natgillin/translations-raw huggingface dataset:
NovoMix 70 is for injection under the skin (subcutaneously).
Zdravilo NovoMix 70 je namenjeno injiciranju pod kožo (subkutani uporabi).
Renal and hepatic impairment
Ledvična ali jetrna okvara
NovoMix 50 is a biphasic suspension of 50% soluble insulin aspart (rapid-acting human insulin analogue) and 50% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Zdravilo NovoMix 50 je dvofazna suspenzija, s 50 % topnega insulina aspart (hitrodelujočega analoga humanega insulina) in 50 % s protaminom kristaliziranega insulina aspart (srednjedolgodelujočega analoga humanega insulina).
NovoMix 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediateacting effect, in the ratio 30/70.
Zdravilo NovoMix 30 je sodobni insulin (insulinski analog), s hitrim in s srednjedolgim delovanjem, v razmerju 30/70.
NovoMix 50 is for injection under the skin (subcutaneously).
Zdravilo NovoMix 50 je namenjeno injiciranju pod kožo (subkutani uporabi).
NovoMix 50 is presented as a suspension for injection.
Zdravilo NovoMix 50 je na voljo v obliki suspenzije za injiciranje.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
Bolniku je treba posebej poudariti, da je treba suspenzijo NovoMix 50 tik pred uporabo resuspendirati.
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 unit/kg body weight.
Pri zdravih prostovoljcih je bila povprečna največja koncentracija v serumu 645 ± 185 pmol/l dosežena okrog 60 minut po subkutanem odmerku 0,30 enote/kg telesne mase.
NovoMix 70 is presented as a suspension for injection.
Zdravilo NovoMix 70 je na voljo v obliki suspenzije za injiciranje.
The pharmacokinetics of NovoMix 30 have not been investigated in elderly patients or in patients with renal or hepatic impairment.
Posebne skupine bolnikov Farmakokinetika zdravila NovoMix 30 ni raziskana pri starejših bolnikih in bolnikih z okvaro ledvic ali jeter.
NovoMix 70 is indicated for treatment of diabetes mellitus in adults.
4.1 Terapevtske indikacije Zdravilo NovoMix 70 je namenjeno zdravljenju sladkorne bolezni pri odraslih.
► After each injection, be sure to remove and discard the needle and store NovoMix 70 without the needle attached.
► Po vsakem injiciranju morate iglo odstraniti in zavreči, zdravilo NovoMix 70 pa shraniti brez nameščene igle.
INFORMATION IN BRAILLE NovoMix 50 FlexPen
PODATKI V BRAILLOVI PISAVI NovoMix 50 FlexPen
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom
The pharmacokinetics of NovoMix 50 have not been investigated in paediatrics, elderly patients or in patients with renal or hepatic impairment.
Posebne skupine bolnikov Farmakokinetika zdravila NovoMix 50 ni raziskana pri otrocih, starejših bolnikih in bolnikih z okvaro ledvic ali jeter.
Instruction on how to use NovoMix 70 suspension for injection in FlexPen.
Navodila za uporabo zdravila NovoMix 70 suspenzija za injiciranje v injekcijskem peresniku FlexPen
1 cartridge contains 3 ml equivalent to 300 units.
En vložek vsebuje 3 ml, kar ustreza 300 enotam.
10 x 3 ml cartridges
10 x 3 ml vložki
► Needles and NovoMix 70 FlexPen must not be shared.
► Igel in zdravila NovoMix 70 FlexPen si ne delite z drugimi.
NovoMix 70 is presented as a suspension for injection in a pre-filled pen.
Zdravilo NovoMix 70 je na voljo v obliki suspenzije za injiciranje v napolnjenem injekcijskem peresniku.
NovoMix 70 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Zdravilo NovoMix 70 FlexPen je napolnjen injekcijski peresnik (barvno označen), namenjen za uporabo z iglami NovoFine ali NovoTwist.
► Do not refill the cartridge.
► Vložkov ne smete znova polniti.
