FrancophonIA/ELRC3.0 huggingface dataset:
English: ► NovoMix 30 FlexPen is only suitable for injecting under the skin.
Croatian: ► NovoMix 30 FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: NovoMix 50 FlexPen is only suitable for injecting under the skin.
Croatian: NovoMix 50 FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: 141-180 mg/dl
Croatian: 7,9 - 10 mmol/l 141 - 180 mg/dl
English: 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine SC use
Croatian: 70% otopine aspart inzulina i 30% aspart inzulina kristaliziranog s protaminom s.c. primjena
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 50/50 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina/aspart inzulina kristaliziranog s protaminom u omjeru 50/50 (što odgovara 3,5 mg).
English: 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine SC use
Croatian: 30% otopine aspart inzulina i 70% aspart inzulina kristaliziranog s protaminom s.c. primjena
English: 1 cartridge contains 3 ml equivalent to 300 units
Croatian: 1 napunjena brizgalica sadrži 3 ml, što odgovara 300 jedinica,
English: Before opening: NovoMix 30 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Croatian: Prije otvaranja: NovoMix 30 FlexPen koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
English: NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: NovoMix 70 Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: ► NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: ► NovoMix 50 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: NovoMix 30 FlexPen is only suitable for injecting under the skin.
Croatian: NovoMix 30 FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: Before opening: NovoMix 70 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Croatian: Prije otvaranja: NovoMix 70 Penfill koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
English: During use or when carried as a spare: NovoMix 70 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 70 Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: During use or when carried as a spare: NovoMix 70 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 70 FlexPen koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Croatian: 70% otopine aspart inzulina i 30% aspart inzulina kristaliziranog s protaminom
English: NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: NovoMix 50 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: NovoMix 30 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: ► NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: ► NovoMix 30 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: ► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: ► NovoMix 70 Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina*/aspart inzulina* kristaliziranog s protaminom u omjeru 50/50 (što odgovara 3,5 mg).
English: NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: NovoMix 50 Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: During use or when carried as a spare: NovoMix 30 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 30 Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: The insulin will work more quickly if you inject around the waist.
Croatian: Ako injicirate inzulin u područje trbuha, početak djelovanja bit će brži.
English: NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: NovoMix 30 Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: Before opening: NovoMix 50 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Croatian: Prije otvaranja: NovoMix 50 Penfill koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
English: During use or when carried as a spare: NovoMix 50 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 50 FlexPen koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: 5 x 3 ml cartridges
Croatian: 5 x 3 ml uložaka 10 x 3 ml uložaka
English: During use or when carried as a spare: NovoMix 50 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 50 Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Croatian: 30% otopine aspart inzulina i 70% aspart inzulina kristaliziranog s protaminom
English: ► If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
Croatian: ► ako inzulin nije jednoliko bijel, zamućen i voden nakon miješanja.
English: ► NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: ► NovoMix 50 Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: Instruction on how to use NovoMix 70 suspension for injection in FlexPen.
Croatian: Upute za uporabu NovoMix 70 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pažljivo pročitajte ove upute.
English: During use or when carried as a spare: NovoMix 30 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 30 FlexPen koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina/aspart inzulina kristaliziranog s protaminom u omjeru 30/70 (što odgovara 3,5 mg).
English: Before opening: NovoMix 30 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Croatian: Prije otvaranja: NovoMix 30 Penfill koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
English: Name and address of the manufacturers responsible for batch release
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: ► NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: ► NovoMix 30 Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: Instruction on how to use NovoMix 50 suspension for injection in FlexPen.
Croatian: Upute za uporabu NovoMix 50 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pažljivo pročitajte ove upute.
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 70/30 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina/aspart inzulina kristaliziranog s protaminom u omjeru 70/30 (što odgovara 3,5 mg).
English: Instruction on how to use NovoMix 30 suspension for injection in FlexPen.
Croatian: Upute za uporabu NovoMix 30 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pažljivo pročitajte ove upute.
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina*/aspart inzulina* kristaliziranog s protaminom u omjeru 30/70 (što odgovara 3,5 mg).
