FrancophonIA/ELRC3.0 huggingface dataset:
English: The concurrent administration of a single dose of oral clarithromycin, (a strong CYP3A4 inhibitor probe) with a single dose of oral Eurartesim led to a modest increase (≤2-fold) in piperaquine exposure in healthy adult subjects.
Croatian: Istovremena primjena jedne peroralne doze klaritromicina (jakog probnog inhibitora CYP3A4) i jedne peroralne doze Eurartesima dovela je u zdravih odraslih ispitanika do malog povećanja (≤2 puta) izloženosti piperakinu.
English: In the tables below, ADRs are listed under system organ class (SOC), and ranked by headings of frequency.
Croatian: U tablici u nastavku nuspojave su navedene prema klasifikaciji organskih sustava i kategorizirane prema učestalosti.
English: Therefore, caution should be applied when co administering Eurartesim with any CYP3A4-inhibitor and ECG monitoring should be considered.
Croatian: Stoga je potreban oprez kada se Eurartesim primjenjuje istovremeno s bilo kojim inhibitorom CYP3A4 te je potrebno razmotriti praćenje EKG-a.
English: Tablet core: pre-gelatinised starch, dextrin, hypromellose (E464), croscarmellose sodium, magnesium stearate (E572).
Croatian: Jezgra tablete: prethodno geliran škrob, dekstrin, hipromeloza (E464), umrežena karmelozanatrij, magnezijev stearat (E572).
English: EU/1/11/716/005 3 film-coated tablets
Croatian: EU/1/11/716/002 6 filmom obloženih tableta
English: Any effects are unlikely to persist beyond 24 hours after the last intake of artenimol.
Croatian: Dvadeset četiri sata nakon zadnjeg uzimanja artenimola najvjerojatnije više neće biti nikakvih učinaka.
English: Therefore, particular attention should be paid when medicinal products that have a narrow therapeutic index (e.g. antiretroviral medicinal products and cyclosporine) are co-administered with Eurartesim.
Croatian: Stoga je potreban osobit oprez kad se istovremeno s Eurartesimom primjenjuju lijekovi s uskim terapijskim indeksom (npr. antiretrovirusni lijekovi i ciklosporin).
English: Influenza, respiratory infections, poor appetite or loss of appetite, dizziness, convulsions (fits), irregular or slow heart rate, cough, vomiting, abdominal pain, diarrhoea, nausea, inflammation or enlargement of the liver, abnormal liver function tests, itching, pain in the muscles or joints.
Croatian: Influenca, infekcije dišnog sustava, smanjeni apetit ili gubitak apetita, omaglica, konvulzije (napadaji), nepravilan ili usporen rad srca, kašalj, povraćanje, bol u trbuhu, proljev, mučnina, upala ili povećanje jetre, poremećeni nalazi testova funkcije jetre, svrbež, bol u mišićima ili zglobovima.
English: If Eurartesim is more suitable for a pregnant woman than other artemisinin-based combination therapies with a higher range of experience (or sulfadoxine-pyrimethamine), Eurartesim may be used in the 2nd and 3rd trimester.
Croatian: Ako je u pojedine trudnice Eurartesim prikladniji od drugih kombiniranih terapija na bazi artemizinina za koje postoji više iskustva (ili kombinacija sulfadoksina i pirimetamina), Eurartesim se može uzimati u drugom i trećem tromjesečju trudnoće.
English: • Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Croatian: • antiaritmici (npr. amiodaron, dizopiramid, dofetilid, ibutilid, prokainamid, kinidin, hidrokinidin, sotalol)
English: • is taking other medicines that can have an effect on heart rhythm, such as: quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine or sotalol; medicines used to treat depression such as amitriptyline, fluoxetine or sertraline; medicines used to treat mental health problems such as phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;
Croatian: • uzimate druge lijekove koji mogu imati učinak na srčani ritam, kao što su: kinidin, dizopiramid, prokainamid, amiodaron, dofetilid, ibutilid, hidrokinidin ili sotalol; lijekovi za liječenje depresije kao što su amitriptilin, fluoksetin ili sertralin; lijekovi za liječenje duševnih bolesti kao što su fenotiazini, sertindol, sultoprid, klorpromazin, haloperidol, mesoridazin, pimozid ili tioridazin; lijekovi za liječenje infekcija.
