natgillin/translations-raw huggingface dataset:
De mest almindeligt rapporterede grad 3 eller 4 bivirkninger var inden for blod og lymfesystem, herunder neutropeni (41,7 %), anæmi (27 %) og trombocytopeni (20,7 %), inden for infektioner og parasitære sygdomme, herunder pneumoni (9 %), samt inden for almene symptomer og reaktioner på administrationsstedet, herunder træthed (4,7 %), pyreksi (3 %) og perifert ødem (1,3 %).
The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema peripheral (1.3%).
• Den anbefalede startdosis af dexamethason er 20 mg pr. dag.
• The recommended starting dose of dexamethasone is 20 mg per day.
Hvis du har taget for meget Imnovid
If you take more Imnovid than you should
Det forventes det, at pomalidomid har en teratogen virkning hos mennesker, hvis det indtages under graviditet (se pkt.
If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is expected (see section 4.4).
• Pomalidomid i kombination med dexamethason Dosisjustering af pomalidomid er ikke nødvendig.
• Pomalidomide in combination with dexamethasone No dose adjustment is required for pomalidomide.
Administration af den potente CYP1A2-hæmmer fluvoxamin sammen med pomalidomid, når ketoconazol var til stede, øgede den gennemsnitlige eksponering for pomalidomid med 107 % (90 % konfidensinterval 91-124 %) sammenlignet med pomalidomid plus ketoconazol.
Co-administration of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of ketoconazole, increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% to 124%] compared to pomalidomide plus ketoconazole.
• Seksuelt samleje kun med en vasektomeret mandlig partner.
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
• Mini-piller kun med ægløsningshæmmende progestogen (f.eks. desogestrel)
• Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Almindelig Hypokaliæmi Hyperglykæmi Hypomagnesiæmi Hypocalcæmi Hypofosfatæmi Hyperkaliæmi Hypercalcæmi
Hypokalaemia Hyperglycaemia Hypomagnaesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
• Den anbefalede dosis af Imnovid er 4 mg pr. dag.
• The recommended dose of Imnovid is 4 mg per day.
I et andet studie, der blev udført for udelukkende at evaluere metaboliske ændringer pga. CYP1A2-hæmning, øgede samtidig administration af fluvoxamin alene og pomalidomid den gennemsnitlige eksponering for pomalidomid med 125 % (90 % konfidensinterval 98- 157 %) sammenlignet med pomalidomid alene.
In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone.
Imnovid kun sammen med dexamethason
Imnovid with dexamethasone only
Septisk shock Clostridium difficile-kolitis Luftvejsinfektion Nedre luftvejsinfektion Lungeinfektion Influenza
Clostridium difficile colitis Respiratory tract infection Lower respiratory tract infection Lung infection
Gennemsnitlig normaliseret AUC-eksponering over for pomalidomid var forøget med 35,8 % med et 90 % CI [7,5 % til 70,0 %] hos patienter med svært nedsat nyrefunktion, der var dialysekrævende (CrCl < 30 ml/minut, dialysekrævende), sammenlignet med patienter med normal nyrefunktion.
Mean normalised AUC exposure to pomalidomide increased by 35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis (CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function.
Hos patienter, der havde fået 1 tidligere antimyelomlinje, var den mediane PFS-tid 20,73 måneder (95 % CI: 15,11; 27,99) i armen med Pom+Btz+LD-Dex og 11,63 måneder (95 % CI: 7,52; 15,74) i armen med Btz+LD-Dex.
In patients who received 1 prior antimyeloma line, median PFS time was 20.73 months (95% CI: 15.11, 27.99) in the Pom + Btz + LD-Dex arm and 11.63 months (95% CI: 7.52, 15.74) in the Btz + LD-Dex arm. A 46% risk reduction was observed with Pom + Btz + LD-Dex treatment (HR = 0.54, 95% CI: 0.36,
Almindelig Pancytopeni
Common Pancytopenia
Bemærk: CI=konfidensinterval, NE = kan ikke estimeres (Not Estimable).
NE = Not Estimable.
• Den anbefalede startdosis af dexamethason er 40 mg pr. dag.
• The recommended starting dose of dexamethasone is 40 mg per day.
Instruktionerne i dosisjustering i denne tabel gælder for pomalidomid i kombination med bortezomib og dexamethason og for pomalidomid i kombination med dexamethason.
Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
• Formularer til rapportering af bivirkninger
• Adverse event reporting forms
• Pomalidomid i kombination med bortezomib og dexamethason Dosisjustering af pomalidomid er ikke nødvendig.
• Pomalidomide in combination with bortezomib and dexamethasone No dose adjustment is required for pomalidomide.
Det er vigtigt at bemærke, at patienter med myelomatose, der behandles med pomalidomid, kan udvikle andre typer kræft.
It is important to note that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
Gennemsnitlig normaliseret AUCeksponering over for pomalidomid var 98,2 % med et 90 % konfidensinterval [77,4 % til 120,6 %] hos patienter med moderat nedsat nyrefunktion (eGFR ≥ 30 til ≤ 45 ml/minut/1,73 m2) sammenlignet med patienter med normal nyrefunktion.
Mean normalised AUC exposure to pomalidomide was 98.2% with a 90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to ≤45 mL/minute/1.73 m2) compared to patients with normal renal function.
• Forhøjet kalium i blodet, hvilket kan forårsage unormal hjerterytme.
• High blood levels of potassium, which may cause abnormal heart rhythm.
• Udslæt.
• Pregnancy.
A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
Name and address of the manufacturer responsible for batch release
Instruktioner i dosisreduktion for dexamethason-relaterede bivirkninger er anført i tabel 6 nedenfor.
Instructions for dose reduction for dexamethasone related adverse reactions are outlined in Table 6 below.
Gennemsnitlig normaliseret AUC-eksponering over for pomalidomid var 100,2 % med et 90 % konfidensinterval [79,7 % til 127,0 %] hos patienter med svært nedsat nyrefunktion, som ikke var dialysekrævende (CrCl < 30 eller eGFR < 30 ml/minut/1,73 m2), sammenlignet med patienter med normal nyrefunktion.
Mean normalised AUC exposure to pomalidomide was 100.2% with a 90% confidence interval [79.7% to 127.0%] in severe renal impairment patients not requiring dialysis (CrCl <30 or eGFR <30 mL/minute/1.73 m2) compared to patients with normal renal function.
Hos kaniner forårsagede pomalidomid embryoføtale udviklingsmæssige misdannelser ved doser i intervallet fra 10 til 250 mg/kg.
In rabbits, pomalidomide at dosages ranging from 10 to 250 mg/kg produced embryo-foetal developmental malforma tions.
Neutropenisk sepsis Pneumoni (bakterie-, virus- og svampeinfektioner, herunder opportunistiske infektioner) Bronkopneumoni Luftvejsinfektion Øvre luftvejsinfektion
Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Du vil få taget blodprøver før behandlingen og regelmæssigt under behandlingen med Imnovid.
Before and during the treatment with Imnovid you will have regular blood tests.
• Muskelspasmer, muskelsvaghed.
• Muscle spasm, muscle weakness.
Instruktioner i dosisjustering af dexamethason Toksicitet
Dexamethasone dose modification instructions Toxicity
Ikke almindelig Cerebrovaskulært anfald
Uncommon Cerebrovascular accident
> 75 år Dosis (cyklus 1-8: Dag 1, 2, 4, 5, 8, 9, 11, 12 i en 21-dages cyklus Cyklus ≥ 9: Dag 1, 2, 8, 9 i en 21dages cyklus)
> 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Udslæt Udslæt = grad 2-3
Rash Rash = Grade 2-3
Dosisniveau -1
Dose Level -1
• skal du bruge sikker prævention i mindst 4 uger før, behandlingen påbegyndes, i al den tid, du får behandlingen, og i mindst 4 uger efter behandlingsophør.
• you must use effective methods of contraception for at least 4 weeks before starting treatment, for the whole time you are taking treatment, and until at least 4 weeks after stopping treatment.
• Den anbefalede startdosis af Imnovid er 4 mg pr. dag.
• The recommended starting dose of Imnovid is 4 mg per day.
En lægeligt superviseret graviditetstest skal udføres enten under selve den konsultation, hvor patienten får ordineret pomalidomid, eller inden for de sidste 3 dage inden konsultationen hos den ordinerende læge.
