FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Croatian: Bolesnici koji su primali placebo bili su ponovno randomizirani u omjeru 1:1 za primanje lijeka Taltz svaka 2 tjedna ili svaka 4 tjedna u 16. ili 24. tjednu, ovisno o statusu postignutog odgovora.
English: When you dispose of the pre-filled pen and the sharps container:
Croatian: Pri zbrinjavanju brizgalice i spremnika za oštre predmete:
English: Taltz 80 mg Q2W (N = 351)
Croatian: Taltz 80 mg svaka 2 tjedna (N = 351)
English: Thrombocytopenia may persist, fluctuate or be transient.
Croatian: Trombocitopenija može biti trajna,
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije Plak psorijaza
English: - signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections
Croatian: - infekcije gornjih dišnih putova praćene simptomima poput grlobolje i začepljena nosa
English: Taltz was efficacious in biologic-naive, biologic-exposed and biologic-failure patients.
Croatian: Taltz je bio djelotvoran u bolesnika prethodno neliječenih biološkim lijekovima, onih prethodno izloženih biološkim lijekovima i onih koji nisu odgovorili na prethodno liječenje biološkim lijekovima.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava manje često neutropenijag, trombocitopenijag
English: (nasopharyngitis).
Croatian: (supkutana injekcija).
English: Commonly asked questions Q. What if I see air bubbles in my syringe?
Croatian: Što ako vidim mjehuriće zraka u štrcaljki?
English: Tinea infection, Herpes simplex (mucocutaneous)c
Croatian: herpes simpleks, genitalni herpes, herpesvirusni dermatitis i genitalni herpes simpleks.
English: Remove the pre-filled pen from your skin.
Croatian: Dignite brizgalicu s kože.
English: a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c p < 0.01 compared with placebo d Patients with Itch NRS > = 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306
Croatian: Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom b p < 0,001 u usporedbi s etanerceptom c p < 0,01 u usporedbi s placebom d Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 135, Taltz 80 mg svaka 4 tjedna N = 293, Taltz 80 mg svaka 2 tjedna N = 303, etanercept N = 306
English: Instructions for use Taltz 80 mg solution for injection in pre-filled syringe
Croatian: Upute za uporabu Taltz 80 mg otopina za injekciju u napunjenoj štrcaljki iksekizumab
English: “1” (rarely limited) a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no effect at all on patient's life.
Croatian: Questionnaire) = Upitnik o učestalosti spolne aktivnosti; b Ukupan DLQI rezultat 0,1 znači da stanje kože nema nikakvog utjecaja na bolesnikov život. sPGA rezultat “0” ili “1” znači “čisto” ili
English: Grey syringe plunger
Croatian: Sivi klip štrcaljke
English: Taltz 80 mg Q4W (N = 386)
Croatian: Taltz 80 mg svaka 4 tjedna (N = 386)
English: Commonly asked questions Q. What if I see air bubbles in the pre-filled pen?
Croatian: Što ako vidim mjehuriće zraka u napunjenoj brizgalici?
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Taltz Lijek čuvajte izvan pogleda i dohvata djece.
English: The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a biologic.
Croatian: Djelotvornost i sigurnost lijeka Taltz dokazana je neovisno o dobi, spolu, rasi, tjelesnoj težini,
English: Taltz 80 mg Q2W (N = 385)
Croatian: Taltz 80 mg svaka 2 tjedna (N = 385)
English: NA
Croatian: O.
English: Taltz 80 mg solution for injection in pre-filled syringe ixekizumab
Croatian: Taltz 80 mg otopina za injekciju u napunjenoj brizgalici iksekizumab
English: Patients were randomised (1:1:1) to receive either placebo or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) for 12 weeks.
Croatian: za primanje placeba ili lijeka Taltz (80 mg svaka dva ili četiri tjedna nakon početne doze od 160 mg)
English: • Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Croatian: Brizgalicu zbrinite u spremnik za oštre predmete ili sukladno uputama svog liječnika, ljekarnika ili medicinske sestre.
English: You may inject in your abdomen (stomach area), in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you.
Croatian: Lijek možete injicirati u trbuh, bedro ili stražnji dio nadlaktice.
