natgillin/translations-raw huggingface dataset:
Metoclopramid: i et klinisk studie blev der ikke påvist nogen farmakokinetisk interaktion mellem en enkelt intravenøs dosis palonosetron og steady state koncentration af peroral metoclopramid, som er en CYP2D6 inhibitor.
Metoclopramide: in a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.
CYP2D6 fremmere og hæmmere: i en populations- farmakokinetisk analyse er det blevet vist, at der ikke var nogen signifikant virkning på palonosetrons clearance, når det blev givet sammen med CYP2D6 fremmere (dexamethason og rifampicin) og hæmmere (herunder amiodaron, celecoxib, chlorpromazin, cimetidin, doxorubicin, fluoxetin, haloperidol, paroxetin, quinidin, ranitidin, ritonavir, sertralin eller terbinafin).
CYP2D6 inducers and inhibitors: in a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Kortikosteroider: palonosetron er indgivet sikkert sammen med kortikosteroider.
Corticosteroids: palonosetron has been administered safely with corticosteroids.
Andre lægemidler: palonosetron er indgivet sikkert sammen med analgetika, antiemetika/ antinauseatika, spasmolytika og antikolinergika.
Other medicinal products: palonosetron has been administered safely with analgesics, antiemetic/ antinauseants, antispasmodics and anticholinergic medicinal products.
3 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/ fostrets udvikling, fødslen eller den postnatale udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
5. 3).
Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
Palonosetron bør derfor ikke anvendes til gravide kvinder, medmindre det af lægen anses for tvingende nødvendigt.
3 There is no experience of palonosetron in human pregnancy so palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Da der ikke findes data vedrørende udskillelsen af palonosetron i modermælk, bør amning ophøre under behandlingen.
As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
Da palonosetron kan fremkalde svimmelhed, somnolens eller træthed, skal patienterne advares, når de kører eller betjener maskiner.
Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.
I kliniske undersøgelser med en dosering på 250 mikrogram (totalt 633 patienter) var de hyppigst observerede bivirkninger, i det mindste muligvis relaterede til Aloxi, hovedpine (9%) og obstipation (5%).
In clinical studies at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9%) and constipation (5%).
I de kliniske undersøgelser blev de følgende bivirkninger observeret som muligvis eller sandsynligvis at have forbindelse med Aloxi.
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to Aloxi.
De blev klassificeret som almindelige (mellem 1% og 10%) eller usædvanlige (mellem 0, 1% og 1%).
These were classified as common (between 1% and 10%) or uncommon (between 0.1% and 1%).
Almindelige bivirkninger
Common ARs
Ikke
Uncommon ARs
(> 1/ 100 til < 1/ 10) Undersøgelser
(> 1/ 100 to < 1/ 10)
Forhøjede transaminaser,
(> 1/ 1,000 to < 1/ 100)
elektrocardiogram QT forlænget Hjerte
Metabolism and nutrition disorders
Tachycardi, bradycardi, ekstrasystoler, myocardieiskæmi, sinustachycardi, sinusarrhythmi, supraventriculære ekstrasystoler
Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Nervesystemet
Psychiatric disorders
Hovedpine
Anxiety, euphoric mood
Somnolens, insomni, paræstesier,
Nervous system disorders
Øjne Øre og labyrint Luftveje, thorax og mediastinum
Headache Dizziness
Svimmelhed
Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy
søvntrang, perifer sensorisk neuropati Øjenirritation, amblyopi Transportsyge, tinnitus Hikke
Eye disorders Ear and labyrinth disorders Cardiac disorders
Mave- tarmkanalen
Eye irritation, amblyopia Motion sickness, tinnitus Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Obstipation Diaré
Vascular disorders
Dyspepsi, abdominalsmerter, øvre abdominalsmerter, mundtørhed, flatulens
Hypotension, hypertension, vein discolouration, vein distended
Nyrer og urinveje Hud og subkutane væv Knogler, led, muskler og bindevæv Metabolisme og ernæring
Respiratory, thoracic and mediastinal disorders
Urinretention, glucosuri Allergisk dermatitis, kløende udslæt Arthralgier Hyperkalæmi, stofskiftesygdomme, hypocalcæmi, hypokalæmi, anorexi, hyperglycæmi, nedsat appaetit
Gastrointestinal disorders Hepato-biliary disorders Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Vaskulære sygdomme
Constipation Diarrhoea
Hypotension, hypertension, misfarvning af vener, distenderetede vener
Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence Hyperbilirubinaemia Dermatitis allergic, pruritic rash Arthralgia
Almene symptomer og reaktioner på administrationsstedet Lever og galdeveje Psykiske forstyrrelser
Renal and urinary disorders General disorders and administration site conditions Investigations
Astheni, feber, træthed, varmefølelse, influenzalignende sygdom Hyperbilirubinæmi Angst, euforisk stemning
Urinary retention, glycosuria Asthenia, pyrexia, fatigue, feeling hot, influenza like illness Elevated transaminases,, electrocardiogram QT prolonged
Meget sjældne tilfælde (< 1/ 10. 000) med overfølsomhedsreaktioner og reaktioner på indgivelsesstedet (brænden, induration, ubehag og smerter) blev rapporteret fra erfaringer efter markedsføring.
