natgillin/translations-raw huggingface dataset:
Subjects were categorized into 4 groups based on estimated glomerular filtration rate
Preskušanci so bili razvrščeni v 4 skupine na podlagi ocenjene hitrosti glomerularne filtracije (eGFR): zdravi prostovoljci (eGFR
The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.
Varnost in farmakokinetika zdravila Ferriprox pri bolnikih s končno ledvično odpovedjo nista znani.
The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Najresnejši neželeni učinek jemanja zdravila Ferriprox je zelo nizka koncentracija belih krvnih celic
Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded pregnant rats and rabbits at doses at least as low as 25 mg/kg/day.
V študijah vpliva na sposobnost razmnoževanja pri brejih podganah in kuncih, ki niso bili obremenjeni z železom, je bil deferipron teratogen in embriotoksičen že pri odmerkih 25 mg/kg/dan.
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with mildly or moderately impaired hepatic function.
Na podlagi rezultatov te študije pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditev režima odmerjanja zdravila Ferriprox ni potrebna.
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Plastenka iz polietilena visoke gostote (HDPE), ki so opremljene z otrokom varno zaporko iz polipropilena.
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
En ml peroralne raztopine vsebuje 100 mg deferiprona (25 g deferiprona v 250 ml).
ml of oral solution (three times/day)
ml peroralne raztopine (trikrat/dan)
Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone.
Pri bolnikih, ki so se zdravili z deferipronom, je bila opažena tudi driska, večinoma blaga in prehodnega značaja.
Ferriprox 100 mg/ml oral solution deferiprone
Ferriprox 100 mg/ml peroralna raztopina deferipron
Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
V primerjavi preskušancev z blago ali zmerno okvaro z zdravimi prostovoljci je bila vrednost AUC deferipron-3-O-glukuronida zmanjšana za 10 % in vrednost Cmax za 20 %.
Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Pri manjšem številu bolnikov so pri jemanju deferiprona ugotovili nizke plazemske vrednosti cinka.
Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Pri bolnikih, ki so se zdravili z deferipronom, so poročali tudi o artropatijah, ki so variirale od blage bolečine v enem ali več sklepih do resnega artritisa z izcedkom in znatno omejeno gibljivostjo.
Ferriprox can be taken with or without food however, you may find it easier to remember to take Ferriprox if you take it with your meals.
Zdravilo Ferriprox se boste morda lažje spomnili vzeti, če ga boste jemali ob obrokih.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v sklepih
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Plastenka iz polietilena visoke gostote (HDPE), ki so opremljene z otrokom varno zaporko iz polipropilena in vsebujejo sušilo.
It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to be obtained for three consecutive weeks, to ensure that the patient recovers fully.
Te preiskave ponavljajte vsak dan. Priporočljivo je, da se po okrevanju od nevtropenije opravljajo tedenske preiskave kompletne krvne slike, števila levkocitov, nevtrofilcev in trombocitov tri tedne zaporedoma.
MARKETING AUTHORISATION HOLDER Apotex B.V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Apotex B.V.
Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
En ml peroralne raztopine vsebuje 100 mg deferiprona (50 g deferiprona v 500 ml).
What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Peroralna raztopina Ferriprox je prozorna, rdečeoranžna tekočina.
The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
(vrednost nevtrofilcev < 0,5 x 109/l) s pojavnostjo 1,1 % (0,6 pojavov bolezni na 100 bolnikov-let zdravljenja) (glejte poglavje 4.4).
What Ferriprox looks like and contents of the pack Ferriprox 1000 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Ferriprox 1000 mg tablete so bele do sivobele filmsko obložene tablete, v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »1000«, druga stran je gladka.
Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Odmerek na kilogram telesne mase je treba izračunati na 2,5 ml. Priporočljive odmerke za telesne mase na vsakih 10 kg najdete v spodnji preglednici.
If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Če se vrednost serumske alanin-aminotransferaze
There are no reports of acute overdose with Ferriprox.
Če ste vzeli večji odmerek zdravila Ferriprox, kot bi smeli Ni poročil o akutnem prevelikem odmerjanju zdravila Ferriprox.
Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
Preglednica odmerkov za filmsko obložene tablete Ferriprox 1000 mg Telesna masa (kg)
What Ferriprox looks like and contents of the pack Ferriprox 500 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Ferriprox 500 mg tablete so bele do sivobele filmsko obložene tablete, v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »500«, druga stran je gladka.
Hypersensitivity reactions
Bolezni imunskega sistema preobčutljivostne reakcije
White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Bele do sivobele, filmsko obložene tablete v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »1000«, druga stran je gladka.
Tablet core
Preglednica odmerkov
Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement, have been reported in children in the post-marketing setting with standard doses of deferiprone.
V obdobju trženja zdravila so pri otrocih, ki so prejemali standardne odmerke deferiprona, poročali o epizodah hipotonije, nestabilnosti, nezmožnosti za hojo in hipertonije z nezmožnostjo gibanja udov.
NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Ferriprox 500 mg filmsko obložene tablete Ferriprox 1000 mg filmsko obložene tablete
Each ml of oral solution contains 100 mg deferiprone.
Ena ml peroralne raztopine vsebuje 100 mg deferiprona.
Not known (frequency cannot be estimated from the available data): − allergic reactions including skin rash or hives
Neznana pogostost (pogostosti ni mogoče določiti iz razpoložljivih podatkov): - alergijske reakcije, vključno s kožnim izpuščajem in koprivnico Bolečine in otekanje sklepov se lahko pojavijo v razponu od blagih bolečin v enem ali več sklepih do hudih bolečin, ki ovirajo gibljivost.
White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Bele do sivobele, filmsko obložene tablete v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »500«, druga stran je gladka.
NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
IME ZDRAVILA Ferriprox 100 mg/ml peroralna raztopina
SYSTEM ORGAN CLASS VERY COMMON
KLASIFIKACIJA PO ORGANSKIH SISTEMIH
How to store Ferriprox
Shranjevanje zdravila Ferriprox
Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Pri bolnikih z blago, zmerno ali hudo okvaro ledvic prilagoditev odmerka ni potrebna (glejte poglavje
Ferriprox 1000 mg film-coated tablets
Ferriprox 1000 mg filmsko obložene tablete
Do not take Ferriprox if you are breast-feeding.
Ne jemljite zdravila Ferriprox, če dojite.
Ferriprox 500 mg film-coated tablets
Ferriprox 500 mg filmsko obložene tablete
Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Če raven feritina v serumu pade pod 500 µg/l, je treba razmisliti o prekinitvi zdravljenja z deferipronom.
Titanium dioxide
Obloga hipromeloza makrogol titanov dioksid
Fatalities and life-threatening situations (caused by agranulocytosis) have been reported with deferiprone in combination with deferoxamine.
Pri sočasnem zdravljenju z deferipronom in deferoksaminom so poročali o smrtnih žrtvah in življenjsko nevarnih situacijah, ki jih povzročajo agranulocitoze.
Ferriprox 1000 mg film-coated tablets deferiprone
Ferriprox 1000 mg filmsko obložene tablete deferipron
Treatment with deferiprone should not be initiated if the patient is neutropenic.
Če ima bolnik nevtropenijo, zdravljenja z deferipronom ne smemo začeti.
Ferriprox 500 mg film-coated tablets deferiprone
Ferriprox 500 mg filmsko obložene tablete deferipron
Overall, fewer Ferriprox-treated patients than deferoxamine-treated patients showed a worsening of cardiac dysfunction from first assessment to last assessment (4% vs. 20%, p=0.007).
ki so jih zdravili z deferoksaminom v obdobju od prvega do zadnjega merjenja (4 % proti 20 %, p = 0,007).
− Keep this leaflet.
− Navodilo shranite.
Method of administration For oral use
B. NAVODILO ZA UPORABO
NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution deferiprone
Navodilo za uporabo Ferriprox 100 mg/ml peroralna raztopina deferipron
Sunset Yellow (E110)
umetna aroma češnje olje poprove mete sončno rumeno FCF (E110)
Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily.
Nemudoma po diagnozi nevtropenije izvedite preiskavo kompletne krvne slike s številom levkocitov, korigiranim za nukleirane eritrocite, številom nevtrofilcev in trombocitov.
− reddish/brown discoloration of urine
- slabost - bruhanje - rdečkastorjav urin
Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/kg/day or greater in non-iron-loaded animals.
