FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP also considered a risk management plan proposed by the MAH detailing annual PSUR reporting for Closamectin Pour-On Solution and associated names, further detailed investigation of pharmacovigilance reports (including collection of data on treated un-affected animals within the same herd) and a proposal for ‘education, training and guidance' of end users to ensure that the risks of the products and the precautions for use are fully understood.
Croatian: CVMP je također razmotrio plan upravljanja rizikom kojeg je predložio nositelj odobrenja navodeći detalje godišnjeg PSUR-a podnijetog za otopinu za polijevanje po koži Closamectin i srodne lijekove, daljnje detaljno istraživanje farmakovigilancijskih izvještaja (uključujući prikupljanje podataka o liječenju nezaraženih životinja unutar istog krda) kao i prijedlog za "edukaciju, obuku i vođenje" krajnjih korisnika kako bi se osiguralo da su isti u potpunosti razumjeli proizvod i mjere opreza za primjenu.
English: Although the underlying mechanism for the adverse events has not yet been determined, the benefitrisk balance of Closamectin Pour-On Solution and associated names was considered favourable subject to amendments to product information and implementation of additional risk mitigation and surveillance measures to provide annual ‘combined' PSURs, further investigate adverse events reported in future and provide ‘education, training and guidance' to end-users to improve understanding related to the risks of the products and the precautions for use.
Croatian: Iako još uvijek nije utvrđen mehanizam nuspojava u podlozi, zaključeno je kako je omjer koristi i rizika za otopinu za polijevanje po koži Closamectin i srodne proizvode povoljan, te predmetom izmjena informacija o proizvodu i implementacije dodatnih mjera za smanjivanje rizika i nadzor kako bi se osigurali godišnji "kombinirani PSUR-ovi, daljnja istraga nuspojava prijavljenih u budućnosti i pružila se "edukacija, obuka i vođenje" krajnjeg korisnika kako bi se poboljšalo razumijevanje povezano s rizicima proizvoda i mjera opreza za uporabu.
English: Grounds for lifting of the suspension of the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France and amendment of the summary of product characteristics and package leaflet
Croatian: Razlozi za uklanjanje suspenzije odobrenja za stavljanja lijeka u promet za OTOPINU ZA POLIJEVANJE PO KOŽI GOVEDA CLOSAMECTIN u Francuskoj i izmjene sažetka opisa svojstava VMP-a i upute o lijeku
English: The product is effective for use in cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice.
Croatian: Proizvod je djelotvoran za primjenu u stoke za liječenje infestacija miješanim trematodima (metilja) i nematodima ili artropodima uzrokovanih oblićima, plućnim crvima, očnim crvima, šugarcima, krpeljima i ušima.
English: The products are effective for use in beef cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice.
Croatian: Proizvodi su djelotvorni za primjenu u stoke za liječenje infestacija miješanim trematodima (metilja) i nematodima ili artropodima uzrokovanih oblićima, plućnim crvima, očnim crvima, šugarcima, krpeljima i ušima.
English: • Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy).
Croatian: • Vermax Pour-On 5mg/ml i 200 mg/ml Soluzione Pour-On per bovini (Italija).
English: Additionally the MAH proposed to implement a risk management plan comprising submission of annual ‘combined' PSUR reports for the products concerning Closamectin Pour-On Solution and associated names (as detailed in Annex I of the Opinion); detailed investigation of future pharmacovigilance reports which should include data collection from treated un-affected animals within the same herd (including farm history and herd health status, assessment of animal health and nutritional status involving biochemistry and micronutrient analysis; investigation of potential closantel toxicity (via blood plasma sampling and post-mortem examinations); and ‘education, training and guidance' for end-users to ensure that the risks of the products and the precautions for use are fully understood.
Croatian: I Mišljenja); detaljna istraga budućih farmakovigilancijskih izvještaja koja treba uključivati skup podataka iz liječenih nezaraženih životinja unutar istog krda (uključujući povijest farme i zdravstveni status krda, ocjenu životinjskog zdravlja i nutricijski status koji obuhvaća biokemijsku i mikronutritivnu analizu; istraga potencijalne toksičnosti klosantela (putem uzoraka krvne plazme i post-mortem ispitivanja); i "edukacija, obuka i vođenje" za krajnje korisnike kako bi se osiguralo da su isti u potpunosti razumjeli rizike proizvoda i mjere opreza za uporabu.
English: Overall summary of the scientific evaluation of Closamectin Pour-On Solution and associated names (see Annex I)
Croatian: Sažetak znanstvenog vrednovanja otopina za polijevanje po koži Closamectin i srodnih lijekova (vidjeti Prilog I.)