English: Before opening: NovoMix 70 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Croatian: Prije otvaranja: NovoMix 70 FlexPen koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C,
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 70/30 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina*/aspart inzulina* kristaliziranog s protaminom u omjeru 70/30 (što odgovara 3,5 mg).
English: What NovoMix 30 contains
Croatian: Sadržaj pakiranja i druge informacije Što NovoMix 30 sadrži
English: Resuspension of NovoMix 50
Croatian: Miješanje lijeka NovoMix 50
English: Before opening: NovoMix 50 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Croatian: Prije otvaranja: NovoMix 50 FlexPen koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C,
English: Resuspension of NovoMix 30
Croatian: Miješanje lijeka NovoMix 30
English: 15 April 2014 EMA/235924/2014
Croatian: 15. travnja 2014. EMA/235924/2014
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Kontaktirajte naše službenike za medije Monika Benstetter ili Martin Harvey
English: • If you have any questions, speak to your doctor or pharmacist.
Croatian: • Ako imate bilo kakvih pitanja, obratite se liječniku ili ljekarniku.
English: More information can be found here.
Croatian: Dodatne informacije dostupne su ovdje.
English: Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures.
Croatian: Važno je napomenuti, da tvrtka mora provesti daljnje istraživanje kako bi se dokazala djelotvornost novih mjera.
English: The results showed an increased risk of myocardial infarction with Protelos/Osseor as compared with placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI, 1.07 to 2.38), and an increased risk of venous thrombotic and embolic events - 1.9% versus 1.3 % with a relative risk of 1.5 (95% CI, 1.04 to 2.19).
Croatian: Rezultati pokazuju povećan rizik od infarkta miokarda uslijed uzimanja lijekova Protelos/Osseor u usporedbi s placebom (1,7% u odnosu na 1,1 %), s relativnim rizikom od 1,6 (95% CI, 1,07 do 2,38), i povećanim rizikom od venskih trombotskih i embolijskih događaja - 1,9% u odnosu na 1,3 % s relativnim rizikom od 1,5 (95% CI, 1,04 do 2,19).
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Croatian: Daljnje informacije o preporukama PRAC-a i osnovne informacije o ovom pregledu dostupne su na internetskim stranicama Agencije.
English: Protelos/Osseor to remain available but with further restrictions
Croatian: Lijekovi Protelos/Osseor ostaju dostupni, no s daljnjim ograničenjima
English: • Before starting treatment, your doctor will assess your risk of heart disease and high blood pressure and continue to check your risk at regular intervals during treatment.
Croatian: • Prije početka liječenja, Vaš će liječnik procijeniti rizik od srčane bolesti i visokog krvnog tlaka te nastaviti provjeravati ovaj rizik u redovitim intervalima tijekom liječenja.
English: The review of Protelos/Osseor was initiated in May 2013 at the request of European Commission under Article 20 of Regulation (EC) No 726/2004.
Croatian: Pregled lijekova Protelos/Osseor započet je u svibnju 2013. na zahtjev Europske komisije sukladno članku 20.
English: In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Croatian: Nadalje, bolesnici liječeni lijekovima Protelos/Osseor trebaju se redovito kontrolirati i pratiti, svakih 6 do 12 mjeseci.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom lijekovi Protelos/Osseor trebaju i dalje ostati opcija za bolesnike koji nemaju anamnezu kardiovaskularnih bolesti, a koji ne mogu uzimati druge lijekove.
English: The patient's risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months;
Croatian: Rizik bolesnika od razvijanja kardiovaskularne bolesti treba evaluirati prije početka liječenja te na redovitoj bazi, načelno svakih 6 do 12 mjeseci;
English: • Doctors should continue to base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks.
Croatian: • Liječnici trebaju i dalje temeljiti svoje odluke za propisivanje lijekova Protelos/Osseor na procjeni rizika za individualne bolesnike.
English: Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine.
Croatian: Dodatne mjere rizika obuhvaćaju dostavljanje edukacijskih materijala propisivačima kako bi se osiguralo da samo odgovarajući bolesnici primaju ovu terapiju.
English: As recommended in a previous review, patients who have a history of certain heart or circulatory problems, such as stroke and heart attack, must not use the medicine.
