natgillin/translations-raw huggingface dataset:
Before you use NovoMix 50 FlexPen, remove it from the refrigerator.
Prije primjene lijeka NovoMix 50 FlexPen izvadite ga iz hladnjaka.
NovoMix 70 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 70 is essentially ‘sodium-free'.
NovoMix 70 sadrži manje od 1 mmol (23 mg) natrija po dozi, tj.
► Needles and NovoMix 70 Penfill must not be shared.
► Igle i NovoMix 70 Penfill ne smiju se dijeliti s drugim osobama.
NovoMix 50 FlexPen 100 units/ml
NovoMix 50 FlexPen 100 jedinica/ml
1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
1 x 3 ml uložak 5 x 3 ml uložaka 10 x 3 ml uložaka
Selecting your dose
Odmjeravanje doze
NovoMix 30 Penfill 100 units/ml
NovoMix 30 Penfill 100 jedinica/ml
MARKETING AUTHORISATION NUMBERS EU/1/00/142/020 1 pen of 3 ml EU/1/00/142/021 5 pens of 3 ml EU/1/00/142/022 10 pens of 3 ml
EU/1/00/142/020 1 brizgalica od 3 ml EU/1/00/142/021 5 brizgalica od 3 ml EU/1/00/142/022 10 brizgalica od 3 ml
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Kristalna faza (50%) sadrži aspart inzulin kristaliziran s protaminom, čiji je profil aktivnosti sličan humanom NPH inzulinu.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Kristalna faza (30%) sadrži aspart inzulin kristaliziran s protaminom, čiji je profil aktivnosti sličan humanom NPH inzulinu.
► Needles and NovoMix 50 FlexPen must not be shared.
► Igle i NovoMix 50 FlexPen ne smiju se dijeliti s drugim osobama.
NovoMix 50 FlexPen EU/1/00/142/014 EU/1/00/142/015 EU/1/00/142/016
EU/1/00/142/014 EU/1/00/142/015 EU/1/00/142/016
NovoMix 50 Penfill 100 units/ml
NovoMix 50 Penfill 100 jedinica/ml
Before you use NovoMix 30 FlexPen, remove it from the refrigerator.
Prije primjene lijeka NovoMix 30 FlexPen izvadite ga iz hladnjaka.
► After each injection, be sure to remove and discard the needle and store NovoMix 30 without the needle attached.
Nakon svakog injiciranja iglu uvijek skinite i bacite u otpad, a potom spremite NovoMix 30 bez nataknute igle.
Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and aqueous.
Nemojte koristiti uložak ako izmiješani inzulin nije jednoliko bijel, zamućen i voden.
Before using NovoMix 30
Prije primjene lijeka NovoMix 30
Only use resuspension if uniformly white, cloudy and aqueous For use by one person only
Mješavinu upotrijebiti samo ako je jednoliko bijela, zamućena i vodena.
Suspension for injection in pre-filled pen 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Suspenzija za injekciju u napunjenoj brizgalici 70% otopine aspart inzulina i 30% aspart inzulina kristaliziranog s protaminom
Uncommon - Oedema Uncommon - Injection site reactions
Manje često - edem Manje često - reakcije na mjestu injiciranja
NovoMix 30 FlexPen 100 units/ml
NovoMix 30 FlexPen 100 jedinica/ml
Always make sure that a drop appears at the needle tip before you inject.
Prije injiciranja uvijek morate provjeriti je li se na vrhu igle pojavila kapljica.
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 50 se primjenjuje supkutanom injekcijom u bedro ili trbušnu stijenku.
50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
50% otopine aspart inzulina i 50% aspart inzulina kristaliziranog s protaminom
NovoMix 70 Penfill is only suitable for subcutaneous injections from a reusable pen.
NovoMix 70 Penfill je prikladan samo za supkutane injekcije iz brizgalice za višekratnu uporabu.
Checking the insulin flow
Provjera protoka inzulina
NovoMix 30 is a biphasic suspension of the insulin analogue, insulin aspart.
Način primjene NovoMix 30 je bifazična suspenzija inzulinskog analoga, aspart inzulina.
Before using NovoMix 50
Prije primjene lijeka NovoMix 50
NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 30 is essentially ‘sodium-free'.
NovoMix 30 sadrži manje od 1 mmol (23 mg) natrija po dozi, tj.
50% soluble insulin aspart and 50% insulin aspart crystallised with protamine SC use
50% otopine aspart inzulina i 50% aspart inzulina kristaliziranog s protaminom s.c. primjena
Administration with FlexPen
Primjena FlexPen brizgalicom
Suspension for injection in pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Suspenzija za injekciju u napunjenoj brizgalici 30% otopine aspart inzulina i 70% aspart inzulina kristaliziranog s protaminom
► Needles and NovoMix 30 FlexPen must not be shared.
► Igle i NovoMix 30 FlexPen ne smiju se dijeliti s drugim osobama.
Do not use the cartridge if the resuspended insulin does not look uniformly white, cloudy and aqueous.