Very rare cases (< 1/ 10,000) of hypersensitivity reactions and injection site reactions (burning, induration, discomfort and pain) were reported from post-marketing experience.
Doser på op til 6 mg har været anvendt i kliniske undersøgelser.
Doses of up to 6 mg have been used in clinical trials.
Den højeste dosisgruppe udviste en lignende bivirkningsfrekvens sammenlignet med de andre dosisgrupper og der blev ikke observeret nogen dosis respons virkninger.
The highest dose group showed a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed.
På grund af det store fordelingsvolumen er det dog usandsynligt, at dialyse vil være en effektiv behandling af Aloxi overdosering.
Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Aloxi overdose.
Antiemetika og antinauseatika, serotonin (5HT3) antagonister.
Antiemetics and antinauseants, serotonin (5HT3) antagonists.
Palonosetron er en selektiv receptorantagonist med høj affinitet til 5HT3 receptoren.
5 Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.
5 I to randomiserede dobbelt blinde undersøgelser med sammenlagt 1. 132 patienter, der fik moderat kvalmefremkaldende kemoterapi omfattende cisplatin ≤ 50 mg/ m2, carboplatin, cyclophosphamid ≤ 1. 500 mg/ m2 og doxorubicin > 25 mg/ m2, blev palonosetron 250 mikrogram og 750 mikrogram sammenlignet med ondansetron 32 mg (halveringstid 4 timer) eller dolasetron 100 mg (halveringstid 7, 3 timer) indgivet intravenøst på dag 1 uden dexamethason.
In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤ 50 mg/ m2, carboplatin, cyclophosphamide ≤ 1,500 mg/ m2 and doxorubicin > 25 mg/ m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone.
I en randomiseret dobbelt blind undersøgelse med sammenlagt 667 patienter, der fik kraftigt kvalmefremkaldende kemoterapi omfattende cisplatin ≥ 60 mg/ m2, cyclophosphamid > 1. 500 mg/ m2 og dacarbazine, blev palonosetron 250 mikrogram og 750 mikrogram sammenlignet med ondansetron 32 mg indgivet intravenøst på dag 1.
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/ m2, cyclophosphamide > 1,500 mg/ m2 and dacarbazine, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg administered intravenously on Day 1.
Dexamethason blev givet profylaktisk før kemoterapi hos 67% af patienterne.
Dexamethasone was administered prophylactically before chemotherapy in 67% of patients.
Den antiemetiske virkning blev iagttaget over 0- 24 timer, 24- 120 timer og 0- 120 timer.
The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Resultaterne af undersøgelserne omhandlende moderat kvalmefremkaldende kemoterapi og for undersøgelsen omhandlende kraftigt kvalmefremkaldende kemoterapi er opsummeret i de følgende tabeller.
Results for the studies on moderately emetogenic chemotherapy and for the study on highly emetogenic chemotherapy are summarised in the following tables.
Selvom den relative virkning af palonosetron ved multiple behandlingscykler ikke er blevet demonstreret i kontrollerede kliniske undersøgelser, fortsatte 875 patienter, der var inkluderet i de tre fase tre undersøgelser, i en åben sikkerhedsundersøgelse og blev behandlet med palonosetron 750 mikrogram i op til 9 yderligere cykler med kemoterapi.
Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical trials, 875 patients enrolled in the three phase 3 trials continued in an open label safety study and were treated with palonosetron 750 micrograms for up to 9 additional cycles of chemotherapy.
