FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the risks associated with melissa leaf 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 matičnjakov list , 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 melissa leaf medicines, 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 matičnjakov list, 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: Any applications for the licensing of medicines containing melissa leaf 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 matičnjakov list moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: The HMPC conclusions on the use of melissa leaf medicines for mild symptoms of stress, sleep aid and mild digestive disorders are based on their ‘traditional use' in these conditions.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže matičnjakov list za blage simptome stresa, pomoć pri usnivanju i blage probavne poremećaje temelje se na njihovoj "tradicionalnoj uporabi" u ovim stanjima.
English: Herbal medicines containing melissa leaf are usually available as a herbal tea to be drunk, and in solid and liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže matičnjakov list obično su dostupni kao biljni čaj koji se pije, te u čvrstim i tekućim oblicima koji se uzimaju kroz usta.
English: Information on the use and licensing of melissa leaf medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju za lijekove koji sadrže matičnjakov list u državama članicama Europske unije mogu se dobiti od nadležnih nacionalnih tijela.
English: A doctor should be consulted if the symptoms persist following 2 weeks of treatment.
Croatian: Ako se simptomi ne povuku nakon 2 tjedna liječenja, potrebno je savjetovati se s liječnikom.
English: In its assessment, the HMPC took into account the well documented use of Melissa leaf for these indications.
Croatian: HMPC je prilikom ocjene uzeo u obzir dobro dokumentiranu uporabu matičnjakovog lista za ove indikacije.
English: Detailed instructions on how to take melissa leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljnije upute o tome kako uzimati lijekove koji sadrže matičnjakov list i tko ih može uzimati dostupne su u uputi o lijeku koja je priložena uz lijek.
English: The HMPC concluded that, on the basis of its long-standing use, melissa leaf can be used for the relief of mild symptoms of stress and to aid sleep.
Croatian: Zaključak HMPC-a je da se, na temelju njegove dugogodišnje uporabe, matičnjakov list može koristiti za ublažavanje blagih simptoma stresa te kao pomoć pri usnivanju.
English: Melissa leaf can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Matičnjakov list je također prisutan i u kombinaciji s drugim biljnim tvarima u određenim biljnim lijekovima.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of melissa leaf.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe matičnjakovog lista.
English: Therefore, the HMPC conclusions on the use of melissa leaf medicines are based on their long-standing use.
Croatian: Stoga se zaključci HMPC-a o uporabi lijekova koji sadrže matičnjakov list temelje na njihovoj dugogodišnjoj uporabi.
English: For practical information about using melissa leaf 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 matičnjakov list bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: For more information about treatment with melissa leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže matičnjakov list pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with melissa leaf medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže matičnjakov list?
English: Melissa leaf is the common name for the leaf of the plant Melissa officinalis L. The plant is cultivated or gathered to obtain the leaf for medicinal use.
Croatian: Matičnjakov list je uobičajeni naziv za list biljke Melissa officinalis L.
English: What evidence supports the use of melissa leaf medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže matičnjakov list?
English: Melissa leaf preparations are obtained by drying and powdering or comminuting (reducing into tiny pieces) the leaf.
Croatian: Pripravci matičnjakovog lista dobivaju se sušenjem i usitnjavanjem lista ili pulveriziranjem u prašak.
English: How are melissa leaf medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže matičnjakov list?
English: Other information about melissa leaf medicines
Croatian: Ostale informacije o lijekovima koji sadrže matičnjakov list
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing melissa leaf.
Croatian: Države članice Europske unije uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže matičnjakov listSvrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže matičnjakov list.
English: Committee on Herbal Medicinal Products (HMPC)
Croatian: EMA/HMPC/310761/2013 Povjerenstvo za biljne lijekove (HMPC)
English: Drink the mixture.
Croatian: Popijte mješavinu.
English: Date of first authorisation: 28 May 2015
Croatian: Datum prvog odobrenja: 28. svibnja 2015.
English: Results are based on confirmed and unconfirmed responses.
Croatian: c Rezultati se temelje na potvrđenim i nepotvrđenim odgovorima.
