FrancophonIA/ELRC3.0 huggingface dataset:
English: Myocardial infarction and cardiac arrest have been observed in association with MabCampath infusion in this patient population.
Slovenian: V tej populaciji bolnikov so v povezavi z infundiranjem zdravila MabCampath ugotavljali miokardni infarkt in zastoj srca.
English: The antibody mediates the lysis of lymphocytes via complement fixation and antibody-dependent cell mediated cytotoxicity.
Slovenian: To protitelo posreduje lizo limfocitov z vezavo komplementa in celično posredovano citotoksičnostjo, odvisno od protiteles.
English: You should inform your doctor if you experience any unusual symptoms after a transfusion.
Slovenian: Če se vam po transfuziji pojavi kakršen koli nenavaden simptom, takoj obvestite zdravnika.
English: • pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence
Slovenian: • bolečine med uriniranjem, zmanjšan tok seča, pogosto uriniranje, prisotnost krvi v seču, nezmožnost zadrževanja seča (inkontinenca)
English: The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.
Slovenian: Pomožne snovi so: dinatrijev edetat, polisorbat 80, kalijev klorid, kalijev dihidrogenfosfat, natrijev klorid, natrijev hidrogenfosfat in voda za injekcije.
English: • heart disorders (heart stopping, heart attack, heart congestion, irregular heart rate) • blood disorders (abnormal clotting, decreased protein, low potassium levels)
Slovenian: • bolezni srca (zastoj srca, srčni infarkt, srčna kongestija, motnje srčnega ritma)
English: Renal function abnormal
Slovenian: • nenormalno delovanje ledvic
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.
Slovenian: Bolezni imunskega sistema: Poročali so o resnih in včasih usodnih avtoimunskih pojavih (npr. avtoimunska hemolitična anemija, avtoimunska trombocitopenija, aplastična anemija, kronična oblika Guillain-Barréjevega sindroma, kronična vnetna demielinizirajoča poliradikulonevropatija).
English: Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the ampoule label.
Slovenian: Zdravila MabCampath ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na ampuli.
English: It is not known if MabCampath can cause foetal harm when administered to a pregnant woman.
Slovenian: Ni znano, ali lahko izpostavljenost nosečnice zdravilu MabCampath škoduje plodu.
English: • fluid in the lungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal findings in the lungs, lymph gland disorders
Slovenian: • tekočina v pljučih, težko dihanje, piski pri dihanju, nahod, nenormalni izvidi plučnega
English: Disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate, water for injections.
Slovenian: Pomožne snovi so: natrijev edetat, polisorbat 80, kalijev klorid, kalijev dihidrogenfosfat, natrijev klorid, natrijev hidrogenfosfat, voda za injekcije.
English: MabCampath Fab binding was observed in lymphoid tissues and the mononuclear phagocyte system.
Slovenian: V limfatičnih tkivih in mononuklearnem fagocitnem sistemu so opažali Fab vezavo zdravila MabCampath.
English: Alemtuzumab was generated by the insertion of six complementarity-determining regions from an IgG2a rat monoclonal antibody into a
Slovenian: Alemtuzumab je pridobljen z vstavitvijo šestih predelov, ki določajo komplementarnost, s podganjega monoklonskega protitelesa IgG2a v človeško imunoglobulinsko molekulo IgG1.
English: HOW TO STORE MABCAMPATH
Slovenian: Kaj vsebuje zdravilo MabCampath
English: Grade 3 or 4 infusion reactions are uncommon after the first week
Slovenian: Reakcije zaradi infundiranja tretje in četrte stopnje se redko pojavijo v prvem tednu zdravljenja.
English: During the first week, your doctor will increase the dose of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.
Slovenian: S tem se bo možnost pojava neželenih učinkov zmanjšala, vaše telo pa bo zdravilo MabCampath bolje prenašalo.