6 Tabel 1:
Table 1:
Procentdel af patientera, der responderer ud fra behandlingsgruppe og fase i undersøgelsen med moderat kvalmefremkaldende kemoterapi sammenlignet med ondansetron.
micrograms (n= 189)%
Aloxi Ondansetron 250 mikrogram 32 milligram (n= 189) (n= 185) Delta%%%
32 milligrams (n= 185)%
Fuldt respons (Ingen kvalme eller opkastning og ingen behovsmedicin)
Complete Response (No Emesis and No Rescue Medication)
24 – 120 timer 0 – 120 timer
24 – 120 hours 0 – 120 hours
kontrol (Fuldt respons og 0 – 24 timer
Complete Control (Complete Response and No More Than Mild Nausea)
p- værdic NS
p-value c
24 – 120 timer 0 – 120 timer
0 – 24 hours 76.2 65.4 24 – 120 hours 66.7 50.3 0 – 120 hours 63.0 44.9 No Nausea (Likert Scale)
< 0, 001 < 0, 001
10.8 16.4 18.1
p- værdic
NS 0.001 0.001 p-value c
0 – 24 timer
0 – 24 hours 60.3 56.8 24 – 120 hours 51.9 39.5
56, 8
3.5 12.4
NS
NS NS
24 – 120 timer 0 – 120 timer
0 – 120 hours Intent-to-treat cohort.
Hensigt- til- at- behandle kohorte b Undersøgelsen var designet til at vise ikke dårligere kvalitet.
The study was designed to show non-inferiority.
En nedre grænse større end – 15% viser ikke dårligere kvalitet mellem Aloxi og kontrollen. c Chi2- test.
A lower bound greater than – 15% demonstrates non-inferiority between Aloxi and comparator. c Chi-square test.
Signifikansniveau α=0, 05.
Significance level at α =0.05.
7 Tabel 2:
6 Table 2:
Procentdel af patientera, der responderer ud fra behandlingsgruppe og fase i undersøgelsen med moderat kvalmefremkaldende kemoterapia sammenlignet med dolasetron.
micrograms (n= 185)%
Aloxi Dolasetron 250 mikrogram 100 milligram (n= 185) (n= 191) Delta%%%
100 milligrams (n= 191)%
[- 3, 4%, 27, 1%] [- 0, 3%, 23, 7%]
[3.4%, 27.1%] [0.3%, 23.7%]
Fuld
p-value c
kontrol (Fuldt respons og 0 – 24 timer
0 – 24 hours
ikke mere end let kvalme) 57, 0 47, 6
47.6
p- værdic NS
NS
p- værdic
p-value c
48, 7
48.7
Hensigt- til- at- behandle kohorte b Undersøgelsen var designet til at vise ikke dårligere kvalitet.
Intent-to-treat cohort. b The study was designed to show non-inferiority.
8 Tabel 3:
Table 3:
Procentdel af patientera, der responderer ud fra behandlingsgruppe og fase i undersøgelsen med kraftigt kvalmefremkaldende kemoterapia sammenlignet med ondansetron Aloxi Ondansetron 250 mikrogram 32 milligram (n= 223) (n= 221) Delta%%%
Delta%
Fuldt respons (Ingen kvalme eller opkastning og ingen behovsmedicin) CI b
Complete Response (No Emesis and No Rescue Medication)
97. 5%
97.5% CI b
0 – 24 timer 59, 2 57, 0 2, 2 24 – 120 timer 45, 3 38, 9 0 – 120 timer 40, 8 33, 0 Fuld kontrol (Fuldt respons og ikke mere end let kvalme)
0 – 24 hours 59.2 57.0 24 – 120 hours 45.3 38.9
[- 8, 8%, 6, 4 7, 8
0 – 120 hours
13, 1%]
[-2.9%, 18.5%]
[- 4, 6%, 17, 3%] [- 2, 9%, 18, 5%] p- værdic
p-value c
0 – 24 timer 56, 5 51, 6 24 – 120 timer 40, 8 35, 3 0 – 120 timer 37, 7 29, 0 Ingen kvalme (Likert skala)
0 – 24 hours 24 – 120 hours 0 – 120 hours No Nausea (Likert Scale)
NS NS NS p- værdic
NS NS NS p-value c
0 – 24 timer 53, 8 49, 3 24 – 120 timer 35, 4 32, 1 0 – 120 timer 33, 6 32, 1 a Hensigt- til- at- behandle kohorte b
0 – 24 hours 24 – 120 hours 0 – 120 hours a
4, 5 3, 3 1, 5
4.5 3.3 1.5
NS NS NS
NS NS NS
Undersøgelsen var designet til at vise ikke dårligere kvalitet.
