FrancophonIA/ELRC3.0 huggingface dataset:
English: Ovulation occurred in two subjects (5.71% of the women) during the second 28-day period, one whom also ovulated in the third period, resulting in an overall ovarian activity rate of 2.86 (95% CI: 0.78 -7.22) over a period of 91 days.
Croatian: Ovulacija je nastupila u dva subjekta (5,71 % žena) tijekom drugog razdoblja od 28 dana, od kojih je jedna ovulirala u trećem razdoblju, što je rezultiralo ukupnom stopom aktivnosti jajnika od 2,86 (95 % CI: 0,78 -7,22) tijekom razdoblja od 91 dana.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of Seasonique and associated names in oral contraception as an extended regimen.
Croatian: • je Odbor pregledao sve podatke koje je dostavio podnositelj zahtjeva u prilog djelotvornosti lijeka Seasonique i povezanih naziva u oralnoj kontracepciji kao produljenog režima.
English: One-year pregnancy rates were statistically significantly lower with the 84/7 regimen compared with the 21/7 (4.4% vs. 7.3%; p<0.0001) and with the 24/4 (4.4% vs. 6.9%, p<0.0001) regimens.
Croatian: Jednogodišnje stope trudnoće bile su statistički niže s režimom 84/7 u odnosu na režim 21/7 (4,4 % u odnosu na 7,3 %; p<,0001) te s režimima 24/4 (4,4 % u odnosu na 6,9 %, p<,0001).
English: • The Committee is also of the opinion that the bleeding pattern associated with the use of Seasonique and associated names constitutes neither a safety issue nor impairs the contraceptive efficacy, and that adequate information is included in the proposed product information in this regard.
Croatian: • je Odbor također smatrao da obrazac krvarenja povezan s primjenom lijeka Seasonique i povezanim nazivima ne predstavlja sigurnosni problem niti narušava kontracepcijsku djelotvornost te da su primjerene informacije uključene u predložene informacije o lijeku u tom smislu.
English: • The Committee is of the opinion that the available data is supportive of the efficacy of Seasonique and associated names as an extended regimen of an existing combined oral contraceptive.
Croatian: • je mišljenje Odbora da dostupni podaci idu u prilog djelotvornosti lijeka Seasonique i povezanih naziva kao produljenih režima postojećeg kombiniranog oralnog kontraceptiva.
English: Therefore the CHMP considered the efficacy of Seasonique adequately demonstrated.
Croatian: Stoga je CHMP zaključio da je djelotvornost lijeka Seasonique primjereno dokazana.
English: In conclusion, as shown in study PSE-302 the total number of bleeding/spotting days was higher for Seasonique than for the comparator, Nordette.
Croatian: Zaključno, kako je dokazano u ispitivanju PSE-302, ukupan broj krvarenja/dana sukrvavog iscjetka iz rodnice bio je veći u grupi koja je primala lijek Seasonique u odnosu na komparator, Nordette.
English: The CHMP was of the opinion that the benefit-risk balance of Seasonique and associated names is considered to be favourable
Croatian: Mišljenje je CHMP-a da se omjer koristi i rizika lijeka Seasonique i povezanih naziva može smatrati povoljnim.
English: Therefore the CHMP considered that the bleeding pattern with Seasonique neither constitutes a safety issue for women nor impairs the contraceptive efficacy and adequate information in this respect is already included in the proposed product information.
Croatian: Stoga je CHMP zaključio da obrazac krvarenja s lijekom Seasonique ne predstavlja sigurnosni problem u žena te ne narušava djelotvornost kontraceptiva i primjerene informacije u tom smislu već su uključene u predloženim informacijama o lijeku.
English: The total number of days with bleeding/spotting within the planned study duration of 1 year was higher for the Seasonique group than for the comparator group (mean 61-62 vs. 55-56 depending on the extrapolation rule).
Croatian: Ukupan broj dana krvarenja/pojave sukrvavog iscjetka iz rodnice u sklopu trajanja planiranog ispitivanja od godine dana bio je veći u grupi koja je primala lijek Seasonique u odnosu na grupu koja je primala komparatorski lijek (prosječno 61-62 u odnosu na 55-56 ovisno o pravilu ekstrapolacije).
