FrancophonIA/ELRC3.0 huggingface dataset:
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Croatian: • neuropatskom boli (bol uslijed živčanog oštećenja), uključujući perifernu neuropatsku bol, poput boli koju osjećaju bolesnici oboljeli od dijabetesa ili herpes zostera (pasca), i središnju neuropatsku bol, poput boli koju osjećaju bolesnici koji imaju ozljedu kralježnične moždine;
English: The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (‘informed consent').
Croatian: Proizvođač lijeka Lyrica suglasan je da se njegovi znanstveni podaci mogu koristiti da potrebe lijeka Pregabalin Pfizer („informirani pristanak”).
English: What measures are being taken to ensure the safe and effective use of Pregabalin Pfizer?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pregabalin Pfizer?
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Pfizer.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Pregabalin Pfizer.
English: It is not intended to provide practical advice on how to use Pregabalin Pfizer.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Pregabalin Pfizer.
English: Pregabalin Pfizer has been compared with placebo (a dummy treatment) in 22 studies.
Croatian: Pregabalin Pfizer uspoređen je s placebom (lažnim liječenjem) u 22 ispitivanja.
English: In epilepsy, the benefits of Pregabalin Pfizer were evaluated in 3 studies involving 1,000 patients that looked at how much it reduced the number of seizures patients had after 11 to 12 weeks.
Croatian: U slučaju epilepsije, koristi od lijeka Pregabalin Pfizer ocijenjene su u 3 ispitivanja koja su obuhvatila 1.000 bolesnika i istražila su u kojoj mjeri je smanjen broj napadaja u bolesnika nakon 11 do 12 tjedana.
English: The most common side effects with Pregabalin Pfizer (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Croatian: Najčešće nuspojave od lijeka Pregabalin Pfizer (kod više od 1 na 10 osoba) su vrtoglavica i somnolencija (pospanost).
English: In neuropathic pain, the benefits of Pregabalin Pfizer were evaluated for up to 12 weeks using a standard pain questionnaire.
Croatian: U slučaju neuropatske boli, koristi od lijeka Pregabalin Pfizer ocijenjene su tijekom razdoblja od 12 tjedana primjenom standardnog upitnika za ocjenu boli.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Pfizer, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Pregabalin Pfizer uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: Pregabalin Pfizer is a medicine that contains the active substance pregabalin.
Croatian: Pregabalin Pfizer je lijek koji sadrži djelatnu tvar pregabalin.
English: The CHMP decided that Pregabalin Pfizer's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Pregabalin Pfizer nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is Pregabalin Pfizer and what is it used for?
Croatian: Što je Pregabalin Pfizer i za što se koristi?
English: Stopping treatment with Pregabalin Pfizer should also be done gradually, over at least a week.
Croatian: Ako se liječenje lijekom Pregabalin Pfizer mora prekinuti, preporučuje se ukidati ga postupno tijekom najmanje tjedan dana.
English: A risk management plan has been developed to ensure that Pregabalin Pfizer is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pregabalin Pfizer.
English: About 45% of the patients taking 600 mg Pregabalin Pfizer a day and about 35% of those taking 300 mg Pregabalin Pfizer a day had a reduction in seizures of 50% or more.
Croatian: U otprilike 45% bolesnika koji su uzimali 600 mg lijeka Pregabalin Pfizer na dan i otprilike 35% onih koji su uzimali 300 mg lijeka Pregabalin Pfizer na dan zabilježeno je smanjenje napadaja od 50% ili više.
English: For more information about treatment with Pregabalin Pfizer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Pregabalin Pfizer pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with Pregabalin Pfizer?
Croatian: Koji su rizici povezani s lijekom Pregabalin Pfizer?
English: The recommended starting dose of Pregabalin Pfizer is 150 mg per day,
Croatian: Preporučena početna doza lijeka Pregabalin Pfizer je 150 mg na dan, podijeljeno u dvije ili tri doze.
