Dipeptiven

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Alanylglutamine 200 mg/mL;  ;  
Available from:
Fresenius Kabi New Zealand Limited
INN (International Name):
Alanylglutamine 200 mg/mL
Dosage:
200 mg/mL
Pharmaceutical form:
Concentrate for infusion
Composition:
Active: Alanylglutamine 200 mg/mL     Excipient: Nitrogen Water for injection
Units in package:
Bottle, glass, 50 mL
Class:
General sale
Prescription type:
General sale
Manufactured by:
Ajinomoto North America Inc
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.
Product summary:
Package - Contents - Shelf Life: Bottle, glass, - 50 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 250 mL - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-5870/1
Authorization date:
2004-07-19

March, 2012

CMI for Dipeptiven

Filename:

DipCMI10312-clean

Page 1 of 2

Changes: indication

Dipeptiven

®

Alanylglutamine

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

question

about

Dipeptiven. It does not contain

all the available information. It

does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you being

given

Dipeptiven

against

benefits this medicine is expected

to have for you.

If you have any concerns about

this medicine, ask your doctor or

pharmacist.

Keep this leaflet. You may need

to read it again.

What

is

Dipeptiven

used

for

and

how

does it work

Dipeptiven

amino

acid/dipeptide

infusion

solution,

which

given

part

parenteral

and/or

enteral

nutritional

therapy.

When

intake of nutrients or food into the

mouth or directly into the gut is

not possible or it is not enough to

supply

body’s

needs

then

nutrients or foods can be given

intravenously

through

gastrointestinal

tract

combination

both.

This

especially

important

people

whose bodies are under physical

stress

from

illness

recent

surgery. During illness or after

surgery

body

requires

nutrition or food. Amino acids are

the building blocks used by the

body

make

proteins.

Dipeptiven is usually given as a

supplement

amino

acid

solutions

amino

acid

containing infusion regimen as

part

complete

nutritional

support.

Your

doctor

have

prescribed

Dipeptiven

another

reason.

your

doctor

have

questions

about

Dipeptiven

been

prescribed for you.

Before

you

are

given Dipeptiven

When

should

NOT

given Dipeptiven ?

You

should

NOT

be

given

Dipeptiven if:

have

allergy

Dipeptiven or any of the

ingredients

listed

end of this leaflet.

have

severe

liver

failure.

have

severe

kidney

failure (if dialysis facilities

are not available).

You have too much acid in

your

blood,

also

called

metabolic acidosis.

If you are not sure whether any

of these apply to you, check

with your doctor.

You

must

tell

your

doctor

before being given Dipeptiven;

If you have any allergies to

other

medicines

other

substances,

such

foods,

preservatives or dyes.

pregnant

intend

become

pregnant. Your doctor will

discuss

risks

benefits

using

Dipeptiven

during

pregnancy.

If you are breastfeeding or

plan to breastfeed. Your

doctor

will

discuss

risks and benefits of using

Dipeptiven

when

breastfeeding.

If you are under 18 years

old.

have

told

your

doctors

about

above, tell them before you are

given Dipeptiven.

Use in Children

There is currently not enough

information to recommend the

use of Dipeptiven in patients

less than 18 years of age.

Taking other medicines.

Some medicines can interact

interfere

with

each

other.

There are currently no known

medicines, which can interfere

or be affected by Dipeptiven.

How

is

Dipeptiven

given

Dipeptiven

given

infusion.

electronic

pump

used

control

speed

infusion.

Dipeptiven is usually given as

a mixture

with

glucose,

fats,

salts,

trace

elements

vitamins. Dipeptiven must only

be given by a doctor or nurse

part

specially-made

solution.

March, 2012

CMI for Dipeptiven

Filename:

DipCMI10312-clean

Page 2 of 2

Changes: indication

How much is given

Your doctor will decide what dose

you will receive. This will depend

your

condition,

other

diseases you may have and your

body weight.

How long it is given

The infusion will be continued for

long

your

condition

requires. At the moment there is

experience

with

Dipeptiven

more

than

weeks.

Side Effects

Dipeptiven, like all other nutrient

solutions

which

given

infusion, may cause side effects

some

people.

side

effects

associated

with

Dipeptiven

have

been detected. Reports of side

effects caused by Dipeptiven are

extremely rare.

If

you

are

given

too

much

(overdose)

This

rarely

happens

Dipeptiven is administered under

the care of a trained professional

hospital

clinic

setting.

