FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious and sometimes life-threatening infusion reactions, which are characterised by allergic-like or anaphylactoid-like reactions, with symptoms including asthma, flushing, urticarial rash, chest pain, fever, hypertension, tachycardia, pruritus, sweating, shortness of breath, facial oedema, chills, back pain, tightness in the chest and throat and/or hypotension may occur within minutes of starting the infusion of Caelyx.
Slovenian: Že nekaj minut po začetku infuzije zdravila Caelyx se lahko pojavijo resne in včasih celo življenje ogrožajoče infuzijske reakcije, za katere je značilen odziv alergijskega ali anafilaktoidnega tipa s simptomi kot so astma, rdečica, urtikarijski izpuščaj, bolečine v prsih, zvišana telesna temperatura, hipertenzija, tahikardija, pruritus, znojenje, težko dihanje, obrazni edem, mrzlica, bolečine v hrbtu, stiskanje v prsih in žrelu in/ali hipotenzija.
English: 509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/m2 every 4 weeks, or doxorubicin
Slovenian: 509 bolnic z napredovalim rakom dojk, ki niso prejele predhodne kemoterapije za metastaze raka dojk, je bilo zdravljenih bodisi z zdravilom Caelyx (n=254) v odmerku 50 mg/m2 na vsake 4 tedne bodisi s standardnim (Opomba: ni v originalu vendar vsebinsko bistveno/Comment: not in the original, but essential for clarity) doksorubicinom (n=255) v odmerku 60 mg/m2 na vsake 3 tedne v klinični raziskavi faze III (I97-328).
English: Caelyx exhibits unique pharmacokinetic properties and must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Slovenian: Zdravilo Caelyx ima zanj značilne farmakokinetične lastnosti in ga ne smete prosto zamenjevati z drugimi pripravki doksorubicinijevega klorida.
English: Caution must be exercised in handling Caelyx solution.
Slovenian: Z raztopino zdravila Caelyx morate ravnati previdno.
English: The protocol-specified objective of demonstrating non-inferiority between Caelyx and doxorubicin was met, the hazard ratio (HR) for progression-free survival (PFS) was 1.00 (95% CI for HR=0.82-1.22).
Slovenian: Razmerje med tveganji (HR) za preživetje brez napredovanja bolezni (PFS) je bilo 1,00 (95% interval zaupanja za HR= 0,82 do 1,22).
English: The appropriate dose of Caelyx must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration.
Slovenian: Ustrezni odmerek zdravila Caelyx morate pred dajanjem razredčiti v 5% (50 mg/ml) raztopini glukoze za infundiranje.
English: The mean apparent half-life was 71.5 hours (range
Slovenian: Srednja vrednost navideznega razpolovnega časa je bila 71,5 ur (razpon od 45,2 do 98,5 ur).
English: Recall of skin reaction due to prior radiotherapy has rarely occurred with Caelyx administration.
Slovenian: Pri bolnikih, ki so imeli kožno reakcijo na predhodno obsevanje, se je med uporabo zdravila Caelyx, kožna reakcija redko ponovno pojavila.
English: Secondary oral neoplasms
Slovenian: Sekundarne neoplazme v ustni votlini
English: Adverse drug reactions identified during the post-marketing experience with Caelyx Neoplasms benign, malignant and unspecified (incl cysts and polyps) very rare secondary oral neoplasms
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) zelo redki sekundarne neoplazme v ustih
English: Cardiovascular disorder
Slovenian: Diseminirani plazmocitom
English: Blood and lymphatic system disorders very common neutropaenia, anaemia, leukopaenia common thrombocytopaenia
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija, anaemija, levkopenija pogosti trombocitopenija
English: Hypochromic anaemia
Slovenian: Anafilaktoidni odziv
English: Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.
Slovenian: Sumijo, da, pri uporabi med nosečnostjo, doksorubicinijev klorid povzroča resne okvare ploda.
English: Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Slovenian: Zdravila Caelyx ne smete prosto zamenjevati z drugimi pripravki doksorubicinijevega klorida.
English: 10 vials 50 mg/25 ml
Slovenian: 1 viala 10 vial 50 mg/25 ml
English: Manufacturer Janssen Pharmaceutica NV
Slovenian: Janssen Pharmaceutica NV Turnhoutseweg 30
English: Asthenia, mucous membrane disorder
Slovenian: Rak dojke/rak jajčnikov/diseminirani plazmocitom
English: Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2-3.0 mg/dl, the first dose is reduced by 25%.