English: The results of subgroup analyses should be interpreted with caution.
Croatian: Rezultate analize podskupina treba tumačiti s oprezom.
English: • Take the capsules at about the same time each day.
Croatian: • Uzimajte kapsule svakog dana u približno isto vrijeme.
English: Then take the next dose at the normal time.
Croatian: Potom uzmite sljedeću dozu u uobičajeno vrijeme.
English: • Male: 84%
Croatian: • Muškarci: 84%
English: Effects in humans are unknown.
Croatian: Učinci u ljudi nisu poznati.
English: If you take more LENVIMA than you should
Croatian: Ako uzmete više LENVIME nego što ste trebali
English: • Median age: 62 years
Croatian: • Medijan dobi: 62 godine
English: Urgent intervention is indicated.
Croatian: Indicirana je hitna intervencija.
English: + = censored observations.
Croatian: + = cenzurirani podaci.
English: This is because it may seriously harm your baby.
Croatian: To može ozbiljno naštetiti Vašem djetetu.
English: • are over 75 years
Croatian: • ste stariji od 75 godina
English: What to do if you forget to take your dose depends on how long it is until your next dose.
Croatian: Što učiniti ako ste zaboravili uzeti dozu ovisi o tome koliko je vremena preostalo do Vaše sljedeće doze.
English: ≥ 2 g / 24 hours
Croatian: ≥2 g / 24 sata
English: The following terms have been combined: a:
Croatian: Sljedeći izrazi su kombinirani: a:
English: When necessary, manage hypertension as recommended in Table 4.
Croatian: Kad je potrebno, liječite hipertenziju kako je preporučeno u tablici 4.
English: The capsules should be taken at about the same time each day, with or without food (see section 5.2).
Croatian: Kapsule treba uzeti svakog dana u otprilike isto vrijeme, s hranom ili bez nje (vidjeti dio 5.2).
English: Symptoms depend on where the fistula is located.
Croatian: Simptomi ovise o mjestu na kojem se fistula nalazi.
English: What LENVIMA is and what it is used for
Croatian: Što je Lenvima i za što se koristi
English: • You can take the capsules with or without food.
Croatian: • Kapsule možete uzeti s hranom ili bez nje.
English: Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggest that it is in the order of 85%.
Croatian: Apsolutna bioraspoloživost nije utvrđena u ljudi; međutim, podaci iz ispitivanja masene bilance ukazuju na to da se nalazi u redu veličine od 85%.
English: The effects of LENVIMA in people younger than 18 years old are not known.
Croatian: Učinci LENVIME u osoba mlađih od 18 godina nisu poznati.
English: • have had recent surgery or radiotherapy
Croatian: • ste nedavno imali kirurški zahvat ili radioterapiju
English: • Body weight: <60 kg -31%, 60-80 kg - 50%, >80 kg - 19%
Croatian: • Tjelesna težina: <60 kg -31%, 60-80 kg - 50%, >80 kg - 19%
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Croatian: Odmah obavijestite liječnika ako primijetite bilo koju od sljedećih nuspojava - može Vam trebati hitno medicinsko liječenje:
English: This is because the medicine passes into breast milk and may seriously harm your breastfed baby.
Croatian: To je zbog toga što lijek prelazi u mlijeko i može ozbiljno naštetiti Vašem dojenčetu.
English: The capsules should be swallowed whole with water.
Croatian: Kapsule treba progutati cijele s vodom.
English: LENVIMA is not recommended for use in children and adolescents.
Croatian: LENVIMA se ne preporučuje za primjenu u djece i adolescenata.
English: • high or low blood pressure
Croatian: • visok ili nizak krvni tlak
English: Resolves to less than 2 g / 24 hours.
Croatian: Povlači se na vrijednost manju od 2 g / 24 sata.
English: • White: 29%, Asian: 69%, Black or African American: 1.4%
Croatian: • Bijelci: 29%, Azijati: 69%, Afroamerikanci ili crne rase: 1,4%
English: Age, sex, weight, race
Croatian: Dob, spol, tjelesna težina, rasa
English: Lenvatinib was not genotoxic.