However,

given

Dipeptiven

quickly

much, you may experience the

following

side

effects:

feeling

sick

(nausea

vomiting),

chills.

Your doctor has information on

how to recognise and treat an

overdose. Ask your doctor if you

have

concerns.

Otherwise,

immediately contact the Poisons

Information

Centre

your

country.

Australia: 13 11 26

New Zealand: 0800 764 766

While you are using Dipeptiven

Your doctor will order blood and

urine tests while you are given

Dipeptiven

monitor

your

progress. From the results, your

dose

Dipeptiven

adjusted.

Storage

Dipeptiven will be stored in the

pharmacy or on the ward. The

infusion solution is kept in a

cool

place,

where

temperature stays below 25°C.

Product Description

Dipeptiven

clear,

colourless

solution,

which

supplied in glass bottles.

It may be supplied from the

pharmacy

mixture

Dipeptiven, glucose, fats and

vitamins. In this case it would

be a milky white mixture in a

plastic bag.

Dipeptiven

comes

three

pack sizes 50mL, 100mL and

250mL.

Ingredients

100mL

contains

N(2)-L-

alanyl-L-glutamine

water

for injections.

Dipeptiven

does

contain

gluten,

lactose,

sucrose,

tartrazine

other

dyes

Further Information

have

more

questions

sure

about

anything,

please

your doctor or pharmacist.

Sponsor

Fresenius Kabi New Zealand

Limited

60 Pavilion Drive

Airport Oaks, Auckland 2022

New Zealand

Freecall: 0800 144 892

® = Registered Trademark

Date of Information

This

leaflet

prepared

March, 2012.

Filename:DipDS0312-clean Page1of5

DATASHEET

NAMEOF MEDICINE

DIPEPTIVEN ®

(N(2)-l-alanyl-l-glutamine200mg/mL)

Concentratefor Solutionfor Infusion

PRESENTATION

Dipeptivenis aclear, colourless concentratefor solutionfor infusion.

Content

100mLcontains:

20gN(2)-L-alanyl-L-glutamine(=8.20gL-alanine,13.46gL-glutamine)

Water for Injections

Theoretical osmolarity 921mosmol/L

Titrationacidity 90 –105mmol NaOH/L

pH value 5.4-6.0

USES

Actions

ThedipeptideN(2)-L-alanyl-L-glutamineisendogenouslysplitintotheaminoacids

glutamineandalanineherebysupplyingglutaminewithinfusionsolutionsforparenteral

nutrition.Thereleasedaminoacidsflowasnutrientsintotheirrespectivebodypools

andaremetabolisedaccordingtotheneedsoftheorganism.Manydisease

conditions,inwhichparenteralnutritionisindicated,areaccompaniedbyaglutamine

depletion,whichglutaminecontaininginfusionregimens counteract.

Pharmacokinetics

N(2)-L-alanyl-L-glutamineisrapidlysplitintoalanineandglutamineafterinfusion.In

man,half-livesofbetween2.4and3.8(interminalrenalinsufficiency4.2min)anda

plasmaclearanceofbetween1.6and2.7L/minweredetermined.Thedisappearance

ofthedipeptidewasaccompaniedbyanequimolarincreaseofthecorrespondingfree

aminoacids.Hydrolysisprobablytakesplaceexclusivelyintheextracellularspace.

RenaleliminationofN(2)-L-alanyl-glutamineunderconstantinfusionisbelow5%and

thus thesameas thatofinfusedaminoacids.

INDICATIONS

Dipeptivenisindicatedaspartofaclinicalnutritionregimeninpatientsin

hypercatabolicand/orhypermetabolicstates.Itshouldbegiventogetherwith

parenteral or enteral nutritionor acombinationofboth.

DOSAGEANDADMINISTRATION

Solutionfor infusionafter mixture withacompatibleinfusionsolution.

Solutionsofmixtureswithanosmolarityabove800mosmol/Lshouldbeinfusedbythe

central venous route.

Adults

Dipeptivenisadministeredparallelwithparenteralnutritionorenteralnutritionora

combinationofboth.Dosagedependsontheseverityofthecatabolicstateandon

aminoacids/proteinrequirement.

Filename:DipDS0312-clean Page2of5

Amaximumdailydosageof2gaminoacids/orproteinperkgbodyweightshouldnot

beexceededinparenteral/enteralnutrition.Thesupplyofalanineandglutaminevia

Dipeptivenshouldbetakenintoconsiderationinthecalculation.Theproportionofthe

aminoacidssuppliedthroughDipeptivenshouldnotexceedapprox.30%ofthetotal

aminoacids/proteinsupply.