English: Eurartesim should not be taken with grapefruit juice as it is likely to lead to increased piperaquine plasma concentrations.
Croatian: Stoga Eurartesim treba uzimati samo s vodom kako je opisano u dijelu 4.2. Eurartesim se ne smije uzimati sa sokom od grejpa, jer će to najvjerojatnije povećati koncentracije piperakina u plazmi.
English: EU/1/11/716/001 3 film-coated tablets EU/1/11/716/002 6 film-coated tablets EU/1/11/716/003 9 film-coated tablets EU/1/11/716/004 12 film-coated tablets
Croatian: EU/1/11/716/003 9 filmom obloženih tableta EU/1/11/716/004 12 filmom obloženih tableta
English: 12 tablets
Croatian: 12 tableta
English: Abnormalities in red blood cells, excessive numbers of platelets, enlargement of some organs (such as liver or spleen), swollen lymph glands, convulsions (fits), headache, abnormal heart sounds (heard by your doctor with a stethoscope), nose bleeds, runny nose, nausea, inflammation of the mouth, inflammation or enlargement of the liver, jaundice, abnormal liver function blood tests, skin itching and inflammation, pain in the joints.
Croatian: Poremećaji crvenih krvnih stanica, preveliki broj krvnih pločica, povećanje nekih organa (kao što su jetra ili slezena), otečenost limfnih žlijezda, konvulzije (napadaji), glavobolja, abnormalni srčani tonovi (koje Vaš liječnik čuje preko stetoskopa), krvarenje iz nosa, curenje iz nosa, mučnina, upala usta, upala ili povećanje jetre, žutica, poremećeni nalazi testova funkcije jetre, svrbež kože i upala, bol u zglobovima.
English: 7 to less than 13 One 160 mg/20 mg tablet a day
Croatian: 7 do manje od 13 Jedna tableta od 160 mg/20 mg na dan
English: Respiratory infections, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), poor appetite or loss of appetite, eye infection, heart rhythm disturbances (change as in adults, ECG changes), abdominal pain, vomiting, diarrhoea, skin inflammation, rash, general weakness.
Croatian: Infekcije dišnog sustava, infekcija uha, anemija, poremećaji različitih vrsta krvnih stanica (bijelih krvnih stanica i krvnih pločica), smanjeni apetit ili gubitak apetita, infekcija oka, poremećaji srčanog ritma (promjena kao u odraslih, EKG promjene), bol u trbuhu, povraćanje, proljev, upala kože, osip, opća slabost.
English: nitrendipine, verapamil, felodipine, amlodipine); - some medicines used to treat HIV (antiretroviral medicinese): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine); - some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone); - medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,
Croatian: verapamil, felodipin, amlodipin); - neki lijekovi za liječenje HIV-a (antiretrovirusni lijekovi): inhibitori proteaze (kao što su amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), nenukleozidni inhibitori reverzne transkriptaze (kao što su efavirenz, nevirapin); - neki lijekovi za liječenje mikrobnih infekcija (kao što su telitromicin, rifampicin, dapson); - lijekovi koji pomažu zaspati: benzodiazepini (kao što su midazolam, triazolam, diazepam,
English: QT/QTc prolonged Heart rate irregular
Croatian: Srčani poremećaji produljen QT/QTc nepravilan rad srca poremećaji srčane provodljivosti srčani šum
English: Alfasigma France Tél: +33 1 45 21 02 69 regulatory.fr@alfasigma.com
Croatian: Alfasigma France Tél: +33 1 45 21 02 69 regulatory.fr@alfasigma.com Ελλάδα
English: • has liver or kidney problems;
Croatian: • imate tegobe s jetrom ili bubrezima;
English: • The Physician Leaflet including the Contraindicated Conditions of Use and Contraindicated
Croatian: • Uputu za liječnika uključujući stanja kontraindicirane primjene i popis lijekova čija je istovremena primjena kontraindicirana.
