FrancophonIA/ELRC3.0 huggingface dataset:
English: CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
Slovenian: IZ = interval zaupanja, OxMdG = oksaliplatin in infundirani 5-FU/FA, OS (overall survival) = celokupno preživetje, PFS (progression-free survival time) = čas preživetja brez napredovanja bolezni
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR % (95% CI) p-value CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
Slovenian: OS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p PFS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p ORR % (95-odstotni IZ) vrednost p IZ = interval zaupanja; KOP = kemoterapija na osnovi platine; ORR (objective response rate) = objektivna stopnja odgovora; OS (overall survival) = celokupno preživetje, PFS (progression-free survival time) = čas preživetja brez napredovanja bolezni
English: No non-clinical data on the effect of cetuximab on wound healing are available to date.
Slovenian: Doslej ni na voljo predkliničnih podatkov o učinku cetuksimaba na celjenje ran.
English: Mucositis may lead to epistaxis.
Slovenian: Mukozitis lahko povzroči epistakso.
English: A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/mL (0.9%) solution for injection at the end of infusion.
Slovenian: Linijo morate ob koncu infundiranja sprati s sterilno raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje.
English: PHARMACEUTICAL FORM Solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA raztopina za infundiranje brezbarvna raztopina
English: Erbitux 5 mg/mL solution for infusion Cetuximab
Slovenian: Erbitux 5 mg/ml raztopina za infundiranje cetuksimab
English: Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression.
Slovenian: Retrospektivno so za ekspresijo gena KRAS analizirali vzorce tumorja približno 81 % bolnikov.
English: KRAS wild-type population
Slovenian: Populacija z nemutiranim tipom KRAS
English: Connect the infusion line and prime it with the diluted Erbitux before starting the infusion.
Slovenian: Preden začnete z dajanjem infuzije, priključite infuzijsko linijo in jo napolnite z razredčenim zdravilom Erbitux.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 63%.
Slovenian: Delež bolnikov s tumorji z nemutiranim tipom KRAS v populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 63-odstoten.
English: Erbitux is usually infused into a vein (given as a drip) once a week.
Slovenian: Zdravilo Erbitux se navadno infundira (vkapava) v veno enkrat na teden.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
Slovenian: Delež bolnikov s tumorji z nemutiranim tipom KRAS pri populaciji bolnikov, ki so jim lahko ocenili status KRAS, je bil 57-odstoten.
English: Erbitux may cause side effects concerning the skin.
Slovenian: Zdravilo Erbitux lahko povzroči neželene učinke, povezane z vašo kožo.
English: There is limited experience in the use of cetuximab in combination with radiation therapy in colorectal cancer.
Slovenian: Izkušnje z uporabo cetuksimaba skupaj z radioterapijo pri raku debelega črevesa in danke so omejene.
English: Common ( 1/100 to < 1/10)
Slovenian: Pogosti (≥ 1/100 do < 1/10)
English: Before starting treatment for metastatic cancer of the large intestine your doctor will test your cancer cells if they contain the normal (wild-type) or mutant form of RAS. You must not receive Erbitux in combination with other anticancer treatment containing oxaliplatin if your cancer cells contain the mutant form of RAS.
Slovenian: Pred začetkom zdravljenja metastatskega raka debelega črevesa bo zdravnik testiral vaše rakave celice, ali vsebujejo običajni (nemutirani) ali mutirani tip RAS.
English: Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Erbitux.
Slovenian: Pred začetkom zdravljenja z zdravilom Erbitux mora biti potrjeno, da gre za status nemutiranega tipa RAS (genov KRAS in NRAS).
English: Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion.
Slovenian: Med samo infuzijo in še najmanj 1 uro po zaključku infuzije je potrebno skrbno nadzorovanje bolnika.
English: Uncommon ( 1/1,000 to < 1/100)
Slovenian: Občasni (≥ 1/1.000 do < 1/100)
English: The KRAS exon 2 status was recognised as predictive factor for the treatment with cetuximab in 4 of the randomised controlled studies (EMR 62 202-013, EMR 62 202-047, CA225006, and CA225025).
Slovenian: Od teh so v štirih randomiziranih nadzorovanih študijah (EMR 62 202-013, EMR 62 202-047, CA225006 in CA225025) ugotovili, da je status gena KRAS (eksona 2) napovedni dejavnik za zdravljenje s cetuksimabom.
