natgillin/translations-raw huggingface dataset:
Den væsentligste toksiske virkning er omfattende myeloablation og pancytopeni, men centralnerve - systemet, lever, lunger og gastrointestinalkanalen kan også blive påvirket.
The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.
Uden sammenhæng med transplantation af hæmatopoietiske progenitorceller ville den anbefalede dosering af Busilvex udgøre en overdosis af busulfan.
In the absence of haematopoietic progenitor cell transplantation, the recommended dosage of Busilvex would constitute an overdose of busulfan.
Det skal tages i betragtning, at en overdosis af Busilvex også øger eksponeringen for DMA.
9 It must be considered that overdose of Busilvex will also increase exposure to DMA.
ATC- kode:
Alkyl sulfonates, ATC code:
Busilvex er et kraftigt virkende cytostatikum og et bifunktionelt alkylerende middel.
Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
9 Dokumentation af sikkerhed og effekt af Busilvex i kombination med cyclophosphamid i et BuCy2 - behandlingsregime før konventionel allogen og/ eller autolog HPCT stammer fra to kliniske forsøg (OMC- BUS- 4 og OMC- BUS- 3).
Clinical trials in adults Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/ or autologous HPCT derive from two clinical trials (OMC-BUS-4 and OMC-BUS-3).
2 prospektive, enkeltgrens, åbne, ukontrollerede fase II- forsøg blev gennemført hos patienter med hæmatologisk sygdom, hvoraf de fleste havde sygdommen i fremskreden grad.
Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
De omfattede sygdomme var akut leukæmi efter første remission, under første eller senere recidiv, under første remission (højrisiko) eller ved induktionssvigt; kronisk myeloid leukæmi i den kroniske eller fremskredne fase; primær refraktær eller resistent recidiverende Hodgkins sygdom eller non - Hodgkin lymfom samt myelodysplastisk syndrom.
Diseases included were acute leukemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin’ s disease or non-Hodgkin’ s lymphoma, and myelodysplastic syndrome.
Patienterne fik doser à 0, 8 mg/ kg busulfan som infusion hver 6. time - 16 doser i alt - efterfulgt af cyclophosphamid i doser på 60 mg/ kg en gang daglig i 2 dage (BuCy2- regime).
Patients received doses of 0.8 mg/ kg busulfan every 6 hours infusion for a total 16 doses followed by cyclophosphamide at 60 mg/ kg once per day for two days (BuCy2 regimen).
I begge forsøg fik alle patienter 16 ud af 16 doser Busilvex.
In both studies, all patients received a 16/ 16 dose regimen of Busilvex.
Tidsrummet frem til absolut neutrofiltal (ANC) > 0, 5x109/ l var 13 dage (interval 9- 29 dage) hos allogene patienter (OMC- BUS 4) og 10 dage (interval 8- 19 dage) hos autologe patienter (OMC- BUS 3).
The time to Absolute Neutrophil Count (ANC) greater than 0.5x109 / l was 13 days (range 9-29 days) in allogenic patients (OMC-BUS 4), and 10 days (range 8-19 days) in autologous patients (OMC-BUS 3).
Generel mortalitet og mortalitet uden recidiv mere end 100 dage efter transplantationen var henholdsvis (8/ 61) 13% og (6/ 61) 10% hos allotransplanterede patienter.
Overall mortality and non- relapse mortality at more than 100 days post-transplant was (8/ 61) 13% and (6/ 61) 10% in allotransplanted patients, respectively.
Kliniske forsøg på pædiatriske patienter Dokumentation af sikkerhed og effekt af Busilvex i kombination med cyclophosphamid i et BuCy4 - behandlingsregimen eller med melphalan i BuMel- regimenet før konventionel allogen og/ eller autolog HPCT stammer fra det kliniske forsøg F60002 IN 101 G0.
Clinical trials in paediatric patients Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy4 or with melphalan in the BuMel regimen prior to conventional allogeneic and/ or autologous HPCT derives from clinical trial F60002 IN 101 G0.
Patienterne blev behandlet i den dosering, der oplyst i pkt.
The patients received the dosing mentioned in section 4.2.
Tidsrummet frem til absolut neutrofiltal (ANC) > 0, 5x109/ l var 21 dage (interval 12- 47 dage) hos allogene patienter og 11 dage (interval 10- 15 dage) hos autologe patienter.
