natgillin/translations-raw huggingface dataset:
Alcohol may intensify and prolong the glucose lowering effect of insulin.
27 Alkohol lahko stopnjuje in podaljša u inek insulina na znižanje glukoze.
28 4.6 Pregnancy and lactation
4. 6 Nose nost in dojenje
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.
Zelo redko - anafilakti ne reakcije Med simptomi generalizirane preob utljivosti so lahko generaliziran izpuš aj na koži, srbenje, znojenje, prebavne motnje, angionevroti ni edem, težko dihanje, palpitacije in znižanje krvnega tlaka.
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.
28 Bolezni živ evja Redko - periferna nevropatija Hitro izboljšanje urejenosti glukoze v krvi lahko spremlja motnja, imenovana akutna bole a nevropatija, ki je ponavadi reverzibilna.
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:
Specifi nega prevelikega odmerjanja za insulin ni mogo e opredeliti, a e so uporabljeni odmerki preveliki glede na bolnikove potrebe, se lahko v zaporednih stopnjah razvije hipoglikemija:
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Zdravilo NovoMix 30 je dvofazna suspenzija insulina aspart (hitrodelujo ega analoga humanega insulina) in s protaminom kristaliziranega insulina aspart (srednjedolgodelujo ega analoga humanega insulina).
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.
29 U inek insulina na znižanje glukoze v krvi je posledica lažjega privzema glukoze zaradi vezave insulina na insulinske receptorje na miši nih in maš obnih celicah ter hkratne inhibicije sproš anja glukoze iz jeter.
The maximum effect is exerted between 1 and 4 hours after injection.
Trajanje delovanja je do 24 ur.
Hours
ure
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 odmerjanje, opisanimi v poglavju 4. 2, je bilo povpre no znižanje HbA1c z zdravilom NovoMix 30 2, 8% (povpre na izhodiš na vrednost je bila 9, 7%).
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.
Metaanaliza je pri bolnikih z diabetesom tipa 2 pokazala manjše tveganje vseh no nih hipoglikemij in hudih hipoglikemij med uporabo zdravila NovoMix 30 kot med uporabo dvofaznega humanega insulina 30.
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.
V njem so primerjali urejenost postprandialne glikemije med uporabo NovoMix 30 ob obrokih in uporabo humanega insulina/ bifaznega humenega insulina ob obrokih ter NPH insulina pred spanjem.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
Kon ni HbA1c je bil zna ilno nižji v skupini z bifaznim humanim inslinom 30 kot v skupini z NovoMix 30.
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.
Insulin aspart v topni fazi zdravila NovoMix 30 obsega 30% celotnega insulina; ta se iz podkožja absorbira hitreje kot topna insulinska komponenta dvofaznega humanega insulina.
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.
Zdravilo NovoMix 30 FlexPen, ki je v uporabi ali ga ima bolnik pri sebi za rezervo: do 4 tedne jih je mogo e hraniti na sobni temperaturi (do 30 °C), toda ostanek je treba po tem asu zavre i.
Do not store above 30°C.
Ne shranjujte v hladilniku!
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
Kadar peresnik NovoMix 30 FlexPen ni v uporabi, naj bo za zaš ito pred svetlobo pokrit s pokrov kom.
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.
Potem ko zdravilo NovoMix 30 FlexPen vzamete iz hladilnika, ga je priporo ljivo pustiti, da doseže sobno temperaturo, preden insulin resuspendirate, kot opisujejo navodila za prvo uporabo.
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).
Steklen vložek (steklo tipa 1) je na enem koncu zaprt z batom iz (brombutilne) gume brez lateksa in na drugi strani z zaporko iz (brombutilne/ poliizoprenske) gume brez lateksa v ve odmernem napolnjenem injekcijskem peresniku za enkratno uporabo s (plasti nim) peresnim injektorjem.
Each pre-filled pen contains 3 ml suspension.
Vsak napolnjen injekciski peresnik vsebuje 3 ml suspenzije.
Cartons of 5 or 10 pre-filled pens.
