natgillin/translations-raw huggingface dataset:
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Dodatak III Izmjene i dopune relevantnih dijelova Sažet(a)ka opisa svojstava lijeka i Upute(a) o lijeku
Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] <invented name> is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle.
• <Zaštićeno ime>se sastoje od progesterona ciproteronacetata i estrogena etinilestradiola te se primjenjuju tijekom 21-og dana mjesečnog ciklusa.
Your doctor will also tell you when you can start using <invented name> again after you are back on your feet.
Nakon potpunog oporavka liječnik će Vam također reći kada možete ponovno početi koristiti <zaštićeno ime>.
Section 4.1 Therapeutic indications [The currently approved indications should be deleted and replaced by the following:] Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
• Liječenje umjerenih do teških oblika akni povezanih s osjetljivošću na androgene (sa ili bez seboreje) i/ili hirzutizom, u žena reproduktivne dobi.
Section 4.3 Contraindications [The following contraindications related to thromboembolism should be included in this section]
• [Sljedeće povezane kontraindikacije moraju se uvrstiti u ovaj dio]
Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - dyslipoproteinemia; - obesity (body mass index over 30 kg/m2);
Ženama starijim od 35 godina mora se strogo savjetovati da ne puše ako žele uzimati <zaštićeno ime>);
How to take < invented name > [the wording below should be inserted in the relevant sections]
• [Donji tekst mora se uvrstiti u odgovarajuće dijelove]
• if you have (or have ever had) a migraine, with visual disturbances
• ako imate problema s Vašim srcem (poremećaj zalistaka, poremećaj ritma).
What you need to know before you use < invented name > [The wording below should be inserted in the relevant sections]
Što morate znati prije nego počnete uzimati <zaštićeno ime>
When using a hormonal contraceptive like < invented name > you are strongly advised to stop smoking, especially if you are older than 35 years; if you are overweight; if you have high blood pressure; if a close relative has had a heart attack or stroke at a young age; if you have a high level of fat in your blood (cholesterol or triglycerides); if you get migraines; if you have a problem with your heart (valve disorder, disturbance of the rhythm).
Liječnik će Vam možda tada savjetovati primjenu drugog liječenja: ako koristite drugi hormonski kontraceptiv ako imate (ili ste nekada imali) krvni ugrušak u nozi (tromboza), plućima (plućna embolija) ili nekom drugom dijelu tijela ako imate (ili ste nekada imali) bolest koja može upućivati na srčani udar u budućnosti (npr. angina pektoris - stanje s jakim bolovima u prsima) ili “mini-moždani udar” (tranzitorna ishemijska ataka) ako imate (ili ste nekada imali) srčani ili moždani udar ako imate stanje koje može povećati rizik od nastanka krvnog ugruška u Vašim arterijama.
[The following to be included below the table of adverse reactions]
• [Sljedeće treba uključiti u tablicu s nuspojavama]
o diabetes affecting your blood vessels o very high blood pressure o a very high level of fat in your blood (cholesterol or triglycerides)
• ako imate visoku razinu masnoće u krvi (kolesterol ili trigliceridi);
Package Leaflet
Moguće nuspojave
When using a hormonal contraceptive like <invented name> you are strongly advised to stop smoking, especially if you are older than 35 years; if one of your close relatives has had a blood clot in the leg, lung or other organ at a young age; if you are overweight; if you must have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a plaster cast.
Ukoliko koristite hormonski kontraceptiv kao što su <zaštićeno ime>, strogo Vam je preporučeno da prestanete pušiti, posebno ako ste stariji od 35 godina;
Antithrombotic treatment should be considered if the use of <invented name> has not been discontinued in advance.
<zaštićeno ime> nije prekinuto na vrijeme.
