qanastek/EMEA-V3 huggingface dataset:
Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Generalizuoti padid jusio jautrumo simptomai apima generalizuot odos b rim, niež jim, prakaitavim, virškinamojo trakto sutrikimus, angioneurozin edem, sunkum kv puojant, stipr širdies plakim ir kraujo spaudimo sumaž jim.
Generalised hypersensitivity reactions are potentially life threatening.
Generalizuotos padid jusio jautrumo reakcijos gali b ti pavojingos gyvybei.
Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Greitas gliukoz s kiekio kraujyje kontrol s pagerinimas gali b ti susij s su tam tikra b kle, vadinama mia skausminga neuropatija, kuri paprastai yra gr žtama.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Ta iau gydymo insulinu sustiprinimas ir staigus glikemijos kontrol s pagerinimas gali b ti susij s su diabetin s retinopatijos blog jimu.
Uncommon - Local hypersensitivity Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Vietin s padid jusio jautrumo reakcijos (paraudimas, patinimas ir niež jimas injekcijos vietoje) gali pasireikšti gydant insulinu.
These reactions are usually transitory and normally they disappear during continued treatment.
Šios reakcijos paprastai praeina savaime ir išnyksta t siant gydym.
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by
Tod l rekomenduojama, kad cukriniu diabetu sergantys pacientai visada nešiot si cukraus turin i produkt. • Stipr s hipoglikemijos epizodai, kai pacientas netenka s mon s, gali b ti gydomi gliukagono (0, 5 - 1 mg) injekcija raumenis ar po oda, kuri sušvirkšti gali tai daryti mokantis asmuo, arba gliukoze, kurios ven turi sušvirkšti medicinos specialistas.
Drugs used in diabetes.
Farmakoterapin grup - vaistai, vartojami cukrinio diabeto gydymui.
NovoMix 50 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 50 yra dvifaz insulino asparto (greitai veikian io žmogaus insulino analogo) ir insulino asparto protamino (vidutinio veikimo žmogaus insulino analogo) suspensija.
The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
Gliukoz s kiek kraujyje mažinantis insulino poveikis pasireiškia tada, kai insulinas, prisijungdamas prie receptori raumen ir riebal l stel se, gerina gliukoz s pasisavinim ir tuo pa iu metu slopina gliukoz s išsiskyrim iš kepen.
NovoMix 50 is a biphasic insulin, which contains 50% soluble insulin aspart.
NovoMix 50 yra dvifazis insulinas, kuriame yra 50% tirpaus insulino asparto.
This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Palyginus su tirpiu žmogaus insulinu, NovoMix 50 poveikis pasireiškia grei iau, tod l gali b ti skiriamas valgant (iki 10 minu i prieš valg arba nuo valgymo pradžios).
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Kristalin faz (50%) sudaro insulino asparto protaminas, kurio veikimo pob dis panašus žmogaus NPH insulino.
When NovoMix 50 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Kai NovoMix 50 švirkš iamas po oda, jis pradeda veikti per 10 - 20 min. po injekcijos.
The maximum effect is exerted between 1 and 4 hours after injection.
Maksimalus poveikis - tarp 1 ir 4 val. po injekcijos.
The duration of action is up to 14 hours to 24 hours (Figure 1).
(1 pav.).
Glucose Infusion Rate
Gliukoz s infuzijos greitis
Hours NovoMix 50
Valandos NovoMix 50
Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
NovoMix 50 veikimo pob dis sveikiems baltiesiems asmenims
15 5.2 Pharmacokinetic properties
5. 2 Farmakokinetin s savyb s
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 50, as compared with soluble human insulin.
Palyginus su tirpiu žmogaus insulinu, insuline asparte B28 pad tyje aminor gšties prolino pakeitimas asparto r gštimi sumažina polink sudaryti heksamerus tirpioje NovoMix 50 frakcijoje.
The insulin aspart in the soluble phase of NovoMix 50 comprises 50% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Insulinas aspartas tirpioje NovoMix 50 faz je sudaro 50% viso insulino; jis iš poodinio sluoksnio rezorbuojamas grei iau nei dvifazio žmogaus insulino tirpi insulino dalis.
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Likusieji 50% yra kristal pavidalo, kaip insulino asparto protaminas; jo rezorbcija ilga, panaši žmogaus NPH insulino.
In healthy volunteers a mean maximum serum concentration of 445 ± 135 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
15 Sveikiems savanoriams vidutin maksimali serumo koncentracija 445 ± 135 pmol/ l susidar pra jus 60 min. po poodin s 0, 30 V/ kg k no svorio doz s.