Slovenian: Toda dokler še ni dodatnih izkušenj, morate odmerek zdravila Caelyx pri bolnikih z okvaro jeter zmanjšati glede na izkušnje kliničnih raziskav raka dojk in raka jajčnikov, in sicer: če je koncentracija bilirubina na začetku zdravljenja med 1,2 in 3,0 mg/dl, prvi odmerek zmanjšajte za 25%.
English: Caelyx resulted in mild to moderate ovarian and testicular atrophy in mice after a single dose of 36 mg/kg.
Slovenian: Zdravilo Caelyx je pri miših po enkratnem odmerku 36 mg/kg povzročilo blago do zmerno atrofijo jajčnikov in mod.
English: Myelosuppression associated with anaemia, thrombocytopaenia, leukopaenia, and rarely febrile neutropaenia, has been reported in Caelyx-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Caelyx, so poročali o mielosupresiji, povezani z anemijo, trombocitopeniji, levkopeniji in redko febrilni nevtropeniji.
English: Turnhoutseweg 30 B-2340 Beerse Belgium
Slovenian: B-2340 Beerse Belgija.
English: Gastrointestinal disorders very common nausea common diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
Slovenian: Bolezni prebavil zelo pogosti navzea pogosti driska, stomatitis, bruhanje, razjede v ustih, bolečina v trebuhu, glositis, zaprtje, navzea in bruhanje
English: Diabetic patients
Slovenian: Pediatrični bolnik
English: 10 vials 20 mg/10 ml
Slovenian: 1 viala 10 vial 20 mg/10 ml
English: The mean apparent half-life was 75.0 hours (range
Slovenian: Srednja vrednost navideznega razpolovnega časa je bila 75,0 ur (razpon od 36,1 do 125 ur).
English: Vascular disorders common vasodilatation
Slovenian: Žilne bolezni pogosti vazodilatacija
English: Ventricular arrhythmia
Slovenian: Srčne bolezni pogosti ventrikularne aritmije
English: G-CSF (or GM-CSF) may be given as concomitant therapy to support the blood count when the ANC count is < 1,000/mm
Slovenian: Kot sočasno zdravljenje za izboljšanje krvne slike lahko v primeru zmanjšanja absolutnega števila nevtrofilcev na < 1.000/mm med naslednjimi krogi uporabite G-CSF (ali GM-CSF).
English: Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood.
Slovenian: Če ste uporabili večji odmerek zdravila Caelyx, kot bi smeli Akutni prevelik odmerek zdravila poslabša neželene učinke zdravila, npr. razjede v ustih, ali zmanjša število levkocitov in trombocitov v krvi.
English: CAELYX LABEL 50 mg/25 ml
Slovenian: CAELYX NALEPKA 50 mg/25ml
English: CAELYX LABEL 20 mg/10 ml
Slovenian: CAELYX NALEPKA 20mg/10ml
English: Contains fully hydrogenated soy phosphatidylcholine (from soyabean) - see section 4.3 Contains less than 1 mmol sodium (23 mg) per dose, and is essentially ‘sodium-free'.
Slovenian: Vsebuje popolnoma hidrogeniran sojin fosfatidilholin (iz zrn soje) - glejte poglavje 4.3.
English: A phase III comparative study of Caelyx versus topotecan in patients with epithelial ovarian cancer following the failure of first-line, platinum-based chemotherapy was completed in 474 patients.
Slovenian: Pri 474 bolnicah z epitelijskim rakom jajčnikov, pri katerih prvo zdravljenje s platinsko kemoterapijo ni bilo uspešno, so opravili primerjalno študijo faze III, v kateri so primerjali zdravilo Caelyx in topotekan.
English: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100)
Slovenian: Neželeni učinki, ki so jih opažali pri bolnikih, ki imajo z aidsom povezan Kaposijev sarkom, razporejeni po kategorijah pogostnosti v skladu s CIOMS III zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100)
English: The incidence of grade 3 and 4 thrombocytopaenia was higher in the combination therapy group than in the monotherapy group (22% vs. 14%).
Slovenian: Incidenca nevtropenije 3. in 4. stopnje je bila večja v skupini, ki je prejemala kombinirano zdravljenje kot v skupini, ki je prejemala monoterapijo (28% v primerjavi s 14%) in tudi incidenca trombocitopenije 3. in 4. stopnje je bila večja v skupini, ki je prejemala kombinirano zdravljenje kot v skupini za monoterapijo (22% v primerjavi s 14%), medtem ko je bila incidenca anemije podobna v obeh terapevtskih skupinah (7% v primerjavi s 5%).