English: The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in either the plaque psoriasis or the psoriatic arthritis studies g Based on reported adverse events h Based on postmarketing reports i Adverse drug reactions in patients treated with ixekizumab in the plaque psoriasis and psoriatic arthritis clinical trials were similar with the exception of the frequencies of influenza (common) and conjunctivitis (common) in the psoriatic arthritis clinical trials
Croatian: iNuspojave zabilježene u bolesnika liječenih iksekizumabom u kliničkim ispitivanjima primjene kod plak psorijaze i psorijatičnog artritisa bile su slične, uz izuzetak učestalosti gripe (često) i konjunktivitisa (često) u kliničkim ispitivanjima kod psorijatičnog artritisa.
English: Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years of age or older and 36 patients were 75 years of age or older.
Croatian: 301 bolesnik imao 65 ili više godina, dok je 36 bolesnika imalo 75 ili više godina.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders.
Croatian: Kratice: N = broj bolesnika u populaciji uključenoj u analizu
English: Taltz 80 mg Q4W (N = 347)
Croatian: Taltz 80 mg svaka 4 tjedna (N = 347)
English: Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Croatian: Jedna napunjena brizgalica sadrži 80 mg iksekizumaba u 1 ml otopine.
English: EU/1/15/1085/004 1 pre-filled syringe EU/1/15/1085/005 2 pre-filled syringes EU/1/15/1085/006 3 pre-filled syringes
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1085/004 1 napunjena štrcaljka
English: EU/1/15/1085/001 1 pre-filled pen EU/1/15/1085/002 2 pre-filled pens EU/1/15/1085/003 3 pre-filled pens
Croatian: EU/1/15/1085/002 2 napunjene brizgalice
English: Water for injections
Croatian: Gumb za injiciranje
English: Taltz 80 mg Q4W (N = 432)
Croatian: Taltz 80 mg svaka 4 tjedna (N = 432)
English: Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution.
Croatian: Jedna napunjena štrcaljka sadrži 80 mg iksekizumaba u 1 ml otopine.
English: Influenzai, Rhinitis, Oral candidiasisd, Conjunctivitisi, Cellulitise
Croatian: Infekcije i infestacije vrlo često infekcija gornjih dišnih putovab često tinea, herpes simpleks (mukokutani)c manje često gripai, rinitis, oralna kandidijazad, konjunktivitisi, celulitise
English: After switching from the 80 mg Q2W dosing regimen to the 80 mg Q4W dosing regimen at Week 12, steady state would be achieved after approximately 10 weeks.
Croatian: Nakon prelaska s režima doziranja 80 mg svaka 2 tjedna na režim doziranja 80 mg svaka 4 tjedna u
English: Patients on Taltz Q2W or Q4W remained on their originally assigned dose of Taltz.
Croatian: Bolesnici koji su primali Taltz svaka 2 tjedna ili svaka 4 tjedna nastavili su primati dozu lijeka Taltz za koju su prvotno bili randomizirani.
English: Serious allergic reaction (may affect up to 1 in 1,000 people) - the signs may include: - difficulty breathing or swallowing - low blood pressure, which can cause dizziness or light-headedness - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps
Croatian: Ozbiljna alergijska reakcija (može se javiti u do 1 na 1000 osoba) - znakovi mogu uključivati: - otežano disanje ili gutanje
English: Before you use the TALTZ pre-filled syringe, read and carefully follow all the step-by-step instructions.
Croatian: Prije nego što upotrijebite TALTZ napunjenu štrcaljku, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
English: Taltz 80 mg Q2W (N = 433)
Croatian: Taltz 80 mg svaka 2 tjedna (N = 433)
English: Taltz 80 mg solution for injection in pre-filled syringe.
Croatian: NAZIV LIJEKA Taltz 80 mg otopina za injekciju u napunjenoj štrcaljki.
English: Concomitant cDMARDs included MTX, leflunomide and sulfasalazine.
Croatian: Celulitis uključuje stafilokokni celulitis i celulitis vanjskog uha te erizipel.
English: What is in this leaflet
Croatian: U svim je ispitivanjima
English: a p<0.05; b p<0.01; c p<0.001 compared with placebo.