Dailydose

1.5-2.5mLofDipeptivenperkgbodyweight(equivalentto0.3 –0.5gN(2)-L-alanyl-

L-glutamineperkgbodyweight).Thisequatesto100to175mLDipeptivenfora

patientof70kgbodyweight.

Maximumdailydose:2.5mLequivalentto0.5gN(2)-L-alanyl-L-glutamineof

Dipeptivenper kgbodyweight.

Themaximumdailydoseof0.5gN(2)-L-alanyl-L-glutamineperkgbodyweightshould

beadministeredincombinationwithatleast1.0gaminoacids/proteinperkgbody

weightperday.WithaminoacidsfromDipeptivenincluded,thisresultsinadaily

dosageofatleast1.5gaminoacids/proteinper kgbodyweight.

ThefollowingadjustmentsareexamplesforthesupplywithDipeptivenandamino

acidsthroughtheparenteralnutritionsolution,and/orproteinthroughenteralnutrition

formula:

Aminoacids/proteinrequirement1.2g/kgbodyweightper day:

0.8gaminoacids/protein+0.4gN(2)-L-glutamineper kgbodyweight

Aminoacids/proteinrequirement1.5g/kgbodyweightper day:

1.0gaminoacids/protein+0.5gN(2)-L-alanyl-L-glutamineper kgbodyweight

Aminoacids/proteinrequirement2g/kgbodyweightper day:

1.5gaminoacids/protein+0.5gN(2)-L-alanyl-L-glutamineper kgbodyweight.

Dipeptivenisaninfusionsolutionconcentratewhichisnotdesignedfordirect

administration.

Patientswithtotal parenteral nutrition

Therateofinfusiondepends onthatofthecarrier solutionandshouldnotexceed0.1g

aminoacids/kgbodyweightper hour.

Dipeptivenshouldbemixedwithacompatibleaminoacidcarriersolutionoranamino

acidcontaininginfusionregimenprior toadministration.

Patientswithtotal enteral nutrition

Dipeptiveniscontinuouslyinfusedover20-24hoursperday.Forperipheralvenous

infusion,diluteDipeptiventoanosmolarity ≤800mosmol/L(e.g.100mLDipeptiven

+100ml saline).

Patientswithcombinedenteral andparenteral nutrition

ThefulldailydosageofDipeptivenshouldbeadministeredwiththeparenteral nutrition,

i.e.mixedwithacompatibleaminoacidsolutionoranaminoacidcontainedininfusion

regimenprior toadministration.

Filename:DipDS0312-clean Page3of5

Therateofinfusiondependsonthatofthecarriersolutionandshouldbeadjusted

accordingtotheproportions or parenteral andenteral nutrition.

Durationofadministration

Thedurationofuseshouldnotexceed3weeks.

Children

Safetyandefficacyinchildrenhavenotbeenestablished.

CONTRAINDICATIONS

Dipeptivenshouldnotbeadministeredtopatientswithsevererenalinsufficiency

(creatinineclearance<25mL/min),severehepaticinsufficiency,severemetabolic

acidosis or knownhypersensitivitytotheactivesubstances or toanyoftheexcipients.

WARNINGSANDPRECAUTIONS

Itisadvisabletoregularlymonitorliverfunctionparametersinpatientswith

compensatedhepatic insufficiency.

Serumelectrolytes,serumosmolarity,waterbalance,acid-basestatusaswellasliver

functiontests(alkalinephosphatase,ALT,AST),possiblesymptomsof

hyperammonaemiashouldbecontrolled.

Theenzymesalkalinephosphatase,GPT,GOT,bilirubinlevel andtheacid-basestatus

shouldbemonitored.

Thechoiceofaperipheralorcentralveindependsonthefinalosmolarityofthe

mixture.Thegeneralacceptedlimitforperipheralinfusionisabout800mosm/Lbutit

variesconsiderablywiththeageandgeneralconditionofthepatientandthe

characteristics oftheperipheral veins.

ExperiencewiththeuseofDipeptivenfor longer periods thanninedays is limited.

Mutagenicandtumorigenicpotential:Invitroandinvivotestgavenoindicationsof

mutagenic potential.

