qanastek/EMEA-V3 huggingface dataset:
Hadovka Office Park Evropská 2590/33d CZ-160 00 Praha 6 Tel: + 420 267 292 111
Evropská 2590/ 33d CZ- 160 00 Praha 6 Tel: + 420 267 292 111
Malta V.J.Salomone Pharma Limited 79, Simpson Street, Marsa HMR 14, Malta.
Marsa HMR 14, Malta.
Postępu 18A PL-02-676 Warszawa Tel.: + 48 22 606-10-50
Postępu 18A PL - 02- 676 Warszawa Tel: + 48 22 606- 10- 50
I-04010 Campoverde di Aprilia (Latina) Tel: + 39 06 928921
94 Italia Abbott SpA I- 04010 Campoverde di Aprilia (Latina) Tel: + 39 06 928921
What is NovoMix?
Kas ir NovoMix?
NovoMix is a range of white suspensions for injection.
NovoMix ir dažādas baltas suspensijas injekcijām.
It is available in cartridges or in prefilled pens.
Tās ir pieejamas kasetnēs vai iepriekš uzpildītos pildspalvinjektoros.
NovoMix contains the active substance insulin aspart 100 units (U) per millilitre: • NovoMix 30:
NovoMix satur aktīvo vielu asparta insulīnu devā 100 vienības (V) mililitrā: • NovoMix 30:
30% soluble insulin aspart (rapid acting) and 70% protamine-crystallised insulin aspart (long acting), • NovoMix 50:
30% šķīstoša asparta insulīna (ātras darbības) un 70% ar protamīnu kristalizēta asparta insulīna (ilgstošas darbības) • NovoMix 50:
50% soluble insulin aspart (rapid acting) and 50% protamine-crystallised insulin aspart (long acting), • NovoMix 70:
50% šķīstoša asparta insulīna (ātras darbības) un 50% ar protamīnu kristalizēta asparta insulīna (ilgstošas darbības) • NovoMix 70:
70% soluble insulin aspart (rapid acting) and 30% protamine-crystallised insulin aspart (long acting).
70% šķīstoša asparta insulīna (ātras darbības) un 30% ar protamīnu kristalizēta asparta insulīna (ilgstošas darbības).
What is NovoMix used for?
Kāpēc lieto NovoMix?
NovoMix is used to treat patients who have diabetes.
NovoMix lieto, lai ārstētu pacientus, kas slimo ar diabētu.
How is NovoMix used?
Kā lieto NovoMix?
NovoMix is administered subcutaneously (under the skin) by injection in the abdominal wall (tummy), or the thigh.
NovoMix ievada subkutāni (zemādā), injicējot vēdera sienā (vēderā) vai augšstilbā.
The deltoid region (shoulder) or the gluteal region (buttocks) may also be used.
Var injicēt arī deltveida muskulī (plecā) vai gūžas apvidū (sēžamvietā).
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Lai atrastu zemāko iedarbīgo devu, regulāri jāpārbauda glikozes (cukura) līmenis pacienta asinīs.
NovoMix is given immediately before a meal, but may be given after a meal if necessary.
NovoMix ievada tieši pirms maltītes, bet, nepieciešamības gadījumā, tās var ievadīt arī pēc maltītes.
The usual dose is between 0.5 and 1.0 U per kilogram body weight per day.
Parastā deva ir no 0, 5 līdz 1, 0 V uz kilogramu ķermeņa svara dienā.
In type 2 diabetes (also known as non-insulin dependent diabetes), NovoMix can be given on its own or together with metformin.
Pie 2. veida diabēta (ko sauc arī par insulīnneatkarīgo diabētu), NovoMix var ievadīt vienas pašas vai kopā ar metformīnu.
NovoMix 30 can also be used with other antidiabetic medicines that can be taken by mouth in combination with insulin, but it should only be used with pioglitazone once the patient ’ s risk of fluid-related side effects has been evaluated.
NovoMix 30 var lietot kopā arī ar citām pretdiabēta zālēm, kuras, kombinācijā ar insulīnu, var ieņemt iekšķīgi, bet tās ir jālieto tikai kopā ar pioglitazonu, kad pacientam ir novērtēts ar šķidrumu saistīto blakusparādību risks.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Sīkāka informācija atrodama zāļu aprakstā (kas arī ir daļa no EPAR).
How does NovoMix work?
Kā NovoMix darbojas?
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Diabēts ir slimība, pie kuras organisms nesaražo pietiekamu daudzumu insulīna, lai kontrolētu glikozes līmeni asinīs.
NovoMix is a replacement insulin which is very similar to the insulin made by the pancreas.
NovoMix ir insulīna aizstājējs, kas ir ļoti līdzīgs insulīnam, ko ražo aizkuņģa dziedzeris.
The active ingredient of NovoMix, insulin aspart, is produced by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
NovoMix aktīvo sastāvdaļu asparta insulīnu iegūst, izmantojot tā dēvēto „ rekombinanto DNS tehnoloģiju ”: to ražo raugs, kas ir saņēmis gēnu (DNS), kurš padara to spējīgu ražot asparta 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged insulin aspart.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged insulīnu.
Insulin aspart is very slightly different from human insulin, and the change means that it is absorbed faster by the body, and can therefore act faster than human insulin.
