Alkeran

Main information

  • Trade name:
  • Alkeran 50 mg Solution for injection
  • Dosage:
  • 50 mg
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Combination pack, 1 x (powder + diluent), 50 mg
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Ampac Fine Chemicals LLC

Documents

Localization

  • Available in:
  • Alkeran 50 mg Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 309
  • Authorization date:
  • 31-12-1969
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

1

ALKERANInjection

MelphalanInjection50mg.

Consumer Medicine Information

What isin thisleaflet

Thisdocumentanswerssome

common questions about

ALKERAN,amedicineusedin

thetreatmentofcertainformsof

cancer.Itdoesnotcontainallof

theavailableinformation.

Itdoesnottaketheplaceof

talkingtoyourdoctor.

Allmedicineshaverisksand

benefits. Your doctor has

weighedtherisksofprescribing

ALKERANagainstthebenefits

heorsheexpectsitwillhave.

Ifyouhaveanyconcernsabout

theuseofthismedicineaskyour

doctororpharmacist.

WhatisALKERANused

for?

ALKERANcontainstheactive

ingredientmelphalan.

ALKERANisamedicineusedin

thetreatmentofcertainformsof

cancer.

ALKERANbelongstoagroupof

medicines called alkylating

agents,whichworkbystopping

thegrowthofcancercellsand

thusinhibitingthespreadofthe

cancer.Cancermedicinesare

alsoknownas cytotoxicagents.

Acomplicationoftumoursis

known as malignancy.

Malignancymayleadtopain,

wasting,nausea,numbnessor

weaknessofthearmsandlegs,

lossofappetite,seizures,joint

achesaswellasproblemswith

yourinternalorganssuchasyour

lungs,kidneys,liveretc.

ALKERANisused:

Inthetreatmentoflocalised

malignantmelanomaofthe

handsandfeet.

usuallyprescribedforuseas

asupportivemeasureafter

surgery.

Inadvancedbutlocalised

casesitisusuallyprescribed

tohelpreducepainand

discomfort.

Amelanomaisatumour

arisingfromthepigment-

producingcellsintheskin.

‘Localised’ means the

tumourhasprobablynot

spreadtootherpartsofthe

body.

Inthetreatmentoflocalised

softtissue(muscleand

flesh)sarcomaofthehands

andfeet.Itisusedinthe

managementofallstagesof

this sarcoma. It is

sometimes given with

another cytotoxic called

actinomycinD.

Asarcomaisamalignanttumour

thatoccursinbonesandsoft

tissue.

It is alsousedin:

Multiplemyeloma(cancer

inthebonemarrow).

Advancedovariancancer.

Advanced neuroblastoma

(cancer in the adrenal

glands)inchildhood.

ALKERANisonlyavailable

throughadoctor’sprescription.

HowALKERANisused

ALKERANisusuallygiven

intravenously(injectedslowlyin

adilutedform)atvariousdoses

andintervals,aloneorwithoneor

moreotherdrugs.Itmayalsobe

usedinconjunctionwithsurgery

andradiotherapy.

Beforeyouaregiven

ALKERAN

When ALKERAN

should NOT beused

Tellyourdoctorif:

Youhavepreviouslyhadan

allergic reaction to

melphalan or any of

ALKERAN’s other

ingredientslistedattheend

ofthisdocument.

Youarepregnant,tryingto

become pregnant,

breastfeedingortryingto

fatherachild.

ALKERANmayaffect thesperm,

eggs and/or unborn baby,

especiallyinthefirsttrimester

(first3months)ofpregnancy.

Reliable contraceptive

precautionsMUSTbetakento

avoidpregnancywhilstyouor

yourpartneraretakingthese

tablets.Yourdoctorwillweigh

uptheexpectedbenefitsof

ALKERANtoyouagainstthe

possiblerisktoyourunbornbaby.

Itisrecommendedthatyouavoid

getting pregnant while on

ALKERAN.

Youhavebeenvaccinated,

orplantobevaccinated

withalivevaccine.

Youareallergictoany

medicines,foods,dyesor

preservatives.

Youaretakinganyother

medicinesthatyouhave

beenprescribed,orhave

boughtfromapharmacy,

supermarketorhealthfood

shop.

If you have recently

undergoneradiotherapyor

chemotherapy.

If you have renal

impairment(reducedkidney

function).

Yourdoctormaydosomeblood

teststocheckthatyourkidneys

areworkingproperlyandthat

yourbloodcount is normal.

Taking other medicines

Somemedicinesmayaffectthe

wayotherswork.

Tellyourdoctorifyouaretaking

anyothermedicines,including

the contraceptive pill or

medicinesyoubuywithouta

prescriptionfromapharmacy,

supermarketorhealthfoodshop.

Ifyouaretakinganyofthe

followingmedicines,tellyour

doctor:

Nalidixicacid(Negram 

),

amedicineusedtotreat

bacterialinfections

Cyclosporin (Neoral 

,

Sandimmun 

) medicines

usedforthepreventionof

transplant rejection

TakingALKERAN

Like all similar substances,

ALKERANwillbeprescribed

andusedonlybydoctorstrained

and experienced in the

management ofcancer.Greatcare

isrequiredinthepreparationand

handlingofALKERAN.Ifyou

arepresentwhenitisbeing

preparedoruseddonotbe

surprisedtoseetheclinician

wearing protective clothing

including special gloves, a

surgical facemask, protective

goggles or glasses, and a

disposableapron.

