FrancophonIA/ELRC3.0 huggingface dataset:
English: Lavender oil medicines should only be used in adults and children over the age of 12 years.
Croatian: Lijekovi koji sadrže lavandino eterično ulje smiju se koristiti samo u odraslih osoba i djece starije od 12 godina.
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Croatian: Za podrobnije informacije o podacima koje je HMPC ocijenio pogledajte izvješće HMPC-a.
English: What is lavender oil?
Croatian: Što je lavandino eterično ulje?
English: Although lavender oil showed a possible effect on anxiety, stress and insomnia, the number of patients per study was too low to establish an effect.
Croatian: Iako je lavandino eterično ulje dokazalo poseban učinak na anksioznost, stres i nesanicu, broj bolesnika po ispitivanju bio premali da bi se utvrdio učinak.
English: Lavender oil is the common name for the essential oil of the plant Lavandula angustifolia Mill.
Croatian: Lavandino eterično ulje je uobičajeni naziv za eterično ulje biljke Lavandula angustifolia Mill.
English: The HMPC concluded that, on the basis of its long-standing use, lavender oil can be used for the relief of mild symptoms of mental stress and exhaustion, and to aid sleep.
Croatian: HMPC je zaključio da se, na temelju njegove dugogodišnje uporabe, lavandino eterično ulje može koristiti za ublažavanje blagih simptoma psihičkog stresa i iscrpljenosti, te kao pomoć pri usnivanju.
English: This summary is not intended to provide practical advice on how to use medicines containing lavender oil.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže lavandino eterično ulje.
English: Herbal medicines containing lavender oil are usually available in liquid forms to be taken by mouth or as a bath additive.
Croatian: Biljni lijekovi koji sadrže lavandino eterično ulje obično su dostupni u tekućem obliku za uzimanje kroz usta ili kao dodatak kupkama.
English: At the time of the HMPC assessment, there were no major concerns over the safety of lavender oil.
Croatian: U vrijeme ocjene od strane HMPC-a ne postoji veća zabrinutost za sigurnu uporabu lavandinog eteričnog ulja.
English: Any applications for the licensing of medicines containing lavender oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže lavandino eterično ulje moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Information on the use and licensing of lavender oil medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju za lijekove koji sadrže lavandino eterično ulje u državama članicama Europske unije mogu se dobiti od nadležnih nacionalnih tijela.
English: Further information on the risks associated with lavender oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže eterično lavandino ulje, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, možete pronaći u monografiji u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of lavender oil, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže lavandino eterično ulje, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: In its assessment, the HMPC also considered studies with lavender oil in patients with different conditions, including anxiety and sleeping disorders.
Croatian: HMPC je prilikom ocjene razmotrio rezultate ispitivanja lavandinog eteričnog ulja u bolesnika s različitim stanjima, uključujući anksioznost i poremećaje spavanja.
English: Only few and mild side effects had been reported in studies with lavender oil, including very rare cases of allergic reactions.
Croatian: U ispitivanjima lavandinog eteričnog ulja prijavljen je samo manji broj blažih nuspojava, uključujući i vrlo rijetke slučajeve alergijskih reakcija.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing lavender oil.
Croatian: Države članice Europske unije uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže lavandino eterično ulje.
English: The HMPC conclusions on the use of medicines containing lavender oil are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže lavandino eterično ulje temelje se na njihovoj „tradicionalnoj uporabi”.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of lavender oil.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe lavandinog eteričnog ulja.
English: Other information about lavender oil medicines
Croatian: Ostale informacije o lijekovima koji sadrže lavandino eterično ulje
English: Detailed instruction on how to take lavender oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o tome kako uzimati lijekove koji sadrže lavandino eterično ulje i tko ih može uzimati dostupne su u uputi o lijeku koja je priložena uz lijek.
English: What are the risks associated with lavender oil medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže lavandino eterično ulje?
English: For practical information about using lavender oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže lavandino eterično ulje bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: What evidence supports the use of lavender oil medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže lavandino eterično ulje?
English: For more information about treatment with lavender oil, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže lavandino eterično ulje pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: Therefore, the HMPC conclusions on the use of lavender oil medicines are based on their long-standing use.