A medically supervised pregnancy test should be performed during the consultation, when pomalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
≤ 75 år Dosis (cyklus 1-8: Dag 1, 2, 4, 5, 8, 9, 11, 12 i en 21-dages cyklus Cyklus ≥ 9: Dag 1, 2, 8, 9 i en 21-dages cyklus)
≤ 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Titandioxid (E171) Indigotin (E132) Brilliant blue FCF (E133) Hvidt blæk
Titanium dioxide (E171) Indigotine (E132) Brilliant blue FCF (E133) White ink
Fordelen ved at bruge Imnovid sammen med dexamethason Når Imnovid anvendes sammen med dexamethason hos personer, som har fået mindst to andre behandlinger, kan det forhindre, at myelomatosen forværres:
When Imnovid is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:
Meget almindelig Neutropeni Trombocytopeni Anæmi
Very Common Neutropenia Thrombocytopenia Anaemia
Propylenglycol (E1520) Ammoniumhydroxid (E527)
Propylene glycol (E1520) Ammonium hydroxide (E527)
Dataafskæring: 7. september 2012
Data cutoff: 07 Sep 2012
c Baseret på Cox proportionale hazards model, som sammenligner hazard-funktionerne relateret til behandlingsgrupperne, d P-værdien er baseret på en non-stratificeret log-rank-test.
Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups.
Imnovid 2 mg hårde kapsler, Imnovid 3 mg hårde kapsler, Imnovid 4 mg hårde kapsler Hvidt blæk
Imnovid 2 mg hard capsules, Imnovid 3 mg hard capsules, Imnovid 4 mg hard capsules White ink
Hvis potente CYP1A2-hæmmere (f.eks. ciprofloxacin, enoxacin og fluvoxamin) administreres sammen med pomalidomid, skal dosis af pomalidomid reduceres med 50 % (se pkt.
If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50% (see sections 4.5 and 5.2).
Det primære effekt endepunkt var progressionsfri overlevelse i henhold til kriterierne fra International
The primary efficacy endpoint was progression free survival by International Myeloma Working Group (IMWG criteria).
For patienter, der testes positive for HBV-infektion, anbefales konsultation med en læge med ekspertise i behandlingen af hepatitis B. Der bør udvises forsigtighed, når pomalidomid anvendes i kombination med dexamethason til patienter, der tidligere er blevet inficeret med HBV, herunder patienter, som er anti-HBc-positive, men HBsAg-negative.
Caution should be exercised when pomalidomide in combination with dexamethasone is used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg negative.
Instruktioner i dosisjustering af pomalidomid∞ Toksicitet
Pomalidomide dose modification instructions Toxicity
Andel af patienter
Propotion of Patients
Almindelig Lungeemboli
Common Pulmonary embolism
Blødningshændelser har omfattet epistaxis, intrakraniel blødning og mave-tarm-blødning.
Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.
Jernoxid, sort (E172) Propylenglycol (E1520) Ammoniumhydroxid (E527)
Iron oxide black (E172) Propylene glycol (E1520) Ammonium hydroxide (E527)
Almindelig Intrakraniel blødning
Common Intracranial haemorrhage
Almindelig Forhøjet urinsyre i blodet
Common Blood uric acid increased
5.3 Prækliniske sikkerhedsdata Toksicitetsstudier med gentagne doser
Repeat-dose toxicology studies
som er gravid eller i den fertile alder, da sædvæsken stadig kan indeholde pomalidomid, selvom den ikke indeholder spermatozoer.
This includes vasectomised males who should wear a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still contain pomalidomide in the absence of spermatozoa.
Virkningen og sikkerheden af pomalidomid i kombination med dexamethason blev evalueret i et multicenter, randomiseret, open-label fase III-studie (CC-4047-MM-003), hvor pomalidomid plus lavdosis-dexamethason (Pom+LD-Dex) blev sammenlignet med monoterapi med højdosis dexamethason (HD-Dex) hos tidligere behandlede voksne patienter med relaps og refraktær myelomatose.
The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in previously treated adult patients with relapsed and refractory multiple myeloma, who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Almindelig Hypomagnesiæmi Hypocalcæmi Hypofosfatæmi Hyperkaliæmi Hypercalcæmi
Hypomagnesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
• Kapselskallen indeholder: gelatine, titandioxid (E171), indigotin (E132), brilliant blue FCF
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF
Bivirkninger rapporteret i det kliniske studie MM-003 hos patienter behandlet med pomalidomid i kombination med dexamethason Systemorganklasse/ foretrukken term
ADRs reported in clinical study MM-003 in patients treated with pomalidomide in combination with dexamethasone.
Ikke almindelig Forhøjet urinsyre i blodet
Uncommon Blood uric acid increased
Dosisjustering eller dosisafbrydelse af dexamethason Instruktioner i dosisafbrydelser eller -reduktioner for lavdosis-dexamethason-relaterede bbivirkninger er anført i tabel 4 og 5 nedenfor.