The risk of arterial thromboembolic complications or of a cerebrovascular accident increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Rizik za nastanak arterijskih tromboembolijskih komplikacija ili cerebrovaskularnog događaja raste s:
• if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism)
• ako je Vaš bliski rođak imao krvni ugrušak u nozi, plućima ili drugom organu u mladosti;
Children and adolescents Daliresp should not be used by children and adolescents under 18 years of age.
Djeca i adolescenti Daliresp nije namijenjen djeci i adolescentima mlađim od 18 godina.
Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015
Datum posljednje obnove: 24. travnja 2015
Daliresp may need to be taken for several weeks to achieve its effect (see section 5.1).
Daliresp je ponekad potrebno uzimati više tjedana da bi se postigao učinak (vidjeti dio 5.1).
In case of an allergic reaction, stop taking Daliresp and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
U slučaju alergijske reakcije, prestanite uzimati Daliresp i odmah se obratite svom liječniku ili se odmah javite na hitni prijem najbliže bolnice.
Daliresp will not help you in this situation.
Daliresp Vam u takvim situacijama neće pomoći.
Other medicines and Daliresp
Drugi lijekovi i Daliresp
If you take more Daliresp than you should
Ako uzmete više Dalirespa nego što ste trebali
1 What Daliresp is and what it is used for
Što je Daliresp i za što se koristi
Interim Study Reports - with each PSUR
Privremena izvješća ispitivanja - sa svakim
Before starting treatment with Daliresp, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Prije početka primjene Dalirespa obavijestite liječnika ako patite od takvih simptoma, kao i o svim dodatnim lijekovima koje uzimate, jer neki mogu povećati vjerojatnost pojave takvih nuspojava.
What Daliresp is and what it is used for What you need to know before you take Daliresp How to take Daliresp
Što je Daliresp i za što se koristi Što morate znati prije nego počnete uzimati Daliresp Kako uzimati Daliresp
Warnings and precautions Talk to your doctor or pharmacist before taking Daliresp
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Daliresp.
You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daliresp may be harmful for the unborn baby.
Tijekom liječenja ovim lijekom ne smijete zatrudnjeti, te morate koristiti učinkovitu metodu kontracepcije za vrijeme liječenja, jer Daliresp može naškoditi nerođenom djetetu.
There is no relevant use of Daliresp in the paediatric population (under 18 years) in the indication COPD.
Nema relevantne primjene Dalirespa u pedijatrijskoj populaciji (do 18 godina) u indikaciji KOPB-a.
It is important to continue taking Daliresp for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Važno je da Daliresp uzimate onoliko dugo koliko je preporučio liječnik, čak i kad nemate simptome, jer se samo tako može održati kontrola plućne funkcije.
You may need to take Daliresp for several weeks to achieve its beneficial effect.
Ponekad je Daliresp potrebno uzimati nekoliko tjedana da biste osjetili povoljan učinak.
The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daliresp are provided with an updated Educational pack.
Nositelj odobrenja će osigurati da svi zdravstveni djelatnici za koje se očekuje da će propisivati Daliresp dobiju obnovljeni edukacijski paket.
Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Daliresp ne treba uvoditi ili terapiju treba prekinuti kod bolesnika s karcinomima (osim bazocelularnog karcinoma).
The need to inform patients about the risks of Daliresp and the precautions for safe use including:
Potrebu da se bolesnike upozori na rizike Dalirespa i mjere opreza za sigurnu primjenu uključujući:
Daliresp is to be used in addition to bronchodilators.
Daliresp treba koristiti kao dodatak bronhodilatatorima..
Daliresp may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Daliresp se može uzimati s drugim lijekovima koji se koriste za liječenje KOPB-a, poput inhalacijskih ili oralnih kortikosteroida ili bronhodilatatora.
Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Obratite se liječniku ako za vrijeme terapije Dalirespom primijetite nenamjerni gubitak težine (koji nije povezan s prehranom ili tjelesnom aktivnošću).
If on one day you have forgotten to take a tablet of Daliresp, just carry on the next day with the next tablet as usual.