Store below 30°C Do not freeze
Shranjujte pri temperaturi do 30 °C.
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
http://www.ema.europa.eu.
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Zdravilo NovoMix 70 se z injekcijo aplicira subkutano v stegno ali trebušno steno.
NovoMix 70 is a biphasic suspension of the insulin analogue, insulin aspart.
Zdravilo NovoMix 70 je dvofazna suspenzija insulinskega analoga, insulina aspart.
NovoMix 70 is a mixture consisting of 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine.
Zdravilo NovoMix 70 je mešanica, ki vsebuje 70 % topnega insulina aspart in 30 % insulina aspart, kristaliziranega s protaminom.
► Needles and NovoMix 50 FlexPen must not be shared.
► Igel in zdravila NovoMix 50 FlexPen si ne delite z drugimi.
► If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
Posvetujte se z zdravnikom: ► če imate težave z ledvicami ali jetri, nadledvično žlezo, hipofizo ali ščitnico, ► če ste telesno bolj dejavni kot ponavadi ali želite spremeniti svojo običajno prehrano, kajti to lahko vpliva na koncentracijo vašega krvnega sladkorja,
5 x 3 ml cartridges
5 x 3 ml vložki
NovoMix 50 FlexPen is a pre-filled, colour-coded, disposable pen containing a mixture of rapid-acting and intermediate-acting insulin aspart in the ratio 50/50.
Kako ravnati z injekcijskim peresnikom NovoMix 50 FlexPen Injekcijski peresnik NovoMix 50 FlexPen je napolnjen, barvno kodiran injekcijski peresnik za enkratno uporabo, ki vsebuje mešanico hitrodelujočega in srednjedolgodelujočega insulina aspart v razmerju 50/50.
► After each injection, be sure to remove and discard the needle and store NovoMix 50 without the needle attached.
► Po vsakem injiciranju morate iglo odstraniti in zavreči, zdravilo NovoMix 50 pa shraniti brez nameščene igle.
NovoMix 50 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Zdravilo NovoMix 50 FlexPen je napolnjen injekcijski peresnik (barvno označen), namenjen za uporabo z iglami NovoFine ali NovoTwist.
NovoMix 30 is for injection under the skin (subcutaneously).
Zdravilo NovoMix 30 je namenjeno injiciranju pod kožo (subkutani uporabi).
A 16-week clinical trial comparing postprandial glycaemic control of meal-related NovoMix 30 with meal-related human insulin/biphasic human insulin 30 and bedtime NPH insulin was performed in 167 patients aged 10 to 18 years.
V njem so primerjali urejenost postprandialne glikemije med uporabo zdravila NovoMix 30 ob obrokih in uporabo humanega insulina/bifaznega humanega insulina 30 ob obrokih ter NPH insulina pred spanjem.
Instruction on how to use NovoMix 50 suspension for injection in FlexPen.
Navodila za uporabo zdravila NovoMix 50 suspenzija za injiciranje v injekcijskem peresniku FlexPen
NovoMix 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 50 is essentially ‘sodium-free'.
Zdravilo NovoMix 50 vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
NovoMix 70 is a biphasic suspension of 70% soluble insulin aspart (rapid-acting human insulin analogue) and 30% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Zdravilo NovoMix 70 je dvofazna suspenzija, s 70 % topnega insulina aspart (hitrodelujočega analoga humanega insulina) in 30 % s protaminom kristaliziranega insulina aspart (srednjedolgodelujočega analoga humanega insulina).
NovoMix 30 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Zdravilo NovoMix 30 FlexPen je napolnjen injekcijski peresnik (barvno označen), namenjen za uporabo z iglami NovoFine ali NovoTwist.
NovoMix 50 is a biphasic suspension of the insulin analogue, insulin aspart.
Zdravilo NovoMix 50 je dvofazna suspenzija insulinskega analoga, insulina aspart.
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Zdravilo NovoMix 50 se z injekcijo aplicira subkutano v stegno ali trebušno steno.
