natgillin/translations-raw huggingface dataset:
Der er ikke gennemført specifikke lægemiddel- kompatibilitetsundersøgelser med Myocet.
Specific drug compatibility studies have not been performed with Myocet.
Det er sandsynligt, at Myocet vil reagere med stoffer, der vides at reagere med konventionelt doxorubicin.
Myocet is likely to interact with substances that are known to interact with conventional doxorubicin.
Plasmakoncentrationerne af doxorubicin og dets metabolit, doxorubicinol, kan forøges, når doxo - rubicin indgives sammen med cyclosporin, verapamil, paclitaxel eller andre stoffer, der hæmmer P - glycoprotein (P- gP).
Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit P-glycoprotein (P-Gp).
Undersøgelser af Myocets virkninger på andre stoffer mangler ligeledes.
Studies of the effect of Myocet on other substances are also lacking.
Doxorubicin kan dog potensere toksiciteten af andre antineoplastiske midler.
However, doxorubicin may potentiate the toxicity of other antineoplastic agents.
Samtidig behandling med andre lægemidler, der er rapporteret kardiotoksiske, eller med kardiologisk aktive stoffer (f. eks. kalciumantagonister) kan øge risikoen for kardiotoksicitet.
Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e. g. calcium antagonists) may increase the risk for cardiotoxicity.
På grund af de kendte cytotoksiske, mutagene og embryotoksiske egenskaber ved doxorubicin bør Myocet ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet should not be used during pregnancy unless clearly necessary.
Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og indtil 6 måneder efter behandlingen.
Women of childbearing potential should use an effective contraceptive during treatment with Myocet and up to 6 months following discontinuation of therapy.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effect on ability to drive and use machines
Det er konstateret, at Myocet kan medføre svimmelhed.
Myocet has been reported to cause dizziness.
Patienter, der lider heraf, bør undgå at føre motorkøretøjer og betjene maskiner.
Patients who suffer from this should avoid driving and operating machinery.
4. 8 Bivirkninger
Clinical Program
Klinisk program Data om uønskede reaktioner (ADR), der er indhentet fra 323 patienter med metastatisk brystkræft i tre randomiserede fase- III- undersøgelser af Myocet som eneste præparat og i kombination med Cyclophosphamid (CPA) udgør databasen i tabel 1.
Adverse drug reactions (ADR) data obtained from 323 patients with metastatic breast cancer in three randomised phase III trials of Myocet as a single agent and in combination with Cyclophosphamide (CPA) have been provided in Table 1 as pooled data.
Behandlingscyklerne var hver 3. uge i hver enkelt undersøgelse og der blev anvendt G- CSF i 38- 56% af cyklerne.
Treatment cycles were every three weeks in each trial and G-CSF was used in 38-56% of the cycles.
Uønskede reaktioner fra database af resultater fra tre randomiserede, kliniske fase- III - undersøgelser af Myocet som eneste præparat og i kombination med Cyclophosphamid (CPA).
Adverse reactions from pooled study results of three randomised Phase III clinical trials of Myocet as a single agent and in combination with Cyclophosphamide (CPA).