Croatian: *p < 0,01 u odnosu na ADA; †p < 0,05 u odnosu na ADA.
English: Before you use the Taltz pre-filled pen, read and carefully follow all the step-by-step instructions.
Croatian: Prije nego što upotrijebite Taltz napunjenu brizgalicu, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
English: Package leaflet: Information for the patient Taltz 80 mg solution for injection in pre-filled syringe ixekizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Taltz 80 mg otopina za injekciju u napunjenoj štrcaljki iksekizumab
English: Instructions for use Taltz 80 mg solution for injection in pre-filled pen
Croatian: Upute za uporabu Taltz 80 mg otopina za injekciju u napunjenoj brizgalici iksekizumab
English: N with baseline GPSS Itch NRS Score ≥3 N=62 N=60 GPSS Genital Itch (≥3 point improvement) N with baseline SFQ Item 2 Score ≥2
Croatian: Broj bolesnika s početnim GPSS NRS rezultatom za svrbež ≥3
English: • Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step instructions.
Croatian: • Prije nego što upotrijebite Taltz napunjenu štrcaljku, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
English: Subjects randomized to TALTZ received an initial dose of 160 mg followed by 80 mg every 2 weeks for 12 weeks.
Croatian: Ispitanici randomizirani za liječenje lijekom Taltz primili su početnu dozu od 160 mg, a zatim dozu od
English: 1 ml solution in a type I clear glass syringe.
Croatian: 6.5 Vrsta i sadržaj spremnika 1 ml otopine u prozirnoj staklenoj štrcaljki (staklo tipa I).
English: ACR 70 response, n (%) Week 24
Croatian: PASI 90, n (%)
English: Package leaflet: Information for the patient Taltz 80 mg solution for injection in pre-filled pen ixekizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Taltz 80 mg otopina za injekciju u napunjenoj brizgalici iksekizumab
English: • Before you use the Taltz pre-filled pen, read and carefully follow all the step-by-step instructions.
Croatian: • Prije nego što upotrijebite Taltz napunjenu brizgalicu, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
English: Upper respiratory tract infectionb
Croatian: Infekcija gornjih dišnih putova uključuje nazofaringitis i infekciju gornjih dišnih putova.
English: Some side effects are uncommon (may affect up to 1 in 100 people): - oral thrush (oral candidiasis).
Croatian: Neke nuspojave su manje česte (mogu se javiti u do 1 na 100 osoba):
English: IXE Q2 (N=103)
Croatian: IKS svaka 2 tj. (N=103)
English: Taltz Q2W (N = 123)
Croatian: PASI 100: Taltz (N=283)
English: 80 mg Q4W (induction) / 80 mg Q4W (maintenance)
Croatian: 80 mg svaka 4 tjedna (terapija održavanja) (N
English: Taltz is injected under the skin (subcutaneous injection).
Croatian: Taltz se injicira pod kožu
English: - The active substance is ixekizumab.
Croatian: Što Taltz sadrži - Djelatna tvar je iksekizumab.
English: This process is called remodelling.
Croatian: Taj se proces zove preoblikovanje.
English: This will help to prevent dehydration.
Croatian: To će pomoći u sprečavanju dehidracije.
English: Aclasta with food and drink
Croatian: Aclasta s hranom i pićem
English: Currently available data for children aged 5 to 17 years are described in section 5.1.
Croatian: Trenutno dostupni podaci za djecu u dobi od 5 do 17 godina opisani su u dijelu 5.1.
English: The educational programme contains the following:
Croatian: Program izobrazbe sadrži sljedeće:
English: Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.
Croatian: Aclasta može djelovati duže od jedne godine, a liječnik će Vam reći ako se trebate ponovo liječiti.
English: The duration of the trial was one year.
Croatian: Ispitivanje je trajalo jednu godinu.
English: Your doctor will let you know when to return for your next dose.
Croatian: Liječnik će Vam objasniti kada ćete se vratiti po sljedeću dozu.
English: You must not be given Aclasta if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Croatian: Ne smijete primati Aclastu ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
English: The clinical relevance of these findings is unknown.
Croatian: Kliniči značaj tih nalaza nije poznat.
