FrancophonIA/ELRC3.0 huggingface dataset:
English: - Hepatic impairment: Patients with clinically significant hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Croatian: - Oštećenje bubrega: Bolesnici s klinički značajnim oštećenjem bubrega mogli bi osjetiti više nuspojava (vidjeti dio 4.2 i 5.2).
English: transdermal patches 9.5 mg/24 h
Croatian: Transdermalni flasteri s rivastigminom 9,5 mg/24 h
English: Each transdermal patch consists of three layers; a backing layer, an adhesive layer containing the medicine and a transparent, split release liner.
Croatian: Jedan transdermalni flaster sastoji se od tri sloja: potpornog sloja, ljepljivog sloja koji sadrži lijek i prozirne zaštitne folije koja se može skinuti.
English: Hepatitis, elevated liver function tests Skin and subcutaneous tissue disorders Common Not known
Croatian: Hepatitis, povišeni rezultati testova funkcije jetre
English: Rivastigmine 13.3 mg/24 h
Croatian: Rivastigmin 13,3 mg/24 h
English: They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Croatian: Mogli bi osjetiti više nuspojava te uslijed toga biti skloniji prekidu liječenja zbog
English: Mean baseline  SD
Croatian: Srednja početna vrijednost  SD
English: What Rivastigmine 3M Health Care Ltd. looks like and contents of the pack The transdermal patches are rectangular with rounded corners, approximately 2.5 cm by 1.8 cm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or 3.5 cm by 2.6 cm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Croatian: Kako Rivastigmin 3M Health Care Ltd. izgleda i sadržaj pakiranja Flasteri su pravokutnog oblika, zaobljenih kuteva, približnih dimenzija 2,5 cm s 1,8 cm (Rivastigmin 3M Health Care Ltd.
English: • Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Croatian: • Držite flaster dlanom pritisnut na mjestu najmanje 30 sekundi.
English: There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer's disease.
Croatian: Nema relevantne primjene Rivastigmina 3M Health Care Ltd. u pedijatrijskoj populaciji u liječenju
English: However, use of rivastigmine patch may lead to allergic contact dermatitis.
Croatian: Prethodna anamneza reakcija na mjestu primjene, koje ukazuju na alergijski kontaktni dermatitis s
English: - Carefully remove any existing patch before putting on a new one.
Croatian: - Pažljivo uklonite postojeći flaster (ako ga imate) prije stavljanja novoga.
English: Other adverse reactions Care must be taken when prescribing Rivastigmine 3M Health Care Ltd. transdermal patches:
Croatian: Druge nuspojave Potreban je oprez kod propisivanja Rivastigmin 3M Health Care Ltd. transdermalnih flastera:
English: The most commonly reported skin irritation events during the first 24 weeks of the double-blind period with rivastigmine 13.3 mg/24 h transdermal patches and rivastigmine 9.5 mg/24 h transdermal patches, respectively were application site erythema (5.7% vs 4.6%) and application site pruritus (3.6% vs 2.8%).
Croatian: Najučestalije prijavljeni događaji nadražaja kože tijekom prva 24 tjedna dvostruko slijepog razdoblja s transdermalnim flasterima s rivastigminom u dozi od 13,3 mg/24 h i u dozi od 9,5 mg/24 h bili su eritem na mjestu primjene (5,7% za prvi u odnosu na 4,6% za drugi) te pruritus na mjestu primjene (3,6% za prvi u odnosu na 2,8% za drugi).
English: Where to apply your Rivastigmine 3M Health Care Ltd. transdermal patch - Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
Croatian: Gdje treba postaviti Rivastigmin 3M Health Care Ltd. transdermalni flaster - Prije postavljanja flastera provjerite da Vam je koža čista, suha i bez dlaka, bez pudera, ulja,
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 4.15 cm2 contains 7.17 mg rivastigmine and delivers 4.6 mg/24 h.
Croatian: 1 transdermalni flaster površine 4,15 cm2 sadrži 7,17 mg rivastigmina i oslobađa 4,6 mg/24 h.