Asparta insulīns ļoti nedaudz atšķiras no cilvēka insulīna un izmaiņas nozīmē to, ka pēc injicēšanas organisms to uzsūc ātrāk, un tas var iedarboties ātrāk nekā cilvēka insulīns.
NovoMix contains insulin aspart in two forms: the soluble form, which acts quickly (within 10 minutes of injection) and the crystallised form, which is absorbed much more slowly during the day.
NovoMix satur divu veidu asparta insulīnu: šķīstošo, kas iedarbojas ātri (10 minūšu laikā pēc injekcijas), un kristālisko, kas uzsūcas daudz lēnāk dienas gaitā.
This gives NovoMix a longer duration of action.
Tas nodrošina ilgāku NovoMix iedarbīgumu.
The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Insulīna aizstājējs darbojas tāpat kā dabīgi ražotais insulīns un palīdz glikozei no asinīm nokļūt šūnās.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Kontrolējot glikozi asinīs, diabēta simptomi un komplikācijas samazinās.
How has NovoMix been studied?
Kā noritēja NovoMix izpēte?
NovoMix 30 has been studied in patients with type 1 or type 2 diabetes (294 patients) where it was compared with human insulin over 12 weeks.
NovoMix 30 tika pētītas, iesaistot pacientus ar 1. vai 2. veida diabētu (294 pacientus), un salīdzinātas ar cilvēka insulīnu 12 nedēļas ilgi.
NovoMix 50 and NovoMix 70 injected three times a day have been compared in 664 patients (with type 1 or type 2 diabetes) to human insulin 30 injected twice a day.
NovoMix 50 un NovoMix 70 tika injicētas trīs reizes dienā, iesaistot 664 pacientus (ar 1. vai 2. veida diabētu), un salīdzinātas ar divreiz dienā injicētu cilvēka insulīnu 30.
The effects of adding NovoMix 30 to other antidiabetic medicines taken by mouth (metformin, sulphonylureas and pioglitazone) have also been studied in four studies involving a total of 905 patients.
Četros pētījumos, iesaistot 905 pacientus, tika pētīts efekts, ko dod NovoMix 30 pievienošana citām pretdiabēta zālēm, ko lieto iekšķīgi (metformīnam, sulfonilurīnvielām un pioglitazonam).
In all studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, before and at the end of the study.
Tas parāda, cik labi tiek regulēts glikozes līmenis asinīs.
What benefit has NovoMix shown during the studies?
Kāds ir NovoMix iedarbīgums šajos pētījumos?
NovoMix 30 gave almost identical results to human insulin at the end of the study.
Pētījuma beigās NovoMix 30 rezultāti bija gandrīz identiski ar cilvēka insulīnu.
NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than human insulin 30.
NovoMix 50 un NovoMix 70 nodrošināja labāku vispārējo glikozes līmeņa regulāciju asinīs nekā cilvēka insulīns 30.
Adding NovoMix 30 to other antidiabetic medicines resulted in better control of blood glucose than the other medicines taken alone.
NovoMix 30 pievienošana citām pretdiabēta zālēm labāk regulēja glikozes līmeni asinīs nekā citas zāles vienas pašas.
What is the risk associated with NovoMix?
Kāds pastāv risks, lietojot NovoMix?
As with other insulins, NovoMix may cause hypoglycaemia (low blood glucose).
Tāpat kā citi insulīni, NovoMix var izsaukt hipoglikēmiju (zemu glikozes līmeni asinīs).
For the full list of all side effects reported with NovoMix, see the Package Leaflet.
Pilns visu NovoMix izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
NovoMix should not be used in people who may be hypersensitive (allergic) to insulin aspart or to any of the other ingredients, or in patients with hypoglycaemia.
NovoMix nedrīkst lietot cilvēki, kam var būt paaugstināta jutība (alerģija) pret asparta insulīnu vai kādu citu šo zāļu sastāvdaļu, vai pacienti ar hipoglikēmiju.
NovoMix doses might also need to be adjusted when given with a number of other medicines which can have an effect on blood glucose.
Ievadot kopā ar vairākām citām zālēm, kas var ietekmēt glikozes līmeni asinīs, var nākties pielāgot NovoMix devas.
For the full list, see the Package Leaflet.
Sīkāka informācija atrodama zāļu lietošanas pamācībā.
Why has NovoMix been approved?
Kāpēc NovoMix tika apstiprinātas?
The Committee for Medicinal products for Human Use (CHMP) decided that NovoMix’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka NovoMix ieguvums cukura diabēta ārstēšanā ir lielāks par šo zāļu radīto risku.
The Committee recommended that NovoMix be given marketing authorisation.
Komiteja ieteica izsniegt NovoMix reģistrācijas apliecību.
Other information about NovoMix:
Cita informācija par NovoMix:
The European Commission granted a marketing authorisation valid throughout the European Union for NovoMix to Novo Nordisk A/ S on 1 August 2000.
Eiropas Komisija 2000. gada 1. augustā izsniedza NovoMix reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam Novo Nordisk A/ S.
The marketing authorisation was renewed on 1 August 2005.
Reģistrācijas apliecība tika atjaunota 2005. gada 1. augustā.
The full EPAR for NovoMix can be found here.