English: What Aclasta is and what it is used for
Croatian: Što je Aclasta i za što se koristi
English: Other medicines and Aclasta
Croatian: Drugi lijekovi i Aclasta
English: All clinical fractures were verified based on the radiographic and/or clinical evidence.
Croatian: Svi klinički prijelomi su bili potvrđeni na temelju radiološkog i/ili kliničkog dokaza.
English: • Key signs and symptoms of serious adverse reactions
Croatian: • Ključni znakovi i simptomi ozbiljnih nuspojava
English: Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Croatian: Liječnik će Vas obavijestiti o simptomima koji su povezani s hipokalcijemijom.
English: No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Croatian: Nije potrebna prilagodba doze, jer su bioraspoloživost, distribucija i eliminacija bili slični kod starijih bolesnika i u mlađih ispitanika.
English: Patients who have received doses higher than those recommended should be carefully monitored.
Croatian: Bolesnici koji su primili doze više od preporučenih, moraju se pažljivo pratiti.
English: Long-term safety data in this population cannot be established from this study.
Croatian: Dugoročni podaci vezani uz sigurnost lijeka u ovoj populaciji se ne mogu ustanoviti iz ovog ispitivanja.
English: Physicians should consider clinical monitoring for these patients.
Croatian: Liječnici trebaju razmotriti kliničko praćenje ovih bolesnika.
English: There are no data available for children under 5 years of age.
Croatian: Nema dostupnih podataka za djecu mlađu od 5 godina.
English: It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Croatian: Važno je nastojati i spriječiti pojavu ONJ jer je to bolno stanje koje može biti teško liječiti.
English: It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Croatian: Važno je da se pažljivo pridržavate tog savjeta kako razina kalcija u Vašoj krvi ne bi postala preniska u razdoblju nakon infuzije.
English: Date of first authorisation: 15 April 2005 Date of latest renewal: 19 January 2015
Croatian: Datum prvog odobrenja: 15. travnja 2005.
English: Thus these results precluded determining a definitive effect of Aclasta on fertility in humans.
Croatian: Zbog toga ovi rezultati onemogućavaju određivanje konačnog učinka Aclaste na plodnost u ljudi.
English: Uncommon Decreased appetite Rare
Croatian: Manje često Smanjeni apetit Rijetko
English: For osteoporosis, Aclasta works for one year.
Croatian: U slučaju osteoporoze, Aclasta djeluje jednu godinu.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti su određene koristeći sljedeći dogovor: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Croatian: Kako bi se smanjio rizik od razvoja osteonekroze čeljusti trebate poduzeti neke mjere opreza.
English: What you need to know before you are given Aclasta
Croatian: Što morate znati prije nego što primite Aclastu
English: Your doctor, pharmacist or nurse knows how to store Aclasta properly.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako pravilno čuvati Aclastu.
English: The frequency of hypocalcaemia was much lower following subsequent infusions.
Croatian: Učestalost hipokalcijemije bila je znatno niža nakon sljedećih infuzija.
English: Your doctor will advise you and decide how long you should be treated with Aclasta.
Croatian: Liječnik će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Aclastom.
English: Poor healing of these fractures has also been reported.
Croatian: Također je prijavljeno slabo zacjeljivanje tih prijeloma.
English: After opening: 24 hours at 2°C - 8°C
Croatian: Nakon otvaranja: 24 sata na 2°C - 8°C.
English: It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.
Croatian: Trenutačno nije jasno uzrokuje li Aclasta te nepravilne otkucaje srca, ali morate se javiti liječniku ako osjetite takve simptome nakon što primite Aclastu.
English: This is especially important for the elderly (≥65 years)and for patients receiving diuretic therapy.
Croatian: To je osobito važno za starije osobe (≥65 godina) i bolesnike koji primaju diuretsku terapiju.
English: There is no clear evidence establishing a link between BMD changes and fracture prevention in children with growing skeletons.
Croatian: Nema jasnih dokaza koji bi potvrdili vezu između promjena u BMD-u i prevencije prijeloma u djece kojima raste skelet.
English: Multipack: 5 bottles, each bottle of 100 ml.
Croatian: Višestruko pakiranje: 5 bočica, svaka je bočica od 100 ml.
