natgillin/translations-raw huggingface dataset:
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen follitropin delta
REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin delta
Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
En napolnjen injekcijski peresnik z večodmernim vložkom vsebuje 36 mikrogramov folitropina delta v 1,08 mililitra raztopine.
Somnolence Dizziness
OVOJNINAH VLOŽEK
• Write down the dose that is left in your pen in column B. Give the injection using the rest of the medicine that is left in your pen.
• V stolpec B si zabeležite, koliko odmerka je še ostalo v vašem injekcijskem peresniku.
The apparent clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to high exposure.
Navidezni očistek folitropina po večkratnih subkutanih odmerkih je nizek, t.j.
Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
En napolnjen injekcijski peresnik z večodmernim vložkom vsebuje 12 mikrogramov folitropina delta v 0,36 mililitra raztopine.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 12 micrograms/0.36 mL injection follitropin delta
IME ZDRAVILA IN POT(I) UPORABE REKOVELLE 12 mikrogramov/0,36 ml injekcija folitropin delta s.c.
Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
En napolnjen injekcijski peresnik z večodmernim vložkom vsebuje 72 mikrogramov folitropina delta v 2,16 mililitra raztopine .
The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the pivotal clinical trials according to MedDRA system organ class and frequency as follows: common
Neželeni učinki iz ključnih kliničnih preskušanj bolnic, zdravljenih z zdravilom REKOVELLE, so navedeni v spodnji preglednici (Preglednica 2).
After first use (in-use period): • The pen may be stored for up to 28 days at 2°C to 25°C.
• Injekcijski peresnik lahko shranjujete do 28 dni pri temperaturi od 2 °C do 25 °C.
When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
Pri zdravljenju s postopki oploditve z biomedicinsko pomočjo je verjetnost za spontani splav večja kot pri naravnem spočetju.
REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution.
REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje En večodmerni napolnjen injekcijski peresnik vsebuje 12 mikrogramov folitropina delta* v 0,36 ml raztopine.
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen follitropin delta
REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin delta
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika in predpisani odmerek.
It is available in packs of 1 cartridge and 6 pen injection needles.
Na voljo je v pakiranjih z 1 vložkom in 6 injekcijskimi iglami za peresnik.
Pack size of 1 pre-filled pen and 9 injection needles (stainless steel).
Zdravilo je na voljo v pakiranju z 1 napolnjenim injekcijskim peresnikom in 9 injekcijskimi iglami (nerjavno jeklo).
It is available in packs of 1 cartridge and 9 pen injection needles.
Na voljo je v pakiranjih z 1 vložkom in 9 injekcijskimi iglami za peresnik.
Pack size of 1 pre-filled pen and 3 injection needles (stainless steel).
Zdravilo je na voljo v pakiranju z 1 napolnjenim injekcijskim peresnikom in 3 injekcijskimi iglami (nerjavno jeklo).
Pack size of 1 pre-filled pen and 6 injection needles (stainless steel).
Zdravilo je na voljo v pakiranju z 1 napolnjenim injekcijsim peresnikom in 6 injekcijskimi iglami (nerjavno jeklo).
The instructions for using the pre-filled pen must be followed carefully.
Skrbno upoštevajte navodila za uporabo napolnjenega injekcijskega peresnika.
It is available in packs of 1 cartridge and 3 pen injection needles.
Na voljo je v pakiranjih z 1 vložkom in 3 injekcijskimi iglami za peresnik.
It is available in packs of 1 pre-filled pen and 9 pen injection needles.
Na voljo je v pakiranjih z 1 napolnjenim injekcijskim peresnikom in 9 injekcijskimi iglami za peresnik.
It is available in packs of 1 pre-filled pen and 6 pen injection needles.
Na voljo je v pakiranjih z 1 napolnjenim injekcijskim peresnikom in 6 injekcijskimi iglami za peresnik.
Step 2: • Pull off the pen cap.
4. korak: • Iglo pritisnite na injekcijski peresnik.
• leak-resistant, and
• omotica,
NAME OF THE MEDICINAL PRODUCT REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Navodilo za uporabo REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje folitropin delta
It is available in packs of 1 pre-filled pen and 3 pen injection needles.