Škatla s 5 ali 10 napolnjenimi injekcijskimi peresniki.
NovoFine S needles are designed to be used with the pre-filled pen.
Za uporabo z napolnjenim injekcijskim peresnikom so namenjene igle NovoFine S.
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
Upoštevati je treba podrobno navodilo, priloženo zdravilu NovoMix 30 FlexPen.
NovoMix 30 FlexPen is for use by one person only.
Zdravilo NovoMix 30 FlexPen je namenjeno uporabi ene same osebe.
NovoMix 30 FlexPen must not be refilled.
Peresnika NovoMix 30 FlexPen se ne sme znova polniti.
33 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Bolniku je treba posebej poudariti, da je treba suspenzijo NovoMix 30 tik pred uporabo resuspendirati.
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 50 FlexPen 100 e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 napolnjeni injekcijski peresnik vsebuje 3 ml, kar ustreza 300 e.
When necessary, NovoMix 50 can be given soon after start of a meal.
Hiter za etek delovanja in zgoden vrh delovanja insulina aspart omogo a uporabo zdravila NovoMix 50 tik pred obrokom. e je potrebno, je mogo e zdravilo NovoMix 50 dati kmalu po za etku obroka.
Optimised metabolic control, including glucose monitoring, is therefore recommended.
Zato je priporo ljiva im boljša urejenost presnove, vklju no s kontrolo glukoze.
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 Tako kot velja za vse insuline, potrebujejo starejši bolniki in bolniki z okvaro jeter ali ledvic intenzivnejši nadzor glukoze, odmerjanje pa je treba prilagoditi posamezno.
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
35 Zdravilo NovoMix 50 vsebuje metakrezol, ki lahko povzro i alergijske reakcije.
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
Po porodu se potreba po insulinu hitro vrne na ravni pred nose nostjo.
37 regimens therefore no specific frequency can be presented.
36 aspart, in bolnikih, ki so dobivali humani insulin.
39 5.2 Pharmacokinetic properties
5. 2 Farmakokineti ne lastnosti
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.
38 nagnjenost k tvorbi heksamerov v topni frakciji zdravila NovoMix 50 v primerjavi s topnim humanim insulinom.
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.
Pri zdravih prostovoljcih je bila popvre na najve ja koncentracija v serumu 445 ± 135 pmol/ l dosežena okrog 60 minut po subkutanem odmerku 0, 30 e. / kg telesne mase.
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.
Zdravilo NovoMix 50 FlexPen, ki je v uporabi ali ga ima bolnik pri sebi za rezervo: do 4 tedne jih je mogo e hraniti na sobni temperaturi (do 30 °C), toda ostanek je treba po tem asu zavre i.
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
Kadar peresnik NovoMix 50 FlexPen ni
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.
Potem ko zdravilo NovoMix 50 FlexPen vzamete iz hladilnika, ga je priporo ljivo pustiti, da doseže sobno temperaturo, preden insulin resuspendirate, kot opisujejo navodila za prvo uporabo.
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).
Steklen vložek (steklo tipa 1) je na enem koncu zaprt z batom iz (bromobutilne) gume brez lateksa in na drugi strani z zaporko iz (bromobutilne/ poliizoprenske) gume brez lateksa, v ve odmernem napolnjenem injekcijskem peresniku za enkratno uporabo s (plasti nim) peresnim injektorjem.
Each pre-filled pen contains 3 ml suspension.
Vsak napolnjen injekcijski peresnik vsebuje 3 ml suspenzije.
Cartons of 1, 5 or 10 pre-filled pens.
Škatle z 1, 5 ali 10 napolnjenimi injekcijskimi peresniki.
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
Upoštevati je treba podrobno navodilo, priloženo zdravilu NovoMix 50 FlexPen.
NovoMix 50 FlexPen is for use by one person only.
Zdravilo NovoMix 50 FlexPen je namenjeno uporabi ene same osebe.
NovoMix 50 FlexPen must not be refilled.
Peresnika NovoMix 50 FlexPen se ne sme znova polniti.