English: In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Croatian: U HORIZON-RFT ispitivanju bilo je randomizirano 508 muškaraca i u 185 bolesnika BMD je bio procijenjen u 24. mjesecu.
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Croatian: To je osobito važno u bolesnika koji uzimaju diuretike („tablete za mokrenje“) i u starijih bolesnika (65 godina starosti ili više).
English: Check with your doctor or nurse if you are not sure.
Croatian: Provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: If you wear dentures you should make sure these fit properly.
Croatian: Ako nosite protezu pobrinite se da dobro prijanja.
English: PARTICULARS TO APPEAR ON THE OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOJ KUTIJI VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Aclasta was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Croatian: Aclasta je primijenjena jedanput godišnje dok u barem 211 bolesnika u ispitivanoj populaciji nisu potvrđeni klinički prijelomi.
English: The majority of these reactions occur within the first three days following Aclasta administration.
Croatian: Većina tih reakcija pojavila se unutar prva tri dana nakon primjene Aclaste.
English: Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Croatian: Nuspojave povezane s prvom infuzijom su vrlo česte (javljaju se kod više od 30% bolesnika), ali su manje česte nakon daljnjih infuzija.
English: Before stopping Aclasta therapy
Croatian: Prije nego što prekinete terapiju Aclastom
English: What Aclasta is and what it is used for What you need to know before you are given Aclasta How Aclasta is given
Croatian: Što je Aclasta i za što se koristi Što morate znati prije nego što primite Aclastu
English: Driving and using machines If you feel dizzy while taking Aclasta, do not drive or use machines until you feel better.
Croatian: Ako osjećate omaglicu dok uzimate Aclastu, nemojte upravljati vozilima ili strojevima dok se ne budete bolje osjećali.
English: At the menopause, a woman's ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
Croatian: U menopauzi ženski jajnici prestaju stvarati ženski hormon estrogen, koji pomaže u održavanju zdravih kostiju.
English: It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Croatian: Važno je uzimati nadomjestke kalcija i vitamina D (na primjer tablete), prema uputama Vašeg liječnika.
English: The majority of patients continued to receive glucocorticoids for the one year duration of the trial.
Croatian: Većina bolesnika nastavila je primati glukokortikosteroide tijekom jedne godine trajanja ispitivanja.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Aclasta on an individual patient basis, particularly after 5 or more years of use.
Croatian: Periodički je potrebno ponovno procijeniti potrebu za nastavkom liječenja na temelju koristi i potencijalnih rizika Aclaste za svakog pojedinog bolesnika, osobito nakon 5 ili više godina primjene.
English: Children and adolescents Aclasta is not recommended for anyone under 18 years of age.
Croatian: Djeca i adolescenti Aclasta se ne preporučuje za osobe mlađe od 18 godina.
English: Histomorphometric analysis showed a 63% reduction in bone turnover.
Croatian: Histomorfometrijska analiza pokazala je 63%-tno smanjenje koštane pregradnje.
English: • When to seek attention from the health care provider
Croatian: • Kada zatražiti pomoć zdravstvenog radnika
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Croatian: • Praćenje kreatinina u serumu treba uzeti u obzir u bolesnika s rizikom.
English: Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker.
Croatian: Mnogi bolesnici s osteoporozom nemaju simptome, ali su svejedno izloženi riziku od loma kostiju, jer je osteoporoza oslabila njihove kosti.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Croatian: INFORMACIJE ZA ZDRAVSTVENE RADNIKE
English: These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Croatian: Ti su rezultati bili u skladu s dokazom biokemijskih markera za normalizaciju koštane pregradnje.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Aclasta.
Croatian: • Bolesnici, osobito stariji i oni koji primaju diuretsku terapiju, moraju biti prikladno hidrirani prije primjene Aclaste.
English: Teratogenicity was observed in rats at doses ≥ 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Croatian: Teratogenost je zapažena u štakora pri dozama ≥0,2 mg/kg, a izražavala se vanjskim, visceralnim i skeletnim malformacijama.
English: - if you have severe kidney problems.
Croatian: - ako imate teške bubrežne probleme.
English: • Physician educational material
Croatian: • Edukativne materijale za liječnika