Na voljo je v pakiranjih z 1 napolnjenim injekcijskim peresnikom in 3 injekcijskimi iglami za peresnik.
A.
V
NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Navodilo za uporabo REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje folitropin delta
NAME OF THE MEDICINAL PRODUCT REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Navodilo za uporabo REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje folitropin delta
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/002
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/005
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/006
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/006
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/004
Needles
Igle
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/001
Constipation Abdominal discomfort
Psihiatrične motnje nihanja razpoloženja
Nervous system disorders
Bolezni živčevja glavobol somnolenca omotica
• Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).
• Odvijte iglo v nasprotni smeri urinega kazalca, da jo odstranite iz injekcijskega peresnika
Step 4:
3. korak:
What REKOVELLE looks like and contents of the pack
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo REKOVELLE
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/003
REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at or below 25 °C for up to 3 months including the period after first use.
Zdravilo REKOVELLE se lahko vzame iz hladilnika in se shranjuje zunaj njega pri temperaturi do
Within the therapeutic dose range, exposure to follitropin delta increases proportionally with the dose.
Navidezni volumen porazdelitve znaša približno 25 l po subkutani uporabi, volumen porazdelitve v stanju dinamičnega ravnovesja po intravenski uporabi pa znaša 9 l. V razponu terapevtskih odmerkov se izpostavljenost folitropinu delta povečuje sorazmerno z odmerkom.
Write down your prescribed dose in column A.
V stolpec A si zabeležite svoj predpisani odmerek.
The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year.
Glavno merilo učinkovitosti v vseh študijah je bilo število recidivov, ki so se pri bolnikih pojavili vsako leto.
Further information on Gilenya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Gilenya.
Nadaljnje informacije o zdravilu Gilenya so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Gilenya.
Gilenya is available as capsules (0.25 mg and 0.5 mg).
Zdravilo Gilenya je na voljo v obliki kapsul (0,25 mg in 0,5 mg).
In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose.
Poleg tega je sklenila, da je treba pri vseh bolnikih po prvem odmerku natančno spremljati srčni utrip.
The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight.
Priporočeni odmerek za odrasle je ena 0,5-miligramska kapsula, ki se jemlje peroralno enkrat na dan, priporočeni odmerek za otroke pa je odvisen od njihove telesne mase.
Gilenya received a marketing authorisation valid throughout the EU on 17 March 2011.
Za zdravilo Gilenya je bilo 17. marca 2011 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Gilenya?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gilenya?
Details on the recommendations for monitoring patients are found in the summary of product characteristics.
Podrobna priporočila o spremljanju bolnikov so na voljo v povzetku glavnih značilnosti zdravila.
An overview of Gilenya and why it is authorised in the EU
Pregled zdravila Gilenya in zakaj je odobreno v EU
It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended.
Zagotoviti mora tudi, da bodo vsi zdravniki, ki predpisujejo zdravilo Gilenya, prejeli informativno gradivo, ki bo vsebovalo pomembne varnostne informacije, vključno s kontrolnim seznamom tveganj, povezanih z zdravilom Gilenya, in primeri, pri katerih njegova uporaba ni priporočena.
Other information about Gilenya
Druge informacije o zdravilu Gilenya
‘Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
„Recidivnoremitentna“ pomeni, da ima bolnik poslabšanja (recidive), ki jim sledijo obdobja izboljšanja (remisij).
As for all medicines, data on the use of Gilenya are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Gilenya stalno spremljajo.
Why is Gilenya authorised in the EU?
Zakaj je zdravilo Gilenya odobreno v EU?
Gilenya contains the active substance fingolimod.
Zdravilo Gilenya vsebuje učinkovino fingolimod.
Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Gilenya, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1phosphate receptor, which is involved in controlling the movement of these cells in the body.
Deluje tako, da zavira delovanje receptorja (tarče) na celicah T, imenovanega receptor za sfingozin-1-fosfat, ki sodeluje pri uravnavanju premikanja teh celic po telesu.
Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems.
Zdravila Gilenya ne smejo uporabljati bolniki, pri katerih obstaja nevarnost okužb zaradi oslabljenega imunskega sistema, bolniki s hudimi okužbami ali dolgotrajnimi aktivnimi okužbami, kot je hepatitis, in bolniki z rakom ali hudimi težavami z jetri.