Croatian: Stoga se zaključak HMPC-a o uporabi lijekova koji sadrže lavandino eterično ulje temelji na dugogodišnjoj uporabi.
English: Lavender oil is obtained by a current of steam through the flowering tops of the plant.
Croatian: Lavandino eterično ulje se dobiva destilacijom vodenom parom iz cvjetnih vršaka.
English: How are lavender oil medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže lavandino eterično ulje?
English: Further information on Vitrakvi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vitrakvi.
Croatian: Više informacija o lijeku Vitrakvi dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/vitrakvi.
English: In addition, the tumours shrank quickly (within 2 months).
Croatian: Osim toga, tumori su se smanjili brzo (u roku od dva mjeseca).
English: Vitrakvi (larotrectinib)
Croatian: Vitrakvi (larotrektinib)
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Croatian: To znači da se očekuju dodatni podatci o lijeku koje tvrtka mora dostaviti.
English: The European Medicines Agency therefore concluded that its benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da njegove koristi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Adult patients should take 100 mg twice a day for as long as the cancer is stable and the side effects are acceptable.
Croatian: Odrasli bolesnici trebaju uzimati 100 mg dvaput na dan sve dok je karcinom stabilan, a nuspojave su podnošljive.
English: Vitrakvi (larotrectinib) EMA/457887/2019
Croatian: Vitrakvi (larotrektinib) EMA/457887/2019
English: What is Vitrakvi and what is it used for?
Croatian: Što je Vitrakvi i za što se koristi?
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove informacije koje postanu dostupne te se ovaj pregled informacija po potrebi ažurira.
English: The most common side effects with Vitrakvi (which may affect more than 1 in 5 people) are tiredness, dizziness, constipation, nausea, vomiting, anaemia (low red blood cell counts) and high blood levels of alanine aminotransferase and aspartate aminotransferase (a sign of liver problems).
Croatian: Najčešće nuspojave povezane s lijekom Vitrakvi (koje se mogu javiti u više od 1 na 5 osoba) jesu umor, omaglica, zatvor, mučnina, povraćanje, anemija (nizak broj crvenih krvnih zrnaca) i visoke razine alanin aminotransferaze i aspartat aminotransferaze (što upućuje na probleme s jetrom).
English: Vitrakvi is available as a liquid (20 mg per ml) and capsules (25 and 100 mg) and is taken by mouth.
Croatian: Lijek Vitrakvi primjenjuje se u obliku tekućine (20 mg po ml) i kapsula (25 i 100 mg) te se uzima na usta.
English: What measures are being taken to ensure the safe and effective use of Vitrakvi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vitrakvi?
English: Vitrakvi has been given ‘conditional authorisation'.
Croatian: Za lijek Vitrakvi izdano je „uvjetno odobrenje”.
English: The dose for children is based on their body surface area (weight and height).
Croatian: Doza za djecu određuje se na temelju površine njihova tijela (težine i visine).
English: Other information about Vitrakvi
Croatian: Ostale informacije o lijeku Vitrakvi
English: It contains the active substance larotrectinib.
Croatian: Sadrži djelatnu tvar larotrektinib.
English: This data will come from the three ongoing studies which aim to confirm the benefits and safety of Vitrakvi and its longer term effect in children.
Croatian: Ti će se podatci dobiti iz tri ispitivanja u tijeku, čiji je cilj potvrditi koristi i sigurnost lijeka Vitrakvi te njegov dugoročniji učinak u djece.
English: An overview of Vitrakvi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Vitrakvi i zašto je odobren u EU-u
English: Vitrakvi is used in patients whose tumours are advanced, have spread to other parts of the body or are not amenable to surgery, and who have no satisfactory alternative treatments.
Croatian: Lijek Vitrakvi koristi se u bolesnika s uznapredovalim tumorima koji su se proširili na druge dijelove tijela ili koji nisu pogodni za kirurški zahvat te za koje ne postoji zadovoljavajuća alternativna terapija.
English: Although studies are still underway, the results released so far show that it is effective at reducing the size of patients' tumours.
Croatian: Premda su ispitivanja još u tijeku, dosad objavljeni rezultati pokazuju da je lijek učinkovit u smanjenju veličine tumora u bolesnika.
English: In these studies, 67% of patients who took Vitrakvi had a reduction in the size of their tumours, and the tumours on average shrank to less than half their original size.
