FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Slovenian: ≥ 100 x 10 9/l, vrednost hemoglobina pa ≥ 9 g/dl (po transfuziji, če je le-ta potrebna).
English: For more information about cisplatin, please refer to the corresponding package leaflet.
Slovenian: Za več informacij o cisplatinu glejte navodilo za uporabo cisplatina.
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Slovenian: Ustrezno količino tako pripravljene raztopine morate še dodatno razredčiti z 9 mg/ml (0,9%) intravensko infuzijsko raztopino natrijevega klorida ali s 50 mg/ml ( 5%) infuzijsko raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
English: Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
Slovenian: Hude oblike (3. ali 4. stopnje) navzea (4%), bruhanje (3%), driska (2%) in mukozitis (1%).
English: Mild abdominal pain was also reported amongst 4 % of patients.
Slovenian: 4% bolnikov je imelo blage bolečine v trebuhu.
English: Packs:
Slovenian: Pakiranja:
English: After reconstitution 1 ml concentrate contains 1 mg topotecan.
Slovenian: Po pripravi 1 ml koncentrata vsebuje 1 mg topotekana.
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: 9/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m 2/day to 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
Slovenian: 9/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo, ali jim je bilo zdravljenje odloženo zaradi nevtropenije, morate odmerek zmanjšati po 0,25 mg/m2/dan, če je treba).
English: The integrated safety data for topotecan monotherapy are presented below.
Slovenian: V nadaljevanju navajamo povzetek podatkov o varnosti topotekana kot samostojnega zdravila.
English: 9/l, and the haemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary).
Slovenian: 9/l, število trombocitov večje ali enako 100 x 10 9/l in vrednost hemoglobina večja ali enaka 9 g/dl (po transfuziji,če je le-ta potrebna).
English: Cisplatin 50 mg/m d.1 + Topotecan 0,75 mg/ m dx3
Slovenian: Topotekan 0,75 mg/m2/dan x 3 na 21 dni
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Slovenian: − Pomožne snovi so: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507)
English: Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
Slovenian: S pripravo nastane koncentrat, ki vsebuje 1 mg topotekana na ml.
English: 5 x 4 mg vial
Slovenian: 5 x 4 mg viala
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Slovenian: Kemična in fizikalna stabilnost raztopine po razredčenju koncentrata z natrijevim kloridom 9 mg/ml (0,9%) raztopino za infundiranje je dokazana za 4 ure pri temperaturi 25 ± 2°C v normalnih svetlobnih razmerah.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 10
Slovenian: Če izberete zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev manj kot 0,5 x 10
English: 5 x 1 mg vial
Slovenian: 5 x 1 mg viala
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Slovenian: DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN
English: 9/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Slovenian: ≥ 9 g/dl (po transfuziji, če je potrebna).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Slovenian: Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti za mielosupresijo določen največji tolerantni odmerek 2,0 mg/m2/dan pri uporabi G-CSF i
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Slovenian: Če utrujenost in astenija ne mineta, je pri vožnji ali upravljanju s stroji potrebna previdnost.
English: Topotecan Actavis can make you feel tired or weak.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Topotekan Actavis lahko povzroči utrujenost in šibkost.
English: Topotecan Actavis 1 mg powder for concentrate for solution for infusion Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Slovenian: Topotekan Actavis 1 mg prašek za koncentrat za raztopino za infundiranje Topotekan Actavis 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
English: Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal products.
Slovenian: Pri odstranjevanju predmetov (brizg, igel itn.), uporabljenih za pripravo in/ali razredčenje citotoksičnih zdravil, sta potrebna ustrezna skrb in upoštevanje previdnostnih ukrepov.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Slovenian: Farmakokinetične študije medsebojnega delovanja zdravila z drugimi zdravili in vivo pri ljudeh niso bile izvedene.
English: - If you get any side effects, talk to your doctor or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Slovenian: Po pripravi vsebuje 1 ml koncentrata 1 mg topotekana.
English: Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Slovenian: Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupni, ki je bila deležna le NPO (vrednost p za lograng = 0,0104).