Hyppighed (som procentdel)
Frequency (as percentage)
reaktioner1, 2
Adverse Reactions1,2
Infektioner og parasitære
Infections and Infestations
(Alle grader) (Grad ≥3)
Infection (All Grades) (Grade ≥ 3) Neutropenic Fever3
Neutropen feber3
Blood and Lymphatic System
Blod og lymfesystem
Disorders
11 9 94 64 6
94 64 6
ANC < 500 & feber > 38˚C 3, 4 ANC > 500 & feber > 38˚C 3, 4 Neutropeni < 2000/ µl < 500/ µl < 500/ µl i ≥ 7 dage Trombocytopeni
< 2000/ µl < 500/ µl < 500/ µl for ≥ 7 days Thrombocytopenia
< 100. 000/ µl < 20. 000/ µl Anæmi
< 100,000/ µl < 20,000/ µl Anaemia
Mave- tarm- kanalen
Gastrointestinal Disorders
< 11 g/ dl < 8 g/ dl Kvalme/ opkastning (Alle grader) (Grad ≥3) Stomatitis/ mucositis
< 11 g/ dl < 8 g/ dl Nausea/ Vomiting (All Grades) (Grade ≥ 3) Stomatitis/ Mucositis
(Alle grader) (Grad ≥3) Diarré
(All Grades) (Grade ≥ 3) Diarrhoea
(Alle grader) (Grad ≥3)
(All Grades) (Grade ≥ 3)
Alopeci - udtalt Hudrelateret toksicitet (f. eks. udslæt, tør hud)
Alopecia - Pronounced
Almene symptomer og
Disorders
(Alle grader) (Grad ≥3) Træthed/ utilpashed/ asteni
(All Grades) (Grade ≥ 3)
reaktioner på administrationsstedet
Administration Site Conditions
(Alle grader) (Grad ≥3) Toksicitet på injektionsstedet
(All Grades) (Grade ≥ 3) Injection Site Toxicity
(Alle Grader) (Grad ≥3)
(All Grades) (Grade ≥ 3)
Incidens af uønskede reaktioner, der af forskeren anses for at være i det mindset sansdsynligvis relaterede, fra database af kliniske forsøg med 323 patienter, der indtager det medicinske præparat.
Incidence of the adverse reaction considered at least possibly related by the investigator, from pooled clinical trials involving 323 patients taking the medicinal product.
2 alle uønskede reaktioner er opstillet efter hyppighed inden for hver enkel systemorganklasse.
2 all adverse reactions have been ranked by frequency within each system organ class.
3 med IV antibiotika og/ eller indlæggelse 4 absolut neutrofil tal (ANC)
3 with IV antibiotics and/ or hospitalisation 4 absolute neutrophil counts (ANC)
Følgende klinisk relevante uønskede reaktioner af grad 3/ 4 med en incidens på < 5% blev ligeledes observeret i kliniske forsøg med 948 patienter med solide tumorer.
The following clinically relevant grade 3/ 4 adverse reactions with an incidence of < 5% were also observed from clinical trials involving 948 patients with solid tumours.
AIDS- patienter med Kaposis sarkom er ikke medtaget.
AIDS patients with Kaposi’ s sarcoma were not included.
6 Incidens under 5% (grad 3 eller 4, muligvis, sandsynligvis, eller klart relateret):
Incidence of less than 5% (Grade 3 or 4, possibly, probably, or definitely related):
Feber, Herpes Zoster, infektion på injektionsstedet, sepsis
6 Infections and Infestations: fever, Herpes Zoster, injection site infection, sepsis
Leukopeni, lymfopeni, neutropen sepsis, purpura
Blood and Lymphatic System Disorders: leukopenia, lymphopenia, neutropenic sepsis, purpura
Anorexi, dehydrering, hypokaliæmi, hyperglykæmi
Metabolism and Nutrition Disorders: anorexia, dehydration, hypokalaemia, hyperglycaemia
Uro
Psychiatric Disorders: agitation
Unormal gang, dysfoni, søvnløshed, somnolens
Nervous System Disorders: abnormal gait, dysphonia, insomnia, somnolence
Arrythmier, cardiomyopati, kongestiv hjertesvigt, perikardial effusion
Cardiac Disorders: arrhythmia, cardiomyopathy, congestive cardiac failure, pericardial effusion
Hedeture, hypotension
Vascular Disorders: hot flushes, hypotension
Smerter i brystet, dyspnø, epistaxis, hæmoptysis, faryngitis, pleural effusion, pneumoni
Respiratory, Thoracic and Mediastinal Disorders: chest pain, dyspnoea, epistaxis, haemoptysis, pharyngitis, pleural effusion, pneumonitis
Obstipation, mavesår, øsophagitis
Gastrointestinal Disorders: constipation, gastric ulcer, oesophagitis
Forhøjet hepatisk transaminase, forhøjet alkalisk fosfatase, forhøjet serum - bilirubin, gulsot
Hepato-Biliary Disorders: increased hepatic transaminases, increased alkaline phosphatase, increased serum bilirubin, jaundice
Rygsmerter, muskelsvaghed, myalgi
Musculoskeletal, Connective Tissue and Bone Disorders: back pain, muscle weakness, myalgia
Follikulitis, negleproblemer, pruritus,
Skin and Subcutaneous Tissue Disorders: folliculitis, nail disorder, pruritus,
Hæmoragisk cystitis, oliguri
Renal and Urinary Disorders: haemorrhagic cystitis, oliguria
Svimmelhed, hovedpine, reaktion på injektionsstedet, smerte, kulderystelser, vægttab
General Disorders and Administration Site Conditions: dizziness, headache, injection site reaction, pain, rigors, weight loss
Post- marketing Data om relevante uønskede reaktioner, der er indhentet ved post- markedsføringsovervågning er opstillet i tabel 2.