English: As expected, due to the extended regimen, the total number of scheduled bleeding/spotting within the planned study duration was 3 times lower for Seasonique than for the comparator (mean 11 vs. 33).
Croatian: Prema očekivanju, uslijed produljenog režima, ukupan broj planiranih dana krvarenja/pojave sukrvavog iscjetka iz rodnice u okviru planiranog trajanja ispitivanja bio je 3 puta manji za lijek Seasonique u odnosu na komparator (prosječno 11 u odnosu na 33).
English: In the pivotal study PSE-301, 3 pregnancies were observed for Seasonique in 1,578 91-day cycles in 621 women aged 18-35 years, resulting in an overall PI of 0.76 with a 95% CI of 0.16 - 2.22 using the Poisson model.
Croatian: U pivotalnom ispitivanju PSE-301, zabilježene su 3 trudnoće za Seasonique u 1 578 ciklusa u trajanju od 91 dana u 621 ženi u dobi od 18 - 35 godina, što je rezultiralo ukupnim PI od 0,76 s 95 % CI od 0,16 do 2,22 primjenom Poisson modela.
English: Indeed, as in the pivotal study PSE-301 the classic Poisson method failed to reach adequate precision for the 95% CI of the overall Pearl Index (PI) point estimate for Seasonique in women aged 18-35 years (point estimate 0.76, 95% CI of 0.16 - 2.22), the Applicant presented additional analyses using a bootstrap method for calculation of the 95% CI.
Croatian: Uistinu, budući da u pivotalnom ispitivanju PSE-301 klasičnom Poisson metodom nije ostvarena primjerena preciznost od 95 % CI-a cjelokupne točke procjene Pearl indeksa (PI) za lijek Seasonique u žena u dobi od 18-35 godina (procjena točke 0,76, 95 % CI od 0,16 - 2,22), podnositelj zahtjeva dostavio je dodatne analize primjenom metode procjene pogreške modela (eng. bootstrap) za izračun 95 % CI-a.
English: Further analyses including both arms (DP384/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique)) of the pivotal study PSE-301 and the supportive study PSE-302 did not provide a more reliable estimation of contraceptive efficacy of Seasonique despite the increase in sample size and resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Croatian: Daljnje analize koje su uključivale obje grupe (DP3-84/30 (veću dozu EE od Seasonique u posljednjih 7 dana ciklusa) i DP384/10 (Seasonique)) pivotalnog ispitivanja PSE-301 i potpornog ispitivanja PSE-302 nisu pružile pouzdanije procjene djelotvornosti kontraceptiva Seasonique usprkos povećanju u veličini uzorka, što je rezultiralo većim PI od 1,67 (95 % CI 0,91 - 2,80).
English: Overall benefit-risk balance
Croatian: Ukupan omjer koristi i rizika
English: The CHMP also considered that the bleeding pattern associated with the use of Seasonique neither constituted a safety issue, nor impaired efficacy.
Croatian: CHMP je također zaključio da obrazac krvarenja povezan s primjenom lijeka Seasonique ne predstavlja razlog za zabrinutost za sigurnu primjenu niti narušava djelotvornost.
English: On the contrary, the total number of unscheduled bleeding/spotting days was twice higher for Seasonique than for the comparator (mean 53 vs. 24).
Croatian: S druge strane, ukupan broj neplaniranih dana krvarenja/pojave sukrvavog iscjetka iz rodnice bio je dvostruko veći za lijek Seasonique u odnosu na komparator (prosječno 53 u odnosu na 24).
English: Of note, combined analyses including both arms (DP3-84/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique regimen)) of the pivotal study PSE-301 and the supportive study PSE-302 resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Croatian: Valja napomenuti da su kombinirane analize koje su obuhvatile obje skupine (DP3-84/30 (više doze EE u odnosu na Seasonique u posljednjih 7 dana ciklusa) i DP3-84/10 (režim Seasonique)) pivotalnog ispitivanja PSE-301 i potvrdno ispitivanje PSE-302 rezultirale PI-em većim od 1,67 (95 % CI 0,912,80).
