natgillin/translations-raw huggingface dataset:
● Oplysende brochure ● Resumé af produktkarakteristika (SPC) samt indlægsseddel og etikettering
The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the following: • Educational brochure • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Nøgleelementer der skal inkluderes i den oplysende brochure
Key elements to be included in the educational brochure
● Risiko for opportunistiske infektioner, specielt CMV viraemia ● Anbefaling til undgåelse af vaccination med levende vacciner i mindst 12 måneder efter MabCampath behandling ● Risiko for infusionsreaktioner o Behov for præmedicinering o At behandling for hypersensitivitetsreaktioner, incl. forholdsregler for genoplivning bør være tilgængelig under administration o At risikoen for infusionsreaktioner er højest i behandlingens første uge o At såfremt reaktionen er moderat eller alvorlig, bør dosering fortsætte på samme niveau (dvs. ingen dosiseskalering), indtil hver dosis tolereres godt. o At såfremt behandlingen tilbageholdes i mere end 7 dage, skal MabCampath genindsættes med gradvis dosiseskalering
• The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
MabCampath 10 mg/ ml koncentrat til infusionsvæske, opløsning
MabCampath 10 mg/ ml concentrate for solution for infusion
Alemtuzumab er et genetisk fremstillet, humaniseret IgG1 kappa monoklonalt antistof specifikt for et 21- 28 kD lymfocyt- celleoverfladeglykoprotein (CD52).
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52).
MabCampath er indikeret til behandling af patienter med kronisk lymfatisk B- celleleukæmi (B- CLL) for hvem fludarabin- kombinationskemoterapi ikke er hensigtsmæssig.
MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B- CLL) for whom fludarabine combination chemotherapy is not appropriate.
MabCampath- opløsningen bør tilberedes i henhold til vejledningen i pkt.
The MabCampath solution must be prepared according to the instructions provided in section 6.6.
2 timer.
All doses should be administered by intravenous infusion over approximately 2 hours.
4. 4).
Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).
4. 4).
Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment (see section 4.4).
I løbet af den første uges behandling bør MabCampath gives i stigende dosering:
During the first week of treatment, MabCampath should be administered in escalating doses:
3 mg den 1. dag, 10 mg den 2. dag og 30 mg den 3. dag under forudsætning af, at hver enkelt dosis tåles godt.
3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated.
Hos de fleste patienter kan dosisøgning op til 30 mg gennemføres på 3- 7 dage.
In most patients, dose escalation to 30 mg can be accomplished in 3-7 days.
4. 4).
However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).
Gennemsnitlig behandlingsvarighed var 11, 7 uger for 1. linje- patienter, og 9, 0 uger for tidligere behandlede patienter.
2 Median duration of treatment was 11.7 weeks for first-line patients and 9.0 weeks for previously treated patients.
2 Så snart en patient opfylder alle laboratoriemæssige og kliniske kriterier på en fuldstændigt respons, bør MabCampath seponeres og patienten kontrolleres.
Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored.
Hvis en patient bliver bedre (dvs. opnår et delvist respons eller en stabiliseret tilstand) og derefter når et plateau uden yderligere bedring i 4 uger eller mere, bør MabCampath i så fald seponeres og patienten kontrolleres.
If a patient improves (i. e. achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored.
Det anbefales, at MabCampath seponeres hos patienter, hvis trombocyttal falder til < 25. 000/ µl eller hvis det absolutte neutrofiletal (ANC) falder til < 250/ µl.
It is recommended that MabCampath should be interrupted in patients whose platelet count falls to < 25,000/μ l or whose absolute neutrophil count (ANC) drops to < 250/μ l.
Hæmatologiske værdier
Hematologic Values
Ændring af dosis *
Dose Modification*
ANC < 250/ μl og/ eller trombocyttal < 25. 000/ μl
ANC < 250/μ L and/ or platelet count ≤ 25,000/μ L
Ved første forekomst
For first occurrence:
Seponer MabCampath- behandlingen.