English: Rivastigmine 4.6 mg/24 h
Croatian: 4,6 mg/24 h.
English: Other medicines and Rivastigmine 3M Health Care Ltd.
Croatian: Drugi lijekovi i Rivastigmin 3M Health Care Ltd.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 8.3 cm2 contains 14.33 mg rivastigmine and delivers 9.5 mg/24 h.
Croatian: 1 transdermalni flaster površine 8,3 cm2 sadrži 14,33 mg rivastigmina i oslobađa 9,5 mg/24 h.
English: No study was conducted with rivastigmine transdermal patches in subjects with hepatic impairment.
Croatian: Nije provedeno nikakvo ispitivanje s transdermalnim flasterima s rivastigminom u ispitanika s oštećenjem bubrega.
English: You should not breast-feed during treatment with Rivastigmine 3M Health Care Ltd. transdermal patches.
Croatian: Ne smijete dojiti tijekom liječenja Rivastigmin 3M Health Care Ltd. transdermalnim flasterima.
English: 9.5 mg/24 h transdermal patches.
Croatian: 9,5 mg/24 h transdermalni flaster
English: - Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of rivastigmine per 24 hours, is 8.3 cm2 and contains 14.33 mg of rivastigmine.
Croatian: 9,5 mg/24 h transdermalni flasteri: Jedan flaster koji oslobađa 9,5 mg rivastigmina tijekom 24 sata ima površinu 8,3 cm2 i sadrži 14,33 mg
English: Rivastigmine capsules 12 mg/day N = 256
Croatian: 12 mg/dan N=256
English: If you forget to use Rivastigmine 3M Health Care Ltd.
Croatian: Ako ste zaboravili primijeniti Rivastigmin 3M Health Care Ltd.
English: Application site skin reactions (e.g. application site erythema, application site pruritus, application site oedema, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue,
Croatian: Kožne reakcije na mjestu primjene (npr. eritem na mjestu primjene, pruritus na mjestu primjene, edem na mjestu primjene, dermatitis na mjestu primjene, nadražaj na mjestu primjene), astenična stanja (npr. umor i astenija), pireksija, gubitak tjelesne težine
English: Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. transdermal patches as follows: - A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Croatian: Na temelju usporedive izloženosti oralnom i transdermalnom rivastigminu (vidjeti dio 5.2), bolesnici liječeni kapsulama ili oralnom otopinom s rivastigminom mogu prijeći na Rivastigmin3M Health Care
English: The percentages decreased in both rivastigmine 13.3 mg/24 h transdermal patch and rivastigmine 9.5 mg/24 h transdermal patch treatment groups over time (>24 weeks): application site erythema (0.8% vs. 1.6%) and application site pruritus (0.4% vs. 1.2%), respectively.
Croatian: Postotci su se tijekom vremena (>24 tjedna) smanjili i u terapijskoj skupini koja je primjenjivala transdermalni flaster s rivastigminom u dozi od 13,3 mg/24 h i u onoj koja je primjenjivala transdermalni flaster s rivastigminom u dozi od 9,5 mg/24 h: eritem na mjestu primjene (0,8% u odnosu na 1,6%) i pruritus na mjestu primjene (0,4% u odnosu na 1,2%).
English: Rivastigmine 9.5 mg/24 h
Croatian: 9,5 mg/24 h
English: - Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patches: Each patch releases 4.6 mg of rivastigmine per 24 hours, is 4.15 cm2 and contains 7.17 mg of rivastigmine.
Croatian: 4,6 mg/24 h transdermalni flasteri: Jedan flaster koji oslobađa 4,6 mg rivastigmina tijekom 24 sata ima površinu 4,15 cm2 i sadrži 7,17 mg
English: - A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
Croatian: - Bolesnik na stabilnoj dozi od 9 mg/dan oralnog rivastigmina koju dobro podnosi može prijeći na transdermalni flaster u dozi od 9,5 mg/24 h.
English: The active substance of Rivastigmine 3M Health Care Ltd. is rivastigmine.
Croatian: Djelatna tvar Rivastigmina 3M Health Care Ltd. je rivastigmin.
