natgillin/translations-raw huggingface dataset:
Der har været indberettet alvorlige bivirkninger ved samtidig brug af selektive serotonin genoptagningshæmmere (SSRI), serotonin norepinefrin genoptagningshæmmere (serotonin norepinephrine reuptake inhibitors, SNRI), tricykliske/tetracykliske antidepressiva og MAO-hæmmere (se pkt.
Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic/tetracyclic antidepressants and MAO inhibitors (see section 4.4).
Tabletovertræk: hypromellose, macrogol (6000), titandioxid (E171), jernoxid rød (E172), kaliumaluminiumsilikat (E555).
Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red (E172) Mica (E555)
Særlige advarsler og forsigtighedsregler vedrørende brugen Generel advarsel
4.4 Special warnings and precautions for use
UPDRS III (c) Udgangspunkt (b)
UPDRS III (c) Baseline (b)
I betragtning af den MAO-hæmmende virkning af safinamid skal der udvises forsigtighed ved samtidig administration af safinamid og sympatomimetika, som dem, der findes i nasale og orale dekongestanter eller lægemidler mod forkølelse, som indeholder efedrin eller pseudoefedrin (se pkt.
In view of the MAO inhibitory activity of safinamide, concomitant administration of safinamide and sympathomimetics, such as those present in nasal and oral decongestants or cold medicinal products containing ephedrine or pseudoephedrine, requires caution (see section 4.4).
Alder (år) (b)
Randomized Age (years) (b)
Hasardspil
Gambling
Søg råd hos lægen i tilfælde af hypertensiv krise (meget højt blodtryk, kollaps), malignt neuroleptika syndrom (forvirring, svedtendens, muskelstivhed, forhøjet legemstemperatur, øget niveau af enzym kreatinin-kinase i blodet), serotoninsyndrom (forvirring, forhøjet blodtryk, muskelstivhed, hallucinationer) samt hypotension.
Seek medical advice in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increase level of enzyme creatine kinase in your blood), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A3/5 ved relevante koncentrationer (Cmax af frit safinamid 0,4 µM ved 100 mg/dag) hos mennesker.
In vitro metabolism studies have indicated that there is no meaningful induction or inhibition of cytochrome P450, CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A3/5 at concentrations which are relevant (Cmax of free safinamide 0.4 µM at 100 mg/day) in man.
I betragtning af den MAO-hæmmende virkning af safinamid frarådes samtidig administration af safinamid og dextromethorphan, eller hvis samtidig behandling er nødvendig, skal der udvises forsigtighed (se pkt.
In view of the MAO inhibitory activity of safinamide, the concomitant administration of safinamide and dextromethorphan is not recommended, or if concomitant treatment is necessary, it should be used with caution (see section 4.4).
Arteriespasme, åreforkalkning, hypertensiv krise
Arterial spasm, arteriosclerosis, hypertensive crisis
Nedsat lægemiddeleffekt, lægemiddeltolerance, kuldefølelse, utilpashed, pyreksi, xerose
Drug effect decreased, drug intolerance, feeling cold, malaise, pyrexia, xerosis
Brug af anden medicin sammen med Xadago
Other medicines and Xadago
Der skal gå mindst 7 dage mellem seponering af safinamid og opstart af behandling med MAOhæmmere eller petidin (se pkt.
At least 7 days must elapse between discontinuation of safinamide and initiation of treatment with MAO inhibitors or pethidine (see section 4.3 and 4.5).
Alvorlige bivirkninger er kendt ved samtidig brug af SSRI´er, SNRI´er, tricykliske/tetracykliske antidepressiva og MAO-hæmmere, som hypertensiv krise (højt blodtryk, kollaps), malignt neuroleptika-syndrom (forvirring, svedtedens, muskelstivhed, hypertermi, øget CPK), serotoninsyndrom (forvirring, hypertension, muskelstivhed, hallucinationer), hypotension.
Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors, such as hypertensive crisis (high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, CPK increase), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Safinamid er forbundet med tilstandsafhængig hæmning af spændingsstyrede natriumkanaler (Na+) og modulation af stimuleret frigivelse af glutamat.
+) channels, and modulation of stimulated release of glutamate.
Erektil dysfunktion Prostatahyperlapsi, brystlidelse, brystsmerter
Erectile dysfunction Benign prostatic hyperplasia, breast disorder, breast pain
Basalcellekræft
Basal cell carcinoma
Det skal du vide, før du begynder at tage Xadago
What you need to know before you take Xadago
Der har været indberetninger om lægemiddelinteraktioner ved samtidig brug af MAO-hæmmere og sympatomimetiske lægemidler.
There have been reports of medicinal product interactions with the concomitant use of MAO inhibitors and sympathomimetic medicinal products.
Den systemiske eksponering af NW-1153 er dog lav (1/10 af safinamid), og da det metaboliseres til sekundære og tertiære metabolitter, er det usandsynligt, at det har nogen klinisk relevans.
This interaction has the potential to reduce the clearance of NW1153 and increase its exposure; however the systemic exposure of NW-1153 is low (1/10 of parent safinamide), and as it is metabolised to secondary and tertiary metabolites, it is unlikely to be of any clinical relevance.
Fertiliteten hos hanrotter påvirkes ikke (se pkt.
Male rat fertility is not affected (see section 5.3).
Et massebalancestudie viste, at plasma AUC0-24t med uændret 14C-safinamid udgjorde ca. 30 % af den samlede radioaktivitet AUC0-24t, hvilket indikerer en omfattende metabolisme.
C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism.
Sekundær virkningsparameter inkluderer OFF tid, UPDRS ll og lll (Unified Parkinson's Disease Rating Scale (samlet vurderingsskema for Parkinson) - pkt.
Secondary efficacy parameters included OFF Time, UPDRS II and III (Unified Parkinson's Disease Rating Scale - sections II and III), and CGI-C (Clinical Global Impression of Change)
Acrochordon, melanocytisk nævus, basalcellepapillom, hudpapillom
Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma
Bevægeforst yrrelser, somnolens, svimmelhed, hovedpine, Parkinsons sygdom
Dyskinesia somnolence dizziness, headache, Parkinson's disease
Hjertebanken, takykardi, bradykardi, arytmi
Palpitations, tachycardia, sinus bradycardia, arrhythmia
Træthed, asteni, gangforstyrrelser, perifert ødem, smerter, varmefølelse
Fatigue, asthenia, gait disturbance, oedema peripheral, pain, feeling hot
Der kræves ingen dosisjustering hos patienter med let nedsat leverfunktion.
No dose adjustment is required in patients with mild hepatic impairment.
Tabletkerne: Mikrokrystallinsk cellulose, crospovidon type A, magnesiumstearat, silica, kolloid vandfri
Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous
Safinamid hæmmer BCRP i tyndtarmen midlertidigt (se pkt.
Safinamide transiently inhibits BCRP in the small intestine (see section 4.5).
Behandling med safinamid er ikke forbundet med øget forekomst af impulskontrolforstyrrelser.
Safinamide treatment has not been associated with any increase in the appearance of ICDs.
20091 Bresso (MI) - Italien tlf.: +39 02 665241 fax: +39 02 66501492:
20091 Bresso (MI) - Italy Tel: +39 02 665241
Pakningsstørrelser og yderligere oplysninger Xadago indeholder: - Aktivt stof: Safinamid.
What Xadago contains - The active substance is safinamide.
Bruges til patienter med svært nedsat leverfunktion (se pkt.
Use in patients with severe hepatic impairment (see section 4.2).
Samtidig behandling med andre monoaminooxidasehæmmere (MAO-hæmmere) (se pkt.
Concomitant treatment with other monoamine oxidase (MAO) inhibitors (see sections 4.4 and 4.5).
Brug af safinamid er kontraindiceret hos patienter med stærkt nedsat leverfunktion (se pkt.