Relevant adverse reactions obtained from post marketing surveillance have been tabulated in Table 2.
Data om uønskede reaktioner indhentet ved post- marketing- overvågning (4½ års data).
Adverse reactions obtained from post-marketing surveillance (4.5 years data).
Uønskede reaktioner
Adverse Reactions
Sygdomme i blod - og lymfesystem
Blood and Lymphatic System Disorders
Behandling af akut overdosering bør fokusere på støttende behandling af forventet toksicitet og kan omfatte indlæggelse, antibiotika, trombocyt - og granulocyttransfusioner og symptomatisk behandling af mucositis.
Treatment of acute overdose should focus on supportive care for expected toxicity and may include hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
7 Farmakoterapeutisk klassifikation:
Pharmaco-therapeutic group:
Cytotoksisk (anthracycliner og dermed forbundne stoffer), ATC- kode:
Cytotoxic agents (anthracyclines and related substances), ATC code:
L01DB01.
L01DB01
Det aktive stof i Myocet er doxorubicin HCl.
7 The active substance in Myocet is doxorubicin HCl.
Doxorubicin kan udøve sin antitumorvirkning og toksiske virkning på en række måder, herunder hæmning af topoisomerase II, interkalering med DNA - og RNA- polymeraser, dannelse af frie radikaler og membranbinding.
Doxorubicin may exert its antitumour and toxic effects by a number of mechanisms including inhibition of topoisomerase II, intercalation with DNA and RNA polymerases, free radical formation and membrane binding.
Liposomal- indkapslet doxo - rubicin sammenlignet med konventionelt doxorubicin blev ikke fundet mere aktivt hos doxorubicin - resistente cellelinier in vitro.
Liposomal-encapsulated compared with conventional doxorubicin was not found more active in doxorubicin resistant cell lines in vitro.
Hos dyr reducerede liposom- indkapslet doxorubicin distributionen til hjertet og de gastrointestinale slimhinder sammenlignet med konventionelt doxorubicin, mens anti - tumor- effektivitet blev opretholdt ved eksperimentelle tumorer.
In animals, liposome-encapsulated doxorubicin reduced the distribution to heart and gastrointestinal mucosa compared with conventional doxorubicin, while antitumoural efficacy in experimental tumours was maintained.
Myocet (60 mg/ m2) + CPA (600 mg/ m2) blev sammenlignet med konventionelt doxorubicin + CPA (i samme doser), og Myocet (75 mg/ m2) + CPA (600 mg/ m2) blev sammenlignet med epirubicin + CPA (i samme doser).
Myocet (60 mg/ m2) + CPA (600 mg/ m2) was compared with conventional doxorubicin + CPA (at the same doses) and Myocet (75 mg/ m2) + CPA (600 mg/ m2) was compared to epirubicin + CPA (at the same doses).
I et tredje forsøg blev Myocet (75 mg/ m2) som monoterapi sammenlignet med konventionelt doxorubicin- monoterapi (ved samme dosis).
In a third trial, Myocet (75 mg/ m2) monotherapy was compared with conventional doxorubicin monotherapy (at the same dose).
