natgillin/translations-raw huggingface dataset:
► NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
► Zdravilo NovoMix 70 Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
NovoMix 50 Penfill is only suitable for subcutaneous injections from a reusable pen.
Zdravilo NovoMix 50 Penfill je primerno samo za podkožno injiciranje z injekcijskim peresnikom za večkratno uporabo.
NovoMix 30 Penfill is only suitable for subcutaneous injections from a reusable pen.
Zdravilo NovoMix 30 Penfill je primerno samo za podkožno injiciranje z injekcijskim peresnikom za večkratno uporabo.
NovoMix 30 FlexPen is only suitable for injecting under the skin.
Zdravilo NovoMix 30 FlexPen je primerno samo za injiciranje pod kožo.
Always remove the needle after each injection and store your FlexPen without the needle attached.
Po vsakem injiciranju morate iglo odstraniti in zavreči, injekcijski peresnik FlexPen pa shraniti brez nameščene igle.
EU/1/00/142/023 1 pen of 3 ml EU/1/00/142/009 5 pens of 3 ml EU/1/00/142/010 10 pens of 3 ml EU/1/00/142/024 1 pen of 3 ml and 7 NovoFine needles EU/1/00/142/025 1 pen of 3 ml and 7 NovoTwist needles
EU/1/00/142/010 10 injekcijskih peresnikov s 3 ml EU/1/00/142/024 1 injekcijski peresnik s 3 ml in 7 igel NovoFine
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.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravila NovoMix 70 FlexPen, ki ga uporabljate ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku.
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.
Pred odprtjem: zdravilo NovoMix 70 FlexPen, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
► NovoMix 30 FlexPen is only suitable for injecting under the skin.
► Zdravilo NovoMix 30 FlexPen je primerno samo za injiciranje pod kožo.
STATEMENT OF ACTIVE SUBSTANCE
za subkutano uporabo
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.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravila NovoMix 70 Penfill, ki ga uporabljate ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku.
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 vsebuje 100 enot topnega insulina aspart*/s protaminom kristaliziranega insulina aspart* v razmerju 50/50 (kar ustreza 3,5 mg).
NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Zdravilo NovoMix 30 Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
What NovoMix 70 contains
Kaj vsebuje zdravilo NovoMix 70
30% soluble insulin aspart and 70% insulin aspart crystallised with protamine SC use
30 % topnega insulina aspart in 70 % insulina aspart, kristaliziranega s protaminom za subkutano uporabo
Check with your doctor, nurse or pharmacist if you are not sure.
Če niste prepričani, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom.
NovoMix 70 FlexPen 100 units/ml suspension for injection in a pre-filled pen 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
NovoMix 70 FlexPen 100 enot/ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku 70 % topnega insulina aspart in 30 % insulina aspart, kristaliziranega s protaminom
NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Zdravilo NovoMix 50 Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
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.
Pred odprtjem: zdravilo NovoMix 70 Penfill, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
NovoMix 30 Penfill 100 units/ml suspension for injection in a cartridge 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
NovoMix 30 Penfill 100 enot/ml suspenzija za injiciranje v vložku 30 % topnega insulina aspart in 70 % insulina aspart, kristaliziranega s protaminom
70% soluble insulin aspart and 30% insulin aspart crystallised with protamine SC use
70 % topnega insulina aspart in 30 % insulina aspart, kristaliziranega s protaminom za subkutano uporabo
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.
Pred odprtjem: zdravilo NovoMix 50 FlexPen, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
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 vsebuje 100 enot topnega insulina aspart/s protaminom kristaliziranega insulina aspart v razmerju 50/50 (kar ustreza 3,5 mg),
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.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravila NovoMix 50 FlexPen, ki ga uporabljate ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku.
If any of these apply, do not use NovoMix 70.