English: For practical information about using Pregabalin Pfizer, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Pregabalin Pfizer pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Other information about Pregabalin Pfizer
Croatian: Ostale informacije o lijeku Pregabalin Pfizer
English: In a smaller study involving 137 patients with central neuropathic pain due to a spinal cord injury, 22% of patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Croatian: U manjem ispitivanju koje je obuhvatilo 137 bolesnika sa središnjom neuropatskom boli uslijed ozljede kralježnične moždine, 22% bolesnika liječenih lijekom Pregabalin Pfizer imalo je smanjenje u rezultatima boli od 50% ili više, u usporedbi s 8% u bolesnika liječenih placebom.
English: In 10 studies involving over 3,000 patients with peripheral neuropathic pain (either diabetic pain or shingles), 35% of the patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
Croatian: U 10 ispitivanja koja su obuhvatila više od 3.000 bolesnika s perifernom neuropatskom boli (bol povezana s dijabetesom ili pasac), 35% bolesnika liječenih lijekom Pregabalin Pfizer imalo je povišene rezultate boli od 50% ili više, u usporedbi s 18% bolesnika liječenih placebom.
English: How is Pregabalin Pfizer used?
Croatian: Kako se Pregabalin Pfizer koristi?
English: Why is Pregabalin Pfizer approved?
Croatian: Zašto je lijek Pregabalin Pfizer odobren?
English: Pregabalin Pfizer was more effective than placebo in generalised anxiety disorder: in 8 studies involving over 3,000 patients, 52% of the patients taking Pregabalin Pfizer had an improvement of 50% or more in their anxiety measured with a standard anxiety questionnaire, compared with 38% of the patients taking placebo.
Croatian: U 8 ispitivanja koja su obuhvatila više od 3.000 bolesnika, u 52% bolesnika koji su uzimali lijek Pregabalin Pfizer zabilježeno je poboljšanje od 50% ili više u njihovoj anksioznosti izmjereno standardnim upitnikom za mjerenje anksioznosti, u usporedbi sa 38% bolesnika koji su uzimali placebo.
English: How does Pregabalin Pfizer work?
Croatian: Kako djeluje Pregabalin Pfizer?
English: What benefits of Pregabalin Pfizer have been shown in studies?
Croatian: Koje su koristi lijeka Pregabalin Pfizer dokazane u ispitivanjima?
English: For the full list of all side effects and restrictions, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka, potražite u uputi o lijeku.
English: Information for women
Croatian: Informacije za žene
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Obratite se našim djelatnicima za odnose s medijima Monika Benstetter ili Martin Harvey
English: • Women who have any questions or concerns should speak to their doctor or pharmacist.
Croatian: • Žene koje imaju dodatnih pitanja ili razloga za zabrinutost trebaju se obratiti svojim liječnicima ili ljekarnicima.
English: 30 September 2014 EMA/631408/2014
Croatian: 30. rujna 2014. EMA/631408/2014
English: • a meta-analysis of three WHO studies3,4,5, which primarily included African and Asian women.
Croatian: • meta analizu triju ispitivanja WHO-a3,4,5, koja su primarno obuhvatila žene afričkog i azijskog podrijetla.
English: For more information on these studies, see the CHMP assessment report for ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf
Croatian: Za više informacija o ovim ispitivanjima pogledajte izvještaj CHMP-a o ocjeni lijeka ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf
English: Studies HRA2914-507, HRA2914-508, HRA2914-509 and HRA2914-513.
Croatian: 6. Ispitivanja HRA2914-507, HRA2914-508, HRA2914-509 i HRA2914-513.
English: Emergency contraceptives work by stopping or delaying ovulation.
Croatian: Hitni kontraceptivi djeluju zaustavljajući ili odgađajući ovulaciju.
English: The review was conducted by the Committee for Medicinal Products for Human Use (CHMP), the Committee responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Pregled je proveo Odbor za lijekove za humanu uporabu (CHMP), koji je odgovoran za pitanja vezana uz lijekove za humanu uporabu, te je on donio konačno mišljenje Agencije.