Ako jedan dan zaboravite uzeti tabletu, sljedeći dan samo nastavite terapiju sa sljedećom tabletom u uobičajeno vrijeme.
• Copies of the patient card to be given to patients or caregivers before they receive Daliresp
• Kopije kartice za bolesnike za uručiti bolesnicima prije nego dobiju Daliresp
Daliresp has been studied in clinical trials for up to one year.
U kliničkim ispitivanjima ispitana je primjena Dalirespa u trajanju do godine dana.
The fact that Daliresp is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Činjenicu da Daliresp nije indiciran za liječenje bolesnika s KOPB-om koji ne odgovaraju odobrenoj indikaciji, niti za bolesnike s astmom ili deficijencijom alfa-1 antitripsina.
Thus Daliresp eases breathing problems.
Daliresp stoga ublažava teškoće s disanjem.
The potential risk of infections: Dalirespshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Potencijalni rizik infekcija: Dalirespne treba uvoditi ili liječenje treba prekinuti kod bolesnika s teškim akutnim infektivnim bolestima.
Hypromellose Macrogol 4000 Titanium dioxide (E171) Iron oxide yellow (E172)
Ovojnica hipromeloza makrogol 4000 titanijev dioksid (E171) željezov oksid, žuti (E172)
Daliresp is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Daliresp nije namijenjen liječenju iznenadnih napada nedostatka zraka (akutni bronhospazam).
The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
Rizik psihijatrijskih poremećaja poput nesanice, tjeskobe, depresije kod bolesnika koji uzimaju Daliresp te potencijalni rizik suicida.
If you stop taking Daliresp
Ako prestanete uzimati Daliresp
Daliresp is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Daliresp se koristi za terapiju održavanja teškog KOPB-a kod odraslih koji su u prošlosti imali često pogoršanje simptoma KOPB-a (takozvane egzacerbacije) i koji imaju kronični bronhitis.
2 What you need to know before you take Daliresp
Što morate znati prije nego počnete uzimati Daliresp
What Daliresp contains - The active substance is roflumilast.
Što Daliresp sadrži - Djelatna tvar je roflumilast.
Daliresp has no influence on the ability to drive and use machines.
Daliresp ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The effect of Daliresp may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Djelovanje Dalirespa može se smanjiti ako se uzima zajedno s rifampicinom (antibiotski lijek) ili fenobarbitalom, karbamazepinom ili fenitoinom (lijekovi koji se propisuju za liječenje epilepsije).
In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomized and treated of whom 2,374 were treated with roflumilast.
U dva jednaka potvrdna jednogodišnja ispitivanja (M2-124 i M2-125) i dva dodatna šestomjesečna ispitivanja (M2-127 i M2-128) ukupno je randomizirano 4768 bolesnika, od kojih je 2374 liječeno roflumilastom.
That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Da Daliresp može izazvati gubitak težine i bolesnici se trebaju redovito vagati i bilježiti težinu na karticu za bolesnike.
If you forget to take Daliresp
Ako ste zaboravili uzeti Daliresp
The potential cardiac risk: Daliresphas not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Potencijalni kardiološki rizik: Daliresp nije ispitan kod bolesnika s kongestivnim zatajenjem srca (NYHA stupanj 3 i 4) stoga se ne preporučuje kod takvih bolesnika.
You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Daliresp.
Proljev, mučninu, bolove u trbuhu ili glavobolju možete osjetiti tijekom prvih tjedana liječenja Dalirespom.
Driving and using machines Daliresp has no influence on the ability to drive and use machines.
Upravljanje vozilima i strojevima Daliresp ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
•Obligation to conduct post-authorisation measures
• Obveza provođenja mjera nakon davanja odobrenja
Do not take Daliresp - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Nemojte uzimati Daliresp - ako ste alergični na roflumilast ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate umjerene ili teške tegobe s jetrom.