In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
2 tipo cukriniu diabetu sergantiems pacientams maksimali koncentracija susidar po 95 min. sušvirkštus doz.
The pharmacokinetics of NovoMix 50 has not been investigated in elderly, children or patients with impaired renal or liver function.
NovoMix 50 farmakokinetika nebuvo tirta vyresnio amžiaus pacientams, vaikams ar pacientams, kuri inkst ar kepen funkcija pažeista.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Tyrim in vitro metu, skaitant prisijungim prie insulino ir IGF- 1 receptori bei poveik l steli augimui, insulinas aspartas veik labai panašiai kaip ir žmogaus insulinas.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Tyrimai taip pat parod, kad insulino asparto prisijungimo prie insulino receptori disociacija atitinka žmogaus insulino.
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
Laikyti šaldytuve 2 °C – 8 °C temperat roje, toliau nuo šaldymo kameros.
16 NovoMix 50 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 50 Penfill užtaisai, kurie naudojami ar nešiojami kaip atsarga: gali b ti laikomi kambario temperat roje (ne aukštesn je kaip 30 °C) iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to allow NovoMix 50 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Iš mus NovoMix 50 Penfill iš šaldytuvo, prieš suplakant insulin pagal instrukcijas, kaip nurodoma naudojantis pirm kart, rekomenduojama palaikyti NovoMix 50 Penfill kambario temperat roje, kad sušilt.
6.5 Nature and contents of container
16 6. 5 Pakuot ir jos turinys
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other.
1 tipo stiklinis užtaisas yra su latekso neturin iu (bromobutilo) guminiu st mokliu ir uždarytas latekso neturin iu (bromobutilo / poliizopreno) guminiu kamš iu.
Each cartridge contains 3 ml suspension.
Kiekviename užtaise yra 3 ml suspensijos.
Cartons of 1, 5 or 10 cartridges.
D žut je gali b ti 1, 5 arba 10 užtais.
NovoMix 50 Penfill is for use by one person only.
NovoMix 50 Penfill skirtas vartoti tik vienam asmeniui.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
Pacientui turi b ti nurodyta, kad prieš pat naudojant NovoMix 50 suspensij b tina suplakti.
NovoMix 50 which has been frozen must not be used.
Jei NovoMix 50 buvo užšaldytas, jo vartoti negalima.
NovoMix 70 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 70 Penfill 100 V/ ml, injekcin suspensija užtaise.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 70/ 30
Tirpus insulinas aspartas / kristalizuotas insulino asparto protaminas * … 100 V/ ml, santykis 70/ 30.
NovoMix 70 is a white suspension.
NovoMix 70 yra balta suspensija.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 70 to be given immediately before a meal.
Kadangi insulinas aspartas pradeda greitai veikti ir anksti pasiekia aktyvumo pik, NovoMix 70 galima skirti prieš pat valg.
When necessary, NovoMix 70 can be given soon after start of a meal.
Kai reikalinga, NovoMix 70 gali b ti vartojamas tuoj pat po valgio.
Dosage of NovoMix 70 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
NovoMix 70 doz individuali, j nustato gydytojas, atsižvelgdamas paciento poreikius.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 70.
Individualus insulino poreikis suaugusiems pacientams paprastai yra tarp 0, 5 ir 1, 0 Vieneto/ kg/ per par, ir tai gali b ti visiškai arba iš dalies patenkinama su NovoMix 70.
In patients with type 2 diabetes, NovoMix 70 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
Pacientams, sergantiems 2 tipo diabetu, NovoMix 70 gali b ti naudojamas vienas arba kartu su metforminu, kai gliukoz s kiekis kraujyje yra nepakankamai kontroliuojamas, vartojant vien tik metformin.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
Gydym kitais insulin preparatais kei iant NovoMix 70, gali reik ti koreguoti doz ir skyrimo laik.
18 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
18 Kaip ir skiriant visus insulinus, vyresniems pacientams arba pacientams, kuriems yra kepen arba inkst funkcijos nepakankamumas, reik t atidžiau tikrinti gliukoz s kiek ir individualiai parinkti doz.
No studies have been performed with NovoMix 70 in children and adolescents under the age of 18 years.
N ra atlikta NovoMix 70 tyrim, skiriant jo vaikams ir paaugliams iki 18 met.
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 70 švirkš iamas po oda šlaun ar pilvo sien.
The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
Skirting injekcijos viet taka NovoMix 70 rezorbcijai n ra tirta.
NovoMix 70 should never be administered intravenously.
NovoMix 70 negalima švirkšti ven.
NovoMix 70 should be administered in immediate relation to a meal.