NovoMix 30 is a biphasic suspension of the insulin analogue, insulin aspart.
Zdravilo NovoMix 30 je dvofazna suspenzija insulinskega analoga, insulina aspart.
NovoMix 30 is presented as a suspension for injection.
Zdravilo NovoMix 30 je na voljo v obliki suspenzije za injiciranje.
Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and aqueous.
Vložka ne uporabite, če suspenzija insulina ni enakomerno bela, motna in vodna.
Always keep the cartridge in the outer carton when you are not using it, in order to protect it from light.
Kadar vložka ne uporabljate, ga vedno shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Pack sizes of 1, 5 and 10 pre-filled pens.
Pakiranja z 1, 5 in 10 napolnjenimi injekcijskimi peresniki.
NovoMix 30 is a mixture consisting of 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine.
Zdravilo NovoMix 30 je mešanica, ki vsebuje 30 % topnega insulina aspart in 70 % insulina aspart, kristaliziranega s protaminom.
Picture A
Uporabno do
Instruction on how to use NovoMix 30 suspension for injection in FlexPen.
Navodila za uporabo zdravila NovoMix 30 suspenzija za injiciranje v injekcijskem peresniku FlexPen
► Needles and NovoMix 70 Penfill must not be shared.
► Igel in zdravila NovoMix 70 Penfill si ne delite z drugimi.
► There are no restrictions on treatment with NovoMix 70 during breast-feeding.
► Pri uporabi zdravila NovoMix 70 med dojenjem ni omejitev.
NovoMix 70 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 70 is essentially ‘sodium-free'.
Zdravilo NovoMix 70 vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
NovoMix 70 is for subcutaneous administration only.
Zdravilo NovoMix 70 je namenjeno zgolj subkutani uporabi.
50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
50 % topnega insulina aspart in 50 % insulina aspart, kristaliziranega s protaminom
Before you use NovoMix 70 FlexPen, remove it from the refrigerator.
Preden boste zdravilo NovoMix 70 FlexPen uporabili, ga vzamite iz hladilnika.
NovoMix 30 is presented as a suspension for injection in a pre-filled pen.
Zdravilo NovoMix 30 je na voljo v obliki suspenzije za injiciranje v napolnjenem injekcijskem peresniku.
NovoMix 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix 30 is essentially ‘sodium-free'.
Zdravilo NovoMix 30 vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
NovoMix 70 FlexPen is a pre-filled, colour-coded, disposable pen containing a mixture of rapid-acting and intermediate-acting insulin aspart in the ratio 70/30.
Kako ravnati z injekcijskim peresnikom NovoMix 70 FlexPen Injekcijski peresnik NovoMix 70 FlexPen je napolnjen, barvno kodiran injekcijski peresnik za enkratno uporabo, ki vsebuje mešanico hitrodelujočega in srednjedolgodelujočega insulina aspart v razmerju 70/30.
► Needles and NovoMix 30 FlexPen must not be shared.
► Igel in zdravila NovoMix 30 FlexPen si ne delite z drugimi.
NovoMix 30 is a biphasic suspension of 30% soluble insulin aspart (rapid-acting human insulin analogue) and 70% protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
Zdravilo NovoMix 30 je dvofazna suspenzija, s 30 % topnega insulina aspart (hitrodelujočega analoga humanega insulina) in 70 % s protaminom kristaliziranega insulina aspart (srednjedolgodelujočega analoga humanega insulina).
► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
Vsebina pakiranja in dodatne informacije), ► če sumite, da se začenja hipoglikemija (nizek krvni sladkor) (glejte poglavje 4, podpoglavje a)
► After each injection, be sure to remove and discard the needle and store NovoMix 30 without the needle attached.
► Po vsakem injiciranju morate iglo odstraniti in zavreči, zdravilo NovoMix 30 pa shraniti brez nameščene igle.