English: Dose escalation
Croatian: Povećavanje doze
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Take off the previous patch before putting ONE new patch on.
Croatian: Ukloniti prethodni flaster prije postavljanja JEDNOG novog flastera.
English: - The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Croatian: Odjednom se smije nositi samo jedan flaster (vidjeti - Flaster treba držati čvrsto pritisnut dlanom najmanje 30 sekundi dok se rubovi dobro ne zalijepe.
English: • Summary of Product Characteristics
Croatian: • Sažetak opisa svojstava lijeka
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 transdermal patch per pouch.
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: - if you have, or have ever had, difficulties in passing urine.
Croatian: - ako imate ili ste imali otežano mokrenje.
English: Other side effects seen with Rivastigmine 3M Health Care Ltd. capsules or oral solution and which may occur with the patch:
Croatian: Ostale nuspojave zabilježene uz primjenu Rivastigmin 3M Health Care Ltd. kapsula ili oralne
English: Hands should be washed with soap and water after removing the patch.
Croatian: Nakon uklanjanja flastera, ruke treba oprati vodom i sapunom.
English: Uncommon (may affect up to 1 in 100 people) - Uneven heart rate (e.g. fast heart rate) - Difficulty sleeping - Accidental falls
Croatian: - Inkontinencija mokraće (nemogućnost zadržavanja mokraće) Manje često (mogu se javiti u do 1 na 100 ljudi) - Problemi s radom srca, poput ubrzanih ili usporenih otkucaja srca
English: Psychiatric disorders Common
Croatian: Infekcija urinarnog trakta
English: IMPORTANT: - Take off the previous patch before putting ONE new patch on. - Only one patch per day.
Croatian: VAŽNO: - Uklonite prethodni flaster prije stavljanja JEDNOG novog flastera.
English: - Hepatic impairment: No dose adjustment is necessary for patients with hepatic impairment.
Croatian: - Oštećenje jetre: U bolesnika s blagim do umjerenim oštećenjem jetre.
English: A relationship between active substance exposure at steady state (rivastigmine and metabolite
Croatian: U bolesnika s Alzheimerovom demencijom uočena je povezanost između izloženosti djelatnoj tvari u stanju dinamičke ravnoteže (rivastigmin i metabolit NAP226-90) i tjelesne težine.
English: The backing layer is transparent to translucent and labelled with “R5” (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or “R10” (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Croatian: Potporni sloj je proziran do zamućen s oznakom „R5“ (Rivastigmin 3M Health Care Ltd.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
Croatian: Rivastigm in 3M Health Care Ltd. 10 cm2
English: - to patients with a history of asthma or obstructive pulmonary disease.
Croatian: U bolesnika s Alzheimerovom bolešću nema nakupljanja rivastigmina ili dekarbamiliranog metabolita.
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
Croatian: Rezultati ADAS-cog-a: Negativna razlika u DLSM-u upućuje na veće poboljšanje kod Rivastigmin 3M Health Care Ltd.a 15 cm2 u usporedbi s Rivastigminom 3M Health Care Ltd. 10 cm2.
English: - Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Croatian: - Dlanom pritisnite flaster čvrsto na mjesto i držite tako najmanje 30 sekundi.
English: ADCS-IADL scores: A positive difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
Croatian: Rezultati ADCS-IADL-a: Pozitivna razlika u DLSM-u upućuje na veće poboljšanje kod Rivastigmin 3M Health Care Ltd.a 15 cm2 u usporedbi s Rivastigminom 3M Health Care Ltd. 10 cm2.
English: How to store Rivastigmine 3M Health Care Ltd.
Croatian: Kako primjenjivati Rivastigmin 3M Health Care Ltd.
English: What is in this leaflet
Croatian: Pogledajte dio
English: Hepatic impairment
Croatian: Oštećenje jetre
English: Marketing Authorisation Holder 3M Health Care Limited, 1 Morley Street,
Croatian: 3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire,
English: Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch.
Croatian: Ne dodirujte oči prstima i operite ruke sapunom i vodom nakon uklanjanja flastera.