English: The increased number of unscheduled bleeding/spotting days with Seasonique appeared not to have an effect on compliance compared to other 21/7-day OC.
Croatian: Čini se da povišeni broj neplaniranih dana krvarenja/pojave sukrvavog iscjetka iz rodnice s lijekom Seasonique nije imao značajnog utjecaja na sukladnost u usporedbi s drugim OC-om.
English: With this method, chosen post-hoc, adequate precision with regard to requirements for hormonal contraceptive methods in the CHMP Guideline on Clinical Investigation of steroid contraceptives in women (EMEA/CPMP/EWP/519/98 Rev. 1) would just be reached (depending on the specific bootstrap simulation) with a point estimate of 0.76 and a 95 % CI of (0.0 - 1.76).
Croatian: Ovom metodom, odabranom post-hoc, primjerena preciznost u vezi sa zahtjevima za hormonalne metode kontracepcije u Smjernici CHMP-a o kliničkom ispitivanju steroidnih kontraceptiva u žena (EMEA/CPMP/EWP/519/98 Rev.
English: This summary was last updated in 05-2015.
Croatian: Sažetak je posljednji put ažuriran u 05.2015.
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Croatian: Obje tvari su antihipertenzivni lijekovi koji su zasebno dostupni u Europskoj uniji (EU) od sredine 1990.-ih.
English: Its use during the first three months of pregnancy is not recommended.
Croatian: Ne preporuča se primjena tijekom prva tri mjeseca trudnoće.
English: The full EPAR for Dafiro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Dafiro nalazi se na internetskim stranicama Agencije : ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patient may need to take separate tablets or capsules before switching to the combination tablet.
Croatian: Bolesnici će morati možda uzimati zasebne tablete ili kapsule prije prelaska na kombinirane tablete.
English: Dafiro is taken by mouth as one tablet once a day with some water.
Croatian: Dafiro se uzima peroralno kao jedna tableta jednom na dan s malo vode.
English: It must not be used in women who are more than three months pregnant.
Croatian: Ne smije se primjenjivati u žena nakon prva tri mjeseca trudnoće.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Croatian: Blokira posebne kanale na površini stanica naziva kalcijski kanali, kroz koje ioni kalcija normalno ulaze u stanice.
English: The medicine can only be obtained with a prescription
Croatian: Lijek izdaje samo na liječnički recept.
English: Amlodipine is a calcium channel blocker.
Croatian: Amlodipin je blokator kalcijskih kanala.
English: Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Croatian: Budući da se amlodipin i valsartan primjenjuju već dugi niz godina, farmaceutska tvrtka je dostavila informacije o dvije tvari iz ranijih ispitivanja i znanstvene literature, kao i novih ispitivanja koja su koristila kombinaciju dvije djelatne tvari.
English: The European Commission granted a marketing authorisation valid throughout the EU for Dafiro on 16 January 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Dafiro na snazi u Europskoj uniji od 16. siječnja 2007.
English: Other information about Dafiro
Croatian: Ostale informacije o lijeku Dafiro
English: In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Croatian: Glavna mjera djelotvornosti u svim ispitivanjima je bilo snižavanje dijastoličkog krvnog tlaka (krvnog tlaka izmjerenog između dva otkucaja srca).
English: This is a summary of the European public assessment report (EPAR) for Dafiro.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Dafiro.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Valsartan je „antagonist angiotenzin II receptora”, što znači da blokira djelovanje hormona u tijelu naziva angiotenzin II.
English: It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Croatian: Dostupan je kao tablete (5 mg amlodipina i 80 mg valsartana; 5 mg amlodipina i 160 mg valsartana; 10 mg amlodipina i 160 mg valsartana).
English: They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Croatian: Djeluju na sličan način kako bi se snizio krvni tlak tako što omogućuju opuštanje 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 Dafiro.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje za izdavanje odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Dafiro.
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Croatian: Krvni je tlak izmjeren u „milimetrima žive” (mmHg).