NovoMix 30 FlexPen 100 units/ml
NovoMix 30 FlexPen 100 enot/ml suspenzija za injiciranje
Before you use NovoMix 70 Penfill, remove it from the refrigerator.
Preden boste zdravilo NovoMix 70 Penfill uporabili, ga vzamite iz hladilnika.
The crystalline phase (70%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Kristalno fazo (70 %) sestavlja s protaminom kristalizirani insulin aspart, ki ima podoben profil delovanja kot humani insulin NPH.
• If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
• Če sta drugi in tretji znak S6, P5, K7, R7, VG, FG ali ZF, je izdelovalec Novo Nordisk A/S,
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol fenol metakrezol cinkov klorid natrijev hidrogenfosfat dihidrat natrijev klorid protaminijev sulfat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
NovoMix 70 FlexPen 100 units/ml
NovoMix 70 FlexPen 100 enot/ml suspenzija za injiciranje
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Kristalno fazo (50 %) sestavlja s protaminom kristalizirani insulin aspart, ki ima podoben profil delovanja kot humani insulin NPH.
NovoMix 70 FlexPen is only suitable for subcutaneous injections.
Zdravilo NovoMix 70 FlexPen je primerno samo za podkožno injiciranje.
NovoMix 30 FlexPen is a pre-filled, colour-coded, disposable pen containing a mixture of rapid-acting and intermediate-acting insulin aspart in the ratio 30/70.
Kako ravnati z injekcijskim peresnikom NovoMix 30 FlexPen Injekcijski peresnik NovoMix 30 FlexPen je napolnjen, barvno kodiran injekcijski peresnik za enkratno uporabo, ki vsebuje mešanico hitrodelujočega in srednjedolgodelujočega insulina aspart v razmerju 30/70.
See Resuspension of NovoMix 30 in section 3.
Glejte poglavje 3, podpoglavje Resuspendiranje zdravila NovoMix 30.
See Resuspension of NovoMix 50 in section 3.
Glejte poglavje 3, podpoglavje Resuspendiranje zdravila NovoMix 50.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile similar to that of human NPH insulin.
Kristalno fazo (30 %) sestavlja s protaminom kristalizirani insulin aspart, ki ima podoben profil delovanja kot humani insulin NPH.
Before you use NovoMix 50 FlexPen, remove it from the refrigerator.
Preden boste zdravilo NovoMix 50 FlexPen uporabili, ga vzamite iz hladilnika.
NovoMix 30 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Zdravilo NovoMix 30 se z injekcijo aplicira subkutano v stegno ali trebušno steno.
Keep the cap on FlexPen in order to protect it from light.
Injekcijski peresnik FlexPen, naj bo pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
Before you use NovoMix 30 FlexPen, remove it from the refrigerator.
Preden boste zdravilo NovoMix 30 FlexPen uporabili, ga vzamite iz hladilnika.
NovoMix 70 Penfill 100 units/ml
NovoMix 70 Penfill 100 enot/ml suspenzija za injiciranje
Before you use NovoMix 30 Penfill, remove it from the refrigerator.
Preden boste zdravilo NovoMix 30 Penfill uporabili, ga vzamite iz hladilnika.
Suspension for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
suspenzija za injiciranje 1 x 3 ml vložek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (CARTRIDGE.
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (NAPOLNJEN INJEKCIJSKI PERESNIK FlexPen)
NovoMix 50 FlexPen is only suitable for subcutaneous injections.
Zdravilo NovoMix 50 FlexPen je primerno samo za podkožno injiciranje.
See Resuspension of NovoMix 70 in section 3.
Glejte poglavje 3, podpoglavje Resuspendiranje zdravila NovoMix 70.
Before you use NovoMix 50 Penfill, remove it from the refrigerator.
Preden boste zdravilo NovoMix 50 Penfill uporabili, ga vzamite iz hladilnika.
► There are no restrictions on treatment with NovoMix 30 during breast-feeding.
► Pri uporabi zdravila NovoMix 30 med dojenjem ni omejitev.