English: A phase III trial (study 478) compared oral topotecan plus Best Supportive Care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan + BSC, 90 days for BSC) and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Slovenian: Raziskava je bila opravljena pri bolnikih, pri katerih je po zdravljenju s terapijo prve izbire prišlo do relapsa (srednji čas do progresije, ki je minil od zdravljenja s terapijo prve izbire: 84 dni za zdravljenje s peroralnim topotekanom v kombinaciji z NPO; 90 dni za zdravljenje z NPO samo) in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
English: Tel: +43 (0)662 435 235 00
Slovenian: Actavis GmbH Tel: +43 (0)662 435 235 00
English: Dosage in renally impaired patients
Slovenian: Odmerjanje pri bolnikih z ledvično okvaro
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Slovenian: Bolniki s predhodno cisplatinsko kemoradioterapijo topotecan/cisplatin (n = 69)
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s topotekanom, so poročali o mielosupresiji, ki je povzročila sepso in smrti zaradi sepse (glejte poglavje 4.8).
English: One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Slovenian: Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil recidiv ≥ 90 dni po dokončanju ene predhodne sheme kemoterapije, je bila opravljena ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte preglednico 1).
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Slovenian: Koncentrat je bledo rumen in ima koncentracijo 1 mg topotekana na ml.
English: oC ± 2
Slovenian: 1. dan +
English: How to use Topotecan Actavis
Slovenian: Kako se uporablja zdravilo Topotekan Actavis
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 10
Slovenian: Če izberete zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev < 0,5 x 10
English: severe bleeding (associated with thrombocytopenia) Immune system disorders
Slovenian: Ni znano hude krvavitve (povezane s trombocitopenijo)
English: Topotecan is not recommended to be used in these patient groups.
Slovenian: Pri teh skupinah bolnikov zdravljenje s topotekanom ni priporočljivo.
English: Ελλάδα Specifar ABEE
Slovenian: Potem je potreben pregled pri
English: Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
Slovenian: Med kliničnimi preskušanji s topotekanom so poročali o smrtnih izidih zaradi nevtropeničnega kolitisa.
English: anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Redki:
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on Day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n=9) and Cmax (23 %, n=11) was noted on day 5.
Slovenian: 13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (12%, n=9) in Cmax (23%, n=11).
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Slovenian: 30 minutne intravenske infuzije enkrat na dan. 1. dan po prejemu odmerka topotekana bolnica prejme še intravensko infuzijo cisplatina v odmerku 50 mg/m2/dan.
English: Median survival (weeks) (95 % CI) Hazard ratio (95 % CI) Response rate (%) (95 % CI) Difference in response rate (95 % CI) Median time to progression (weeks) (95 % CI) Hazard ratio (95 % CI) N = total number of patients treated.
Slovenian: Mediana vrednost (95 % interval zaupanja) Razmerje tveganja (95 % interval zaupanja)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 July 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
English: Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Slovenian: Srednji čas preživetja bolnikov v skupini, ki je prejemala topotekan je bil 25,0 tednov, v skupini, ki je prejemala kombinacijo CAV pa 24,7 tedna.
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Slovenian: Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih v obeh študijah sta peroralni in intravenski topotekan pri bolnikih z recidivom občutljivega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
English: Median (95 % C.I) Hazard ratio (95 % C.I.)
Slovenian: Razmerje tveganja (95 % interval zaupanja) Log rank p-vrednost
English: Insufficient data are available to make a recommendation for patients with a creatinine clearance <20 ml/min.
Slovenian: Samostojno zdravljenje (drobnocelični pljučni karcinom) Za zdravljenje bolnikov z očistkom kreatinina < 20 ml/min ne moremo priporočiti ustreznih odmerkov, saj imamo premalo izkušenj.
English: Initial dose The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Slovenian: Začetni odmerek Priporočeni odmerek topotekana je 0,75 mg/m2/dan.
English: How to store Topotecan Actavis
Slovenian: Dajanje zdravila Topotekan Actavis
English: The mean metabolite:parent AUC ratio was less than 10 % for both total topotecan and topotecan lactone.
Slovenian: Tako za skupni topotekan kot topotekan lakton je srednje razmerje AUC-jev presnovek: izvorna učinkovina manjše od 10 %.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Slovenian: Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95% interval zaupanja: 2,6; 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95% intervala zaupanja: 2,9; 9,6), razmerje tveganja 1,15 (0,59; 2,23).
