natgillin/translations-raw huggingface dataset:
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 50.
Necesarul individual de insulin este cuprins obi nuit între 0, 5 i 1, 0 Unit i/ kg i zi la pacien ii adul i i poate fi asigurat total sau par ial de NovoMix 50.
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.
Necesarul zilnic de insulin poate fi mai mare la pacien ii cu rezisten la insulin (de exemplu datorit obezit ii) sau mai mic la pacien ii cu produc ie rezidual de insulin endogen.
Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration.
Trecerea de la anumite preparate de insulin la NovoMix 50 poate face necesar ajustarea dozei sau a momentului administrarii.
As with all insulins, close glucose monitoring is recommended during transition and the initial weeks thereafter (see section 4.4).
4. 4).
Adjustment of dosage may also be necessary if patients change their diet.
De asemenea, poate fi necesar ajustarea dozei dac pacien ii î i modific dieta obi nuit.
Physical activity may reduce the patients’ insulin requirements.
Activitatea fizic poate reduce nevoia de insulin a pacientului.
In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications.
La pacien ii cu diabet zaharat, un control metabolic optimizat întârzie efectiv debutul i încetine te progresia complica iilor tardive ale diabetului.
Optimised metabolic control, including glucose monitoring, is therefore recommended.
De aceea se recomanda controlul metabolic optimizat, inclusiv monitorizarea glicemiei.
11 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.
11 monitorizarea glicemiei trebuie intensificat i dozajul ajustat conform nevoilor individuale ale pacientului.
No studies have been performed with NovoMix 50 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.
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 50 se administreaz subcutanat prin injectare în coaps sau peretele abdominal.
Injection sites should be alternated within the same region.
Locurile de injectare trebuie alternate în cadrul aceleia i regiuni.
As with all types of insulin, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Ca i în cazul celorlalte insuline durata ac iunii variaz în func ie de doz, locul inject rii, fluxul sanguin, temperatur i activitatea fizic.
The influence of different injection sites on the absorption of NovoMix 50 has not been investigated.
Nu a fost investigat influen a diferitelor locuri de injectare asupra absorb iei NovoMix 50.
NovoMix 50 should never be administered intravenously.
NovoMix 50 nu se administreaz niciodat intravenos.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia (see section 4.8 and section 4.9).
4. 8 i 4. 9).
NovoMix 50 should be administered in immediate relation to a meal.
NovoMix 50 se administreaz strict în func ie de orarul meselor.
Patients taking NovoMix 50 may need a change in dosage from that used with their usual insulin.
La pacien ii trata i cu NovoMix 50 poate fi necesar modificarea posologiei folosit în cazul insulinei lor uzuale.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Ca în orice tratament cu insulin, pot ap rea reac ii la locul de injectare, care includ: durere, prurit,
On rare occasions, injection site reactions may require discontinuation of NovoMix 50.
În cazuri rare, reac iile la locul de injectare pot necesita întreruperea administr rii NovoMix 50.
12 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 con ine metacrezol care poate produce reac ii alergice.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics and danazol.
Urm toarele substan e pot cre te necesarul de insulin al pacientului: contraceptive orale, tiazide, glucocorticoizi, hormoni tiroidieni, simpatomimetice i danazol.
There is limited clinical experience with NovoMix 50 in pregnancy.
Experien a clinic privind folosirea insulinei aspart în timpul sarcinii este limitat.
There are no restrictions on treatment with NovoMix 50 during lactation.
În timpul al pt rii nu exist restric ii privind tratamentul cu NovoMix 50.
However, the NovoMix 50 dosage may need to be adjusted.
Totu i, poate fi necesar ajustarea dozei de NovoMix 50.
No studies on the effects on the ability to drive and use machines have been performed.
Nu au fost efectuate studii privind efectul asupra capacit ii de a conduce vehicule sau de a folosi utilaje.
As for other insulin products, hypoglycaemia, in general is the most frequently occurring undesirable effect.
13 este, în general, cea mai frecvent reac ie advers.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Aceasta poate s apar dac doza de insulin este prea mare comparativ cu necesarul de insulin.
In clinical trials and during marketed use the frequency varies with patient population and dose
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.
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.
14 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.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Insuline si analogi injectabili cu ac iune intermediar combinat cu ac iune rapid.
NovoMix 50 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 50 este o suspensie bifazic de insulin aspart (analog de insulin uman cu ac iune rapid) i protamin insulin aspart cristalizat (analog de insulin uman cu ac iune intermediar).
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.
NovoMix 50 is a biphasic insulin, which contains 50% soluble insulin aspart.
NovoMix 50 este o insulin bifazic care con ine 50% insulin aspart solubil.
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Faza cristalin (50%) este reprezentat de protamin insulina aspart cristalizat, care are un profil de ac iune similar cu cel al insulinei umane NPH.
When NovoMix 50 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Când NovoMix 50 se injecteaz subcutanat, debutul ac iunii survine în decurs de 10- 20 minute de la injectare.
The duration of action is up to 14 hours to 24 hours (Figure 1).
Durata de ac iune este de pân la 14- 24 ore (figura 1).
