Dipeptiven, concentrate for solution for infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

L-alanyl-l glutamine

Fáanlegur frá:

Fresenius AG

ATC númer:

B05XB; B05XB02

INN (Alþjóðlegt nafn):

L-alanyl-l glutamine

Skammtar:

200 milligram(s)/millilitre

Lyfjaform:

Concentrate for solution for infusion

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Amino acids; alanyl glutamine

Leyfisstaða:

Not marketed

Leyfisdagur:

1996-05-20

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPEPTIVEN CONCENTRATE FOR SOLUTION FOR INFUSION
N(2)-L-alanyl-L-glutamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
WHAT IS IN THIS LEAFLET
1.
What Dipeptiven is and what it is used for
2.
What you need to know before you are given Dipeptiven
3.
How you are given Dipeptiven
4.
Possible side effects
5.
How to store Dipeptiven
6.
Contents of the pack and other information
1.
WHAT DIPEPTIVEN IS AND WHAT IT IS USED FOR
Dipeptiven
supplements the protein part of nutrition in conditions when there is
an increased need. It is given
to you as an infusion (IV).
Dipeptiven
is usually used as part of a balanced intravenous and/or enteral diet,
together with salts, trace
elements and vitamins.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DIPEPTIVEN
YOU SHOULD NOT BE GIVEN DIPEPTIVEN:
•
if you have a severely impaired liver or kidney
•
if you have metabolic acidosis - a state in which the blood pH is low
•
if you are in circulatory shock – a state in which the blood flow in
the body is low
•
if you have hypoxia – a state in which oxygen level is low
•
if you have multiple organ failure – a state in which two or more
organs do not function normally
•
if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6). Symptoms of an allergic reaction may include a high
temperature, shivering, rash or shortness
of breath.
•
if you are pregnant or breastfeeding
Dipeptiven MUST BE DILUTED BEFORE USE.
Dipeptiven will be added to another solution before it is given to
you. Your doctor or nurse will make sure the solution is prepared
correctly before you receive a

Vara einkenni

Health Products Regulatory Authority
03 May 2023
CRN00DFV3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dipeptiven, concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE QUANTITY
N(2)-_L_-alanyl-_L_-glutamine 200 mg (= 82.0 mg _L_-alanine, 134.6 mg
_L_-glutamine)
theoretical osmolarity: 921 mosmol/l
titration acidity: 90 – 105 mmol NaOH/l
pH value: 5.4 - 6.0
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dipeptiven is indicated as part of a clinical nutrition regimen in
patients in hypercatabolic and/or hypermetabolic states. It
should be given together with parenteral or enteral nutrition or a
combination of both.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Solution for infusion after mixture with a compatible infusion
solution.
Solutions of mixtures with an osmolarity above 800 mosmol/l should be
infused by the central venous route.
Adults
Dipeptiven is administered in-parallel with parenteral nutrition or
enteral nutrition or a combination of both. Dosage depends
on the severity of the catabolic state and on amino acids/protein
requirement.
A maximum daily dosage of 2g amino acids and/or protein per kg body
weight should not be exceeded in parenteral/enteral
nutrition. The supply of alanine and glutamine via Dipeptiven should
be taken into consideration in the calculation. The
proportion of the amino acids supplied through Dipeptiven should not
exceed approximately 30% of the total amino
acids/protein 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-