English: 4.2 Posology and method of administration MabCampath should be administered under the supervision of a physician experienced in the use of
Slovenian: Zdravljenje z zdravilom MabCampath mora potekati pod nadzorom zdravnika z izkušnjami pri onkološkem zdravljenju.
English: • dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless
Slovenian: • omotica, vrtoglavica, omedlevica, drgetanje ali tresenje, nemir
English: Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused though the same intravenous line.
Slovenian: Raztopini zdravila MabCampath ne smete dodati drugih zdravil in je tudi ne smete infundirati hkrati z drugimi zdravili po isti intravenski liniji.
English: Although it has not been studied, it is recommended that patients should not receive live viral vaccines in, at least, the 12 months following MabCampath therapy.
Slovenian: Priporočljivo je, da bolniki vsaj 12 mesecev po zdravljenju z zdravilom MabCampath niso cepljeni z živimi virusnimi cepivi, čeprav to niso preučevali.
English: Uncommon side effects (affects 1 to 10 patients in every 1,000 patients treated in clinical trials):
Slovenian: Občasni neželeni učinki (pojavili so se pri 1 do 10 bolnikih od 1.000 bolnikov v kliničnih preskušanjih)
English: What MabCampath looks like and contents of the pack MabCampath is a concentrate for solution for infusion that comes in a glass vial.
Slovenian: Izgled zdravila MabCampath in vsebina pakiranja Zdravilo MabCampath je na voljo v stekleni viali v obliki koncentrata za raztopino za infundiranje.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Slovenian: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija
English: Severe anaphylactic and other hypersensitivity reactions, including anaphylactic shock and angioedema, have been reported following MabCampath administration.
Slovenian: Po uporabi zdravila MabCampath so poročali o hudih anafilaktičnih in drugih preobčutljivostnih reakcijah, vključno z anafilaktičnim šokom in angioedemi.
English: Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia (B-CLL) who had failed previous therapy with purine analogues.
Slovenian: Farmakokinetične lastnosti so preučevali pri bolnikih s kronično limfocitno levkemijo celic B (B- KLL), ki še niso bili zdravljeni z zdravilom MabCampath in pri katerih predhodno zdravljenje s purinskimi analogi ni bilo uspešno.
English: Medicinal product subject to restricted medical prescription (See Annex 1: Summary of Product
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (Glej Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: What MabCampath looks like and contents of the pack MabCampath is a concentrate for solution for infusion that comes in a glass ampoule.
Slovenian: Izgled zdravila MabCampath in vsebina pakiranja Zdravilo MabCampath je na voljo v stekleni ampuli v obliki koncentrata za raztopino za infundiranje.
English: One ml contains 10 mg of alemtuzumab.
Slovenian: 1 ml vsebuje 10 mg alemtuzumaba.
English: please tell your doctor or pharmacist.
Slovenian: Posvetujte se z zdravnikom.
English: Colourless to slightly yellow concentrate.
Slovenian: Koncentrat za raztopino za infundiranje Brezbarven do rahlo rumen koncentrat
English: Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):
Slovenian: Pogosti neželeni učinki (pojavili so se pri 1 do 10 bolnikih od 100 bolnikov v kliničnih preskušanjih)
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and
Slovenian: Za opis neke reakcije in njenih sinonimov ter povezanih stanj je uporabljen najprimernejši izraz po klasifikaciji MedDRA.
English: Your doctor will inform you accordingly
Slovenian: Zdravnik vam bo morda predpisal tudi
English: The vial contents should be inspected for particulate matter and discolouration prior to administration.
Slovenian: Pred uporabo je treba pregledati, da vsebina viale ne vsebuje delcev in da ni obarvana.
English: Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of
Slovenian: Pozneje je priporočeni odmerek 30 mg na dan, apliciran trikrat na teden vsak drugi dan, največ 12 tednov.
