Quatriga extra Nitrogen Infusionsvätska, emulsion

Nchi: Uswidi

Lugha: Kiswidi

Chanzo: Läkemedelsverket (Medical Products Agency)

Viambatanisho vya kazi:

alanin; arginin; fenylalanin; fiskolja, rik på omega-3-syror; glukosmonohydrat; glycin; histidin; isoleucin; kalciumkloriddihydrat; kaliumklorid; leucin; lysinacetat; magnesiumsulfatheptahydrat; metionin; natriumacetattrihydrat; natriumglycerofosfat, vattenfritt; olivolja, raffinerad; prolin; serin; sojaolja, raffinerad; taurin; treonin; triglycerider, medellångkedjiga; tryptofan; tyrosin; valin; zinksulfatheptahydrat

Inapatikana kutoka:

Fresenius Kabi AB

ATC kanuni:

B05BA10

INN (Jina la Kimataifa):

alanine; arginine; phenylalanine; fish oil, rich in omega-3 fatty acids; glukosmonohydrat; glycine; histidine; isoleucine; kalciumkloriddihydrat; potassium chloride; leucine; lysinacetat; magnesiumsulfatheptahydrat; methionine; natriumacetattrihydrat; natriumglycerofosfat, non-water-based; olive oil, refined; proline; serine; soybean oil, refined; taurine; threonine; triglycerides, medellångkedjiga; tryptophan; tyrosine; valine; zinksulfatheptahydrat

Dawa fomu:

Infusionsvätska, emulsion

Tungo:

glycerol Hjälpämne; alanin 14 mg Aktiv substans; arginin 12 mg Aktiv substans; glycin 11 mg Aktiv substans; histidin 3 mg Aktiv substans; isoleucin 5 mg Aktiv substans; leucin 7,4 mg Aktiv substans; lysinacetat 9,3 mg Aktiv substans; metionin 4,3 mg Aktiv substans; fenylalanin 5,1 mg Aktiv substans; prolin 11,2 mg Aktiv substans; serin 6,5 mg Aktiv substans; treonin 4,4 mg Aktiv substans; tryptofan 2 mg Aktiv substans; tyrosin 0,4 mg Aktiv substans; valin 6,2 mg Aktiv substans; kalciumkloriddihydrat 0,574 mg Aktiv substans; natriumglycerofosfat, vattenfritt 3,48 mg Aktiv substans; magnesiumsulfatheptahydrat 1,92 mg Aktiv substans; kaliumklorid 3,48 mg Aktiv substans; natriumacetattrihydrat 4,1 mg Aktiv substans; zinksulfatheptahydrat 17,8 mikrog Aktiv substans; fiskolja, rik på omega-3-syror 30 mg Aktiv substans; olivolja, raffinerad 50 mg Aktiv substans; triglycerider, medellångkedjiga 60 mg Aktiv substans; sojaolja, raffinerad 60 mg Aktiv substans; glukosmonohydrat 462 mg Aktiv substans; taurin 1 mg Aktiv substans

Dawa ya aina:

Receptbelagt

Bidhaa muhtasari:

Förpacknings: Trekammarpåse, 1 x 506 ml; Trekammarpåse, 1 x 1012 ml; Trekammarpåse, 4 x 1012 ml; Trekammarpåse, 6 x 506 ml; Trekammarpåse, 1 x 1518 ml; Trekammarpåse, 4 x 1518 ml; Trekammarpåse, 1 x 2025 ml; Trekammarpåse, 4 x 2025 ml; Trekammarpåse, 1 x 2531 ml; Trekammarpåse, 3 x 2531 ml

Idhini hali ya:

Godkänd

Idhini ya tarehe:

