natgillin/translations-raw huggingface dataset:
9/L, blood monitoring should be performed monthly until levels return to 1.0x10
9/l, je treba krvne preiskave opravljati vsak mesec, dokler niso vrednosti dveh zaporednih krvnih preiskav 1,0 x 10
If the lymphocyte count falls below 0.7x10
Če število limfocitov kadar koli pade pod 0,7 x 10
Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Ena gastrorezistentna tableta vsebuje 34,2 mg laktoze (v obliki monohidrata).
In the third week, Skilarence 30 mg is taken three times daily (1 tablet in the morning, 1 at midday, and 1 in the evening).
V tretjem tednu se zdravilo Skilarence 30 mg vzame trikrat na dan (1 tableta zjutraj, 1 opoldan in 1 zvečer).
The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths.
- dimetilfumarat ali druge fumarate: učinkovina zdravila Skilarence, dimetilfumarat, se uporablja tudi v drugih zdravilih, kot so tablete, mazila in kopeli.
Skilarence is for oral use.
Zdravilo Skilarence je namenjeno za peroralno uporabo.
Lymphopenia: If the lymphocyte count falls below 1.0x10
Limfopenija: če število limfocitov pade pod vrednost 1,0 x 10
For monitoring recommendations and clinical management of adverse reactions, see section 4.4.
Za priporočila glede spremljanja in klinične obravnave neželenih učinkov glejte poglavje 4.4.
How to store Skilarence 6.
Shranjevanje zdravila Skilarence 6.
Do not breast-feed during treatment with Skilarence.
V času zdravljenja z zdravilom Skilarence ne dojite.
What Skilarence 120 mg looks like and contents of the pack Skilarence 120 mg is a blue, round tablet with a diameter of approximately 11.6 mm.
Izgled zdravila Skilarence 120 mg in vsebina pakiranja Zdravilo Skilarence 120 mg je modra, okrogla tableta s premerom približno 11,6 mm.
Very rare side effects (may affect up to 1 in 10,000 people): - acute lymphatic leukaemia (a type of blood cancer) - decrease in all types of blood cells (pancytopenia)
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): - akutna limfatična levkemija (vrsta krvnega raka) - upadanje števila vseh vrst krvnih celic (pancitopenija)
EU/1/17/1201/002 40 tablets EU/1/17/1201/003 70 tablets EU/1/17/1201/004 90 tablets EU/1/17/1201/005 100 tablets EU/1/17/1201/006 120 tablets EU/1/17/1201/007 180 tablets EU/1/17/1201/008 200 tablets EU/1/17/1201/009 240 tablets EU/1/17/1201/012 300 tablets EU/1/17/1201/010 360 tablets EU/1/17/1201/011 400 tablets
EU/1/17/1201/003 70 tablet EU/1/17/1201/004 90 tablet EU/1/17/1201/005 100 tablet EU/1/17/1201/006 120 tablet EU/1/17/1201/007 180 tablet EU/1/17/1201/008 200 tablet EU/1/17/1201/009 240 tablet EU/1/17/1201/012 300 tablet EU/1/17/1201/010 360 tablet EU/1/17/1201/011 400 tablet
No specific studies have been performed in patients with renal impairment.
Specifičnih študij z bolniki z ledvično okvaro niso izvedli.
In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening).
V prvem tednu se zdravilo Skilarence 30 mg vzame enkrat na dan (1 tableta zvečer).
By contrast, unconjugated monomethyl fumarate is detectable in plasma.
V plazmi pa je mogoče zaznati nekonjugiran monometilfumarat.
How to take Skilarence
Kako jemati zdravilo Skilarence
In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening).
V drugem tednu se zdravilo Skilarence 30 mg vzame dvakrat na dan (1 tableta zjutraj in 1 zvečer).
Skilarence is contraindicated during pregnancy (see section 4.3).
Zdravilo Skilarence je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
9/L, lymphopenia below 1.0x10
9/l, limfopenija s številom limfocitov 1,0 x 10
Do not crush, break, dissolve or chew the tablet.
Tablet ne drobite, razpolavljajte, raztapljajte ali žvečite.
Skilarence has not been studied in patients with pre-existing gastrointestinal disease.