Pilns NovoMix EPAR teksts ir atrodams šeit.
This summary was last updated in 08-2007.
Šis kopsavilkums pēdējo reizi tika atjaunināts 08. – 2007.
cartridge (glass)
Kārtridžs (stikls)
cartridge (glass) in pre- filled pen
Kārtridžs (stikls) pildspalvveida pilnšļircē
NovoMix 30 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 30 Penfill 100 V/ ml, suspensija injekcij m k rtridž.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*……... 100 U/ ml in the ratio of 30/ 70
Š stošs asparta insul ns * / kristaliz ts protam na asparta insul ns * ……. 100 V/ ml attiec b 30/ 70.
* produced by recombinant DNA technology in Saccharomyces cerevisiae.
* ieg ts ar rekombinantas DNS tehnolo ijas pal dz bu no Saccharomyces cerevisiae.
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart.
Viena asparta insul na (insulinum aspartum) vien ba atbilst 6 nmol, 0, 035 mg s li nesaturošam bez dens asparta insul nam.
1 cartridge contains 3 ml equivalent to 300 U.
1 k rtridž ir 3 ml, kas atbilst 300 V.
NovoMix 30 is a white suspension.
NovoMix 30 ir balta suspensija.
NovoMix 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal.
NovoMix 30 ir tr ks darb bas s kums nek divf zu cilv ka insul nam, un tas parasti j ievada tieši pirms dienreizes.
When necessary, NovoMix 30 can be given soon after a meal.
Ja nepieciešams, NovoMix 30 var ievad t t l t p c dienreizes.
NovoMix 30 is administered subcutaneously in the thigh or in the abdominal wall.
NovoMix 30 ievada subkut ni augšstilb vai v dera priekš j sien.
If convenient, the gluteal or deltoid region may be used.
Ja ir rti, var injic t ar s žas vai deltveida musku a apvid.
Injection sites should be rotated within the same region.
Injekcijas vietas viena anatomisk apvidus robež s j maina.
As with all insulins the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
T pat k visiem insul niem, darb bas ilgums b s atš ir gs atkar b no devas, injekcijas vietas, asinsrites, temperat ras un fizisk s aktivit tes l me a.
The influence of different injection sites on the absorption of NovoMix 30 has not been investigated.
Nav p t ts, k NovoMix 30 uzs kšanos ietekm injekciju izdar šana atš ir g s viet s.
NovoMix 30 should never be administered intravenously.
NovoMix 30 nekad nedr kst ievad t intravenozi.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
Nieru vai aknu darb bas trauc jumi var mazin t pacienta nepieciešam bu p c insul na.
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred.
NovoMix 30 var lietot b rniem un pusaudžiem s kot no 10 gadu vecuma, gad jumos, kad priekšroka tiek dota kombin tas darb bas insul nam.
For children 6-9 years limited clinical data exists (see section 5.1).
Par b rniem vecum no 6 l dz 9 gadiem kl niskie dati ir ierobežoti (skat t apakšpunkt 5. 1).
No studies have been performed in children under the age of 6 years.
Nav veikti p t jumi par b rniem, kuri jaun ki par 6 gadiem.
Dose recommendation:
Devas rekomend cija:
Dosage of NovoMix 30 is individual and determined in accordance with the needs of the patient.
NovoMix 30 deva ir individu la un tiek noteikta, emot v r pacienta nepieciešam bu.
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.
2. tipa diab ta pacientiem NovoMix 30 var lietot monoterapij vai kombin cij ar peror liem pretdiab ta l dzek iem, kuriem ir apstiprin ta lietošana kombin cij ar insul nu, ja glikozes l me a asin s kontrole ir nepietiekama lietojot tikai šos peror los pretdiab ta l dzek us vien.
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).
Pacientiem ar 2. tipa diab tu, ieteicam NovoMix 30 s kumdeva ir 6 V brokast s un 6 V vakari s (vakara dienreiz).
When using
2 NovoMix 30 var uzs kt ar vienreiz dien ar 12 V vakari s (vakara dienreiz).
2 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.
Ja lietojot NovoMix 30 vienreiz dien deva sasniedz 30 V, ir ieteicams p riet uz div m reiz m, sadalot devu vien d s brokastu un vakari u dev s.
If twice daily dosing with NovoMix 30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).
Ja NovoMix 30 doz šana divreiz dien atk rtoti noved pie hipoglik mijas dienas laik, r ta devu var sadal t r ta un pusdienu dev s (doz šana tr sreiz dien).
The following titration guideline is recommended for dose adjustments:
Devas piel gošanai ir ieteicami sekojoši titr šanas nor d jumi:
Pre-meal blood glucose level
Glikozes l menis asin s pirms šanas < 4, 4 mmol/ l < 80 mg/ dL 4, 4 – 6, 1 mmol/ l 80 – 110 mg/ dL 6, 2 – 7, 8 mmol/ l 111 – 140 mg/ dL 7, 9 – 10 mmol/ l 141 – 180 mg/ dL > 10 mmol/ l > 180 mg/ dL
NovoMix 30 dose adjustment
NovoMix 30
4.4 – 6.1 mmol/ l
devas piel gošana - 2V 0 +2V +4V +6V
The lowest of three previous days’ pre-meal levels should be used.