NovoMix 70 tur t b ti vartojamas, esant betarpiškam ryšiui su maistu.
Patients taking NovoMix 70 may need a change in dosage from that used with their usual insulin.
Pacientams, vartojantiems NovoMix 70, gali reik ti pakeisti doz, kuri buvo skiriama vartojant jiems prast insulin preparat.
On rare occasions, injection site reactions may require discontinuation of NovoMix 70.
Retais atvejais reikia nutraukti NovoMix 70 vartojim, kad išnykt injekcijos vietos reakcijos.
19 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 sud tyje yra metakrezolio, kuris gali sukelti alergines reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
19 4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
A number of medicinal products are known to interact with the glucose metabolism.
Žinoma, kad nemažai vaist veikia gliukoz s metabolizm.
There is limited clinical experience with NovoMix 70 in pregnancy.
Turima ribota klinikin patirtis, vartojant NovoMix 70 n štumo metu.
There are no restrictions on treatment with NovoMix 70 during lactation.
Žindymo metu n ra joki apribojim gydyti NovoMix 70.
However, the NovoMix 70 dosage may need to be adjusted.
Ta iau NovoMix 70 doz gali reik ti koreguoti.
In clinical trials and during marketed use the frequency varies with patient population and dose
Klinikini tyrim metu bendras hipoglikemijos dažnis, gydant pacientus insulinu aspartu ir žmogaus insulinu, buvo panaš s.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
20 Klinikiniais tyrimais nustatytas nepageidaujam reakcij dažnis, susij s su insulino asparto vartojimu, pateikiamas žemiau.
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Pavieniai spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip (< 10000), skaitant ir pavienius pranešimus.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Kiekvienoje dažnumo grup je nepageidaujami reiškiniai išvardinami sunkumo maž jimo tvarka.
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by
Tod l rekomenduojama, kad cukriniu diabetu sergantys pacientai nuolat nešiot si cukraus turin i produkt. • Stipr s hipoglikemijos epizodai, kai pacientas netenka s mon s, gali b ti gydomi gliukagono (0, 5 - 1 mg) injekcija raumenis ar po oda, kuri sušvirkšti gali tai daryti mokantis asmuo, arba gliukoze, kurios ven turi sušvirkšti medicinos specialistas.
NovoMix 70 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 70 yra dvifaz insulino asparto (greitai veikian io žmogaus insulino analogo) ir insulino asparto protamino (vidutinio veikimo žmogaus insulino analogo) suspensija.
NovoMix 70 is a biphasic insulin, which contains 70% soluble insulin aspart.
NovoMix 70 yra dvifazis insulinas, kuriame yra 70% tirpaus insulino asparto.
This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Palyginus su tirpiu žmogaus insulinu, NovoMix 70 poveikis pasireiškia grei iau, tod l gali b ti skiriamas valgant (iki 10 minu i prieš valg arba nuo valgymo pradžios).
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Kristalin faz (30%) sudaro insulino asparto protaminas, kurio veikimo pob dis panašus žmogaus NPH insulino.
When NovoMix 70 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Kai NovoMix 70 švirkš iamas po oda, jis pradeda veikti per 10 - 20 min. po injekcijos.
Hours NovoMix 70
Valandos NovoMix 70
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
NovoMix 70 (BIAsp 70) veikimo pob dis sveikiems baltiesiems asmenims
22 5.2 Pharmacokinetic properties
5. 2 Farmakokinetin s savyb s
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 70, as compared with soluble human insulin.
Palyginus su tirpiu žmogaus insulinu, insuline asparte B28 pad tyje aminor gšties prolino pakeitimas asparto r gštimi sumažina polink sudaryti heksamerus tirpioje NovoMix 70 frakcijoje.
The insulin aspart in the soluble phase of NovoMix 70 comprises 70% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Insulinas aspartas tirpioje NovoMix 70 faz je sudaro 70% viso insulino; jis iš poodinio sluoksnio
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Likusieji 30% yra kristal pavidalo, kaip insulino asparto protaminas; jo rezorbcija ilga, panaši žmogaus NPH insulino.
In healthy volunteers a mean maximum serum concentration of 645 ± 185 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
Sveikiems savanoriams vidutin maksimali serumo koncentracija 645 ± 185 pmol/ l susidar pra jus 60 min. po poodin s 0, 30 V/ kg k no svorio doz s.
In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
2 tipo cukriniu diabetu sergantiems pacientams maksimali koncentracija susidar po 75 min. sušvirkštus doz.
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 U/ kg body weight.
1 tipo cukriniu diabetu sergantiems pacientams vidutin maksimali serumo koncentracija 721 ± 184 pmol/ l susidar pra jus 60 min. po poodin s 0, 30 V/ kg k no svorio doz s.
