natgillin/translations-raw huggingface dataset:
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking Betaferon.
Tako kot pri drugih interferonih beta so bili tudi pri prejemnikih zdravila Betaferon opisani redki primeri hude jetrne okvare, vključno s primeri jetrne odpovedi.
The most serious events often occurred in patients exposed to other drugs or substances known to be associated with hepatotoxicity or in the presence of comorbid medical conditions (e. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Resni neželeni učinki so se pogosto pojavili pri bolnikih, ki so prejemali še druga zdravila ali snovi z znanimi hepatotoksičnimi učinki in pri bolnikih s sočasnimi boleznimi (npr. metastatsko maligno boleznijo, hudo okužbo in sepso, zlorabo alkohola).
The occurrence of elevations in serum transaminases should lead to close monitoring and investigation.
Pri povečanju vrednosti serumskih transaminaz je potreben skrben nadzor in preiskave.
Withdrawal of Betaferon should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundices.
Če se vrednosti transaminaz pomembno povečajo ali če jih spremljajo klinični simptomi zlatenice, je treba razmisliti o prekinitvi zdravljenja z zdravilom Betaferon.
In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
V odsotnosti kliničnih znakov jetrne okvare in po normalizaciji jetrnih encimov je mogoče ponovno uvesti zdravljenje z ustreznim nadaljnjim spremljanjem jetrnega delovanja.
Caution should be used and close monitoring considered when administering Interferon beta to patients with severe renal failure.
Pri uporabi interferona beta pri bolnikih s hudo ledvično okvaro je treba biti previden; bolnike je treba pozorno spremljati.
4 Cardiac disorders
4 Srčne bolezni
It should also be used with caution in patients who suffer from pre-existing cardiac disorders, Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Betaferon.
Bolnike s pomembnimi srčnimi boleznimi, kot so kongestivna srčna odpoved, bolezen koronarnih arterij ali aritmija, je treba spremljati zaradi možnega poslabšanja bolezni srca, zlasti na začetku zdravljenja z zdravilom Betaferon.
While Betaferon does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Čeprav zdravilo Betaferon nima znane neposredne toksičnosti za srce, so lahko gripi podobni simptomi, povezani z uporabo interferonov, za bolnike s pomembno boleznijo srca stresni.
During the postmarketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Betaferon therapy.
V pomarketinškem obdobju so zelo redko poročali o poslabšanju bolezni srca pri bolnikih z boleznijo srca, do katerega je prišlo na začetku zdravljenja z zdravilom Betaferon.
If this occurs and a relationship to Betaferon is suspected, treatment should be discontinued.
Če obstaja sum na povezavo z uporabo zdravila Betaferon, je treba zdravljenje prekiniti.
Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Lahko pride do resnih preobčutljivostnih reakcij (redke, vendar hude akutne reakcije, kot je bronhospazem, anafilaksa in urtikarija).
If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Če so reakcije hude, je treba zdravljenje z zdravilom Betaferon prekiniti in ustrezno ukrepati.
Injection site necrosis has been reported in patients using Betaferon (see section 4.8).
Pri bolnikih, ki prejemajo zdravilo Betaferon, so poročali o nekrozi na mestu injiciranja (glejte poglavje 4. 8).
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/ her physician before continuing injections with Betaferon.
Če bolnik opazi poškodbo kože, ki je lahko povezana z otekanjem ali vlaženje na mestu injiciranja, mu je treba svetovati, da se pred nadaljevanjem injiciranja zdravila Betaferon posvetuje z zdravnikom.
If the patient has multiple lesions Betaferon should be discontinued until healing has occurred.
Če ima bolnik več lezij, je treba zdravljenje z zdravilom Betaferon do njihove zacelitve prekiniti.
Patients with single lesions may continue on Betaferon provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Betaferon.
Če nekroza ni preveč razširjena, se lahko pri bolnikih s posameznimi lezijami nadaljuje zdravljenje z zdravilom Betaferon, ker je pri nekaterih bolnikih med uporabo zdravila Betaferon prišlo do celjenja nekroze na mestu injiciranja.
− use an aseptic injection technique − rotate the injection sites with each dose.
Za zmanjšanje tveganja za nekrozo na mestu injiciranja, je treba bolnikom svetovati, da: − izvedejo injiciranje v aseptičnih pogojih, − pri vsakem odmerku zamenjajo mesto injiciranja.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Pri bolniku je treba redno kontrolirati postopek samoinjiciranja, zlasti če so se pojavile reakcije na mestu injiciranja.
In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Pri 43 do 55% teh bolnikov je med poznejšim opazovalnim obdobjem v posameznih preskušanjih prišlo do konverzije v stabilni antigensko negativni status (na osnovi dveh zaporednih negativnih titrov).