English: • EMR 62 202-002: This randomised study in patients with recurrent and/or metastatic squamous cell cancer of the head and neck who had not received prior chemotherapy for this disease compared the combination of cetuximab and cisplatin or carboplatin plus infusional 5-fluorouracil (222 patients) to the same chemotherapy alone (220 patients).
Slovenian: • EMR 62 202-002: V tej randomizirani študiji na bolnikih s ponavljajočim in/ali metastatskim rakom skvamoznih celic glave in vratu, ki pred tem niso prejemali kemoterapije za to bolezen, so primerjali kombinacijo cetuksimaba in cisplatina ali karboplatina skupaj z 5-fluorouracilom v infuziji (222 bolnikov) z enako kemoterapijo brez cetuksimaba (220 bolnikov).
English: • EMR 62 202-007: This randomised study in patients with metastatic colorectal cancer after failure of irinotecan-based treatment for metastatic disease as the last treatment before study entry compared the combination of cetuximab and irinotecan (218 patients) with cetuximab monotherapy (111 patients).
Slovenian: • EMR 62 202-007: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom po neuspešnem zdravljenju metastatske bolezni z irinotekanom kot zadnjim zdravljenjem pred vstopom v študijo primerjali kombinacijo cetuksimaba in irinotekana (218 bolnikov) s samostojnim cetuksimabom (111 bolnikov).
English: Further post-hoc analyses on mutations on RAS genes other than KRAS exon 2 have been evaluated.
Slovenian: Post-hoc so poleg gena KRAS (eksona 2) ocenili tudi analize mutacij na genih RAS.
English: What Erbitux contains
Slovenian: Kaj vsebuje zdravilo Erbitux
English: If you receive Erbitux with radiation therapy, some of the side effects you may experience can also be related to this combination, such as:
Slovenian: Če zdravilo Erbitux prejemate v kombinaciji z obsevanjem, so lahko nekateri neželeni učinki, ki se bodo morda pojavili, povezani s to kombinacijo:
English: What is inthis leaflet
Slovenian: Kaj vsebuje navodilo
English: Each vial of 20 mL contains 100 mg cetuximab.
Slovenian: Ena viala z 20 ml vsebuje 100 mg cetuksimaba.
English: In all indications, Erbitux is administered once a week.
Slovenian: Zdravilo Erbitux pri vseh indikacijah infundirajte enkrat na teden.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Slovenian: Delež bolnikov s tumorji z nemutiranim tipom KRAS v populaciji bolnikov, ki so jim lahko ocenili KRAS, je bil 58odstoten.
English: Driving and using machines
Slovenian: Odmerjanje in uporaba
English: For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population (65%).
Slovenian: Za oceno statusa RAS so bile iz vseh vzorcev tumorja, ki so jih lahko ocenili znotraj populacije z nemutiranim tipom KRAS eksona 2, poleg mutacije gena KRAS eksona 2, določene tudi druge mutacije (65 %).
English: • CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients).
Slovenian: • CA225006: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom, ki so se na začetku zdravljenja metastatske bolezni zdravili s kombinacijo oksaliplatina in fluoropirimidina, primerjali kombinacijo cetuksimaba in irinotekana (648 bolnikov) s samostojnim iritonekanom (650 bolnikov).
English: CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Slovenian: IZ = interval zaupanja; FOLFIRI = irinotekan in infundirani 5-FU/FA; ORR (objective response rate) = objektivna stopnja odgovora (bolniki s popolnim odgovorom ali delnim odgovorom); OS (overall survival) = celokupno preživetje, PFS (progression-free survival time) = čas preživetja brez napredovanja bolezni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 20 mL contains 100 mg cetuximab (5 mg/mL).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala z 20 ml vsebuje 100 mg cetuksimaba (5 mg/ml).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Erbitux 5 mg/mL solution for infusion
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Erbitux 5 mg/ml raztopina za infundiranje cetuksimab intravenska uporaba
English: NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion
Slovenian: IME ZDRAVILA Erbitux 5 mg/ml raztopina za infundiranje
English: • EMR 62 202-047: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid (FOLFOX4) (169 patients) to the same chemotherapy alone (168 patients).