English: MabCampath 10 mg/ml concentrate for solution for infusion Alemtuzumab
Slovenian: MabCampath 10 mg/ml koncentrat za raztopino za infundiranje alemtuzumab
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 30 mg/ml
English: Haematuria Urinary incontinence Urine flow decreased Polyuria
Slovenian: Bolezni ledvic in sečil hematurija urinska inkontinenca zmanjšan tok seča poliurija motnje delovanja ledvic
English: MabCampath 30 mg/ml concentrate for solution for infusion Alemtuzumab
Slovenian: MabCampath 30 mg/ml koncentrat za raztopino za infundiranje alemtuzumab
English: • abscess, skin redness or allergic skin reaction, blistering of the skin • confusion, anxiety, depression, sleeplessness
Slovenian: • ognojek, pordela koža ali alergijske kožne reakcije, mehurji na koži
English: If more MabCampath is given than recommended Your doctor will treat you, as appropriate, if you have any side effects.
Slovenian: Če boste imeli kakršnekoli neželene učinke, vas bo zdravnik ustrezno zdravil.
English: Cardiac arrest Myocardial infarction Atrial fibrillation Supraventricular tachycardia Arrhythmia Bradycardia Abnormal ECG
Slovenian: Občasno tahikardija miokardni infarkt atrijska fibrilacija supraventrikularna tahikardija aritmija bradikardija nenormalen EKG
English: Animal reproduction studies have not been conducted with MabCampath.
Slovenian: Študij o vplivu zdravila MabCampath na sposobnost razmnoževanja pri živalih niso izvedli.
English: Anxiety Syncope Dizziness Tremor Paraesthesia Hypoesthesia Headache
Slovenian: Bolezni živčevja omedlevica vrtoglavica omotičnost tremor parestezija hipestezija glavoboli
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.
Slovenian: V obdobju povečevanja odmerka je od 30 do 60 minut pred vsakim infundiranjem zdravila MabCampath in kot je klinično indicirano priporočljiva premedikacija s peroralnimi ali intravenskimi steroidi.
English: However, other medicinal products should not be added to the MabCampath infusion or simultaneously infused through the same
Slovenian: Znanih inkompatibilnosti z drugimi zdravili ni. Infuzijski raztopini zdravila MabCampath se ne sme dodajati drugih zdravil ali jih infundirati istočasno po isti intravenski liniji.
English: Staphylococcal bacteraemia Tuberculosis Bronchopneumonia Herpes ophthalmicus Beta haemolytic streptococcal infection Candidiasis Genital candidiasis Urinary tract infection Cystitis
Slovenian: Infekcije in parazitske bolezni citomegalovirusna viremija pljučnica sepsa okužba s citomegalovirusom bronhitis stafilokokna bakteriemija faringitis tuberkuloza oralna kandidoza bronhopnevmonija herpes ophtalamicus beta hemolitična streptokokna okužba kandidoza kandidoza spolovil vnetje sečil vnetje mehurja glivične okužbe nazofaringitis rinitis
English: Temperature change sensation
Slovenian: • spremembe okusa
English: There are no dose modifications recommended for severe lymphopenia given the mechanism of action
Slovenian: Za resno limfopenijo zaradi mehanizma delovanja zdravila MabCampath ni priporočljivih sprememb odmerkov.
English: Gradual escalation from 10 to 30 mg 30 mg iv 3 x weekly 30 mg iv 3 x weekly 30 mg iv 3 x weekly
Slovenian: Alkilirajoči agensi Fludarabin Število prejšnjih shem (razpon) Začetna odmerna shema postopno povečevanje od 3 do 10 do 30 mg postopno povečevanje od 10 do 30 mg postopno povečevanje od 10 do 30 mg
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev
English: Cytogenetic Analyses in first line B-CLL patients:
Slovenian: Citogenetska analiza predhodno nezdravljenih bolnikov z B-KLL
English: NAME OF THE MEDICINAL PRODUCT MabCampath 30 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA MabCampath 30 mg/ml koncentrat za raztopino za infundiranje
English: NAME OF THE MEDICINAL PRODUCT MabCampath 10 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA MabCampath 10 mg/ml koncentrat za raztopino za infundiranje
English: - HIV.