Intent-to-treat cohort. b The study was designed to show non-inferiority.
Virkningen af palonosetron på blodtryk, hjerterytme og ekg- parametre, herunder QTc, var sammelignelig med ondansetron og dolasetron i de kliniske CINV- forsøg.
7 The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in CINV clinical trials.
I ikke- kliniske forsøg kunne palonosetron blokere de ionkanaler, der er involveret i den ventrikulære de - og repolarisering, og stoffet kunne forlænge varigheden af aktionspotentialet.
In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarisation and to prolong action potential duration.
Virkningen af palonosetron på QTc- intervallet blev undersøgt i et dobbeltblindet, randomiseret, parallelt, placebo - og positivkontrolleret forsøg (moxifloxacin) i mænd og kvinder.
The effect of palonosetron on QTc interval was evaluated in a double blind, randomised, parallel, placebo and positive (moxifloxacin) controlled trial in adult men and women.
Formålet var at undersøge ekg - virkningen af intravenøst palonosetron ved enkeltdoser på 0, 25, 0, 75 eller 2, 25 mg i 221 raske forsøgsdeltagere.
The objective was to evaluate the ECG effects of IV administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Forsøget viste ingen virkning på varigheden af QT/ QTc- intervallet eller noget andet ekg - interval ved doser på op til 2, 25 mg.
The study demonstrated no effect on QT/ QTc interval duration as well as any other ECG interval at doses up to 2.25 mg.
40 timer.
Absorption Following intravenous administration, an initial decline in plasma concentrations is followed by slow elimination from the body with a mean terminal elimination half-life of approximately 40 hours.
Middel maksimal plasmakoncentration (Cmax) og arealet under koncentrations- tids kurven (AUC0- ∞) er overvejende dosis - proportional i dosisområdet fra 0, 3– 90 μg/ kg hos sunde forsøgspersoner og hos cancerpatienter.
Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞) are generally dose-proportional over the dose range of 0.3– 90 μ g/ kg in healthy subjects and in cancer patients.
Efter intravenøs indgift af tre doser 0, 25 mg palonosetron én gang hver anden dag hos 11 patienter med testikelkræft var den gennemsnitlige stigning (± SD) i plasmakoncentration fra dag 1 til dag 5 42 ± 34%.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34%.
9 Efter intravenøs indgift af palonosetron 0, 25 mg én gang dagligt i tre dage i 12 raske forsøgsdeltagere var den gennemsnitlige stigning (± SD) i plasma- palonosetronkoncentration fra dag 1 til dag 3 110 ± 45%.
After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45%.
Farmakokinetiske simuleringer indikerer, at den overordnede eksponering (AUC0- ∞) af 0, 25 mg intravenøst palonosetron én gang dagligt i 3 dage i træk var sammenlignelig med en enkelt iv- dosis på 0, 75 mg, selvom Cmax for 0, 75 mg enkeltdosen var højere.
Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
6, 9 to 7, 9 l/ kg.
Distribution Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/ kg.
62% af palonosetron er bundet til plasmaproteiner.
Approximately 62% of palonosetron is bound to plasma proteins.
50% metaboliseres, således at der dannes to primære metabolitter, som har mindre end 1% af palonosetrons 5HT3 receptor antagonistvirkning.
Metabolism Palonosetron is eliminated by dual route, about 40% eliminated through the kidney and with approximately 50% metabolised to form two primary metabolites, which have less than 1% of the 5HT3 receptor antagonist activity of palonosetron.
In vitro metabolismeundersøgelser har vist, at CYP2D6 og i mindre omfang CYP3A4 og CYP1A2 isoenzymerne er involveret i metabolismen af palonosetron.
In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron.
Palonosetron hæmmer ikke og inducerer ikke cytokrom P450 isoenzymer i klinisk relevante koncentrationer.
Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations.
40% af den indgivne dosis som uændret aktivt stof.
Elimination After a single intravenous dose of 10 micrograms/ kg [14C]-palonosetron, approximately 80% of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40% of the administered dose, as unchanged active substance.