The pharmacokinetics of NovoMix 70 has not been investigated in elderly, children or patients with impaired renal or liver function.
NovoMix 70 farmakokinetika nebuvo tirta vyresnio amžiaus pacientams, vaikams ar pacientams, kuri inkst ar kepen funkcija pažeista.
23 6.4 Special precautions for storage
6. 4 Specialios laikymo s lygos
NovoMix 70 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 Penfill užtaisai, kurie naudojami ar nešiojami kaip atsarga: gali b ti laikomi kambario temperat roje (ne aukštesn je kaip 30 ºC iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to allow NovoMix 70 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
23 Iš mus NovoMix 70 Penfill iš šaldytuvo, prieš suplakant insulin pagal instrukcijas, kaip nurodoma naudojantis pirm kart, rekomenduojama palaikyti NovoMix 70 Penfill kambario temperat roje, kad sušilt.
NovoMix 70 Penfill is for use by one person only.
NovoMix 70 Penfill skirtas vartoti tik vienam asmeniui.
The necessity of resuspending the NovoMix 70 suspension immediately before use is to be stressed to the patient.
Pacientui turi b ti nurodyta, kad prieš pat naudojant NovoMix 70 suspensij b tina suplakti.
NovoMix 70 which has been frozen must not be used.
Jei NovoMix 70 buvo užšaldytas, jo vartoti negalima.
NovoMix 30 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 30 FlexPen 100 V/ ml, injekcin suspensija užpildytoje švirkštimo priemon je.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*………… 100 U/ ml in the ratio of 30/ 70
Tirpus insulinas aspartas * / kristalizuotas insulino asparto protaminas * … 100 V/ ml, santykis 30/ 70.
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 užpildytoje švirkštimo priemon je esantys 3 ml atitinka 300 V.
NovoMix 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal.
NovoMix 30 dozavimas yra individualus ir nustatomas atsižvelgiant paciento poreikius.
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred.
NovoMix 30 gali b ti skiriamas vaikams ir paaugliams nuo 0 met ir vyresniems, kai teikiama pirmenyb insulin mišini vartojimui.
For children 6-9 years limited clinical data exists (see section 5.1).
Turima ribota klinikin patirtis, skiriant vaisto 6- 9 met vaikams (ži r kite skyri 5. 1).
No studies have been performed in children under the age of 6 years.
Neatlikta joki tyrim su NovoMix 30, skiriant jo vaikams iki 6 met amžiaus.
In patients with type 2 diabetes, NovoMix 30 can be given in monotherapy or in combination with oral antidiabetic drugs for which the combination with insulin is approved, when the blood glucose is inadequately controlled with those oral antidiabetic drugs alone.
Pacientams, sergantiems 2 tipo cukriniu diabetu, NovoMix 30 gali b ti skiriamas vienas arba kartu su geriamaisiais vaistais nuo diabeto, kuri vartojimas kartu su insulinu yra patvirtintas, jei gliukoz s
For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 U at breakfast and 6 U at dinner (evening meal).
Pacientams, sergantiems 2 tipo cukriniu diabetu, rekomenduojama pradin NovoMix 30 doz, yra 6 V pusry i metu ir 6 V vakarien s metu (vakarinio valgymo).
26 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
Vartojant NovoMix 30 vien kart per dien ir pasiekus 30 V doz, j rekomenduojama dalinti dvi lygias dalis, švirkš iant pusry i ir vakarien s metu.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Padid j s jautrumas aktyviajai arba bet kuriai pagalbinei medžiagai. • Hipoglikemija.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Nepakankam dozi vartojimas, ar gydymo nutraukimas, ypa sergant nuo insulino priklausomu cukriniu diabetu, gali paskatinti hiperglikemijos ir diabetin s ketoacidoz s atsiradim; šios b kl s yra pavojingos gyvybei.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
4. 8 ir 4. 9
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Palyginti su dvifaziu žmogaus insulinu, NovoMix 30 gali tur ti stipresn cukraus kiek kraujyje mažinant poveik iki 6 val. po injekcijos.
27 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.
Gliukoz s kiekio reguliavimas gali padidinti hipoglikemijos epizod rizik, tod l tai reikia atkreipti d mes nustatant dozes, kaip pažym ta 4. 2 skyriuje.
As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of insulin may be necessary.
Tuomet, gali reik ti mažinti insulino doz.
A number of medicinal products are known to interact with the glucose metabolism.
Žinoma, kad nemažai vaist s veikauja su gliukoz s metabolizmu.