Yourdoctorwilldecidehow

muchALKERANyouwillbe

given.Yourdoctorwillvaryyour

dosedependingonyourweight

andthetypeofcanceryoumay

have,aswellasyourresponseto

WhiletakingALKERAN

Thingsyou should do

Tellyourdoctorifyoufeel

thatALKERANisnot

helpingyourcondition.

Tellyourdoctorifyou

becomepregnant,planning

tobecomepregnantorare

breastfeeding.

Drinkplentyofwaterto

makesurethatyourkidneys

areworkingproperlyand

yourbodyissufficiently

hydrated.

Aswithallmedicinesused

totreatcancer,youshould

usereliablecontraception

whentakingMYLERAN,

whetheryouaremaleor

female.

Thingsyoushouldnot

do

Donotbreastfeedunless

yourdoctortellsyouthatit

isallright todoso

Donottakeanyother

medicationswhetherthey

requireaprescriptionornot

withoutfirstconsultingwith

yourdoctororpharmacist.

IftoomuchALKERAN

isgiven (overdose)

Youmayfeelnauseaandtheurge

tovomit.Diarrhoeasometimes

alsooccurs.Youmayalsofeel

weakandtired.Tellyourdoctor

ifyouarefeelingunwell.

Side-Effects

Tellyourdoctororpharmacistas

soonaspossibleifyouhaveany

problems while using

ALKERAN,evenifyouthinkthe

problemsareNOTconnected

withthemedicineorareNOT

LISTEDinthisdocument.

ALKERANcancausesomeside-

effects.Iftheyoccurtheyare

mostlikelytobeminorand

temporary.However,somemay

beseriousandneedmedical

attention.

Commonside-effectsinclude:

Bonemarrowdepression

leadingtoreducedblood

countsandatendencyto

bruiseeasily.Thebruises

canbeobvious,largeand

dark.Asaresultyoumay

feeltiredanddizzy,get

headaches,lookpale.

Diarrhoea,vomitingand

inflammationofthemouth

(mouthulcers).

Allergicreactionssuchas

itchinessandskinrashes,

hivesandswellingofthe

face,shortnessofbreath.

Cardiacarrestissometimes

(butrarely)associatedwith

suchreactions.

Hairloss(uncommonat

normaldoses).

Asensationofwarmth

and/ortingling.

Haemolyticanaemia.This

resultsfromthedestruction

ofredbloodcells.Asa

resultyoumayfeeltired

anddizzy,getheadaches,

lookpalewithayellowing

oftheskinand/oreyes.

Ifyouthinkyouarehavingan

allergic (hypersensitivity)

reactiontoALKERANTELL

YOUR DOCTOR

IMMEDIATELY.Symptoms

include:

Severeskinrash,itchingor

hives.

Swellingoftheface,lips,

mouthorthroat.

Difficulty breathing and

swallowing.

Fever

Lowbloodpressure(feeling

dizzyandweak)

Ifanyoftheseside-effects

persist,oraretroublesome,tell

yourdoctor.

Askyourdoctororpharmacistto

answeranyquestionsyoumay

have.

Inwomen,ALKERANmay

cause the menstrual cycle

(period)tochange.Tellyour

doctorifyounoticeanything

different.

ALKERANmayaffectbothmale

andfemalefertility.Yourdoctor

willprobablydiscussthiswith

you.

Tellyourdoctorifyounoticeany

changes.

Thisisnotacompletelistofall

possiblesideeffects.

Tellyourdoctorifyounotice

anythingelsethatismakingyou

feelunwell,evenifitisnoton

thislist.

Askyourdoctororpharmacistif

youdon'tunderstandanythingin

thislist.

Donotbealarmedbythislistof

possiblesideeffects.Youmay

not experienceanyofthem.

Product Description

ALKERANInjectionisdispensed

asaunitpackcomprising50mg

ofMelphalanintheformofa

freeze-driedpowderanda10mL

vialofaliquidintowhichthe

powderisdissolvedimmediately

beforeuse.

Ingredients

ALKERANInjection(freeze-

dried),Melphalan,Hydrochloric

Acid,PovidoneK12,Solvent-

diluentforALKERANInjection,

Sodium Citrate, Propylene

Glycol,Ethanol(96percent),

WaterforInjection.

Manufacturer

ALKERANissuppliedby:

GlaxoWellcomeNewZealand

Limited

Quay Tower

CnrAlbertandCustomsSt

Private Bag 106600

Downtown Auckland

NewZealand

Fax(09)3672910

Furtherinformation

Yourdoctororclinicianisthe

bestpersontogiveyouadviceon

theuseofALKERANanditsuse

inthetreatmentofaparticular

condition.Youmayalsobeable

tofindgeneralinformationabout

yourillnessanditstreatment

fromothersourcesincluding

booksinpubliclibraries.

Theinformationprovidedinthis

document applies only to

ALKERAN.

ALKERAN™isatrademarkof

theGlaxoSmithKlineGroupof

Companies.

Thecopyrightofthisdocument

belongstoGlaxoSmithKline.The

documentmaybereproducedbut

not alteredinanyway.

Version1.0

PreparedNovember2004.

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