Instructions on dose interruptions or reductions for low-dose dexamethasone related adverse reactions are outlined in Tables 4 and 5 below.
Brochure til kvindelige patienter i den fertile alder
Brochure for women patients with childbearing potential
KM median HD-DEX = 34,0 [23,4-39,9] Progression/død; POM+LD-DEX =75/284 HD-DEX = 56/139
POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.53 (0.37, 0.74) KM median: POM+LD-DEX=NE [48.1, NE] KM median: HD-DEX = 34.0[23.4, 39.9] Events: POM+LD-DEX=75/284 HD-DEX=56/139
Dosisjustering eller dosisafbrydelse af pomalidomid Instruktioner i dosisafbrydelser eller -reduktioner for pomalidomid relaterede bivirkninger er anført i tabel 2 og 3 nedenfor.
Instructions for dose interruptions or reductions for pomalidomide related adverse reactions are outlined in Table 2 and 3.
• hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid - da Imnovid forventes at være skadeligt for det ufødte barn.
• if you are pregnant or think you may be pregnant or are planning to become pregnant - this is because Imnovid is expected to be harmful to an unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and breast-feeding - information for women and men” below).
Dosisniveau -2
Dose Level -2
Døde n (%) Overlevelsestid (uger) Mediana
Progression Free Survival Time (weeks) Median a
• Råd om sikkerhed, som er relevante for kvinder i den fertile alder o Nødvendigheden af at undgå føtal eksponering o Beskrivelse af PPP
• Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for effective contraception (even if woman has amenorrhoea) and definition of effective contraception
Imnovid 1 mg hårde kapsler Imnovid 2 mg hårde kapsler Imnovid 3 mg hårde kapsler Imnovid 4 mg hårde kapsler
Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules
Ødem ≥ grad 3
Oedema ≥ Grade 3
Muskelsvaghed ≥ grad 2
Muscle weakness ≥ Grade 2
Almindelig Hyperkaliæmi Hyponatriæmi
Common Hyperkalaemia Hyponatraemia
• Alt sundhedspersonale, som har til hensigt at ordinere (og udlevere) pomalidomid, modtager en informationspakke til læger inden ordination (og hvor det er hensigtsmæssigt og efter aftale med den relevante nationale myndighed, inden udleveringen).
• Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following:
Af hensyn til miljøet skal al ikke anvendt medicin afleveres på apoteket efter endt behandling.
Any unused medicine should be returned to the pharmacist at the end of treatment.
Knogler, led, muskler og bindevæv
muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes.
Dosisjustering eller dosisafbrydelse af dexamethason Instruktioner i dosisjustering for dexamethason-relaterede bivirkninger er anført i tabel 4.
Instructions for dose modification for dexamethasone related adverse reactions are outlined in Table 4.
>75), sygdomspopulation (refraktær over for både lenalidomid og bortezomib versus ikke refraktær over for begge aktive stoffer) og antal tidligere behandlinger mod myelom (=2 versus.
Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs >75),diseases population (refractory to both lenalidomide and bortezomib vs not refractory to both active substances), and prior number of anti myeloma therapy (=2 vs >2).
• nogle lægemidler mod svampeinfektion, såsom ketoconazol
• some antifungals such as ketaconazole
Imnovid 1 mg hårde kapsler Imnovid 2 mg hårde kapsler Imnovid 3 mg hårde kapsler Imnovid 4 mg hårde kapsler pomalidomid
Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules pomalidomide
Almindelig Katarakt
Common Cataract
Almindelig Nedsat bevidsthed
Common Depressed level of consciousness
Tumorlysesyndrom
Pneumonia
I alt 559 patienter indgik og blev randomiseret i studiet: 281 i armen med Pom+Btz+LD-Dex og 278 i armen med Btz+LD-Dex.
A total of 559 patients were enrolled and randomised in the study: 281 in the Pom+Btz+LD-Dex arm and 278 in the Btz+LD-Dex arm. 54% of patients were male with median age for the overall population of 68 years (min, max: 27, 89 years).