Croatian: Lenvatinib nije bio genotoksičan.
English: Grade 3 (despite optimal antihypertensive therapy)
Croatian: 3. stupnja (unatoč optimalnoj antihipertenzivnoj terapiji)
English: Eight healthy, demographically matched subjects served as controls and received a 10-mg dose.
Croatian: Osam zdravih ispitanika sličnih demografskih karakteristika služilo je kao kontrola i primilo dozu od 10 mg.
English: • headache and back pain
Croatian: • glavobolja i bol u leđima
English: Nephrotic syndrome ------
Croatian: Nefrotski sindrom ------
English: Dose adjustments are based only on toxicities observed and not on body weight changes during treatment.
Croatian: Prilagodbe doze temelje se samo na zabilježenoj toksičnosti, a ne na promjenama tjelesne težine tijekom liječenja.
English: Clinical data are not available in this population (see section 4.2).
Croatian: Klinički podaci nisu dostupni za ovu populaciju (vidjeti dio 4.2).
English: Includes cases with a fatal outcome.
Croatian: †: Uključuje slučajeve sa smrtnim ishodom.
English: The mechanism of action for hypothyroidism is not fully elucidated.
Croatian: Mehanizam djelovanja za hipotireozu nije u potpunosti razjašnjen.
English: Recommended action
Croatian: Preporučeni postupak
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 20%; BCLC stage C: 80%
Croatian: • Barcelona Clinic Liver Cancer (BCLC) stadij B: 20%; BCLC stadij C: 80%
English: Your doctor will help you decide whether the treatment should be continued.
Croatian: Liječnik će Vam pomoći da odlučite hoćete li nastaviti s liječenjem.
English: Estimated with Cox proportional hazard model.
Croatian: Procijenjeno pomoću Coxovog modela proporcionalnih hazarda.
English: The safety and efficacy of lenvatinib in children aged 2 to <18 years have not yet been established (see section 5.1).
Croatian: Sigurnost i djelotvornost lenvatiniba u djece u dobi od 2 do <18 godina nisu još ustanovljene (vidjeti dio 5.1).
English: (cannot be estimated from the available data)
Croatian: • nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Grade 4 (despite medical management)
Croatian: 4. stupnja (unatoč medicinskom zbrinjavanju)
English: What LENVIMA looks like and contents of the pack
Croatian: Kako LENVIMA izgleda i sadržaj pakiranja
English: • have high blood pressure
Croatian: • imate visok krvni tlak
English: The Efron method was used for ties.
Croatian: Za veze je korištena Efronova metoda.
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Croatian: Liječenje treba nastaviti sve dok se opaža klinička korist ili do pojave neprihvatljive toksičnosti.
English: Median (95% CI) e Lenvatinib (N= 478)
Croatian: Medijan (95% CI) e Lenvatinib (N= 478)
English: • you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na lenvatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The suspension is to be swallowed.
Croatian: Suspenziju treba popiti.
English: • If you become pregnant while being treated with LENVIMA, tell your doctor immediately.
Croatian: • Ako zatrudnite dok se liječite LENVIMOM, odmah obavijestite svog liječnika.
English: Includes all haemorrhage terms.
Croatian: Uključuje sve hemoragijske pojmove.
English: No adjustment of starting dose is required on the basis of race (see section 5.2).
Croatian: Nije potrebna prilagodba početne doze na temelju rase (vidjeti dio 5.2).
English: The additional liquid must be swallowed.
Croatian: Dodatna tekućina mora se popiti.
English: Therefore, mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Croatian: Stoga se mortalitet može pripisati komplikacijama povezanima s primarnim duodenalnim lezijama uz mogući doprinos dodatnih toksičnih učinaka na nezrele ciljne organe.
English: • The recommended dose of LENVIMA depends on your body weight when you first start treatment.
Croatian: • Preporučena doza lijeka LENVIMA ovisi o Vašoj tjelesnoj težini kada prvi put započinjete liječenje.
English: Talk to your doctor if you experience any new or unsual symptoms such as coughing when swallowing.