The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/ l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
93% af de allogene patienter udviste fuldstændig kimærisme.
93% of allogeneic patients showed complete chimerism.
Busilvexs farmakokinetik er undersøgt.
10 The pharmacokinetics of Busilvex has been investigated.
Informationerne om metabolisme og elimination baserer sig på oral busulfan.
The information presented on metabolism and elimination is based on oral busulfan.
Pharmakokinetik for voksne Absorption Farmakokinetikken for intravenøst busulfan blev undersøgt hos 124 evaluerbare patienter efter 2 timers intravenøs infusion af i alt 16 doser i løbet af 4 dage.
Pharmacokinetics in adults Absorption The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2- hour intravenous infusion for a total of 16 doses over four days.
Der opnåedes samstemmende blodeksponering ved sammenligning af plasmakoncentrationer hos voksne patienter, der fik busulfan peroralt og intravenøst i doser på hhv.
Similar blood exposure was observed when comparing plasma concentrations in adult patients receiving oral and intravenous busulfan at 1 mg/ kg and 0.8 mg/ kg respectively.
En populationsfarmakokinetisk analyse omfattende 102 patienter påviste lav interpersonlig (CV=21%) og intrapersonlig (CV=12%) variabilitet i busulfan efter lægemiddeleksponering
Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Distribution Terminalt fordelingsvolumen Vz lå i intervallet 0, 62- 0, 85 l/ kg.
Distribution Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/ kg.
10 Der blev opnået busulfankoncentrationer i cerebrospinalvæske, som var sammenlignelige med koncentrationerne i plasma, om end disse koncentrationer formentlig er utilstrækkelige til at udvirke antineoplastisk aktivitet.
Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
32%.
Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Metabolisme Busulfan metaboliseres hovedsageligt gennem konjugation med glutathion (spontant og gennem glutathion- S- transferase).
Metabolism Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-S- transferase mediated).
Dernæst metaboliseres glutathion- konjugatet yderligere i leveren ved oxidation.
The glutathione conjugate is then further metabolised in the liver by oxidation.
Elimination Total plasmaclearance lå i intervallet 2, 25- 2, 74 ml/ min/ kg.
Elimination Total clearance in plasma ranged 2.25 - 2.74 ml/ minute/ kg.
Terminalhalveringstiden lå i intervallet 2, 8 til 3, 9 timer.
The terminal half-life ranged from 2.8 to 3.9 hours.
Omtrent 30% af den indgivne dosis udskilles med urinen i løbet af 48 timer med 1% som uomdannet busulfan.
Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Farmakokinetisk linearitet Der blev påvist stigende busulfaneksponering proportionelt med dosis efter intravenøs busulfan op til 1 mg/ kg.
Pharmacokinetic linearity The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/ kg.
Farmakokinetiske/ farmakodynamiske forhold Litteraturen om busulfan peger på et terapeutisk vindue mellem 900 og 1500 μMol. min for AUC.
Pharmacokinetic/ pharmacodynamic relationships The literature on busulfan suggests a therapeutic window between 900 and 1500 µMol. minute for AUC.
Under kliniske forsøg med intravenøst busulfan lå 90% af patienternes AUC under den øvre AUC - grænse (1. 500 μmol/ min), og mindst 80% lå inden for det tilsigtede terapeutiske vindue (9001500 μMol. min).
During clinical trials with intravenous busulfan, 90% of patients AUCs were below the upper AUC limit (1500 µMol. minute) and at least 80% were within the targeted therapeutic window (900- 1500 µMol. minute).
Særlige populationer Virkningen af nyredysfunktion på fordelingen af intravenøst busulfan er ikke vurderet.
Special populations The effects of renal dysfunction on intravenous. busulfan disposition have not been assessed.
Farmakokinetik for pædiatriske patienter Med baggrund i de undersøgte kliniske data blev en kontinuerlig variation inden for området 2, 49 til 3, 92 ml/ min/ kg fastlagt hos børn i alderen < 6 måneder og op til 17 år.
Pharmacokinetics in paediatric patients A continuous variation of clearance ranging from 2.49 to 3.92 ml/ minute/ kg has been established in children from < 6 months up to 17 years old.