Withhold MabCampath therapy.
Genoptag behandlingen med 30 mg, når ANC ≥ 500/ μl og trombocyttallet er ≥ 50. 000/ μl.
Resume MabCampath at 30 mg when ANC ≥ 500/μ L and platelet count ≥ 50,000/μ L.
Ved anden forekomst
For second occurrence:
Genoptag behandlingen med 10 mg når ANC ≥ 500/ μl og trombocyttallet er ≥ 50. 000/ μl.
Resume MabCampath at 10 mg when ANC ≥ 500/μ L and platelet count ≥ 50,000/μ L.
Ved tredje forekomst
For third occurrence:
Seponer MabCampath- behandlingen.
Discontinue MabCampath therapy.
≥ 50% fald fra baseline hos patienter, hvor behandling startes med baseline- ANC ≤ 250/ μl og/ eller baseline- trombocyttal ≤ 25. 000/ μl.
≥ 50% decrease from baseline in patients initiating therapy with a baseline ANC ≤ 250/μ L and/ or a baseline platelet count ≤ 25,000/μ L
Genoptag behandlingen med 30 mg, når baselineværdien( erne) er nået.
Resume MabCampath at 30 mg upon return to baseline value(s).
Genoptag behandlingen med 10 mg, når baselineværdien( erne) er nået.
Resume MabCampath at 10 mg upon return to baseline value(s).
* Hvis behandlingen har været seponeret i ≥ 7 dage, startes MabCampath - behandlingen med 3 mg med optrapning til 10 mg og derefter 30 mg, alt efter hvordan patienten tåler behandlingen.
*If the delay between dosing is ≥ 7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg and then to 30 mg as tolerated
Børn og unge (under 17- år:)
Children and adolescents (below 17 years of age):
Der er ikke foretaget undersøgelser.
No studies have been conducted.
MabCampath er ikke anbefalet til brug af børn og unge.
MabCampath is not recommended for use in the paediatric age group.
Ældre (over 65- år):
Elderly (over 65 years of age):
4. 4).
Patients should be monitored carefully (see section 4.4).
Patienter med nedsat nyre - og leverfunktion:
Patients with renal or hepatic impairment:
4. 4).
3 No studies have been conducted.
- overfølsomhed eller anafylaktiske reaktioner på alemtuzumab, på museproteiner eller på
- hypersensitivity to alemtuzumab, to murine proteins or to any of the excipients;
- patienter med aktive systemiske infektioner;
- patients with active systemic infections;
- patienter med HIV;
- patients infected with HIV;
- patienter med andre aktive maligne tilstande;
- patients with active second malignancies;
- graviditet.
- pregnancy.
Akutte bivirkninger, som kan opstå i løbet af den initiale dosisoptrapning, og hvor nogle af dem kan skyldes cytokinfrigivelse, omfatter hypotension, kulderystelser, feber, åndenød, kuldegysninger og hududslæt.
Acute adverse reactions, which may occur during initial dose escalation and some of which may be due to the release of cytokines, include hypotension, chills/ rigors, fever, shortness of breath and rashes.
Hyppigheden af infusionsreaktioner var højest i den første behandlingsuge og faldt i den anden eller tredje behandlingsuge hos patienter behandlet med MabCampath både som 1. linje- behandling og hos tidligere behandlede patienter.
The frequency of infusion reactions was highest in the first week of therapy, and declined in the second or third week of treatment, in patients treated with MabCampath both as first line therapy and in previously treated patients.
Hvis disse hændelser er moderate til alvorlige, bør doseringenfortsætte på det samme niveau forud for hver dosisøgning, og med passende præmedicinering, indtil hver dosis tåles godt.
If these events are moderate to severe, then dosing should continue at the same level prior to each dose escalation, with appropriate premedication, until each dose is well tolerated.
