FrancophonIA/ELRC3.0 huggingface dataset:
English: 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine SC use
Maltese: 30 % insulin aspart solubbli u 70 % insulin aspart ikkristallizzat bi protamine Għal użu taħt il-ġilda
English: Pregnancy
Maltese: unitajiet
English: When NovoMix 30 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Maltese: Meta NovoMix 30 ikun injettat minn taħt il-ġilda, jibda jaħdem fiżmien 10 sa 20 minuta millinjezzjoni.
English: This will make sure you get the full dose.
Maltese: Dan jassigura li tkun ħadt id-doża kollha.
English: Figure 1: Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
Maltese: Figura 1: Il-Profil ta' l-Attività għal NovoMix 50 f'Pazjenti Kawkasi b'Saħħithom
English: In type 2 diabetic patients, the maximum concentration was reached about 95 minutes after dosing, and concentrations well above zero for not less than 14 hours post-dosing were measured.
Maltese: F'pazjenti biddijabete ta' tip 2, il-konċentrazzjoni massima ntlaħqet madwar 95 minuta wara li ngħatat id-doża, u konċentrazzjonijiet 'il fuq sewwa minn żero għal mhux inqas minn 14-il siegħa wara li ngħatat id-doża ġew imkejla.
English: NovoMix 50 is a mixture consisting of 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine.
Maltese: NovoMix 50 huwa taħlita li tikkonsisti minn 50% insulin aspart li jinħall u 50% insulin aspart ikkristallizzat bi protamine.
English: Instruction on how to use NovoMix 70 suspension for injection in FlexPen.
Maltese: Istruzzjonijiet dwar kif tuża NovoMix 70 suspensjoni għall-injezzjoni ġo FlexPen.
English: NovoMix 70 is a mixture consisting of 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine.
Maltese: NovoMix 70 huwa taħlita li tikkonsisti minn 70% insulin aspart li jinħall u 30% insulin aspart ikkristallizzat bi protamine.
English: 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine SC use
Maltese: 70 % insulin aspart solubbli u 30 % insulin aspart ikkristallizzat bi protamine Għal użu taħt il-ġilda
English: A 16-week clinical trial comparing postprandial glycaemic control of meal-related NovoMix 30 with meal-related human insulin/biphasic human insulin 30 and bedtime NPH insulin was performed in 167 patients aged 10 to 18 years.
Maltese: Studju kliniku li ġie magħmul f'167 pazjent ta' età bejn 10 u 18-il sena u li dam 16-il ġimgħa, qabbel il-kontroll gliċemiku ta' wara l-ikel ta' NovoMix 30 mogħti mal-ħin ta' l-ikel ma' l-insulina umana
English: Resuspension of NovoMix 70
Maltese: Suspensjoni mill-ġdid ta' NovoMix 70
English: Suspension for injection in pre-filled pen 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Maltese: Suspensjoni għall-injezzjoni fi skartoċċ 50 % insulin aspart solubbli u 50 % insulin aspart ikkristallizzat bi protamine
English: The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Maltese: Il-fażi kristallina (30%) tikkonsisti f'insulin aspart ikkristallizzat bi protamine, li għandu profil ta' attività li jixbah lil dak ta' l-insulina NPH umana .
English: NovoMix 30 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Maltese: NovoMix 30 FlexPen hija pinna mimlija għal-lest (b'kulur partikolari) magħmula biex tintuża mallabar NovoFine jew NovoTwist.
English: Big outer needle cap
Maltese: Is-selettur tad-doża jirritorna fuq iż-0
English: The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Maltese: Il-fażi kristallina (50%) tikkonsisti f'insulin aspart ikkristallizzat bi protamine, li għandu profil ta' attività li jixbah lil dak ta' l-insulina NPH umana .
English: Instruction on how to use NovoMix 30 suspension for injection in FlexPen.
Maltese: Istruzzjonijiet dwar kif tuża NovoMix 30 suspensjoni għall-injezzjoni ġo FlexPen.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 70 Penfill 100 units/ml suspension for injection in cartridge NovoMix 70 FlexPen 100 units/ml suspension for injection in pre-filled pen
Maltese: NovoMix 70 Penfill 100 unità/ml suspensjoni għall-injezzjoni fi skartoċċ.
English: NovoMix 50 is a biphasic insulin, which contains 50% soluble insulin aspart.
