natgillin/translations-raw huggingface dataset:
2 Study C08-002: 3 patients received ESA which was discontinued after eculizumab initiation Study C08-003: 8 patients received ESA which was discontinued in 3 of them during eculizumab therapy aHUS Study C10-004 enrolled 41 patients who displayed signs of thrombotic microangiopathy (TMA).
Študija C08-003: 8 bolnikov je prejelo ESA, kar je bilo prekinjeno pri 3 med zdravljenjem z ekulizumabom.
• Initial phase: 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every week for the first 4 weeks.
• začetna faza: 900 mg zdravila Soliris se daje v obliki 25-45-minutne intravenske infuzije enkrat na teden prve 4 tedne,
How to store Soliris
Shranjevanje zdravila Soliris
Soliris has not been studied in paediatric patients with refractory gMG or NMOSD.
Pri pediatričnih bolnikih z refraktarno gMG ali NMOSD zdravila Soliris niso proučevali.
Rare
aHUS
• infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), Haemophilus influenzae infection, gum infection, impetigo, bacterial sexual transmitted disease (gonorrhea)
Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov: • glivična okužba (okužba z glivico Aspergillus), okužba sklepa (bakterijski artritis), okužba z bakterijo Haemophilus influenzae, okužba dlesni, impetigo, bakterijska spolno prenosljiva bolezen (gonoreja ali kapavica),
Patients received meningococcal vaccination prior to receipt of Soliris.
Pred pričetkom jemanja zdravila Soliris so bili bolniki cepljeni proti meningokokom.
for Soliris and 68.3 for placebo, based on 125 study patients (p=0.0698).
125 bolnikov, vključenih v študijo (p = 0,0698).
In PNH patients, uncontrolled terminal complement activation and the resulting complement-mediated intravascular haemolysis are blocked with Soliris treatment.
Pri bolnikih s PNH sta zaradi zdravljenja z zdravilom Soliris zavrta nekontrolirana aktivacija terminalnega komplementa in posledična intravaskularna hemoliza, ki je posredovana s komplementom.
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
Neisseria meningitidis in drugimi vrstami Neisseria species, vključno z diseminirano gonorejo,
In a 26 week toxicity study performed in mice with a surrogate antibody directed against murine C5, treatment did not affect any of the toxicity parameters examined.
V 26-tedenski toksikološki študiji na miših z nadomestnim protitelesom, usmerjenim proti mišjemu
TMA Event-Free Status, n (%)
stanje brez TMA dogodka, n (%)
Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Pred jemanjem zdravila Soliris se posvetujte z zdravnikom, da bi tako najmanj dva tedna pred začetkom zdravljenja zanesljivo prejeli cepivo proti bakteriji Neisseria meningitidis, t.j.
ADRs identified in postmarketing reports
c Neželeni učinki, ugotovljeni v poročilih po prihodu zdravila na trg.
In patients with aHUS, their kidney and blood cells, including platelets, can be inflamed which can lead to low blood counts (thrombocytopenia and anaemia), reduced or lost kidney function, blood clots, tiredness and difficulty in functioning.
kar lahko povzroči nizko število krvnih celic (trombocitopenijo in anemijo), zmanjšano ali odsotno delovanje ledvic, krvne strdke, utrujenost in zmanjšano zmogljivost.
Genitourinary tract gonococcal infection, Haemophilus influenzae infection,
gonokokna okužba genitourinarnega trakta,
• dyspnoea (difficulty breathing), nose bleed, stuffy nose (nasal congestion), throat irritation, runny nose
• dispneja (oteženo dihanje), krvavenje iz nosu, zamašen nos (kongestija nosu), draženje v žrelu,
Sepsis is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Soliris, se meningokokne okužbe pogosto začnejo s sepso (glejte poglavje 4.8).
- If you get any side effects, talk to your doctor, pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
Change from baseline at 12 weeks in Plasma Free Haemoglobin (mg/dL) Change from baseline Type III RBC clone size (Percent of aberrant cells) Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (patients) 10.5 (6.66)
Sprememba velikosti klona tip III RBC od izhodišča (odstotek aberantnih celic) Sprememba na lestvici »PedsQL
Soliris has not been evaluated in paediatric patients with NMOSD.