Ir j izmanto zem kais no triju iepriekš jo dienu glikozes l me a asin s r d t jiem pirms šanas.
The dose should not be increased if hypoglycaemia occurred within these days.
Deva nav j palielina, ja šaj s dien s ir radusies hipoglik mija.
Dose adjustments can be made once a week until target HbA1c is reached.
Devas piel gošanu var veikt reizi ned, kam r tiek sasniegts HbA1c m r a lielums.
Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.
Lai nov rt tu iepriekš j s devas atbilst bu, ir j izmanto pirms - šanas glikozes l me a asin s r d t ji.
The combination of NovoMix 30 with pioglitazone should only be considered following clinical evaluation of the patient’ s risk of developing signs or symptoms of fluid-related adverse events.
NovoMix 30 lietošana kombin cij ar pioglitazonu var tikt apsv rta tikai p c tam, kad pacientam veikta ar š idrumu saist to blakuspar d bu paz mju vai simptomu rašan s riska kl niska nov rt šana.
The initiation of NovoMix 30 should be undertaken cautiously titrating to the lowest dose required to achieve glycaemic control (see section 4.4)
NovoMix 30 lietošana j uzs k, devu uzman gi titr jot l dz maz kajai, kas nepieciešama glik mijas kontroles sasniegšanai (skat t apakšpunkt 4. 4).
In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day.
Pacientiem ar 1. tipa diab tu individu l nepieciešam ba p c insul na parasti ir robež s no 0, 5 l dz 1, 0 vien bai/ kg dien.
NovoMix 30 may fully or partially meet this requirement.
NovoMix 30 to var nodrošin t piln gi vai da ji.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. due to obesity), and lower in patients with residual endogenous insulin production.
Dien nepieciešamais insul na daudzums var b t liel ks pacientiem, kuriem ir rezistence pret insul nu (piem ram, aptaukošan s d), un maz ks pacientiem, kuriem ir saglab jusies endog n insul na produkcija.
When transferring a patient from biphasic human insulin to NovoMix 30, start with the same dose and regimen.
Kad pacientam nomaina divf zu cilv ka insul nu uz NovoMix 30, j s k ar t du pašu devu un terapijas rež mu.
Then titrate according to individual needs (See titration guidelines in table above).
Tad devu titr saska ar individu l m vajadz b m (titr šanas nor d jumus skat t tabul augst k).
NovoMix 30 can be used in elderly patients; however there is limited experience with the use of NovoMix 30 in combination with OADs in patients older than 75 years.
NovoMix 30 var lietot gados vec ki pacienti, lai gan pieredze par NovoMix 30 lietošanu kombin cij ar peror liem pretdiab ta l dzek iem pacientiem, kuri vec ki par 75 gadiem, ir ierobežota.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Paaugstin ta jut ba pret akt vo vielu vai k du no pal gviel m. • Hipoglik mija.
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.
Neatbilstošu devu lietošana vai terapijas p rtraukšana, paši insul natkar ga diab ta pacientiem, var izrais t hiperglik miju un diab tisko ketoacidozi - st vok us, kas var beigties let li.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
dienreizes izlaišana vai nepl nota, liela fiziska slodze var izrais t hipoglik miju (skat t apakšpunktus 4. 8 un 4. 9).
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection.
Sal dzinot ar divf zu cilv ka insul nu, NovoMix 30 var b t vair k izteikts glikozes l meni pazeminošais efekts l dz 6 stund m p c injekcijas.
This may have to be compensated for in the individual patient, through adjustment of insulin dose and/ or food intake.
To var kompens t pacientam individu li ar insul na devas piel gošanu un/ vai uzturu.
Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Pacientiem, kuru glikozes l me a kontrole asin s ir stipri uzlabojusies, piem ram, intensific tas insul nterapijas d, var main ties hipoglik mijas parastie br din juma simptomi un pacienti par to j br dina.
3 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.
Stingr ka glikozes l me a kontrole var palielin t hipoglik mijas epizožu potenci lu un t d prasa pašu uzman bu devas intensifik cijas laik, k aprakst ts apakšpunkt 4. 2.
NovoMix 30 should be administered in immediate relation to a meal.
3 NovoMix 30 j ievada tieš saist b ar dienreizi.
The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
T p c straujš darb bas s kums j paredz pacientiem ar blakusslim b m vai rst šanas laik ar citiem medikamentiem, kad var sagaid t aizkav tu uzturvielu uzs kšanos.
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
Blakus saslimšanas, paši infekcijas, parasti palielina pacienta nepieciešam bu p c insul na.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Pacientiem p c insul na tipa nomai as, hipoglik mijas agr nie br din juma simptomi var main ties vai k t v j k izteikti, nek lietojot iepriekš jo insul nu.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Pacienta p reja uz jaunu insul na tipu vai cita z mola insul nu j veic stingr medi u uzraudz b.
Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue), and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
Mainot lietojam insul na koncentr ciju, z molu (ražot ju), tipu, izcelsmi (dz vnieku, cilv ka, cilv ka insul na analogs) un/ vai ražošanas metodi (rekombinantas DNS tehnolo ijas pret dz vnieku izcelsmes insul nu), var rasties vajadz ba main t t devu.
Patients taking NovoMix 30 may need a change in dosage from that used with their usual insulin.