Safinamide use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Beskrivelse af udvalgte bivirkninger
Description of selected adverse dreactions
Lægemidler, der er OAT3-hæmmere, kan reducere clearance af NW-1153, når de gives samtidigt med safinamid.
Medicinal products that are inhibitors of OAT3 given concomitantly with safinamide may reduce clearance of NW-1153, i.e., and thus may increase its systemic exposure.
Lægemidler for forhøjet kolesterol som f.eks. rosuvastatin, pitavastatin, pravastatin Fluourquinolon antibiotika som f.eks. ciprofloxacin Lægemidler, der påvirker immunsystemet som f.eks. methotrexat Lægemidler til behandling af metastatiske carcinomer som f.eks. topotecan Lægemidler til behandling af smerter og inflammation som f.eks. diclofenac Lægemidlert til behandling af type 2 diabetes som f.eks. glyvurid, metformin Lægemidler til behandling af virusinfektioner som f.eks. aciclovir, ganciclovir
Ask your doctor for advice before taking any of the following medicines together with Xadago: - Cold or cough remedies containing dextromethorphan, ephedrine or pseudoephedrine - Medicines called selective serotonin reuptake inhibitors (SSRIs) typically used to treat anxiety disorders, and some personality disorders (e.g. fluoxetine or fluvoxamine) - Medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine - Medicines for high cholesterol such as rosuvastatin, pitavastatin, pravastatin - Fluoroquinolone antibiotic such as ciprofloxacin - Medicines that affect the immune system such as methotrexate - Medicines to treat metastatic carcinoma such as topotecan - Medicine to treat pain and inflammation such as diclofenac - Medicines to treat type 2 diabetes such as glyburide, metformin - Medicines to treat virus infection such as aciclovir, ganciclovir
Farmakoterapeutisk klassifikation: Antiparkinsonmiddel, monoaminooxidase-B-hæmmer.
Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD03.
Imperiøs vandladningstrang, polyuri, pyuri, tøven ved urinering
Micturition urgency, polyuria, pyuria, urinary hesitation
Alopeci, blærer, kontaktdermatitis, dermatose, blodudtrædning, aktinisk keratose, nattesved, hudsmerte, pigmenteringssygdom, psoriasis, arp
Alopecia, blister, dermatitis contact, dermatosis, ecchymosis, lichenoid keratosis, night sweats, pain of skin, pigmentation disorder, psoriasis, seborrhoeic dermatitis
Urinvejsinfektion Bronkopneumoni, byld, næsesvælgrumskatar, pyodermia, rhinitis, tandinfektion,
Urinary tract infection Bronchopneumonia, furuncle, nasopharyngitis, pyoderma, rhinitis, tooth infection, viral infection
Vægttab, vægtstigning, øget blod-kreatinfosfokinase, forøget antal blodtriglycerider, stigning i blodsukker, øget blod i urinen, forøget alkalisk fosfatase i blodet,
Weight decreased, weight increased, blood creatine phosphokinase increased, blood triglycerides increased, blood glucose increased, blood urea increased, blood alkaline phosphatase increased, blood bicarbonate increased, blood creatinine increased, electrocardiogram QT prolonged, liver function test
Fertiliteten hos hanrotter var upåvirket.
Male rat fertility was not affected.
Der har også været observationer af impuls-kontrolforstyrrelser med andre MAO-hæmmere.
Some reports of ICDs have also been observed with other MAO-inhibitors.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zambon S.p.A.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Hvis patientens tilstand forværres fra moderat til svært nedsat leverfunktion, skal safinamid seponeres (se pkt.
If patients progress from moderate to severe hepatic impairment safinamide should be stopped (see section 4.4).