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Croatian: Snižavanjem krvnog tlaka, smanjuju se i rizici povezani s visokim krvnim tlakom, poput primjerice moždanog udara.
English: For more information about treatment with Dafiro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Dafiro pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Croatian: Peto, manje ispitivanje usporedilo je ove kombinacije s lizinoprilom i hidroklorotiazidom (druge kombinacije koja se koristi za liječenje hipertenzije) u 130 bolesnika s ozbiljnom hipertenzijom.
English: Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out.
Croatian: Provedeno je pet glavnih ispitivanja koja su obuhvatila gotovo 5.200 bolesnika, od kojih je većina imala blagu do umjerenu hipertenziju.
English: The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone.
Croatian: Kombinacija amlodipina i valsartana bila je djelotvornija u snižavanju krvnoga tlaka od placeba ili terapije samo valsartanom ili amlodipinom.
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines.
Croatian: Farmaceutska je tvrtka također dostavila dokaz da su koncentracije amlodipina i valsartana u krvi bile jednake u osoba koje su uzimale Dafiro i osoba koje su uzimale druge lijekove.
English: Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment).
Croatian: Dva su ispitivanja (koja su obuhvatila gotovo 3.200 bolesnika) usporedila amlodipin, valsartan ili kombinaciju obje tvari s placebom (prividnim liječenjem).
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.
Croatian: Blokirajući receptore na koje se angiotenzin II normalno vezuje, valsartan zaustavlja djelovanje hormona te omogućuje širenje krvnih žila.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Croatian: Kada ioni kalcija ulaze u stanice u mišićima stjenka krvnih žila dolazi do kontrakcije.
English: The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Croatian: Najčešće nuspojave lijeka Dafiro (koje se mogu javiti u 1 do 10 osoba na 100 osoba) su glavobolja, nazofaringitis (upala nosa i grla), influenca (gripa), hipokalemija (mala koncentracija kalija u krvi), različiti tipovi edema (oticanje), iscrpljenost (umor), rumenilo (crvenilo), astenija (slabost) i napadaji vrućine.
English: In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively.
Croatian: U ispitivanjima koja su usporedila kombinacije u bolesnika koji su već uzimali amlodipin ili valsartan, krvni tlak u bolesnika koji su uzimali samo valsartan snizio se za 6,6 mmHg nakon osam tjedana u usporedbi s 9,6 i 11,4 mmHg u bolesnika koji su dodali 5 ili 10 mg amlodipina.
English: Why has Dafiro been approved?
Croatian: Zašto je Dafiro odobren?
English: Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan.
Croatian: Dva su ispitivanja (koja su obuhvatila 1.891 bolesnika) usporedila kombinacije u bolesnika čija hipertenzija nije bila primjereno kontrolirana s 10 mg amlodipina ili sa 160 mg valsartana.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Croatian: Angiotenzin II je snažan vazokonstriktor (tvar koja sužava krvne žile).
English: The CHMP decided that Dafiro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Dafiro nadmašuju s njim povezane rizike te je preporučilo davanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Dafiro?
Croatian: Koji su rizici povezani s lijekom Dafiro?
English: The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Croatian: Doza lijeka Dafiro koja se primjenjuje ovisi o dozama amlodipina ili valsartana koje je bolesnik ranije uzimao.
English: What is Dafiro?
Croatian: Što je Dafiro?
English: Dafiro must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Croatian: Dafiro se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na amlodipin ili druge lijekove iz klase „derivati dihidropiridina”, na valsartan ili bilo koju drugu pomoćnu tvar.
English: Dafiro must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Croatian: Dafiro se ne smije primjenjivati u bolesnika koji imaju ozbiljno oštećenje jetre ili probleme sa žući, u bolesnika s određenim srčanim tegobama i bolesnika s ozbiljnom hopetenzijom (niskim krvnim tlakom).
English: By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Croatian: Smanjivanjem dotoka kalcija u stanice, amlodipin sprječava kontrakciju stanica te pomaže pri opuštanju krvnih žila.