Pacientiem, kuri sa em NovoMix 30, var b t nepieciešama devas mai a, sal dzinot ar iepriekš lietotajiem insul niem.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Ja nepieciešams main t devu, to var dar t pirmaj lietošanas reiz vai dažu pirmo ned u vai m nešu laik.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
Devas piel gošana var b t nepieciešama ar tad, ja pacienti uzs k palielin tu fizisko aktivit ti vai maina ierasto di tu.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Ja vingrojumi tiek veikti t l t p c dienreizes, var palielin ties hipoglik mijas risks.
On rare occasions, injection site reactions may require discontinuation of NovoMix 30.
Retos gad jumos reakcijas injekcijas viet var pras t NovoMix 30 terapijas p rtraukšanu.
Combination of NovoMix 30 with pioglitazone:
NovoMix 30 kombin cija ar pioglitazonu:
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Pioglitazonu lietojot kombin cij ar insul nu, paši pacientiem ar sirds mazsp jas riska faktoriem, p cre istr cijas period sa emti zi ojumi par sirds mazsp jas gad jumiem.
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when NovoMix 30 is used in combination with pioglitazone.
Lietojot NovoMix 30 kombin cij ar pioglitazonu, j nov ro vai pacientiem nerodas sirds mazsp jas paz mes vai simptomi, erme a masas pieaugums un t ska.
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.
K sekas paaugstin tai insul na jut bai, pacientiem, kuri sa em pioglitazonu du l terapij ar insul nu, var b t devas- atkar gs hipoglik mijas risks, un var b t nepieciešama insul na devas samazin šana.
A number of medicinal products are known to interact with the glucose metabolism.
Zin mi daudzi medikamenti, kas mijiedarbojas ar glikozes vielmai u.
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.
Nepieciešam bu p c insul na var mazin t š das vielas: peror lie pretdiab ta l dzek i (PPD), oktreot ds, monoam noksid zes inhibitori (MAOI), neselekt vie beta adrenoblokatori, angiotens na konvert još enz ma (AKE) inhibitori, salicil ti, alkohols, anabolie stero di un sulfanilam di.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Nepieciešam bu p c insul na var palielin t š das vielas: peror lie pretapaug ošan s l dzek i, tiaz di, glikokortiko di, vairogdziedzera hormoni, simpatomim tiskie l dzek i un danazols.
Beta-blocking agents may mask the symptoms of hypoglycaemia.
Beta blokatori var mask t hipoglik mijas simptomus.
Alcohol may intensify and prolong the glucose lowering effect of insulin.
Alkohols var pastiprin t un paildzin t glikozi pazeminošo insul na efektu.
4 4.6 Pregnancy and lactation
4. 6 Gr tniec ba un z d šana
There is limited clinical experience with NovoMix 30 in pregnancy.
Kl nisk pieredze par NovoMix 30 lietošanu gr tniec bas laik ir ierobežota.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
4 Dz vnieku reprodukcijas p t jumi attiec b uz embriotoksicit ti vai teratogenit ti neliecin ja par jebk du asparta insul na un cilv ka insul na atš ir bu.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Kopum emot, sieviet m ieteicama pastiprin ta diab ta terapijas kontrole visu gr tniec bas laiku un tad, ja pl no gr tniec bu.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Nepieciešam ba p c insul na parasti mazin s pirmaj trimestr un p c tam palielin s otraj un trešaj trimestr.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
P c dzemd b m, nepieciešam ba p c insul na tri atjaunojas l men, k ds tas bijis pirms gr tniec bas.
There are no restrictions on treatment with NovoMix 30 during lactation.
Nav ierobežojumu rst šanai ar NovoMix 30 z d šanas laik.
Insulin treatment of the breast-feeding mother presents no risk to the baby.
M tes rst šana ar insul nu nerada risku b rnam, kuru baro ar m tes pienu.
However, the NovoMix 30 dosage may need to be adjusted.
Tom r var b t nepieciešams piel got NovoMix 30 devu.
No studies on the effects on the ability to drive and use machines have been performed.
Nav veikti p t jumi, lai nov rt tu ietekmi uz sp ju vad t transportl dzek us un apkalpot meh nismus.
Adverse drug reactions observed in patients using NovoMix products are mainly dose-dependent and due to the pharmacologic effect of insulin.
Pacientiem, kuri lieto NovoMix prepar tus, nov rot s z u nev lam s blakuspar d bas galvenok rt ir devas- atkar gas un insul na farmakolo isk efekta izrais tas.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
T pat k citiem insul niem, biež k sastopam blakuspar d ba ir hipoglik mija.
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.
T var rasties, ja insul na deva ir p r k liela sal dzinot ar insul na nepieciešam bu un t d prasa pašu uzman bu devas intensifik cijas laik, k aprakst ts apakšpunkt 4. 2.
In clinical trials and during marketed use the frequency varies with patient population and dose regimens therefore no specific frequency can be presented.
Kl niskos p t jumos un p cre istr cijas nov rojumos t s biežums vari starp pacientu grup m un doz šanas rež miem, t d noteikts hipoglik mijas biežums nevar b t uzr d ts.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
Kl nisko p t jumu laik hipoglik mijas visp r jais biežums neatš r s pacientiem, kuri tika rst ti ar asparta insul nu un cilv ka insul nu.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuras ir attiecin tas uz asparta insul nu, uzskait tas zem k.