English: Haematological toxicity (ANC or platelets) - Management of patients with breast or ovarian cancer
Slovenian: Hematološka toksičnost (absolutno število nevtrofilcev ali trombociti) ukrepanje pri bolnicah z rakom dojk ali jajčnikov STOPNJA ABSOLUTNO ŠTEVILO NEVTROFILCEV AŠN
English: Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx.
Slovenian: Ker zdravilo Caelyx ne vsebuje nobenega konzervansa ali bakteriostatika, mora biti postopek opravljen strogo aseptično.
English: Folliculitis, fungal infection, cold sores (non-herpetic), upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni pogosti faringitis folikulitis, glivične okužbe, razjede (neherpetične), okužba zgornjih dihal občasni faringitis
English: AIDS-related KS patients with splenectomy
Slovenian: Bolniki z okvaro ledvic
English: Some of these effects may be related to your disease and not to Caelyx; - general feeling of tiredness, weakness, feeling of pins and needles or pain in hands and feet; - hair loss.
Slovenian: - splošen občutek utrujenosti, oslabelost, mravljinčenje ali bolečine v dlaneh in stopalih - izpadanje las
English: Over the dose range of 10 mg/m 2-60 mg/m 2 Caelyx displayed non-linear pharmacokinetics.
Slovenian: V manjših odmerkih (10 do 20 mg/m2) ima Caelyx linearno farmakokinetiko, v odmernem območju od 10 do 60 mg/m2 pa je njegova farmakokinetika nelinearna.
English: AE by body system Breast cancer All severities n=254
Slovenian: Rak dojk Vse jakosti n=254
English: Lacrimation, blurred vision
Slovenian: Očesne bolezni pogosti solzenje, zamegljen vid
English: Reproductive system and breast disorders Common
Slovenian: Motnje reprodukcije in dojk pogosti eritem skrotuma
English: Nervous system disorders common dizziness uncommon paresthesia
Slovenian: Bolezni živčevja pogosti omotica občasni parestezija
English: Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Caelyx treatment.
Slovenian: Zaradi možnosti resnih neželenih učinkov pri dojenčku mora ženska pred začetkom zdravljenja z zdravilom Caelyx prenehati dojiti, ker se veliko zdravil, vključno z antraciklini, izloča v mleko pri ljudeh.
English: Immune system disorders Common
Slovenian: Bolezni imunskega sistema pogosti alergijske reakcije
English: Vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
Slovenian: pogosti suha koža, obarvanje kože alopecija, izpuščaj vezikulobulozni izpuščaj, pruritus, eksfoliativni dermatitis, kožne bolezni, makulopapulozni izpuščaj, potenje, akne, kožne razjede
English: - taking cool baths during hot weather; - avoiding vigorous exercise that might cause trauma to the feet (e.g., jogging); - avoiding exposure of skin to very hot water (e.g., jacuzzis, saunas); - avoiding tight fitting footwear or high-heeled shoes.
Slovenian: Načini za preprečevanje in zdravljenje sindroma dlani in stopal: - namakanje dlani in/ali stopal v posodi z mrzlo vodo, kadar je le mogoče (npr. med gledanjem televizije, branjem ali poslušanjem radia) - roke in stopala naj bodo nepokriti (brez rokavic, nogavic itd.) - zadrževanje na hladnih mestih - v vročem vremenu si privoščite hladne kopeli - izogibanje intenzivni telesni vadbi, pri kateri bi si lahko poškodovali stopala (npr. jogging) - kože ne izpostavljajte zelo vroči vodi (npr. v kopeli z mehurčki ali savni) - ne nosite tesno prilegajočih se čevljev ali čevljev z visoko peto
English: Infection, oral moniliasis, herpes zoster, urinary tract infection
Slovenian: Infekcijske in parazitske bolezni pogosti herpes simpleks, herpes zoster herpes zoster pljučnica, nazofaringitis, okužbe zgornjih dihal, kandidiaza v ustni votlini
English: Grade 3 (blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
Slovenian: Zmanjšajte odmerek za 25%; vrnite se na 4-tedenski presledek telesnih dejavnosti; majhni mehurji ali razjede s premerom, manjšim od 2 cm) Stopnja 3 (mehurji, razjede ali otekanje, ki ovirajo hojo ali normalne vsakodnevne dejavnosti; nošenje običajnih oblačil ni mogoče)
English: Pyrexia
Slovenian: Občasni pireksija
English: Very rare side effects (may affect up to 1 in 10,000 people) - serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis); - oral cancer may occur when Caelyx is taken for a long time (more than one year).