Hvis behandlingen seponeresi i mere end 7 dage bør MabCampath genoptages med gradvis dosisøgning.
If therapy is withheld for more than 7 days, MabCampath should be reinstituted with gradual dose escalation.
Der bør udvises forsigtighed ved behandling af patienter med iskæmisk hjertesygdom, angina og/ eller patienter, som behandles med antihypertensiva.
Caution should be used in treating patients with ischaemic heart disease, angina and/ or in patients receiving an antihypertensive medicinal product.
Vurdering og løbende overvågning af hjertefunktion (f. eks. ekkokardiografi, hjerterytme og kropsvægt) bør overvejes hos patienter, der tidligere er blevet behandlet med potentielt kardiotoksiske midler.
Assessment and ongoing monitoring of cardiac function (e. g. echocardiography, heart rate and body weight) should be considered in patients previously treated with potentially cardiotoxic agents.
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.
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.
Desuden kan der gives et peroralt antihistamin f. eks. difenhydramin 50 mg og et analgetikum f. eks. paracetamol 500 mg.
In addition, an oral antihistamine, e. g. diphenhydramine 50 mg, and an analgesic, e. g. paracetamol 500 mg, may be given.
CD4 og CD8 T- celletallet begynder at stige fra uge 8- 12 under behandlingen og fortsætter med at stige i flere måneder efter seponering af behandlingen.
CD4 and CD8 T-cell counts begin to rise from weeks 8-12 during treatment and continue to recover for several months following the discontinuation of treatment.
Hos patienter, der får MabCampath som 1. linje- behandling, blev der opnået restitution af CD4+ tal til ≥200 celler/ µL 6 måneder efter behandling, 2 måneder efter behandlingen var medianen dog 183 celler/ µl.
In patients receiving MabCampath as first line therapy, the recovery of CD4+ counts to ≥ 200 cells/ µl occurred by 6 months post-treatment, however, at 2 months post-treatment the median was 183 cells/μ l.
Hos tidligere behandlede patienter, der fik MabCampath, er mediantiden for at nå et niveau på 200 celler/ µl er 2 måneder efter den sidste infusion med MabCampath, men det kan tage mere end 12 måneder at nærme sig niveauet fra før behandlingen.
In previously treated patients receiving MabCampath, the median time to reach a level of 200 cells/μ l is 2 months following last infusion with MabCampath but may take more than 12 months to approximate pretreatment levels.
Det anbefales stærkt at initiere antiinfektiøs profylakse (f. eks. trimetoprim/ sulfametoksazol 1 tablet 2 gange dagligt, 3 gange ugentligt eller anden profylakse mod Pneumocystis jiroveci pneumoni (PCP) og et effektivt peroralt antiherpesmiddel som f. eks. famciclovir 250 mg 2 gange dagligt), under behandlingen og i minimum 2 måneder efter afslutning af behandlingen med MabCampath eller indtil CD4+- tallet er steget til 200 celler/ µl eller mere, afhængig af hvad der indtræffer senest.
It is highly recommended that anti-infective prophylaxis (e. g. trimethoprim/ sulfamethoxazole 1 tablet twice daily, 3 times weekly, or other prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and an effective oral anti-herpes agent, such as famciclovir, 250 mg twice daily) should be initiated while on therapy and for a minimum of 2 months following completion of treatment with MabCampath or until the CD4+ count has recovered to 200 cells/μ l or greater, whichever is the later.
Asymptomatisk laboratorie- positiv Cytomegalovirus (CMV) viræmi bør ikke nødvendigvis betragtes
4 Asymptomatic laboratory positive Cytomegalovirus (CMV) viraemia should not necessarily be considered a serious infection requiring interruption of therapy.
Der bør foretages løbende klinisk vurdering for symptomatisk CMV- infektion under behandling med MabCampath i mindst 2 måneder efter afsluttet behandling.