Uncommon (> 1/ 1,000 ,< 1/100) and rare (> 1/10 ,000, < 1/1,000).
Biežums tiek defin ts š di: ret k (> 1/ 1000, < 1/ 100) un reti (> 1/ 10 000, < 1/ 1000).
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Atseviš i spont ni gad jumi tiek defin ti k oti reti (< 1/ 10 000), ieskaitot atseviš us zi ojumus.
Immune system disorders Uncommon - Urticaria, rash, eruptions
Im n s sist mas trauc jumi Ret k - n trene, izsitumi.
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.
Visp r jas paaugstin tas jut bas simptomi var b t eneraliz ti das izsitumi, nieze, sv šana, gastrointestin li trauc jumi, angioneirotiska t ska, apgr tin ta elpošana, pa trin ta sirdsdarb ba un asinsspiediena pazemin šan s.
Generalised hypersensitivity reactions are potentially life threatening.
Visp r j s paaugstin tas jut bas reakcijas var b t dz v bai b stamas.
5 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.
5 Ret k - refrakcijas trauc jumi.
Eye disorders Uncommon - Refraction disorder Refraction anomalies may occur upon initiation of insulin therapy.
Uzs kot insul nterapiju iesp jami refrakcijas trauc jumi.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Tom r insul nterapijas intensifik cija ar p kš u glik mijas kontroles uzlabošanos var izrais t diab tisk s retinop tijas pasliktin šanos.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Ja nemaina d rienu vietu anatomisk apvidus robež s, injekcijas viet var att st ties lipodistrofija.
Uncommon - Local hypersensitivity Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Ret k - lok la hipersensitivit te. rst šanas laik ar insul nu iesp jamas lok las paaugstin tas jut bas reakcijas (aps rtums, piet kums un nieze injekcijas viet).
These reactions are usually transitory and normally they disappear during continued treatment.
Parasti š s reakcijas ir p rejošas un, turpinot rst šanu, izz d.
General disorders and administration site conditions Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Uzs kot insul nterapiju, var att st ties t ska.
Oedema and weight increase may occur when NovoMix 30 is used in combination with OADs.
Lietojot NovoMix 30 kombin cij ar peror lajiem pretdiab ta l dzek iem, var b t t ska un erme a masas pieaugums.
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
Tom r hipoglik mijai var b t vair kas pak pes, ja tiek ievad tas liel kas devas nek pacientam nepieciešams:
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Vieglu hipoglik miju var rst t, peror li lietojot glikozi vai produktus, kuru sast v ir cukurs.
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 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
T d diab ta pacientiem iesaka vienm r n s t l dzi dažus cukuru saturošus produktus. • Smagu hipoglik miju, kad pacients zaud sama u, var rst t ar glikagonu (0, 5 l dz 1 mg), ko apm c ta persona ievada intramuskul ri vai subkut ni, vai ar glikozi, ko medic nas darbinieks ievada intravenozi.
Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Glikoze intravenozi j ievada ar tad, ja 10 l dz 15 min šu laik nav atbildes reakcijas uz glikagonu.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Atg stot sama u, pacientam ieteicams peror li lietot og hidr tus, lai izvair tos no atk rtotas hipoglik mijas.
Drugs used in diabetes.
Farmakoterapeitisk grupa: z les diab ta rst šanai.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Insul ni un analogi injekcij m, vid jas darb bas kombin ti ar tras darb bas.
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 30 ir asparta insul na (tras darb bas cilv ka insul na analoga) un kristaliz ta protam na asparta insul na (vid ji ilgas darb bas cilv ka insul na analoga) divf zu suspensija.
6 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.
Insul ns pazemina glikozes l meni asin s, jo tas saist s ar musku š nu un taukš nu receptoriem, veicinot glikozes nok šanu audos un vienlaikus nom cot glikozes izdal šanos no akn m.
NovoMix 30 is a biphasic insulin, which contains 30% soluble insulin aspart.
NovoMix 30 ir divf zu insul ns, kas satur 30% š stoša asparta insul na.
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.
Tam ir straujš darb bas s kums, kas auj to lietot tuv k dienreizei (0 l dz 10 min tes pirms vai p c dienreizes uzs kšanas), sal dzinot ar š stošo cilv ka insul nu.
The crystalline phase (70%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin (Figure 1).
Krist lisk f ze (70%) sast v no kristaliz ta protam na asparta insul na, kam ir cilv ka NPH insul nam l dz gs darb bas profils (1. att.).
When NovoMix 30 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Ja NovoMix 30 tiek injic ts subkut ni, darb ba s kas 10 l dz 20 min šu laik p c injekcijas.
The maximum effect is exerted between 1 and 4 hours after injection.
Maksim l iedarb ba tiek sasniegta starp 1. un 4. stundu p c injekcijas.
The duration of action is up to 24 hours.
Darb bas ilgums ir l dz 24 stund m.
Glucose infusion rate
6 Glikozes inf zijas trums
Hours
Stundas
Figure 1:
1. att.:
Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
NovoMix 30 (____) un divf zu cilv ka insul na 30 (_ _ _) darb bas profils veselam cilv kam.