Kaj morate vedeti, preden boste uporabili zdravilo NovoMix 70 Ne uporabljajte zdravila NovoMix 70:
MARKETING AUTHORISATION NUMBERS EU/1/00/142/004 5 cartridges of 3 ml EU/1/00/142/005 10 cartridges of 3 ml
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/00/142/014 1 injekcijski peresnik s 3 ml EU/1/00/142/015 5 injekcijskih peresnikov s 3 ml
► NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
► Zdravilo NovoMix 50 Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
► NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
► Zdravilo NovoMix 30 Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
• If the moving procedure alone is not enough to give a uniformly white, cloudy and aqueous liquid, repeat the rolling and moving procedures described above until the liquid appears uniformly white, cloudy and aqueous.
• Če s tem postopkom ne dobite enakomerno bele, motne in vodne tekočine, ga ponavljajte,
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.
Pred odprtjem: zdravilo NovoMix 30 FlexPen, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
NovoMix 30 FlexPen 100 units/ml suspension for injection in a pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
NovoMix 30 FlexPen 100 enot/ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku 30 % topnega insulina aspart in 70 % insulina aspart, kristaliziranega s protaminom
NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Zdravilo NovoMix 50 Penfill je namenjeno za uporabo v sistemih za dajanje insulina Novo Nordisk in iglami NovoFine ali 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.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravila NovoMix 30 Penfill, ki ga uporabljate ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku.
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.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravila NovoMix 30 FlexPen, ki ga uporabljate ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku.
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.
Med uporabo in ko zdravilo uporabljate kot rezervo: zdravila NovoMix 50 Penfill, ki ga uporabljate ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku.
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.
Pred odprtjem: zdravilo NovoMix 30 Penfill, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
How to store NovoMix 50
Shranjevanje zdravila NovoMix 50
12 units Residual scale
12 enot merilo preostanka igla (primer)
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.
Pred odprtjem: zdravilo NovoMix 50 Penfill, ki ga ne uporabljate, shranjujte v hladilniku pri temperaturi 2 °C - 8 °C in ne blizu hladilnega elementa.
► Inject the insulin under your skin.
Kako injicirati zdravilo NovoMix 30 ► Insulin injicirajte pod kožo.
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 vsebuje 100 enot topnega insulina aspart/s protaminom kristaliziranega insulina aspart v razmerju 30/70 (kar ustreza 3,5 mg),
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 vsebuje 100 enot topnega insulina aspart/s protamin kristaliziranega insulina aspart v razmerju 70/30 (kar ustreza 3,5 mg),
NovoMix 30 is for subcutaneous administration only.
Zdravilo NovoMix 30 je namenjeno zgolj subkutani uporabi.
How to store NovoMix 70
Shranjevanje zdravila NovoMix 70
What you need to know before you use NovoMix 30
Kaj morate vedeti, preden boste uporabili zdravilo NovoMix 30 Ne uporabljajte zdravila NovoMix 30:
How to store NovoMix 30
Shranjevanje zdravila NovoMix 30
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 vsebuje 100 enot topnega insulina aspart*/s protaminom kristaliziranega insulina aspart* v razmerju 30/70 (kar ustreza 3,5 mg).
1 x 3 ml pre-filled pen
5 x 3 ml vložek
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 vsebuje 100 enot topnega insulina aspart*/s protaminom kristaliziranega insulina aspart* v razmerju 70/30 (kar ustreza 3,5 mg).
Patients transferred to NovoMix 70 from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Bolniki, ki preidejo na zdravilo NovoMix 70 z druge vrste insulina,
NAME OF THE MEDICINAL PRODUCT NovoMix 50 Penfill 100 units/ml
IME ZDRAVILA IN POT UPORABE NovoMix 50 Penfill 100 enot/ml suspenzija za injiciranje
Pack sizes of 1, 5 and 10 pre-filled pens of 3 ml.
Pakiranja z 1, 5 in 10 vložki po 3 ml. Na trgu morda ni vseh navedenih pakiranj.
Patients transferred to NovoMix 50 from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Bolniki, ki preidejo na zdravilo NovoMix 50 z druge vrste insulina,
If any of these apply, do not use NovoMix 50.