Efter en enkelt intravenøs bolusindgift til raske forsøgspersoner var den totale clearance fra kroppen af palonosetron 173 ± 73 ml/ min og den renale clearance var 53 ± 29 ml/ min.
After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/ min and renal clearance was 53 ± 29 ml/ min.
40 timer.
The low total body clearance and large volume of distribution resulted in a terminal elimination half-life in plasma of approximately 40 hours.
Ældre: alder påvirker ikke palonosetrons farmakokinetik.
Elderly: age does not affect the pharmacokinetics of palonosetron.
Køn: køn påvirker ikke palonosetrons farmakokinetik.
8 Gender: gender does not affect the pharmacokinetics of palonosetron.
Pædiatriske patienter: der findes ingen farmakokinetiske data fra patienter under 18- års alderen.
Paediatric patients: no pharmacokinetic data are available in patients below 18 years of age.
Nedsat nyrefunktion: let til moderat nedsat nyrefunktion påvirker ikke signifikant palonosetrons farmakokinetiske parametre.
Renal impairment: mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Den totale kropsclearance hos disse patienter er dog den samme som hos raske forsøgspersoner.
Severe renal impairment reduces renal clearance, however total body clearance in these patients is similar to healthy subjects.
Nedsat leverfunktion: nedsat leverfunktion påvirker ikke signifikant palonosetrons totale kropsclearance sammenlignet med raske forsøgspersoner.
Hepatic impairment: hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
I ikke- kliniske forsøg blev der kun iagttaget virkninger ved eksponering, som ansås for i tilstrækkelig grad at overstige maksimal eksponering for mennesker, og disse er derfor kun af ringe relevans ved klinisk brug.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Ikke- kliniske undersøgelser peger på, at palonosetron kun ved meget høje koncentrationer kan blokere ionkanaler involveret i ventrikulær de - og repolarisation og forlænge aktionspotentialets varighed.
Nonclinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
10 Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/ fostrets udvikling, fødslen eller den postnatale udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
4. 6).
Only limited data from animal studies are available regarding the placental transfer (see section 4.6).
FARMACEUTISKE OPLYSNINGER
6 PHARMACEUTICAL PARTICULARS
Mannitol Dinatriumedetat Natriumcitrat Citronsyremonohydrat Vand til injektion Natriumhydroxidopløsning Saltsyreopløsning
Mannitol Disodium edetate Sodium citrate Citric acid monohydrate Water for injections Sodium hydroxide solution Hydrochloric acid solution
Efter åbning af hætteglasset, skal ikke anvendt opløsning kasseres.
Upon opening of the vial, any unused solution should be discarded.
Findes i pakninger med 1 hætteglas indeholdende 5 ml opløsning.
9 Available in packs of 1 vial containing 5 ml of solution.
6. 6 Regler for destruktion
6.6 Special Precautions for disposal
Ikke anvendt opløsning skal kasseres.
Single use only, any unused solution should be discarded.
Damastown Mulhuddart Dublin 15 Irland
Damastown Mulhuddart Dublin 15 Republic of Ireland
22 marts 2005
22 March 2005
VIRKSOMHEDSGODKENDELSEANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
INDEHAVERAF VIRKSOMHEDSGODKENDELSE ANSVARLIG( E) FOR BATCHFRIGIVELSE
11 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Damastown, Mulhuddart, Dublin 15 Irland
Damastown, Mulhuddart, Dublin 15 Republic of Ireland
Indehaveren af markedsføringstilladelsen skal oplyse Europa- Kommissionen om markedsføringsplanen for det lægemiddel, der er godkendt i henhold til denne beslutning.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
14 BILAG III
12 ANNEX III
16 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE:
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING:
Aloxi 250 mikrogram injektionsvæske, opløsning Palonosetron (som hydroklorid)
Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride)
50 mikrogram/ ml (som hydroklorid)
One vial of 5 ml contains 250 micrograms of palonosetron 50 micrograms/ ml (as hydrochloride)
Indeholder også mannitol, dinatriumedetat, natriumcitrat, citronsyremonohydrat, vand til injektion natriumhydroxidopløsning og saltsyreopløsning.
Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide solution and hydrochloric acid solution
1 hætteglas - 5 ml
1 vial - 5 ml
Til intravenøs anvendelse Kun til engangsbrug Ubrugt opløsning skal kasseres
For intravenous use Single use only Any unused solution should be discarded
INFORMATION I BRAILLE- SKRIFT
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING: