natgillin/translations-raw huggingface dataset:
Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Score; izhodiščna vrednost ≥ 13) je v dveh s placebom nadzorovanih kliničnih študijah Faze III v Združenih državah Amerike in v eni s placebom in z zdravilno učinkovino nadzorovani klinični študiji, izpeljani v Evropi, prejemalo 8 mg silodozin enkrat na dan.
For this purpose Urorec 4 mg hard capsules are available.
ta namen je na voljo zdravilo Urorec 4 mg trde kapsule.
Urorec 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Urorec 8 mg trde kapsule Ena trda kapsula vsebuje 8 mg silodozina.
Ask your doctor whether or not you should postpone or temporarily stop taking Urorec when undergoing cataract surgery.
Če se pripravljate na operacijo sive mrene, vprašajte svojega zdravnika, če lahko odložite začetek jemanja ali začasno prenehate z jemanjem zdravila Urorec.
Europe
Österreich
Urorec 8 mg hard capsules
Urorec 8 mg trde kapsule
Urorec 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Urorec 4 mg trde kapsule Ena trda kapsula vsebuje 4 mg silodozina.
Urorec 4 mg hard capsules
Urorec 4 mg trde kapsule
Dizziness
Izločanje
Urorec 8 mg hard capsules Urorec 4 mg hard capsules
Urorec 4 mg trde kapsule Urorec 8 mg trde kapsule
Reproductive system and breast disorders
Motnje reprodukcije in dojk motnje ejakulacije,
No. of patients
Študija Skupina Število bolnikov
NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules silodosin
Urorec 4 mg trde kapsule silodozin
NAME OF THE MEDICINAL PRODUCT Urorec 8 mg hard capsules silodosin
Urorec 8 mg trde kapsule silodozin
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
How to store Urorec
Shranjevanje zdravila Urorec
When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, an increase in silodosin AUC of approximately 30% was observed, but Cmax and half-life were not affected.
Ob sočasni uporabi silodozina in zmernih zaviralcev CYP3A4 kot je diltiazem so opazili približno
What Urorec looks like and contents of the pack Urorec 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Zdravilo Urorec 8 mg so bele, neprozorne, trde želatinske kapsule.
Talk to your doctor or pharmacist before taking Urorec
Pred začetkom jemanja zdravila Urorec se posvetujte z zdravnikom ali farmacevtom.
Urticaria1 Drug eruption1
medikament ni izpušèaj1
These issues were considered to be of serious public health concern.
Ocenjeno je bilo, da ta vprašanja predstavljajo resne pomisleke glede javnega zdravja.
The Reference Member State was United Kingdom and the Concerned Member States were Austria, Germany, Finland, Ireland, Italy, Luxembourg, Netherlands and Sweden.
Referenčna država članica je bilo Združeno kraljestvo, zadevne države članice pa Avstrija, Nemčija, Finska, Irska, Italija, Luksemburg, Nizozemska in Švedska.
The final opinion was converted into a Decision by the European Commission on 22 July 2008.
Končno mnenje je bilo spremenjeno v sklep Evropske komisije dne 22. julija 2008.
The arbitration procedure started on 20 September 2007 with the adoption of a List of Questions.
Postopek arbitraže se je pričel 20. septembra 2007 s sprejemom seznama vprašanj.
The Applicant provided written explanations on 30 November 2007 and on 3 March 2008.
Predlagatelj je dne 30. novembra 2007 in 3. marca 2008 poslal pisna pojasnila.
The Decentralised Procedure UK/H/0892/01/DC started on 12 April 2006.
Decentralizirani postopek UK/H/0892/01/DC se je pričel 12. aprila 2006.
The Rapporteur was Dr Tomas Salmonson (SE) and Co-Rapporteur was Dr Ian Hudson (UK).
Poročevalec je bil dr. Tomas Salmonson (Švedska), soporočevalec pa dr. Ian Hudson (Združeno kraljestvo).
The conditions of the Marketing Authorisation are provided in Annex IV.
Pogoji dovoljenja za promet so navedeni v Dodatku IV.
London, 23 July 2008 EMEA/CHMP/428671/2008
London, 23. julij 2008 EMEA/427601/2008
Significant difference had been identified with regard to the lack of sufficient safety and efficacy evidence, the emergence of bacterial resistance caused by the use of Oracea and the insufficient demonstration of a positive benefit: risk ratio.
Ugotovljene so bile pomembne razlike glede pomanjkanja zadostnih dokazov o varnosti in učinkovitosti, razvoja bakterijske odpornosti, ki je posledica uporabe zdravila Oracea, in glede nezadostno dokazanega pozitivnega razmerja med koristmi in tveganji.
The list of the medicinal product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Oracea International Non-Proprietary Name (INN): doxycycline monohydrate
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA ZDRAVILO Oracea Mednarodno nelastniško ime (INN): doksiciklin monohidrat
These Member States were not able to reach an agreement and therefore the United Kingdom referred the reasons for disagreement to the CHMP on 27 July 2007.
Omenjene države niso mogle doseči soglasja, zato je Združeno kraljestvo dne 27. julija 2007 Odboru za zdravila za uporabo v humani medicini (CHMP) posredovalo razloge za nesoglasje.
Oracea, 40 mg, modified release capsules is an antibiotic (doxycycline), indicated for the reduction of papulopustular lesions in adult patients with facial rosacea.
Zdravilo Oracea, 40 mg, kapsule s prirejenim sproščanjem, je antibiotik (doksiciklin), indiciran za zmanjševanje papulopustularnih lezij pri odraslih bolnikih z obrazno rozaceo.
During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem aprila 2008 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, menil, da ugovori, zaradi katerih je bil sprožen postopek napotitve v skladu s členom 29, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom Oracea, ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
The applicant FGK Representative Service GmbH submitted an application for Marketing Authorisation Application of Oracea, 40 mg, modified release capsule on the basis of the marketing application to the UK on 28 February 2006.
Predlagatelj, FGK Representative Service GmbH, je dne 28. februarja 2006 predložil vlogo za dovoljenje za promet z zdravilom Oracea, 40 mg, kapsule s prirejenim sproščanjem, na podlagi vloge za dovoljenje za promet, predložene v Združenem kraljestvu.
A positive opinion was therefore adopted by consensus on 24 April 2008 and the grounds for opinion, the conditions of the Marketing Authorisation and the amended SPC, labelling and package leaflet of the relevant Member State were annexed.
Tako je bilo 24. aprila 2008 s soglasjem sprejeto pozitivno mnenje, ki so mu bili priloženi utemeljitev mnenja, pogoji dovoljenja za promet z zdravilom ter dopolnjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice.
The full EPAR for Perjeta 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 Perjeta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Perjeta is used in the following situations:
Zdravilo Perjeta se uporablja v naslednjih primerih:
Perjeta received a marketing authorisation valid throughout the European Union on 4 March 2013.
Za zdravilo Perjeta je bilo 4. marca 2013 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Perjeta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Perjeta?
The recommended first dose is 840 mg given over one hour.
Priporočeni prvi odmerek je 840 mg, ki se infundira eno uro.
An overview of Perjeta and why it is authorised in the EU
Pregled zdravila Perjeta in zakaj je odobreno v EU
What is Perjeta and what is it used for?
Kaj je zdravilo Perjeta in za kaj se uporablja?
As for all medicines, data on the use of Perjeta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Perjeta stalno spremljajo.
What benefits of Perjeta have been shown in studies?
Kakšne koristi zdravila Perjeta so se pokazale v študijah?
The Agency considered that, despite the side effects of Perjeta, the overall safety profile was acceptable.
Agencija je zaključila, da je kljub neželenim učinkom splošen varnostni zdravila Perjeta profil sprejemljiv.
Why is Perjeta authorised in the EU?
Zakaj je bilo zdravilo Perjeta odobreno v EU?
Other information about Perjeta
Druge informacije o zdravilu Perjeta
What are the risks associated with Perjeta?
Kakšna tveganja so povezana z zdravilom Perjeta?
Side effects reported with Perjeta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Perjeta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Perjeta, see the package leaflet or contact a doctor or pharmacist.
Za več informacij glede uporabe zdravila Perjeta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Perjeta have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Perjeta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
Bolniki, ki so prejemali zdravilo Perjeta, so brez poslabšanja bolezni živeli 18,5 meseca, bolniki, ki so prejemali placebo, pa 12,4 meseca.
Perjeta was shown to be of benefit in patients whose cancer was at a high risk of coming back: after 4 years, the disease had not spread in 90% of patients with ‘node-positive' cancer treated with Perjeta compared with 87% of those receiving placebo; for those with ‘hormone-receptor negative' cancer, this figure was 91% of patients treated with Perjeta, and 89% of patients given placebo.
Zdravilo Perjeta se je izkazalo kot koristno pri bolnicah, pri katerih je bilo tveganje za ponovitev veliko: po štirih letih se bolezen še ni razširila pri 90 % bolnic z rakom s „pozitivnimi bezgavkami“, zdravljenih z zdravilom Perjeta, in pri 87 % bolnic, ki so prejemale placebo; pri raku z „negativnimi hormonskimi receptorji“ je bil ta delež 91 % bolnic, zdravljenih z zdravilom Perjeta, in 89 % bolnic, ki so prejemale placebo.
The most common side effects (affecting more than 3 in 10 people) with Perjeta when given with trastuzumab and chemotherapy are neutropenia (low levels of neutrophils, a type of white blood cell important for fighting infections), diarrhoea, nausea (feeling sick), vomiting, hair loss and tiredness.
Najpogostejši neželeni učinki (ki so se pojavili pri več kot 3 od 10 bolnikov) zdravila Perjeta v kombinaciji s trastuzumabom in kemoterapijo so nevtropenija (nizko število nevtrofilcev, vrste belih krvnih celic, pomembnih za boj proti okužbam), driska, navzeja (siljenje na bruhanje), bruhanje, izguba las ter utrujenost.
The studies looked at how many patients responded to treatment (i.e. patients who had no cancer cells in the breast after surgery).
Opazovali so, koliko bolnikov se je odzvalo na zdravljenje (tj. pri koliko bolnikih po kirurškem posegu v dojkah ni bilo rakavih celic).
This is followed by a dose of 420 mg every three weeks, with each dose given over half an hour to one hour.
Temu sledi 420-miligramski odmerek vsake tri tedne s 30-minutno do enourno infuzijo.
It also activates cells of the immune system (the body's natural defences), which then kill the cancer cells.
Poleg tega aktivira celice imunskega sistema (naravnega obrambnega mehanizma telesa), da te sčasoma uničijo rakave celice.
The most common severe side effect (affecting more than 1 in 10 people) is neutropenia, with or without fever.
Najpogostejši hudi neželeni učinek (ki se je pojavil pri več kot 1 od 10 bolnikov) je nevtropenija s povišano telesno temperaturo ali brez nje.
• treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery.
• za zdravljenje metastatskega raka dojke (raka, ki se je razširil na druge dele telesa) pri bolnikih, ki se še niso zdravili s kemoterapijo ali zdravili, zasnovanimi za delovanje na HER2, ali za zdravljenje raka dojke, ki se je po zdravljenju ponovil lokalno in ga ni mogoče odstraniti s kirurškim posegom.
HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
HER2-pozitivni rak dojke je agresivna oblika raka dojke, ki jo ima približno eden od petih bolnikov z rakom dojke.
Perjeta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who is experienced in using cancer medicines and in a hospital setting where resuscitation equipment is available.
Predpisovanje in izdaja zdravila Perjeta je le na recept, zdravljenje z njim pa se lahko uvede samo pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka, in samo v bolnišnicah, v katerih je na voljo oprema za oživljanje.
The main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
Glavno merilo učinkovitosti je bil čas preživetja bolnikov brez napredovanja bolezni (čas preživetja, med katerim se bolezen ni poslabšala).
Perjeta has also been studied in two main studies involving a total of 642 patients with earlier stages of breast cancer who were to undergo surgery.
Zdravilo Perjeta so proučili tudi v dveh glavnih študijah, ki sta vključevali skupno 642 bolnikov z zgodnjim stadijem raka dojke, pri katerih naj bi bil opravljen kirurški poseg.
A fourth ongoing study compared Perjeta with placebo (both given with trastuzumab and chemotherapy) in 4,805 women with early breast cancer who had had surgery to remove the cancer.
V četrti študiji, ki še poteka, so zdravilo Perjeta primerjali s placebom (oboje v kombinaciji s trastuzumabom in kemoterapijo) pri 4 805 ženskah z zgodnjim rakom dojke, pri katerih je bil rak odstranjen s kirurškim posegom.
Perjeta has been studied in one main study involving 808 adults with previously untreated HER2positive metastatic breast cancer.
Zdravilo Perjeta so raziskali v eni glavni študiji, v katero je bilo vključenih 808 odraslih s predhodno nezdravljenim metastatskim HER2-pozitivnim rakom dojke.
In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
V navedenih primerih se zdravilo Perjeta uporablja skupaj s trastuzumabom in docetakselom (drugima zdraviloma za zdravljenje raka),
The European Medicines Agency considered that Perjeta has been shown to benefit patients with metastatic cancer by extending the amount of time patients lived without their disease getting worse as well as how long they lived.
Evropska agencija za zdravila je ocenila, da je zdravilo Perjeta izkazalo koristi pri podaljšanju časa, ki so ga bolniki z metastatskim rakom dojke preživeli brez poslabšanja bolezni, in pri podaljšanju življenja teh bolnikov nasploh.
For the full list of all side effects and restrictions with Perjeta, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Perjeta glejte navodilo za uporabo.
Perjeta is given by infusion (drip) into a vein.
Zdravilo Perjeta se daje z infundiranjem (kapalno infuzijo) v veno.
Perjeta is a cancer medicine for treating adults with ‘HER2-positive' breast cancer (where a protein called HER2 is found on the cancer cells).
Perjeta je zdravilo proti raku za zdravljenje odraslih s HER2-pozitivnim rakom dojke (pri katerem je na rakavih celicah prisotna beljakovina HER2).
Patients were treated until their disease got worse or the side effects of treatment became unmanageable.
Zdravljenje bolnikov je trajalo do poslabšanja bolezni ali pojava neobvladljivih neželenih učinkov.
In the first study, 46% of the patients treated with Perjeta plus trastuzumab and docetaxel responded to treatment, compared with 29% of patients who received trastuzumab and docetaxel alone.
V prvi študiji se je na zdravljenje odzvalo 46 % bolnikov, ki so jih zdravili z zdravilom Perjeta in trastuzumabom ter docetakselom, in 29 % bolnikov, ki so prejemali samo trastuzumab in docetaksel.
How is Perjeta used?
Kako se zdravilo Perjeta uporablja?
• treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery.
• zdravljenje zgodnjega raka dojke z velikim tveganjem za ponovitev, v kombinaciji s trastuzumabom in kemoterapijo, potem ko je bil bolnik operiran.
The active substance in Perjeta, pertuzumab, is a monoclonal antibody, a type of protein that has been designed to attach to HER2, a protein found on HER2-positive cancer cells.
Učinkovina v zdravilu Perjeta, pertuzumab, je monoklonsko protitelo, vrsta beljakovine, ki je bila zasnovana tako, da se pritrdi na beljakovino HER2, ki je prisotna na površini HER2-pozitivnih rakavih celic.
It considered that this would provide an additional benefit when added to other medicines for HER2-positive cancer, notably trastuzumab.
Zato je presodila, da lahko zdravilo dodatno koristi bolnikom, ki ga uporabljajo z drugimi zdravili za zdravljenje HER2-pozitivnega raka dojke, še zlasti trastuzumabom.
Response to treatment in the second study ranged from 57% to 66% where Perjeta was given with trastuzumab and chemotherapy medicines.
Odziv na zdravljenje v drugi študiji, kjer so zdravilo dajali v kombinaciji s trastuzumabom in različnimi zdravili za kemoterapijo, je znašal od 57 do 66 %.
In these studies, Perjeta was given with trastuzumab or chemotherapy or both.
V teh študijah so zdravilo Perjeta dajali skupaj s trastuzumabom in/ali kemoterapijo.
• treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
• zdravljenje lokalno napredovalega, vnetnega raka dojke ali zgodnjega stadija raka dojke z velikim tveganjem za ponovitev, v kombinaciji s trastuzumabom in kemoterapijo, preden je bolnik operiran,
Treatment with Perjeta should be interrupted or stopped permanently if the patient gets certain side effects.
Če se pri bolniku pojavijo nekateri neželeni učinki, je treba zdravljenje z zdravilom Perjeta prekiniti ali trajno ukiniti.
How does Perjeta work?
Kako zdravilo Perjeta deluje?
The company that markets Perjeta will carry out a study to assess the effects of using Perjeta and trastuzumab together with a type of cancer medicines called taxanes, in previously untreated patients with HER2-positive metastatic or locally advanced breast cancer.
Podjetje, ki trži zdravilo Perjeta, bo pri predhodno nezdravljenih bolnikih s HER2-pozitivnim metastatskim rakom dojke ali lokalno napredovalim rakom dojke izvedlo študijo za oceno učinkovitosti zdravljenja s kombinacijo zdravila Perjeta in trastuzumaba skupaj z vrsto zdravil za zdravljenje raka, imenovano taksani.
The effects of Perjeta were compared with placebo (a dummy treatment) when given together with other cancer medicines (trastuzumab and docetaxel).
Učinke zdravila Perjeta v kombinaciji z drugimi zdravili za zdravljenje raka (trastuzumabom in docetakselom) so primerjali s placebom (zdravilom brez učinkovine).
Perjeta contains the active substance pertuzumab.
Zdravilo Perjeta vsebuje učinkovino pertuzumab.
pertuzumab stops HER2 producing signals that cause the cancer cells to grow.
S tem prepreči, da bi beljakovina tvorila signale, ki spodbujajo rast rakavih celic.
Perjeta has also been shown to improve the outcome of patients with earlier stages of breast cancer, when used with trastuzumab and chemotherapy.
Poleg tega je zdravilo Perjeta v kombinaciji s trastuzumabom in kemoterapijo izboljšalo zdravstveno stanje bolnikov z zgodnjim stadijem raka dojke.
Blister (PVC/aluminium) 70x1 tablets
70x1 tableta
EU number administration
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Side effects are mostly mild or moderate.
Neželeni učinki so večinoma blagi ali zmerni.
Because the medicine's effects may take time to show, patients should be monitored for several weeks after starting treatment or changing the dose.
Ker se učinki zdravila lahko pokažejo šele po določenem času, je treba bolnike spremljati več tednov po uvedbi zdravljenja ali spremembi odmerka.
Most of the side effects are as expected with antipsychotic medicines and many can be treated.
Večina neželenih učinkov je takšnih, kot se pričakujejo pri antipsihotičnih zdravilih, in številni med njimi se lahko zdravijo.
The full EPAR for Reagila 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 Reagila je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Reagila?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Reagila?
This is a summary of the European public assessment report (EPAR) for Reagila.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Reagila.
Other information about Reagila
Druge informacije o zdravilu Reagila
Reagila is an antipsychotic medicine used to treat schizophrenia in adults.
Reagila je antipsihotično zdravilo, ki se uporablja za zdravljenje shizofrenije pri odraslih.
The PANSS score, which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms), was around 96 at the start of treatment.
Rezultat po lestvici PANSS, ki ima vrednosti v razponu od 30 (brez simptomov) do 210 (najhujši simptomi), je bil na začetku zdravljenja okrog 96.
Reagila is available as capsules (1.5, 3, 4.5 and 6 mg) to be taken by mouth.
Zdravilo Reagila je na voljo v obliki kapsul (1,5, 3, 4,5 in 6 mg), ki se jemljejo peroralno.
Therefore, the European Medicines Agency decided that Reagila's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Reagila večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Reagila must not be taken at the same time as certain other medicines called strong or moderate CYP3A4 inhibitors or inducers.
Zdravilo Reagila se ne sme jemati hkrati z določenimi drugimi zdravili, imenovanimi močni ali zmerni zaviralci ali induktorji CYP3A4.