Paræstesi, balancesygdomme, hypoæstesi, dystoni, gener i hovedet, dysartri, besvimelse, kognitiv forstyrrelse
Paraesthesia, balance disorder, hypoaesthesia, dystonia, head discomfort, dysarthria, syncope, cognitive disorder
20091 Bresso (MI) - Italien
Via Lillo del Duca 10 20091 Bresso (MI) - Italy
Opbevaring af Xadago
How to store Xadago
Kakesi, hyperkaliæmi
Cachexia, hyperkalaemia
OFF tid (timer) (c) Udgangspunkt (b) LSM forandring (SE)
OFF time (hrs) (c) Baseline (b)
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Der er indberettet alvorlige bivirkninger ved samtidig anvendelse af petidin og MAO-hæmmere.
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors.
Ualmindelige (kan påvirke op til 1 ud af 100 personer): urininfektion, hudkræft, lavt jernindhold i blodet, lavt antal hvide blodlegemer, abnormalitet af de røde blodlegemer, mindre appetit, højt fedtindhold i blodet, øget appetit, forhøjet blodsukker, at se ting, som ikke er der, føle sig trist, unormale drømme, frygt og bekymring, forvirret, humørsvingninger, øget interesse for sex, unormale tanker og opfattelsesevne, rastløshed, søvnforstyrrelser, følelsesløshed, ustabilitet, nedsat følesans, vedvarende unormale muskelsammentrækninger, ubehag i hovedet, talebesvær, besvimelse, svækket hukommelse, sløret syn, blinde pletter i synsfeltet, dobbeltsyn, lysskyhed, lidelse i det lysfølsomme lag bag i øjet, øjenrødme øget tryk i øjet, følelse af, at rummet drejer rundt, følelse af hjertebanken, hurtige hjerterytme, uregelmæssig hjerterytme, langsom puls, højt blodtryk, lavt blodtryk, vener, der er blevet store og snoede, hoste, vejrtrækningsbesvær, løbende næse, forstoppelse, halsbrand, opkastning, tør mund, diarré, mavesmerter, brændende følelse i maven, tarmluft, mæthedsfornemmelse, savlen, mundblister, svedtendens, kløe generel lysfølsomhed, hudrødme, rygsmerter, ledsmerter, kramper,
Uncommon (may affect up to 1 in 100 people): urine infection, skin cancer, low iron in your blood, low white cell count, red blood cell abnormality, decreased appetite, high fat in blood, increased appetite, high blood sugar, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusional state, mood swings , increased interest in sex, abnormal thinking and perception, restlessness, sleep disorder, numbness, unsteadiness, loss of sensation, sustained abnormal muscle contraction, head discomfort, difficulty in speaking, fainting, memory impairment, blurring of vision, blind spot, double vision, aversion to light, disorders of the light sensitive layer at the back of your eye, redness of the eyes, increased pressure in the eye, sensation of room spinning, feeling of heart beating, fast heartbeat, irregular heartbeat, slowed heartbeat , high blood pressure, low blood pressure, veins that have become large and twisted, cough, difficult breathing, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, burning stomach, wind, feeling full, drooling, mouth ulcer, sweating, itching, sensitive to light, redness of the skin, back pain, joint pain, cramps, stiffness, pain in legs or arms, muscle weakness, sensation of heaviness, increased urination at night, pain upon urination, difficulty in having sex in males, fatigue, feeling weak, unsteady walking, swelling of your feet, pain, feeling hot, weight loss, weight gain, abnormal blood tests, high fat in your blood, increased sugar in your blood, abnormal ECG, liver function test abnormal, abnormal urine tests, blood pressure decreased, blood pressure increased, abnormal eye test, fracture of your foot.
Sådan skal du tage Xadago
How to take Xadago
Patienter og plejere bør være opmærksomme på, at kompulsiv adfærd såsom tvangshandlinger, tvangstanker, sygeligt spillemisbrug, øget seksuel lyst, hyperseksualitet, impulsiv opførsel og kompulsiv købe- eller forbrugsadfærd er rapporteret i forbindelse med andre lægemidler for Parkinsons sygdom.