English: The review of emergency contraceptives containing levonorgestrel and ulipristal acetate was initiated in January 2014 at the request of Sweden, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled hitnih kontraceptiva koji sadrže levonorgestrel i ulipristal acetat pokrenut je u siječnju 2014. na zahtjev Švedske u skladu s člankom 31. Direktive 2001/83/EZ.
English: For ulipristal acetate, the Agency considered the following data:
Croatian: U slučaju ulipristal acetata, Agencija je razmotrila sljedeće podatke:
English: EllaOne can only be obtained with a prescription.
Croatian: EllaOne izdaje se samo na liječnički recept.
English: Both meta-analyses did not include off-label use (i.e. intake later than 72 hours after unprotected sexual intercourse).
Croatian: Nijedna od navedenih meta analiza nije obuhvatila uporabu mimo indikacija (odnosno primjenu 72 sata nakon nezaštićenog seksualnog odnosa ).
English: The CHMP opinion was then forwarded to the European Commission, which issued a final legally binding decision on 30 September 2014.
Croatian: Mišljenje CHMP-a zatim je proslijeđeno Europskoj komisiji koja je donijela konačnu pravno obvezujuću odluku 30. rujna 2014.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that these emergency contraceptives could continue to be used in women of all weights as the benefits were considered to outweigh the risks.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji preporučio je da se ovi hitni kontraceptivi nastave koristiti u žena svih tjelesnih težina budući da se smatra kako koristi nadmašuju rizike.
English: Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions.
Croatian: Slično je i u slučaju ulipristal acetata: iako ograničeni podaci iz kliničkih ispitivanja ukazuju na mogući trend smanjenog kontracepcijskog djelovanja, podaci su previše ograničeni i nedovoljno precizni za donošenje konačnih zaključaka.
English: The emergency contraceptives included in this review are medicines containing levonorgestrel, such as Norlevo, Levonelle/Postinor and Levodonna, which have been authorised in the EU through national procedures.
Croatian: Hitni kontraceptivi obuhvaćeni ovim pregledom bili su lijekovi koji sadrže levonorgestrel, poput lijekova Norlevo, Levonelle/Postinor i Levodonna, koji su odobreni za primjenu u EU-u putem nacionalnih postupaka.
English: The review also included a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the EU in 2009.
Croatian: Pregled je također obuhvatio središnje odobreni lijek, ellaOne, koji sadrži ulipristal acetat te za koji je odobrenje za stavljanje u promet u EU-u izdano 2009.
English: The CHMP recommendation was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 30 September 2014.
Croatian: Preporuka CHMP-a dostavljena je Europskoj komisiji koja je donijela pravno obvezujuću odluku primjenjivu na razini EU-a 30. rujna 2014.
English: It concluded that the limited data available do not support with certainty the previous conclusion that their contraceptive effect is reduced in women with high bodyweight.
Croatian: Zaključeno je da dostupni ograničeni podaci ne podržavaju sa sigurnošću prethodni zaključak da je njihovo kontracepcijsko djelovanje smanjeno u žena s povišenom tjelesnom težinom.
English: However, in order to maximise the likelihood that they will work, it is important that they are taken as soon as possible after unprotected intercourse.
Croatian: No, da bi se povećali izgledi za djelovanje ovih kontraceptiva, važno je da se uzmu što je prije moguće nakon nezaštićenog seksualnog odnosa.
English: Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse.
Croatian: Žene valja podsjetiti da hitne kontraceptive treba uzeti što je prije moguće nakon nezaštićenog seksualnog odnosa.
English: Having assessed all the available evidence on the effectiveness of emergency contraceptives, the CHMP considered that the data available are too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo.
Croatian: Nakon ocjene svih dostupnih dokaza o djelotvornosti hitnih kontraceptiva, CHMP je zaključio da su dostupni podaci previše ograničeni te da nisu dovoljno robusni za donošenje sigurnog zaključka da se kontracepcijsko djelovanje smanjuje s povećanjem tjelesne težine, kako je navedeno u informacijama o lijeku za Norlevo.
