natgillin/translations-raw huggingface dataset:
27 Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
4. 2.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
29 Urm toarele substan e pot cre te necesarul de insulin al pacientului: contraceptive orale, tiazide, glucocorticoizi, hormoni tiroidieni, simpatomimetice i danazol.
28 4.6 Pregnancy and lactation
4. 6 Sarcina i al ptarea
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
30 În cadrul fiec rei grupe de frecven, reac iile adverse sunt prezentate în ordinea descresc toare a gravit ii.
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.
Tulbur ri ale sistemului nervos Rare - neuropatie periferic Controlul glicemic îmbun t it rapid poate fi asociat cu o condi ie denumit neuropatie acut dureroas, care de obicei este reversibil.
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.
Efectul insulinei de sc dere a glicemiei se datore te leg rii de receptorii insulinei de la nivelul celulelor musculare i adipoase, cu facilitarea consecutiv a capt rii glucozei i inhibarea simultan a producerii sale în ficat.
Figure 1:
Figure 1:
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.
Dup 16 s pt mâni de tratament, principala variabil a eficacit ii - hemoglobina glicozilat HbA1c - nu difer la pacien ii 32 trata i cu NovoMix 30 în asociere cu metformin si pacien ii trata i cu metformin i sulfoniluree.
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.
În cazul pacien ilor cu diabet zaharat de tip 2, o meta- analiz a demonstrat existen a unui risc global mai sc zut de apari ie a episoadelor hipoglicemice nocturne i a hipoglicemiilor majore în urma tratamentului cu NovoMix 30, comparativ cu insulina uman bifazic 30.
NovoMix 30 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 30 FlexPen aflat în uz sau transportat ca rezerv: poate fi p strat la temperatura camerei (sub 30°C) pân la 4 s pt mâni, îns orice rest trebuie îndep rtat.
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
Când nu este în uz, p stra i NovoMix 30 FlexPen acoperit cu capacul, pentru a fi protejat de lumin.
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.
Dup scoaterea din frigider a NovoMix 30 FlexPen, este recomandat s l sa i NovoMix 30 FlexPen s ajung la temperatura camerei înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
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).
Cartu (sticl tip 1) închis cu piston de cauciuc f r latex (bromobutil) la un cap t i cu disc din
Each pre-filled pen contains 3 ml suspension.
Fiecare stilou injector (pen) preumplut con ine 3 ml suspensie.
Cartons of 5 or 10 pre-filled pens.
Cutii con inând 5 sau 10 stilouri injectoare (pen- uri) preumplute.
NovoFine S needles are designed to be used with the pre-filled pen.
Acele NovoFine S sunt destinate utiliz rii împreun cu stiloul injector (pen) preumplut.
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
Trebuie urmate instruc iunile detaliate care înso esc NovoMix 30 FlexPen.
NovoMix 30 FlexPen is for use by one person only.
NovoMix 30 FlexPen este de uz individual.
NovoMix 30 FlexPen must not be refilled.
NovoMix 30 FlexPen nu trebuie reumplut.
33 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Se va atrage aten ia pacientului asupra necesit ii de refacere a suspensiei NovoMix 30, imediat înainte de utilizare.
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 50 FlexPen 100 U/ ml, suspensie injectabil în stilou injector (pen) preumplut.
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.
36 monitorizarea glicemiei trebuie intensificat i dozajul ajustat conform nevoilor individuale ale pacientului.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
37 aceleia i regiuni anatomice poate ajuta la reducerea sau prevenirea acestor reac ii.
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 con ine metacrezol care poate produce reac ii alergice.
37 regimens therefore no specific frequency can be presented.
Din studiile clinice i din experien a de dup punerea pe pia a medicamentului frecven a variaz cu popula ia de pacien i i cu regimurile de dozaj, de aceea nu poate fi prezentat o frecven specific.