Nemojte koristiti brizgalicu ako izmiješani inzulin nije jednoliko bijel, zamućen i voden.
Before you use NovoMix 50 Penfill, remove it from the refrigerator.
Prije primjene lijeka NovoMix 50 Penfill izvadite ga iz hladnjaka.
Before you use NovoMix 30 Penfill, remove it from the refrigerator.
Prije primjene lijeka NovoMix 30 Penfill izvadite ga iz hladnjaka.
NovoMix 50 Penfill is only suitable for subcutaneous injections from a reusable pen.
NovoMix 50 Penfill je prikladan samo za supkutane injekcije iz brizgalice za višekratnu uporabu.
NovoMix 30 is presented as a suspension for injection in a pre-filled pen.
NovoMix 30 je suspenzija za injekciju u napunjenoj brizgalici.
NovoMix 30 Penfill is only suitable for subcutaneous injections from a reusable pen.
NovoMix 30 Penfill je prikladan samo za supkutane injekcije iz brizgalice za višekratnu uporabu.
NovoMix 70 FlexPen EU/1/00/142/020 EU/1/00/142/021 EU/1/00/142/022
EU/1/00/142/020 EU/1/00/142/021 EU/1/00/142/022
How to store NovoMix 30
Kako čuvati NovoMix 30
► Needles and NovoMix 50 Penfill must not be shared.
► Igle i NovoMix 50 Penfill ne smiju se dijeliti s drugim osobama.
NovoMix 70 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
NovoMix 70 FlexPen je napunjena brizgalica (označena bojom) namijenjena uporabi s iglama
NovoMix 30 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 30 se primjenjuje supkutanom injekcijom u bedro ili trbušnu stijenku.
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Preostalih 70% je u kristalnoj fazi, kao aspart inzulin kristaliziran s protaminom; on ima produljen apsorpcijski profil sličan humanom NPH
► Needles and NovoMix 30 Penfill must not be shared.
► Igle i NovoMix 30 Penfill ne smiju se dijeliti s drugim osobama.
► NovoMix 70 FlexPen is only suitable for injecting under the skin.
► NovoMix 70 FlexPen je prikladan samo za ubrizgavanje pod kožu.
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Preostalih 50% je u kristalnoj fazi, kao aspart inzulin kristaliziran s protaminom; on ima produljen apsorpcijski profil sličan humanom NPH
MARKETING AUTHORISATION NUMBERS EU/1/00/142/004 5 cartridges of 3 ml EU/1/00/142/005 10 cartridges of 3 ml
12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/142/004 5 uložaka od 3 ml
NovoMix 70 FlexPen is only suitable for injecting under the skin.
NovoMix 70 FlexPen je prikladan samo za ubrizgavanje pod kožu.
NovoMix 50 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
NovoMix 50 FlexPen je napunjena brizgalica (označena bojom) namijenjena uporabi s iglama
Before opening: Store in a refrigerator (2°C to 8°C) During use: Do not refrigerate.
Prije otvaranja: čuvati u hladnjaku (2°C do 8°C).
► NovoMix 50 FlexPen is only suitable for injecting under the skin.
► NovoMix 50 FlexPen je prikladan samo za ubrizgavanje pod kožu.
► NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
► NovoMix 70 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Preostalih 30% je u kristalnoj fazi, kao aspart inzulin kristaliziran s protaminom; on ima produljen apsorpcijski profil sličan humanom NPH
NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
NovoMix 70 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
Read the following instructions carefully before using your FlexPen.
Za dodatne informacije pročitajte upute za uporabu Vaše brizgalice.
6 seconds.
8 mm.
► NovoMix 30 FlexPen is only suitable for injecting under the skin.
► NovoMix 30 FlexPen je prikladan samo za ubrizgavanje pod kožu.
NovoMix 50 FlexPen is only suitable for injecting under the skin.
NovoMix 50 FlexPen je prikladan samo za ubrizgavanje pod kožu.
141-180 mg/dl
7,9 - 10 mmol/l 141 - 180 mg/dl
70% soluble insulin aspart and 30% insulin aspart crystallised with protamine SC use
70% otopine aspart inzulina i 30% aspart inzulina kristaliziranog s protaminom s.c. primjena
1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 50/50 (equivalent to 3.5 mg).
1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina/aspart inzulina kristaliziranog s protaminom u omjeru 50/50 (što odgovara 3,5 mg).
30% soluble insulin aspart and 70% insulin aspart crystallised with protamine SC use
30% otopine aspart inzulina i 70% aspart inzulina kristaliziranog s protaminom s.c. primjena
1 cartridge contains 3 ml equivalent to 300 units
1 napunjena brizgalica sadrži 3 ml, što odgovara 300 jedinica,
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.
Prije otvaranja: NovoMix 30 FlexPen koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
NovoMix 70 Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
► NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
► NovoMix 50 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
NovoMix 30 FlexPen is only suitable for injecting under the skin.
NovoMix 30 FlexPen je prikladan samo za ubrizgavanje pod kožu.
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.
Prije otvaranja: NovoMix 70 Penfill koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
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.
Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 70 Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
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.
Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 70 FlexPen koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
70% otopine aspart inzulina i 30% aspart inzulina kristaliziranog s protaminom
NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
NovoMix 50 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
NovoMix 30 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
► NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
► NovoMix 30 Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
► NovoMix 70 Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
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).
1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina*/aspart inzulina* kristaliziranog s protaminom u omjeru 50/50 (što odgovara 3,5 mg).
NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
NovoMix 50 Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
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.
Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 30 Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
The insulin will work more quickly if you inject around the waist.
Ako injicirate inzulin u područje trbuha, početak djelovanja bit će brži.
NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
NovoMix 30 Penfill je namijenjen uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
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.
Prije otvaranja: NovoMix 50 Penfill koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
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.
Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 50 FlexPen koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
5 x 3 ml cartridges
5 x 3 ml uložaka 10 x 3 ml uložaka
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.
Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 50 Penfill koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
30% otopine aspart inzulina i 70% aspart inzulina kristaliziranog s protaminom
► If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
► ako inzulin nije jednoliko bijel, zamućen i voden nakon miješanja.
► NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
► NovoMix 50 Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
Instruction on how to use NovoMix 70 suspension for injection in FlexPen.
Upute za uporabu NovoMix 70 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pažljivo pročitajte ove upute.
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.
Tijekom uporabe ili kad se lijek nosi kao rezervni: NovoMix 30 FlexPen koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70 (equivalent to 3.5 mg).
1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina/aspart inzulina kristaliziranog s protaminom u omjeru 30/70 (što odgovara 3,5 mg).
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.
Prije otvaranja: NovoMix 30 Penfill koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C, dalje od rashladnih dijelova.
Name and address of the manufacturers responsible for batch release
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
► NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
► NovoMix 30 Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
Instruction on how to use NovoMix 50 suspension for injection in FlexPen.
Upute za uporabu NovoMix 50 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pažljivo pročitajte ove upute.
1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 70/30 (equivalent to 3.5 mg).
1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina/aspart inzulina kristaliziranog s protaminom u omjeru 70/30 (što odgovara 3,5 mg).
Instruction on how to use NovoMix 30 suspension for injection in FlexPen.
Upute za uporabu NovoMix 30 suspenzije za injekciju u brizgalici FlexPen Prije uporabe brizgalice FlexPen pažljivo pročitajte ove upute.
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).
1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina*/aspart inzulina* kristaliziranog s protaminom u omjeru 30/70 (što odgovara 3,5 mg).
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.
Prije otvaranja: NovoMix 70 FlexPen koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C,
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).
1 ml suspenzije sadrži 100 jedinica otopine aspart inzulina*/aspart inzulina* kristaliziranog s protaminom u omjeru 70/30 (što odgovara 3,5 mg).
What NovoMix 30 contains
Sadržaj pakiranja i druge informacije Što NovoMix 30 sadrži
Resuspension of NovoMix 50
Miješanje lijeka NovoMix 50
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.
Prije otvaranja: NovoMix 50 FlexPen koji ne koristite morate čuvati u hladnjaku na 2°C do 8°C,
Resuspension of NovoMix 30
Miješanje lijeka NovoMix 30
15 April 2014 EMA/235924/2014
15. travnja 2014. EMA/235924/2014
Contact our press officers Monika Benstetter or Martin Harvey
Kontaktirajte naše službenike za medije Monika Benstetter ili Martin Harvey
• If you have any questions, speak to your doctor or pharmacist.
• Ako imate bilo kakvih pitanja, obratite se liječniku ili ljekarniku.
More information can be found here.
Dodatne informacije dostupne su ovdje.
Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures.
Važno je napomenuti, da tvrtka mora provesti daljnje istraživanje kako bi se dokazala djelotvornost novih mjera.
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).
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).
Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Daljnje informacije o preporukama PRAC-a i osnovne informacije o ovom pregledu dostupne su na internetskim stranicama Agencije.
Protelos/Osseor to remain available but with further restrictions
Lijekovi Protelos/Osseor ostaju dostupni, no s daljnjim ograničenjima
• 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.
• 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.
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.
Pregled lijekova Protelos/Osseor započet je u svibnju 2013. na zahtjev Europske komisije sukladno članku 20.
In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Nadalje, bolesnici liječeni lijekovima Protelos/Osseor trebaju se redovito kontrolirati i pratiti, svakih 6 do 12 mjeseci.
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.
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.
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;
Rizik bolesnika od razvijanja kardiovaskularne bolesti treba evaluirati prije početka liječenja te na redovitoj bazi, načelno svakih 6 do 12 mjeseci;
• Doctors should continue to base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks.
• Liječnici trebaju i dalje temeljiti svoje odluke za propisivanje lijekova Protelos/Osseor na procjeni rizika za individualne bolesnike.
Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine.
Dodatne mjere rizika obuhvaćaju dostavljanje edukacijskih materijala propisivačima kako bi se osiguralo da samo odgovarajući bolesnici primaju ovu terapiju.
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.
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.
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.
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.
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.
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.
'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.'
„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.”