Slovenian: • EMR 62 202-047: Ta randomizirana študija pri bolnikih z metastatskim kolorektalnim rakom, ki še niso bili zdravljeni zaradi metastatske bolezni, je primerjala kombinacijo cetuksimaba in oksaliplatina ter stalnega infudiranega 5-fluorouracila/folinske kisline (FOLFOX4) (169 bolnikov) z enako kemoterapijo brez cetuksimaba (168 bolnikov).
English: What Erbitux is
Slovenian: Kaj je zdravilo Erbitux
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov)
English: Each mL of the solution for infusion contains 5 mg cetuximab.
Slovenian: En mililiter raztopine za infundiranje vsebuje 5 mg cetuksimaba.
English: Odds Ratio (95% CI) p-value
Slovenian: razmerje tveganja (95-odstotni IZ) vrednost p ORR
English: Each vial of 100 mL contains 500 mg cetuximab.
Slovenian: Ena viala s 100 ml vsebuje 500 mg cetuksimaba.
English: Rare ( 1/10,000 to < 1/1,000)
Slovenian: Redki (≥ 1/10.000 do < 1/1.000)
English: • EMR 62 202-013: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI) (599 patients) to the same chemotherapy alone (599 patients).
Slovenian: • EMR 62 202-013: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom, ki še niso bili zdravljeni zaradi metastatske bolezni, primerjali kombinirano terapijo s cetuksimabom in irinotekanom ter infundiranim 5-fluorouracil/folinsko kislino (FOLFIRI) (599 bolnikov) z enako kemoterapijo brez cetuksimaba.
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value Best overall response rate
Slovenian: OS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p PFS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p Najboljša celokupna stopnja odziva
English: • inflammation of the lining of the intestine and mouth
Slovenian: • vnetje črevesne in ustne sluznice
English: CI = confidence interval, FOLFOX4 = oxaliplatin plus continuous infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time, NE = not estimable
Slovenian: IZ = interval zaupanja; FOLFOX4 = oksaliplatin in stalni infundirani 5-FU/FA; ORR (objective response rate) = objektivna stopnja odgovora (bolniki s popolnim odgovorom ali delnim odgovorom); OS (overall survival) =
English: For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population.
Slovenian: Za oceno statusa RAS so bile iz vseh vzorcev tumorja, ki so jih lahko ocenili znotraj populacije z nemutiranim tipom KRAS (eksona 2), poleg mutacije gena KRAS eksona 2, določene tudi druge mutacije.
English: RAS mutant population
Slovenian: Populacija z nemutiranim tipom RAS Populacija z mutiranim tipom RAS
English: (95% CI) p-value BSC = best supportive care, CI = confidence interval, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Slovenian: NPO = najboljši podporni oskrbi, IZ = interval zaupanja; ORR (objective response rate) = objektivna stopnja odgovora (bolniki s popolnim odgovorom ali delnim odgovorom); OS (overall survival) = celokupno preživetje, PFS (progression-free survival time) = čas preživetja brez napredovanja bolezni
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI)
Slovenian: OS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p PFS meseci, mediana (95-odstotni IZ)
English: Vascular disorders Uncommon:
Slovenian: Pogostnost neznana:
English: BN
Slovenian: NPO
English: Citric acid monohydrate Sodium hydroxide Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid glicin polisorbat 80 citronska kislina monohidrat natrijev hidroksid voda za injekcije
English: What Erbitux is used for
Slovenian: Za kaj uporabljamo zdravilo Erbitux
English: Posology
Slovenian: Predzdravljenje
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
Slovenian: OS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p PFS meseci, mediana (95-odstotni IZ) razmerje tveganja (95-odstotni IZ) vrednost p ORR
English: Radiation therapy + cetuximab
Slovenian: Radioterapija in cetuksimab
English: How to store Erbitux
Slovenian: Shranjevanje zdravila Erbitux
English: • dizziness
Slovenian: • luščenje
English: Do not breast-feed your baby during the period over which you are being treated with Erbitux and for two months after the last dose.
Slovenian: V času, ko se zdravite z zdravilom Erbitux, in še dva meseca po zadnjem odmerku zdravila ne smete dojiti.
English: Intravenous use.