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
39 stadii dac sunt administrate doze prea mari comparativ cu necesarul pacien ilor:
38 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
Pacien ii cu diabet zaharat vor fi sf tui i s aib întotdeauna asupra lor alimente care con in zah r. • Episoade hipoglicemice severe, cu pierderea cuno tin ei, care se trateaz fie cu glucagon (0, 5 - 1 mg) injectat intramuscular sau subcutanat de c tre o persoan instruit, fie cu glucoz introdus intravenos de c tre personalul medical.
Glucose Infusion Rate
40 Rata de perfuzie a glucozei
39 5.2 Pharmacokinetic properties
5. 2 Propriet i farmacocinetice
40 NovoMix 50 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 50 FlexPen aflat în uz sau transportat ca rezerv: poate fi p strat la temperatura camerei (sub 30°C) pân la 4 s pt mâni, îns orice rest trebuie îndep rtat.
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
Când nu este în uz, p stra i NovoMix 50 FlexPen acoperit cu capacul, pentru a fi protejat de lumin.
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.
Dup scoaterea din frigider a NovoMix 50 FlexPen, este recomandat s l sa i NovoMix 50 FlexPen s ajung la temperatura camerei înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
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).
Cartu (sticl tip 1) închis cu piston de cauciuc f r latex (bromobutil) la un cap t i cu disc din cauciuc f r latex (bromobutil/ poliizopren) la cel lalt, într- un stilou injector (pen) preumplut multidoz de unic folosin cu un injector (plastic).
Cartons of 1, 5 or 10 pre-filled pens.
Cutii con inând 1, 5 sau 10 stilouri injectoare (pen- uri) preumplute.
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
Trebuie urmate instruc iunile detaliate care înso esc NovoMix 50 FlexPen.
NovoMix 50 FlexPen is for use by one person only.
NovoMix 50 FlexPen este de uz individual.
NovoMix 50 FlexPen must not be refilled.
NovoMix 50 FlexPen nu trebuie reumplut.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
42 Se va atrage aten ia pacientului asupra necesit ii de refacere a suspensiei NovoMix 50, imediat înainte de utilizare.
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 70 FlexPen 100 U/ ml, suspensie injectabil în stilou injector (pen) preumplut.
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.
44 monitorizarea glicemiei trebuie intensificat i dozajul ajustat conform nevoilor individuale ale pacientului.
No studies have been performed with NovoMix 70 in children and adolescents under the age of 18 years.
Nu au fost efectuate studii cu NovoMix 50 la copii i adolescen ii sub 18 ani.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
45 aceleia i regiuni anatomice poate ajuta la reducerea sau prevenirea acestor reac ii.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 con ine metacrezol care poate produce reac ii alergice.
44 regimens therefore no specific frequency can be presented.
Din studiile clinice i din experien a de dup punerea pe pia a medicamentului frecven a variaz cu popula ia de pacien i i cu regimurile de dozaj, de aceea nu poate fi prezentat o frecven specific.
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
47 stadii dac sunt administrate doze prea mari comparativ cu necesarul pacien ilor:
45 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
Pacien ii cu diabet zaharat vor fi sf tui i s aib întotdeauna asupra lor alimente care con in zah r. • Episoade hipoglicemice severe, cu pierderea cuno tin ei, care se trateaz fie cu glucagon (0, 5 - 1 mg) injectat intramuscular sau subcutanat de c tre o persoan instruit, fie cu glucoz introdus intravenos de c tre personalul medical.
Glucose Infusion Rate
48 Rata de perfuzie a glucozei
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
Profilul activit ii NovoMix 70 la subiec i caucazieni s n to i.
46 5.2 Pharmacokinetic properties
5. 2 Propriet i farmacocinetice
In healthy volunteers a mean maximum serum concentration of 645 ± 185 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
La voluntari s n to i valoarea medie a concentra iei serice maxime, de 645 ± 185 pmol/ l, a fost realizat dup circa 60 minute de la injectarea subcutanat a unei doze de 0, 30 U/ kg.
In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
La pacien ii cu diabet zaharat tip 1, concentra ia maxim plasmatic de 721± 184 pmol/ l, a fost realizat dup 60 minute de la injectarea subcutanat a unei doze de 0, 3 U/ kg.