Ongoing clinical assessment should be performed for symptomatic CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.
Forbigående grad 3 eller 4 neutropeni forekommer meget almindeligt 5- 8 uger efter påbegyndelse af behandlingen.
Transient grade 3 or 4 neutropenia occurs very commonly by weeks 5-8 following initiation of treatment.
4. 2).
MabCampath treatment may be reinstituted following resolution of the haematological toxicity (see section 4.2).
Det foreslås ikke, at der skal udføres regelmæssig og systematisk kontrol af CD52- udtrykket som rutinemæssig klinisk procedure.
It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice.
I tilgængelige data fra 1. linje- patienter behandlet med MabCampath, observeredes intet tab af CD52- ekspression omkring tidspunktet for sygdomsprogression eller død.
In data available from first line patients treated with MabCampath, loss of CD52 expression was not observed around the time of disease progression or death.
Patienterne kan få allergiske reaktioner eller hypersensitivitetsreaktioner på MabCampath og på murine antistoffer eller kimære- monoklonale antistoffer.
Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric monoclonal antibodies.
4. 2).
Medicinal products for the treatment of hypersensitivity reactions, as well as preparedness to institute emergency measures in the event of reaction during administration is necessary (see section 4.2).
4. 6 og 5. 3).
Males and females of childbearing potential should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy (see sections 4.6 and 5.3).
Der er ikke foretaget undersøgelser, som specifikt er rettet mod virkningen af alder på fordeling og toksicitet af MabCampath.
No studies have been conducted which specifically address the effect of age on MabCampath disposition and toxicity.
Databasernes størrelse er dog begrænset.
In the studies in first line and previously treated patients no substantial differences in safety and efficacy related to age were observed; however the sizes of the databases are limited.
Det er kendt, at humant IgG passerer placenta.
MabCampath is contraindicated during pregnancy.
MabCampath kan eventuelt også passere gennem placenta og dermed potentielt forårsage depletering af føtale B - og T- lymfocytter.
Human IgG is known to cross the placental barrier; MabCampath may cross the placental barrier as well and thus potentially cause foetal B and T cell lymphocyte depletion.
Der er ikke udført dyre- reproduktionsundersøgelser med MabCampath.
Animal reproduction studies have not been conducted with MabCampath.
Det vides ikke, om MabCampath kan forårsage
It is
5 skade på fosteret, hvis det gives til en gravid kvinde eller om det kan påvirke forplantningsevnen.
5 not known whether MabCampath can cause foetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
Fertile mænd og kvinder bør anvende effektive antikonceptionsmetoder under behandlingen og i 6 måneder efter behandling med MabCampath.
Males and females of childbearing capacity should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy.
Der er ikke foretaget undersøgelser vedrørende af indflydelse på evnen til at føre bil eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
Nedenstående tabeller rapporterer bivirkninger efter MedDRA- systemets organklasser (MedDRA SOCsFrekvenserne er baseret på kliniske forsøgsdata.
The frequencies are based on clinical trial data.
Den mest passendeMedDRA term er benyttet til at beskrive en vis reaktion og dens synonymer og relaterede betingelser.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Hyppighederne er defineret som: meget almindelige ≥ 1/ 10, almindelige ≥ 1/ 100 til < 1/ 10, ikke - almindelige ≥ 1/ 1, 000 til < 1/ 100.
The frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100).
Der er ingen tilgængelige informationer for hændelser, der forekommer med lavere hyppighed på grund af størrelsen af den undersøgte population; n=147 for 1. linje- patienter og n=149 for tidligere behandlede patienter.
No information is available for events that occur at lower frequency, due to the size of the population studied; n=147 for first line treated patients and n=149 for previously treated patients.
Bivirkninger hos 1. linje- patienter
Undesirable effects in first line patients
Ca.
