SmofKabiven Electrolyte Free
Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Pakkausseloste
(PIL)
06-02-2022
Valmisteyhteenveto
(SPC)
06-02-2022
Aktiivinen ainesosa:
Alanine 14 g/L; ; ; Arginine 12 g/L; ; ; Glycine 11 g/L; ; ; ; Histidine 3 g/L; ; ; ; Isoleucine 5 g/L; ; ; ; Leucine 7.4 g/L; ; ; ; ; Lysine acetate 9.3 g/L equivalent to L-Lysine 6.6 g; ; ; Methionine 4.3 g/L; ; ; Phenylalanine 5.1 g/L; ; ; Proline 11.2 g/L; ; Serine 6.5 g/L; ; ; ; Taurine 1 g/L; ; Threonine 4.4 g/L; ; ; ; Tryptophan 2 g/L; ; ; Tyrosine 0.4 g/L; ; Valine 6.2 g/L; ; ; ; ; Glucose monohydrate 462 g/L equivalent to glucose (anhydrous) 420 g/L; ; ; Fish oil 30 g/L; Medium-chain triglycerides 60 g/L; ; Olive oil 50 g/L; ; Soya oil 60 g/L;
Saatavilla:
Fresenius Kabi New Zealand Limited
INN (Kansainvälinen yleisnimi):
Alanine 14 g/L
Lääkemuoto:
Emulsion for infusion
Koostumus:
Active: Alanine 14 g/L Arginine 12 g/L Glycine 11 g/L Histidine 3 g/L Isoleucine 5 g/L Leucine 7.4 g/L Lysine acetate 9.3 g/L equivalent to L-Lysine 6.6 g Methionine 4.3 g/L Phenylalanine 5.1 g/L Proline 11.2 g/L Serine 6.5 g/L Taurine 1 g/L Threonine 4.4 g/L Tryptophan 2 g/L Tyrosine 0.4 g/L Valine 6.2 g/L Excipient: Glacial acetic acid Nitrogen Water for injection Active: Glucose monohydrate 462 g/L equivalent to glucose (anhydrous) 420 g/L Excipient: Hydrochloric acid Nitrogen Water for injection Active: Fish oil 30 g/L Medium-chain triglycerides 60 g/L Olive oil 50 g/L Soya oil 60 g/L Excipient: dl-Alpha tocopherol Egg lecithin Glycerol Nitrogen Sodium hydroxide Sodium oleate Water for injection
Kpl paketissa:
Bag, plastic, Biofine 3-chamber, 986mL, 1 dose unit
luokka:
General sale
Prescription tyyppi:
General sale
Valmistaja:
Kyowa Hakko Bio Co., Ltd
Käyttöaiheet:
Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated
Tuoteyhteenveto:
Package - Contents - Shelf Life: Bag, plastic, Biofine 3-chamber, 2463mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 1970mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 1477mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 986mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 2463mL - 3 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 1970mL - 4 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 1477mL - 4 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber, 986mL - 4 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze
Valtuutus päivämäärä:
2012-05-18
Pakkausseloste
Page 1 of 2
SMOFKABIVEN
® ELECTROLYTE FREE
Amino acids 5.1%, lipids 3.8% & glucose 12.7%
CONSUMER MEDICINE INFORMATION - NEW ZEALAND
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
SmofKabiven Electrolyte Free. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and benefits. Your doctor
has weighed the risks of you given
SmofKabiven
Electrolyte
Free
against any benefits they expect it
will have for you.
PLEASE READ THIS LEAFLET CAREFULLY.
IF YOU HAVE ANY QUESTIONS OR ARE
UNSURE
ABOUT
ANYTHING,
PLEASE
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED
TO READ IT AGAIN.
WHAT
IS
SMOFKABIVEN
ELECTROLYTE
FREE
USED
FOR
SmofKabiven
Electrolyte
Free
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) and lipids (fat) in a
plastic bag.
A health care professional will give
you SmofKabiven Electrolyte Free
when other forms of feeding are
not
good
enough
or
have
not
worked.