Den terminale halveringstid var fra 2, 26 til 2, 52 timer.
The terminal half life ranged from 2.26 to 2.52 h.
4. 2 og baseret på kropsvægt, gav mulighed for at opnå en lignende mål- AUC, uanset børnenes alder, og kunne sammenlignes med de voksne patienters plasmaeksponering.
The dosing recommended in section 4.2. allows to achieve a similar AUC whatever the children's age, the targeted range of AUCs being the one used for adults.
De inter - og intrapersonlige variabiliteter var lavere end henholdsvis 20% og 10%.
Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively.
Farmakokinetiske/ farmakodynamiske forbindelser:
11 Pharmacokinetic/ pharmacodynamic relationships:
Den vellykkede optagelse af cellerne hos alle patienter i fase II- forsøg indikerede, at mål- AUC’ erne var korrekte.
The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
En farmakokinetisk/ farmakodynamisk forbindelse blev observeret mellem stomatitis og AUC’ er hos autologe patienter og mellem en stigning i bilirubin og AUC’ er i en kombineret analyse af autologe og allogene patienter.
PK/ PD relationship was observed between stomatitis and AUCs in autologous patients and between bilirubin increase and AUCs in a combined autologous and allogeneic patient analysis.
Busulfan inducerede kromosomafvigelser in vitro (gnaver - og humane celler) og
Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Der er observeret forskellige kromosomafvigelser i celler fra patienter, der fik peroralt busulfan.
Various chromosome aberrations have been observed in cells from patients receiving oral busulfan.
Busulfan er teratogent hos rotter, mus og kaniner.
Busulfan is teratogen in rats, mice and rabbits.
Busulfan depleterede oocytter hos hunrotter og inducerede sterilitet hos hanrotter og - hamstere.
Busulfan depleted oocytes of female rats, and induced sterility in male rats and hamster.
Gentagne doser af DMA medførte tegn på levertoksicitet, hvoraf det første var stigninger i enzymer i klinisk- kemiske serumprøver efterfulgt af histopatologiske forandringer i hepatocytterne.
Repeated doses of DMA produced signs of liver toxicity, the first being increases in serum clinical enzymes followed by histopatological changes in the hepatocytes.
En dosis DMA på 400 mg/ kg/ dag administreret under organogenese gav signifikante udviklingsmæssige anomalier.
Doses of 400 mg/ kg/ day DMA administered during organogenesis caused significant developmental anomalies.
Misdannelserne omfattede alvorlige anomalier i hjerte og/ eller større kar: en fælles truncus arteriosis og ingen ductus arteriosis, coarctio af truncus pulmonalis og a. pulmonalis, intraventrikulære hjertedefekter.
The malformations included serious heart and/ or major vessels anomalies: a common truncus arteriosis and no ductus arteriosis, coarctation of the pulmonary trunk and the pulmonary arteries, intraventricular defects of the heart.
DMA nedsætter fertiliteten hos han - og hungnavere.
DMA decreases fertility in male and female rodents.
En enkelt subkutan dosis på 2, 2 g/ kg administreret på 4. drægtighedsdag afsluttede drægtigheden hos 100% af forsøgshamsterne.
A single s. c. dose of 2.2 g/ kg administered on gestation day 4 terminated pregnancy in 100% of tested hamster.
Hos rotter medførte en døgndosis DMA på 450 mg/ kg hos rotter i 9 dage inaktiv spermatogenese.
In rats, a DMA daily dose of 450 mg/ kg given to rats for nine days caused inactive spermatogenesis.
6. 6.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
2 år Fortyndet opløsning:
2 years 12 Diluted solution
Kemisk og fysisk holdbarhed efter fortynding med 5% isotonisk glukoseopløsning eller med 9 mg/ ml (0, 9%) isotonisk NaCl- opløsning er påvist som følger:
Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ ml (0.9%) solution for injection has been demonstrated for:
- 8 timer (inklusive infusionstid) efter fortynding, hvis opbevaring sker ved 20 °C ± 5 °C.
- 8 hours (including infusion time) after dilution when stored at 20 °C ± 5 °C
- 12 timer efter fortynding, hvis opbevaring sker ved 2 °C - 8 °C efterfulgt af 3 timers opbevaring
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C ± 5 °C
ved 20 °C ± 5 °C (inklusive infusionstid).