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated cisplatin use.
Slovenian: Za celoten seznam neželenih učinkov, povezanih s cisplatinom, glejte podatke za predpisovanje cisplatina.
English: ITT population Cisplatin 50 mg/m d.1 q21 d.
Slovenian: Vključene bolnice (ITT populacija) cisplatin 50 mg/m
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 10
Slovenian: Nadaljevalni odmerki Pred naslednjo uporabo topotekana mora biti število nevtrofilcev ≥ 1 x 10
English: malaise
Slovenian: Dojenje
English: 9/l and/or a platelet count of < 100 x 10
Slovenian: 9/l in/ali števila
English: In another randomised phase III trial which compared IV topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Slovenian: Pri bolnikih z relapsom dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24,3%, na kombinacijo CAV pa 18,3%.
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Slovenian: V glavnem se presnavlja s hidrolizo laktonskega obroča do karboksilata z odprtim obročem.
English: Guidelines for the safe handling and disposal of antineoplastic agents Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Slovenian: Smernice za varno ravnanje in odlaganje antineoplastičnih zdravil
English: Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.)
Slovenian: Plazemski očistek pri bolnikih z ledvično okvaro (očistek kreatinina 41−60 ml/min) se je v primerjavi s kontrolno skupino zmanjšal na približno 67%.
English: Österreich Actavis GmbH
Slovenian: Actavis Deutschland GmbH & Co.
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan, as Topotecan Actavis 1 mg contains a 10 % overage of fill.
Slovenian: Ker vsebuje Topotekan Actavis 10% prebitek, ima nastala bledo rumena raztopina koncentracijo 1 mg topotekana na ml.
English: The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
Slovenian: Pri kombiniranem zdravljenju raka materničnega vratu s cisplatinom med kliničnimi preskušanji so bili neželeni učinki topotekana enaki kot pri samostojnem zdravljenju s topotekanom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 mg topotecan (as hydrochloride).
Slovenian: Ena viala vsebuje 4 mg topotekana (v obliki klorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mg topotecan (as hydrochloride).
Slovenian: Ena viala vsebuje 1 mg topotekana (v obliki klorida).
English: : 4.9, 9.5) for the cisplatin arm with a hazard ratio of 0.75 (0.49, 1.16).
Slovenian: Pri bolnicah (n = 102) s ponovitvijo po 180 dneh je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 9,9 meseca (95% interval zaupanja: 7; 12,6) v skupini, ki je prejemala cisplatin, pa 6,3 meseca (95% interval zaupanja: 4,9; 9,5), razmerje tveganja 0,75 (0,49; 1,16).
English: Topotecan Actavis is not recommended in case of severe kidney impairment; - if you have liver problems.
Slovenian: Zdravila Topotekan Actavis ni priporočljivo uporabljati pri bolnikih s hudo okvaro ledvic.
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion
Slovenian: Topotekan Actavis 4 mg prašek za koncentrat za raztopino za infundiranje
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Slovenian: Topotekan Actavis 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion topotecan
Slovenian: Topotekan Actavis 1 mg prašek za koncentrat za raztopino za infundiranje topotekan
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Slovenian: Celična posledica zaviranja topoizomeraze I je razpad posameznih verig DNA, na katere se veže encim, na dele.
English: CLINICAL PARTICULARS
Slovenian: Pediatrični bolniki
English: Hazard ratio (95 % C.I.)
Slovenian: Razlika v deležu odziva (95 % IZ)
English: Not applicable.
Slovenian: če je treba).
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion
Slovenian: Topotekan Actavis 1 mg prašek za koncentrat za raztopino za infundiranje
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Slovenian: Med vsakodnevno uporabo se topotekan kopiči le malo ali sploh ne.
English: You must tell your doctor immediately if you experience any of the following serious side effects.
Slovenian: Če se vam pojavi kateri od naslednjih resnih neželenih učinkov, morate to nemudoma povedati zdravniku.
English: anaphylactic reaction angioedema urticaria
Slovenian: prašek za koncentrat za raztopino za infundiranje rumen prašek
English: Cytotoxic
Slovenian: Topotekan Actavis
English: Hepatobiliary disorders Common:
Slovenian: Bolezni imunskega sistema Pogosti:
English: Topotecan Actavis; - if your blood cell counts are too low.
