FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome.
Danish: Alvorlige bivirkninger, herunder åndedrætsbesvær, lungebetændelse, voldsom kortåndethed, besvimelse, hjerteanfald, lavt antal røde blodlegemer og lavt antal blodplader, infektioner, blødning i hjernen (intrakraniel blødning) er forekommet med dødelig udgang.
English: The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage.
Danish: Brug af latexhandsker og sikkerhedsbriller anbefales for at undgå at blive udsat for stoffet i tilfælde af brud på hætteglasset eller andet utilsigtet spild.
English: • pins and needles or burning sensation of the skin
Danish: • prikkende, stikkende eller brændende fornemmelser på huden
English: Median PFS was superior in patients with sole 13q deletion treated with MabCampath (24.4 v 13.0 months; p=0.0170 stratified by Rai Stage).
Danish: Median PFS var højere hos patienter med kun 13q deletion behandlet med MabCampath (24,4 v 13,0 måneder; p=0,0170 stratificeret efter Rai-stadium).
English: Vomiting Abdominal pain
Danish: Abdominal-smerter
English: • weight loss, dehydration, thirst, swelling of the lower legs, temperature change sensation, low
Danish: • vægttab, udtørring, tørst, hævede underben, følelse af temperaturskift, lavt kalcium- eller
English: • dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless
Danish: • svimmelhed, fornemmelse af at det hele kører rundt, besvimelse, rystende eller skælvende
English: The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the ampoule or other accidental spillage.
Danish: Brug af latexhandsker og sikkerhedsbriller anbefales for at undgå at blive udsat for stoffet i tilfælde af brud på ampullen eller andet utilsigtet spild.
English: Gingival bleeding Haematology test abnormal
Danish: Gingiva blødning Hæmatologisk test abnorm
English: 4.2 Posology and method of administration MabCampath should be administered under the supervision of a physician experienced in the use of
Danish: MabCampath bør indgives under kontrol af en læge med erfaring i cancerbehandling.
English: Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):
Danish: Meget almindelige bivirkninger (forekommer hos mindst 1 ud af 10 behandlede ved afprøvning på
English: Infusion site reaction Pain
Danish: Reaktion på infusionsstedet Smerter
English: • abnormal liver function, constipation, indigestion, passing abdominal gas
Danish: • abnorm leverfunktion, forstoppelse, fordøjelsesbesvær, afgang af tarmluft
English: Lymphoma - like disorder
Danish: Lymfom-lignende sygdom
English: No short or long term animal studies have been conducted with MabCampath to assess carcinogenic
Danish: Der er ikke gennemført kort- eller langvarige dyrestudier med MabCampath m.h.p.
English: Hyperhidrosis Erythema
Danish: Hyperhidrose
English: België/Belgique/Belgien/ Luxemburg/ Luxembourg
Danish: Danmark/Norge/Sverige/Suomi/Finland/ Ísland
English: The most frequent adverse reactions with MabCampath are: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnoea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anaemia), infections (CMV viraemia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety).
Danish: De hyppigste bivirkninger ved MabCampath er følgende: infusionsreaktioner (feber, kulderystelser, hypotension, urticaria, kvalme, hududslæt, takykardi, dyspnø), cytopenier (neutropeni, lymfopeni, trombocytopeni, anæmi), infektioner (cytomegalovirus viræmi, cytomegalovirus infektion eller andre infektioner), gastrointestinale symptomer (kvalme, opkastning, smerter i maven) og neurologiske symptomer (søvnløshed, angst).
English: Infusion reactions: Serious and sometimes fatal reactions, including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency and cardiac arrest have been observed.
Danish: Bivirkninger ved infusion: Der er indberettet alvorlige bivirkninger, som nogen gange har dødelig udgang, herunder bronkospasme, hypoksi, synkope, lungeinfiltrater, akut respiratorisk distress syndrom (ARDS), respirationsstop, myokardieinfarkt, arytmier, akut hjerteinsufficiens og hjertestop.
English: Acute infusion reactions including fever, chills, nausea, vomiting, hypotension, fatigue, rash, urticaria, dyspnoea, headache, pruritus and diarrhoea have been reported.
Danish: Der er indberettet akutte reaktioner ved infusion herunder feber, kulderystelser, kvalme, opkastning, hypotension, træthed, udslæt, urticaria, dyspnø, hovedpine, pruritus og diaré.
English: The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.