(including infusion time).
12 Ud fra et mikrobiologisk synspunkt bør produktet anvendes umiddelbart efter fortynding.
From a microbiological point of view, the product should be used immediately after dilution.
Hvis det ikke anvendes umiddelbart, er brugeren ansvarlig for opbevaringstid og - betingelser før brug, som normalt ikke overstiger de ovenfor angivne betingelser, når fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Opbevares i køleskab (2 °C – 8 °C) Den fortyndede opløsning må ikke nedfryses.
Do not freeze the diluted solution.
6. 3.
For storage conditions of the diluted medicinal product see section 6.3
10 ml koncentrat til infusionsopløsning i klare hætteglas (type I- glas) med butylgummiprop, der er dækket af et rødt flip- off- låg af aluminium.
10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.
8 hætteglas pr. æske
8 vials per box
Tilberedning af Busilvex Der bør fastlægges procedurer for korrekt håndtering og bortskaffelse af lægemidler mod cancer.
Preparation of Busilvex Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Alle procedurer for overførsel kræver nøje overholdelse af aseptiske forhold, idet overførsel fortrinsvis skal udføres i en vertikal LAF- bænk.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood
Som for andre cytostatika skal der udvises forsigtighed ved håndtering og tilberedning af Busilvex - opløsningen:
As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution:
Det anbefales at anvende beskyttelseshandsker og - tøj.
- The use of gloves and protective clothing is recommended.
Hvis Busilvex eller den fortyndede Busilvex- opløsning kommer i kontakt med hud eller slimhinder, skal de berørte områder omgående skylles med rigeligt vand.
- If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with
Beregning af mængden af Busilvex, der skal fortyndes, og af infusionsvæsken Busilvex skal fortyndes før brug med enten 9 mg/ ml (0, 9%) isotonisk NaCl- opløsning eller 5% isotonisk glukoseopløsning.
Busilvex must be diluted prior to use with either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose solution for injection 5%.
0, 5 mg/ ml, skal mængden af infusionsvæske være 10 gange voluminet af Busilvex.
The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ ml.
Y (kg) x D (mg/ kg) = A ml Busilvex skal fortyndes 6 (mg/ ml)
Y (kg) x D (mg/kg) = A ml of Busilvex to be diluted
Y: patientens legemsvægt i kg D:
Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2)
Busilvex- dosis (se pkt. 4. 2) Mængde infusionsvæske:
• Quantity of diluent:
13 Til tilberedning af den endelige infusionsopløsning tilsættes (A) ml Busilvex til (B) ml infusionsvæske (9 mg/ ml (0, 9%) isotonisk NaCl- opløsning eller 5% isotonisk glukoseopløsning):
To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Fremstilling af infusionsopløsningen Busilvex skal tilberedes af sundhedspersonale under anvendelse af steril overførselsmetode.
Preparation of the solution for infusion
• Der anvendes en sprøjte, der ikke er af polycarbonat, isat kanyle:
• Busilvex must be prepared by a healthcare professional using sterile transfer techniques.Using a non polycarbonate syringe fitted with a needle:
- den beregnede mængde Busilvex skal udtages af hætteglasset.
- the calculated volume of Busilvex must be removed from the vial.
- sprøjtens indhold skal overføres til en infusionspose (eller - sprøjte), som allerede indeholder den
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which
beregnede mængde af den valgte infusionsvæske.
already contains the calculated amount of the selected diluent.
Busilvex må ikke overføres til en infusionspose, som ikke indeholder 9 mg/ ml (0, 9%) isotonisk NaCl- opløsning eller 5% isotonisk glukoseopløsning.
Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
• Den fortyndede opløsning skal blandes grundigt ved at vende op og ned på posen flere gange.
• The diluted solution must be mixed thoroughly by inverting several times
1 ml infusionsopløsning indeholder 0, 5 mg busulfan.
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan
Efter fortynding udgør Busilvex en klar, farveløs opløsning.
Diluted Busilvex is a clear colourless solution
5 ml 9 mg/ ml (0, 9%) isotonisk NaCl- opløsning eller 5% isotonisk glukoseopløsning.
Instructions for use Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Hele den ordinerede dosis Busilvex skal indgives i løbet af 2 timer.