Maltese: NovoMix 50 hu insulina bifażika li fiha 50% insulin aspart li jinħall.
English: The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Maltese: Il-50% li jibqa' jkun f'sura kristallina bħala insulin aspart ikkristallizzat bi protamine; dan għandu profil ta' assorbiment imtawwal li jixbah lil dak ta' l-insulina NPH umana.
English: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Maltese: Studji fuq ir-riproduzzjoni ta' l-annimali ma żvelaw l-ebda differenzi bejn insulin aspart u l-insulina umana fir-rigward ta' l-embrijutossiċità jew it-teratoġeniċità.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 30 Penfill 100 units/ml suspension for injection in cartridge NovoMix 30 FlexPen 100 units/ml suspension for injection in pre-filled pen
Maltese: NovoMix 30 Penfill 100 unità/ml suspensjoni għall-injezzjoni fi skartoċċ.
English: NovoMix 30 is a biphasic insulin, which contains 30% soluble insulin aspart.
Maltese: NovoMix 30 hu insulina bifażika li fiha 30% insulin aspart li jinħall.
English: • There is limited experience with NovoMix 30 in children aged 6-9 years.
Maltese: • Hemm esperjenza limitita b'NovoMix 30 fit-tfal b'etajiet minn 6-9 snin.
English: NovoMix 30 Penfill 100 units/ml suspension for injection in a cartridge 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Maltese: NovoMix 30 Penfill 100 unità/ml suspensjoni għall-injezzjoni fi skartoċċ 30 % insulin aspart solubbli u 70 % insulin aspart ikkristallizzat bi protamine
English: In healthy volunteers, a mean maximum serum concentration of 140 ± 32 pmol/l was reached about 60 minutes after a subcutaneous dose of 0.20 unit/kg body weight.
Maltese: F'voluntiera b'saħħithom il-medja tal-konċentrazzjoni massima fisserum ta' 140 ± 32 pmol/l intlaħqet madwar 60 minuta wara li ngħatat doża taħt il-ġilda ta' 0.20 unitajiet/kg ta' piż tal-ġisem.
English: NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 30 is essentially ‘sodium-free'.
Maltese: Kull doża ta' NovoMix 30 fiha inqas minn 1 mmol ta' sodium (23 mg), jiġifieri NovoMix 30 huwa bażikament ‘bla sodium'.
English: NovoMix 30 is a mixture consisting of 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine.
Maltese: NovoMix 30 huwa taħlita li tikkonsisti minn 30% insulin aspart li jinħall u 70% insulin aspart ikkristallizzat bi protamine.
English: NovoMix 50 FlexPen 100 units/ml suspension for injection in a pre-filled pen 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Maltese: FlexPen 100 unità/ml suspensjoni għall-injezzjoni f'pinna mimlija għal-lest. 50 % insulin aspart solubbli u 50 % insulin aspart ikkristallizzat bi protamine
English: Suspension for injection in pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Maltese: Suspensjoni għall-injezzjoni fi skartoċċ 30 % insulin aspart solubbli u 70 % insulin aspart ikkristallizzat bi protamine
English: NovoMix 70 will start to lower your blood sugar 10-20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 14-24 hours.
Maltese: NovoMix 70 jibda jbaxxi z-zokkor fid-demm tiegħek minn 10-20 minuta wara li jiġi injettat, effett massimu jseħħ bejn 1 u 4 sigħat wara l-injezzjoni u l-effett idum sa 14 - 24 siegħa.
English: NovoMix 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 50 is essentially ‘sodium-free'.
Maltese: Kull doża ta' NovoMix 50 fiha inqas minn 1 mmol ta' sodium (23 mg), jiġifieri NovoMix 50 huwa bażikament ‘bla sodium'.
English: A number of medicinal products are known to interact with the glucose metabolism.
Maltese: Rata ta' linfużjoni ta' glucose
English: Novo Nordisk A/S Novo Allé
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novo Nordisk A/S
English: Suspension for injection in pre-filled pen 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Maltese: Suspensjoni għall-injezzjoni fi skartoċċ 70 % insulin aspart solubbli u 30 % insulin aspart ikkristallizzat bi protamine
English: Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
Maltese: Kontroll iktar strett tal-livelli ta' glucose jista' jżid il-potenzjal għal episodji ipogliċemiċi u għalhekk teħtieġ attenzjoni speċjali matul l-intensifikazzjoni tad-doża kif spjegat fil-qosor f'sezzjoni 4.2.