Pri pediatričnih bolnikih z NMOSD zdravila Soliris niso ocenjevali.
U.S.A.
Velika Britanija
Statistic
Statistični parameter
Soliris has not been evaluated in paediatric patients with refractory gMG.
Pri pediatričnih bolnikih z refraktarno gMG zdravila Soliris niso ocenjevali.
SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
In children and adolescent PNH patients (aged 11 years to less than 18 years) included in the paediatric
Pediatrična populacija Pri otrocih in mladostnikih s PNH (starih od 11 do manj kot 18 let), ki so bili vključeni v pediatrično študijo PNH M07-005, se je zdel varnostni profil podoben, kot so ga opazovali pri odraslih bolnikih s
Baseline eGFR (mL/min/1.73 m2 ), median (min,
izhodiščna LDH (enot/l), mediana (min, maks) izhodiščna eGFR (ml/min/1,73 m2), mediana (min, maks)
• muscle cramp, muscle aches, back and neck pain, bone pain, joint swelling, pain in the limbs (arms and legs)
• mišični krči, bolečine v mišicah, bolečina v križu in vratu, kostna bolečina, otekanje sklepov,
Must be diluted before use.
Pred uporabo zdravilo razredčite.
Interrupting or ending treatment with Soliris may cause your aHUS symptoms to come back.
Prekinitev ali prenehanje zdravljenja z zdravilom Soliris lahko povzroči, da se simptomi aHUS znova pojavijo.
Complete TMA response was maintained by all responders.
Vsi bolniki, ki so se klinično pomembno odzvali na zdravljenje, so vzdrževali popoln TMA odgovor.
Gender - Female (%) History of Aplastic Anaemia or MDS (%) Concomitant Anticoagulants (%) Concomitant Steroids/Immunosuppressant Treatments (%)
Anamneza aplastične anemije ali MDS (%) Sočasno zdrav.
Dyspnoea, Epistaxis, Throat irritation, Nasal congestion, Rhinorrhoea
draženje v žrelu, zamašen nos, rinoreja
Headache Dizziness, Dysgeusia
Bolezni sečil okvara ledvic, disurija, hematurija
Through data cut-off (October 12, 2012), with median duration of Soliris therapy of 44 weeks (range: 1 dose to 88
NA 1 Ob koncu zbiranja podatkov (12. oktober 2012), mediano trajanje zdravljenja z zdravilom Soliris je bilo
Table 17: Baseline Characteristics of Paediatric and Adolescents Patients Enrolled in aHUS Study
Preglednica 17: Izhodiščne značilnosti pediatričnih in mladostniških bolnikov, vključenih v študijo aHUS C10-003
Biotransformation
Spremenljivka
PE/PI Event-Free Status, n (%) New Dialysis Event-Free Status, n (%)
26 tednih, mediana (razpon) izboljšanje CKD za ≥ 1 stadij, n (%) stanje brez dogodka PE/PI, n (%) stanje brez dogodka nove dialize, n (%)
Patients received meningococcal vaccination prior to initiating treatment with Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Bolniki so bili cepljeni proti meningokoku pred začetkom zdravljenja z zdravilom Soliris ali pa so prejeli profilaktično zdravljenje z ustreznimi antibiotiki do 2 tedna po cepljenju.
If PNH patients discontinue treatment with Soliris they should be closely monitored for signs and symptoms of serious intravascular haemolysis.
Prekinitev zdravljenja pri bolnikih s PNH Pri bolnikih s PNH, ki prekinejo zdravljenje z zdravilom Soliris, je treba skrbno nadzirati znake in simptome resne intravaskularne hemolize.
Change from baseline at 12 weeks of PedsQLTM Multidimensional Fatigue (parents)
Multidimensional Fatigue« od izhodišča ob 12. tednu (bolniki) Sprememba na lestvici »PedsQL
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label
PODATKI NA ZUNANJI OVOJNINI škatla
Total
povprečje
In aHUS Study C08-003A/B, the median duration of Soliris therapy was approximately 114 weeks
V študiji aHUS C08-003A/B je bilo mediano trajanje zdravljenja z zdravilom Soliris približno 114 tednov (razpon: od 26 do 129 tednov).