English: carbamazepine or phenytoin; - medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin,
Croatian: karbamazepin ili fenitoin; - lijekovi koji se primjenjuju nakon presađivanja organa i kod autoimunih bolesti (kao što su ciklosporin, takrolimus); - spolni hormoni, uključujući one koje sadrže hormonski kontraceptivi (kao što su gestoden,
English: 3 x 320 mg / 40 mg tablets 4 x 320 mg / 40 mg tablets
Croatian: 3 x 320 mg / 40 mg tablete 4 x 320 mg / 40 mg tablete
English: Rhinorrhoea Epistaxis
Croatian: Prijavljivanje nuspojava
English: 9 tablets
Croatian: 9 tableta
English: In the European Safety Registry 25 patients weighing ≥ 100 kg (range 100 -121 kg) were treated with 4
Croatian: Prema Europskom registru podataka o sigurnosti primjene 25 bolesnika tjelesne težine ≥100 kg
English: When co-administered to healthy women, Eurartesim exerted only a minimum effect on an estrogen/progestinic combination oral contraceptive treatment increasing the ethynilestradiol rate of absorption (expressed by geometric mean Cmax) of about 28% but not significantly changing the exposure to ethynilestradiol and levonorgestrel and not influencing contraception activity as demonstrated by the similar plasma concentrations of follicle stimulating hormone (FSH), luteinizing hormone (LH) and progesterone observed after oral contraceptive treatment with or without concomitant Eurartesim administration.
Croatian: Kada se istovremeno primjenjivao u zdravih žena, Eurartesim je imao samo minimalni učinak na kombinaciju oralnih kontraceptiva estrogen/progestin s tim da je povećao brzinu apsorpcije etinilestradiola (izraženo kao geometrijska sredina Cmax) za oko 28%.
English: Cardiac conduction disorders Sinus arrhythmias Bradycardia
Croatian: Srčani poremećaji produljeni QTc tahikardija poremećaji srčane provodljivosti sinusne aritmije bradikardija
English: The 320 mg/40 mg tablets have two 'σ' letters on one side and come in blisters containing 3, 6, 9 or 12
Croatian: Tablete od 320 mg/40 mg imaju dva slova ‘σ' na jednoj strani i isporučuju se u blisterima koji sadrže
English: Take at least 3 hours before or after food.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Uzeti najmanje 3 sata prije ili poslije jela.
English: • That Eurartesim has a potential to prolong the QTc interval that may lead to potentially lethal arrhythmias.
Croatian: Uputa za liječnika treba sadržavati sljedeće ključne poruke: • Da Eurartesim može produljiti QTc interval što može dovesti do potencijalno smrtonosnih aritmija.
English: Uncommon ( may affect up to 1 in 100 people)
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba)
English: P. falciparum infection
Croatian: P. falciparum infekcija dišnih puteva influenca
English: >12 to ≤18 years >18 to ≤64 years DM04011 (n=1524) ≤1 year >1 to ≤2 years
Croatian: DM04010 (n=1087) ≤5 godina >5 do ≤12 godina >12 do ≤18 godina >18 do ≤64 godina
English: In patients, mean Cmax (CV%) and AUCINF of artenimol (observed after the first dose of Eurartesim) were 752 (47%) ng/ml and 2,002 (45 %) ng/ml*h, respectively.
Croatian: U bolesnika je prosječni Cmax (CV%) artenimola iznosio 752 (47%) ng/ml, a prosječni AUCINF 2,002 (45%) ng/ml*h (opaženi nakon prve doze Eurartesima).