Warnings and precautions Talk to your doctor before taking Xadago - If you have liver problems - Patients and carers should be made aware that certain compulsive behaviours such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying have been reported with other medicines for Parkinson's disease.
Xadago 50 mg filmovertrukne tabletter
Xadago 50 mg film-coated tablets
Kompulsive symptomer, delirium, desorientering, illusion, impulshandlinger, manglende sexlyst, tvangstanker, paranoia, præmatur ejakulation, søvnanfald, social angst, selvmordstanker
Rare abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder disorientation, illusion, impulsive behaviour, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation
Forstoppelse, dyspepsi, opkastning, tør mund, diarré, mavesmerter, gastritis, flatulens, oppustethed, spytudskillelse, gastroøsofageal reflukssygdom, aftøs stomatitis
Nausea Constipation, dyspepsia, vomiting, dry mouth, diarrhoea, abdominal pain, gastritis, flatulence, abdominal distension,
Hoste, dyspnø,
Cough, dyspnoea, rhinorrhoea
Xadago 100 mg er orange til kobberfarvede, runde, bikonkave filmovertrukne tabletter på 9 mm i diameter med metallisk glans, præget med ”100” på den ene side af tabletten.
Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet.
Der kræves ingen dosisjustering for patienter med nedsat nyrefunktion.
Renal impairment No change in dose is required for patients with renal impairment.
Denne forholdsregel er baseret på forekomsten af alvorlige reaktioner (f.eks. serotonin syndrom), selvom det er sjældent, at det er sket, når SSRI og dextromethorphan har været anvendt sammen med MAO-hæmmere.
The concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided (see section 4.4), this precaution is based on the occurrence of serious adverse reactions (e.g. serotonin syndrome), although rare, that have occurred when SSRIs and dextromethorphan have been used with MAO inhibitors.
Orange til kobberfarvet, rund, bikonkav, filmovertrukket tablet på 7 mm diameter med metallisk glans, præget med styrken ”50” på den ene side af tabletten.
Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet.
Xadago 100 mg filmovertrukne tabletter
Xadago 100 mg film-coated tablets
Orange til kobberfarvet, rund, bikonkav, filmovertrukket tablet på 9 mm diameter med metallisk glans, præget med styrken ”100” på den ene side af tabletten.
Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet.
Gulsot
BLISTER
Amidase FAAH kunne katalysere dannelsen af NW-1153 i mindre grad, og derfor er det sandsynligt, at andre amidaser er med i omdannelsen til NW-1153.
The amidase FAAH was able to catalyse the formation of NW-1153 at low rates only.
Xadago 50 mg filmovertrukne tabletter Xadago 100 mg filmovertrukne tabletter Safinamid
Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets safinamide
Italien tlf.: +39 02665241 fax: +39 02 66501492
Fax: +39 02 66501492
Udgangspunkt (b) LSM forandring (SE) LS Diff vs placebo 95 % CI p-værdi
95% CI p-value UPDRS II (c) Baseline (b)
Hvis patientens tilstand forværres fra moderat til svært nedsat leverfunktion, skal behandling med safinamid seponeres (se pkt.
In case patients progress from moderate to severe hepatic impairment, treatment with safinamide should be stopped (see sections 4.2, 4.3 and 5.2).
Svagsynethed, kromatopsi, diabetisk øjensygdom, rødsyn, øjenblødning, øjensmerter, øjenlågsødem, langsynethed, hornhindebetændelse, forøget tåresekretion, natteblindhed, optisk ødem, presbyopi, skelen
Amblyopia, chromatopsia, diabetic retinopathy, erythropsia, eye haemorrhage, eye pain, eyelid oedema, hypermetropia, keratitis, lacrimation increased, night blindness, papilloedema, presbyopia, strabismus
Rygsmerter, ledsmerter, muskelsammentræknin ger, muskelstivhed, ekstremitetsmerter, muskelslaphed, tunghedsfølelse
Back pain, arthralgia, muscle spasms, muscle rigidity, pain in extremity, muscular weakness, sensation of heaviness
Safinamid skal tages oralt.