Change From Baseline MG-ADL Total Score
povprečje (min, maks) Izhodiščni rezultat lestvice MG-ADL
indicative of high disease activity, regardless of transfusion history (see section 5.1).
Klinična korist zdravila Soliris je bila dokazana pri bolnikih s hemolizo s kliničnim(i) simptomom(i), ki nakazuje(jo) veliko aktivnost bolezni, ne glede na transfuzijsko anamnezo (glejte poglavje 5.1); - atipičnega hemolitično-uremičnega sindroma (aHUS) (glejte poglavje 5.1).
Daily TMA Intervention Rate, median (range) Before eculizumab On eculizumab treatment 1 Through data cut-off (September 4, 2012), with median duration of Soliris therapy of 50 weeks (range: 13
1 Do zaključka zbiranja podatkov (4. septembra 2012) z medianim trajanjem zdravljenja z zdravilom Soliris
Any prior intubation since diagnosis (MGFA
Kakršna koli predhodna ventilacijska podpora od diagnoze, n (%) Kakršna koli predhodna intubacija od diagnoze (skupina V MGFA), n (%)
Excipients with known effect: Sodium (5 mmol per vial) For the full list of excipients, see section 6.1.
Pomožna(e) snov(i) z znanim učinkom: natrij (5 mmolov na vialo).
Time from current clinical TMA manifestation until first study dose (months), median ( min, max) Baseline platelet count (× 109/L), median (, min, max ) Baseline LDH (U/L), median (, min, max) Baseline eGFR (mL/min/1.73m2), median (min, max)
(min, maks) izhodiščna LDH (enot/l) mediana (min, maks) izhodiščna eGFR (ml/min/1,73 m2), mediana (min, maks)
shortness of breath (dyspnoea), anaemia (haemoglobin <100 g/L), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Ti bolniki so imeli veliko aktivnost bolezni, kar je opredeljeno z zvečano hemolizo (LDH ≥ 1,5 x zgornja meja normale) in prisotnostjo povezanih kliničnih simptomov: utrujenost, hemoglobinurija, bolečine v trebuhu, zasoplost (dispneja), anemija (hemoglobin < 100 g/l), večji neželeni žilni dogodek (vključno s trombozo), disfagija ali erektilne motnje.
Pharmacokinetics and Drug Metabolism
Farmakokinetika in presnova zdravila:
Fertility No specific study of eculizumab on fertility has been conducted.
Posebne študije o vplivu ekulizumaba na sposobnost razmnoževanja niso bile izvedene.
weeks, median (range)
(mediana, mg/dl)
Median Duration of complete hematologic normalization, weeks (range) 1
pri 26 tednih vsi bolniki (N = 22) pri 26 tednih popolna hematološka normalizacija, n (%) mediano trajanje popolne hematološke normalizacije, tedni (razpon)1
Complete Hematologic Normalization, n (%)
Bolniki z normalizacijo števila trombocitov, n (%)
At the last evaluation, 19 of 22 patients (86%) achieved eGFR
Pri zadnjem ocenjevanju je 19 od 22 bolnikov (86 %) doseglo izboljšanje eGFR za ≥ 15 ml/min/1,73 m2 od izhodišča.
NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion Eculizumab
Navodilo za uporabo Soliris 300 mg koncentrat za pripravo raztopine za infundiranje ekulizumab
Number of patients with prior MG crisis since diagnosis, n (%)
≥ 3 predhodna imunosupresivna zdravljenja* od diagnoze, n (%) Število bolnikov s predhodnimi eksacerbacijami od diagnoze, n (%) Število bolnikov s predhodno krizo MG od diagnoze, n (%)
A total of 15 paediatric patients (aged 2 months to 12 years) received Soliris in aHUS Study C09-001r.