5 The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
5 Pojav nevtralizirajoče aktivnosti je povezan z zmanjšanjem klinične učinkovitosti, ki se nanaša le na recidivno aktivnost.
Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
Nekatere analize kažejo, da bi bil ta učinek lahko večji pri bolnikih z višjim titrom nevtralizirajoče aktivnosti.
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (88) of the patients treated immediately with Betaferon; of these, 47% (41) returned to negative status over a 3 year period.
V študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so nevtralizacijsko aktivnost, izmerjeno vsakih 6 mesecev, opazili vsaj enkrat pri 32% (88) bolnikov, takoj zdravljenih z zdravilom Betaferon, med njimi se jih je v treh letih 47% (41) vrnilo na negativni status.
Within this period, the development of neutralising activity was not associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), and time to confirmed EDSS progression).
V tem obdobju razvoj nevtralizacijske aktivnosti ni bil povezan z zmanjšanjem klinične učinkovitosti (glede na čas do klinično potrjene multiple skleroze (CDMS - clinically definite multiple sclerosis) in čas do napredovanja potrjenega po EDSS).
However, this has not been investigated in vivo and its clinical significance is uncertain.
In vitro je dokazano, da zdravilo Betaferon navzkrižno reagira z naravnim interferonom beta, vendar to ni raziskano in vivo; klinični pomen tega ni jasen.
There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Betaferon therapy.
Podatkov o bolnikih, pri katerih se je razvila nevtralizacijska aktivnost in so dokončali zdravljenje z zdravilom Betaferon, je malo in so nedokončni.
The effect of alternate-day administration of 250 microgram (8.0 million IU) of Betaferon on drug metabolism in multiple sclerosis patients is unknown.
Učinek uporabe 250 mikrogramov (8 milijonov i. e.) zdravila Betaferon vsak drugi dan na presnovo zdravil pri bolnikih z multiplo sklerozo ni znan.
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Betaferon.
ACTH, ki je trajalo do 28 dni.
Due to the lack of clinical experience in multiple sclerosis patients, the use of Betaferon together with immunomodulators other than corticosteroids or ACTH is not recommended.
Zaradi pomanjkanja kliničnih izkušenj z zdravilom Betaferon, ga pri bolnikih z multiplo sklerozo ni priporočljivo uporabljati skupaj z drugimi imunomodulatorji (razen kortikosteroidov ali ACTH).
Caution should be exercised when Betaferon is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. anti-epileptics.
Previdnost je potrebna pri sočasni uporabi zdravila Betaferon in zdravil, ki imajo ozek terapevtski indeks in katerih očistek je v največji meri odvisen od jetrnega sistema citokrom P450 npr. antiepileptiki.
Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
Dodatna previdnost je potrebna pri sočasni uporabi kateregakoli zdravila, ki vpliva na hematopoetski sistem.
• Pregnancy
• Nosečnost
There is limited information on the use of Betaferon in pregnancy.
Podatkov o uporabi zdravila Betaferon med nosečnostjo je malo.
• Women of child-bearing potential
• Ženske v rodni dobi
If the patient becomes pregnant or plans to become pregnant while taking Betaferon, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Če bolnica med uporabo zdravila Betaferon zanosi ali načrtuje nosečnost, jo je treba seznaniti z možnimi nevarnostmi; v poštev pride prekinitev zdravljenja (glejte poglavje 5. 3).
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of Betaferon in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
Pri bolnicah, pri katerih obstaja pred začetkom zdravljenja veliko tveganje za poslabšanje bolezenskih znakov, je treba
6 • Lactation
6 pretehtati tveganje za resen relaps po prekinitvi zdravljenja z zdravilom Betaferon zaradi nosečnosti glede na povečano tveganje za spontani splav.
It is not known whether interferon beta-1b is excreted in human milk.
Ni znano, ali se interferon beta- 1b izloča v materino mleko.
Because of the potential for serious adverse reactions in nursing infants a decision should be made whether to discontinue breast- feeding or Betaferon therapy.
Zaradi možnih resnih neželenih učinkov zdravila Betaferon pri dojenih otrocih, se je treba odločiti bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Betaferon.
Central nervous system-related adverse events associated with the use of Betaferon might influence the ability to drive and use machines in susceptible patients.
Z zdravilom Betaferon povezani neželeni učinki na osrednje živčevje bi pri dovzetnih bolnikih lahko vplivali na sposobnost vožnje in upravljanja s stroji.
a) At the beginning of treatment adverse reactions are common but in general they subside with further treatment.
a) Na začetku zdravljenja so neželeni učinki pogosti, a z nadaljevanjem zdravljenja praviloma izzvenijo.