English: Transdermal patches
Croatian: Transdermalni flasteri s rivastigminom
English: DB-week 48 Value Change 264 4.1 268 4.9 -0.8 (-2.1,
Croatian: Srednja početna vrijednost  SD Srednja promjena nakon 24 tjedna  SD -0,1  9,1
English: If you stop using Rivastigmine 3M Health Care Ltd. Tell your doctor or pharmacist if you stop using the patch.
Croatian: Obratite se svom liječniku ili ljekarniku ako prestanete koristiti flaster.
English: - A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Croatian: - Bolesnik koji primjenjuje oralni rivastigmin u dozi od 6 mg/dan može prijeći na transdermalni
English: Backing layer
Croatian: Zaštitna folija:
English: Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
Croatian: 4,6 mg/24 h transdermalni flaster Rivastigmin 3M Health Care Ltd.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rivastigmin 3M Health Care Ltd.
English: Week 48 Value
Croatian: n Srednja vrijednost
English: The 24-week results for the three assessment tools are summarised in Table 2.
Croatian: Rezultati nakon 24 tjedna za tri ocjenske skale
English: Skin irritation
Croatian: Nadražaj kože
English: p-value versus placebo *p<0.05 versus placebo
Croatian: p-vrijednost u odnosu na placebo ADCS-CGIC
English: EXP.
Croatian: ITT: eng.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
Croatian: Rivastigm in 3M Health Care Ltd. 10 cm n Srednja n Srednja vrijednost
English: Change 265 -4.4 271 -6.2 2.2 (0.8,
Croatian: Izvor: Ispitivanje D2340-Tablica 11-6 i Tablica 11-7
English: Otherwise your doctor will restart your treatment on Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h.
Croatian: Ako se dobro podnosi, liječnik može razmotriti povećavanje doze na 13,3 mg/24 h (3M Health Care Ltd.
English: Acrylate copolymer adhesive
Croatian: Adhezivni matriks s lijekom: ljepilo od akrilatnog kopolimera izopropil miristat
English: - The patch can be used in everyday situations, including bathing and during hot weather.
Croatian: - Ako flaster otpadne, potrebno je primijeniti novi za ostatak dana, a zatim ga treba zamijeniti u - Flaster se može koristiti u svakodnevnim situacijama, uključujući tijekom kupanja i za vrućeg - Flaster ne smije biti izložen nikakvim vanjskim izvorima vrućine (npr. prekomjernoj sunčevoj svjetlosti, saunama, solariju) tijekom duljih vremenskih razdoblja.
English: ADAS-Cog LOCF
Croatian: LOCF - eng.
English: - Keep this medicine out of the sight and reach of children.
Croatian: Vratite iskorišteni flaster u vrećicu i odložite ga tako da mu djeca nemaju pristup.
English: This summary was last updated in 04-2016.
Croatian: Ovaj je sažetak posljednji put ažuriran u 04. 2016.
English: The patient should not lie down for one hour after taking the tablet.
Croatian: Bolesnica ne smije leći jedan sat nakon uzimanja tablete.
English: (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.)
Croatian: (U područjima s tvrdom vodom, u kojima voda iz slavine sadrži mnogo otopljenog kalcija, može se koristiti voda iz boce s niskom razinom minerala.)
English: If the tablet is used, the dose is one tablet every month, preferably on the same date each month.
Croatian: Ako se uzima tableta, doza je jedna tableta svakog mjeseca, poželjno istog datuma svakog mjeseca.
English: What measures are being taken to ensure the safe and effective use of Bonviva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bonviva?
English: The dose by injection is 3 mg once every three months.
Croatian: Injekcijom se ubrizgava doza od 3 mg, i to jedanput svaka tri mjeseca.
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour.
Croatian: Tablete se ne smiju primjenjivati u bolesnica koje imaju abnormalan ezofagus ili koje ne mogu stajati, odnosno uspravno sjediti najmanje jedan sat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Bonviva na snazi u Europskoj uniji od 23. veljače 2004.
English: The medicine can only be obtained with a prescription.
