SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

Country: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

Calcium chloride dihydrate eqv. calcium chloride; Fish oil, rich in omega-3 acids; Glucose monohydrate eqv. glucose; Glycine; L-Alanine; L-Arginine; L-Histidine; L-Isoleucine; L-Leucine; L-Lysine acetate equv. L-Lysine; L-Methionine; L-Phenylalanine; L-Proline; L-Serine; L-Threonine; L-Tryptophan; L-Tyrosine; L-Valine; Magnesium sulfate heptahydrate as magnesium sulfate; Olive oil, refined; Potassium Chloride; Sodium acetate trihydrate as sodium acetate; Sodium glycerophosphate hydrated as sodium glycerophosphate; Soy-bean oil, refined; Taurine; Triglycerides, medium-chain; Zinc sulfate heptahydrate as zinc sulfate

থেকে পাওয়া:

FRESENIUS KABI (SINGAPORE) PTE LTD

এটিসি কোড:

B05BA10

ফার্মাসিউটিকাল ফর্ম:

INJECTION, EMULSION

রচনা:

Calcium chloride dihydrate eqv. calcium chloride 0.28g/1000ml; Fish oil, rich in omega-3 acids 4.3g/1000ml; Glucose monohydrate eqv. glucose 85g/1000ml; Glycine 7.2g/1000ml; L-Alanine 9.2g/1000ml; L-Arginine 7.9g/1000ml; L-Histidine 2g/1000ml; L-Isoleucine 3.3g/1000ml; L-Leucine 4.8g/1000ml; L-Lysine acetate equv. L-Lysine 4.3g/1000ml; L-Methionine 2.8g/1000ml; L-Phenylalanine 3.3g/1000ml; L-Proline 7.3g/1000ml; L-Serine 4.3g/1000ml; L-Threonine 2.9g/1000ml; L-Tryptophan 1.3g/1000ml; L-Tyrosine 0.26g/1000ml; L-Valine 4.1g/1000ml; Magnesium sulfate heptahydrate as magnesium sulfate 0.61g/1000ml; Olive oil, refined 7.2g/1000ml; Potassium Chloride 2.3g/1000ml; Sodium acetate trihydrate as sodium acetate 1.6g/1000ml; Sodium glycerophosphate hydrated as sodium glycerophosphate 2.3g/1000ml; Soy-bean oil, refined 8.7g/1000ml; Taurine 0.65g/1000ml; Triglycerides, medium-chain 8.7g/1000ml; Zinc sulfate heptahydrate as zinc sulfate 0.0066g/1000ml

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

Fresenius Kabi AB, Site Uppsala

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2021-03-24

তথ্য লিফলেট

xxx xxx
_SMOFKABIVEN EXTRA NITROGEN_
emulsion for infusion
-
if you have high blood (serum) levels of the salts (electrolytes)
included in SmofKabiven extra Nitrogen
-
if you have fluid in the lungs (acute pulmonary oedema)
-
if you have too much body fluid (hyperhydrated)
-
if you have heart failure that is not treated
-
if you have a defect in your blood clotting system (hemophagocy-
totic syndrome)
-
if you are in an unstable condition, such as after serious trauma,
uncontrolled diabetes, acute heart attack, stroke, blood clot, me-
tabolic 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 newborn babies or children under 2 years of age
Warnings and precautions
Talk to your doctor before using SmofKabiven extra Nitrogen if you
have:
-
kidney problems
-
diabetes mellitus
-
pancreatitis (inflammation of the pancreas)
-
liver problems
-
hypothyrodism (thyroid problems)
-
sepsis (serious infection)
If you during the infusion 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 extra Nitrogen is not meant for newborn babies or
children younger than 2 years of age.
SmofKabiven extra Nitrogen can be given to children and adolescents
from 2 to 16/18 years old.
Other medicines and SmofKabiven extra Nitrogen
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 extra Nitrogen during pregnancy
or breast-feeding is lacking. SmofKabiven extra Nitrogen should
therefore be given to pregnant or breast-feeding women only if the
doctor find it necessary. The use

পণ্য বৈশিষ্ট্য

SmPC 16-455, 2017-03-10
1 (12)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SmofKabiven extra Nitrogen, emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven 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
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