Croatian: Kako je preporučeno u prethodnom pregledu, bolesnici koji imaju anamnezu određenih problema sa srcem ili optokom, poput moždanog i srčanog udara, ne smiju koristiti lijek.
English: Both committees worked in close collaboration and the PRAC's recommendation was instrumental for us to fully assess the benefit-risk profile of the medicine', said Tomas Salmonson, chair of the CHMP.
Croatian: Oba su Povjerenstva usko surađivala, a preporuka PRAC-a bio je naš instrument za potpunu ocjenu profila omjera koristi i rizika lijeka, ” rekao je Tomas Salmonson, predsjednik CHMP-a.
English: In addition these patients should continue to be evaluated regularly by their doctor and treatment should be stopped if patients develop heart or circulatory problems, such as uncontrolled high blood pressure or angina.
Croatian: Nadalje, liječnici trebaju i dalje redovito evaluirati ove bolesnike, a terapiju treba prekinuti ako se u bolesnika razviju problemi sa srcem ili optokom, poput nekontroliranog visokog krvnog tlaka ili angine.
English: 'However, the CHMP considered that, for patients who have no alternative treatment, regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified by the PRAC so that these patients can continue to have access to the medicine.'
Croatian: „No, CHMP je zaključio da će, u slučaju bolesnika koji nemaju alternativno liječenje, redoviti pregledi i praćenje isključiti kardiovaskularne bolesti u dostatnoj mjeri kako bi se smanjio rizik kojeg je PRAC identificirao tako da ovi bolesnici mogu nastaviti uzimati lijek.”
English: In deciding on how Protelos/Osseor should be used, the CHMP took into account the PRAC's analysis of its benefits and risks as well as advice from osteoporosis experts that there is a group of patients who could benefit from the medicine.
Croatian: Prilikom donošenja odluke o načinu primjene lijekova Protelos/Osseor, CHMP je razmotrio analizu koristi i rizika koju je proveo PRAC kao i savjet stručnjaka za osteoporozu da postoji grupa bolesnika koji bi mogli imati koristi od lijeka.
English: The PRAC's recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP) responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Preporuke PRAC-a su zatim dostavljene Povjerenstvu za primjenu lijekova u ljudi (CHMP) odgovornom za sva pitanja u vezi s lijekovima za uporabu u ljudi, koje je usvojilo konačno mišljenje Agencije.
English: This final EMA recommendation on the use of Protelos/Osseor was based on an analysis of pooled data from randomised studies in around 7,500 post-menopausal women with osteoporosis.
Croatian: Ova konačna preporuka EMA-e o primjeni lijekova Protelos/Osseor temelji se na analizi podataka prikupljenih u randomiziranim ispitivanjima na otprilike 7.500 žena u postmenopauzi oboljelih od osteoporoze.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 15 April 2014.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj komisiji, koja ga je potvrdila i usvojila kao svoju konačnu pravno obvezujuću odluku valjanju na razini EU dana 15. travnja 2014.
English: 'The CHMP agreed with the PRAC's overall assessment of the risks of Protelos/Osseor.
Croatian: „CHMP je se slaže sa cjelokupnom ocjenom rizika za lijekove Protelos/Osseor PRAC-a.
English: It is also used to treat severe osteoporosis in men who are at high risk of fracture.
Croatian: Koristi se također za liječenje teškog oblika osteoporoze u muškaraca koji su izloženi velikom riziku od prijeloma.
English: These final recommendations from the Agency's Committee for Medicinal Products for Human Use (CHMP) come after initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the medicine due to its cardiovascular risk.
Croatian: Ove konačne preporuke Povjerenstva za lijekove za primjenu kod ljudi (CHMP-a) pri Agenciji izdane su nakon prvotnog savjeta Povjerenstva za procjenu rizika na području farmakovigilancije (PRAC) za suspenziju lijeka uslijed kardiovaskularnog rizika.
English: The first stage of this review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Prvu fazu ovog pregleda provelo je Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC), povjerenstvo odgovorno za ocjenu sigurnosnih pitanja za lijekove za primjenu u ljudi, koje je donijelo niz preporuka.
English: • Doctors should review their patients currently on Protelos/Osseor as necessary.