Safety data in first-line B-CLL patients are based on adverse reactions that occurred on study in 147 patients enrolled in a randomized, controlled study of MabCampath as a single agent administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks, inclusive of dose escalation period.
97% af 1. linje- patienterne oplevede birvirkninger; de mest almindeligt indberettede bivirkninger hos 1. linje- patienterne forekom sædvanligvis i den første behandlingsuge.
Approximately 97% of first-line patients experienced adverse reactions; the most commonly reported reactions in first line patients usually occurred in the first week of therapy.
SystemOrgan- Klasse MEDDRA
6 SYSTEM ORGAN CLASS MEDDRA
MEGET ALMINDELIG
VERY
ALMINDELIG
COMMON COMMON
IKKE- ALMINDELIG
UNCOMMON
Cytomegalovirus viræmi
Cytomegalovirus viraemia
Sepsis
Sepsis
Cytomegalovirus - infektion
Cytomegalovirus infection
Bronkitis Faryngitis Oral candidiasis:
Bronchitis Pharyngitis Oral candidiasis
Stafylococ- baseret bakteriæmi Tuberkulose Bronkopneumoni Herpes ophthalmicus Beta- hæmolytisk streptococinfektion Candidiasis Genital candidiasis Urinvejsinfektion Cystitis Tinea corporis Nasofaryngitis
Staphylococcal bacteraemia Tuberculosis Bronchopneumonia Herpes ophthalmicus Beta haemolytic streptococcal infection Candidiasis Genital candidiasis Urinary tract infection Cystitis Body tinea Nasopharyngitis Rhinitis
Sygdomme i blod - og lymfesystemet
Blood and lymphatic system disorder
Febril neutropeni Neutropeni Leukopeni Trombocytopeni Anæmi
Febrile neutropenia Neutropenia Leukopenia Thrombocytopenia Anaemia
Agranulocytose Lymfopeni Lymfadenopati Epistaxis
Agranulocytosis Lymphopenia Lymphadenopathy Epistaxis
Anafylaktisk reaktion Hypersensitivitet
Anaphylactic reaction Hypersensitivity
Stofskifte - og ernæringssygdomme
Metabolic and nutrition disorders
Tumorlysesyndrom Hyperglykæmi Nedsat total protein Anoreksi
Tumour lysis syndrome Hyperglycaemia Protein total decreased Anorexia
Synkope Svimmelhed Tremor Paræstesi Hypoæstesi Hovedpine
Syncope Dizziness Tremor Paraesthesia Hypoesthesia Headache
Hjertelidelser
Cardiac disorders
Cyanose Bradykardi Takykardi Sinustakykardi
Cyanosis Bradycardia Tachycardia Sinus tachycardia
Hjertestop Myokardieinfarkt Angina pectoris Atrieflimmer Arytmi, supraventirkulær Sinusbradykardi Supraventrikulære ekstrasystoler
Cardiac arrest Myocardial infarction Angina pectoris Atrial fibrillation Arrhythmia supraventricular Sinus bradycardia Supraventricular extrasystoles
Ortostatisk hypotension Hedeture Rødmen
Orthostatic hypotension Hot flush Flushing
Respiratoriske, thorax - og mediastina- lidelser
Respiratory, thoracic and mediastinal disorders
Bronkospasme Dyspnø
Bronchospasm Dyspnoea
Hypoxi Pleural effusion Dysfoni Rinorré
Hypoxia Pleural effusion Dysphonia
Sygdomme i mave - tarmkanalen
SYSTEM ORGAN CLASS MEDDRA
Kvalme
COMMON
Opkastning Mavesmerter
UNCOMMON Rhinorrhoea
Ileus Oralt ubehag Maveubehag Diarré
Ileus
Sygdomme i hud og subkutane væv
disorders
Allergisk dermatit
Dermatitis allergic
Udslæt med pruritus
Rash pruritic
Pruritus Hyperhidrose Erytem
Pruritus Hyperhidrosis Erythema
Udslæt, makuløst Udslæt, erytematøst Dermatitis
Rash macular Rash erythematous Dermatitis
Myalgi Muskuloskeletale smerter Rygsmerter
Myalgia Musculoskeletal pain Back pain
Knoglesmerter Artralgi Muskuloskeletale brystsmerter Muskelspasmer
Bone pain Arthralgia Musculoskeletal chest pain Muscle spasms
Nedsat urinudskillelse Dysuri
Urine output decreased Dysuria
Feber Kulderystelser
Fever Chills
Mucosal inflammation Erytem på infusionsstedet Lokaliseret ødem Ødem på infusionsstedet Malaise
Mucosal inflammation Infusion site erythema Localised oedema Infusion site oedema Malaise
Grad 3 - eller 4- reaktioner ved infusion er ikke - almindeligt forekommende efter den første behandlingsuge.