Daliresp contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Daliresp sadrži djelatnu tvar roflumilast, a to je protuupalni lijek koji zovemo inhibitorom fosfodiesteraze-4.
Daliresp tablets contain lactose.
Daliresp tablete sadrže laktozu.
Daliresp 500 micrograms
Daliresp 500 mikrograma
Daliresp is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Daliresp je kontraindiciran kod bolesnika s umjerenim ili teškim zatajenjem jetre (Child Pugh B ili C).
Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Daliresp je indiciran za terapiju održavanja teške kronične opstruktivne plućne bolesti (KOPB) (postbronhodilatacijski FEV1 manji od 50% predviđenog) povezane s kroničnim bronhitisom kod odraslih bolesnika s učestalim egzacerbacijama u anamnezi, kao dodatak liječenju bronhodilatatorima.
All patients should be informed about the risks of Daliresp and the precautions for safe use and should be given a patient card before starting Daliresp.
Bolesnike treba obavijestiti o rizicima Dalirespa i mjerama predostrožnosti za sigurnu primjenu, te im prije početka terapije uručiti karticu za bolesnike.
The clinical data with Daliresp in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daliresp should be used with caution in these patients.
Klinički podaci o primjeni Dalirespa kod bolesnika s blagim oštećenjem jetre klasificiranim kao Child-Pugh A nisu dovoljni da bi se preporučilo smanjenje doze (vidjeti dio 5.2), stoga Daliresp kod tih bolesnika treba koristiti uz oprez.
Daliresp contains Lactose
Daliresp sadrži laktozu
Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Primjena Dalirespa kod bolesnika s kongestivnim zatajenjem srca (NYHA stupnjevi 3 i 4) nije ispitana te se liječenje takvih bolesnika ne preporučuje.
In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
U kliničkim ispitivanjima kod bolesnika s KOPB-om, približno 16% bolesnika liječenih Dalirespom imalo je nuspojave (u usporedbi s 5% na placebu).
The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Dalirespshould not be initiated or should be stopped in these patients.
Nedostatak iskustva kod bolesnika s HIV-infekcijom ili aktivnim hepatitisom, s teškim imunološkim bolestima (npr. multipla skleroza, eritemski lupus, multifokalna leukoencefalopatija) ili koji se liječe imunosupresivnom terapijom (osim kratkotrajne terapije sistemskim kortikosteroidima).Kod takvih bolesnika Dalirespne treba uvoditi ili terapiju treba prekinuti.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daliresp (see section 4.3).
Bolesnici s umjerenim i teškim oštećenjem jetre klasificiranim kao Child-Pugh B ili C ne smiju uzimati Daliresp (vidjeti dio 4.3).
Rescue medicinal products Daliresp is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Lijekovi za hitno ublažavanje simptoma Daliresp nije indiciran kao lijek za hitno ublažavanje akutnog bronhospazma.
How to store Daliresp
Kako čuvati Daliresp
Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase 4 (PDE4) inhibitory activity.
I roflumilast i roflumilast N-oksid snažno inhibiraju fosfodiesterazu 4 (PDE4).
If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended todiscontinue treatment with Daliresp.
Ako dođe do pojave novih ili pogoršanja postojećih psihijatrijskih simptoma ili ako se prepoznaju suicidalne misli ili ponašanje, preporučuje se prekinuti liječenje Dalirespom.
Analysis
Model analize
3 How to take Daliresp
Kako uzimati Daliresp
Daliresp is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Daliresp se ne preporučuje bolesnicima koji u povijesti bolesti imaju depresiju povezanu sa suicidalnim mislima ili ponašanjem.
Women of childbearing age should be advised to use an effective method of contraception during treatment.
Ženama u reproduktivnoj dobi treba savjetovati da tijekom liječenja koriste učinkovitu metodu kontracepcije. roflumilast se ne preporučuje ženama u reproduktivnoj dobi koje ne koriste kontracepciju.