Croatian: U tim su se ispitivanjima smanjili tumori u 67 % bolesnika koji su uzimali lijek Vitrakvi, a u prosjeku su se smanjili na manje od polovice njihove prvotne veličine.
English: Since Vitrakvi has been given conditional authorisation, the company that markets Vitrakvi will provide further data on its effects.
Croatian: Budući da je lijek Vitrakvi dobio uvjetno odobrenje, tvrtka koja stavlja lijek Vitrakvi u promet mora dostaviti dodatne podatke o njegovoj učinkovitosti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vitrakvi have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Vitrakvi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Three ongoing studies in 102 patients with solid tumours with NTRK gene fusion showed that Vitrakvi is effective at reducing the size of patients' tumours.
Croatian: Tri ispitivanja koja se trenutno provode na 102 bolesnika sa solidnim tumorima s fuzijom gena NTRK pokazala su da je lijek Vitrakvi učinkovit u smanjenju veličine tumora u bolesnika.
English: Vitrakvi differs from many other cancer medicines by targeting certain tumours with a specific gene arrangement wherever they occur in the body.
Croatian: Lijek Vitrakvi razlikuje se od mnogih drugih lijekova protiv raka po tome što cilja na određene tumore s posebnom raspodjelom gena, gdje god da se pojave u tijelu.
English: For more information about using Vitrakvi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Vitrakvi pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: In addition, the short time taken to shrink the tumours is important in relieving patients' symptoms.
Croatian: Osim toga, kratko vrijeme potrebno za smanjenje tumora značajno je u ublažavanju simptoma u bolesnika.
English: Side effects reported with Vitrakvi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Vitrakvi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Tumours with NTRK gene fusion produce an abnormal protein (TRK fusion protein), which causes the uncontrolled growth of cancer cells.
Croatian: Tumori s fuzijom gena NTRK proizvode abnormalan protein (TRK fuzijski protein) koji uzrokuje nekontrolirani rast stanica raka.
English: As for all medicines, data on the use of Vitrakvi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Vitrakvi kontinuirano se prate.
English: What are the risks associated with Vitrakvi?
Croatian: Koji su rizici povezani s lijekom Vitrakvi?
English: Why is Vitrakvi authorised in the EU?
Croatian: Zašto je lijek Vitrakvi odobren u EU-u?
English: NTRK gene fusion is a rare genetic abnormality that can occur in tumours from different parts of the body such as the lungs, thyroid glands and intestines.
Croatian: Fuzija gena NTRK rijetka je genetska anomalija koja se može javiti u tumorima na raznim dijelovima tijela, primjerice na plućima, štitnjači i u crijevima.
English: The active substance in Vitrakvi, larotrectinib, blocks the action of this protein, preventing the excessive growth of cancer cells and thereby slowing down the worsening of the cancer.
Croatian: Djelatna tvar u lijeku Vitrakvi, larotrektinib, blokira djelovanje tog proteina i time sprječava prekomjeran rast stanica raka te usporava pogoršanje stanja.
English: How does Vitrakvi work?
Croatian: Kako djeluje Vitrakvi?
English: Most side effects are mild to moderate.
Croatian: Većina nuspojava bila je blaga do umjerena.
English: What information is still awaited for Vitrakvi?
Croatian: Koje se još informacije očekuju o lijeku Vitrakvi?
English: Vitrakvi should be started by a doctor experienced in using cancer medicines and can only be obtained with a prescription.
Croatian: Liječenje lijekom Vitrakvi treba započeti i nadzirati liječnik iskusan u primjeni lijekova protiv raka, a lijek se izdaje samo na recept.
English: Vitrakvi is a cancer medicine for treating solid tumours with NTRK gene fusion.
Croatian: Lijek Vitrakvi lijek je za liječenje raka koji se koristi za liječenje solidnih tumora s fuzijom gena za neurotropnu receptorsku tirozin kinazu (NTRK).
English: As for its safety, the side effects of Vitrakvi appear manageable.
Croatian: U pogledu sigurnosti, smatra se da se nuspojave lijeka Vitrakvi mogu kontrolirati.
English: What benefits of Vitrakvi have been shown in studies?
Croatian: Koje su koristi od lijeka Vitrakvi utvrđene u ispitivanjima?