Grade 3 or 4 infusion reactions are uncommon after the first week of therapy.
Sikkerhedsdata hos tidligere behandlede B- CLL patienter er baseret på 149 patienter, der deltog i enkeltgrenede undersøgelser af MabCampath (Forsøg 1, 2 og 3).
Safety data in previously treated B-CLL patients are based on 149 patients enrolled in single-arm studies of MabCampath (Studies 1, 2, and 3).
ORGANKLASSE MEDDRA
SYSTEM ORGAN CLASS MEDDRA
USÆDVANLIG
UNCOMMON
Sepsis Pneumoni
Sepsis
Cytomegalovirus infektion Pneumocystis jiroveci - infektion
Cytomegalovirus infection
Bakterieinfektion Virusinfektion
Bacterial infection
Herpes simplex
Pneumonia
Sygdomme i blod - og lymfesystem
Pneumocystis jiroveci infection
Trombo- cytopeni
Viral infection
Pancytopeni
Herpes simplex
Dissemineret intravaskulær koagulation
Pneumonitis Fungal infection Candidiasis Herpes zoster Abscess
Hæmolytisk anæmi, nedsat haptoglobin
Fungal dermatitis Laryngitis Rhinitis Onychomycosis
8 ORGANKLASSE MEDDRA
8
MEGET ALMINDELIG
Urinary tract infection Sinusitis Bronchitis Upper respiratory tract infection Pharyngitis Infection Neoplasms, benign, malignant and unspecified (incl. cysts and polyps)
USÆDVANLIG Abnorm hæmatologitest
Lymphoma – like disorder
Forstyrrelser i immunsystemet
Blood and lymphatic system disorder
Stofskifte- sygdomme og ernærings- betingede sygdomme
Granulocytopenia Thrombocytopenia
Hyponatriæmi Hypocalcæmi Vægttab Dehydrering Tørst
Febrile neutropenia Pancytopenia
Hypokalæmi Forværring af diabetes mellitus
Aplasia bone marrow Disseminated intravascular coagulation
Psykiske lidelser
Anaemia
Konfusion Angst
Leukopenia
Depersonalisation Personligheds - forstyrrelser
Haemolytic anaemia, Decreased haptoglobin
Depression Somnolens Søvnløshed
Lymphopenia Purpura
Abnorm tankegang Impotens Nervøsitet
Bone marrow depression Epistaxis Gingival bleeding Haematology test abnormal
Sygdomme i nervesystemet
Immune system disorders
Vertigo Svimmelhed Tremor Paræstesi Hypæstesi Hyperkinesi Tab af smagssans
Allergic reaction Severe anaphylactic and other hypersensitivity reactions
Øjensygdomme Sygdomme i det ydre og det indre øre
Metabolic and nutrition disorders
Konjunktivitis
Anorexia
Endoftalmitis Døvhed Tinnitus
Hyponatraemia Hypocalcaemia Weight decrease Dehydration Thirst
Palpitationer Takykardi
Hypokalaemia Diabetes mellitus aggravated