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia) and injection site reactions, which is mainly due to the pharmacological effects of the medicinal product and injection site reactions.
Najpogostejši neželeni učinki so kompleks gripi podobnih simptomov (zvišana telesna temperatura, mrzlica, artralgija, splošno slabo počutje, znojenje, glavobol ali mialgija) in reakcije na mestu injiciranja do katerega pride predvsem zaradi farmakoloških učinkov zdravila in reakcij na mestu injiciranja.
Injection site reactions occurred frequently after administration of Betaferon.
Po uporabi zdravila Betaferon pogosto pride do reakcij na mestu injiciranja.
Redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8 million IU) Betaferon treatment.
Z uporabo 250 mikrogramov (8 milijonov i. e.) zdravila Betaferon so statistično pomembno povezane naslednje reakcije: rdečica, otekanje, sprememba barve kože, vnetje, bolečina, preobčutljivost, nekroza in nespecifične reakcije.
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see section 4.2).
Na splošno se na začetku zdravljenja priporoča titriranje odmerka, da bi povečali toleranco za zdravilo Betaferon (glejte poglavje 4. 2).
Flu-like symptoms may also be reduced by administration of non- steroidal anti-inflammatory drugs.
Simptomi podobni gripi, se lahko zmanjšajo z uporabo nesteroidnih protivnetnih zdravil.
b) The following adverse event listing is based on reports from clinical trials (table 1, adverse events and laboratory abnormalities) and from the post marketing surveillance (table 2, reporting rates based on spontaneous adverse drug reaction reports classified as 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) of Betaferon use.
b) Spodnja seznama neželenih učinkov temeljita na poročilih iz kliničnih preskušanj (preglednica 1, neželeni učinki in nenormalni izvidi laboratorijskih preiskav) in iz pomarketinškega spremljanja uporabe zdravila Betaferon (preglednica 2, pogostnost navedb temelji na podatkih iz spontanih poročil o neželenih učinkih zdravila; zelo pogosto ≥ 1/ 10, pogosto ≥ 1/ 100 do < 1/ 10, občasno ≥ 1/ 1. 000 do < 1/ 100, redko ≥ 1/ 10. 000 do 1/ 1. 000, zelo redko < 1/ 10. 000).
Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Izkušnje z zdravilom Betaferon so pri bolnikih z MS omejene, zato je mogoče, da neželenih učinkov, ki se pojavljajo zelo redko, še niso opazili.
7 Table 1 (adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%).
7 Preglednica 1 (neželeni učinki in nenormalni izvidi laboratorijskih preiskav s pogostnostjo ≥ 10% in ustrezni odstotki pri placebu; statistično značilno povezani neželeni učinki < 10%)
SystemOrganClass
recidivno - Organski sistem
Single Event suggestive of
dogodek, ki
Secondary Secondary Progressive Progressive
sekundarno
Relapsing Remitting
sekundarno
Adverse Event and Laboratory Abnormalities
remitentna
Multiple Sclerosis (BENEFIT) #
kaže na
Multiple Multiple Sclerosis Sclerosis (European (North Study) American Study)
progresivna
Multiple Sclerosis
progresivna
Betaferon Betaferon 250 250
multipla
Betaferon 250 microgram
neželeni učinek in
Betaferon 250
multiplo
microgram microgram
multipla
(Placebo)
multipla
microgram
skleroza
(Placebo) (Placebo)
sklerozo
n=317 (n=308)
skleroza
(Placebo)
skleroza
Infections and infestations
(BENEFIT) # nenormalen izvid laboratorijske preiskave
n=292 (n=176)
(evropska študija)
n=360 (n=358)
(severno - ameriška študija)
n=124 (n=123)
Infekcijske in parazitske
Infection Abscess
Betaferon 250 Betaferon 250 Betaferon 250 mikrogramov mikrogramov mikrogramov (placebo) (placebo) (placebo) n = 292 n = 360 n = 317 (n = 176) (n = 358) (n = 308) bolezni
6% (3%) 0% (1%)
Betaferon 250 mikrogramov (placebo) n = 124 (n = 123)
13% (11%) 4% (2%)
infekcije absces
11% (10%) 4% (5%)
6% (3%) 13% (11%) 11% (10%) 0% (1%) 4% (2%) 4% (5%)
