OLICLINOMEL N7-1000E

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CALCIUM CHLORIDE DIHYDRATE; GLUCOSE AS MONOHYDRATE; GLYCINE; L- ALANINE; L- ISOLEUCINE; L- LEUCINE; L- LYSINE AS HYDROCHLORIDE; L- METHIONINE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; REFINED SOYA-BEAN OIL; SODIUM ACETATE DIHYDRATE; SODIUM GLYCEROPHOSPHATE

Available from:

TEVA MEDICAL MARKETING LTD.

ATC code:

N/A

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

REFINED SOYA-BEAN OIL 200 G / 1000 ML; CALCIUM CHLORIDE DIHYDRATE 0.74 G / 1000 ML; GLUCOSE AS MONOHYDRATE 4000.00 G / 1000 ML; MAGNESIUM CHLORIDE 1.12 G / 1000 ML; POTASSIUM CHLORIDE 4.47 G / 1000 ML; SODIUM GLYCEROPHOSPHATE 5.36 G / 1000 ML; SODIUM ACETATE DIHYDRATE 6.12 G / 1000 ML; L- VALINE 5.80 G / 1000 ML; L- TYROSINE 0.40 G / 1000 ML; L- TRYPTOPHAN 1.80 G / 1000 ML; L- THREONINE 4.20 G / 1000 ML; L- SERINE 5.00 G / 1000 ML; L- PROLINE 6.80 G / 1000 ML; L- PHENYLALANINE 5.60 G / 1000 ML; L- METHIONINE 4.00 G / 1000 ML; L- LYSINE AS HYDROCHLORIDE 5.80 G / 1000 ML; L- LEUCINE 7.30 G / 1000 ML; L- ISOLEUCINE 6.00 G / 1000 ML; L-HISTIDINE 4.80 G / 1000 ML; GLYCINE 10.30 G / 1000 ML; L-ARGININE 11.50 G / 1000 ML; L- ALANINE 20.70 G / 1000 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER S.A., BELGIUM

Therapeutic indications:

Parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Authorization date:

2013-09-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_________
APRIL 27, 2014
__
םש
רישכת
תילגנאב
רפסמו
םושירה
_____________
OLICLINOMEL
N7-1000E: 139 44 30709 21
םש
לעב
םושירה
_
עבט
לקידמ
קוויש
םיגרואה ,מ"עב
8
דודשא ,
77100
_
___
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE & ADMINISTRATION
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
The
infusion
must
be
stopped
immediately if any signs or symptoms
of
an
allergic
reaction
(such
as
sweating, fever, chills, headache, skin
rashes or) develop. This medicinal
product contains soybean oil and egg
phosphatide. Soybean and egg proteins
may cause hypersensitivity reactions.
Cross-allergic
reactions
between
soybean and peanut proteins have been
observed.
Fat overload syndrome has been
reported with similar products.
Reduced ability to remove the lipids
contained in Oliclinomel may result in
a "fat overload syndrome" which may
be caused by overdose, however, the
signs and symptoms but may also
occur when the product is
administered according to instructions
(see also section 4.8).
Hepatic Insufficiency
Use with caution in patients with
hepatic insufficiency because of
the risk of developing or
worsening neurological disorders
associated with
hyperammonaemia. Regular
clinical and laboratory tests are
required particularly , blood
glucose, electrolytes and
triglycerides.
The infusion must be stopped immediately if any signs
or symptoms of an allergic reaction (such as sweating,
fever, chills, headache, skin rashes or
dyspnea or
bronchospasm)
develop.
This
medicinal
product
contains soybean oil and egg phosphatide. Soybean and
egg proteins may cause hypersensitivity reactions.
Cross-allergic reactions between

Summary of Product characteristics

Oliclinomel N7- 1000 E, 9. 6. 2015, RH
."רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
:רשואמ ןולע
ינוי
2015
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been checked
and approved.” Date of approval: June 2015.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OLICLINOMEL N7-1000E, EMULSION FOR INFUSION.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This medicinal product is presented in the form of a 3-compartment
bag.
There are four different bag sizes, with the following volumes :
COMPARTMENT
1000 ML
1500 ML
2000 ML
2500 ML
lipid emulsion
200 ml
300 ml
400 ml
500 ml
amino acid solution
400 ml
600 ml
800 ml
1000 ml
glucose solution
400 ml
600 ml
800 ml
1000 ml
Composition of a 1000 ml bag
ACTIVE SUBSTANCES
20% LIPID EMULSION
COMPARTMENT
(CORRESPONDING TO
20G/100ML)
(200 ML)
10% AMINO ACID
SOLUTION COMPARTMENT
(CORRESPONDING TO
10G/100ML)
(400 ML)
40% GLUCOSE SOLUTION
COMPARTMENT
(CORRESPONDING TO
40G/100ML)
(400 ML)
Refined olive oil
+ refined soya oil*
40.00 g
Alanine
8.28 g
Arginine
4.60 g
Glycine
4.12 g
Histidine
1.92 g
Isoleucine
2.40 g
Leucine
2.92 g
Lysine
2.32 g
(As lysine hydrochloride)
(2.90g)
Methionine
1.60 g
Phenylalanine
2.24 g
Proline
2.72 g
Serine
2.00 g
Threonine
1.68 g
Tryptophan
0.72 g
Tyrosine
0.16 g
Valine
2.32 g
Sodium Acetate, 3H2O
2.45 g
Sodium
glycerophosphate, 5H2O
2.14 g
Potassium chloride
1.79 g
Magnesium chloride,
6H2O
0.45 g
Anhydrous glucose
160.00g
(As glucose monohydrate)
(176.00 g)
Calcium chloride, 2H2O
0.30 g
* Mixture of refined olive oil (approximately 80%) and refined soya
oil (approximately 20%)
For full list of excipients, see 6.1.
Oliclinomel N7- 1000 E, 9. 6. 2015, RH Page 2 of 14
After the contents of the three compartments have been mixed, the
ternary mixture for each of the bag
presentations provides the following:
PER BAG
1 LITRE
1.5 LITRES
2 LITRES
2.5 LITRES
Nitrogen (g)
6.6
9.9
13.2
16.5
Amino acids (g)
40
60
80
100
Glucose (g)
16