Slovenian: Način uporabe
English: NN:
Slovenian: Občasni:
English: A doctor experienced in the use of anticancer medicines will supervise your Erbitux therapy.
Slovenian: Zdravljenje z zdravilom Erbitux bo potekalo pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
English: Hepatobiliary disorders Very common:
Slovenian: Očesne bolezni Pogosti:
English: Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Slovenian: Po polnjenju linije z zdravilom Erbitux ali sterilno raztopino natrijev klorid 9 mg/ml (0,9%) raztopina za injiciranje lahko začnete z infundiranjem zdravila.
English: ORR
Slovenian: Lot
English: 5 (5 x 1) vials (multipack)
Slovenian: 5 (5 pakiranj po 1) vial (skupno pakiranje)
English: 10 (2 x 5) pre-filled pens (multipack)
Slovenian: 10 (2 pakiranji po 5) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: 1 pre-filled pen + 7 NovoFine Plus needles
Slovenian: 1 napolnjen injekcijski peresnik + 7 igel NovoFine Plus
English: The CHMP considered the following:
Slovenian: Odbor CHMP je upošteval naslednje:
English: These concerns were raised with the applicant during the procedure but were never adequately addressed.
Slovenian: O teh zadržkih je bil predlagatelj med postopkom obveščen, vendar niso bili nikoli zadovoljivo razrešeni.
English: Grounds for re-examination
Slovenian: Razlogi za ponovni pregled
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Slovenian: odbor CHMP meni, da na podlagi člena 12 Uredbe (ES) št. 726/2004 varnost zadevnega zdravila ni ustrezno ali zadovoljivo dokazana.
English: It is only being approved for short term periods of treatment (less than three months) and its long term cardiac toxicity is unknown.
Slovenian: Uporaba zdravila je bila odobrena le za kratkotrajna obdobja zdravljenja (manj kot tri mesece), njegova dolgoročna toksičnost za srce pa ni znana.
English: as the safety of the above mentioned medicinal product was not sufficiently demonstrated, the applicant submitted detailed grounds for the re-examination of the grounds for refusal.
Slovenian: Ker varnost zgoraj navedenega zdravila ni bila zadovoljivo prikazana, je predlagatelj predložil podrobne razloge za ponoven pregled razlogov za zavrnitev.
English: The applicant presented in their submission the following grounds for re-examination:
Slovenian: Predlagatelj je v svoji predloženi dokumentaciji predstavil naslednje razloge za ponovni pregled:
English: Another concern was the feasibility to exclude patients with moderate depression from treatment.
Slovenian: Drug zadržek pa je predstavljala izvedljivost izključitve bolnikov z zmerno depresijo iz zdravljenja.
English: Overall summary of the scientific evaluation of Qsiva
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Qsiva
English: Additionally, the Committee noted that the actual patient numbers treated with the recommended mid dose were limited.
Slovenian: Poleg tega je odbor opozoril, da je bilo dejansko število bolnikov, zdravljenih s priporočenim srednjim odmerkom, omejeno.
English: The applicant addressed specifically the CHMP´s four initial principal grounds for refusal:
Slovenian: Predlagatelj je posebej obravnaval štiri začetne temeljne razloge odbora CHMP za zavrnitev: 1.
English: There is remaining uncertainty whether the updated risk minimisation measures as proposed by the applicant could effectively prevent such off-label use.
Slovenian: Ostaja negotovost, ali bi posodobljeni ukrepi za zmanjšanje tveganja, kot jih je predlagal predlagatelj, lahko učinkovito preprečili nenamensko uporabo,
English: However, due to the voluntary nature of the registry the expected participation was considered to be low and hence its capacity to minimise off-label use remained uncertain.
Slovenian: Zaradi prostovoljne narave registra pa je pričakovati nizko udeležbo, zato njegov potencial za zmanjševanje nenamenske uporabe ostaja vprašljiv.
English: Although these showed no obvious increased frequency of events with treatment, the data are of limited value as the duration of follow-up was relatively short and the total number of events was small.
Slovenian: Čeprav niso pokazali očitne povečane pogostnosti teh dogodkov ob zdravljenju, imajo ti podatki omejeno vrednost, saj je bilo sledenje relativno kratko, skupno število dogodkov pa majhno.