V študiji aHUS C09-001r je bilo skupaj zdravljenih 15 pediatričnih bolnikov (starih od 2 meseca do 12 let) z zdravilom Soliris.
Patients in aHUS C10-003 received Soliris for a minimum of 26 weeks.
Bolniki v študiji aHUS C10-0043 so prejemali zdravilo Soliris najmanj 26 tednov.
• pain in thejoints (arms and legs)
srbenje kože (pruritus), • bolečine v sklepih (rokah in nogah),
Pneumonia, Upper respiratory tract infection, Bronchitis, Nasopharyngitis, Urinary tract infection, Oral Herpes
Infekcijske in parazitske bolezni pljučnica, okužba zgornjih dihal, bronhitis, vnetje nosu in žrela, okužba sečil,
Platelet count normalization TMA event-free status Complete TMA response eGFR improvement ≥ 15 mL/min/1.73m2
mediana (razpon) pred ekulizumabom ob zdravljenju z ekulizumabom Bolniki z izboljšanjem eGFR ≥ 15 ml/min/1,73 m2, n (%)
Paraesthesia, Tremor Syncope
Bolezni živčevja glavobol omotica, disgevzija mravljinčenje, tremor sinkopa
Renal impairment, Dysuria, Haematuria
Haemophilus influenzae, impetigo, vnetje dlesni
*One patient achieved eGFR improvement after renal transplant A total of 22 paediatric and adolescents patients (aged 5 months to 17 years) received Soliris in aHUS Study C10-003.
Zdravilo Soliris v študiji aHUS C10-003 je prejelo vsega skupaj 22 pediatričnih in mladostniških bolnikov (starih od 5 mesecev do 17 let).
- If you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na ekulizumab, beljakovine, pridobljene iz mišjih produktov, druga monoklonska protitelesa ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če niste bili cepljeni proti meningokokni okužbi, razen če jemljete antibiotike za zmanjšanje tveganja okužbe, dokler ne mineta 2 tedna po cepljenju; - če imate meningokokno okužbo.
The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause: - A significant fall in your red blood cell counts (anaemia), - Confusion or change in how alert you are, - Chest pain, or angina, - An increase in your serum creatinine level (problems with your kidneys), or - Thrombosis (blood clotting).
- zmedenost ali spremembo pozornosti, - bolečine v prsnem košu ali angino, - zvišanje ravni serumskega kreatinina (težave z ledvicami) ali
Soliris N = 20
N = 20
Please speak to your doctor before stopping Soliris.
Preden prenehate jemati zdravilo Soliris se posvetujte z zdravnikom.
In clinical trials, no PNH, aHUS, refractory gMG or NMOSD patients experienced an infusion reaction which required discontinuation of Soliris.
V kliničnih preskušanjih ni imel noben bolnik s PNH, aHUS, refraktarno gMG ali NMOSD
NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion
Soliris 300 mg koncentrat za raztopino za infundiranje
For intravenous use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo.
Paroxysmal Nocturnal Haemoglobinuria
Paroksizmalna nočna hemoglobinurija
• disease with thyroid overactivity (Basedow's disease)
• bolezen z zvečanim delovanjem ščitnice (Basedowova bolezen), • motnje spanja, neobičajne sanje,
Number of PE/PI sessions in 7 days prior to first dose of eculizumab, median (min, max) Baseline platelet count (× 109/L), mean (SD) Baseline LDH (U/L), mean (SD) Patients without identified mutation, n (%)
Število terapij PE/PI v 7 dneh pred prvim odmerkom ekulizumaba, mediana (min, maks)
Patients received meningococcal vaccination prior to receipt of Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Pred prejemom zdravila Soliris so bili bolniki cepljeni proti meningokokom ali pa so prejemali ustrezno antibiotično profilakso z ustreznim antibiotikom, dokler nista minila 2 tedna po cepljenju.