Zdravila Skilarence niso preučevali pri bolnikih z obstoječo boleznijo prebavil.
Concurrent therapy with nephrotoxic substances (e.g. methotrexate, ciclosporin, aminoglycosides, diuretics, NSAIDs or lithium) may increase the potential for renal adverse reactions (e.g. proteinuria) in patients taking Skilarence.
Sočasno zdravljenje z nefrotoksičnimi snovmi (npr. z metotreksatom, ciklosporinom, aminoglikozidi, diuretiki, nesteroidnimi protivnetnimi zdravili [NSAR] ali z litijem) lahko pri bolnikih, ki jemljejo zdravilo Skilarence, poveča potencial za neželene ledvične reakcije (npr. za proteinurijo).
Swallow Skilarence tablets whole with liquid.
Tablete zdravila Skilarence pogoltnite cele z nekaj tekočine.
Further improvement was seen by week 16
Dodatno izboljšanje so opazili do 16. tedna (-50,8 %).
Gastro-resistant tablet.
gastrorezistentna tableta
PASI 75 and PGA score clear or almost clear and non-inferior (using a non-inferiority margin of -15%) to the active comparator (p<0.0003) based on PASI 75.
Po 16 tednih zdravljenja so dokazali, da je zdravilo Skilarence boljše od placeba (p < 0,0001) na podlagi ocen PASI 75 in PGA »brez znakov« ali »skoraj brez znakov« in da ni slabše (uporabljena meja neinferiornosti je bila 15 %) od aktivne primerjave (p < 0,0003) na podlagi ocene PASI 75.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
- Druge sestavine zdravila so: laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, magnezijev stearat, metakrilna kislina - etil akrilat kopolimer (1 : 1), smukec, trietil citrat, titanov dioksid (E171), simetikon, indigo karmin (E132) in sodium hydroxid.
PGA score clear or almost clear, n (%) p-value b
Ocena PGA »brez znakov« ali »skoraj brez znakov«, n (%) p-vrednost b
No specific studies have been performed in patients with hepatic impairment.
Specifičnih študij z bolniki z okvaro jeter niso izvedli.
EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets
EU/1/17/1201/001 42 tablet EU/1/17/1201/013 70 tablet
Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects.
Ko boste začeli jemati zdravilo Skilarence, bo zdravnik preverjal, kako se vaše stanje izboljšuje in bo spremljal morebitne resne neželene učinke.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.
- Druge sestavine zdravila so: laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, magnezijev stearat, metakrilna kislina - etil akrilat kopolimer (1 : 1), smukec, trietil citrat, titanov dioksid (E171) in simetikon.
Dimethyl fumarate has been shown to cross the placental membrane into foetal blood in rats.
Dokazali so, da dimetilfumarat prek membrane placente podgan prehaja v kri plodu.
There were no effects on foetal body weights or malformations attributed to maternal administration of dimethyl fumarate during the embryo-foetal development study in rats.
V času študije razvoja zarodka in plodu pri podganah učinkov na telesne mase zarodkov ali malformacij, ki bi jih lahko pripisali dajanju dimetilfumarata materam, ni bilo.
What Skilarence is used for
Za kaj se uporablja zdravilo Skilarence
You may feel dizzy or tired after taking Skilarence.
Po jemanju zdravila Skilarence ste lahko omotični ali utrujeni.
Therefore, Skilarence is contraindicated during breastfeeding (see section 4.3).
Zato je zdravilo Skilarence kontraindicirano med dojenjem (glejte poglavje 4.3).
No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2).
Pri bolnikih z blago do zmerno ledvično okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
Therapy should be discontinued and caution is advised if other pathological results occur.
Če se pojavijo drugi patološki rezultati, je treba zdravljenje prekiniti, hkrati pa je priporočljivo previdno ravnanje.
Common Common Common Rare
pogosti pogosti pogosti redki
Common Common Common
Skupni dnevni odmerek
Very common
pogosti občasni
Dizziness and fatigue may occur following administration of Skilarence (see section 4.8).
Po dajanju zdravila Skilarence se lahko pojavita omotica ali utrujenost (glejte poglavje 4.8).
Skilarence 120 mg gastro-resistant tablets dimethyl fumarate
Skilarence 120 mg gastrorezistentne tablete dimetilfumarat
Name and address of the manufacturer responsible for batch release
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Industrias Farmaceuticas Almirall, S.A.
What Skilarence 120 mg contains - the active substance is dimethyl fumarate.
Kaj vsebuje zdravilo Skilarence 120 mg - Učinkovina je dimetilfumarat.
Skilarence 30 mg gastro-resistant tablets dimethyl fumarate
Skilarence 30 mg gastrorezistentne tablete dimetilfumarat
PGA score clear or almost clear, n (%) p-value a a
Ocena PGA »brez znakov« ali »skoraj brez znakov«, n (%) p-vrednost a a
Skilarence 30 mg gastro-resistant tablets Skilarence 120 mg gastro-resistant tablets
Skilarence 30 mg gastrorezistentne tablete Skilarence 120 mg gastrorezistentne tablete
What Skilarence 30 mg contains - the active substance is dimethyl fumarate.
Kaj vsebuje zdravilo Skilarence 30 mg - Učinkovina je dimetilfumarat.
Lactose monohydrate Cellulose microcrystalline Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Skilarence 30 mg in Skilarence 120 mg Jedro: laktoza monohidrat mikrokristalna celuloza premrežen natrijev karmelozat brezvoden koloidni silicijev dioksid magnezijev stearat
- constipation - gas (flatulence), stomach discomfort, indigestion - decreased appetite - headache - feeling tired - weakness - feeling hot - abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling - pink or red blotches on the skin (erythema)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - porast števila vseh belih krvničk (levkocitoza) - porast števila specifičnih belih krvničk, imenovanih eozinofilci - porast vrednosti določenih encimov v krvi (ki jih uporabljamo za preverjanje zdravja vaših jeter) - bruhanje - zaprtje - vetrovi (napenjanje), občutek neugodja v trebuhu, prebavne motnje - zmanjšan tek - glavobol - občutek utrujenosti - šibkost - občutek vročine - nenormalni občutki na koži, kot so srbenje, pekoča koža, zbadanje, žgečkanje ali ščemenje - rožnate ali rdeče lise na koži (eritem)
Hence, Skilarence is contraindicated in patients with severe renal impairment (see section 4.3).
Zato je zdravilo Skilarence kontraindicirano pri bolnikih s hudo okvaro delovanja ledvic (glejte poglavje 4.3).
Fatigue Feeling hot Asthenia
Žilne bolezni vročinsko oblivanje zelo pogosti
Skilarence has not been studied in patients with severe hepatic impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
Zdravila Skilarence niso preučili pri bolnikih s hudo okvaro jeter in uporaba zdravila Skilarence je pri teh bolnikih kontraindicirana (glejte poglavje 4.3).
One tablet contains 120 mg dimethyl fumarate.
Ena tableta vsebuje 120 mg dimetilfumarata.
Skilarence has not been studied in patients with severe hepatic impairment and is contraindicated in these patients (see section 4.3).
Zdravila Skilarence niso preučevali pri bolnikih s hudo okvaro delovanja jeter in je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
One tablet contains 30 mg dimethyl fumarate.
Ena tableta vsebuje 30 mg dimetilfumarata.
Skilarence has not been studied in patients with severe renal impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
Zdravila Skilarence niso preučili pri bolnikih s hudo okvaro ledvic, zato je uporaba zdravila Skilarence pri teh bolnikih kontraindicirana (glejte poglavje 4.3).
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Skilarence is contraindicated in patients with severe gastrointestinal disease (see sections 4.3).
Zdravilo Skilarence je kontraindicirano pri bolnikih s hudo boleznijo prebavil (glejte poglavje 4.3).
OUTER CARTON - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
ZUNANJA ŠKATLA - SKILARENCE 30 mg GASTROREZISTENTNE TABLETE
Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Ena gastrorezistentna tableta vsebuje 120 mg dimetilfumarata.
Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Ena gastrorezistentna tableta vsebuje 30 mg dimetilfumarata.
MARKETING AUTHORISATION NUMBER
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
What Skilarence is
Kaj je zdravilo Skilarence
Titanium dioxide (E171) Simethicone
Obloga: kopolimer metakrilne kisline in etilakrilata (1 : 1) smukec trietilcitrat titanov dioksid (E171) simetikon
OUTER CARTON - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
ZUNANJA ŠKATLA - SKILARENCE 120 mg GASTROREZISTENTNE TABLETE
BLISTER FOIL - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
PRETISNI OMOT S FOLIJO - SKILARENCE 120 mg GASTROREZISTENTNE TABLETE
BLISTER FOIL - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
PRETISNI OMOT S FOLIJO - SKILARENCE 30 mg GASTROREZISTENTNE TABLETE
The kidney was identified as a major target organ of toxicity in non-clinical studies.
V predkliničnih študijah so dokazali, da je ledvica glavni tarčni organ toksičnosti.
Allergic skin reaction*
Bolezni kože in podkožja eritem pekoč občutek na koži pruritus alergične reakcije na koži*
Midday
Opoldne
decrease in all white blood cells (leukopenia) - reddening of the face or body (flushing) - diarrhoea - bloating, stomach pain or stomach cramps - feeling sick (nausea)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - upadanje števila belih krvničk, imenovanih limfociti (limfopenija) - upadanje števila vseh belih krvničk (levkopenija) - rdečina obraza ali telesa (zardevanje) - driska - napihnjenost, bolečine v trebuhu ali trebušni krči - slabost
Dyspepsia
Odmerek
Common Common Uncommon Not known
pogosti pogosti občasni neznana
Common
United Kingdom
OTHER
b
Investigations
Ocena
How to store Skilarence
Shranjevanje zdravila Skilarence
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema limfopenija levkopenija eozinofilija levkocitoza akutna limfatična levkemija* nereverzibilna pancitopenija*
The committee considered that the study failed to show beneficial effects in the population studied.
Odbor je presodil, da s študijo pri proučevani populaciji niso dokazali koristnih učinkov.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Potem ko je odbor CHMP ocenil odgovore družbe na zadnji sklop vprašanj, so nekatera vprašanja še vedno ostala nerešena.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to collect additional information that the CHMP requested in relation to this application.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da potrebuje več časa za zbiranje dodatnih informacij, ki jih je odbor CHMP zahteval v povezavi s to vlogo.
The company presented results of a main study in 168 patients looking at the effects of the medicine on exacerbations (sudden worsening of symptoms) of the disease.
Družba je predstavila rezultate glavne študije pri 168 bolnikih o učinkih zdravila na izbruhe (nenadna poslabšanja simptomov) bolezni.
A lack of this enzyme can cause damage to the lungs (such as emphysema and airway obstruction) which leads to breathing problems.
Pomanjkanje tega encima lahko povzroči poškodbe pljuč (kot sta emfizem in zapora dihalnih poti), ki privedejo do težav z dihanjem.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vloga je bila umaknjena po tem, ko je odbor CHMP že ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin) EMA/440995/2017
Umik vloge za pridobitev dovoljenja za promet z zdravilom Infinia (antitripsin alfa-1) EMA/440995/2017
There were also concerns that patients taking Infinia may produce antibodies against it which could reduce its effects or make patients more prone to allergic reactions.
Obstajali so tudi pomisleki, da se pri bolnikih, ki jemljejo zdravilo Infinia, lahko pojavijo protitelesa proti zdravilu, kar bi zmanjšalo njegove učinke ali pa bi bolniki postali dovzetnejši za alergijske reakcije.
The medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the length of time patients went without having an exacerbation.
Zdravilo so primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo trajanje obdobja, v katerem bolniki niso doživeli izbruha.
How does Infinia work?
Kako zdravilo Infinia deluje?
In addition, there were concerns about the tolerability and safety profile of the medicine, since patients who were taking Infinia had to stop treatment due to side effects more often than patients taking placebo.
Poleg tega so obstajali pomisleki o prenašanju zdravila in njegovem varnostnem profilu, saj so morali bolniki, ki so jemali zdravilo Infinia, zaradi neželenih učinkov pogosteje prekiniti zdravljenje kot bolniki, ki so jemali placebo.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Infinia.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Infinia.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Infinia did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Infinia ne odtehtajo z njim povezanih tveganj.
What was Infinia expected to be used for?
Za kaj naj bi se zdravilo Infinia uporabljalo?
On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1antitrypsin.
Družba Kamada BioPharma Limited je dne 21. junija 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Infinia, namenjenim za zdravljenje odraslih s pljučno boleznijo, ki je posledica prirojenega pomanjkanja antitripsina alfa-1.
What is Infinia?
Kaj je zdravilo Infinia?
It is obtained from human blood and was intended to replace the missing protein in the lungs of patients with alpha-1-antitrypsin deficiency.
Pridobiva se iz človeške krvi in naj bi nadomestila manjkajočo beljakovino v pljučih bolnikov s pomanjkanjem antitripsina alfa-1.
Infinia is a medicine containing the active substance alpha-1-antitrypsin (also known as alpha1proteinase inhibitor).
Infinia je zdravilo, ki vsebuje zdravilno učinkovino antitripsin alfa-1 (znan tudi kot zaviralec proteinaze alfa1).
The active substance in Infinia, alpha-1-antitrypsin, is a protein in the blood which protects lung tissue from damage.
Zdravilna učinkovina v zdravilu Infinia, antitripsin alfa-1, je beljakovina v krvi, ki pljučno tkivo ščiti pred poškodbo.
Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Infinia (antitripsin alfa-1)
Other medicines containing alpha-1-antitrypsin are authorised in the EU for the same disease but are given as an infusion (drip) into a vein.
Za isto bolezen so v EU odobrena tudi druga zdravila, ki vsebujejo antitripsin alfa-1, vendar se dajejo z infundiranjem (kapalno infuzijo) v veno.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Infinia could not have been approved for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Infinia ni mogoče odobriti za zdravljenje odraslih s pljučno boleznijo, ki je posledica prirojenega pomanjkanja antitripsina alfa-1.
It was to be available as a solution to be inhaled.
Na voljo naj bi bilo v obliki raztopine za inhaliranje.
The medicine was expected to be used for treating lung disease in adults with congenital (inborn) deficiency of alpha-1-antitrypsin.
Zdravilo naj bi se uporabljalo za zdravljenje pljučne bolezni pri odraslih s kongenitalnim (prirojenim) pomanjkanjem antitripsina alfa-1.
Infinia was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for the treatment of emphysema due to congenital alpha-1-antitrypsin deficiency.
Zdravilo Infinia je bilo 16. novembra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje emfizema, ki je posledica prirojenega pomanjkanja antitripsina alfa-1.
In addition, the company will perform a study to further investigate the risk of blood clots.
Poleg tega bo družba izvedla študijo, v kateri bo dodatno raziskala tveganje za nastanek krvnih strdkov.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoely on 27 July 2011.
Evropska komisija je dovoljenje za promet z zdravilom Zoely, veljavno po vsej Evropski uniji, izdala 27. julija 2011.
What measures are being taken to ensure the safe and effective use of Zoely?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoely?
One tablet a day is taken for as long as contraception is required, starting with an active tablet on the first day of the cycle.
Vzeti je treba eno tableto na dan, dokler je potrebna kontracepcija, pri čemer je treba začeti z aktivno tableto na prvi dan ciklusa.
A lower Pearl Index represents a lower chance of getting pregnant.
Nižji Pearlov indeks pomeni manjšo možnost zanositve.
Zoely is a contraceptive pill.
Zdravilo Zoely je kontracepcijska tableta.
Other information about Zoely
Druge informacije o zdravilu Zoely
No clinical study data on Zoely are available in adolescents under 18 years old.
Podatki iz kliničnih študij zdravila Zoely pri mladostnicah, mlajših od 18 let, niso na voljo.
Zoely was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Zdravilo Zoely so proučevali v dveh glavnih študijah, v kateri je bilo vključenih 4 433 žensk v starosti od 18 do 50 let.
The full EPAR for Zoely can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoely je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Glavno merilo učinkovitosti je bilo število žensk v starosti od 18 do 35 let, ki so zanosile v času jemanja zdravila ali kmalu po njegovem prenehanju, izraženo s stopnjo nosečnosti ob uporabi „Pearlovega indeksa“.
The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Pearlov indeks je standardni način za merjenje učinkovitosti kontracepcijskih sredstev, ki meri število neželenih nosečnosti na 100 žensk na leto (kar ustreza 1 300 menstrualnim ciklom).