Croatian: Obratite se liječniku ako osjetite bilo kakve nove ili neobične simptome kao što je kašalj pri gutanju.
English: If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
Croatian: Ako bolesnik propusti dozu i ne može je uzeti u roku od 12 sati, onda tu dozu treba preskočiti i uzeti sljedeću u uobičajeno vrijeme primjene.
English: Paediatric patients have not been studied.
Croatian: Pedijatrijski bolesnici nisu ispitani.
English: Reversibility of the toxicologic changes was observed at the end of a 4-week recovery period in all animal species investigated.
Croatian: Reverzibilnost toksikoloških promjena bila je opažena na kraju četverotjednog razdoblja oporavka u svih ispitanih životinjskih vrsta.
English: The minimal washout period in clinical trials was 4 weeks.
Croatian: Minimalno razdoblje ispiranja u kliničkim ispitivanjima iznosilo je 4 tjedna.
English: Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules.
Croatian: Poliamid/aluminij/PVC/aluminij blisteri koji sadrže 10 kapsula.
English: This leaflet was last revised in 09/2019
Croatian: Ova uputa je zadnji puta revidirana: 09.2019.
English: • Absence of macroscopic portal vein invasion (MPVI): 79%
Croatian: • Odsutnost makroskopske invazije portalne vene (MPVI): 79%
English: Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Croatian: Lenvatinib se ne smije primjenjivati tijekom trudnoće, osim ako to nije jasno potrebno te nakon pažljive procjene potreba majke i rizika za fetus.
English: Cardiac dysfunction Grade 3
Croatian: Srčana disfunkcija 3. stupnja
English: Life-threatening consequences (malignant hypertension, neurological deficit, or hypertensive crisis)
Croatian: Životno ugrožavajuće posljedice (maligna hipertenzija, neurološki deficit ili hipertenzivna kriza)
English: • Demographic and baseline disease characteristics were similar between the lenvatinib and the sorafenib groups and are shown below for all 954 randomised patients:
Croatian: • Demografska i početna obilježja bolesti bila su slična između skupine na lenvatinibu i sorafenibu i prikazana su u nastavku za svih 954 randomiziranih bolesnika:
English: Independent radiologic review.
Croatian: Neovisni radiološki pregled.
English: • Do not take LENVIMA if you are planning to become pregnant during your treatment.
Croatian: • Nemojte uzeti LENVIMU ako planirate zatrudnjeti tijekom liječenja.
English: • decrease in the number of white blood cells
Croatian: • smanjenje broja bijelih krvnih stanica
English: • Aetiology: Hepatitis B (50%), Hepatitis C (23%), alcohol (6%)
Croatian: • Etiologija: hepatitis B (50%), hepatitis C (23%), alkohol (6%)
English: • loss of body fluids (dehydration)
Croatian: • gubitak tjelesne tekućine (dehidracija)
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of other medicinal products on lenvatinib
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Učinak drugih lijekova na lenvatinib
English: Target lesions previously treated with radiotherapy or locoregional therapy had to show radiographic evidence of disease progression.
Croatian: Ciljne lezije koje su prethodno liječene radioterapijom ili lokoregionalnom terapijom trebale su pokazati radiografski dokaz progresije bolesti.
English: Effect of lenvatinib on other medicinal products
Croatian: Učinak lenvatiniba na druge lijekove
English: System Organ Class (MedDRA terminology*)
Croatian: Klasifikacija organskih sustava (MedDRA terminologija*)
English: These findings were reversible at the end of a 4-week recovery period.
Croatian: Ovi su nalazi bili reverzibilni na kraju četverotjednog razdoblja oporavka.
English: Hepatic encephalopathy also occurred more frequently in patients aged 75 years and older.
Croatian: Hepatička encefalopatija javila se također češće u bolesnika u dobi od 75 ili više godina.
English: Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg.
Croatian: Daljnja sniženja doze treba razmotriti u svakog bolesnika pojedinačno jer su dostupni podaci za doze niže od 10 mg ograničeni.
English: • Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP'.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i svakom blisteru iza ‘EXP'.
English: Lung metastases may also increase the risk of pneumothorax.