Kaj morate vedeti, preden boste uporabili zdravilo NovoMix 50 Ne uporabljajte zdravila NovoMix 50:
NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Apliciranje s sistemom za dajanje insulina Zdravilo NovoMix 70 Penfill je namenjeno za uporabo v sistemih za dajanje insulina Novo Nordisk in iglami NovoFine ali NovoTwist.
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 zdravila Protelos/Osseor se je začel maja 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
• If you have any questions, speak to your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures.
Pomembno je, da družba izvede dodatne raziskave, s katerimi bo potrdila učinkovitost novih ukrepov.
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 so pokazali povečano tveganje za miokardni infarkt pri uporabi zdravila Protelos/Osseor v primerjavi s placebom (1,7 % v primerjavi z 1,1 %) z relativnim tveganjem 1,6 (95-odstotni IZ, 1,07 do 2,38) in povečano tveganje za venske trombotične in embolične dogodke1,9 % v primerjavi z 1,3 %, z relativnim tveganjem 1,5 (95-odstotni IZ, 1,04 do 2,19).
Protelos/Osseor to remain available but with further restrictions
Zdravilo Protelos/Osseor bo še naprej na voljo, vendar z dodatnimi omejitvami
'The PRAC will continue to monitor the safety of Protelos /Osseor and the effectiveness of risk minimisation in long term use.'
„Odbor PRAC bo še naprej spremljal varnost zdravila Protelos/Osseor ter učinkovitost ukrepov za zmanjšanje tveganja pri dolgotrajni uporabi.“
In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Poleg tega je treba bolnike, ki se zdravijo z zdravilom Protelos/Osseor, redno spremljati in pregledovati na vsakih 6 do 12 mesecev.
It is also used to treat severe osteoporosis in men who are at high risk of fracture.
Prav tako se uporablja za zdravljenje hude osteoporoze pri moških z velikim tveganjem za zlome.
'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.'
„Vendar je odbor CHMP menil, da bo pri bolnikih, ki nimajo nobene druge možnosti zdravljenja, redno pregledovanje in spremljanje za izključitev srčno-žilnih bolezni zadostno zmanjšalo tveganje, ki ga je ugotovil odbor PRAC, da lahko zdravilo za te bolnike ostane še naprej dostopno.“
• 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.
• Pred začetkom zdravljenja bo zdravnik ocenil, kakšno je vaše tveganje za bolezni srca in visok krvni tlak, ter tveganje nato ocenjeval v rednih časovnih presledkih tudi med zdravljenjem.
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;
Tveganje za razvoj srčno-žilne bolezni pri bolniku je treba oceniti pred začetkom zdravljenja in nato še v rednih časovnih presledkih, praviloma na vsakih 6 do 12 mesecev.
'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.
„Odbor PRAC je med celotnim postopkom tesno sodeloval z odborom CHMP in čeprav se zavedamo, da se priporočila obeh odborov razlikujejo, je naše razumevanje razmerja med tveganji in koristmi zdravila zelo usklajeno, imamo pa tudi enako mnenje o pomembnosti učinkovitega spremljanja srčno-žilnega tveganja,“ je dejala June Raine, predsednica odbora PRAC.
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.
Odbor CHMP je mnenje predložil Evropski komisiji, ki ga je potrdila in 15. aprila 2014 izdala končni pravno zavezujoči sklep, ki velja za celotno EU.
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.
Poleg tega morajo zdravniki te bolnike še naprej redno spremljati in zdravljenje prekiniti, če se pri njih pojavijo težave s srcem ali ožiljem, na primer nenadzorovan visok krvni tlak ali angina.
Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine.
Dodatni ukrepi za zmanjšanje tveganja vključujejo razdelitev izobraževalnega gradiva zdravstvenim delavcem, ki predpisujejo to zdravilo, da se zagotovi, da se bo uporabljalo samo pri ustrezni skupini bolnikov.
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.
Odbora sta pri svojem delu tesno sodelovala, priporočilo odbora PRAC pa je bilo ključno za našo celovito oceno razmerja med tveganji in koristmi zdravila,“ je dejal Tomas Salmonson, predsednik odbora CHMP.