The Agency decided that Gilenya's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je sklenila, da so koristi zdravila Gilenya večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Gilenya is a type of medicine known as a ‘disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Gilenya je vrsta zdravila, znana kot „zdravilo za spreminjanje poteka bolezni“, ki se uporablja za zdravljenje odraslih in otrok, starejših od 10 let, z zelo aktivno recidivno-remitentno multiplo sklerozo (MS), tj. boleznijo živcev, pri kateri vnetje uniči zaščitno ovojnico, ki obdaja živčne celice.
The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis in both adults and children and noted that it had the benefit of being taken by mouth while most other medicines for this disease are given by injection.
Evropska agencija za zdravila je zaključila, da obstajajo jasni dokazi o koristih zdravila Gilenya pri recidivno-remitentni multipli sklerozi pri odraslih in tudi otrocih, in ugotovila, da je koristno, če se jemlje peroralno, saj se večina drugih zdravil za to bolezen daje z injiciranjem.
For more information about using Gilenya, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Gilenya glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Gilenya have been shown in studies?
Kakšne koristi je zdravilo Gilenya izkazalo v študijah?
The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information.
Gradivo bo prav tako vključevalo informacije o registru za zbiranje podatkov o dojenčkih, ki so se rodili ženskam, zdravljenim z zdravilom Gilenya, ter opozorilno kartico za bolnike s ključnimi informacijami o varnosti zdravila.
In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord.
Pri multipli sklerozi imunski sistem (obrambni mehanizem telesa) nepravilno napade zaščitno ovojnico, ki obdaja živce v možganih in hrbtenjači.
What are the risks associated with Gilenya?
Kakšna tveganja so povezana z zdravilom Gilenya?
Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain.
Prav tako se ne sme uporabljati pri bolnikih z določenimi boleznimi, ki vplivajo na srce in krvne žile, ali pri tistih, pri katerih so se v preteklosti pojavile tovrstne bolezni ali težave pri oskrbi možganov s krvjo.
What is Gilenya and what is it used for?
Kaj je zdravilo Gilenya in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Gilenya upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis.
V treh glavnih študijah pri odraslih in eni glavni študiji pri otrocih so ugotovili, da je bilo zdravilo Gilenya učinkovitejše od placeba (zdravila brez učinkovine) in interferona beta-1a (drugega zdravila za zdravljenje multiple skleroze) pri bolnikih z recidivno-remitentno multiplo sklerozo.
The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation.
Družba, ki trži zdravilo Gilenya, bo izvedla študijo za oceno tveganja neželenih učinkov na srce in krvni obtok.
Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis.
Predpisovanje in izdaja zdravila Gilenya je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.
Zdravilo Gilenya se uporablja, kadar bolezen ostane aktivna kljub ustreznem zdravljenju z vsaj enim drugim zdravilom za spreminjanje poteka bolezni oziroma je zelo huda in se hitro poslabšuje.
The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems).
Najpogostejši neželeni učinki zdravila Gilenya (ki se lahko pojavijo pri več kot 1 bolniku od 10) so gripa, sinuzitis (vnetje sinusov), glavobol, kašelj, driska, bolečine v hrbtu in povišana raven jetrnih encimov (znak težav z jetri).
Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a.
Recidivi so se pojavili pri 14 % (15 od 107) bolnikov, ki so prejemali zdravilo Gilenya, v primerjavi s 54 % (58 od 107) bolnikov, ki so prejemali interferon beta-1a.
The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment.
Najresnejši neželeni učinki so okužbe, makularni edem (otekanje osrednjega dela mrežnice v zadnjem delu očesa) in preddvorno-prekatna blokada (vrsta motnje srčnega ritma) ob začetku zdravljenja.
Women should not become pregnant while taking Gilenya and for two months after treatment has stopped.
Ženske se morajo med zdravljenjem z zdravilom Gilenya in dva meseca po zdravljenju izogibati zanositvi.
However, because of possible side effects, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly.
Vendar je zaradi možnih neželenih učinkov zdravila Gilenya sklenila, da se lahko uporablja samo pri bolnikih, ki zdravilo resnično potrebujejo, ker se niso odzvali na vsaj eno drugo zdravljenje z zdravilom za spreminjanje poteka bolezni ali je njihova bolezen huda in se hitro poslabšuje.