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) - resne kožne reakcije, kot so razširjeno luščenje kože, mehurji in razjede na sluznici
English: Cardiac toxicity also may occur at cumulative anthracycline doses lower than 450 mg/m2 in patients with prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy.
Slovenian: Pri bolnikih, ki so jim predhodno obsevali mediastinum ali pri tistih, ki so sočasno zdravljeni s ciklofosfamidom, pa se lahko kardiotoksičnost pojavi že pri kumulativnih odmerkih antraciklina, manjših od 450 mg/m
English: Abdominal pain, constipation, diarrhoea, dyspepsia, mouth ulceration
Slovenian: pogosti šibkost, zvišana telesna temperatura, bolečine astenija, mukozitis NOS
English: Breast cancer/Ovarian cancer/Multiple myeloma
Slovenian: Rak dojk in rak jajčnikov
English: Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride.
Slovenian: Zdravilo Caelyx je pegiliran liposomski pripravek doksorubicinijevega klorida, ki v krvnem obtoku ostane dolgo časa.
English: Platelet count < 25,000/mm Haemoglobin < 8 g/dl ANC < 500/mm
Slovenian: Če je na kateri koli dan infundiranja zdravila po 1. dnevu posameznega kroga: - število trombocitov < 25.000/mm - hemoglobin < 8 g/dl - AŠN < 500/mm
English: Grade 2 1,000 - < 1,500 50,000 - < 75,000 Wait until ANC  1,500 and platelets
Slovenian: 25.000 - < 50.000 Počakajte, da bo AŠN  1.500 in število trombocitov  75.000; nato ponovite odmerek, ne da bi ga zmanjšali.
English: Treatment related undesirable effects reported in breast cancer clinical trials (50 mg/m2 every 4 weeks) (Caelyx-treated patients) by severity, MedDRA system organ class and preferred term
Slovenian: Neželeni učinki, povezani z zdravljenjem, o katerih so poročali v kliničnih preskušanjih pri bolnicah z rakom dojk (50 mg/m vsake 4 tedne) (bolnice, zdravljene z zdravilom Caelyx), razporejeni po resnosti in organskih sistemih, skladno s priporočenimi izrazi po klasifikaciji MedDRA zelo pogosti ( 1/10); pogosti ( 1/100, < 1/10); občasni ( 1/1.000, < 1/100)
English: Caelyx has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Caelyx nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, vendar so v dosedanjih kliničnih študijah med njegovo uporabo v redkih primerih (< 5%) opažali omotico in zaspanost.
English: How to store Caelyx
Slovenian: Kako boste prejeli zdravilo Caelyx
English: See the SPC for bortezomib.
Slovenian: Za navodila glejte povzetek glavnih značilnosti zdravila za bortezomib.
English: Dry skin, skin discolouration, pigmentation abnormal, erythema
Slovenian: pogosti suha koža, obarvanje kože, nenormalna pigmentacija kože, eritem izpuščaj bulozni izpuščaj, dermatitis, eritematozni izpuščaj, bolezni nohtov, luskasta koža občasni nenormalna pigmentacija kože, eritem
English: See Table 6 for undesirable effects reported in Caelyx-treated patients.
Slovenian: Za neželene učinke, o katerih so poročali pri bolnicah, zdravljenih z zdravilom Caelyx, glejte Preglednico 6.
English: Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Slovenian: Bolezni krvi in limfatičnega sistema pogosti levkopenija, anemija, nevtropenija, trombocitopenija levkopenija, anemija trombocitemija občasni nevtropenija
English: Batch
Slovenian: TROMBOCITI
English: Ovarian cancer patients
Slovenian: Bolnice z rakom jajčnikov
English: The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat hand-foot syndrome, below); - pain or sores in mouth or throat, nausea, vomiting, diarrhoea, constipation, loss of appetite, weight loss; - decrease in the number of white blood cells, which can increase the chances of infections.
Slovenian: - bolečine ali rane v ustih ali žrelu, slabost, bruhanje, driska, zaprtje, izguba teka, hujšanje - zmanjšanje števila levkocitov, ki lahko poveča nevarnost za okužbe.