47 6.4 Special precautions for storage
6. 4 Special precautions for storage
NovoMix 70 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 FlexPen aflat în uz sau transportat ca rezerv: poate fi p strat la temperatura camerei (sub 30°C) pân la 4 s pt mâni, îns orice rest trebuie îndep rtat.
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
Când nu este în uz, p stra i NovoMix 70 FlexPen acoperit cu capacul, pentru a fi protejat de lumin.
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.
Dup scoaterea din frigider a NovoMix 70 FlexPen, este recomandat s l sa i NovoMix 70 FlexPen s ajung la temperatura camerei înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
Trebuie urmate instruc iunile detaliate care înso esc NovoMix 70 FlexPen.
NovoMix 70 FlexPen is for use by one person only.
50 NovoMix 70 FlexPen este de uz individual.
NovoMix 70 FlexPen must not be refilled.
NovoMix 70 FlexPen nu trebuie reumplut.
49 ANNEX II
51 ANEXA II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
PRODUC TORUL SUBSTAN EI BIOLOGIC ACTIVE I DE IN TORII AUTORIZA IEI DE FABRICA IE RESPONSABILI PENTRU ELIBERAREA SERIEI
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.
Prospectul tip rit al medicamentului trebuie s men ioneze numele i adresa produc torului responsabil pentru eliberarea seriei respective.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
CONDI II SAU RESTRIC II PRIVIND FURNIZAREA I UTILIZAREA IMPUSE • DE IN TORULUI AUTORIZA IEI DE PUNERE PE PIA
Medicinal product subject to medical prescription.
Medicament cu eliberare pe baz de prescrip ie medical.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
CONDI II SAU RESTRIC II CU PRIVIRE LA SIGURAN A I EFICACITATEA • UTILIZ RII MEDICAMENTULUI
51 ANNEX III
53 ANEXA III
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
55 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 U/ ml Suspensie injectabil în cartu 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%),
1 ml suspensie con ine insulin aspart (ADNr) (30% insulin aspart solubil cristalizat cu protamin) 100 U (3, 5 mg)
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glicerol, fenol, metacrezol, zinc (sub form de clorur), clorur de sodiu, fosfat disodic dihidrat, sulfat de protamin, hidroxid de sodiu, acid clorhidric i ap pentru preparate injectabile
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Subcutanat Cartu ele NovoMix 30 Penfill sunt destinate utiliz rii cu dispozitivele Novo Nordisk de administrare a insulinei A se citi prospectul înainte de utilizare
OTHER SPECIAL WARNINGS, IF NECESSARY
ALT ATEN IONARE SPECIAL, DAC ESTE NECESAR
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
Omogeniza i suspensia injectabil conform instruc iunilor NovoMix 30 Penfill este pentru utilizare strict personal
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
A se p stra la frigider (2°C – 8°C) A nu se congela A se p stra cartu ul în ambalajul original, pentru a fi protejat de lumin ° În timpul utiliz rii: a nu se congela sau a nu se p stra la temperaturi peste 30°C A se utiliza în decurs de 4 s pt mâni
MARKETING AUTHORISATION NUMBERS
NUM RUL AUTORIZA IEI DE PUNERE PE PIA
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
57 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
LABEL
ETICHET
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 Penfill 100 U/ ml Suspensie injectabil Insulin aspart s. c.