Slovenian: - če imate premajhno število krvnih celic.
English: What Topotecan Actavis contains - The active substance is topotecan.
Slovenian: Zdravilo Topotekan Actavis vsebuje natrij
English: This overview was last updated in 12-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 12-2018.
English: Further information on Orkambi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Orkambi.
Slovenian: Nadaljnje informacije o zdravilu Orkambi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Orkambi.
English: The study is to evaluate how the disease progresses in the two groups of children.
Slovenian: Študija naj bi ocenila napredek bolezni pri dveh skupinah otrok.
English: The tablets or granules are taken every 12 hours with fat-containing foods.
Slovenian: Tablete ali zrnca se jemljejo vsakih 12 ur s hrano, ki vsebuje maščobo.
English: Orkambi received a marketing authorisation valid throughout the EU on 19 November 2015.
Slovenian: Zdravilo Orkambi je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 19. novembra 2015.
English: Overall the number of exacerbations was reduced by 39% when compared with placebo.
Slovenian: Celokupno število poslabšanj se je v primerjavi s placebom zmanjšalo za 39 %.
English: What measures are being taken to ensure the safe and effective use of Orkambi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Orkambi?
English: Other information about Orkambi
Slovenian: Druge informacije o zdravilu Orkambi
English: The European Medicines Agency decided that Orkambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Orkambi večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: The beneficial effects of Orkambi were smaller than expected for a medicine that treats the mechanism of the disease rather than its symptoms.
Slovenian: Koristni učinki zdravila Orkambi so bili manjši, kot bi bilo pričakovati pri zdravilu, ki zdravi mehanizem bolezni, ne njenih simptomov.
English: As for all medicines, data on the use of Orkambi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Orkambi stalno spremljajo.
English: Orkambi (lumacaftor / ivacaftor)
Slovenian: Orkambi (lumakaftor/ivakaftor)
English: There was improvement in CFTR protein activity as measured by a decrease in the amount of chloride in sweat after 24 weeks of treatment.
Slovenian: Prišlo je do izboljšanja delovanja beljakovine CFTR, kar je bilo izmerjeno z zmanjšanjem količine klorida v znoju po 24 tednih zdravljenja.
English: The recommended dose depends on the age and weight of the patient.
Slovenian: Priporočeni odmerek je odvisen od starosti in telesne mase bolnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orkambi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Orkambi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: All children were treated with Orkambi.
Slovenian: Vsi otroci so bili zdravljeni z zdravilom Orkambi.
English: Stopping treatment with Orkambi caused chloride levels to rise again.
Slovenian: S prenehanjem zdravljenja z zdravilom Orkambi je prišlo do ponovnega povečanja ravni klorida.
English: Orkambi is used in patients who have inherited the mutation from both parents.
Slovenian: Zdravilo Orkambi se uporablja pri bolnikih, ki so podedovali mutacijo od obeh staršev.
English: However, as cystic fibrosis caused by F508del mutation is particularly severe, the observed effects were considered clinically relevant for patients with no other option.
Slovenian: Ker pa je cistična fibroza, ki jo povzroča mutacija F508del, še posebno težka, je bilo presojeno, da so opaženi učinki za bolnike, ki nimajo druge možnosti, klinično pomembni.
English: An overview of Orkambi and why it is authorised in the EU
Slovenian: Pregled zdravila Orkambi in zakaj je odobreno v EU
English: What benefits of Orkambi have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Orkambi izkazalo v študijah?
English: Treatment with Orkambi also reduced the number of exacerbations (flares-up) requiring hospital admission or antibiotic therapy.
Slovenian: Zdravljenje z zdravilom Orkambi je tudi zmanjšalo število poslabšanj (izbruhov) bolezni, zaradi katerih sta bila potrebna sprejem v bolnišnico ali zdravljenje z antibiotiki.
English: What are the risks associated with Orkambi?
Slovenian: Kakšna tveganja so povezana z zdravilom Orkambi?
English: Why is Orkambi authorised in the EU?
Slovenian: Zakaj je zdravilo Orkambi odobreno v EU?
English: For more information about using Orkambi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Orkambi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.