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 70 FlexPen 100 e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku
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.
Tako kot velja za vse insuline, potrebujejo starejši bolniki in bolniki z okvaro jeter ali ledvic intenzivnejši nadzor glukoze, odmerjanje pa je treba prilagoditi posamezno.
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.
Zaradi sprememb v jakosti, znamki (izdelovalec), tipu, izvoru (živalski, humani, analog humanega insulina) in/ ali na inu izdelave (tehnologija rekombinantne DNA v primerjavi z insulini živalskega izvora), imajo lahko za posledico spremembo odmerjanja.
If dosage adjustment is needed, it may be done with the first dose or during the first few weeks or months.
Bolniki, ki uporabljajo zdravilo NovoMix 70, utegnejo potrebovati spremembo odmerjanja v primerjavi s svojim obi ajnim insulinom. e je potrebna prilagoditev odmerka, jo je mogo e narediti pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
42 Zdravilo NovoMix 70 vsebuje metakrezol, ki lahko povzro i alergijske reakcije.
44 regimens therefore no specific frequency can be presented.
43 aspart, in bolnikih, ki so dobivali humani insulin.
46 5.2 Pharmacokinetic properties
5. 2 Farmakokineti ne lastnosti
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.
45 nagnjenost k tvorbi heksamerov v topni frakciji zdravila NovoMix 70 v primerjavi s topnim humanim insulinom.
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.
Zdravilo NovoMix 70 FlexPen, ki je v uporabi ali ga ima bolnik pri sebi za rezervo: do 4 tedne jih je
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
Kadar peresnik NovoMix 70 FlexPen ni v uporabi, naj bo za zaš ito pred svetlobo pokrit s pokrov kom.
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.
Potem ko zdravilo NovoMix 70 FlexPen vzamete iz hladilnika, ga je priporo ljivo pustiti, da doseže sobno temperaturo, preden insulin resuspendirate, kot opisujejo navodila za prvo uporabo.
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
Upoštevati je treba podrobno navodilo, priloženo zdravilu NovoMix 70 FlexPen.
NovoMix 70 FlexPen is for use by one person only.
Zdravilo NovoMix 70 FlexPen je namenjeno uporabi ene same osebe.
NovoMix 70 FlexPen must not be refilled.
Peresnika NovoMix 70 FlexPen se ne sme znova polniti.
49 ANNEX II
47 DODATEK II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE U INKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠ ANJE SERIJE
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.
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproš anje zadevne serije.
51 ANNEX III
49 DODATEK III
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 e. / ml suspenzija za injiciranje v injekcijskem vložku insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
(3, 5 mg) insulina aspart (rDNA) (30% topnega insulina aspart in 70% insulina aspart, kristaliziranega s protaminom),
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glicerol, fenol, metakrezol, cink (kot klorid), natrijev klorid, natrijev hidrogenfosfat dihidrat, protaminijev sulfat, natrijev hidroksid, klorovodikovo kislino, vodo za injekcije.
METHOD AND ROUTE OF ADMINISTRATION
POSTOPEK IN, E JE POTREBNO, POT( I) UPORABE ZDRAVILA
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Injekcijski vložki NovoMix 30 Penfill so namenjeni za uporabo z insulinskimi sistemi Novo Nordisk.
OTHER SPECIAL WARNINGS, IF NECESSARY
DRUGA POSEBNA OPOZORILA, E SO POTREBNA
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
Injekcijski vložki NovoMix 30 Penfill so namenjeni uporabi ene same osebe.
54 9.
52 9.
°
Injekcijski vložek shranjujte v zunanji ovojnini, da ga zaš itite pred svetlobo!
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
Porabite v 4 tednih!
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
IME ZDRAVILA IN, E JE POTREBNO, POT( I) UPORABE
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 Penfill 100 e. / ml suspenzija za injiciranje insulin aspart Za subkutano uporabo.