In a 3 month trial in patients with type 1 and type 2 diabetes NovoMix 30 showed equal control of glycosylated haemoglobin compared to treatment with biphasic human insulin 30.
Tr s m nešus ilg p t jum ar NovoMix 30 1. tipa un 2. tipa cukura diab ta pacientiem, tika uzr d ta tikpat liela efektivit te glikoz t hemoglob na l me a kontrol k rst jot ar divf zu cilv ka insul nu 30.
Insulin aspart is equipotent to human insulin on a molar basis.
Asparta insul na molarit te ir identiska cilv ka insul na molarit tei.
Compared to biphasic human insulin 30, administration of NovoMix 30 before breakfast and dinner resulted in lower postprandial blood glucose after both meals (breakfast and dinner).
Sal dzinot ar divf zu cilv ka insul nu 30, ievadot NovoMix 30 pirms brokast m un vakari m, tiek sasniegts zem ks postprandi lais glikozes l menis asin s p c ab m dienreiz m (brokast m un vakari m).
A meta-analysis including nine trials in patients with type 1 and type 2 diabetes showed that fasting blood glucose was higher in patients treated with NovoMix 30, than in patients treated with biphasic human insulin 30.
Meta- anal ze par 9 p t jumiem pacientiem ar 1. un 2. tipa diab tu uzr d ja, ka glikozes l menis asin s tukš d ša bija augst ks pacientiem, kuri rst ti ar NovoMix 30, nek pacientiem, kuri rst ti ar divf zu cilv ka insul nu 30.
In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix 30 either alone or in combination with metformin, or to metformin together with sulfonylurea.
Vien p t jum 341 pacients ar 2. tipa cukura diab tu tika randomiz ts rst šanai ar NovoMix 30 monoterapij vai kombin cij ar metform nu vai rst šanai ar metform nu kombin cij ar sulfanilur nvielas prepar tu.
The primary efficacy variable - HbA1c after 16 weeks of treatment - did not differ between patients with NovoMix 30 combined with metformin and patients with metformin plus sulfonylurea.
Prim rais efektivit tes main gais raksturlielums – HbA1c p c 16 rst šanas ned m – neatš r s starp pacientiem, kuri tika rst ti ar NovoMix 30 kombin cij ar metform nu, un pacientiem, kuri lietoja metform nu un sulfanilur nvielas prepar tu.
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.
Šai p t jum 57% pacientu s kotn jais HbA1c l menis bija virs 9%; šiem pacientiem rst šana ar NovoMix 30 kombin cij ar metform nu deva noz m gi zem ku HbA1c l meni nek metform ns kombin cij ar sulfanilur nvielas prepar tu.
In one study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycaemic agents alone, were randomised to treatment with twice daily NovoMix 30 (117 patients) or once daily insulin glargine (116 patients).
Vien p t jum pacienti ar 2. tipa diab tu, kuriem kontrole ar tikai peror liem hipoglikemiz jošiem l dzek iem bija nepietiekama, tika randomiz ti rst šanai ar NovoMix 30 divreiz dien (117 pacienti) vai glarg na insul nu vienreiz dien (116 pacienti).
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%).
P c 28 ned u rst šanas, sekojot apakšpunkt 4. 2 aprakst tajiem doz šanas nor d jumiem, vid j HbA1c samazin šan s ar NovoMix 30 bija 2, 8% (vid ji uz b zl nijas = 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).
Ar NovoMix 30 66% un 42% pacientu saniedza HbA1c l meni attiec gi zem 7% un 6, 5%, un vid j tukšas d šas glik mija bija samazin ta par apm ram 7 mmol/ L (no 14, 0 mmol/ L uz b zl nijas uz 7, 1 mmol/ L).
7 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.
Pacientiem ar 2. tipa diab tu meta- anal ze uzr d ja samazin tu kop jo nakts hipoglik miju epizožu un smagas hipoglik mijas risku lietojot NovoMix 30, sal dzinot ar divf zu cilv ka insul nu 30.
The risk of overall daytime hypoglycaemic episodes was increased in patients treated with NovoMix 30
Pacientiem, kurus rst ja ar NovoMix 30, bija palielin ts kop jo dienas hipoglik mijas epizožu risks.
Children and adolescents:
B rni un pusaudži:
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 subjects aged 10 to 18 years.
16 ned as ilgs kl niskais p t jums, kur sal dzin ja postprandi lo glik mijas kontroli, lietojot NovoMix 30 dienreizes laik vai cilv ka insul nu/ divf zu cilv ka insul nu dienreizes laik un NPH insul nu pirms gul tiešanas, tika veikts 167 pacientiem 10 – 18 gadu vecum.
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.
Vid j HbA1c v rt ba visu p t juma laiku saglab j s l dz ga k p t juma s kum ab s terapijas grup s, un, sal dzinot NovoMix 30 un divf zu cilv ka insul na 30 lietošanu, hipoglik mijas biežuma atš ir bas nekonstat ja.
In a smaller (54 subjects) and younger (age range 6 to 12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycaemic episodes and the postprandial glucose increase was significantly lower with NovoMix 30 compared to biphasic human insulin 30.