Oral antidiabetic drugs (OAD), octreotide, monoamine oxidase inhibitors (MAOIs), non-selective beta-adrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Šios medžiagos gali sumažinti insulino poreik: geriamieji priešdiabetiniai vaistai, oktreotidas, monoaminoksidaz s inhibitoriai (MAOI), neselektyv s beta - adrenoblokatoriai, angiotenzin konvertuojan i ferment (AKF) inhibitoriai, salicilatai, alkoholis, anaboliniai steroidai ir sulfonamidai.
The following substances may increase the patient’ s insulin requirements:
Šios medžiagos gali padidinti insulino poreik:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
27 geriamieji kontraceptikai, tiazidai, gliukokortikoidai, skydliauk s hormonai, simpatomimetikai ir danazolis.
28 4.6 Pregnancy and lactation
4. 6 N štumo ir žindymo laikotarpis
However, the NovoMix 30 dosage may need to be adjusted.
Ta iau NovoMix 30 doz gali reik ti sureguliuoti.
The advisability of driving should be considered in these circumstances.
Esant šioms aplinkyb ms, reik t apsvarstyti galimyb vairuoti.
It may occur if the insulin dose is too high in relation to the insulin requirement and therefore require special attention during dose intensification as outlined in section 4.2.
Taip gali atsitikti, jei insulino doz yra per didel, lyginant su insulino poreikiu ir tod l b tina atkreipti tai d mes, nustatnt insulino dozes, kaip pažym ta 4. 2 skyriuje.
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip (< 1/ 10000), skaitant ir pavienius pranešimus.
Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim ir kraujo spaudimo maž jim.
29 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Greitas gliukoz s kiekio kraujyje pagerinimas gali b ti susij s su tam tikra b kle, vadinama mia skausminga neuropatija, kuri paprastai yra gr žtama.
Drugs used in diabetes.
Farmakoterapin grup: vaistai, varojami cukrinio diabeto gydymui.
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
29 NovoMix 30 yra dvifaz insulino asparto (greitai veikian io žmogaus insulino analogo) ir insulino asparto kristalizuoto protamino (vidutinio veikimo žmogaus insulino analogo) suspensija.
30 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
Gliukoz s kiek kraujyje mažinantis insulino poveikis pasireiškia tod l, kad insulinas, prisijungdamas prie receptori raumenyse ir riebal l stel se, gerina gliukoz s suvartojim ir tuo pa iu metu slopina gliukoz s išsiskyrim iš kepen.
After 28 weeks treatment following the dosing guideline outlined in section 4.2, the mean reduction in HbA1c was 2.8% with NovoMix 30 (mean at baseline = 9.7%).
30 remiantis dozavimo rekomendacijomis (pažym tomis 4. 2 dalyje), vidutinis HbA1c sumaž jimas vartojant NovoMix 30 buvo 2, 8% (vidutiniškai nuo bazinio =9, 7).
With NovoMix 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/ L (from 14.0 mmol/ L at baseline to 7.1 mmol/ L).
Vartojant NovoMix 30, 66% ir 42% pacient pasiek HbA1c lyg žemiau 7% ir 6, 5% atitinkamai ir FPG vidurkis buvo sumažintas apie 7 mmol/ l (nuo 14, 0 mmol/ l iki bazinio 7, 1 mmol/ l).
31 In patients with type 2 diabetes a meta-analysis showed a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia with NovoMix 30 compared to biphasic human insulin 30.
Pacientams, sergantiems 2 tipo diabetu ir vartojusiems NovoMix 30, tyrim duomenys rodo sumaž jusi naktini ir sunki hipoglikemij rizik, lyginant su dvifaziu žmogaus insulinu 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Galutinis HbA1C buvo žymiai mažesnis gydant dvifaziu žmogaus insulinu 30 nei NovoMix 30.
However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6– 12 years) and adolescents (13– 17 years) with type 1 diabetes.
Ta iau, farmakokinetin s ir farmakodinamin s tirpaus insulino asparto savyb s buvo tirtos, vaisto vartojant vaikams (6- 12 met) ir paaugliams (13- 17 met), sergantiems 1 tipo diabetu.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
NovoMix 30 farmakokinetika nebuvo tirta vyresnio amžiaus pacientams ir vaikams ar pacientams, kuri inkst ar kepen funkcija buvo pažeista.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
31 kad insulino asparto prisijungimo prie insulino receptori disociacija atitinka žmogaus insulino.
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Suderinamumo tyrim neatlikta, tod l šio vaistinio preparatomaišyti su kitais negalima.