Pri odmerkih 100 mg/kg/dan in več so pri živalih, neobremenjenih z železom, zabeležili atrofije timusa, limfatičnih tkiv in mod ter hipertrofijo nadledvičnih žlez.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/108/002
MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/004
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/108/004
NAME OF THE MEDICINAL PRODUCT Ferriprox 1000 mg film-coated tablets deferiprone
Navodilo za uporabo Ferriprox 1000 mg filmsko obložene tablete deferipron
Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Ferriprox 500 mg filmsko obložene tablete Jedro tablete mikrokristalna celuloza magnezijev stearat koloiden silicijev dioksid
Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia.
Za dogodke nevtropenije (ANC < 1,5x109/l in > 0,5x109/l) Bolnika opozorite na takojšnje prenehanje jemanje deferiprona in vseh drugih zdravil, ki bi lahko povzročila nevtropenijo.
NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets deferiprone
Navodilo za uporabo Ferriprox 500 mg filmsko obložene tablete deferipron
MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/108/001
In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
zaužitega odmerka pojavi v urinu v prvih 24 urah, in sicer v obliki prostega deferiprona,
Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi prečiščena voda hidroksietilceluloza glicerol (E422) klorovodikova kislina, koncentrirana, za uravnavanje pH
Clear, reddish orange-coloured liquid.
Prozorna, rdečeoranžna tekočina.
See table below for recommended doses for body weights at 10 kg increments.
Priporočljive odmerke za telesne mase na vsakih
(eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR
≥ 90 ml/min/1,73 m2), blaga levična okvara (eGFR 60-89 ml/min/1,73 m2), zmerna ledvična okvara
Not known (frequency cannot be estimated from the available data): - allergic reactions including skin rash or hives
- povečanje apetita Neznana pogostost (pogostosti ni mogoče določiti iz razpoložljivih podatkov):
Investigations
ZDRAVILA
Immediately interrupt deferiprone if the patient experience infection.
Če se pri bolniku pojavi okužba, takoj prekinite zdravljenje z deferipronom.
These events occur rarely.
Omenjeni dogodki so redki.
Information received after cut-off date 30 January 2013
Podatki, prejeti po presečnem datumu 30. januar 2013
Several databases were consulted.
Pregledanih je bilo več podatkovnih zbirk.
In 30% of cases the indication for prescription was unknown.
V 30 % primerov indikacija za predpis zdravila ni bila znana.
The wording agreed by the PhVWP is entirely implemented only in 11 Member States.
Besedilo, ki ga je odobrila delovna skupina, se v celoti uporablja samo v 11 državah članicah.
Overall, VTE could be fatal in 1-2% of the cases.
VTE je lahko smrtna v 1-2 % primerov.
This was also one of the main points that the expert group meeting recommended to PRAC.
To je bil tudi eden glavnih predlogov, ki jih je odboru PRAC posredovala strokovna skupina.
CMDh position
Stališče CMDh
Following the media attention after the initiation of the referral procedure a number of reports were submitted reciprocally.
Po medijsko odmevnem začetku napotitvenega postopka so bila recipročno predložena številna poročila.
In that study there was a significant subjective improvement in hirsutism, however no objective evaluation was performed.
V tej študiji so opazili znatno subjektivno izboljšanje hirzutizma, vendar pa niso izvedli objektivnega ocenjevanja.
In some Member States is also authorised for alopecia androgenetica.
V nekaterih državah članicah so odobrena tudi za androgeno alopecijo.
The reporting frequency is less than the incidence of VTE as reported in epidemiological studies.
Pogostost poročanja je manjša kot pojavnost VTE, zabeležena v epidemioloških študijah.
There were no cases reporting ATE with a fatal outcome.
V nobenem primeru niso poročali o ATE s smrtnim izidom.
After an initially higher risk (the first year), the risk drops to a constant lower level.
Visoko tveganje na začetku (med prvim letom) se kasneje zmanjša na konstantno nižjo raven.
Total number of cycles number of pregnancies Pearl Index two-sided 95% confidence interval
Skupaj število ciklusov število nosečnosti Pearlov indeks dvostranski 95-odstotni interval zaupanja
Contraceptive effect
Kontracepcijski učinek
Of these 175 cases, 15 reported fatal outcome (4 medically confirmed and 11 non-medically confirmed consumer reports).