English: ½ x 160 mg / 20 mg tablet
Croatian: ½ x 160 mg / 20 mg tableta
English: In patients mean (CV%) Cmax and AUC0-24 (observed after the first dose of Eurartesim) were 179 (62%) ng/ml and 1,679 (47%) ng/ml*h, respectively.
Croatian: U bolesnika je prosječni (CV%) Cmax iznosio 179 (62%) ng/ml, a AUC0-24 1679 (47%) ng/ml*h (opaženi nakon prve doze Eurartesima).
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija
English: A tabular overview of the frequency of the ADRs in paediatric patients is given below.
Croatian: Tablični popis učestalosti nuspojava u pedijatrijskih bolesnika prikazan je u nastavku.
English: Effect of Eurartesim on co-administered medicinal products Piperaquine is metabolised by, and is an inhibitor of CYP3A4.
Croatian: Učinak Eurartesima na istovremeno primijenjene lijekove Piperakin je inhibitor CYP3A4, koji ga i metabolizira.
English: - omeprazole (used to treat diseases related to gastric acid production); - paracetamol (used to treat pain and fever); - theophylline (used to improve bronchial air flow); - nefazodone (used to treat depression); - aprepitant (used to treat nausea); - some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.
Croatian: - paracetamol (primjenjuje se za liječenje bola i vrućice); - teofilin (primjenjuje se za poboljšanje protoka zraka kroz bronhe); - nefazodon (primjenjuje se za liječenje depresije); - aprepitant (primjenjuje se za liječenje mučnine); - neki plinovi (kao što su enfluran, halotan i izofluran) koji se primjenjuju kao opći anestetici.
English: Tel: +39 051 6489602
Croatian: Tel: +39 051 6489602 Faks: +39 051 388689
English: 3 tablets
Croatian: 3 tablete
English: 1 x 160 mg / 20 mg tablet
Croatian: 1 x 160 mg / 20 mg tableta
English: Eurartesim contains the active substances piperaquine tetraphosphate and artenimol.
Croatian: Eurartesim sadrži djelatne tvari piperakintetrafosfat i artenimol.
English: Hepatomegaly Abnormal liver function tests
Croatian: Poremećaji jetre i žuči hepatitis hepatomegalija poremećene vrijednosti testova jetrene funkcije
English: Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400
Croatian: Film ovojnica hipromeloza (E464) titanijev dioksid (E171)
English: Vomiting Diarrhoea Abdominal pain
Croatian: Poremećaji probavnog sustava povraćanje proljev bol u abdomenu stomatitis mučnina
English: 24 to less than 36 Two 320 mg/40 mg tablets a day
Croatian: 24 do manje od 36 Dvije tablete od 320 mg/40 mg na dan
English: These include some of the types of medicines used to treat bacterial infections (macrolides [such as erythromycin or clarithromycin] and fluoroquinolones [such as moxifloxacin and sparfloxacin]) or fungal infections (including fluconazole and imidazole) as well as pentamidine (used to treat a specific type of pneumonia) and saquinavir (for treatment of HIV); antihistamines used to treat allergies or inflammation such as terfenadine, astemizole or mizolastine; certain medicines used to treat stomach problems such as cisapride, domperidone or droperidol; other medicines such as vinca alkaloids and arsenic trioxide (used to treat certain cancers), bepridil (used to treat angina), diphemanil (used to treat stomach disturbances), levomethadyl and methadone (used to treat drug addiction), and probucol (used to treat high blood cholesterol levels).
Croatian: kao i pentamidin (primjenjuje se za liječenje posebne vrste upale pluća) i sakvinavir (za liječenje HIV-a); antihistaminici za liječenje alergija ili upale, kao što su terfenadin, astemizol ili mizolastin; određeni lijekovi za liječenje želučanih tegoba kao što su cisaprid, domperidon ili droperidol; drugi lijekovi kao što su vinka alkaloidi i arsens trioksid (primjenjuju se za liječenje određenih vrsta raka), bepridil (primjenjuje se za liječenje angine), difemanil (primjenjuje se za liječenje želučanih tegoba), levometadil i metadon (primjenjuje se za liječenje ovisnosti o drogama), i probukol (primjenjuje se za liječenje visokih razina kolesterola u krvi).