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NovoMix 50 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 50 Penfill 100 e. / ml suspenzija za injiciranje v injekcijskem vložku insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 50% and insulin aspart crystallised with protamine 50%),
(3, 5 mg) insulina aspart (rDNA) (50% topnega insulina aspart in 50% insulina aspart, kristaliziranega s protaminom)
PHARMACEUTICAL FORM AND CONTENTS
SEZNAM POMOŽNIH SNOVI
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Injekcijski vložki NovoMix 50 Penfill so namenjeni za uporabo z insulinskimi sistemi Novo Nordisk.
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
Injekcijski vložki NovoMix 50 Penfill so namenjeni uporabi ene same osebe.
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 Penfill 100 e. / ml suspenzija za injiciranje insulin aspart Za subkutano uporabo.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NovoMix 70 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 70 Penfill 100 e. / ml suspenzija za injiciranje v injekcijskem vložku insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
(3, 5 mg) insulina aspart (rDNA) (70% topnega insulina aspart in 30% insulina aspart, kristaliziranega s protaminom).
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glicerol, fenol, metakrezol, cink (kot klorid), natrijev klorid, natrijev hidrogenfosfat dihidrat, protaminijev sulfat, natrijev hidroksid, klorovodikovo kislino, vodo za injekcije
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Injekcijski vložki NovoMix 70 Penfill so namenjeni za uporabo z insulinskimi sistemi Novo Nordisk.
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
Injekcijski vložki NovoMix 70 Penfill so namenjeni uporabi ene same osebe.
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
59 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 Penfill 100 e. / ml suspenzija za injiciranje insulin aspart Za subkutano uporabo.
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
60 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 30 FlexPen 100 e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
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
Pred uporabo natan no preberite priloženo navodilo!
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
NovoMix 30 FlexPen je namenjen uporabi ene same osebe.
°
Peresnik naj bo pokrit s pokrov kom, da ga zaš itite pred svetlobo!
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
Porabite v 4 tednih!
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
62 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 FlexPen 100 e. / ml suspenzija za injiciranje insulin aspart Za subkutano uporabo.
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
63 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NovoMix 50 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 50 FlexPen 100 e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
NovoMix 50 FlexPen je namenjen uporabi ene same osebe.
66 8.
64 8.
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 FlexPen 100 e. / ml suspenzija za injiciranje insulin aspart Za subkutano uporabo.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
66 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NovoMix 70 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 70 FlexPen 100 e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku insulin aspart
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
(3, 5 mg) insulina aspart (r- DNA) (70% topnega insulina aspart in 30% insulina aspart, kristaliziranega s protaminom)
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
NovoMix 70 FlexPen je namenjen uporabi ene same osebe.
69 8.
67 8.
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 FlexPen 100 e. / ml suspenzija za injiciranje insulin aspart Za subkutano uporabo.
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 e. / ml suspenzija za injiciranje v injekcijskem vložku insulin aspart
Read all of this leaflet carefully before you start using this medicine. – Keep this leaflet.
Preden za nete uporabljati vaš insulin, natan no preberite navodilo! – Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. – e imate dodatna vprašanja, se posvetujte z zdravnikom, z diabetološko sestro ali s farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NOVOMIX 30 IN ZA KAJ GA UPORABLJAMO
NovoMix 30 is an insulin analogue to treat diabetes.
Zdravilo NovoMix 30 je insulinski analog za zdravljenje diabetesa.
It comes in a 3 ml cartridge, called Penfill, which fits into a delivery system.
Na voljo je v 3- ml vložkih, imenovanih Penfill, ki se jih vstavi v sistem za dajanje insulina.
NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%).
Zdravilo NovoMix 30 je mešanica hitrodelujo ega insulinskega analoga (30%) in dolgodelujo ega insulinskega analoga (70%).
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 24 hours.
To pomeni, da za ne sladkor v krvi zniževati v 10 do 20 minutah po uporabi, doseže najve ji u inek v 1 do 4 urah in deluje do 24 ur.
It may be used in combination with certain oral antidiabetic drugs.
Zdravilo NovoMix 30 se lahko uporablja v kombinaciji z dolo enimi peroralnimi antidiabetiki.