English: The CHMP recommended that the results of these studies should be included in the product information of emergency contraceptives, but that the statements on the impact of bodyweight in the product information for Norlevo should be deleted.
Croatian: CHMP je preporučio uvrštavanje rezultata ovih ispitivanja u informacije o lijeku za hitne kontraceptive, no izjave o utjecaju tjelesne težine u informacijama o lijeku za Norlevo treba izbrisati.
English: Glasier A et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
Croatian: Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
English: References.
Croatian: Literatura.
English: For emergency contraceptives containing levonorgestrel, the Agency considered the following data:
Croatian: U slučaju hitnih kontraceptiva koji sadrže levonorgestrel, Agencija je razmotrila sljedeće podatke:
English: 4. von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
Croatian: Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
English: 3. von Hertzen H et al. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
Croatian: Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
English: • Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI).
Croatian: • Hitni kontraceptivi mogu se nastaviti uzimati s ciljem sprječavanja neželjene trudnoće u žena bilo koje tjelesne mase ili indeksa tjelesne težine (ITM).
English: The CHMP considered that, with side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman's bodyweight.
Croatian: Mišljenje je CHMP-a da je, s obzirom na općenito blage nuspojave, sigurnosni profil hitnih kontraceptiva povoljan te da se mogu nastaviti uzimati bez obzira na tjelesnu težinu žene.
English: • An EU-wide review was carried out to assess whether emergency contraceptives are less effective in overweight or obese women.
Croatian: • Na razini EU-a proveden je pregled s ciljem ocjene djelovanja hitnih kontraceptiva u slučaju žena s prekomjernom tjelesnom težinom ili gojaznih žena.
English: On 24 July 2014, the European Medicines Agency concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Croatian: Europska agencija za lijekove zaključila je svoj pregled hitnih kontraceptiva koji sadrže levonorgestrel ili ulipristal acetat s ciljem ocjene utjecaja povišene tjelesne težine na djelotvornost ovih lijekova u sprječavanju neželjene trudnoće nakon nezaštićenog seksualnog odnosa ili u slučaju neuspješnosti kontracepcijske metode.
English: The available data are limited and not robust enough to support with certainty the previous conclusion of decreased contraceptive effect with increased bodyweight/BMI.
Croatian: Dostupni podaci ograničeni su i nisu dovoljno robusni kako bi podržali sa sigurnošću prethodni zaključak o smanjenom djelovanju kontraceptiva u slučaju povišene tjelesne težine/ITM-a.
English: For levonorgestrel-containing products, some clinical studies have suggested a reduced effectiveness in women with high bodyweight, but in others no trend for a reduced effect with increasing bodyweight was observed.
Croatian: U slučaju lijekova koji sadrže levonorgestrel, pojedina klinička ispitivanja ukazuju na smanjenu djelotvornost u žena s velikom tjelesnom težinom, no u slučaju drugih nije uočen trend smanjivanja djelovanja u slučaju povišene tjelesne težine.
English: • Women are reminded that emergency contraception is an occasional ‘rescue' method, which does not work as well as regular methods of contraception, such as the pill.
Croatian: • Žene se podsjeća da su hitni kontraceptivi iznimna rezervna metoda sprječavanja trudnoće, koja ne djeluje jednako dobro kao uobičajene redovne metode kontracepcije, poput kontracepcijske pilule.
English: • Healthcare professionals should continue to remind women that emergency contraception is an occasional ‘rescue' method and should not replace a regular contraceptive method.
Croatian: • Zdravstveni djelatnici trebaju podsjetiti žene da hitne kontraceptive treba primjenjivati samo povremeno kao iznimnu rezervnu metodu sprječavanja trudnoće, a ne kao zamjenu za redovne kontracepcijske metode.