Patients transferred to NovoMix 30 from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
utegnejo potrebovati večje število dnevnih injekcij ali drugačen odmerek kot med uporabo svojih običajnih insulinskih zdravil.
Always keep the pen cap on your FlexPen when you are not using it, in order to protect it from light.
Kadar injekcijskega peresnika FlexPen ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
NovoMix 70 Penfill and NovoMix 70 FlexPen:
NovoMix 70 Penfill in NovoMix 70 FlexPen: Novo Nordisk A/S
NovoMix 30 FlexPen is only suitable for subcutaneous injections.
Zdravilo NovoMix 30 FlexPen je primerno samo za podkožno injiciranje.
1 pre-filled pen contains 3 ml equivalent to 300 units.
En napolnjen injekcijski peresnik vsebuje 3 ml, kar ustreza 300 enotam.
70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
70 % topnega insulina aspart in 30 % insulina aspart, kristaliziranega s protaminom
NAME OF THE MEDICINAL PRODUCT NovoMix 50 FlexPen 100 units/ml
IME ZDRAVILA IN POT UPORABE NovoMix 50 FlexPen 100 enot/ml suspenzija za injiciranje
NAME OF THE MEDICINAL PRODUCT NovoMix 70 Penfill 100 units/ml suspension for injection in cartridge NovoMix 70 FlexPen 100 units/ml suspension for injection in pre-filled pen
IME ZDRAVILA NovoMix 70 Penfill 100 enot/ml suspenzija za injiciranje v vložku
► There are no restrictions on treatment with NovoMix 50 during breast-feeding.
► Pri uporabi zdravila NovoMix 50 med dojenjem ni omejitev.
► Needles and NovoMix 50 Penfill must not be shared.
► Igel in zdravila NovoMix 50 Penfill si ne delite z drugimi.
No clinical studies with NovoMix 70 have been carried out in children and adolescents under the age of 18 years.
Uporaba pri otrocih in mladostnikih Pri otrocih in mladostnikih do 18. leta starosti klinične študije z zdravilom NovoMix 70 niso bile izvedene.
► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
► Vložki NovoMix 70 Penfill so namenjeni za uporabo v sistemih za dajanje insulina Novo Nordisk in z iglami NovoFine ali NovoTwist.
NovoMix 30 Penfill 100 units/ml
NovoMix 30 Penfill 100 enot/ml suspenzija za injiciranje
NovoMix 50 Penfill and NovoMix 50 FlexPen:
NovoMix 50 Penfill in NovoMix 50 FlexPen: Novo Nordisk A/S
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Preostalih 70 % je v kristalni obliki, kot insulin aspart, kristaliziran s protaminom, ki ima podaljšan potek absorpcije, podoben humanemu insulinu NPH.
50% soluble insulin aspart and 50% insulin aspart crystallised with protamine SC use
50 % topnega insulina aspart in 50 % insulina aspart, kristaliziranega s protaminom za subkutano uporabo
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Preostalih 50 % je v kristalni obliki, kot insulin aspart, kristaliziran s protaminom, ki ima podaljšan potek absorpcije, podoben humanemu insulinu NPH.
NovoMix 50 FlexPen 100 units/ml suspension for injection in a pre-filled pen 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
NovoMix 50 FlexPen 100 enot/ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku 50 % topnega insulina aspart in 50 % insulina aspart, kristaliziranega s protaminom
NovoMix 70 FlexPen is only suitable for injecting under the skin.
Zdravilo NovoMix 70 FlexPen je primerno samo za injiciranje pod kožo.
Only use resuspension if uniformly white, cloudy and aqueous For use by one person only
Suspenzijo uporabite le, če je enakomerno bela, motna in vodna.
