DIPEPTIVEN INFUSION

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

N(2)-L-ALANYL-L-GLUTAMINE

Saatavilla:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC-koodi:

B05XB02

Annos:

20 g/100ml

Lääkemuoto:

INJECTION

Koostumus:

N(2)-L-ALANYL-L-GLUTAMINE 20 g/100ml

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

FRESENIUS KABI AUSTRIA GMBH

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

1999-10-08

Pakkausseloste

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DIPEPTIVEN
®
Qualitative and quantitative composition
100 ml contains:
20 g N(2)-L-alanyl-L-glutamine (= 8.20 g L-alanine, 13.46 g L-glutamine)
Water for injections
theoretical osmolarity 
921 mosmol/l
titration acidity 
90 - 105 mmol NaOH/l
pH value 
 5.4 - 6.0
Pharmaceutical form
Concentrate for solution for infusion
Therapeutical indication
Dipeptiven
®
  is  indicated  as  part  of  an  intravenous  parenteral 
nutrition  regimen  as  a  supplement  to  amino  acid  solutions  or 
an  amino  acid  containing  infusion  regimen,  e.g.  in  patients  in 
hypercatabolic and/or hypermetabolic states.
Posology and method of administration
For central venous infusion after addition to a compatible infusion 
solution.  Solutions  of  mixtures  with  an  osmolarity  above  800 
mosmol/l should be infused by the central venous route.
_Adults_
Dosage depends on the severity of the catabolic state and on amino 
acid requirement. A maximum daily dosage of 2 g amino acids/kg 
body weight should not be exceeded in parenteral nutrition. The 
supply of alanine and glutamine via Dipeptiven
®
 should be taken 
into consideration in the calculation. The proportion of the amino 
acid supplied through Dipeptiven should not exceed approx. 30% 
of the total amino acid supply.
_Daily dose_
1.5 - 2.5 ml of Dipeptiven per kg body weight (equivalent to 0.3 
- 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight). This equates 
to 100 to 175 ml Dipeptiven for a patient of 70 kg body weight.
Reproduction toxicity: In animal trials, no indications of teratogenic 
or other embryotoxic and peripostnatal injuries could be observed 
up to a dosage of 1.6 g N(2)-L-alanyl-L-glutamine/kg b.w. per day.
Local tolerance: Following repeated i.v. infusion of N(2)-L-alanine-
L-glut

Valmisteyhteenveto

DIPEPTIVEN
®
M089414/06
Active substance: N(2)-L-alanyl-L-glutamine
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml contains:
20 g N(2)-L-alanyl-L-glutamine (= 8.20 g L-alanine, 13.46 g
L-glutamine)
Water for injections
theoretical osmolarity
921 mosmol/l
titration acidity
90 - 105 mmol NaOH/l
pH value
5.4 - 6.0
PHARMACEUTICAL FORM
Concentrate for solution for infusion
THERAPEUTICAL INDICATION
Dipeptiven
®
is indicated as part of an intravenous parenteral nutrition regimen as
a supplement to amino acid
solutions or an amino acid containing infusion regimen, e.g. in
patients in hypercatabolic and/or hypermetabolic
states.
POSOLOGY AND METHOD OF ADMINISTRATION
For central venous infusion after addition to a compatible infusion
solution. Solutions of mixtures with an osmolarity
above 800 mosmol/l should be infused by the central venous route.
_ADULTS _
Dosage depends on the severity of the catabolic state and on amino
acid requirement. A maximum daily dosage
of 2 g amino acids/kg body weight should not be exceeded in parenteral
nutrition. The supply of alanine and
glutamine via Dipeptiven
®
should be taken into consideration in the calculation. The proportion
of the amino acid
supplied through Dipeptiven should not exceed approx. 30% of the total
amino acid supply.
_DAILY DOSE _
1.5 - 2.5 ml of Dipeptiven per kg body weight (equivalent to 0.3 - 0.5
g N(2)-L-alanyl-L-glutamine per kg body
weight). This equates to 100 to 175 ml Dipeptiven for a patient of 70
kg body weight.
Maximum daily dose: 2.5 ml equivalent to 0.5 g
N(2)-L-alanyl-L-glutamine of Dipeptiven
®
per kg body weight.
The maximum daily dose of 0.5 g N(2)-L-alanyl-L-glutamine per kg body
weight should be administered in
combination with a compatible amino acid solution providing at least
1.0 g amino acids per kg body weight and day.
This results in a daily dosage of at least 1.5 g amino acids per kg
body weight.
The following adjustments are examples for the supply with Dipeptiven
and other amino acids through the carrier
solution:
Amino acid requireme