English: Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Maltese: Octreotide u lanreotide (użati għall-kura ta' l-akromegalija, disturb ormonali rari li normalment iseħħ f'adulti fl-età bejn 40 u 60 sena, ikkawżat minn produzzjoni eċċessiva ta' l-ormon ta' tkabbir millglandola pitwitarja) jistgħu kemm iżidulek kif ukoll inaqqsulek il-livell taz-zokkor fid-demm tiegħek.
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).
Maltese: Millilitru ta' suspensjoni fih 100 unità ta' insulin aspart* li jinħall/ insulin aspart* ikkristallizzat bi protamine f'proporzjon ta' 50/50 (ekwivalenti għal 3.5 mg).
English: 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: 5 x 3 ml pinen mimlijin għal-lest
English: The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Maltese: Is-70% li jibqa' jkun f'sura kristallina bħala insulin aspart ikkristallizzat bi protamine; dan għandu profil ta' assorbiment imtawwal li jixbah lil dak ta' l-insulina NPH umana.
English: In this trial, 57% of the patients had baseline HbA1c above 9%; in these patients, treatment with NovoMix 30 in combination with metformin resulted in significantly lower HbA1c than metformin in combination with sulfonylurea.
Maltese: HbA1c ta' iktar minn 9%; f'dawn ilpazjenti, kien hemm iktar tnaqqis b'mod sinifikanti fl- HbA1c permezz tal-kura ta' NovoMix 30 flimkien ma' metformin milli bil-kura ta' metformin flimkien ma' sulfonylurea.
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Maltese: Il-glukosju għandu jingħata minn ġol-vini jekk il-pazjent ma jirrispondix għal glucagon fi żmien 10 sa 15-il minuta.
English: The influence of different injection sites on the absorption of NovoMix 30 has not been investigated.
Maltese: L-effett ta' siti differenti tal-injezzjoni fuq ir-rata ta' assorbiment ta' NovoMix 30 ma ġietx investigata.
English: The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Maltese: It-30% li jibqa' jkun f'sura kristallina bħala insulin aspart ikkristallizzat bi protamine; dan għandu profil ta' assorbiment imtawwal li jixbah lil dak ta' l-insulina NPH umana.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/142/004 5 cartridges of 3 ml EU/1/00/142/005 10 cartridges of 3 ml
Maltese: EU/1/00/142/005 10 skartoċċi ta' 3 ml
English: Resuspension of NovoMix 30
Maltese: Suspensjoni mill-ġdid ta' NovoMix 30
English: The influence of different injection sites on the absorption of NovoMix 50 has not been investigated.
Maltese: L-effett ta' siti differenti tal-injezzjoni fuq ir-rata ta' assorbiment ta' NovoMix 50 ma ġietx investigata.
English: 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
Maltese: NovoMix 70 Penfill 100 unità/ml suspensjoni għall-injezzjoni fi skartoċċ 70 % insulin aspart solubbli u 30 % insulin aspart ikkristallizzat bi protamine
English: NovoMix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
Maltese: NovoMix 30 huwa indikat għall-kura tad-dijabete mellitus fl-adulti, fl-adolexxenti u fit-tfal minn 10 snin 'il fuq.
English: NovoMix 70 is presented as a suspension for injection.
Maltese: NovoMix 70 jiġi bħala suspensjoni għall-injezzjoni.
English: ► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: ► L-iskrataċ ta' NovoMix 70 Penfill huma maħsuba biex jintużaw mas-sistema tal-għoti tal insulina Novo Nordisk u mal-labar tat-toġ NovoFine jew NovoTwist.
English: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching.
Maltese: Bħal kull terapija oħra bl-insulina, jista' jkun hemm xi reazzjonijiet fil-post ta' l-injezzjoni u dawn jinkludu uġigħ, ħmura, urtikarja, infjammazzjoni, tbenġil, nefħa u ħakk.
English: NovoMix 30 Penfill EU/1/00/142/004 EU/1/00/142/005
Maltese: EU/1/00/142/004
English: The safety and efficacy of NovoMix 70 in children below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' NovoMix 70 fit-tfal taħt l-età ta' 18-il sena ma ġewx stabbiliti.