Croatian: • Liječnici trebaju, prema potrebi, ponovno pregledati svoje bolesnike koji trenutno uzimaju Protelos/Osseor.
English: The CHMP's recommendations were sent to the European Commission, which endorsed them and issued a final legally binding decision valid throughout the EU.
Croatian: Preporuke CHMP-a dostavljene su Europskoj Komisiji, koja ih je potvrdila i izdala konačnu pravno obvezujuću odluku primjenjivu na razini EU.
English: The current recommendations add to EMA recommendations made in April 2013 not to use Protelos/Osseor in patients with known circulatory problems.
Croatian: Trenutne preporuke nadovezuju se na preporuke EMA-e, koje je Agencija donijela u travnju 2013. godine vezano uz nekorištenje lijekova Protelos/Osseor u bolesnika s problemima optoka.
English: The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis.
Croatian: Europska agencija za lijekove zaključila je svoj pregled lijekova Protelos/Osseor, te je preporučila daljnje ograničavanje uporabe lijekova na bolesnike koji se ne mogu liječiti drugim lijekovima odobrenima za liječenje osteoporoze.
English: Protelos/Osseor (strontium ranelate) is authorised in the EU to treat severe osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and who are at high risk of fracture (broken bones) to reduce the risk of fractures of the spine and the hip.
Croatian: Lijekovi Protelos/Osseor (stroncij ranelat) odobren je za primjenu u EU za liječenje teškog oblika osteoporoze (bolesti koja čini kosti lomljivima) u žena koje su prošle menopauzu te koje su izložene riziku od prijeloma (slomljenih kostiju) sa ciljem smanjivanja rizika od prijeloma kralježnice i kuka.
English: In addition, available data do not show evidence of an increased cardiovascular risk with Protelos/Osseor in patients who did not have a history of heart or circulatory problems.
Croatian: Nadalje, dostupni podaci nisu dostavili nikakav dokaz o povećanju kardiovaskularnog rizika od lijekova Protelos/Osseor u bolesnika koji nisu imali anamnezu problema sa srcem ili optokom.
English: 'The PRAC has worked closely with the CHMP throughout the procedure and while we acknowledge that the recommendations of the two committees differed, our understanding of the medicine's benefit-risk profile is closely aligned and we share a common view of the importance of effective monitoring of cardiovascular risk', said June Raine, chair of the PRAC.
Croatian: „PRAC je usko surađivao sa CHMP-om tijekom postupka, te iako priznajemo da se preporuke dva Povjerenstva razlikuju, naše razumijevanje profila omjera koristi i rizika lijeka je usklađeno te dijelimo isto mišljenje o važnosti učinkovitog praćenja kardiovaskularnog rizika”, rekla je June Raine, predsjednica PRAC-a. „PRAC će nastaviti praćenje sigurne primjene lijekova Protelos /Osseor kao i učinkovito smanjivanje rizika dugotrajne primjene.
English: • You should not take Protelos/Osseor if you have or have had heart or circulatory problems such as stroke, heart attack, or obstruction of the blood flow in the arteries.
Croatian: • Ne smijete uzimati lijekove Protelos/Osseor ako bolujete ili ste bolovali od problema sa srcem ili optokom poput moždanog udara, srčanog udara ili opstrukcije krvnog protoka u arterijama.
English: Regarding the benefits, the efficacy data showed an effect in preventing fractures, including in patients at high risk of fracture.
Croatian: U vezi s koristima, podaci o djelotvornosti dokazuju djelovanje u sprječavanju prijeloma, uključujući u bolesnika izloženih visokom riziku od prijeloma.
English: • Your treatment with Protelos/Osseor will be stopped if you develop heart or circulatory problems during treatment.
Croatian: • Liječenje lijekovima Protelos/Osseor treba prekinuti ako razvijete probleme sa srcem ili optokom tijekom liječenja.
English: In arriving at its conclusions, the CHMP noted that study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture.
Croatian: Pri donošenju zaključka, CHMP je napomenuo da su podaci ispitivanja pokazali povoljno djelovanje u sprječavanju prijeloma, uključujući i u bolesnika izloženih visokom riziku od prijeloma.