What Daliresp looks like and contents of the pack Daliresp 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Daliresp 500 mikrograma filmom obložene tablete su žute filmom obložene tablete u obliku slova D, s utisnutim “D” s jedne strane.
Daliresp 500 micrograms tablets roflumilast
Daliresp 500 mikrograma tablete roflumilast
The educational pack should contain the following: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
• Sažetak opisa svojstava lijeka i uputu o lijeku za Daliresp
Daliresp 500 micrograms film-coated tablets roflumilast
Daliresp 500 mikrograma filmom obložene tablete roflumilast
Laboratorio Tau, S.A. Tel: +34 91 301 91 00
Tel: +34 91 301 91 00
(LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Daliresp se ne preporučuje ako imate jednu ili više sljedećih bolesti: - tešku imunološku bolest poput HIV-infekcije, multiple skleroze (MS), eritemskog lupusa (LE) ili progresivne multifokalne leukoencefalopatije (PML) - tešku akutnu infektivnu bolest poput tuberkuloze ili akutnog hepatitisa, - karcinom (osim bazocelularnog karcinoma, vrste sporo napredujućeg karcinoma kože) - ili teško oštećenje funkcije srca Ne postoje primjereni podaci o primjeni Dalirespa u takvim okolnostima.
Daliresp 500 micrograms film-coated tablets
Daliresp 500 mikrograma filmom obložene tablete
It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Može zatražiti ponovno ispitivanje mišljenja u roku od 15 dana nakon primitka obavijesti o ovome negativnom mišljenju.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 November 2015 EMA/765377/2015 EMEA/H/C/003858
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. studenoga 2015. EMA/861010/2015 EMEA/H/C/003858
This means that it was intended to be similar to a biological medicine (the ‘reference medicine') already authorised in the European Union (EU).
To znači da je bilo planirano da bude sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u Europskoj uniji (EU).
It was to be available as a solution for injection.
Trebao je biti dostupan kao otopina za injekciju.
Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.
U dvama dodatnim ispitivanjima u bolesnika koji boluju od dijabetesa tipa 1 i 2 uspoređena je sigurnost i učinkovitost lijekova Solumarv i Humulin S.
What is Solumarv?
Što je Solumarv?
Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively.
Dijabetes je bolest pri kojoj tijelo ne proizvodi dovoljno inzulina kako bi se kontrolirala razina šećera u krvi ili kada tijelo ne može učinkovito koristiti inzulin.
The CHMP's main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail.
Glavna zabrinutost CHMP-a bila je da tvrtka nije dovoljno detaljno definirala postupak proizvodnje Solumarva.
Solumarv was developed as a biosimilar medicine.
Solumarv je razvijen kao biosličan lijek.
The reference medicine for Solumarv in this application was Humulin S.
U ovome zahtjevu referentni lijek za Solumarv bio je Humulin S.
The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee's opinion.
Tvrtka je obavijestila CHMP da ne postoje klinička ispitivanja ili programi milosrdnog davanja na koje utječe mišljenje CHMP-a.
The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine.
Tvrtka je predstavila rezultate ispitivanja u zdravih ljudi koja su provedena kako bi se dokazalo da je Solumarv sličan svojem referentnom lijeku Humulinu S u smislu biološkog djelovanja i načina na koji tijelo podnosi lijek.
Refusal of the marketing authorisation for Solumarv (insulin human) EMA/765377/2015
Odbijanje odobrenja za stavljanje u promet lijeka Solumarv (ljudski inzulin) EMA/861010/2015
Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.
Solumarv se trebao koristiti za liječenje bolesnika s dijabetesom kojima je potreban inzulin kako bi regulirali razine šećera u krvi.
As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S's.
Nije se moglo dokazati da je Solumarv koji je korišten u kliničkim ispitivanjima bio reprezentativan za serije planirane za stavljanje na tržište te da je njegova kvaliteta bila usporediva s kvalitetom lijeka Humulin S.