English: 36 to less than 75 Three 320 mg/40 mg tablets a day
Croatian: 36 do manje od 75 Tri tablete od 320 mg/40 mg na dan
English: A heart problem, called QT prolongation, can occur while taking Eurartesim and for some days after taking the last dose.
Croatian: Za vrijeme uzimanja Eurartesima i nekoliko dana nakon uzimanja zadnje doze može nastati srčani poremećaj, koji se zove produljenje QT intervala.
English: tablets 320/40 mg PQP/artenimol for 3 days.
Croatian: (raspon 100-121 kg) primalo je 4 tablete od 320/40 mg piperakina/artenimola tijekom 3 dana.
English: SOC
Croatian: Za
English: 2 x 320 mg / 40 mg tablets
Croatian: 2 x 320 mg / 40 mg tablete
English: Hypromellose (E464) Croscarmellose sodium Magnesium stearate (E572)
Croatian: Jezgra tablete škrob, prethodno geliran dekstrin hipromeloza (E464) karmelozanatrij, umrežena magnezijev stearat (E572)
English: Package leaflet: information for the user Eurartesim 160 mg/20 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Eurartesim 160 mg/20 mg filmom obložene tablete piperakintetrafosfat/artenimol
English: 1 x 320 mg / 40 mg tablet
Croatian: 1 x 320 mg / 40 mg tableta
English: What you need to know before you or your child takes Eurartesim Do not take Eurartesim if you or your child:
Croatian: Nemojte uzimati Eurartesim ako Vi ili Vaše dijete:
English: Pruritis
Croatian: Doziranje
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava konvulzija glavobolja
English: The active substances are piperaquine tetraphosphate and artenimol.
Croatian: Djelatne tvari su piperakintertrafosfat i artenimol.
English: Eurartesim 160 mg/20 mg film-coated tablets.
Croatian: NAZIV LIJEKA Eurartesim 160 mg/20 mg filmom obložene tablete
English: Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate) and 40 mg artenimol.
Croatian: Jedna filmom obložena tableta sadrži 320 mg piperakintetrafosfata (u obliku tetrahidrata) i 40 mg artenimola.
English: Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate) and 20 mg artenimol.
Croatian: Jedna filmom obložena tableta sadrži 160 mg piperakintetrafosfata (u obliku tetrahidrata) i 20 mg artenimola.
English: Eurartesim 320 mg/40 mg film-coated tablets.
Croatian: NAZIV LIJEKA Eurartesim 320 mg/40 mg filmom obložene tablete
English: Respiratory tract infection Influenza
Croatian: Infekcije i infestacije influenca infekcija
English: Arthralgia
Croatian: Astenija
English: Concomitant Medication checklist
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Fax: +39 051 388689
Croatian: Τηλ: +357 24-638833
English: Eurartesim 160 mg/20 mg tablets piperaquine tetraphosphate/artenimol
Croatian: Eurartesim 160 mg/20 mg tablete piperakintetrafosfat/artenimol
English: Alfasigma Belgium sprl/bvba Tel: +32 (0)2 420 93 16 eurartesim.be@alfasigma.com
Croatian: Teл/Tel/Tlf/ Sími/Puh: +39 051 6489602 alfasigmaspa@legalmail.it
English: Eurartesim 320 mg/40 mg tablets piperaquine tetraphosphate / artenimol
Croatian: Eurartesim 320 mg/40 mg tablete piperakintetrafosfat/artenimol
English: Four 320 mg/40 mg tablets a day
Croatian: Četiri tablete od 320 mg/40 mg na dan
English: − If you get any side effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 20 mg artenimol.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 160 mg piperakintetrafosfata (u obliku tetrahidrata; PQP) i 20 mg artenimola.