Tabel 3 Oversigt over antitumor- effekt for kombinations - og monoterapiundersøgelser
Table 3 Antitumour efficacy summary for combination and single-agent studies
Myocet/ CPA (60/ 600
Myocet/ CPA Dox 60/ CPA Myocet/ CPA (60/ 600 (60/ 600 (75/ 600
Dox 60/ CPA Myocet/ CP (60/ 600 A
Epi/ CPA (75/ 600
Epi/ CPA Myocet (75/ 600 (75 mg/ m2) (75
Myocet (75 mg/ m2) (75
mg/ m2) mg/ m2)
mg/ m2) mg/ m2) mg/ m2) mg/ m2)
mg/ m2) (n=80)
(n=80)
Tumor - responsrate
Tumour response rate Relative Risk
(0, 64- 156)
(0.64-1.56)
Median PFS (måneder) a
Median PFS (months)a Risk Ratio
5, 5
1.03
7, 7
5.5
5, 6
7.7
2, 9
1.52
3, 2
5.6
1, 03
2.9
1, 52
0.87
0, 87
3.2
PFS, progressionsfri overlevelse; Dox, doxorubicin; Epi, epirubicin; Relativ risiko, komparator taget som reference; Risikoforholdstal, Myocet taget som reference. a Sekundært slutpunkt
PFS, progression-free survival; Dox, doxorubicin; Epi, epirubicin; Relative Risk, comparator taken as reference; Risk Ratio, Myocet taken as reference a Secondary endpoint
Plasma- farmakokinetikken for totalt doxorubicin hos patienter, der modtager Myocet, viser en høj grad af variabilitet patienterne imellem.
The plasma pharmacokinetics for total doxorubicin in patients receiving Myocet shows a high degree of inter-patient variability.
Generelt er plasmakoncentrationerne for totalt doxorubicin dog betydeligt højere med Myocet end med konventionelt doxorubicin, mens data tyder på, at de maksimale plasmakoncentrationer af frit (ikke liposom- indkapslet) doxorubicin er lavere med Myocet end med konventionelt doxorubicin.
In general however, the plasma levels of total doxorubicin are substantially higher with Myocet than with conventional doxorubicin, while the data indicate that peak plasma levels of free (not liposome-encapsulated) doxorubicin are lower with Myocet than with conventional doxorubicin.
Tilgængelige farmakokinetiske data udelukker konklusioner vedrørende forholdet mellem plasmakoncentrationer af totalt/ frit doxorubicin og dets virkning på Myocets effekt/ sikkerhed.
Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/ free doxorubicin and its influence on the efficacy/ safety of Myocet.
Clearance for totalt doxorubicin var 5, 1 ± 4, 8 l/ t, og distributionsvolumen ved steady- state (Vd) var 56, 6 ± 61, 5 l, mens clearance og Vd efter konventionelt doxorubicin var henholdsvis 46, 7 ± 9, 6 l/ t og 1. 451 ± 258 1.
The clearance of total doxorubicin was 5.1 ± 4.8 l/ h and the volume of distribution at steady state (Vd) was 56.6 ± 61.5 l whereas after conventional doxorubicin, clearance and Vd were 46.7 ± 9.6 l/ h and 1,451 ± 258 l, respectively.
Den vigtigste metabolit af doxorubicin i kredsløbet, doxorubicinol, dannes via aldo- keto- reduktase.
The major circulating metabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase.
De højeste plasmakoncentrationer for frit doxo - rubicinol forekommer senere i plasma med Myocet end med konventionelt doxorubicin.
The peak levels of doxorubicinol occur in the plasma later with Myocet than with conventional doxorubicin.
Myocets farmakokinetik er ikke blevet specielt undersøgt hos patienter med nyre - eller lever - insufficiens.
The pharmacokinetics of Myocet have not been specifically studied in patients with renal insufficiency.
En reduktion af Myocet -
Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
8 dosis har vist sig at være hensigtsmæssig i patienter med nedsat leverfunktion (se pkt.
8 5.3 Preclinical safety data
4. 5).
Studies of genotoxicity, carcinogenicity and reproductive toxicity of Myocet have not been performed but doxorubicin is known to be both mutagenic and carcinogenic and may cause toxicity to reproduction.
Myocet doxorubicin HCl Laktose
Myocet doxorubicin HCl • lactose
Myocet- liposomer • Æggephosphatidylcholin • Cholesterol • Citronsyre • Natriumhydroxid • Vand til injektionsvæske
Myocet liposomes • egg phosphatidylcholine • cholesterol • citric acid • sodium hydroxide • water for injections
Myocet buffer • Natriumcarbonat • Vand til injektionsvæske
Myocet buffer • sodium carbonate • water for injections
Efter rekonstitution er der påvist kemisk og fysisk anvendelsesstabilitet i op til 8 timer ved 25°C og i op til 5 dage ved 2°C- 8°C.
Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C – 8ο C.
Hvis det ikke anvendes straks, er opbevaringstider og - forhold for brugsklart materiale forud for anvendelse brugerens ansvar og vil normalt ikke være mere end 24 timer ved 2°C - 8°C, medmindre rekonstitution og fortynding er sket under kontrollerede og validerede aseptiske forhold.
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 24 hours at 2ο C – 8ο C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Opbevares i køleskab (2ºC – 8ºC).
Store in a refrigerator (2ºC – 8ºC).
Myocet fås i æsker med 2 sæt af de tre bestanddele.
Myocet is available in cartons containing 2 sets of the three constituents.
Natriumchlorid til injektionsvæske 0, 9%, der anvendes til opløsning af doxorubicin HCl, medfølger ikke i pakken.
Sodium chloride for injection 0.9%, needed to dissolve doxorubicin HCl, is not provided in the package.
9 Myocet doxorubicin HCl Type I hætteglas af glas indeholdende 50 mg doxorubicin HCl som frysetørret pulver, lukket med grå butylgummipropper og orange aluminiumforseglinger, der kan vippes af.
Myocet doxorubicin HCl Type I glass vials containing 50 mg of doxorubicin HCl lyophilised powder, sealed with grey butyl rubber stoppers and orange flip-off aluminium seals.
Myocet liposomer Type I blyglas- hætteglas indeholdende mindst 1, 9 ml liposomer lukket med grå silikonerede propper og grønne aluminiumforseglinger, der kan vippes af.
9 Myocet liposomes Type I flint glass tubing vials containing not less than 1.9 ml of liposomes, sealed with siliconised grey stopper and green flip-off aluminium seals.
Myocet buffer Hætteglas af glas indeholdende mindst 3 ml buffer, lukket med grå silikonerede propper og blå aluminiumforseglinger, der kan vippes af.
Myocet buffer Glass vials containing not less than 3 ml of buffer, sealed with siliconised grey stopper and blue aluminium flip-off seals.
ASEPTISK TEKNIK SKAL STRENGT OVERHOLDES UNDER HELE HÅNDTERINGEN AF MYOCET, DA DET IKKE INDEHOLDER NOGET KONSERVERINGSMIDDEL.
Preparation of Myocet ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF MYOCET SINCE NO PRESERVATIVE IS PRESENT.
Der kan anvendes to alternative metoder: en Techne DB- 3 Dri Block- opvarmer eller et vandbad • Tænd for Techne DB- 3 Dri Block- varmeren og indstil styringen på 75- 76°C.
Set up Two alternative heating methods can be used: a Techne DB-3 Dri Block heater or a water bath: • Turn on the Techne DB-3 Dri Block heater and set the controller to 75-76°C.
Kontrollér temperaturindstillingspunktet ved at kontrollere termometeret/ termometrene på hver enkelt varmeblokindsats. • Hvis der anvendes vandbad, tændes for vandbadet, så det finder sin balance ved 58°C (55- 60°C).
Verify the temperature set point by checking the thermometer(s) on each heat block insert. • If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55-60°C).
(Bemærk, at selv om kontrolindstillingerne på vandbadet og varmeblokkene indstilles til forskellige temperaturniveauer, vil temperaturen på indholdet i hætteglassene ligge inden for det samme område (55- 60°C)).
(Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55-60°C)).
• Tag æsken med Myocet indholdsstofferne ud af køleskabet.
Remove the carton of Myocet constituents from the refrigerator.
Opbland doxorubicin HCl • Træk 20 ml saltvand til injektion (0. 9%), uden konserveringsmidler, op (medfølger ikke i pakken), og injicér det i hvert hætteglas med Myocet doxorubicin HCl beregnet til opblanding. • Ryst det grundigt med bunden i vejret for at sikre, at doxorubicinet opløses helt.