Danish: - Øvrige indholdsstoffer: natriumedetat, polysorbat 80, kaliumklorid, kaliumdihydrogenfosfat, natriumklorid, dibasisk natriumfosfat og vand til injektionsvæsker.
English: Premedications
Danish: Præmedicinering
English: Immune system disorders: Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain Barré syndrome and its chronic form, chronic inflammatory demyelinating polyradiculoneuropathy have been reported.
Danish: Forstyrrelser i immunsystemet: Der er indberettet tilfælde af alvorlige autoimmune fænomener, nogen gange med dødelig udgang , herunder autoimmun hæmolytisk anæmi, autoimmun trombocytopeni, aplastisk anæmi, Guillain Barré-syndrom og dets kroniske form, kronisk inflammatorisk demyelinerende polyradiculoneuropati.
English: Anxiety Syncope Dizziness Tremor Paraesthesia Hypoesthesia Headache
Danish: Svimmelhed Tremor Paræstesi Hypoæstesi Hovedpine
English: Endophthalmitis Deafness Tinnitus
Danish: Døvhed Tinnitus
English: Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):
Danish: Almindelige bivirkninger (forekommer hos 1 til 10 ud af 100 behandlede ved afprøvning på patienter):
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: Hypoxia Pleural effusion Dysphonia Rhinorrhoea
Danish: Pleural effusion Dysfoni Rinorré
English: Medicinal product subject to restricted medical prescription (See Annex 1: Summary of Product
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Resume MabCampath at 30 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl.
Danish: Genoptag behandlingen med 30 mg, når ANC ≥ 500/l og trombocyttallet er ≥ 50.000/l.
English: Treatment consists of discontinuation of MabCampath
Danish: Behandlingen består af ophør med MabCampath og symptomatisk behandling.
English: One ml contains 10 mg of alemtuzumab.
Danish: En ml indeholder 10 mg alemtuzumab.
English: The vial contents should be inspected for particulate matter and discolouration prior to administration.
Danish: Ampulindholdet bør inspiceres for partikler og misfarvning forud for indgift.
English: What MabCampath looks like and contents of the pack MabCampath is a concentrate for solution for infusion that comes in a glass ampoule.
Danish: MabCampath er en koncentreret opløsning til infusion, der leveres i et hætteglas.
English: Resume MabCampath at 10 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl.
Danish: Genoptag behandlingen med 10 mg når ANC ≥ 500/l og trombocyttallet er ≥ 50.000/l.
English: Upper respiratory tract infection
Danish: Øvre luftvejsinfektion Faryngitis
English: Pharyngitis Infection
Danish: Fungal infektion
English: Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line (see section 4.5).
Danish: Andre lægemidler må ikke blandes med MabCampath infusionen eller infunderes samtidigt gennem den samme intravenøse infusionsslange (se pkt.
English: Haematuria Urinary incontinence Urine flow decreased Polyuria
Danish: Hæmaturi Urininkontinens Nedsat urinproduktion Polyuri
English: CMV infection during treatment with MabCampath had no measurable impact on progression free survival (PFS).
Danish: Tilstedeværelsen af asymptomatisk positiv PCR for CMV eller symptomatisk PCR positiv CMV infektion under behandling med MabCampath havde ingen målbar invirkning på den progressionsfri overlevelse (PFS).
English: Body tinea
Danish: Tinea corporis Nasofaryngit Rinit
English: Disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate, water for injections.
Danish: Natriumedetat, polysorbat 80, kaliumklorid, kaliumdihydrogenfosfat, natriumklorid, dibasisk
English: Patients with renal or hepatic impairment
Danish: Patienter med nedsat nyre- og leverfunktion
English: The ampoule contents should be inspected for particulate matter and discolouration prior to administration.
Danish: Ampullens indhold bør inspiceres for partikler og misfarvning forud for indgift.
English: Eructation Dry mouth
Danish: Ødem i munden
English: However, other medicinal products should not be added to the MabCampath infusion or simultaneously infused through the same
Danish: Andre lægemidler må dog ikke blandes med MabCampath-infusionen eller infunderes samtidigt gennem den samme intravenøse
English: Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused though the same intravenous line.
Danish: Andre lægemidler bør ikke blandes med MabCampath-infusionsopløsningen eller samtidigt infunderes gennem den samme intravenøse adgang.