English: INFORMATION IN BRAILLE NovoMix 50 Penfill
Maltese: INFORMAZZJONI BIL-BRAILLE NovoMix 50
English: The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
Maltese: L-effett ta' siti differenti tal-injezzjoni fuq ir-rata ta' assorbiment ta' NovoMix 70 ma ġietx investigata.
English: During clinical trials, the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Maltese: Matul l-istudji kliniċi, ma kien hemm ebda differenza flammont totali ta' ipogliċemiji f'pazjenti kkurati b'insulin aspart u f'dawk ikkurati b'insulina umana.
English: In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Maltese: B'mod ġenerali, il-kontroll intensifikat tal-glucose fid-demm u l-monitoraġġ ta' nisa tqal bid-dijabete huma rakkomandati matul it-tqala u meta t-tqala tkun qed tiġi ppjanata.
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).
Maltese: Millilitru ta' suspensjoni fih 100 unità ta' insulin aspart* li jinħall/ insulin aspart* ikkristallizzat bi protamine f'proporzjon ta' 70/30 (ekwivalenti għal 3.5 mg).
English: Resuspension of NovoMix 50
Maltese: Suspensjoni mill-ġdid ta' NovoMix 50
English: • Keep this leaflet.
Maltese: L-għatu ta' ġewwa tal labra
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Maltese: Informazzjoni li mhiex klinika , magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u effett tossiku fuq is-sistema riproduttiva u fuq l
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 50/50 (equivalent to 3.5 mg).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Millilitru ta' suspensjoni fih 100 unità ta' insulin aspart li jinħall/ insulin aspart ikkristallizzat bi protamine f'proporzjon ta' 50/50 (ekwivalenti għal 3.5 mg).
English: NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: NovoMix 70 Penfill huwa magħmul biex jintuża mas-sistemi tal-għoti tal-insulina NovoNordisk u mal-labar NovoFine jew NovoTwist.
English: NovoMix 30 can also be initiated once daily with 12 units at dinner (evening meal).
Maltese: NovoMix 30 jista' wkoll jinbeda darba kuljum bi 12-il unità waqt il-pranzu (l-ikla ta' filgħaxija).
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).
Maltese: Millilitru ta' suspensjoni fih 100 unità ta' insulin aspart* li jinħall/ insulin aspart* ikkristallizzat bi protamine f'proporzjon ta' 30/70 (ekwivalenti għal 3.5 mg).
English: 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
Maltese: NovoMix 30 FlexPen 100 unità/ml suspensjoni għall-injezzjoni f'pinna mimlija għal-lest. 30 % insulin aspart solubbli u 70 % insulin aspart ikkristallizzat bi protamine
English: In patients with type 2 diabetes, NovoMix 30 can be given as monotherapy.
Maltese: F'pazjenti b'dijabete ta' tip 2, NovoMix 30 jista' jingħata bħala monoterapija.
English: NovoMix 50 will start to lower your blood sugar 10-20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 14-24 hours.
Maltese: NovoMix 50 jibda jbaxxi z-zokkor fid-demm tiegħek minn 10-20 minuta wara li jiġi injettat, l-effett massimu jseħħ bejn 1 u 4 sigħat wara l-injezzjoni u l-effett idum sa 14-24 siegħa.
English: How to use NovoMix 30
Maltese: ► NovoMix 30
English: In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/l was reached about 60 minutes after a subcutaneous dose of 0.30 unit/kg body weight.
Maltese: F'pazjenti bid-dijabet tat-tip1 il-medja tal-konċentrazzjoni massima fis-serum ta' 721 ± 184 pmol/l intlaħqet madwar 60 minuta wara li ngħatat doża minn taħt il-ġilda ta' 0.30 unitajiet/kg ta' piż tal-ġisem.
English: Combination of NovoMix with pioglitazone
Maltese: Jekk tinsa tieħu l-insulina
English: a) Summary of serious and very common side effects Low blood sugar (hypoglycaemia) is a very common side effect.
Maltese: a) Sommarju ta' effetti sekondarji serji u komuni ħafna
English: High blood sugar (hyperglycaemia)
Maltese: KARTUNA TA' BARRA (PINNA MIMLIJA GĦAL-LEST.FlexPen)
English: NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: NovoMix 30 Penfill huwa magħmul biex jintuża mas-sistemi tal-għoti tal-insulina NovoNordisk u mal-labar NovoFine jew NovoTwist.
