SmofKabiven Central emulsion for infusion, Excel bags

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

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

Saatavilla:

Fresenius Kabi Limited

ATC-koodi:

B05BA; B05BA10

INN (Kansainvälinen yleisnimi):

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 sulpha

Annos:

0 gram(s)

Lääkemuoto:

Emulsion for infusion

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Solutions for parenteral nutrition; combinations

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2009-08-28

Pakkausseloste

V003/GZ
_SMOFKABIVEN CENTRAL_
Emulsion for infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your doctor will decide on the dose for you individually depending
on your body weight and function. SmofKabiven Central will be
given to you by a healthcare professional.
If you use more SmofKabiven Central than you should
It
is
unlikely
that
you
will
receive
too
much
medicine
as
SmofKabiven Central is given to you by a healthcare professional.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Common (may affect up to 1 in 10 people): a slightly raised body
temperature.
Uncommon (may affect up to 1 in 100 people): high blood
(plasma) levels of compounds from the liver, lack of appetite,
nausea, vomiting, chills, dizziness and headache.
Rare (may affect up to 1 in 1,000 people): low or high blood
pressure, difficulty in breathing, fast heart beat (tachycardia).
Hypersensitivity reactions (that can give symptoms like swelling,
fever, fall in blood pressure, skin rashes, wheals (raised red areas),
flushing, headache). Sensations of hot and cold. Paleness. Light
blue coloured lips and skin (because of too less oxygen in the
blood). Pain in the neck, back, bones, chest and loins.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
For UK - You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
For Ireland - You can report directly via;
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: [phone]
Fax: [phone]
Website: www.hpra.ie
e-mail: [e-mail]
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store SmofKabiven Central
Keep this medicine out of the sight and reach of children.
Store in overpouch. Do not store above 25°C. Do not freeze.
Read all of this leaflet carefully before you start using this
medicine because it

Valmisteyhteenveto

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.
This corresponds to the following total compositions:
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
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
(as heptahydrate)
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
Medium-chain
triglycerides
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
H
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