English: Orthostatic hypotension Hot flush
Danish: Ortostatisk hypotension Hedeture
English: Mucosal inflammation Infusion site erythema Localised oedema Infusion site oedema Malaise
Danish: Erytem på infusionsstedet Lokaliseret ødem Ødem på infusionsstedet Malaise
English: Resume MabCampath at 30 mg upon return to baseline value(s).
Danish: Genoptag behandlingen med 30 mg, når baselineværdien(erne) er nået.
English: Leg pain Hypertonia
Danish: Bensmerter Hypertoni
English: Not Applicable
Danish: Ikke aktuelt
English: Withhold MabCampath therapy.
Danish: Seponer MabCampath-behandlingen.
English: • generally feeling unwell, weakness, pain in various parts of the body (muscle, back, chest,
Danish: • reaktioner på stedet for indsprøjtning, herunder rødme, hævelse, smerte, blå mærker, betændelse • almen følelse af utilpashed, svaghed, smerter forskellige steder i kroppen (muskler, ryg, bryst,
English: Medicinal product subject to medical prescription.
Danish: Opbevaringsforhold for det fortyndede lægemiddel er anført under pkt.
English: Musculoskeletal chest pain
Danish: Muskuloskeletale smerter
English: It is recommended that patients be premedicated with oral or intravenous steroids 30 - 60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated.
Danish: Når dosis øges, og når det er klinisk indiceret, anbefales det, at patienterne præmedicineres med orale eller intravenøse steroider 30-60 minutter før infusion med MabCampath.
English: MabCampath 10 mg/ml concentrate for solution for infusion Alemtuzumab
Danish: MabCampath 10 mg/ml, koncentrat til infusionsvæske, opløsning Alemtuzumab
English: Each ampoule contains 30 mg of alemtuzumab.
Danish: Hver ampul indeholder 30 mg alemtuzumab.
English: Cardiac arrest Myocardial infarction Atrial fibrillation Supraventricular tachycardia Arrhythmia Bradycardia Abnormal ECG
Danish: Myokardie- infarkt Atrieflimmer Supraventrikulær takykardi
English: Uncommon
Danish: Ikke-almindelig
English: • abscess, skin redness or allergic skin reaction, blistering of the skin • confusion, anxiety, depression, sleeplessness
Danish: • bylder, hudrødmen eller allergiske hudreaktioner, blæredannelse på huden
English: Resume MabCampath at 10 mg upon return to baseline value(s).
Danish: Genoptag behandlingen med 10 mg, når baselineværdien(erne) er nået.
English: Oral discomfort Stomach discomfort Diarrhoea
Danish: Oralt ubehag Maveubehag Diarré
English: If particulate matter is present or the concentrate is coloured, then the vial should not be used.
Danish: Hvis der er partikler til stede eller koncentratet er farvet, bør hætteglasset ikke anvendes.
English: Your doctor will treat you for
Danish: Hvis det sker, vil din læge sørge for at behandle dem.
English: please tell your doctor or pharmacist.
Danish: Du bør spørge din læge til råds.
English: You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus) during your MabCampath therapy and for at least 2 months afterwards.
Danish: Mens du er i behandling med MabCampath samt i mindst to måneder derefter vil du blive undersøgt for symptomer på en bestemt type virusinfektion ved navn CMV (cytomegalovirus).
English: Conjunctivitis
Danish: Konjunktivit
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabCampath 30 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MabCampath 30 mg/ml, koncentrat til infusionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabCampath 10 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MabCampath 10 mg/ml, koncentrat til infusionsvæske, opløsning
English: In addition, an oral antihistamine, e.g. diphenhydramine 50 mg, and an analgesic, e.g. paracetamol 500 mg, may be given.
Danish: Desuden kan der gives et peroralt antihistamin f.eks. difenhydramin 50 mg og et analgetikum f.eks. paracetamol 500 mg. I tilfælde af, at en akut infusionsreaktion vedvarer, kan infusionstiden forlænges op til 8 timer fra tidspunktet for tilberedningen af MabCampath som infusionsopløsning.
English: Urticaria
Danish: Paræstesi
English: NAME OF THE MEDICINAL PRODUCT MabCampath 10 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN MabCampath 10 mg/ml koncentrat til infusionsvæske, opløsning
English: Cytogenetic analyses in first line B-CLL patients:
Danish: 1. linje-B-CLL-patienter
English: Hyponatraemia Hypocalcaemia Weight decrease Dehydration Thirst
Danish: Vægttab Dehydrering Tørst
English: Pulmonary oedema Peripheral oedema Periorbital oedema Mucosal ulceration Infusion site bruising Infusion site dermatitis Infusion site pain
Danish: Mucosal ulceration Misfarvning på infusionsstedet Dematitis på infusionsstedet Smerter på infusionsstedet
English: - HIV.