BEFORE
YOU
ARE
GIVEN
SMOFKABIVEN
ELECTROLYTE FREE
You must NOT use this product:
if
you
are
allergic
(hypersensitive) to any of
the
ingredients
of
SmofKabiven
Electrolyte
Free
if you are allergic to fish or
egg
if
you
are
allergic
to
peanuts,
soya
or
corn
(maize)
as
SmofKabiven
Electrolyte
Free
contains
soya oil
if you have too much fat in
the
blood
(hyperlipidaemia)
if
you
have
serious
liver
disease
if
you
have
blood
clotting
problems
(coagulation
disorders)
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) which is
uncontrolled
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
Lue koko asiakirja
Valmisteyhteenveto
NEW ZEALAND DATA SHEET
Page 1 of 20
1.
PRODUCT NAME
SmofKabiven
®
Electrolyte Free (Infusion, emulsion)
_AMINO ACIDS 5.1% _
Alanine,
Arginine,
Glycine,
Histidine,
Isoleucine,
Leucine,
Lysine
acetate,
Methionine,
Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan,
Tyrosine, Valine
_LIPIDS 3.8% _
Soya oil
Fish oil - rich in Omega-3 acids
Medium chain triglycerides
Olive oil
_GLUCOSE 12.7% _
Glucose monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Electrolyte Free is a three chamber bag system of amino
acid solution, glucose
solution and lipid emulsion for intravenous infusion.
Each bag contains the following partial volumes depending on the four
pack sizes.
986 ML
1477 ML
1970 ML
2463 ML
PER
1000 ML
Amino acid solution (mL)
500
750
1000
1250
508
Glucose 42% (mL)
298
446
595
744
302
Lipid emulsion (mL)
188
281
375
469
190
This corresponds to the following total compositions:
ACTIVE INGREDIENTS (G)
986 ML
1477 ML
1970 ML
2463 ML
PER
1000 ML
Alanine
7.0
10.5
14.0
17.5
7.1
Arginine
6.0
9.0
12.0
15.0
6.1
Glycine
5.5
8.2
11.0
13.8
5.6
Histidine
1.5
2.2
3.0
3.7
1.5
Isoleucine
2.5
3.8
5.0
6.2
2.5
Leucine
3.7
5.6
7.4
9.4
3.8
Lysine (as acetate)
3.3
5.0
6.6
8.4
3.4
Methionine
2.2
3.2
4.3
5.4
2.2
Phenylalanine
2.6
3.8
5.1
6.4
2.6
Proline
5.6
8.4
11.2
14.0
5.7
Serine
3.2
4.9
6.5
8.1
3.3
Taurine
0.50
0.75
1.0
1.2
0.50
Threonine
2.2
3.3
4.4
5.4
2.2
Tryptophan
1.0
1.5
2.0
2.5
1.0
Tyrosine
0.20
0.30
0.40
0.49
0.20
Valine
3.1
4.6
6.2
7.6
3.1
NEW ZEALAND DATA SHEET
Page 2 of 20
ACTIVE INGREDIENTS (G)
986 ML
1477 ML
1970 ML
2463 ML
PER
1000 ML
Glucose (as monohydrate)
_ _
125
187
250
313
127
Soya oil
11.3
16.9
22.5
28.1
11.4
Medium chain triglycerides
11.3
16.9
22.5
28.1
11.4
Olive oil
9.4
14.1
18.8
23.4
9.5
Rich in omega-3 fish oil
5.6
8.4
11.3
14.0
5.7
_Corresponding to: _
986 ML
1477 ML
1970 ML
2463 ML
PER
1000 ML
Amino acids (g)
50
75
100
125
51
Nitrogen (g)
8
12
16
20
8
Lipids (g)
38
56
75
94
38
Carbohydrates - Glucose (anhydrous)(g)
125
187
250
313
127
Acetate (mmol)
1
73
110
147
183
74.5
Phospha
Lue koko asiakirja