Studiesinvestigatingthetumorigenicpotentialwerenotcarriedout.Carcinogenic

effectsare nottobeexpected.

Dipeptivenis presumedtobesafeor unlikelytoproduceaneffectontheabilitytodrive

or usemachinery

Useinpregnancyandlactation

AsthereiscurrentlyinsufficientdataonadministrationofDipeptiventopregnant

women,nursingmothersandchildren,administrationofthepreparationinthese

patientgroups is notrecommended.

Reproductiontoxicity:Inanimaltrials,noindicationsofteratogenicorother

embryotoxicandperipostnatalinjuriescouldbeobserveduptoadosageof1.6gN(2)-

L-alanyl-L-glutamine/kgbodyweightper day.

Filename:DipDS0312-clean Page4of5

ADVERSEREACTIONS

Noneknownwhencorrectlyadministered.

INTERACTIONS

Nointeractionsare knowntodate.

OVERDOSAGE

Aswithotherinfusionsolutions,chills,nauseaandvomitingcanoccur,whenthe

infusionrateofDipeptivenisexceeded.Infusionshallbestoppedimmediatelyinthis

case.

PHARMACEUTICAL PRECAUTIONS

Instructions foruse

Dipeptivenisaninfusionsolutionconcentratewhichisnotdesignedfordirect

administration.Thecontainerandthesolutionshouldbeinspectedvisuallypriorto

use.Useonlyclear,particle-freesolutionandundamagedcontainer.Forsingleuse

only.

Theadditionoftheconcentratetothecarriersolutionpriortoapplicationshouldtake

placeunderasepticconditions.Thoroughmixingandcompatibilitymustbeensured.

Unusedsolutionshouldbedisposedof.

Dipeptivenisinfusedwiththecarriersolution.Fordetailssee Dosageand

Administration section.

STORAGE

Store below25

C.

Shelflife:24months

Donotuseafter theexpirydatestatedonthelabel.

Anyremainingsolutionfromtheopenedcontainer mustbediscarded.

MEDICINESCLASSIFICATION

General SaleMedicine

PACKAGEQUANTITIES

Glass bottlesof50mL,100mLand250mL.

FURTHER INFORMATION

Preclinical safetydata

Acuteandsubchronictoxicity:Amatrixofdosagefindingtestswereconductedonrats

anddogsover1to7days.Intherats,infusionof50mL/kgbodyweightofa10%,

15%,20%and30%solutionofN(2)-L-alanyl-L-glutamineover4h/dayledtotonic

spasms,increasedrespiratoryrateandexitus.Infusionof50mL/kgbodyweightofa

10%solution(5gN(2)-L-alanyl-glutamine/kgbodyweight)resultedinnecroticareasat

theinfusionsite,reducedbodyweightandyellowingofthekidneysintherats(6

h/day), andatemporaryincreaseinheart rateinthedog(8h/day).

Investigationswerecarriedoutindogs(8h/day)andinrats(6h/day)with0.5and1.5g

N(2)-L-alanyl-L-glutamine/kgbodyweightperdayover13weeksandwith4.5gN(2)-L-

alanyl-L-glutamine/kgbodyweightper dayi.v.over 6weeks.

Filename:DipDS0312-clean Page5of5

Inthedogs,vomitingoccurred.Withthehighdosetonicortonic-cloniccramps,

increasedsalivation,ataxia,sedationandlateral positionwere observed.

Localtolerance:Followingrepeatedi.v.infusionofN(2)-L-alanine-L-glutamine(5and

10%solution)over13weeks,intolerancereactionsoccurredattheinfusionsites

(swellings,discolourations,necrosis)intheratsanddogsfrom0.5g/kgbodyweight

onwards.Histopathologically,substance-inducedinflammatoryreactionswithmildto

fullydevelopeddermatitispurulentanecroticansandosteomalaciaofthetailvertebrae,

thrombophlebitisandperiphlebitis,wereobservedintherats.Inthedog,perivascular

inflammatoryreactions and,occasionally,vessel blockagewere observed.

Thetestsconductedonthedogonlocaltoleranceafterasingle,intraarterial,

paravenousandintramuscularadministrationgavenoindicationsofunusual

intolerancereactions withincorrectadministration.

NAMEANDADDRESS

Sponsor

FreseniusKabi NewZealandLimited

60PavilionDrive

Airport Oaks,Auckland2022

NewZealand

Freecall:0800144892

DATEOFPREPARATION

19March2012

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