Blood and lymphatic system disorders Lymphocyte count decreased (< 1500/ mm³) Λ °
Bolezni krvi in limfatičnega sistema zmanjšano število limfocitov (< 1500/ mm³) × Λ °
Absolute neutrophil count × decreased (< 1500/ mm³) Λ *°
zmanjšano absolutno število nevtrofilcev (< 1500/ mm³) × Λ * °
White blood cell count × decreased (< 3000/ mm³) Λ *°
zmanjšano število levkocitov (< 3000/ mm³) × Λ * °
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) × Psychiatric disorders
Presnovne in prehranske motnje zmanjšana vrednost glukoze (< 55 mg/ dl) × Psihiatrične motnje
Depression Anxiety Nervous system disorders
depresija tesnoba Bolezni živčevja
Headache Λ Dizziness Insomnia Migraine Paresthesia Eye disorders
glavobol Λ omotica nespečnost migrena parestezija Očesne bolezni
Conjunctivitis Abnormal vision Λ Ear and labyrinth disorders
konjunktivitis Λ
Ear pain Cardiac disorders
Ušesne bolezni, vključno z motnjami labirinta bolečine v ušesu Srčne bolezni
< 1% (1%)
1% (1%)
Palpitation * Vascular disorders
palpitacije * Žilne bolezni
Vasodilatation Hypertension °
vazodilatacija
Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Bolezni dihal, prsnega koša in mediastinalnega prostora okužbe zgornjih dihal
Single Event suggestive of
sekundarno
Secondary Progressive
remitentna
Secondary Progressive
progresivna
Relapsing Remitting
progresivna
Adverse Event and Laboratory Abnormalities
neželeni učinek
Multiple Sclerosis (BENEFIT) #
(BENEFIT) # nenormalen izvid
Multiple Sclerosis (European Study)
(evropska
Multiple Sclerosis (North American Study)
študija)
Multiple Sclerosis
študija)
Betaferon 250 microgram
Betaferon 250
microgram microgram
mikrogramov
(Placebo)
mikrogramov
(Placebo)
(placebo) n = 292 (n = 176)
n=292 (n=176)
(placebo) n = 360 (n = 358)
n=360 (n=358)
n = 317 (n = 308)
n=124 (n=123)
n = 124 (n = 123)
Cough increased Dyspnea * Gastrointestinal disorders
močnejši kašelj dispneja * Bolezni prebavil
Diarrhoea Constipation Nausea Vomiting Λ Abdominal pain ° Hepatobiliary disorders
driska zaprtje navzeja bruhanjeΛ bolečine v trebuhu °
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
Bolezni hepatobiliarnega sistema povečane vrednosti alanin - aminotransferaze (SGPT > 5- kratna izhodiščna vrednost) × Λ * °
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
povečane vrednosti aspartat - aminotransferaze (SGOT > 5- kratna izhodiščna vrednost) × Λ * ° Bolezni kože in podkožja
Skin and subcutaneous tissue disorders Skin disorder Λ
kožne spremembe
Rash °
izpuščaj Λ °
Musculoskeletal and connective tissue disorders Hypertonia° Myalgia * ° Myasthenia
Bolezni mišično- skeletnega sistema in vezivnega tkiva hipertonija ° mialgija * ° miastenija
Back pain Pain in extremity Renal and urinary disorders
bolečine v hrbtu bolečine v okončinah Bolezni sečil
Urinary retention
zastoj urina
Urinary protein positive (> 1+)×
pozitiven izvid beljakovin v seču (> 1+) ×
Urinary incontinence Urinary urgency
urinska inkontinenca nuja za mokrenje Motnje reprodukcije in dojk
Reproductive system and breast disorders Dysmenorrhea Menstrual disorder *
menstruacijske motnje *
2% (0%) 1% (2%)
1% (2%)
< 1% (< 1%) 9% (13%)
9% (13%)
Metrorrhagia Impotence
metroragija
General disorders and administration site conditions Injection site reaction Λ § (various kinds) * °
Splošne težave in spremembe na mestu aplikacije reakcija na mestu injiciranja (različne vrste) Λ * ° §
Injection site necrosis * ° & Λ
nekroza na mestu injiciranja * °
Flu-like symptoms *° Fever Λ * °
gripi podobni & Λ simptomi * °
Adverse Event and Laboratory Abnormalities
zvišana telesna temperatura Λ * °
Multiple Sclerosis (BENEFIT) #
13% (5%)
(Placebo)
40% (13%)
microgram
29% (24%)
(Placebo) (Placebo)
59% (41%)
n=317 (n=308)
bolečine bolečine v prsnem košu °
(Placebo)
4% (4%) 1% (0%)
n=292 (n=176)
31% (25%) 5% (4%)
