.6 g
Histidine
0.8 g
1.5 g
2.2 g
3.0 g
3.7 g
1.5 g
Isoleucine
1.3 g
2.5 g
3.8 g
5.0 g
6.2 g
2.5 g
Leucine
1.9 g
3.7 g
5.6 g
7.4 g
9.4 g
3.8 g
Lysine (as acetate)
1.7 g
3.3 g
5.0 g
6.6 g
8.4 g
3.4 g
Methionine
1.1 g
2.2 g
3.2 g
4.3 g
5.4 g
2.2 g
Phenylalanine
1.3 g
2.6 g
3.8 g
5.1 g
6.4 g
2.6 g
Proline
2.8 g
5.6 g
8.4 g
11.2 g
14.0 g
5.7 g
Serine
1.6 g
3.2 g
4.9 g
6.5 g
8.1 g
3.3 g
Taurine
0.25 g
0.50 g
0.75 g
1.0 g
1.2 g
0.5 g
Threonine
1.1 g
2.2 g
3.3 g
4.4 g
5.4 g
2.2 g
Tryptophan
0.5 g
1.0 g
1.5 g
2.0 g
2.5 g
1.0 g
Tyrosine
0.10 g
0.20 g
0.30 g
0.40 g
0.49 g
0.20 g
Valine
1.6 g
3.1 g
4.6 g
6.2 g
7.6 g
3.1 g
Calcium chloride
(as dihydrate)
0.14 g
0.28 g
0.42 g
0.56 g
0.69 g
0.28 g
Sodium glycerophosphate
(as hydrate)
1.1 g
2.1 g
3.1 g
4.2 g
5.2 g
2.1 g
Magnesium sulphate
(as heptahydrate)
0.30 g
0.60 g
0.90 g
1.2 g
1.5 g
0.61 g
Potassium chloride
1.1 g
2.2 g
3.4 g
4.5 g
5.7 g
2.3 g
Sodium acetate
(as trihydrate)
0.9 g
1.7 g
2.6 g
3.4 g
4.2 g
1.7 g
Zinc sulphate
(asheptahydrate)
0.0033 g 0.0065 g 0.0097 g 0.013 g
0.016 g 0.0066 g
Glucose
(as monohydrate)
63 g
125 g
187 g
250 g
313 g
127 g
Soya-bean oil, refined
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
Medi