Slovenian: Тел.
English: Vertigo Dizziness Tremor Paresthesia Hypoesthesia Hyperkinesia Taste loss
Slovenian: Bolezni živčevja vrtoglavica omedlevica omotica motnje ravnotežja tremor distonija parestezija hiperestezija hipoestezija nevropatija hiperkinezija motnje okusa izguba okusa
English: CMV infection during treatment with MabCampath had no measurable impact on progression free survival (PFS).
Slovenian: Za prisotnost asimptomatskega pozitivnega PCR na CMV ali simptomatskega pozitivnega PCR na okužbo s CMV med zdravljenjem z zdravilom MabCampath ni bilo mogoče izmeriti učinka okužbe na preživetje brez napredovanja bolezni (PFS).
English: B-CLL pts who had failed to respond or relapsed following treatment with conventional chemotherapy
Slovenian: Število bolnikov Diagnostična skupina fludarabinom neuspešno bolniki s B-KLL, ki se niso odzvali na zdravljenje s konvencionalno kemoterapijo ali se je bolezen po njem ponovila bolniki s B-KLL (in eden s PLL), ki se niso odzvali na zdravljenje s fludarabinom ali se je bolezen po njem ponovila
English: Pharyngitis Infection
Slovenian: Pediatrična populacija
English: Acute infusion reactions including fever, chills, nausea, vomiting, hypotension, fatigue, rash, urticaria, dyspnoea, headache, pruritus and diarrhoea have been reported.
Slovenian: Najpogosteje so poročali o akutnih reakcijah zaradi infundiranja kot so zvišana telesna temperatura, mrzlica, navzeja, bruhanje, hipotenzija, utrujenost, izpuščaj, urtikarija, dispneja, glavobol, srbenje in driska.
English: Confusion Anxiety Depression Somnolence Insomnia
Slovenian: Psihiatrične motnje zmedenost depersonalizacija anksioznost osebnostna motnja depresija blodnje zaspanost impotenca nespečnost
English: Orthostatic hypotension Hot flush
Slovenian: Žilne bolezni hipotenzija hipertenzija ortostatska hipotenzija vročinski obliv rdečica
English: If particulate matter is present or the concentrate is coloured, then the ampoule should
Slovenian: Če so prisotni delci ali je koncentrat obarvan, se ampule ne sme uporabiti.
English: One ml contains 30 mg of alemtuzumab.
Slovenian: 1 ml vsebuje 30 mg alemtuzumaba.
English: 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.
Slovenian: Pri bolnikih, ki so bili predhodno zdravljeni s potencialno kardiotoksičnimi zdravili, je treba oceniti srčno funkcijo in jo redno spremljati (npr. ehokardiografija, srčna frekvenca in telesna masa).
English: Mucositis
Slovenian: AMPULA
English: If particulate matter is present or the solution is coloured, then the vial should not be used.
Slovenian: Če so v njej delci ali je obarvana, je ne smete uporabiti.
English: Musculoskeletal chest pain
Slovenian: • paraliza tankega črevesja
English: During that time the solution may be stored
Slovenian: Navodilo je bilo odobreno
English: • abnormal liver function, constipation, indigestion, passing abdominal gas
Slovenian: • nenormalno delovanje jeter, zaprtje, težave z želodcem, vetrovi
English: 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.
Slovenian: Podatki o varnosti pri bolnikih, ki so se zdravili (zdravljenje prvega izbora) zaradi B-KLL, temeljijo na neželenih učinkih, ki so jih opazili v randomiziranem, nadzorovanem kliničnem preskušanju z zdravilom MabCampath (kot monoterapija) v katerega je bilo vključenih 147 bolnikov.