Danish: Тел.
English: Uncommon side effects (affects 1 to 10 patients in every 1,000 patients treated in clinical trials):
Danish: Ikke almindelige bivirkninger (forekommer hos 1 til 10 ud af 1000 behandlede ved afprøvning på
English: Hypersensitivity
Danish: Anafylaktisk reaktion Hypersensitivitet
English: • bleeding and inflammation of the gums, blisters on the tongue, nosebleeds
Danish: • blødning og infektion i tandkødet, blærer på tungen, næseblod • væske i lungerne, vejrtrækningsbesvær, ru, hvæsende lyd ved vejrtrækning, rindende næse,
English: If particulate matter is present or the solution is coloured, then the vial should not be used.
Danish: Hvis der er partikler til stede eller opløsningen er farvet, bør hætteglasset ikke anvendes.
English: MabCampath is contraindicated during pregnancy.
Danish: MabCampath må ikke gives til patienter, som er gravide.
English: Each vial contains 30 mg of alemtuzumab.
Danish: Hvert hætteglas indeholder 30 mg alemtuzumab.
English: NAME OF THE MEDICINAL PRODUCT MabCampath 30 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN MabCampath 30 mg/ml, koncentrat til infusionsvæske, opløsning
English: If particulate matter is present or the solution is coloured, then the ampoule should not
Danish: Hvis der er partikler til stede eller opløsningen er farvet, bør ampullen ikke anvendes.
English: Genzyme Europe B.V. Képviselet Tel: +36 1 310 7440
Danish: Képviselet Tel: +36 1 310 7440
English: Onychomycosis
Danish: Agranulocytose
English: MabCampath 30 mg/ml concentrate for solution for infusion Alemtuzumab
Danish: MabCampath 30 mg/ml koncentrat til infusionsvæske.
English: One ml contains 30 mg of alemtuzumab.
Danish: 1 ml indeholder 30 mg alemtuzumab.
English: Asthenia
Danish: Infektion
English: Nervous system disorders
Danish: Impotens Nervøsitet Synkope
English: Gastrointestinal disorders
Danish: Dissemineret intravaskulær koagulation
English: Headache
Danish: Hjertelidelser
English: There are no definitive studies of MabCampath which assess its impact on fertility.
Danish: Der er ikke foretaget definitive undersøgelser af MabCampath m.h.p.
English: België/Belgique/Belgien/ Luxemburg/ Luxembourg Genzyme Belgium N.V., Tél/Tel: + 32 2 714 17 11
Danish: Genzyme A/S, (Danmark/Tanska/Danmörk), Tlf/Puh./Sími: + 45 32712600
English: Nausea
Danish: Ødemer
English: Throat tightness Pulmonary infiltration Pleural effusion Breath sounds decreased
Danish: Nedsatte respirationslyde Respiratorisk forstyrrelse Gastrointestinal blødning Gastroenteritis Ulcerøs stomatitis
English: Nasopharyngitis Rhinitis
Danish: Erytematøst udslæt
English: Agranulocytosis Lymphopenia Lymphadenopathy Epistaxis
Danish: Knoglemarvsdepression Epistaxis
English: Flushing disorders
Danish: Dehydrering Konfusion
English: Muscle spasms Urine output decreased Dysuria
Danish: Muskuloskeletale brystsmerter Muskelspasmer Nedsat urinudskillelse Dysuri
English: Lactation
Danish: Dyspepsi
English: If particulate matter is present or the concentrate is coloured, then the ampoule should
Danish: Hvis der er partikler til stede eller koncentratet er farvet, bør ampullen ikke anvendes.
English: MabCampath may be reinstituted after the infection or toxicity has resolved.
Danish: Behandling med MabCampath kan eventuelt genoptages efter at infektionen eller den toksiske reaktion er gået i ro. MabCampath skal seponeres permanent, hvis der opstår autoimmun anæmi eller autoimmun trombocytopeni.