The entire prescribed Busilvex dose should be delivered over two hours.
0, 3- 0, 6 ml), som primes med lægemiddelopløsningen, inden den egentlige infusion med Busilvex iværksættes, og derefter skylles med 9 mg/ ml (0, 9%) isotonisk NaCl- opløsning eller 5% isotonisk glukoseopløsning.
In this case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Ikke anvendt lægemiddel samt affald herfra bør bortskaffes i overensstemmelse med lokale krav til cytostatika.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
14 7 MARKETING AUTHORISATION HOLDER
Pierre Fabre Médicament 45, Place Abel Gance F- 92654 Boulogne Billancourt Cedex Frankrig
Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
8 MARKETING AUTHORISATION NUMBER(S)
14 EU/ 1/ 03/ 254/ 002
EU/1/03/254/002
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/ FORNYELSE AF TILLADELSEN
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09. juli 2003 Dato for seneste fornyelse:
09 July, 2003 Date of latest renewal:
08. juli 2008
08 July, 2008
INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
16 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Pierre Fabre Médicament Production Site Aquitaine Pharm International Avenue du Béarn - Idron F- 64320 Frankrig
Pierre Fabre Médicament Production Site Aquitaine Pharm International Avenue du Béarn -Idron F-64320 France
19 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Box containing 8 vials of 10ml)
Busilvex 6 mg/ ml koncentrat til infusionsvæske, opløsning busulfan
Busilvex 6 mg/ml concentrate for solution for infusion busulfan
En ml koncentrat indeholder 60 mg busulfan, hvilket giver 0, 5 mg/ ml busulfan efter fortynding.
One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Koncentrat til infusionsvæske, opløsning Æske med 8 engangshætteglas à 10 ml 60 mg pr. hætteglas
Concentrate for solution for infusion Box of 8 single use vials of 10 ml 60 mg per vial
ANVENDELSESMÅDE OG INDGIVELSESVEJ( E)
METHOD AND ROUTE OF ADMINISTRATION
Intravenøs anvendelse (i. v.) Skal fortyndes før brug Læs indlægssedlen før brug
Intravenous use (IV) Must be diluted before use Read the package leaflet before use
Cytotoxisk middel, særlige instruktioner vedrørende håndtering
Cytotoxic agent, special handling instructions
Opbevares i køleskab (2 °C – 8 °C)
Store in a refrigerator (2°C – 8°C)
Ikke anvendt lægemiddel eller affald herfra bortskaffes i overensstemmelse med lokale regler
Any unused product or waste material should be disposed of in accordance with local requirements
Pierre Fabre Médicament 45, Place Abel Gance F- 92654 Boulogne Billancourt Cedex Frankrig
Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne Billancourt cedex France
21 MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE EMBALLAGE
21 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
{Æske indeholdende 4 hætteglas à 10 ml)
{box containing 4 vials of 10ml)
Koncentrat 10 ml
Concentrate 10 ml
Intravenøs anvendelse (i. v.) Skal fortyndes før brug
Intravenous use (IV) Must be diluted before use
Læs indlægssedlen før brug
Read the leaflet before use
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
23 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Busilvex 6 mg/ ml sterilt koncentrat IV
Busilvex 6 mg/ml sterile concentrate IV
INFORMATION TIL BRUGEREN
25 PACKAGE LEAFLET:INFORMATION FOR THE USER
Busilvex 6 mg/ ml koncentrat til infusionvæske, opløsning busulfan
Busilvex 6 mg/ml concentrate for solution for infusion. busulfan.
Læs denne indlægsseddel omhyggeligt, inden De begynder at bruge medicinen.
Read all of this leaflet carefully before you start using this medicine.
- Spørg lægen eller apoteket, hvis der er mere, De vil vide
- If you have further questions, ask your doctor or your pharmacist.
. - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Oversigt over indlægssedlen:
please tell your doctor or pharmacist
Busilvex 'virkning og hvad De skal bruge det til 2.
What Busilvex is and what it is used for 2.
Det skal De vide, før De begynder at bruge Busilvex 3.
How to use Busilvex 4.
Sådan skal De bruge Busilvex 4.
Possible side effects 5 How to store Busilvex 6.
Bivirkninger 5.
Further information