Glucose Infusion Rate
15 Rata de perfuzie a glucozei
Hours NovoMix 50
Ore NovoMix 50
Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
Profilul activit ii NovoMix 50 la subiec i caucazieni s n to i.
15 5.2 Pharmacokinetic properties
5. 2 Propriet i farmacocinetice
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.
În insulina aspart substituirea aminoacidului prolin cu acid aspartic în pozi ia B28 reduce tendin a de a forma hexameri în frac iunea solubil a NovoMix 50, comparativ cu insulina uman solubil.
The insulin aspart in the soluble phase of NovoMix 50 comprises 50% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Insulina aspart din faza solubil a NovoMix 50 reprezint 50% din totalul de insulin; aceasta este absorbit mai repede din esutul subcutanat decât componenta solubil a insulinei umane bifazice.
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Restul de 50% este constituit din forma cristalin a protamin insulinei aspart cristalizat; aceasta are un profil de absorb ie prelungit, similar cu cel al insulinei NPH umane.
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.
La voluntari s n to i valoarea medie a concentra iei serice maxime, de 445 ± 135 pmol/ l, a fost realizat dup circa 60 minute de la injectarea subcutanat a 0, 30 U/ kg.
In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
La pacien ii cu diabet zaharat de tip 2, concentra ia maxim a fost realizat dup 95 minute de la administrare.
The pharmacokinetics of NovoMix 50 has not been investigated in elderly, children or patients with impaired renal or liver function.
Farmacocinetica NovoMix 50 nu a fost studiat la vârstnici, copii sau pacien i cu insuficien renal sau hepatic.
Do not freeze.
Nu se congeleaz
16 NovoMix 50 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
Cartu ele de NovoMix 50 Penfill aflate în uz sau transportate ca rezerv: pot fi p strate la temperatura camerei (sub 30°C) pân la 4 s pt mâni, îns orice rest trebuie îndep rtat.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to allow NovoMix 50 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Dup scoaterea din frigider a NovoMix 50 Penfill este recomandat s l sa i NovoMix 50 Penfill 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.
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.
Cartons of 1, 5 or 10 cartridges.
Cutii con inând 1, 5 sau 10 cartu e.
NovoMix 50 Penfill is for use by one person only.
NovoMix 50 Penfill este de uz individual.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
17 Se va atrage aten ia pacientului asupra necesit ii de refacere a suspensiei NovoMix 50, imediat înainte de utilizare.
NovoMix 50 which has been frozen must not be used.
NovoMix 50 care a fost înghe at nu trebuie utilizat.
NovoMix 70 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 70 Penfill 100 U/ ml, suspensie injectabil în cartu.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 70/ 30
Insulin aspart solubil * i protamin insulin aspart cristalizat * ……... 100 U/ ml în raport de 70/ 30
NovoMix 70 is a white suspension.
NovoMix 70 este o suspensie de culoare alb.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 70 to be given immediately before a meal.
Datorit debutului s u rapid i a unei activit i maxime precoce, NovoMix 70 poate fi administrat, imediat înainte de mas.
When necessary, NovoMix 70 can be given soon after start of a meal.
Când este necesar, NovoMix 70 poate fi administrat la scurt timp dup începerea mesei.
Dosage of NovoMix 70 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Doza de NovoMix 70 se stabile te individual la recomand rile medicului i în concordan cu nevoile pacientului.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 70.
Necesarul individual de insulin este cuprins obi nuit între 0, 5 i 1, 0 Unit i/ kg i zi la pacien ii adul i i poate fi asigurat total sau par ial de NovoMix 70.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
Trecerea de la anumite preparate de insulin la NovoMix 70 poate face necesar ajustarea dozei sau a momentului administrarii.
18 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
19 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 70 la copii i adolescen ii sub 18 ani.
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
NovoMix 70 se administreaz subcutanat prin injectare în coaps sau peretele abdominal.
Injection sites should be alternated within the same region.
Locurile de injectare trebuie schimbate prin rota ie în cadrul aceleia i regiuni.
The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
Nu a fost investigat influen a diferitelor locuri de injectare asupra absorb iei NovoMix 70.
NovoMix 70 should never be administered intravenously.
NovoMix 70 nu se administreaz niciodat intravenos.
NovoMix 70 should be administered in immediate relation to a meal.
NovoMix 70 se administreaz strict în func ie de orarul meselor.
Patients taking NovoMix 70 may need a change in dosage from that used with their usual insulin.
La pacien ii trata i cu NovoMix 70 poate fi necesar modificarea posologiei folosit în cazul insulinei lor uzuale.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
20 aceleia i regiuni anatomice poate ajuta la reducerea sau prevenirea acestor reac ii.
On rare occasions, injection site reactions may require discontinuation of NovoMix 70.
În cazuri rare, reac iile la locul de injectare pot necesita întreruperea administr rii NovoMix 70.
19 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 con ine metacrezol care poate produce reac ii alergice.
There is limited clinical experience with NovoMix 70 in pregnancy.
Experien a clinic privind folosirea insulinei aspart în timpul sarcinii este limitat.
There are no restrictions on treatment with NovoMix 70 during lactation.