Croatian: Lijek se izdaje samo na liječnički recept.
English: Bonviva ibandronic acid
Croatian: Bonviva ibandronatna kiselina
English: The studies looked at the change in the density of the bones in the spine and the hip over two years.
Croatian: U tim se ispitivanjima promatrala promjena u gustoći kostiju u kralježnici i kuku u razdoblju od dvije godine.
English: Other information about Bonviva
Croatian: Ostale informacije o lijeku Bonviva
English: Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
Croatian: Bolesnice koje uzimaju lijek Bonviva također trebaju uzimati nadomjeske vitamina D i kalcija ako ih putem hrane ne dobivaju u dovoljnoj mjeri.
English: This is a summary of the European public assessment report (EPAR) for Bonviva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Bonviva.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Croatian: Osteoporoza je uobičajenija u žena u postmenopauzi kada se snižavaju razine ženskog hormona estrogena, s obzirom na to da estrogen pomaže pri održavanju kosti zdravima.
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 Bonviva.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Bonviva.
English: Bonviva has been studied in three main studies involving women with osteoporosis.
Croatian: Lijek Bonviva ispitivan je u tri glavna ispitivanja na ženama s osteoporozom.
English: The most serious side effects with Bonviva are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut) irritation and eye inflammation.
Croatian: Najteže su nuspojave zabilježene pri primjeni lijeka Bonviva anafilaktička reakcija (teška alergijska reakcija), atipični prijelomi femura (neobičan oblik prijeloma natkoljenice), osteonekroza čeljusti (oštećenje kosti čeljusti koje može dovesti do boli, ranica u ustima ili pomicanja zubi), gastrointestinalne iritacije (u želucu i crijevima) i upala oka.
English: A risk management plan has been developed to ensure that Bonviva is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Bonviva.
English: The 2.5-mg once-daily tablets used in the studies are no longer authorised.
Croatian: Tablete od 2,5 mg koje se uzimaju jedanput dnevno i koje su se koristile u ispitivanjima više nisu odobrene.
English: Blocking the action of these cells leads to less bone loss.
Croatian: Onemogućavanje djelovanja tih stanica rezultira smanjenjem gubitka kosti.
English: Gradually, the bones become thin and fragile, and more likely to break.
Croatian: Kosti postupno postaju tanke i krhke te podložnije lomovima.
English: In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Croatian: Osim toga, tvrtka koja lijek Bonviva stavlja u promet osigurat će karticu za bolesnice koje primaju lijek putem infuzije s informacijama o riziku od osteonekroze čeljusti i uputama o tome da se obrate svom liječniku ako uoče naznačene simptome.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bonviva, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Bonviva nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels).
Croatian: Lijek Bonviva ne smije se primjenjivati u bolesnica s hipokalcemijom (niskom razinom kalcija u krvi).
English: The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Bonviva, ibandronatna kiselina, jest bisfosfonat.
English: What is the risk associated with Bonviva?
Croatian: Koji su rizici povezani s lijekom Bonviva?
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Croatian: Djeluje tako da onemogućuje djelovanje osteoklasta, stanica koje su uključene u razgradnju koštanog tkiva.
English: Bonviva can be given either as a tablet or as an injection into a vein.
Croatian: Lijek Bonviva može se davati ili u obliku tablete ili putem intravenske injekcije.
English: Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
Croatian: U ispitivanjima je utvrđeno da lijek smanjuje rizik od prijeloma kralježnice, no nije utvrđeno djelovanje na rizik od prijeloma vrata femura (gornjeg dijela bedrene kosti).
English: The CHMP decided that Bonviva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Bonviva nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
Croatian: Dostupan je u obliku tableta (od 150 mg) i otopine za ubrizgavanje putem napunjene štrcaljke (3 mg).
English: The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Croatian: Najčešće su nuspojave lijeka Bonviva (zabilježene u između 1 i 10 na 100 bolesnica) artralgija (bol u zglobovima) i simptomi slični gripi (prehladi).
English: The full EPAR for Bonviva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Bonviva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Bonviva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What is Bonviva?
Croatian: Što je Bonviva?