English: The measures detailed in the risk management plan proposed by the MAH were supported, with additional refinement described below.
Croatian: Uz niže opisana dodatna pojašnjenja podržane su mjere detaljno opisane u planu upravljanja rizikom koje je predložio nositelj odobrenja.
English: the CVMP has recommended lifting of the suspension of the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France; variations of the marketing authorisations for Closamectin Pour-On Solution and associated names as referred in Annex I in order to amend the summary of product characteristics and package leaflet in line with recommended changes in the product information as set out in Annex III; and conditions of the marketing authorisations as set out in Annex IV.
Croatian: CVMP preporučio je uklanjanje suspenzije odobrenja za stavljanje VMP-a OTOPINA ZA POLIJEVANJE PO KOŽI GOVEDA CLOSAMECTIN u promet u Francuskoj; izmjene odobrenja za stavljanje VMP-a u promet za otopinu za polijevanje u koži Closamectin i srodne proizvode navedene u Dodatku
English: ADVERSE REACTIONS
Croatian: Jačina
English: Add, to all products (if not already present): 4.5 Special precautions for use Special precautions for use in animals
Croatian: 4.5 Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
English: Sweden Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Croatian: Švedska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
English: Germany Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Croatian: Njemačka Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
English: Slovakia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Croatian: Slovačka Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
English: Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Croatian: Slovenija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
English: Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Croatian: Rumunjska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
English: Belgium Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Croatian: Španjolska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
English: Do not freeze.
Croatian: Ne zamrzavaj.
English: SPECIAL WARNING, IF NECESSARY
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO
English: EXP (month/year)
Croatian: EXP (mjesec/godina)
English: Date of first authorisation: 18/02/2011 Date of last renewal: 02/12/2015
Croatian: Datum prvog odobrenja: 18/02/2011 Datum posljednjeg produljenja odobrenja: 02/12/2015
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: The reactions may last longer.
Croatian: Neželjeni učinci mogu trajati i duže.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ: PO TEŽINI, VOLUMENU ILI BROJU DOZA
English: Not all pack sizes may be marketed.
Croatian: Ne moraju sve veličine pakovanja biti na tržištu.
English: Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Croatian: Vrlo rijetko može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
English: Suspension for injection.
Croatian: Suspenzija za injekcije.
English: Keep out of the sight and reach of children.
Croatian: Drži izvan pogleda i dosega djece.
English: Apply usual aseptic procedures.
Croatian: Prilikom cijepljenja treba primijeniti uobičajene aseptičke procedure.
English: Store and transport refrigerated (2 °C-8 °C).
Croatian: Čuvaj i prevozi rashlađeno (2°C - 8°C).
English: The best time for a blood sample to be taken is around 28 days after vaccination.
Croatian: Najpogodnije vrijeme za uzimanje uzoraka krvi je oko 28 dana nakon cijepljenja.
English: Vaccinate healthy animals only.
Croatian: Cijepi samo zdrave životinje.
English: Light pink to pale yellow homogeneous suspension
Croatian: Svjetlo ružičasta do blijedo žuta homogena suspenzija.
English: Veterinary surgeons may wish to consider two vaccinations.
Croatian: Tada veterinar može uzeti u obzir dvije vakcinacije.
English: As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
Croatian: Posljedica toga je da cjepivo stimulira aktivni imunitet protiv virusa bjesnoće kod mačaka.
English: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Croatian: Kalijev klorid Natrijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfatdihidrat Magnezijev kloridheksahidrat Kalcijev klorid-dihidrat Voda za injekcije
English: After inoculation, the virus expresses the protective protein, but does not replicate in the cat.
Croatian: Nakon inokulacije virus izražava zaštitne proteine, ali se ne množi u mački.
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCE
Croatian: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCUSKA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 10 vials of suspension for injection Box of 50 vials of suspension for injection Box of 2 vials of suspension for injection
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija s 10 bočica suspenzije za injekciju Kutija s 50 bočica suspenzije za injekciju Kutija s 2 bočice suspenzije za injekciju
English: EXP (month/year) Once broached, use immediately.
Croatian: EXP (mjesec/godina) Jednom otvoreno, primijeni odmah.
English: Do not mix with any other veterinary medicinal product except those mentioned above.
Croatian: Ne miješati ni s jednim drugim veterinarsko medicinskim proizvodom osim s onim prethodno navedenim.