English: 9 tablets Film-coated tablets.
Croatian: Filmom obložene tablete, 3 tablete Filmom obložene tablete, 6 tableta Filmom obložene tablete, 9 tableta Filmom obložene tablete, 12 tableta
English: (ADR).
Croatian: A.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Alfasigma S.p.A.
English: Film-coated tablet 3 tablets
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta
English: What Eurartesim is and what it is used for What you need to know before you or your child takes Eurartesim How to take Eurartesim
Croatian: Vi ili Vaše dijete počnete uzimati Eurartesim Kako uzimati Eurartesim
English: • The Patient Information Leaflet
Croatian: Uputa o lijeku: Informacije za korisnika
English: Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg artenimol (artenimol).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 320 mg piperakintetrafosfata (u obliku tetrahidrata; PQP) i 40 mg artenimola.
English: − At the request of the European Medicines Agency.
Croatian: • Uputu o lijeku.
English: Piperaquine tetraphosphate/artenimol
Croatian: Alfasigma Belgium sprl/bvba
English: EU/2/11/127/001 Recuvyra 50 mg/ml Transdermal
Croatian: EU/2/11/127/001 Recuvyra 50 mg/ml
English: N/A
Croatian: Dodatak A
English: Invented Name administration
Croatian: Izmišljeno ime
English: 1 vial + 1 adapter + 15 syringes + 15 applicator tips
Croatian: 1 bočica (10 ml) 1 adapter za bočicu štrcaljki 15 vrhova aplikatora
English: Dogs Transdermal use Vial (glass) 10 ml
Croatian: Tip I boca boje jantara koja sadrži 10 ml otopine
English: Elderly (65 years and older)
Croatian: Stariji (65 godina i stariji)
English: Levetiracetam Teva must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Levetiracetam Teva se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: You may take Levetiracetam Teva with or without food.
Croatian: Levetiracetam Teva možete uzeti s ili bez hrane.
English: The elimination half-life was approximately 5 hours.
Croatian: Poluvijek eliminacije iznosio je oko 5 sati.
English: Date of first authorisation: 26 August 2011 Date of latest renewal: 15 July 2016
Croatian: Datum posljednje obnove odobrenja: 15. srpanj 2016.
English: Transparent PVC/PVdC - aluminium blisters.
Croatian: Prozirni PVC/PVdC - aluminij blisteri.
English: A risk of birth defects for your unborn child cannot be completely excluded.
Croatian: Ne može se u potpunosti isključiti rizik uzrokovanja urođenih defekata za Vaše nerođeno dijete.
English: What Levetiracetam Teva is and what it is used for
Croatian: Što je Levetiracetam Teva i za što se koristi
English: If you take more Levetiracetam Teva than you should
Croatian: Ako uzmete više Levetiracetama Teva nego što ste trebali
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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 za savjet prije nego uzmete ovaj lijek.
English: The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Croatian: Filmom obložene tablete moraju se uzimati peroralno i progutati s dovoljnom količinom tekućine, a mogu se uzeti sa ili bez hrane.
English: Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Croatian: Stoga se makrogol ne smije uzimati oralno jedan sat prije i jedan sat nakon uzimanja levetiracetama.
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Croatian: Levetiracetam, kao ni njegov primarni metabolit, ne vežu se značajno za proteine plazme (<10%).
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9 % of the dose).
Croatian: Jedan nastaje hidroksilacijom pirolidonskog prstena (1,6% doze), a drugi otvaranjem pirolidonskog prstena (0,9% doze).
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Croatian: Ne smijete voziti ili upravljati strojevima dok se ne utvrdi da nije smanjena Vaša sposobnost za provođenje tih aktivnosti.
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Croatian: <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Croatian: Levetiracetam se koristi za oblik epilepsije u kojem napadaji započinju u jednoj strani mozga, ali se nakon toga mogu proširiti na veća područja u obje strane mozga (parcijalni napadaj sa ili bez sekundarne generalizacije).