English: Gastrointestinal haemorrhage Ulcerative stomatitis Stomatitis
Slovenian: Bolezni prebavil gastrointestinalna krvavitev gastroenteritis ulcerativni stomatitis ulceracija jezika stomatitis gingivitis bolečine v trebuhu kolcanje dispepsija riganje zaprtje suha usta flatulenca
English: Depersonalisation Personality disorder Abnormal thinking Impotence Nervousness
Slovenian: Psihiatrične motnje zmedenost depersonalizacija anksioznost osebnostna motnja depresija blodnje zaspanost impotenca nespečnost živčnost
English: Hypoxia Pleural effusion Dysphonia Rhinorrhoea
Slovenian: Žilne bolezni hipotenzija hipertenzija periferna ishemija vazospazem zardevanje
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabCampath 30 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MabCampath 30 mg/ml koncentrat za raztopino za infundiranje alemtuzumab
English: Steroids may be discontinued as appropriate, once dose escalation has been achieved.
Slovenian: Ko je doseženo željeno povečanje odmerka, lahko steroide nehate uporabljati, če je to primerno.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabCampath 10 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MabCampath 10 mg/ml koncentrat za raztopino za infundiranje alemtuzumab
English: System organ class
Slovenian: ŠTEVILKA SERIJE Serija
English: Malaise
Slovenian: Živčnost
English: Treatment consists of discontinuation of MabCampath
Slovenian: Zdravljenje obsega prekinitev zdravljenja z zdravilom MabCampath in podporno zdravljenje.
English: Read the leaflet for the shelf life of the reconstituted product.
Slovenian: Za rok uporabnosti rekonstituiranega zdravila preberite navodilo za uporabo.
English: Peripheral ischaemia
Slovenian: Genzyme Ltd.
English: Chlorambucil n=148
Slovenian: Stratificirani test logrank: p=0,0001
English: Throat tightness Pulmonary infiltration Pleural effusion Breath sounds decreased
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora hipoksija stridor hemoptiza stiskanje v grlu bronhospazem pljučni infiltrat kašelj plevralni izliv oslabitev dihalnih šumov bolezni dihal
English: Respiratory disorder
Slovenian: • bolezni kostnega mozga
English: The presence of asymptomatic positive PCR for CMV or symptomatic PCR positive
Slovenian: Ugotavljanje CMV s PCR (verižna reakcija s polimerazo)
English: Endophthalmitis Deafness Tinnitus
Slovenian: Očesne bolezni konjunktivitis endoftalmitis
English: Each vial contains 30 mg of alemtuzumab.
Slovenian: Ena viala vsebuje 30 mg alemtuzumaba.
English: Muscle spasms Urine output decreased Dysuria
Slovenian: Bolezni ledvic in sečil zmanjšan tok seča disurija
English: Mucosal inflammation Infusion site erythema Localised oedema Infusion site oedema Malaise
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost vnetje sluznice astenija eritem na mestu aplikacije lokaliziran edem edem na mestu aplikacije slabotnost
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.
Slovenian: Med zdravljenjem z zdravilom MabCampath in še vsaj dva meseca po koncu zdravljenja bo zdravnik preverjal, če imate simptome virusne okužbe s CMV (citomegalovirus).
English: Discontinue MabCampath therapy.
Slovenian: Zdravljenje z zdravilom MabCampath je treba prekiniti.
English: Genzyme Europe B.V. Képviselet Tel: +36 1 310 7440
Slovenian: Képviselet Tel: +36 1 310 7440
English: Each ampoule contains 30 mg of alemtuzumab.
Slovenian: Ena ampula vsebuje 30 mg alemtuzumaba.
English: Resume MabCampath at 10 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl.
Slovenian: Ko je vrednost ANC ≥ 500/μl in število trombocitov ≥ 50,000/μl, se lahko ponovno začne zdravljenje z zdravilom MabCampath 10 mg.