V 15 od teh 175 primerov so poročali o smrtnem izidu (4 zdravniško potrjena in 11 zdravniško nepotrjenih poročil potrošnikov).
It is evident that in the current approved indications in EU, off-label use is observed.
Očitno je, da je pri trenutno odobrenih indikacijah v EU prisotna uporaba, ki ni skladna z indikacijami.
This does not indicate a higher incidence in this age group but only a higher reporting rate in this age group, as patient exposure has not been provided in age categories.
To ne pomeni večje pojavnosti pri tej starostni skupini, ampak zgolj višjo stopnjo poročanja, saj izpostavljenost bolnic ni bila podana v starostnih kategorijah.
Misdiagnosis is a realistic possibility since TE has diffuse symptoms and is a rare event in population of healthy young women.
Napačna diagnoza je stvarna možnost, saj se TED kaže z razpršenimi simptomi in se redko pojavi pri populaciji zdravih mladih žensk.
One of these 968 cases was reported from clinical trial ME94162 / AI58.
O enem od teh 968 primerov so poročali iz kliničnega preskušanja ME94162/AI58.
• The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
• PRAC je zaključil tudi, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za bolnice in zdravstvene delavce.
Similar to acne treatment, percentages of improvement vary per study, and depend on the methods applied for evaluation of effects.
Podobno kot pri zdravljenju aken so bili odstotki izboljšanja v posameznih študijah različni, saj so bili odvisni od uporabljenih metod za ocenjevanje učinkov.
*calculated as the total number of cycles, n=21,196, minus the number of cycles, n=450, in which medication was missed.
*izračunana kot skupno število ciklusov, n = 21 196, zmanjšano za število ciklusov, n = 450, pri katerih je bilo zdravilo izpuščeno.
When diagnosis is not made and no treatment is started, or when the thrombosis does not give any clear symptoms, the clot can move upwards to the lung (pulmonary embolism) or the brain (cerebral embolism).
Če se ne postavi diagnoze in začne zdravljenja ali če se tromboza ne kaže z jasnimi simptomi, lahko strdek potuje navzgor v pljuča (pljučna embolija) ali možgane (možganska embolija).
Post-marketing safety surveillance studies
Študije spremljanja varnosti v obdobju trženja
The IMS prescription data have limited value because they do not include a category of “contraception in the absence of acne”.
Podatki o predpisovanju zdravila IMS so le delno uporabni, saj ne vključujejo kategorije „kontracepcija ob odsotnosti aken“.
Conclusions on safety
Zaključki glede varnosti
Cyproterone has the strongest anti-androgen activity.
Ciproteron ima najmočnejši antiandrogeni učinek.
This missing information would be essential to assess the true motives of the prescribers in choosing one product over another.
Te manjkajoče informacije bi bile ključne za ugotovitev pravih razlogov, zaradi katerih zdravniki izberejo eno zdravilo namesto drugega.
Guideline on clinical investigation of steroid contraceptives in women.
Smernice za klinične raziskave steroidnih kontracepcijskih sredstev pri ženskah.
Conclusions on efficacy
Zaključki glede učinkovitosti
Arterial thromboembolic events may be lifethreatening or may have a fatal outcome.
Arterijski trombembolični dogodki so lahko življenjsko nevarni oziroma se lahko končajo s smrtnim izidom.
INAS-SCORE was initiated after the launch of Qlaira (dienogest/estradiol valerate, step down dose regimen) in Europe (September 2009) and USA (October 2010) and is a prospective noninterventional post-approval safety study conducted in Austria, France, Germany, Italy, Poland, Sweden, UK and the US.
Študijo INAS-SCORE so začeli izvajati po začetku trženja zdravila Qlaira (dienogest/estradiol valerat, shema z zmanjševanjem odmerka) v Evropi (septembra 2009) in ZDA (oktobra 2010), gre pa za prospektivno neintervencijsko študijo varnosti po odobritvi dovoljenja za promet, ki so jo izvedli v Avstriji, Franciji, Nemčiji, Italiji, na Poljskem, Švedskem, v Združenem kraljestvu in Združenih državah.
The PRAC also agreed on the need of a risk management plan to be submitted as these medicinal products do not have an EU risk management plan in place.
PRAC se je dogovoril tudi, da je treba predložiti načrt za obvladovanje tveganja, saj za tovrstna zdravila ni na voljo načrta EU za obvladovanje tveganja.
They include benzoylperoxide, retinoids, antibiotics, salicylic acid, and azelaic acid.
Med njimi so benzoilperoksid, retinoidi, antibiotiki, salicilna kislina in azelainska kislina.
This is expected in view of the differences in anti-androgenic properties of cyproterone, drospirenone and desogestrel.
To je bilo mogoče pričakovati zaradi razlik v antiandrogenih lastnostih ciproterona, drospirenona in dezogestrela.
Acne without androgenic features
Akne brez androgenih lastnosti
Alopecia androgenetica
Androgena alopecija
Cohort studies
Kohortne študije
Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili pod določenimi pogoji
Due to the observational nature of these two studies comparing newly marketed combined oral contraceptives with a comparator group there was no restriction of the comparator group to specific oral hormonal combinations.
Zaradi opazovalne narave teh dveh študij, v katerih primerjajo kombinirana peroralna kontracepcijska sredstva, ki so bila na novo dana na trg, s primerjalno skupino, v primerjalni skupini ni bilo omejitev glede specifičnih peroralnih hormonskih kombinacij.
In both studies all enrolled women receiving a prescription for an oral contraceptive were questioned about the reason for the prescription at baseline (after having received the prescription).
V obeh študijah so vse vključene ženske, ki so prejele recept za peroralna kontracepcijska sredstva, povprašali o razlogih za predpis recepta ob izhodišču (potem ko so prejele recept).
No study collected such data and therefore this design limitation must be kept in mind when interpreting the data.
Ker v nobeni od študij niso zbrali tovrstnih podatkov, je treba te pomanjkljivosti pri zasnovi upoštevati pri razlaganju rezultatov.
Patients were between 13 and 63 years old (mean 27 years, median 25 years) at the time of the event.
Bolnice so bile v času dogodka stare od 13 do 63 let (povprečje 27 let, mediana 25 let).
In addition, there are other known alternative pharmacological treatments for severe androgenic symptoms (especially hirsutism).
Prav tako obstajajo druga alternativna farmakološka zdravljenja za resne simptome androgenizacije (zlasti hirzutizem).
The only difference in clinical outcome was a significantly improved Ferriman Gallwey (FG) score at 12 months when cyproterone acetate was compared with flutamide.
Edina razlika v kliničnem izidu je bilo znatno izboljšanje rezultata na FerrimanGallweyevi (FG) lestvici po 12 mesecih, ko so ciproteron acetat primerjali s flutamidom.
No age was reported for 91 (9.4%) patients.
O starosti niso poročali pri 91 (9,4 %) bolnicah.
The time to relief of symptoms is at least three months and the effects are more pronounced with longer treatment duration.
Za izboljšanje simptomov so potrebni najmanj trije meseci, učinki pa so večji, če zdravljenje traja dlje časa.
Furthermore PRAC agreed on other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of thromboembolic events.
PRAC se je dogovoril tudi o drugih spremembah informacij o zdravilu, dodatnih dejavnostih farmakovigilance in ukrepih za zmanjšanje tveganja, da bi zmanjšali tveganje za trombembolične dogodke.
The combined therapy with CPA/EE and CPA 10 mg has a different safety profile as reflected in the labelling of CPA 10 mg.
Kombinirano zdravljenje s CPA/EE in CPA 10 mg ima drugačen varnostni profil, kot je označeno pri CPA 10 mg.
88 (9.1%) ADR reports referred to patients less than 18 years of age, 639 (66%) patients were between 18 and 35 years of age and 150 (15.5%) reports referred to patients older than 35 years of age.
88 (9,1 %) poročil o neželenih učinkih je bilo povezanih z bolnicami, mlajšimi od 18 let, 639 (66 %) bolnic je bilo starih od 18 do 35 let, 150 (15,5 %) poročil pa je bilo povezanih z bolnicami, starejšimi od 35 let.