În timpul al pt rii nu exist restric ii privind tratamentul cu NovoMix 70.
However, the NovoMix 70 dosage may need to be adjusted.
Totu i, poate fi necesar ajustarea dozei de NovoMix 70.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Aceasta poate s apar dac doza de insulin este
In clinical trials and during marketed use the frequency varies with patient population and dose
Hipoglicemia sever poate determina pierderea cuno tin ei i/ sau convulsii i poate avea ca rezultat afectarea temporar sau permanent a func iei cerebrale, chiar moarte.
20 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.
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:
Hipoglicemia se poate dezvolta în mai multe
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
22 stadii dac sunt administrate doze prea mari comparativ cu necesarul pacien ilor:
21 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.
NovoMix 70 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 70 este o suspensie bifazic de insulin aspart (analog de insulin uman cu ac iune rapid) i protamin insulin aspart cristalizat (analog de insulin uman cu ac iune intermediar).
NovoMix 70 is a biphasic insulin, which contains 70% soluble insulin aspart.
NovoMix 70 este o insulin bifazic care con ine 70% insulin aspart solubil.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Faza cristalin (30%) este reprezentat de protamin insulina aspart cristalizat, care are un profil de ac iune similar cu cel al insulinei umane NPH.
When NovoMix 70 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Când NovoMix 70 se injecteaz subcutanat, debutul ac iunii survine în decurs de 10- 20 minute de la injectare.
Glucose Infusion Rate
23 Rata de perfuzie a glucozei
Hours NovoMix 70
Ore NovoMix 70
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
Profilul activit iil NovoMix 70 la subiec i caucazieni s n to i.
22 5.2 Pharmacokinetic properties
5. 2 Propriet i farmacocinetice
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.
În insulina aspart substituirea aminoacidului prolin cu acid aspartic în pozi ia B28 reduce tendin a de a forma hexameri în frac iunea solubil a NovoMix 70, comparativ cu insulina uman solubil.
The insulin aspart in the soluble phase of NovoMix 70 comprises 70% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Insulina aspart din faza solubil a NovoMix 70 reprezint 70% din totalul de insulin; aceasta este absorbit mai repede din esutul subcutanat decât componenta solubil a insulinei umane bifazice.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Restul de 30% este constituit din forma cristalin a protamin insulinei aspart cristalizat; aceasta are un profil de absorb ie prelungit, similar cu cel al insulinei NPH umane.
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, 3 U/ kg.
In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
La pacien ii cu diabet zaharat tip 2, concentra ia maxim a fost realizat dup 75 minute de la administrare.
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 plasmatic maxim de 721± 184 pmol/ l, a fost realizat dup 60 minute de la injectarea subcutanat a unei doze de 0, 3 U/ kg.
The pharmacokinetics of NovoMix 70 has not been investigated in elderly, children or patients with impaired renal or liver function.
Farmacocinetica NovoMix 70 nu a fost studiat la vârstnici, copii sau pacien i cu insuficien renal sau hepatic.
23 6.4 Special precautions for storage
6. 4 Precau ii speciale pentru p strare
NovoMix 70 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
Cartu ele de NovoMix 70 Penfill aflate în uz sau transportate ca rezerv: pot fi p strate la temperatura camerei (sub 30°C) pân la 4 s pt mâni, îns orice rest trebuie îndep rtat.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to allow NovoMix 70 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Dup scoaterea din frigider a NovoMix 70 Penfill este recomandat s l sa i NovoMix 70 Penfill s ajung la temperatura camerei înainte de a omogeniza insulina conform instruc iunilor pentru prima utilizare.
NovoMix 70 Penfill is for use by one person only.
25 NovoMix 70 Penfill este de uz individual.
The necessity of resuspending the NovoMix 70 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 70, imediat înainte de utilizare.
NovoMix 70 which has been frozen must not be used.
NovoMix 70 care a fost înghe at nu trebuie utilizat.
NovoMix 30 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 30 FlexPen 100 U/ ml, suspensie injectabil în stilou injector (pen) preumplut.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*………… 100 U/ ml in the ratio of 30/ 70
Insulin aspart solubil * i protamin insulin aspart cristalizat * ……... 100 U/ ml în raport de 30/ 70
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 stilou injector (pen) preumplut con ine 3 ml echivalent cu 300 U.
For children 6-9 years limited clinical data exists (see section 5.1).
5. 1)
No studies have been performed in children under the age of 6 years.
Nu au fost efectuate studii cu NovoMix 30 la copii cu vîrsta sub 6 ani.
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.
27 medicamente antidiabetice orale pentru care este aprobat asocierea cu insulin, atunci când acele medicamente antidiabetice orale în monoterapie nu realizeaz un control glicemic satisf c tor.
26 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
4. 4).
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.
Totu i exist o experien limitat privind utilizarea NovoMix 30 în asociere cu ADO la pacien i cu vârsta peste 75 de ani.
• Hypersensitivity to the active substance or to any of the excipients • Hypoglycaemia.
• Hipersensibilitate la substan a activ sau la oricare dintre excipien i. • Hipoglicemie