Imnovid 1 mg hårde kapsler Hvidt blæk
Imnovid 1 mg hard capsules White ink
Log-rank p-værdi=< 0,001 (tosidet) HR (95 % CI) 0,45 (0,35-0,59)
POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.45 (0.35, 0.59) Events: POM+LD-DEX=164/302 HD-DEX=103/153
Dosisjustering eller dosisafbrydelse af bortezomib
Bortezomib dose modification or interruption
Almindelig Akut nyreskade Kronisk nyreskade Urinretention
Acute kidney injury Chronic kidney injury Urinary retention
• Sterilisation ved lukning af æggelederne
• Tubal sterilisation
Forhøjet alaninaminotransferase Vægtreduktion
Alanine aminotransferase increased Weight decreased
• Kapselskallen indeholder: gelatine, titandioxid (E171), indigotin (E132) og gul jernoxid (E172) samt hvidt og sort blæk.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron oxide (E172) and white and black ink.
Meget almindelig Perifer sensorisk neuropati Svimmelhed
Very Common Peripheral sensory neuropathy Dizziness
Øvre luftvejsinfektion Luftvejsinfektion Nedre luftvejsinfektion Lungeinfektion Influenza
Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection
• IMN: Imnovid; DEX: Dexamethason Lægemiddelnavn Dag IMN DEX
Medicine name Day IMN DEX
Lever og galdeveje Ikke almindelig Hyperbilirubinæmi
Hepatobiliary disorders Uncommon Hyperbilirubinaemia
Almindelig Abdominalsmerter Øvre abdominalsmerter Stomatitis
Common Diarrhoea Vomiting Abdominal pain Constipation
Lægemiddelnavn
Medicine name
Hård kapsel Imnovid 1 mg hårde kapsler
Hard capsule Imnovid 1 mg hard capsules
Beslutninger om dosisafbrydelse eller dosisgenoptagelse sker efter lægens skøn i henhold til produktresuméet.
However, dose interruption or resumption decisions are at the physician's discretion per Summary of Product Characteristics (SmPC).
Ikke almindelig Øvre abdominalsmerter Stomatitis
Uncommon Abdominal pain upper Stomatitis
• En brochure til mænd
• Brochure for male patients
Ikke almindelig Cerebrovaskulært anfald Intrakraniel blødning
Cerebrovascular accident Intracranial haemorrhage
Titandioxid (E171) Indigotin (E132) Gul jernoxid (E172) Erythrosin (E127) Hvidt blæk
Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) Erythrosin (E127) White ink
Øvre luftvejsinfektion Viral øvre luftvejsinfektion
Upper respiratory tract infection Viral upper respiratory tract infection
Imnovid 2 mg hårde kapsler: Mørkeblå, uigennemsigtig hætte og orange uigennemsigtig kapselunderdel, præget med ”POML2 mg”.
Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written on them.
Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Imnovid:
Talk to your doctor, pharmacist or nurse before taking Imnovid if:
Ikke almindelig Hyperbilirubinæmi
Uncommon Hyperbilirubinaemia
• Nedsat natrium i blodet, hvilket kan forårsage træthed og forvirring, muskeltrækninger, epileptiske anfald og koma.
• Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits
Nedsat bevidsthed Perifer sensorisk neuropati Svimmelhed
Depressed level of consciousness Peripheral sensory neuropathy Dizziness
Almindelig Febril neutropeni Leukopeni Lymfopeni
Common Febrile neutropenia Leucopenia Lymphopenia
39.960 ng•t/ml (nanogram•time/ml) ved denne lavest testede dosis, og eksponeringsratio var 99 gange i forhold til en klinisk dosis på 4 mg).
Therefore, the NOAEL for these observed effects was < 25 mg/kg/day (AUC 24h was 39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold relative to a 4 mg clinical dose).
Mørkeblå, uigennemsigtig overdel og gul, uigennemsigtig underdel, præget med ”POML” med hvidt blæk og ”1 mg” med sort blæk, størrelse 4, hård gelatinekapsel.
Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule.
Meget almindelig Muskelsvaghed Rygsmerter
Very Common Muscular weakness Back pain
Kvinder i den fertile alder skal benytte mindst en sikker kontraception i mindst 4 uger før pomalidomid-behandlingen, under behandlingen, og i mindst 4 uger efter behandlingen.
Women of childbearing potential must use at least one effective method of contraception for at least 4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
• Hver kapsel indeholder 1 mg pomalidomid.
• Each capsule contains 1 mg of pomalidomide.
Almindelig Udslæt Pruritus
Common Rash Pruritus
• ét andet lægemiddel - der kaldes ‘dexamethason', til personer, hvis myelomatose er forværret,
• one other medicine - called ‘dexamethasone' in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.