For oral use.
Sjælden forhøjet plasmakuldioxid, forhøjet kreatinin i blodet, forlænget elektrokardiogram QT, abnormal leverfunktionstest, abnormal urinanalyse, stigning i blodtryk, fald i blodtryk, abnormale øjensymptomprocedur er hjertemislyd, abnormal hjertestress-test, lavere hæmatokrit, lavere hæmoglobin, lavere internationalt normaliseret ratio, lavere lymfocyttal, lavere trombocyttal, forhøjet lavdensitetlipoprotein
Blood calcium decreased, blood potassium decreased, blood cholesterol decreased, body temperature increased, cardiac murmur, cardiac stress test abnormal, haematocrit decreased, haemoglobin decreased, international normalised ratio decreased, lymphocyte count decreased,
Samtidig behandling med petidin (se pkt.
Concomitant treatment with pethidine (see sections 4.4 and 4.5).
100 Placebo 50
xadago 50 mg
Abnormal koordinationsevne, opmærksomhedsforsty rrelse, smagsforstyrrelse, hyporefleksi, radikulær smerte, uro i benene, bedøvelse
Coordination abnormal, disturbance in attention, dysgeusia, hyporeflexia, radicular pain, Restless Legs Syndrome, sedation
LÆGEMIDLETS NAVN XADAGO 100 mg tabletter safinamid
Xadago 100 mg tablets safinamide
Hver filmovertrukket tablet indeholder safinamid methansulfonat svarende til 100 mg safinamid Alle hjælpestoffer er anført under pkt.
Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide.
Dopaminerge bivirkninger
Dopaminergic side effects
Morbus Bechterew (spondylitis ankylopoietica), lændesmerte, hævelser i leddene, muskuloskeletale smerter myalgi, nakkesmerter, artrose, synovialcyste
Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst
LÆGEMIDLETS NAVN XADAGO 50 mg tabletter safinamid
Xadago 50 mg tablets safinamide
Hver filmovertrukket tablet indeholder safinamid methansulfonat svarende til 50 mg safinamid Xadago 100 mg filmovertrukne tabletter
Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide.
Xadago 50 mg er orange til kobberfarvede, runde, bikonkave filmovertrukne tabletter på 7 mm i diameter med metallisk glans, præget med ”50” på den ene side af tabletten.
What Xadago looks like and contents of the pack Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet.
Hjerteinfarkt
Cardiac disorders
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - filmovertrukne tabletter
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
LÆGEMIDLETS NAVN Xadago 100 mg filmovertrukne tabletter safinamid
Xadago 100 mg film-coated tablets safinamide
LÆGEMIDLETS NAVN Xadago 50 mg filmovertrukne tabletter safinamid
Xadago 50 mg film-coated tablets safinamide
INFORMATION I BRAILLESKRIFT xadago 100 mg
xadago 100 mg
Knoglebrud i foden Kvæstelse, fedtemboli, kranietraume, mundlæsion, knoglelæsion
Contusion, fat embolism, head injury, mouth injury, skeletal injury
Blodmangel, leukopeni, erytrocytabnormitet
Anaemia, leukopenia, red blood cell abnormality
LÆGEMIDLETS NAVN Xadago 50 mg filmovertrukne tabletter Xadago 100 mg filmovertrukne tabletter
Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets
Steinbeisstrasse 2
Hyperbilirubinaemia
Sjælden mediastinum rhinorrhoea dysfoni, smerter i orapharynx, spasmer i oropharynx
Bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm
Hvis du har taget for mange Xadago
If you take more Xadago than you should
Mavesår, opkastningsfornemmel ser, øvre mave-tarmblødning
Peptic ulcer, retching, upper gastrointestinal haemorrhage
Impuls-kontrolforstyrrelser
Impulse control disorders (ICDs)
Xadagos virkning og anvendelse
What Xadago is and what it is used for