In atypical Haemolytic Uremic Syndrome (aHUS), refractory generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD):
Pri atipičnem hemolitično uremičnem sindromu (aHUS), refraktarni generalizirani miasteniji gravis
Nervous system disorders
MedDRA glede na organske sisteme
Tabulated list of adverse reactions
Anamnestična pogostnost recidivov,
Gastroesophageal reflux disease, Gingival pain
bolečina v trebuhu zaprtje, dispepsija, napihnjen trebuh gastroezofagealna refluksna bolezen,
Table 18: Efficacy Outcomes in Prospective aHUS Study C10-003
Preglednica 18: Izidi učinkovitosti v prospektivni študiji aHUS C10-003 Parameter učinkovitosti od 1 mesec do < 12 let
Treatment Discontinuation for PNH
Bolniki s PNH
002A/B C08-003A/B, C10-004) one in paediatric and adolescent patients (C10-003 ) and 30 patients in one retrospective study (C09-001r) were used to evaluate the efficacy of Soliris in the treatment of aHUS.
(C08-002A/B, C08-003A/B, C10-004), eni pri pediatričnih in mladostniških bolnikih (C10-003) in pri
Soliris is indicated in adults for the treatment of: - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor
Zdravilo Soliris je indicirano pri odraslih za zdravljenje: - refraktarne generalizirane miastenije gravis (gMG) pri bolnikih, ki so pozitivni za protitelesa proti acetilholinskemu receptorju (AChR) (glejte poglavje 5.1); - specifične oblike nevromielitisa vidnega živca (neuromyelitis optica spectrum disorderNMOSD) pri bolnikih, ki so pozitivni za protitelesa proti akvaporinu-4 (anti-aquaporin-4AQP4), z recidivnim potekom bolezni (glejte poglavje 5.1).
Patients in aHUS Study C08-002 A/B received Soliris for a minimum of 26 weeks.
Bolniki brez identificirane mutacije, n (%) Bolniki v študiji aHUS C08-002A/B so prejemali zdravilo Soliris najmanj 26 tednov.
• Treatment with eculizumab increases the risk of severe infection and sepsis, especially of Neisseria meningitidis and other Neisseria species, including disseminated gonorrhoeae.
• zdravljenje z ekulizumabom zveča tveganje za hude okužbe in sepso, zlasti z bakterijo
Tinnitus, Vertigo
nahod (rinoreja),
LDH AUC at end of study (median, U/L x Day)
LDH AUC ob koncu študije
TMA Event-free Status, n (%) 95% CI
Bolniki z nenormalnim izhodiščem, n/n (%) Stanje brez TMA dogodkov, n (%) (95-%
For 300 mg doses, use 30 ml of Soliris (10 mg/ml)
Za 300 mg odmerke uporabite 30 ml zdravila Soliris (10 mg/ml) in dodajte 30 ml vehikla za redčenje.
Vaccines against serogroups A, C, Y, W 135 and B where available are recommended in preventing the commonly pathogenic meningococcal serogroups.
Cepiva proti seroskupinam A, C, Y, W 135 in B,
6.1 List of excipients Sodium phosphate, monobasic Sodium phosphate, dibasic Sodium chloride
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat natrijev hidrogenfosfat natrijev klorid polisorbat 80
• upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex)
• okužba zgornjih dihal, kašelj, bolečina v žrelu (orofaringealna bolečina), bronhitis, mehurčki na ustnicah (herpes simpleks), • driska, bruhanje, slabost (navzea), bolečine v trebuhu, izpuščaj, izpadanje las (alopecija),
• menstrual disorder
• spazem ustnih mišic, • menstrualne motnje,
Reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris.
Po uvedbi zdravila Soliris so opazili zmanjšanje aktivnosti terminalnega komplementa in zvečanje števila trombocitov glede na izhodišče.
Pyrexia, Fatigue, Influenza like illness
Splošne težave in spremembe na mestu aplikacije pireksija, utrujenost, gripi podobna bolezen nelagodje v prsnem košu,
CKD improvement by ≥1 stage, n (%)
tedni (razpon)1 stanje brez TMA dogodka, n (%)
In paediatric aHUS patients (aged 2 months to less than 18 years) included in the aHUS studies C08-002,
Varnostni profil pri pediatričnih bolnikih z aHUS (starih od 2 meseca do manj kot 18 let), ki so bili vključeni v študije aHUS C08-002, C08-003, C09-001r in C10-003, se je zdel podoben kot tisti, ki so ga opazovali pri odraslih bolnikih z aHUS.