Reconstitute doxorubicin HCl • Withdraw 20 ml sodium chloride for injection (0.9%), preservative free, (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation. • Shake well in the inverted position to ensure doxorubicin is fully dissolved.
• Opvarm hætteglasset med det opblandede Myocet doxorubicin HCl i Techne DB- 3 Dri Block varmeren med termometeret i blokken på (75- 76°C) i 10 minutter (ikke længere end 15 minutter).
Heat in water bath or dry heat block • Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75-76°C) for 10 minutes (not to exceed 15 minutes).
Hvis der anvendes vandbad til opvarmning af hætteglasset med Myocet doxorubicin HCl, skal temperaturen stå på 55- 60°C i 10 minutter (ikke længere end 15 minutter). • Mens det varmer fortsættes med trin 4
If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55-60°C for 10 minutes (not to exceed 15 minutes). • While heating proceed to step 4
Justér liposomernes pH • Træk 1, 9 ml Myocet liposomer op.
Adjust Ph of liposomes • Withdraw 1.9 ml of Myocet liposomes.
Opbygget tryk kan kræve udluftning. • Ryst omhyggeligt.
Pressure build-up may require venting. • Shake well.
10 • Med en sprøjte trækkes hele indholdet op af hætteglasset med pH- justerede liposomer fra Myocet - bufferhætteglasset. • Tag hætteglasset med det rekonstituerede Myocet doxorubicin HCl op af vandbadet eller varme - blokken.
Add Ph-adjusted liposomes to doxorubicin • Using syringe, withdraw the entire vial contents of Ph-adjusted liposomes from the Myocet buffer vial. • Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block.
Derefter injiceres de pH- justerede liposomer ØJEBLIKKELIGT (inden for 2 minutter) i hætteglasset med det opvarmede, rekonstituerede Myocet doxorubicin HCl.
Then IMMEDIATELY (within 2 minutes) inject Ph-adjusted liposomes into vial of heated reconstituted Myocet doxorubicin HCl.
Fjern den trykudluftende anordning. • RYST DET KRAFTIGT. • VENT MINDST 10 MINUTTER INDEN ANVENDELSE, IMENS OPBEVARES MEDICINEN VED STUETEMPERATUR.
Remove venting device. • SHAKE VIGOROUSLY. • WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.
Techne DB- 3 Dri Block Heater er fuldt godkendt til brug ved konstitution af Myocet.
10 The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet.
Der skal anvendes tre indsatser med hver to 43, 7 mm åbninger pr. indsats.
Three inserts, each with two 43.7mm openings per insert must be used.
Den fremkomne, rekonstituerede præparation af Myocet indeholder 50 mg doxorubicin HCl/ 25 ml liposom- dispersion (2 mg/ ml).
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/ 25 ml of liposomal dispersion (2 mg/ ml).
50 mg rekonstitueret Myocet, så der opnås en slutkoncentration på 0, 4- 1, 2 mg/ ml doxorubicin.
After reconstitution the finished product must be further diluted in 0.9% (w/ v) sodium chloride for injection, or 5% (w/ v) glucose for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet so that a final concentration of 0.4 to 1.2 mg/ ml doxorubicin is obtained.
Når liposomdispersionen er opblandet, skal opløsningen til infusion indeholdende liposom- indkapslet doxorubicin være en rødorange, uigennemsigtig, homogen dispersion.
Once constituted, the liposomal dispersion for infusion containing liposome-encapsulated doxorubicin should be a red orange opaque homogeneous dispersion.
Præparationen må ikke anvendes, hvis den indeholder fremmed partikelmateriale.
Do not use the preparation if foreign particulate matter is present.
Procedure for korrekt bortskaffelse Alle ubrugte produkter eller affaldsmaterialer skal bortskaffes i overensstemmelse med lokale krav.
Procedure for proper disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort Frankrig
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort France
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE / FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
St Mary’ s Pharmaceutical Unit Quadrant Centre Cardiff Business Park Llanishan Cardiff Wales CF14 5RA Storbritannien
St Mary’ s Pharmaceutical Unit Quadrant Centre Cardiff Business Park, Llanishan, Cardiff, Wales CF14 5RA United Kingdom
GP- Pharm Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spanien
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