English: Cardiac disorders Common
Slovenian: Srčne bolezni pogosti srčno-žilne bolezni
English: Reduction in haemoglobin and platelets were less frequently (< 5%) reported.
Slovenian: Redkeje (< 5%) so poročali o znižanju koncentracije hemoglobina in števila trombocitov.
English: Musculoskeletal and connective tissue disorders Common
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti bolečine v hrbtu, mialgija
English: Dry skin, skin discolouration
Slovenian: PPE*, izpuščaj pogosti suha koža
English: AIDS-related KS
Slovenian: Z aidsom povezan Kaposijev sarkom
English: Respiratory, thoracic and mediastinal disorders common dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja, okrepljen kašelj
English: Caelyx must be handled and disposed of in a manner consistent with that of other anticancer medicinal products.
Slovenian: Za ravnanje s tem zdravilom in odstranjevanje ostankov zdravila veljajo enaka pravila kot za druga zdravila proti raku.
English: Dehydration, hypokalaemia, hyperkalaemia, hypomagnesaemia, hyponatraemia, hypocalcaemia
Slovenian: Bolezni živčevja pogosti parestezije, somnolenca glavobol, omotica, nevropatija, hipertonija občasni parestezije, somnolenca
English: Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Slovenian: Bolezni prebavil zelo pogosti zaprtje, driska, slabost, stomatitis, bruhanje pogosti bolečine v trebuhu, dispepsija, razjede v ustih slabost, stomatitis, bruhanje, bolečine v trebuhu, driska razjede v ustih, ezofagitis, slabost in bruhanje, gastritis, disfagija, suha usta, napenjanje, gingivitis, motnje okusa občasni zaprtje, dispepsija, razjede v ustih
English: Withdraw patient
Slovenian: Zdravljenje prekinite
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Sandoz on 11 December 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rivastigmine Sandoz, veljavno po vsej Evropski uniji, odobrila 11. decembra 2009.
English: The full EPAR for Rivastigmine Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rivastigmine Sandoz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
Slovenian: Prav tako ga ne smejo uporabljati bolniki, pri katerih obstaja sum, da so v preteklosti doživeli hudo alergijsko reakcijo, imenovano „alergijski kontaktni dermatitis“, na obliže zdravila Exelon.
English: Rivastigmine Sandoz should be given twice a day, with morning and evening meals.
Slovenian: Zdravilo Rivastigmine Sandoz se daje dvakrat na dan ob jutranjem ali večernem obroku.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Sandoz.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rivastigmine Sandoz.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Sandoz by the patient.
Slovenian: Zdravljenje se lahko začne samo, če je na voljo negovalec, ki redno spremlja uporabo zdravila Rivastigmine Sandoz pri bolniku.
English: Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine Sandoz is being increased.
Slovenian: Na splošno sta med najpogostejšimi neželenimi učinki (opaženimi pri več kot 1 od 10 bolnikov) navzeja (slabost, opažena pri 38 bolnikih od 100) in bruhanje (opaženo pri 23 bolnikih od 100), zlasti v obdobju povečevanja odmerka zdravila Rivastigmine Sandoz.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine Sandoz's benefits did not outweigh its risks.
Slovenian: Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Rivastigmine Sandoz ne odtehtajo njegovih tveganj.
English: For more information about treatment with Rivastigmine Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rivastigmine Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP concluded that Rivastigmine Sandoz has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Slovenian: CHMP je zaključil, da ima zdravilo Rivastigmine Sandoz pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
English: Treatment with Rivastigmine Sandoz should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Slovenian: Zdravljenje z zdravilom Rivastigmine Sandoz mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem Alzheimerjeve bolezni ali demence pri bolnikih s Parkinsonovo boleznijo.
English: Rivastigmine Sandoz must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Slovenian: Zdravila Rivastigmine Sandoz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rivastigmin, druge derivate karbamata ali katero koli drugo sestavino zdravila.
English: Therefore, the Committee decided that Rivastigmine Sandoz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zato sklenil, da so koristi zdravila Rivastigmine Sandoz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: All of the studies lasted six months and compared the effects of Rivastigmine Sandoz with those of placebo (a dummy treatment).
Slovenian: Vse študije so trajale šest mesecev, v njih pa so primerjali učinke zdravila Rivastigmine Sandoz z učinki placeba (zdravila brez zdravilne učinkovine).