NovoMix 30 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 30 FlexPen, kurie vartojami ar nešiojami kaip atsarga: gali b ti laikomi kambario temperat roje (ne aukštesn je kaiip 30 ºC) iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
Laikykite švirkšto dangtel užd t ant NovoMix 30 FlexPen, kai jo nenaudojate, kad preparatas b t apsaugotas nuo šviesos.
After removing NovoMix 30 FlexPen from the refrigerator it is recommended to allow NovoMix 30 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Iš mus NovoMix 30 FlexPen iš šaldytuvo, prieš suplakant insulin pagal instrukcijas, kaip nurodoma naudojantis pirm kart, rekomenduojama palaikyti NovoMix 30 FlexPen kambario temperat roje, kad sušilt.
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other in a multidose disposable pre-filled pen with a pen injector (plastic).
1 tipo stiklinis užtaisas yra su latekso neturin iu (bromobutilo) guminiu st mokliu ir yra uždarytas latekso neturin iu (bromobutilo/ poliizopreno) guminiu kamš iu bei d tas daugiadoz užpildyt švirkštimo priemon su injektoriumi (plastikiniu).
Each pre-filled pen contains 3 ml suspension.
Vienoje užpildytoje švirkštimo priemon je yra 3 ml suspensijos.
Cartons of 5 or 10 pre-filled pens.
D žut je gali b ti 5 ar 10 užpildyt švirkštimo priemoni.
NovoFine S needles are designed to be used with the pre-filled pen.
NovoFine S adatos yra skirtos naudoti su užpildyta švirkštimo priemone.
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
Reikia laikytis kartu su 32 NovoMix 30 FlexPen pateiktos išsamios naudojimo instrukcijos.
NovoMix 30 FlexPen is for use by one person only.
NovoMix 30 FlexPen yra skirtas vartoti tik vienam asmeniui.
NovoMix 30 FlexPen must not be refilled.
NovoMix 30 FlexPen iš naujo užpildyti negalima.
33 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Pacientui turi b ti nurodyta, kad prieš naudojant NovoMix 30 suspensij b tina suplakti.
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 50 FlexPen 100 V/ ml, injekcin suspensija užpildytoje švirkštimo priemon je.
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 užpildytoje švirkštimo priemon je yra 3 ml, atitinkantys 300 V.
35 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
34 Kaip ir skiriant visus insulinus, vyresniems pacientams arba pacientams, kuriems yra kepen arba inkst funkcijos nepakankamumas, reik t atidžiau tikrinti gliukoz s kiek ir individualiai parinkti doz.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Padid j s jautrumas veikliajai arba bet kuriaipagalbinei medžiagai. • Hipoglikemija.
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 sud tyje yra metakrezolio, kuris gali sukelti alergines reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
35 4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
36 Klinikini tyrim metu nustatytas nepageidaujam reakcij dažnis, susij s su insulino asparto vartojimu, pateikiamas žemiau.
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip (< 10000), skaitant ir pavienius pranešimus.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Injekciai insulinai ir analogai, vidutinio veikimo, kombinuoti su greito veikimo.
Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
NovoMix 50 (BIAsp 50) veikimo pob dis sveikiems baltiesiems asmenims
39 5.2 Pharmacokinetic properties
5. 2 Farmakokinetin s savyb s
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Likusieji 50% yra kristal
In healthy volunteers a mean maximum serum concentration of 445 ± 135 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
Sveikiems savanoriams vidutin maksimali serumo koncentracija 445 ± 135 pmol/ l susidar pra jus 60 min. po poodin s 0, 30 V/ kg k no svorio doz s.
40 NovoMix 50 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 50 FlexPen, kurie naudojami ar nešiojami kaip atsarga: gali b ti laikomi kambario temperat roje (ne aukštesn je kaip 30 ºC) iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
Laikyti užpildytos švirkštimo priemon s dangtel užd t ant NovoMix 50 FlexPen, kai juo nesinaudojate, kad preparatas b t apsaugotas nuo šviesos.
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to allow NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
Iš mus NovoMix 50 FlexPen iš šaldytuvo, prieš suplakant insulin kaip nurodoma naudojantis pirm kart, rekomenduojama palaikyti NovoMix 50 FexPen kambario temperat roje, kad sušilt.
6.5 Nature and contents of container
39 6. 5 Pakuot ir jos turinys
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other in a multidose disposable pre-filled pen with a pen injector (plastic).
1 tipo stiklinis užtaisas yra su latekso neturin iu (bromobutilo) guminiu st mokliu ir yra uždarytas latekso neturin iu (bromobutilo / poliizopreno) guminiu kamš iu bei d tas kit daugiadoz užpildyt švirkštimo priemon su injektoriumi (plastikiniu).