English: Hypertension Vasospasm Flushing
Danish: Vasospasmer Rødmen Hypoxi
English: Fertility
Danish: Dermatit
English: Bronchospasm Dyspnoea
Danish: Skeletsmerter Rygsmerter
English: Pneumonia Bronchitis Pharyngitis Oral candidiasis
Danish: Oral candidiasis:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs
English: Arthralgia Myalgia Skeletal pain Back pain
Danish: Atrieflimmer Arytmi, supraventirkulær Sinusbradykardi
English: Palpitation Tachycardia
Danish: Ikke-almindelig Supraventrikulær takykardi Arytmi
English: Weight decreased Tumour lysis syndrome Hyperglycaemia
Danish: Tumorlysissyndrom Hyperglykæmi Nedsat total protein Anoreksi
English: Bacterial infection Viral infection Fungal dermatitis Laryngitis Rhinitis
Danish: Tandkødsblødning Abnorm hæmatologitest Allergisk reaktion
English: Anorexia
Danish: Pneumonitis
English: Aplasia bone marrow Disseminated intravascular coagulation Haemolytic anaemia, Decreased haptoglobin Bone marrow depression
Danish: Hæmolytisk anæmi, Nedsat haptoglobin
English: Metabolism and nutritional disorders: Tumour lysis syndrome with fatal outcome has been reported.
Danish: Stofskiftesygdomme og ernæringsbetingede sygdomme: Der er indberettet tilfælde af
English: Oedema mouth Oedema
Danish: Abnorm gangart Dystoni
English: incontinence
Danish: Konjunktivitis
English: Content Package size
Danish: Indgivelsesvej Emballage Indhold Pakningsstø rrelse
English: Tmax is between 3 and 8 hours.
Danish: Tmax er mellem 3 og 8 timer.
English: 8501 Novo mesto SLOVENIA
Danish: 8501 Novo mesto SLOVENIEN
English: Date of first authorisation: 29 April 2013 Date of latest renewal: 18 January 2018
Danish: Dato for første markedsføringstilladelse: 29. april 2013 Dato for seneste fornyelse: 18. januar 2018
English: Children and adolescents Marixino is not recommended for children and adolescents under the age of 18 years.
Danish: Børn og unge Marixino anbefales ikke til børn og unge under 18 år.
English: - Do not take a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Danish: Det samme kan gøre sig gældende for ketamin og dextromethorphan (se også punkt 4.4).
English: BLISTER (PVC/PVDC-Alu FOIL)
Danish: Blister (PVC/PVDC-Alu folie)
English: In general, the observed side effects are mild to moderate.
Danish: De bivirkninger, der er set, er generelt milde til moderate.
English: Some factors that may raise urine pH (see section 5.2 'Elimination') may necessitate careful monitoring of the patient.
Danish: Visse faktorer, der kan forhøje urin-pH (se punkt 5.2), kan nødvendiggøre omhyggelig monitorering af patienten.
English: About 45 % of memantine is bound to plasma-proteins.
Danish: Omkring 45% af memantin bindes til plasmaproteiner.
English: Marixino with food and drink
Danish: Brug af Marixino sammen med mad og drikke
English: Memantine has an absolute bioavailability of approximately 100 %.
Danish: Memantin har en absolut biotilgængelighed på ca. 100%.
English: This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Danish: Denne dosis vil blive øget hver uge med 5 mg, indtil den anbefalede (vedligeholdelses-)dosis er nået.
English: Paediatric population No data available.
Danish: Pædiatrisk population Der foreligger ingen data.
English: If you forget to take Marixino - If you find you have forgotten to take your dose of Marixino, wait and take your next dose at the usual time.
Danish: Hvis du har glemt at tage Marixino - Hvis du har glemt at tage din dosis af Marixino, skal du vente og tage din næste dosis på det sædvanlige tidspunkt.
English: Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Danish: Alzheimers sygdom er blevet sat i forbindelse med depression, selvmordstanker og selvmord.
English: As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
Danish: Da virkningerne hverken er observeret i langtidsstudier med gnavere eller med ikke-gnavere, er den kliniske relevans af disse observationer ukendt.
English: You may experience increased symptoms as described in section 4.
Danish: Du kan opleve forøgede symptomer, som beskrevet i punkt 4 “Bivirkninger”.
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Danish: Hvis der er tegn og symptomer på generel overstimulering af centralnervesystemet (CNS), skal det overvejes at give omhyggelig symptomatisk, klinisk behandling.
English: Adverse reactions are ranked according to system organ class, using the following convention:very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter organklassesystem med følgende betegnelser: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This effect was only observed at high doses in rodents.
Danish: Denne virkning blev kun observeret hos gnavere ved høje doser.