English: Aplasia bone marrow Disseminated intravascular coagulation Haemolytic anaemia, Decreased haptoglobin Bone marrow depression
Slovenian: Bolezni krvi in limfatičnega sistema granulocitopenija febrilna nevtropenija aplazija kostnega mozga pancitopenija diseminirana intravaskularna koagulacija levkopenija hemolitična anemija, znižanje haptoglobina limfopenija depresija kostnega mozga purpura epistaksa krvavitev iz dlesni nenormalne vrednosti hematoloških testov
English: incontinence
Slovenian: • impotenca
English: Lactation
Slovenian: • hripavost
English: MabCampath will be given at 30 mg three times per calendar week on alternate days, for up to 12 weeks.
Slovenian: Nato se priporoča odmerek 30 mg na dan, trikrat na teden vsak drugi dan, največ 12 tednov.
English: Hyponatraemia Hypocalcaemia Weight decrease Dehydration Thirst
Slovenian: Presnovne in prehranske motnje hiponatriemija hipokaliemija hipokalciemija poslabšanje sladkorne bolezni zmanjšanje telesne mase dehidracija žeja
English: Bacterial infection Viral infection Fungal dermatitis Laryngitis Rhinitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalno delovanje jeter
English: Cyanosis Bradycardia Tachycardia Sinus tachycardia
Slovenian: Genzyme Flanders bvba Cipalstraat 8
English: Haematologic values
Slovenian: Parametri učinkovitosti
English: Resume MabCampath at 30 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl.
Slovenian: Ko je vrednost ANC ≥ 500/μl in število trombocitov ≥ 50,000/μl, se lahko ponovno začne zdravljenje z zdravilom MabCampath 30 mg.
English: Tell your doctor immediately if you experience any of these side effects.
Slovenian: Če se vam pojavi katerikoli od teh neželenih učinkov, takoj obvestite zdravnika.
English: Febrile neutropenia Pancytopenia Leukopenia Lymphopenia Purpura
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija agranulocitoza nevtropenija limfopenija levkopenija limfadenopatija trombocitopenija epistaksa anemija
English: Bronchospasm Dyspnoea
Slovenian: Očesne bolezni konjunktivitis
English: Rash pruritic Rash macular Rash erythematous Dermatitis
Slovenian: Bayer Schering Pharma AG Müllerstrasse 178
English: Allergic reaction
Slovenian: DODATNE INFORMACIJE
English: Stridor
Slovenian: Serija
English: Oedema mouth Oedema
Slovenian: България Джензайм ЕООД
English: Hypokalaemia Diabetes mellitus aggravated
Slovenian: • visoke vrednosti krvnega sladkorja, poslabšanje sladkorne bolezni
English: Dermatitis allergic Pruritus
Slovenian: Profilaktični antibiotiki
English: Urinary tract infection Sinusitis
Slovenian: Bolezni imunskega sistema anafilaktična reakcija preobčutljivost
English: Upper respiratory tract infection
Slovenian: Občasno sinusitis bronhitis vnetje zgornjih dihalnih poti faringitis okužba
English: Content Package size
Slovenian: Pakiranje Vsebina Velikost pakiranj a
English: EU Number
Slovenian: EU (MA) številka Izmišljen o ime
English: Tmax is between 3 and 8 hours.
Slovenian: Tmax je med 3 in 8 urami.
English: • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanj tveganja (RMP)
English: Date of first authorisation: 29 April 2013 Date of latest renewal: 18 January 2018
Slovenian: Datum prve odobritve: 29. april 2013 Datum zadnjega podaljšanja: 18. januar 2018
English: Once daily
Slovenian: enkrat na dan
English: Children and adolescents Marixino is not recommended for children and adolescents under the age of 18 years.
Slovenian: Otroci in mladostniki Zdravila Marixino ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
English: Paediatric population No data available.
Slovenian: Pediatrična populacija Podatkov ni na voljo.
English: КРКА България ЕООД Teл.
Slovenian: Представителство на КРКА България ЕООД Teл.