English: In addition, patient registry and drug utilization study was proposed to be conducted to repeatedly evaluate the effectiveness of these measures.
Slovenian: Poleg tega je predlagal uvedbo registra bolnikov in študije uporabe zdravila, s katerima bi trajno ocenjevali učinkovitost teh ukrepov.
English: The effect was similar in examined subpopulations, but experience in older subjects and patients with cardiovascular disease was very limited.
Slovenian: Učinek je bil podoben v preučevanih podpopulacijah, izkušnje s starejšimi preiskovanci in bolniki z kardiovaskularnimi obolenji pa so bile zelo omejene.
English: Treatment with Qsiva 7.5/46 mg and 15/92 mg for 28 and 56 weeks resulted in clinically relevant reductions of body weight, with a maximum effect after approx. 36-40 weeks of treatment.
Slovenian: Zdravljenje z zdravilom Qsiva 7,5/46 mg in 15/92 mg v obdobju 28 in 56 tednov je povzročilo klinično pomembno zmanjšanje telesne mase z največjim učinkom po približno 36−40 tednih zdravljenja.
English: However, no additional weight loss was seen in the second year, rather there was a mean weight gain in all groups.
Slovenian: V drugem letu pa niso opazili dodatne izgube telesne mase, pač pa povprečno pridobivanje telesne mase v vseh skupinah.
English: Topiramate is known as a teratogenic substance causing congenital malformations.
Slovenian: Topiramat je znan kot teratogena snov, ki povzroča prirojene okvare.
English: • Safety issues
Slovenian: • Vidiki varnosti
English: With regard to reported cases of suicidal ideation in patients treated with Qsiva during the clinical studies, regular assessments in this regard would be required.
Slovenian: Glede na poročanje o samomorilnih mislih bolnikov, zdravljenih z zdravilom Qsiva v kliničnih študijah, bi bile v zvezi s tem potrebna redna ocenjevanja.
English: Importantly, there were no increases in major depression diagnoses (by PHQ-9 questionaire), emergent antidepressant use, or suicidality (by C-SSRS questionaire) in the programme.
Slovenian: Pomembno je, da niso opazili povečanja v diagnozah velikih depresivnih motenj (po vprašalniku PHQ-9), novi uporabi antidepresivov ali samomorilnosti (po vprašalniku C-SSRS) v programu.
English: The proposed patient registry was considered a key component to gather long term data on the safety of Qsiva and on the effectiveness of the risk minimisation measures, especially in relation to off-label use.
Slovenian: Predlagani register bolnikov je bil upoštevan kot ključna komponenta za zbiranje dolgoročnih podatkov o varnosti zdravila Qsiva in učinkovitosti ukrepov za zmanjšanje tveganja, še posebej v zvezi z nenamensko uporabo.
English: • Quality issues
Slovenian: • Vidiki kakovosti
English: The specification of the finished product was to be revised based on the batch data results and a second identity test method included for each drug substance.
Slovenian: Specifikacijo končnega izdelka naj bi pregledali na podlagi rezultatov podatkov o seriji in na podlagi druge metode identifikacijskega preskusa, ki naj bi bila vključena za vsako osnovno učinkovino.
English: Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Qsiva.
Slovenian: Zato je odbor CHMP priporočil zavrnitev izdaje dovoljenja za promet z zdravilom Qsiva.
English: The magnitude of the weight loss was larger compared to previously approved weight reducing agents.
Slovenian: Obseg izgubljene telesne mase je bil v primerjavi s predhodno odobrenimi sredstvi za zmanjšanje telesne mase večji.
English: Many of these adverse events were also reported with Qsiva as a fixed-dose combination of phentermine/topiramate in four pivotal Phase III studies and two supportive Phase II studies.
Slovenian: O mnogih od teh neželenih učinkov so poročali tudi ob uporabi zdravila Qsiva kot kombinaciji fiksnih odmerkov fentermina/topiramata v štirih ključnih študijah 3. faze in dveh podpornih študijah 2. faze.
English: Existing data from phentermine use has major limitations and cannot be extrapolated with regard to conclusions on the safety profile of Qsiva.
Slovenian: Obstoječi podatki o uporabi fentermina imajo velike omejitve in jih ni mogoče ekstrapolirati v povezavi z zaključki o varnostnem profilu zdravila Qsiva.