Resuspend according to instructions
Omogeniza i suspensia injectabil conform instruc iunilor
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
58 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
NovoMix 50 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 50 Penfill 100 U/ ml Suspensie injectabil în cartu 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%),
1 ml suspensie con ine insulin aspart (ADNr) (50% insulin aspart solubil cristalizat cu protamin) 100 U (3, 5 mg)
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glicerol, fenol, metacrezol, zinc zinc (sub form de clorur), clorur de sodiu, fosfat disodic dihidrat, sulfat de protamin, hidroxid de sodiu, acid clorhidric i ap pentru preparate injectabile
1 x 3 ml 5 x 3 ml 10 x 3 ml
1 x 3 5 x 3
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Subcutanat Cartu ele NovoMix 50 Penfill sunt destinate utiliz rii cu dispozitivele Novo Nordisk de administrare a insulinei A se citi prospectul înainte de utilizare
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
Omogeniza i suspensia injectabil conform instruc iunilor NovoMix 50 Penfill este pentru utilizare strict personal
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
60 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 Penfill 100 U/ ml Suspensie injectabil Insulin aspart s. c.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
NovoMix 70 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 70 Penfill 100 U/ ml Suspensie injectabil în cartu 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%),
1 ml suspensie con ine insulin aspart (ADNr) (70% insulin aspart solubil cristalizat cu protamin) 100 U (3, 5 mg)
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
Subcutanat Cartu ele NovoMix 70 Penfill sunt destinate utiliz rii cu dispozitivele Novo Nordisk de administrare a insulinei A se citi prospectul înainte de utilizare
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
Omogeniza i suspensia injectabil conform instruc iunilor NovoMix 70 Penfill este pentru utilizare strict personal
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 Penfill 100 U/ ml Suspensie injectabil Insulin aspart s. c.
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
64 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 30 FlexPen 100 U/ ml Suspensie injectabil în stilou injector (pen) preumplut Insulin aspart
5 x 3 ml 10 x 3 ml
5 x 3
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
Subcutanat Destinat utiliz rii împreun cu acele de unic folosin NovoFine sau NovoTwist de maxim 8 mm lungime Acele nu sunt incluse A se citi prospectul înainte de utilizare
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
Omogeniza i suspensia injectabil conform instruc iunilor NovoMix 30 FlexPen este pentru utilizare strict personal
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
A se p stra la frigider (2°C – 8°C) A nu se congela A se p stra stiloul injector (pen- ul) acoperit cu capacul, pentru a fi protejat de lumin ° În timpul utiliz rii: a nu se congela sau a nu se p stra la temperaturi peste 30°C A se utiliza în decurs de 4 s pt mâni
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 FlexPen 100 U/ ml Suspensie injectabil Insulin aspart s. c.
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
NovoMix 50 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 50 FlexPen 100 U/ ml Suspensie injectabil în stilou injector (pen) preumplut Insulin aspart
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
Omogeniza i suspensia injectabil conform instruc iunilor NovoMix 50 FlexPen este pentru utilizare strict personal
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 FlexPen 100 U/ ml Suspensie injectabil Insulin aspart s. c.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
NovoMix 70 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 70 FlexPen 100 U/ ml Suspensie injectabil în stilou injector (pen) preumplut Insulin aspart
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
Omogeniza i suspensia injectabil conform instruc iunilor NovoMix 70 FlexPen este pentru utilizare strict personal
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
LABEL
EICHET
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 FlexPen 100 U/ ml Suspensie injectabil Insulin aspart s. c.
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 U/ ml suspensie injectabil în cartu Insulin aspart
Read all of this leaflet carefully before you start using this medicine. – Keep this leaflet.
Citi i cu aten ie i în întregime acest prospect înainte de a începe s utiliza i acest medicament. – P stra i acest prospect.
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
S- ar putea s fie necesar s - l reciti i. – Dac ave i orice întreb ri suplimentare, adresa i- v medicului dumneavoastr, asistentei medicale specializate în tratarea diabetului zaharat sau farmacistului. – Acest medicament a fost prescris pentru dumneavoastr.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
Le poate face r u, chiar dac au acelea i simptome cu ale dumneavoastr. – Dac vreuna dintre reac iile adverse devine grav sau dac observa i orice reac ie advers nemen ionat în acest prospect, v rug m s - i spune i medicului dumneavoastr, asistentei medicale specializate în tratarea diabetului zaharat sau farmacistului.
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
CE ESTE NOVOMIX 30 I PENTRU CE SE UTILIZEAZ
NovoMix 30 is an insulin analogue to treat diabetes.
NovoMix 30 este un analog de insulin utilizat în tratamentul diabetului zaharat.
It comes in a 3 ml cartridge, called Penfill, which fits into a delivery system.
Medicamentul este disponibil în cartu a 3 ml, denumit Penfill, destinat utiliz rii cu un dispozitiv de administrare a insulinei.