The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis.
Učinkovina v zdravilu Gilenya, fingolimod, zmanjšuje sposobnost premikanja celic T (vrste belih krvnih celic, ki so del imunskega sistema) iz bezgavk do možganov in hrbtenjače ter tako omejuje škodo, ki jo te celice povzročijo pri multipli sklerozi.
Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption.
Ker zdravilo Gilenya upočasnjuje srčni utrip ter lahko vpliva na električno dejavnost in ritem srca, je pred in med zdravljenjem treba pri bolniku preveriti krvni tlak in delovanje srca.
The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya.
Na seznamu bodo navedene tudi informacije o testiranju in spremljanju bolnikov, ki ju je treba izvajati pred in začetkom zdravljenja z zdravilom Gilenya in po njem ter po ponovni uvedbi zdravljenja z njim.
In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years.
V dveh študijah, v kateri je bilo vključenih 2 355 bolnikov, so v dveletnem obdobju zdravilo Gilenya primerjali s placebom.
How is Gilenya used?
Kako se zdravilo Gilenya uporablja?
How does Gilenya work?
Kako zdravilo Gilenya deluje?
For the full list of side effects of Gilenya, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Gilenya, glejte navodilo za uporabo.
In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year.
V tretji študiji, ki je vključevala 1 292 bolnikov, so v enoletnem obdobju zdravilo Gilenya primerjali z interferonom beta-1a.
In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years.
V študiji, ki je vključevala 215 otrok, so zdravilo Gilenya do dve leti primerjali z interferonom beta-1a.
Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.
Pri bolnikih, ki so prejemali zdravilo Gilenya, je bilo v primerjavi s tistimi, ki so prejemali interferon beta-1a, približno polovico manj recidivov.
Patients treated with Gilenya had around half the number of relapses compared with patients given placebo.
V primerjavi z bolniki, ki so prejemali placebo, je bilo pri tistih, ki so prejemali zdravilo Gilenya, približno polovico manj recidivov.
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Končna stopnja postopka pregleda je pravno zavezujoč sklep, ki ga sprejme Evropska komisija in je veljaven v vseh državah članicah EU.
9 February 2018 EMA/152535/2018 - Corr. 1
9. februar 2018 EMA/76828/2018
Healthcare professionals prescribing Esmya in the EU will receive a letter with further details.
Zdravstveni delavci, ki predpisujejo zdravilo Esmya v EU, bodo prejeli dopis z dodatnimi podrobnostmi.
If the tests indicate that you have a liver problem, your treatment will be stopped.
Če preiskave pokažejo, da imate težave z jetri, bo zdravljenje prekinjeno.
• As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well.
• Kot previdnostni ukrep pri jemanju zdravila Esmya boste morali opraviti krvne preiskave, s katerimi bodo preverili, ali vaša jetra dobro delujejo.
• Advise your patients about the signs and symptoms of liver injury.
• Bolnice opozorite o znakih in simptomih okvare jeter.
• If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems.
• Če se pri vas pojavi siljenje na bruhanje (navzeja), bruhanje, bolečine v zgornjem predelu trebuha, pomanjkanje teka, utrujenost ali porumenelost oči ali kože, se nemudoma posvetujte z zdravnikom, ker so to lahko znaki težav z jetri.
The PRAC's final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion.
Končna priporočila tega odbora bodo poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki bo sprejel končno mnenje.
These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017.
Ta priporočila so začasni ukrep za zaščito zdravja bolnic do zaključka pregleda zdravila Esmya, ki se je začel 30. novembra 2017.
Information for patients
Informacije za bolnice
It is used for up to 3 months before women undergo surgery to remove the fibroids and can also be used long-term but with treatment breaks in other women.
Pri nekaterih ženskah se uporablja do tri mesece pred kirurškim posegom za odstranitev leiomiomov, pri drugih pa za dolgoročno zdravljenje s prekinitvami.
• If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA's review of the medicine is complete.
• Če je bilo predvideno, da boste začeli zdravljenje z zdravilom Esmya ali da boste začeli nov cikel zdravljenja s tem zdravilom, bo vaš zdravnik njegov začetek odložil, dokler postopek pregleda zdravila pri agenciji ne bo zaključen.