Urticaria, Erythema, Petechiae, Hyperhidrosis, Dry skin
Bolezni kože in podkožja izpuščaj, pruritus, alopecija urtikarija, eritem, petehije, hiperhidroza,
Diarrhoea, Vomiting, Nausea, Abdominal pain
Bolezni prebavil driska, bruhanje, navzea,
Supplemental Soliris Dose
Časovno usklajevanje dodatnega odmerka zdravila Soliris
TMA-event free status was defined as the absence for at least 12 weeks of the following: decrease in platelet count of > 25% from baseline, PE/PI, and new dialysis.
Stanje brez TMA dogodkov je bilo definirano kot odsotnost naslednjih parametrov vsaj 12 tednov: znižanje števila trombocitov za
Chest discomfort, Asthenia, Chest pain, Infusion site pain, Chills
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, bolečina v ustih in žrelu dispneja, epistaksa,
LDH level at baseline (median , U/L)
Izhodiščna LDH (enot/l), povprečje (SD)
(≥1/10,000 to <1/1,000)
Redki (≥ 1/10.000 do
Change in platelet count through week 26 (109/L)
C10-004 (N = 41) pri 26 tednih sprememba števila trombocitov do 26. tedna (109/l)
Adjusted adjudicated ARR
Očesne bolezni zamegljen vid draženje veznice
In all studies, the dose of eculizumab was 600 mg every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
7 ± 2 dni v obdobju 4 tednov, čemur je sledil odmerek 900 mg 7 ± 2 dni kasneje in nato odmerek
Paired t-test
Študija aHUS
Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (parents) Change from baseline at 12 weeks of PedsQLTM Multidimensional Fatigue (patients)
Multidimensional Fatigue« od izhodišča ob 12. tednu (starši) Atipični hemolitično uremični sindrom
Hepatobiliary disorders
mielodisplastični sindrom
Time from first diagnosis until screening in months, median (min, max) Time from current clinical TMA manifestation until screening in months, median (min, max)
Čas od nedavno klinično izražene TMA do presejalnih testov v mesecih, mediana (min, maks)
Treatment effect a
P - vrednost
The risks of stopping Soliris include an increase in the inflammation of your platelets, which may cause: - A significant fall in your platelets (thrombocytopenia), - A significant rise in destruction of your red blood cells, - Decreased urination (problems with your kidneys), - An increase in your serum creatinine level (problems with your kidneys), - Confusion or change in how alert you are, - Chest pain, or angina, - Shortness of breath, or - Thrombosis (blood clotting).
- bistven porast uničenja rdečih krvnih celic, - zmanjšano uriniranje (težave z ledvicami), - zvišanje ravni serumskega kreatinina (težave z ledvicami),
For intravenous use
Način uporabe
Double Blind
boleče dlesni
If you experience any of the following symptoms, you should immediately inform your doctor: - headache with nausea or vomiting - headache with a stiff neck or back - fever - rash - confusion - severe muscle aches combined with flu-like symptoms
- glavobol s slabostjo ali bruhanjem; - glavobol z otrdelim vratom ali hrbtom;
Posology
vrednost
Change From Baseline QMG Total Score
Izhodiščni rezultat lestvice QMG povprečje (SD)
Onbrez Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Uporaba zdravila Onbrez Breezhaler je v času nosečnosti upravičena le v primeru, da pričakovane koristi presegajo možna tveganja.
Do not use Onbrez Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Onbrez Breezhaler - če ste alergični na indakaterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Zviševanje dnevnega odmerka zdravila Onbrez Breezhaler preko najvišjega odmerka 300 mikrogramov ni primerno.
In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Onbrez Breezhaler (i.e. medicines such as salmeterol and formoterol).
Še posebno pomembno je, da zdravniku poveste, če: zaradi težav z dihanjem uporabljate zdravila, ki so podobna zdravilu Onbrez Breezhaler (na primer zdravila, kot sta salmeterol in formoterol).