NAME OF THE MEDICINAL PRODUCT NovoMix 30 Penfill 100 units/ml suspension for injection in cartridge NovoMix 30 FlexPen 100 units/ml suspension for injection in pre-filled pen
IME ZDRAVILA NovoMix 30 Penfill 100 enot/ml suspenzija za injiciranje v vložku
MARKETING AUTHORISATION NUMBERS EU/1/00/142/011 1 cartridge of 3 ml EU/1/00/142/012 5 cartridges of 3 ml EU/1/00/142/013 10 cartridges of 3 ml
EU/1/00/142/011 1 vložek s 3 ml EU/1/00/142/012 5 vložkov s 3 ml EU/1/00/142/013 10 vložkov s 3 ml
NAME OF THE MEDICINAL PRODUCT NovoMix 50 Penfill 100 units/ml suspension for injection in cartridge NovoMix 50 FlexPen 100 units/ml suspension for injection in pre-filled pen
IME ZDRAVILA NovoMix 50 Penfill 100 enot/ml suspenzija za injiciranje v vložku
► Needles and NovoMix 30 Penfill must not be shared.
► Igel in zdravila NovoMix 30 Penfill si ne delite z drugimi.
► NovoMix 70 FlexPen is only suitable for injecting under the skin.
► Zdravilo NovoMix 70 FlexPen je primerno samo za injiciranje pod kožo.
NovoMix 70 Penfill is only suitable for subcutaneous injections from a reusable pen.
Zdravilo NovoMix 70 Penfill je primerno samo za podkožno injiciranje z injekcijskim peresnikom za večkratno uporabo.
Do not use the insulin, if it does not look uniformly white, cloudy and aqueous after resuspension.
Če suspenzija insulina ni enakomerno bela, motna in vodna, je ne uporabite.
► NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
► Vložki NovoMix 50 Penfill so namenjeni za uporabo v sistemih za dajanje insulina Novo Nordisk in z iglami NovoFine ali NovoTwist.
Pointer
Injiciranje
NovoMix 50 Penfill 100 units/ml suspension for injection in a cartridge 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
NovoMix 50 Penfill 100 enot/ml suspenzija za injiciranje v vložku 50 % topnega insulina aspart in 50 % s protaminom kristaliziranega insulina aspart
NovoMix 50 is for subcutaneous administration only.
Zdravilo NovoMix 50 je namenjeno zgolj subkutani uporabi.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Preostalih 30 % je v kristalni obliki, kot insulin aspart, kristaliziran s protaminom, ki ima podaljšan potek absorpcije, podoben humanemu insulinu NPH.
MARKETING AUTHORISATION NUMBERS EU/1/00/142/017 1 cartridge of 3 ml EU/1/00/142/018 5 cartridges of 3 ml EU/1/00/142/019 10 cartridges of 3 ml
EU/1/00/142/017 1 vložek s 3 ml EU/1/00/142/018 5 vložkov s 3 ml EU/1/00/142/019 10 vložkov s 3 ml
NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
Zdravilo NovoMix 70 Penfill je primerno samo za injiciranje pod kožo z injekcijskim peresnikom za večkratno uporabo.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Če ste noseči ali če dojite, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom, preden vzamete katero koli zdravilo.
What NovoMix 30 contains
Kaj vsebuje zdravilo NovoMix 30
► NovoMix 50 FlexPen is only suitable for injecting under the skin.
► Zdravilo NovoMix 50 FlexPen je primerno samo za injiciranje pod kožo.
NovoMix 50 FlexPen is only suitable for injecting under the skin.
Zdravilo NovoMix 50 FlexPen je primerno samo za injiciranje pod kožo.
No clinical studies with NovoMix 50 have been carried out in children and adolescents under the age of 18 years.
Uporaba pri otrocih in mladostnikih Pri otrocih in mladostnikih do 18. leta starosti klinične študije z zdravilom NovoMix 50 niso bile izvedene.
MARKETING AUTHORISATION NUMBERS EU/1/00/142/020 1 pen of 3 ml EU/1/00/142/021 5 pens of 3 ml EU/1/00/142/022 10 pens of 3 ml
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/00/142/020 1 injekcijski peresnik s 3 ml EU/1/00/142/021 5 injekcijskih peresnikov s 3 ml