Maz k (54 pacienti) un jaun k (6 – 12 g. v.) popul cij, kas tika rst ta dubultmask t, krustot 7 p t jum (12 ned as sa emot katru terapijas veidu), hipoglik mijas gad jumu biežums un postprandi l s glikozes l me a palielin šan s, lietojot NovoMix 30, bija daudz maz ka nek lietojot divf zu cilv ka insul nu 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Beigu HbA1c v rt ba ar divf zu cilv ka insul nu 30 rst to pacientu grup bija noz m gi maz ka nek ar NovoMix 30 rst to pacientu grup.
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 30, as compared with soluble human insulin.
Asparta insul na B28 poz cij aminosk bi prol nu aizvietojot ar asparag nsk bi, nov ro samazin tu tendenci veidoties heksam riem NovoMix 30 š stošaj f z, sal dzinot ar š stošo cilv ka insul nu.
The insulin aspart in the soluble phase of NovoMix 30 comprises 30% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Asparta insul ns NovoMix 30 š stošaj f z veido 30% no kop j insul na: no zem das tas uzs cas daudz tr k nek divf zu cilv ka insul na sast v esoš š stoš insul na da a.
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Atlikušie 70% ir krist lisk form k kristaliz ts protam na asparta insul ns; tas uzs cas l n k, l dz gi k cilv ka NPH insul ns.
The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
Sal dzinot ar divf zu cilv ka insul nu 30, insul na maksim l koncentr cija serum ar NovoMix 30 ir vid ji par 50% augst ka.
The time to maximum concentration is, on average, half of that for biphasic human insulin 30.
Maksim l s koncentr cijas sasniegšanas laiks vid ji ir uz pusi s ks nek divf zu cilv ka insul nam 30.
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 U/ kg body weight.
Veseliem br vpr t gajiem vid ji maksim l koncentr cija serum 140 ± 32 pmol/ l tika sasniegta apm ram 60 min šu laik p c 0, 20 V/ kg erme a masas devas ievad šanas subkut ni.
The mean half life (t½) of NovoMix 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hours.
NovoMix 30 vid jais pusperiods (t1/ 2), kas raksturo protam na saist t s frakcijas uzs kšan s trumu, bija apm ram 8 l dz 9 stundas.
Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
Insul na s kotn jais l menis serum atjaunoj s 15 l dz 18 stundu laik p c devas ievad šanas subkut ni.
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.
2. tipa cukura diab ta pacientiem maksim l koncentr cija tika sasniegta apm ram 95 min šu laik p c devas ievad šanas, un koncentr ciju, kas iev rojami liel ka par nulli, v l var ja konstat t ne maz k k 14 stundas p c devas ievad šanas.
The pharmacokinetics of NovoMix 30 has not been investigated in children or adolescents.
NovoMix 30 farmakokin tika b rniem un pusaudžiem nav p t ta.
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 u š stoš asparta insul na farmakokin tisk s un farmakodinamisk s paš bas ir p t tas b rniem (6 – 12 g. v.) un pusaudžiem (13 – 17 g. v.) ar 1. tipa cukura diab tu.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Asparta insul na uzs kšan s abu vecuma grupu p rst vjiem notika tri, tmax bija l dz gs k pieaugušajiem.
However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Ta u Cmax ab s vecuma grup s bija atš ir ga, kas akcent individu las asparta insul na titr šanas noz m bu.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
NovoMix 30 farmakokin tika nav p t ta gados vec kiem cilv kiem vai pacientiem ar pav jin tu nieru vai aknu funkciju.
Non-clinical data with insulin aspart reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Ne- kl niskajos standartp t jumos ar asparta insul nu ieg tie dati par farmakolo isko droš bu, atk rtotu devu toksicit ti, genotoksicit ti un toksisku ietekmi uz reproduktivit ti neliecina par pašu risku cilv kam.
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.
Testos in vitro, ieskaitot insul na saist šanos ar IGF- 1 receptoru viet m un ietekmi uz š nu augšanu, asparta insul ns darbojas l dzv rt gi cilv ka insul nam.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
P t jumi ar par d juši, ka asparta insul na saist šan s p rtraukšana ar insul na receptoru ir ekvivalenta cilv ka insul nam.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glicer ns Fenols Metakrezols Cinks (k hlor ds) N trija hlor ds Din trija fosf ta dihidr ts Protam na sulf ts N trija hidroks ds (pH korekcijai) S lssk be (pH korekcijai)
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Sader bas p t jumu tr kuma d š s z les nedr kst sajaukt (lietot mais jum) ar citiem produktiem.
The in-use shelf life is 4 weeks (not above 30°C).
Lietošanas laik der guma termi š ir 4 ned as (l dz 30°C).
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
Uzglab t ledusskap (2°C – 8°C) atstatus no sald tavas nodal juma.
NovoMix 30 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 30 Penfill k rtridži lietošanas laik vai n s jot l dzi rezervei: var tikt uzglab ti apk rt j temperat r (l dz 30°C) ne ilg k k 4 ned as, bet tad jebk ds p rpalikums ir j izmet.
Keep the cartridges in the outer carton in order to protect from light.
K rtridžu uzglab t r j iepakojum, lai pasarg tu no gaismas.
After removing NovoMix 30 Penfill from the refrigerator it is recommended to allow NovoMix 30 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
P c NovoMix 30 Penfill iz emšanas no ledusskapja, ir ieteicams aut tam sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.