n=360 (n=358)
59% (59%) 15% (8%)
n=124 (n=123)
52% (48%) 15% (15%)
Pain Chest pain ° Peripheral edema Asthenia * Chills Λ * ° Sweating * Malaise * × Laboratory abnormality Λ
periferni edem astenija * mrzlica Λ * ° potenje * splošno slabo počutje *
4% (4%) 1% (0%) 0% (0%) 22% (17%) 5% (1%) 2% (1%) 0% (1%)
0% (0%) 22% (17%) 5% (1%) 2% (1%) 0% (1%)
31% (25%) 5% (4%) 7% (7%) 63% (58%) 23% (7%) 6% (6%) 8% (5%)
7% (7%) 63% (58%) 23% (7%) 6% (6%) 8% (5%)
59% (59%) 15% (8%) 21% (18%) 64% (58%) 22% (12%) 10% (10%) 6% (2%)
21% (18%) 64% (58%) 22% (12%) 10% (10%) 6% (2%)
52% (48%) 15% (15%) 7% (8%) 49% (35%) 46% (19%) 23% (11%) 15% (3%)
7% (8%) 49% (35%) 46% (19%) 23% (11%) 15% (3%)
Significantly associated with Betaferon treatment for patients with first event suggestive of MS, p < 0.05 * Significantly associated with Betaferon treatment for RRMS, p < 0.05 ° Significantly associated with Betaferon treatment for SPMS, p < 0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i. e. the following terms: injection site hemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site edema, and injection site atrophy & “ Flu-like symptom complex ” denotes flu syndrome and/ or a combination of at least two AEs from fever, chills, myalgia, malaise, sweating. # During the third year of the BENEFIT study, no change of the known risk profile of Betaferon was observed.
nenormalen izvid laboratorijske preiskave Λ pomembno povezano z zdravljenjem z zdravilom Betaferon pri bolnikih s prvim kliničnim dogodkom, ki kaže na MS, p < 0, 05 * statistično značilno povezano z uporabo zdravila Betaferon pri RR- MS, p < 0, 05 ° statistično značilno povezano z uporabo zdravila Betaferon pri SP- MS, p < 0, 05 § reakcije na mestu injiciranja (različne vrste) sestavljajo vsi neželeni učinki na mestu injiciranja, kot so krvavitev na mestu injiciranja, preobčutljivost na mestu injiciranja, vnetje na mestu injiciranja, hipertrofija na mestu injiciranja, nekroza na mestu injiciranja, bolečina na mestu injiciranja, reakcija na mestu injiciranja, edem na mestu injiciranja in atrofija na mestu injiciranja & "kompleks gripi podobnih simptomov" pomeni sindrom gripe in/ ali kombinacijo vsaj dveh izmed naslednjih neželenih učinkov: zvišana telesna temperatura, mrzlica, mialgija, občutek neugodja, potenje. # V tretjem letu študije BENEFIT niso ugotovili sprememb tveganja zaradi uporabe zdravila Betaferon.
10 Table 2 (reporting rates (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) based on spontaneous adverse drug reaction reports).
10 Preglednica 2 (pogostnost navedb temelji na podatkih iz spontanih poročil o neželenih učinkih zdravila; zelo pogosto ≥ 1/ 10, pogosto ≥ 1/ 100 do < 1/ 10, občasno ≥ 1/ 1. 000 do < 1/ 100, redko ≥ 1/ 10. 000 do < 1/ 1. 000, zelo redko < 1/ 10. 000)
System Organ Class
≥ 1/ 10. 000 do <
Common ≥ 1/ 100 to < 1/ 10
≥ 1/ 100 do < 1/ 10
Rare ≥ 1/ 10,000 to < 1/ 1,000
1/ 1. 000
Blood and lymphatic system disorders
limfadenopatija anemija, Bolezni krvi in trombocitopenija, limfatičnega levkopenija sistema anafilaktične Bolezni imunskega reakcije sistema hipertiroidizem, Bolezni hipotiroidizem, endokrinega motnje v sistema delovanju ščitnice povečane Presnovne in vrednosti prehranske motnje trigliceridov v krvi, anoreksija depresija (glejte zmedenost, Psihiatrične motnje Bolezni živčevja
Lymphadenopathy
poglavje 4. 4)
Immune system disorders Endocrine disorders
tesnoba, čustvena labilnost, poskus samomora (glejte poglavje 4. 4) konvulzije
Anaphylactic reactions Hyperthyroidism, Hypothyroidism, Thyroid disorder
Srčne bolezni Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Metabolism and nutrition disorders
hipertenzija
Blood triglycerides increased Anorexia
kardiomiopatija, tahikardija, palpitacije bronhospazem, dispneja
Depression (see also section 4.4)
bruhanje, navzeja