English: EU/2/10/117/001 (10 vials) EU/2/10/117/002 (50 vials) EU/2/10/117/003 (2 vials)
Croatian: EU/2/10/117/001 (10 bočica) EU/2/10/117/002 (50 bočica) EU/2/10/117/003 (2 bočice)
English: Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Croatian: Tip I staklena bočica zatvorena gumenim čepom i zapečaćena aluminijskom kapicom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Croatian: OSNOVNI PODACI KOJI TREBAJU BITI NAPISANI NA MALIM JEDINICAMA UNUTARNJEG PAKOVANJA
English: Most of these reactions were noted during the 2 days following the vaccine injection.
Croatian: Većina je ovih reakcija zabilježena tijekom 2 dana nakon vakcinacije.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCE
Croatian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCUSKA
English: Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries.
Croatian: Kod putovanja u zemlje koje zahtijevaju serološko testiranje na bjesnoću:iskustvo pokazuje da neke cijepljene životinje, dok su zaštićene, možda neće iskazivati titar protutijela od 0,5 IU/ml koji se zahtijeva u nekim zemljama.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samo injiciranja, odmah potraži pomoć liječnika i pokaži mu uputu o VMP ili etiketu.
English: Duration of immunity after revaccination: 3 years.
Croatian: Trajanje imuniteta nakon revakcinacije: 3 godine.
English: In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days.
Croatian: Vrlo rijetko može se javiti blaga prolazna apatija, kao i blaga anoreksija ili povišena temperatura (iznad 39,5 °C), koje obično traju 1 ili 2 dana.
English: Purevax Rabies suspension for injection
Croatian: Purevax Rabies suspenzija za injekcije
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Croatian: Neškodljivost veterinarsko medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Croatian: Bilo koji neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni kod primjene ovih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with MERIAL non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni i dokazujuda se ovo cjepivo smije pomiješati i primijeniti s ne adjuviranim cjepivima MERIAL koja sadrže različite kombinacije komponenti protiv virusnog rinotraheitisa mačaka, kaliciviroze, panleukopenije i klamidioze mačaka.
English: The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus.
Croatian: Cijepni soj vCP65 je rekombinantni virus boginja kanarinca koji izražava glikoprotein G gena od virusa bjesnoće.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja jednog tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)
English: Canarypox recombinants are known to be safe for humans.
Croatian: Poznato je da su rekombinirani virusia boginja kanarinca sigurni su za ljude.
English: Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of MERIAL non-adjuvanted vaccine against feline leukaemia.
Croatian: Dostupni podaci o djelotvornosti dokazuju da se ovo cjepivo smije primijeniti najmanje 14 dana prije ili poslije primijene MERIAL-ovog ne adjuviranog cijepiva protiv leukemije mačaka.
English: Shelf life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: odmah upotrijebi.
English: Most of these reactions were noted during the 2 days following the vaccine injection
Croatian: Većina jeovih reakcija zabilježena tijekom 2 dana nakon vakcinacije
English: A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most.
Croatian: Vrlo rijetko se može javiti i prolazna lokalna reakcija (bol pri palpaciji, ograničen otok koji može postati čvorast, hipertermija na mjestu vakcinacije, a u nekim slučajevima eritem), koja obično nestaje tijekom 1 ili najviše 2 tjedna.
English: METHOD AND ROUTE OF ADMINISTRATION
Croatian: METODE I NAČIN PRIMJENE
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Croatian: NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA
English: Administer one dose of 1 ml according to the following vaccination scheme:
Croatian: Inicirajte jednu dozu od 1 ml cjepiva u skladu sa sljedećim rasporedom cijepljenja:
English: DOSAGE FOR EACH SPECIES, ROUTEAND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, METODE I NAČIN PRIMJENE
English: Disposal: Read package leaflet.
Croatian: Odlaganje: pročitaj uputu o VMP-u.
English: Vaccine against rabies infection.
Croatian: Cjepivo protiv zaraze bjesnoćom.
English: 4.2 Indications for use, specifying the target species
Croatian: 4.2 Indikacije za primjenu, s navedenimciljnim vrstama životinja
English: Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8.
Croatian: Ne miješaj s bilo kojim drugim veterinarsko-medicinskim proizvodom osim onih navedenih u odjeljku
English: Primary vaccination: 1 injection from 12 weeks of age, Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Croatian: Prvo cijepljenje: 1 injekcija od 12 tjedana starosti, Revakcinacija: 1. godina nakon prvog cijepljenja, a zatim u razmacima od po 3 godine.
English: Duration of immunity after primary vaccination: 1 year.