Each pre-filled pen contains 3 ml suspension.
Kiekvienoje užpildytoje švirkštimo priemon je yra 3 ml suspensijos.
Cartons of 1, 5 or 10 pre-filled pens.
D žut je gali b ti 1, 5 arba 10 užpildyt švirkštimo priemoni.
NovoFine S needles are designed to be used with the pre-filled pen.
NovoFine S adatos yra skirtos naudoti su užpildytomis švirkštimo priemon mis.
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
Reikia laikytis nurodym, kurie yra pateikti prie NovoMix 50 FlexPen prid toje išsamioje naudojimosi instrukcijoje.
NovoMix 50 FlexPen is for use by one person only.
NovoMix 50 FlexPen skirtas vartoti tik vienam asmeniui.
NovoMix 50 FlexPen must not be refilled.
NovoMix 50 FlexPen negalima pildyti pakartotinai.
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 70 FlexPen 100 V/ ml, injekcin suspensija užpildytoje švirkštimo priemon je.
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart.
Vienas insulino aparto (insulinum aspartum) vienetas atitinka 6 nmol, 0, 035 mg bedruskio, bevandenio insulino asparto.
42 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
41 Kaip ir skiriant visus insulinus, vyresniems pacientams arba pacientams, kuriems yra kepen arba inkst funkcijos nepakankamumas, reik t atidžiau tikrinti gliukoz s kiek ir individualiai parinkti doz.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 sud tyje yra metakrezolio, kuris gali sukelti alergines reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
42 4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
43 Klinikini tyrim metu nustatytas nepageidaujam reakcij dažnis, susij s su insulino asparto vartojimu, pateikiamas žemiau.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Kiekvienoje dažnumo grup je nepageidaujami reiškiniai išvardinami sunkumo maž jimo tvarka..
46 5.2 Pharmacokinetic properties
5. 2 Farmakokinetin s savyb s
The insulin aspart in the soluble phase of NovoMix 70 comprises 70% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Insulinas aspartas tirpioje NovoMix 70 faz je sudaro 70% viso insulino; jis iš poodinio sluoksnio rezorbuojamas grei iau nei dvifazio žmogaus insulino tirpi insulino dalis.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Likusieji 30% yra kristal
47 6.4 Special precautions for storage
6. 4 Specialios laikymo s lygos
NovoMix 70 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 FlexPen, kurie naudojami ar nešiojami kaip atsarga: gali b ti laikomi kambario temperat roje (ne aukštesn je kaiip 30 °C) iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
Laikyti užpildytos švirkštimo priemon s dangtel užd t ant NovoMix 70 FlexPen, kai juo nesinaudojate, kad preparatas b t apsaugotas nuo šviesos.
After removing NovoMix 70 FlexPen from the refrigerator it is recommended to allow NovoMix 70 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
46 Iš mus NovoMix 70 FlexPen iš šaldytuvo, prieš suplakant insulin kaip nurodoma naudojantis pirm kart, rekomenduojama palaikyti NovoMix 70 FexPen kambario temperat roje, kad sušilt.
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other in a multidose disposable pre-filled pen with a pen injector (plastic).
1 tipo stiklinis užtaisas yra su latekso neturin iu (bromobutilo) guminiu st mokliu ir yar uždarytas latekso neturin iu (bromobutilo / poliizopreno) guminiu kamš iu bei d tas kit daugiadoz užpildyt švirkštimo priemon su injektoriumi (plastikiniu).
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
Reikia laikytis nurodym, kurie yra pateikti prie NovoMix 70 FlexPen prid toje išsamioje naudojimosi instrukcijoje.
NovoMix 70 FlexPen is for use by one person only.
NovoMix 70 FlexPen skirtas vartoti tik vienam asmeniui.
NovoMix 70 FlexPen must not be refilled.
NovoMix 70 FlexPen negalima pildyti pakartotinai.
Any unused product or waste material should be disposed of in accordance with local requirements.