2018-10-15

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Quatriga extra Nitrogen emulsion for infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHATS IS IN THIS LEAFLET
1.
What Quatriga extra Nitrogen is and what it is used for
2.
What you need to know before you use Quatriga extra Nitrogen
3.
How to use Quatriga extra Nitrogen
4.
Possible side effects
5.
How to store Quatriga extra Nitrogen
6.
Contents of the pack and other information
1.
WHAT QUATRIGA EXTRA NITROGEN
IS AND WHAT IT IS USED FOR
Quatriga extra Nitrogen is an emulsion for infusion given into your
blood by a drip (intravenous infusion).
The product contains amino acids (components used to build proteins),
glucose (carbohydrates), lipids (fat)
and salts (electrolytes) in a plastic bag and can be given to adults
and children aged 2 years and above.
A healthcare professional will give you Quatriga extra Nitrogen when
other forms of feeding are not good
enough or have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE QUATRIGA EXTRA NITROGEN
DO NOT USE QUATRIGA EXTRA NITROGEN
-
if you are allergic (hypersensitive) to active substances or any of
the other ingredients of this medicine
(listed in section 6)
-
if you are allergic to fish or egg
-
if you are allergic to peanuts or soya you should not use this
product. Quatriga extra Nitrogen contains
soya-bean oil
-
if you have too much lipids in the blood (hyperlipidemia)
-
if you have serious liver disorder
-
if you have blood clotting problems (coagulation disorder)
-
if your body has problems using amino acids
-
if you have serious kidney disease without access to dialysis
-
if you are in acute shock
-
if you have too much sugar in your blood (hyperglycaemia

Tabia za bidhaa

1 (12)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Quatriga extra Nitrogen, emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quatriga extra Nitrogen consists of a three chamber bag system. Each
bag contains the following
partial volumes depending on the five pack sizes.
506 ML
1012 ML
1518 ML
2025 ML
2531 ML
PER 1000 ML
Amino acid solution 10%
with electrolytes
331 ml
662 ml
993 ml
1325 ml
1656 ml
654 ml
Glucose 42%
102 ml
204 ml
306 ml
408 ml
510 ml
202 ml
Lipid emulsion 20%
73 ml
146 ml
219 ml
292 ml
365 ml
144 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
506 ML
1012 ML
1518ML
2025 ML
2531 ML
PER 1000 ML
Alanine
4.6 g
9.3 g
14 g
19 g
23 g
9.2 g
Arginine
4.0 g
7.9 g
12 g
16 g
20 g
7.9 g
Glycine
3.6 g
7.3 g
11 g
15 g
18 g
7.2 g
Histidine
1.0 g
2.0 g
3.0 g
4.0 g
5.0 g
2.0 g
Isoleucine
1.7 g
3.3 g
5.0 g
6.6 g
8.3 g
3.3 g
Leucine
2.4 g
4.9 g
7.3 g
9.8 g
12 g
4.8 g
Lysine (as acetate)
2.2 g
4.4 g
6.6 g
8.7 g
11 g
4.3 g
Methionine
1.4 g
2.8 g
4.3 g
5.7 g
7.1 g
2.8 g
Phenylalanine
1.7 g
3.4 g
5.1 g
6.8 g
8.4 g
3.3 g
Proline
3.7 g
7.4 g
11 g
15 g
19 g
7.3 g
Serine
2.2 g
4.3 g
6.5 g
8.6 g
11 g
4.3 g
Taurine
0.33 g
0.66 g
1.0 g
1.3 g
1.7 g
0.65 g
Threonine
1.5 g
2.9 g
4.4 g
5.8 g
7.3 g
2.9 g
Tryptophan
0.66 g
1.3 g
2.0 g
2.7 g
3.3 g
1.3 g
Tyrosine
0.13 g
0.26 g
0.40 g
0.53 g
0.66 g
0.26 g
Valine
2.1 g
4.1 g
6.2 g
8.2 g
10 g
4.1 g
Calcium chloride dihydrate
_corresponding to_
Calcium chloride
0.14 g
0.29 g
0.43 g
0.58 g
0.72 g
0.28 g
Sodium glycerophosphate
(hydrate)
_corresponding to_
Sodium glycerophosphate
1.2 g
2.3 g
3.5 g
4.6 g
5.8 g
2.3 g
Magnesium sulphate heptahydrate
_corresponding to_
Magnesium sulphate
0.31 g
0.62 g
0.92 g
1.2 g
1.5 g
0.61 g
Potassium chloride
1.2 g
2.3 g
3.5 g
4.6 g
5.8 g
2.3 g
Sodium acetate trihydrate
_corresponding to_
Sodium acetate
0.82 g
1.6 g
2.5 g
3.3 g
4.1 g
1.6 g
Zinc sulphate heptahydrate
_corresponding to_
Zinc sulphate
0.0033 g
0.0066 g
0.010 g
0.013 g
0.017 g
0.0066 g
2 (12)
Glucose monohydrate
_corresponding