Croatian: Trajanje imuniteta nakon prvog cijepljenja: 1 godina.
English: ATC vet code:QI06AD08.
Croatian: Farmakoterapijska grupa: Drugi imunološki lijekovi za mačke, ATC vet code:QI06AD08.
English: 1 ml contains: Rabies recombinant canarypox virus (vCP65) ................................................................. ≥ 106.8 FAID50
Croatian: 1 ml sadrži Rekombinirani virus boginja kanarinca, (vCP65) ........................................................... ≥ 106.8 FAID50
English: Box of 2 or 10 or 50 vials of 1 dose.
Croatian: Kutija s 2 ili 10 ili 50 bočica koje sadrže jednu dozu.
English: Onset of immunity: 4 weeks after the primary vaccination course.
Croatian: Početak imuniteta: 4 tjedna nakon prvog ciklusa iz kalendara cijepljenja.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih kod primjene ovog proizvoda
English: No adverse reactions other than those already mentioned in section 4.6 have been observed after the administration of 10 doses.
Croatian: Nakon primjene 10 doza cjepiva nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku 4.6. Reakcije mogu potrajati i duže.
English: Rabies recombinant canarypox virus (vCP65) ................................................................ ≥ 106.8 FAID*50 *Fluorescent assay infectious dose 50 %
Croatian: Rekombinirani virus boginja kanarinca(vCP65) ........................................................... ≥ 10 6.8 FAID*50 * Za flourescentnu podlogu infektivna doza je 50 %
English: Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
English: No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of 10 doses.
Croatian: Nakon primjene 10 doza nisu primijećeni drugačiji neželjeni učinci od onih koji su navedeni u odjeljku „Nuspojave“.
English: Administer one dose of 1 ml according to the following vaccination scheme: Primary vaccination course: 1 injection from 12 weeks of age, Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Croatian: Prvo cijepljenje: 1 injekcija nakon 12 tjedana starosti, Revakcinacija: 1. godinu nakon prvog cijepljenja, a zatim u razmacima od po 3 godine.
English: Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
Croatian: U slučaju nehotičnog samo iniciranja prolazno se mogu pojaviti blage lokalne i/ili sistemske reakcije.
English: Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Croatian: Kako bi se spriječila smrtnost izazvana infekcijom virusom bjesnoće aktivno se imuniziraju mačake a stare 12 tjedana i starije.
English: For animal treatment only
Croatian: Samo za primjenu na životinjama.
English: Box of 50 vials of 1 dose.
Croatian: Kutija s 50 bočica sa po jednom dozom.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOÐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOÐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI KOD ČUVANJA
English: Box of 10 vials of 1 dose.
Croatian: Kutija s 10 bočica sa po jednom dozom.
English: Box of 2 vials of 1 dose.
Croatian: Kutija s 2 bočice sa po jednom dozom.
English: Memantine should not be used during pregnancy unless clearly necessary.
Croatian: Memantin ne bi trebalo upotrebljavati tijekom trudnoće, osim ako to nije izričito potrebno.
English: In another case of a large overdose, the patient also survived and recovered.
Croatian: U drugom slučaju predoziranja velikom dozom, bolesnik je također preživio, te se oporavio.
English: 2 Isolated cases reported in post-marketing experience.
Croatian: 2 Izolirani slučajevi prijavljeni u postmarketinškom razdoblju.
English: Date of latest renewal: 08 January 2018
Croatian: Datum posljednje obnove odobrenja: 8. siječnja 2018
English: It belongs to a group of medicines known as anti-dementia medicines.
Croatian: Spada u skupinu lijekova poznatih kao lijekovi protiv demencije.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži važne podatke za Vas.
English: Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Croatian: Neki čimbenici koji mogu povisiti pH mokraće (vidjeti dio 5.2 »Eliminacija«) mogu zahtijevati pažljivo nadziranje bolesnika.
English: Memantine has an absolute bioavailability of approximately 100%.
Croatian: Memantin ima apsolutnu bioraspoloživost od približno 100%.
English: Continue to take Memantine Mylan as long as it is of benefit to you.
Croatian: Nastavite uzimati Memantin Mylan onoliko dugo koliko od nje imate koristi.
English: Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Croatian: Umjerena do teška Alzheimerova bolest obično uzrokuje oštećenje sposobnosti upravljanja vozilima i kompromitira sposobnost rada na strojevima.
English: Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Croatian: Liječnik će Vam reći dopušta li Vam bolest sigurno upravljanje vozilima i rad na strojevima.