Nesuvartot preparat ar atliekas reikia tvarkyti laikantis vietini reikalavim
49 ANNEX II
47 II PRIEDAS
NovoMix 30 Penfill and NovoMix 30 FlexPen:
NovoMix 30 Penfill ir NovoMix 30 FlexPen
NovoMix 50 Penfill and NovoMix 50 FlexPen:
NovoMix 50 Penfill ir NovoMix 50 FlexPen:
NovoMix 70 Penfill and NovoMix 70 FlexPen:
NovoMix 70 Penfill ir NovoMix 70 FlexPen:
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Informaciniame vaistinio preparato lapelyje turi b ti nurodyta gamintojo, atsakingo už konkre ios serijos išleidim, pavadinimas ir adresas
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• S LYGOS AR APRIBOJIMAI, SKIRTI SAUGIAM IR VEIKSMINGAM VAISTINIO PREPARATO VARTOJIMUI UŽTIKRINTI
51 ANNEX III
49 III PRIEDAS
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
OUTER CARTON
IŠORIN PAKUOT
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 V/ ml Injekcin suspensija užtaise Insulinum aspartum
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
1 ml suspensijos yra 100 V (3, 5 mg) insulino asparto (rDNR) (30% tirpaus insulino asparto ir 70% kristalizuoto insulino asparto protamino),
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glicerolio, fenolio, metakrezolio, cinko (chlorido pavidalu), natrio chlorido, dinatrio fosfato dihidrato, protamino sulfato, natrio hidroksido, vandenilio chlorido r gšties, injekcinio vandens.
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel.
OTHER SPECIAL WARNINGS, IF NECESSARY
KITI SPECIAL S SP JIMAI (JEI REIKIA)
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
NovoMix 30 Penfill užtaisai yra skirti vartoti tik vienam asmeniui.
EXP/
Tinka iki /
°
Negalima užšaldyti.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cartridges in the outer carton in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
Suvartoti per 4 savaites.
MARKETING AUTHORISATION NUMBERS
RINKODAROS TEIS S NUMERIS
EU/ 1/ 00/ 142/ 004 5 x 3 ml EU/ 1/ 00/ 142/ 005 10 x 3 ml
EU/ 1/ 00/ 142/ 004 5 x 3 ml EU/ 1/ 00/ 142/ 005 10 x3 ml
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
LABEL
ETIKET
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 Penfill 100 V/ ml Injekcin suspensija Insulinum aspartum s. c.
Resuspend according to instructions
Suplakti pagal instrukcijas.
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
NovoMix 50 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 50 Penfill 100 V/ ml Injekcin suspensija užtaise Insulinum aspartum
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 50% and insulin aspart crystallised with protamine 50%),
1 ml suspensijos yra 100 V (3, 5 mg) insulino asparto (rDNR) (50% tirpaus insulino asparto ir 50% kristalizuoto insulino asparto protamino),
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel.
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
NovoMix 50 Penfill užtaisai yra skirti vartoti tik vienam asmeniui.
MARKETING AUTHORISATION NUMBERS
RINKODRAOS TEIS S NUMERIS
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 Penfill 100 V/ ml Injekcin suspensija Insulinum aspartum s. c.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
NovoMix 70 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 70 Penfill 100 V/ ml Injekcin suspensija užtaise Insulinum aspartum
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
1 ml suspensijos yra 100 V (3, 5 mg) insulino asparto (rDNR) (70% tirpaus insulino asparto ir 30% kristalizuoto insulino asparto protamino),
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel.
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
NovoMix 70 Penfill užtaisai yra skirti vartoti tik vienam asmeniui.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
SPECIALIOS ATSARGUMO PRIEMON S, D L NESUVARTOTO VAISTINIO PREPARATO AR JO ATLIEK TVARKYMO (JEI REIKIA)
MARKETING AUTHORISATION NUMBERS
RINKODAROS PAŽYM JIMO NUMERIS
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
59 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 Penfill 100 V/ ml Injekcin suspensija Insulinum aspartum s. c.
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
60 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 30 FlexPen 100 V/ ml Injekcin suspensija užpildytoje švirkštimo priemon je Insulinum aspartum
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel.
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
NovoMix 30 FlexPen skirtas vartoti tik vienam asmeniui.
°
Laikykite užpildytos švirkštimo priemon s dangtel užd t, kad vaistinis preparatas b t apsaugotas nuo šviesos.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cap on the pen in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
Suvartoti per 4 savaites.
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
62 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 FlexPen 100 V/ ml Injekcin suspensija Insulinum aspartum s. c.
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
63 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
NovoMix 50 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 50 FlexPen 100 V/ ml Injekcin suspensija užpildytoje švirkštimo priemon je Insulinum aspartum
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
NovoMix 50 FlexPen yra skirtas vartoti tik vienam asmeniui.
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 FlexPen 100 V/ ml Injekcin suspensija Insulinum aspartum s. c.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
66 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
NovoMix 70 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 70 FlexPen 100 V/ ml Injekcin suspensija užpildytoje švirkštimo priemon je Insulinum aspartum
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
NovoMix 70 FlexPen yra skirtas vartoti tik vienam asmeniui.
SPECIAL STORAGE CONDITIONS
SPECIALIOS LAIKYMO S LYGO
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I