Croatian: Plućne metastaze mogu također povećati rizik od pneumotoraksa.
English: No significant drug-drug interaction is therefore expected between lenvatinib and other CYP3A4/Pgp substrates.
Croatian: Stoga se ne očekuju značajne lijek-lijek interakcije između lenvatiniba i drugih supstrata CYP3A4/Pgp.
English: Refer also to section 4.8, Other special populations.
Croatian: Vidjeti također dio 4.8 Druge posebne populacije.
English: Food does not affect the extent of absorption, but slows the rate of absorption.
Croatian: Hrana ne utječe na opseg apsorpcije, ali usporava brzinu apsorpcije.
English: Each carton contains 30 ,60,or 90 hard capsules.
Croatian: Jedna kutija sadrži 30, 60 ili 90 tvrdih kapsula.
English: Avoid driving or using machines if you feel dizzy or tired.
Croatian: Izbjegavajte upravljati vozilima i strojevima ako osjećate omaglicu ili umor.
English: Taking this medicine
Croatian: Kako uzimati ovaj lijek
English: Similarly, no induction of P-gp mRNA expression was observed .
Croatian: Slično tome, nije opažena indukcija ekspresije P-gp mRNK.
English: The median time to first dose reduction was 2.8 months.
Croatian: Medijan vremena do prvog sniženja doze iznosio je 2,8 mjeseci.
English: • belong to an ethnic group other than White or Asian
Croatian: • ne pripadate bjelačkoj ili azijatskoj etničkoj skupini
English: Serious complications of poorly controlled hypertension, including aortic dissection, have been reported.
Croatian: Zabilježene su ozbiljne komplikacije uslijed loše kontrolirane hipertenzije, uključujući disekciju aorte.
English: The primary risk factor identified was dehydration and/or hypovolemia due to gastrointestinal toxicity.
Croatian: Utvrđeno je da je primarni čimbenik rizika dehidracija i/ili hipovolemija zbog gastrointestinalne toksičnosti.
English: Lenvatinib exhibited good oral bioavailability in dogs (70.4%) and monkeys (78.4%).
Croatian: Lenvatinib je pokazao dobru peroralnu bioraspoloživost u pasa (70,4%) i majmuna (78,4%).
English: Juvenile animal toxicity studies
Croatian: Ispitivanja toksičnosti na mladim životinjama
English: The median cumulative RAI activity administered prior to study entry was 350 mCi (12.95 GBq).
Croatian: Medijan kumulativne aktivnosti RAI-ja primijenjenog prije ulaska u ispitivanje iznosio je 350 mCi (12,95 GBq).
English: In addition, pneumothorax has been reported with and without clear evidence of a bronchopleural fistula.
Croatian: Nadalje, zabilježen je pneumotoraks sa i bez jasnog dokaza bronhopleuralne fistule.
English: These proteins can be present in high amounts in cancer cells, and by blocking their action LENVIMA may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
Croatian: Ti proteini mogu biti prisutni u velikim količinama u stanicama raka, pa blokiranjem njihovog rada LENVIMA može usporiti brzinu kojom se stanice raka umnažaju i tumor raste te pomoći da se prekine opskrba krvlju koja je raku potrebna.
English: This includes herbal preparations and medicines without a prescription.
Croatian: To uključuje biljne pripravke i lijekove koje možete nabaviti bez recepta.
English: See section 4.2 for dosing recommendation.
Croatian: Vidjeti dio 4.2 za preporuke o doziranju.
English: Patients who experience these symptoms should use caution when driving or operating machines.
Croatian: Bolesnici kod kojih se jave ti simptomi moraju biti oprezni kad upravljaju vozilima i rade sa strojevima.
English: Elevated transaminase levels asociated with signs of hepatotoxicity, were also observed in rats, dogs and monkeys.
Croatian: Povišene razine transaminaza povezane sa znakovima hepatotoksičnosti također su bile opažene u štakora, pasa i majmuna.
English: In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity.
Croatian: U citosolu ljudske jetre, lenvatinib nije inhibirao aktivnost aldehid oksidaze.
English: Contraception, pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.