English: How is Vitrakvi used?
Croatian: Kako se Vitrakvi primjenjuje?
English: The patients were followed up for an average of four and a half years.
Croatian: Bolesnici su u prosjeku praćeni tijekom razdoblja do četiri i pol godine.
English: This summary was last updated in 08-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u 08.2015.
English: It is available as tablets (20, 40 and 80 mg).
Croatian: Dostupan je u obliku tableta (20, 40 i 80 mg).
English: The full EPAR for Micardis is available on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Micardis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Micardis must not be used in women who are more than three months pregnant.
Croatian: Micardis ne smiju uzimati žene koje su trudne dulje od tri mjeseca.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Micardis on 16 December 1998.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Micardis na snazi u Europskoj uniji od 16. prosinca 1998.
English: Its use during the first three months of pregnancy is not recommended.
Croatian: Ne preporučuje se primjena tog lijeka u žena tijekom prva tri mjeseca trudnoće.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Croatian: Također omogućuje srcu da lakše pumpa krv, što može pomoći pri smanjivanju rizika od budućih kardiovaskularnih problema.
English: Other information about Micardis
Croatian: Ostale informacije o lijeku Micardis
English: If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Croatian: Ako se ne postigne ciljna vrijednost krvnog tlaka, doza se može povećati na 80 mg ili se može dodati neki drugi lijek protiv hipertenzije, kao što je hidroklorotiazid.
English: The main measure of effectiveness was the reduction in the number of patients who died or were admitted to hospital, or who had a heart attack or stroke.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje broja bolesnika koji su preminuli ili su hospitalizirani, ili koji su imali srčani ili moždani udar.
English: What measures are being taken to ensure the safe and effective use of Micardis?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Micardis?
English: Micardis is a medicine that contains the active substance telmisartan.
Croatian: Micardis je lijek koji sadrži djelatnu tvar telmisartan.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Croatian: Primjenjuje se u bolesnika koji imaju problema zbog krvnih ugrušaka u prošlosti (npr. srčanu bolest, moždani udar ili arterijsku bolest) ili koji imaju dijabetes tipa 2 koji je oštetio neki organ (npr. oči, srce ili bubrege).
English: The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Croatian: Glavna mjera djelotvornosti bilo je sniženje dijastoličkog krvnog tlaka (krvnog tlaka izmjerenog između dvaju otkucaja srca).
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Croatian: To omogućuje snižavanje krvnog tlaka, čime se smanjuju rizici povezani s visokim krvnim tlakom, kao što su nastanak srčanog ili moždanog udara.
English: This is a summary of the European public assessment report (EPAR) for Micardis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Micardis.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Croatian: Za potrebe prevencije kardiovaskularnih problema, preporučena doza iznosi 80 mg jedanput na dan.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Croatian: Blokiranjem receptora na koje se angiotenzin II obično veže, telmisartan sprječava učinak hormona i na taj način omogućuje širenje krvnih žila.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Micardis.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Micardis.
English: Various doses of Micardis were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Croatian: Različite doze lijeka Micardis uspoređene su s placebom (prividnim liječenjem) te s drugim lijekovima za liječenje hipertenzije (atenololom, lizinoprilom, enalaprilom i amlodipinom).
English: Why has Micardis been approved?
Croatian: Zašto je Micardis odobren?
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Croatian: nesanica (poteškoće sa spavanjem), sinkopa (nesvjestica), vertigo (vrtoglavica), bradikardija (usporena frekvencija srca), hipotenzija (niski krvni tlak), dispneja (otežano disanje), kašalj, abdominalna bol (bol u trbuhu), proljev, dispepsija (žgaravica), flatulencija (plinovi), povraćanje, hiperhidroza (prekomjerno znojenje), pruritus (svrbež), osip, mijalgija (mišićna bol), bol u leđima, grčevi mišića, oštećenja funkcije bubrega (smanjena funkcija bubrega), uključujući iznenadno zatajenje bubrega, bol u prsima, astenija (slabost) i povišene koncentracije kreatinina u krvi (markera razgradnje mišića).
English: Micardis was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Croatian: Micardis je uspoređen s ramiprilom (još jednim lijekom za prevenciju kardiovaskularnih problema) te s kombinacijom obaju lijekova.