English: Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Croatian: U bolesnika koji su uzimali samo amlodipin zabilježeno je snižavanje za 10,0 mmHg, u usporedbi s 11,8 mmHg u bolesnika koji su dodali 160 mg valsartana.
English: Dafiro is a medicine that contains two active substances, amlodipine and valsartan.
Croatian: Dafiro je lijek koji sadrži dvije djelatne tvari: amlodipin i valsartan.
English: Dafiro must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Croatian: Dafiro se također ne smije primjenjivati u kombinaciji s lijekovima koji sadrže aliskiren (koriste se također za liječenje esencijalne hipertenzije) u bolesnika s dijabetesom tipa 2 ili u bolesnika s umjerenim do ozbiljnim oštećenjem bubrega.
English: What is Dafiro used for?
Croatian: Za što se Dafiro koristi?
English: Dafiro is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Croatian: Dafiro se koristi u bolesnika koji imaju esencijalnu hipertenziju (visoki krvni tlak), koji nije odgovarajuće kontroliran samo amlodipinom ili valsartanom. „Esencijalno” znači da hipertenzija nema očiti uzrok.
English: For the full list of all side effects reported with Dafiro, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih s lijekom Dafiro potražite u uputi o lijeku.
English: What benefit has Dafiro shown during the studies?
Croatian: Koje su koristi lijeka Dafiro utvrđene u ispitivanjima?
English: How does Dafiro work?
Croatian: Kako djeluje Dafiro?
English: Dafiro contains two active substances, amlodipine and valsartan.
Croatian: Dafiro sadrži dvije djelatne tvari, amlodipin i valsartan.
English: How has Dafiro been studied?
Croatian: Kako se Dafiro primjenjuje?
English: Approximately 25 µg
Croatian: otprilike 25 µg
English: 50 (5 X 10) vials + 50 (5 X 10) pre-filled syringes without needles (multipack)
Croatian: 50 (5 x 10) bočica + 50 (5 x 10) napunjenih štrcaljki bez igala (višestruko pakiranje)
English: and tetanus toxoid (T), adsorbed (PRP-T)
Croatian: toksoid tetanusa (T), adsorbiran (PRP-T)
English: Content (concentration)
Croatian: Primarno pakiranje Sastav (koncentracija)
English: MA (EU) number (Invented)n ame
Croatian: Broj (EU) odobrenja
English: 10 vials + 10 pre-filled syringes + 20 needles
Croatian: 10 bočica + 10 napunjenih štrcaljki +20 igli
English: 1 vial + 1 prefilled syringe + 2 needles
Croatian: 1 bočica + 1 napunjena štrcaljka +2 igle
English: _ _1 After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid, adsorbed
Croatian: --1Nakon rekonstitucije, 1 doza (0,5 ml) sadrži: toksoid difterije, adsorbiran toksoid tetanusa, adsorbiran toksoid pertusisa1, adsorbiran filamentozni hemaglutinin, adsorbiran pertaktin, adsorbiran površinski antigen virusa hepatitisa B (S protein), adsorbiran konjugiran kapsularni polisaharid Haemophilus influenzae tipa b (PRP)
English: 1 vial + 1 prefilled syringe without needle
Croatian: 1 bočica + 1 napunjena štrcaljka bez igle
English: 10 vials + 10 prefilled syringes without needles
Croatian: 10 bočica + 10 napunjenih štrcaljki bez igala
English: Moreover, the intended use does not require medical supervision.
Croatian: Štoviše, predviđena uporaba ne zahtjeva liječnički nadzor.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da iako nema dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna, te postoji dokaz o njihovoj sigurnoj uporabi na ovaj način tijekom najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: The plant is cultivated or gathered to obtain the oil for medicinal use.
Croatian: Biljka se uzgaja ili sakuplja kako bi se dobilo ulje za medicinsku uporabu.
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have full baths with lavender oil.
Croatian: Bolesnici s otvorenim ranama, kožnim problemima, vrućicom, ozbiljnim infekcijama te ozbiljnim srčanim i cirkulacijskim poremećajima ne smiju primjenjivati kupke cijeloga tijela s lavandinim eteričnim uljem.