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 velikim tveganjem, zaključil, da mora zdravilo Protelos/Osseor ostati dostopno bolnikom, ki v anamnezi nimajo srčno-žilnih bolezni in ne morejo uporabljati drugih zdravil.
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.
Pri sprejemanju odločitve glede uporabe zdravila Protelos/Osseor je odbor CHMP upošteval analizo koristi in tveganj, ki jo je izvedel odbor PRAC, ter mnenje strokovnjakov za osteoporozo, da obstaja skupina bolnikov, ki bi jim zdravilo lahko koristilo.
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.
To končno priporočilo Evropske agencije za zdravila glede uporabe zdravila Protelos/Osseor temelji na analizi združenih podatkov iz randomiziranih študij pri približno 7 500 ženskah po menopavzi, ki so imele osteoporozo.
• Doctors should continue to base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks.
• Odločitev zdravnikov, ali bodo predpisali zdravilo Protelos/Osseor, mora še naprej temeljiti na oceni tveganj za posameznega bolnika.
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.
Priporočila je nato posredoval Odboru za zdravila za uporabo v humani medicini (CHMP), pristojnemu za vsa vprašanja, povezana z zdravili za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
Regarding the benefits, the efficacy data showed an effect in preventing fractures, including in patients at high risk of fracture.
Kar zadeva koristi zdravila, so podatki o učinkovitosti pokazali učinek pri preprečevanju zlomov, med drugim tudi pri bolnikih z velikim tveganjem za zlome.
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.
Zdravilo Protelos/Osseor (stroncijev ranelat) je v EU odobreno za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah, pri katerih je že nastopila menopavza in pri katerih obstaja veliko tveganje za zlome (zlomljene kosti), da se zmanjša tveganje za zlome hrbtenice in kolka.
The CHMP's recommendations were sent to the European Commission, which endorsed them and issued a final legally binding decision valid throughout the EU.
Odbor CHMP je priporočila predložil Evropski komisiji, ki jih je potrdila in izdala končni pravno zavezujoči sklep, ki velja za celotno EU.
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.
Prvo fazo pregleda je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in podal več priporočil.
• Doctors should review their patients currently on Protelos/Osseor as necessary.
• Zdravniki naj po potrebi ponovno ocenijo zdravljenje pri bolnikih, ki trenutno uporabljajo zdravilo Protelos/Osseor.
• 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.
• Zdravila Protelos/Osseor ne smete uporabljati, če imate ali ste kdaj imeli težave s srcem ali ožiljem, kot so možganska kap, srčna kap ali zapora krvnega pretoka v arterijah.
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.
Pri sprejemanju zaključkov je odbor CHMP upošteval, da so podatki iz študij pokazali ugoden učinek pri preprečevanju zlomov, med drugim tudi pri bolnikih z velikim tveganjem za zlome.
'The CHMP agreed with the PRAC's overall assessment of the risks of Protelos/Osseor.
„Odbor CHMP se je strinjal s splošno oceno tveganj, povezanih z zdravilom Protelos/Osseor, ki jo je podal odbor PRAC.
The current recommendations add to EMA recommendations made in April 2013 not to use Protelos/Osseor in patients with known circulatory problems.
Sedanja priporočila dopolnjujejo priporočila Evropske agencije za zdravila, sprejeta aprila 2013, z omejitvijo, da se zdravilo Protelos/Osseor ne sme uporabljati pri bolnikih z ugotovljenimi težavami z ožiljem.
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.
Evropska agencija za zdravila je zaključila pregled zdravila Protelos/Osseor ter priporočila dodatno omejitev uporabe zdravila, in sicer na bolnike, ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ta končna priporočila izdal, potem ko je Odbor za oceno tveganja na področju farmakovigilance (PRAC) najprej priporočil začasni umik dovoljenja za promet z zdravilom zaradi z njim povezanega srčno-žilnega tveganja.
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.
Poleg tega razpoložljivi podatki ne kažejo, da se pri uporabi zdravila Protelos/Osseor poveča srčno-žilno tveganje pri bolnikih, ki v anamnezi niso imeli bolezni srca ali ožilja.