English: The results of this analysis conflict with the results above and show no trend for a reduced efficacy with increasing bodyweight/BMI (pregnancy rate was 0.99% [CI: 0.70-1.35] in women with BMI 18.525; 0.57% [CI: 0.21-1.24] in women with BMI 25-30; and 1.17% [CI: 0.24-3.39] in women with BMI ≥30).
Croatian: Rezultati ove analize proturječni su prethodno navedenim rezultatima te ne pokazuju trend smanjenja djelotvornosti s povećanjem tjelesne težine/ITM-a (stopa trudnoće iznosila je 0,99% [CI: 0,70-1,35] u žena s ITM-om 18,5-25; 0,57% [CI: 0,21-1,24] u žena s ITM-om 25-30; i 1,17% [CI: 0,24-3,39] u žena s ITM-om ≥30),
English: • Emergency contraceptives can continue to be taken after unprotected intercourse or contraceptive failure, regardless of the woman's bodyweight.
Croatian: • Hitni kontraceptivi mogu se i dalje uzimati nakon nezaštićenog seksualnog odnosa ili u slučaju neuspješnosti kontracepcijske metode, bez obzira na tjelesnu težinu žene.
English: They should only be used as an occasional ‘rescue' method as they do not work as well as regular contraceptive methods.
Croatian: Treba ih primjenjivati samo povremeno kao iznimnu rezervnu metodu sprječavanja trudnoće budući da ne djeluju podjednako dobro kao redovite kontracepcijske metode.
English: • a meta-analysis of two published studies1,2, which primarily included Caucasian women, where a reduced contraceptive efficacy was observed with increased bodyweight or BMI (pregnancy rate was 0.96% [CI: 0.44-1.82] in women with BMI 18.5-25; 2.36% [CI: 1.02-4.60] in women with BMI 25-30; and 5.19% [CI: 2.62-9.09] in women with BMI ≥30).
Croatian: • meta analizu dvaju objavljenih ispitivanja1,2, koja su primarno obuhvatila bjelkinje, u slučaju kojih je smanjena kontracepcijska djelotvornost uočena u slučaju povišene tjelesne težine ili ITM-a (stopa trudnoće iznosila je 0,96% [CI: 0,44-1,82] u žena s ITM-om 18,5-25; 2,36% [CI: 1,024,60] u žena s ITM-om 25-30; i 5,19% [CI: 2,62-9,09] u žena s ITM-om ≥30).
English: In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.
Croatian: U studenom 2013., po završetku nacionalnog postupka, informacije o lijeku za hitni kontraceptiv koji sadrži levonorgestrel, Norlevo, ažurirane su na temelju rezultata iz dva klinička ispitivanja kako bi se naglasilo da je Norlevo manje djelotvoran u žena s tjelesnom težinom od 75 kg ili više te da nije djelotvoran u žena s tjelesnom težinom većom od 80 kg.
English: Those containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure, while ulipristal acetate can be used up to 120 hours.
Croatian: Oni koji sadrže levonorgestrel mogu se koristiti do 72 sata, a ulipristal acetat do 120 sati, nakon nezaštićenog seksualnog odnosa ili u slučaju neuspješnosti kontracepcijske metode.
English: • Emergency contraceptives are used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Croatian: • Hitni kontraceptivi koriste se za sprječavanje neželjene trudnoće nakon nezaštićenog seksualnog odnosa ili u slučaju neuspješnosti kontracepcijske metode.
English: Levonorgestrel-containing emergency contraceptives are available 'over the counter' in several European countries.
Croatian: Hitni kontraceptivi koji sadrže levonorgestrel dostupni su bez liječničkog recepta u nekoliko europskih država.
English: Lancet 1998; 352: 428-33.
Croatian: Lancet 1998; 352: 428-33. 4. von Hertzen H et al.
English: Emergency contraceptives are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Croatian: Hitni kontraceptivi mogu se koristiti za sprječavanje neželjene trudnoće nakon nezaštićenog seksualnog odnosa ili u slučaju neuspješnosti kontracepcijske metode.