English: ► NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: ► L-iskrataċ ta' NovoMix 30 Penfill huma maħsuba biex jintużaw mas-sistema tal-għoti tal insulina Novo Nordisk u mal-labar tat-toġ NovoFine jew NovoTwist.
English: In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day.
Maltese: F'pazjenti b'dijabete ta' tip 1, il-ħtieġa individwali ta' l-insulina normalment hi ta' bejn 0.5 u 1.0
English: Drinking alcohol and taking NovoMix 30
Maltese: Meta tixrob l-alkoħol u tieħu NovoMix 30
English: Mean HbA1c remained similar to baseline throughout the trial in both treatment groups, and there was no difference in hypoglycaemia rate with NovoMix 30 or biphasic human insulin 30.
Maltese: Il-ħin għall-konċentrazzjoni massima hu, bħala medja, nofs il-ħin meħtieġ għall-insulina umana bifażika 30.
English: How to use NovoMix 70
Maltese: ► NovoMix 70
English: NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: Penfill huma maħsuba biex jintużaw mas-sistema tal-għoti tal insulina Novo Nordisk u mal-labar tat-toġ NovoFine jew NovoTwist.
English: NovoMix 30 FlexPen is only suitable for subcutaneous injections.
Maltese: NovoMix 30 m'għandux jintuża ġo pompi tal-insulina għall-infużjoni.
English: The pharmacokinetics of NovoMix 30 have not been investigated in elderly patients or in patients with renal or hepatic impairment.
Maltese: Il-farmakokinetika ta' NovoMix 30 ma ġietx investigata f'pazjenti anzjani jew f'pazjenti b'indeboliment renali jew epatiku.
English: Checking the insulin flow
Maltese: • Tinjetta wisq insulina
English: Pack sizes of 5 and 10 cartridges.
Maltese: Pakketti ta' daqsijiet ta' 5 jew 10 skartoċċi.
English: The crystalline phase (70%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Maltese: Il-fażi kristallina (70%) tikkonsisti f'insulin aspart ikkristallizzat bi protamine, li għandu profil ta' attività li jixbah lil dak ta' l-insulina NPH umana (Figura 1).
English: 15 April 2014 EMA/235924/2014
Maltese: EMA/235924/2014
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).
Maltese: Ir-riżultati wrew żieda fir-riskju ta' infart mijokardijaku bi Protelos / Osseor meta mqabbla mal-plaċebo (1.7% kontra 1.1%), b'riskju relattiv ta' 1.6 (95% CI, 1.07-2.38), u żieda fir-riskju ta' episodji trombotiċi fil-vini u avvenimenti emboliċi - 1.9% kontra 1.3% b'riskju relattiv ta' 1.5 (95% CI,
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.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Protelos/Osseor to remain available but with further restrictions
Maltese: Protelos/Osseor jibqa' disponibbli iżda b'aktar restrizzjonijiet
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.
Maltese: Ir-reviżjoni ta' Protelos/Osseor inbdiet f'Mejju 2013 fuq talba tal-Kummissjoni Ewropea skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: 'The CHMP agreed with the PRAC's overall assessment of the risks of Protelos/Osseor.
Maltese: ‘Is-CHMP qabel mal-valutazzjoni ġenerali tal-PRAC tar-riskji ta' Protelos/Osseor.
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.
Maltese: ‘Il-PRAC ħadem mill-qrib mal-CHMP matul il-proċedura u filwaqt li aħna nirrikonoxxu li rrakkomandazzjonijiet taż-żewġ kumitati kienu differenti, il-fehim tagħna tal-profil benefiċċju-riskju talmediċina huwa allinjat mill-qrib u nikkondividu fehma komuni tal-importanza ta' monitoraġġ effettiv ta' riskju kardjovaskulari ‘, qalet June Raine, president tal-PRAC.'Il-PRAC se jkompli jimmonitorja ssigurtà ta' Protelos/Osseor u l-effikaċja tal-minimizzazzjoni tar-riskju fl-użu fit-tul.'
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.
Maltese: ħarġet deċiżjoni finali legalment vinkolanti valida fl-UE kollha.
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.
Maltese: Protelos/Osseor (strontium ranelate) huwa awtorizzat fl-UE biex jikkura l-osteoporożi severa (marda li ddgħajjef l-għadam) f'nisa li għaddew mill-menopawża u li huma f'riskju għoli ta' ksur (għadam miksur) biex jitnaqqas ir-riskju ta' ksur tas-sinsla u l-ġenbejn.