natgillin/translations-raw huggingface dataset:
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
În timpul studiilor clinice frecven a hipoglicemiei, în general, nu difer între pacien ii trata i cu insulin aspart i cei trata i cu insulin uman.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
Frecven ele reac iilor adverse din studiile clinice, care pot fi considerate, în general, a fi datorate insulinei aspart, sunt prezentate în continuare.
Uncommon (> 1/ 1,000 ,< 1/100) and rare (> 1/10 ,000, < 1/1,000).
Frecven ele sunt definite ca: mai pu in frecvente (> 1/ 1000, < 1/ 100) i rare (> 1/ 10000, < 1/ 1000).
Isolated spontaneous cases are presented as very rare defined as (< 1/ 10,000), including isolated reports.
Cazurile spontane izolate sunt prezentate ca foarte rare, definite ca (< 1/ 10000), inclusiv raport ri izolate.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
5 În cadrul fiec rei grupe de frecven, reac iile adverse sunt prezentate în ordinea descresc toare a gravit ii.
Immune system disorders Uncommon - Urticaria, rash, eruptions
Tulbur ri ale sistemului imunitar Mai pu in frecvente – urticarie, eritem, erup ii
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.
Foarte rare – reac ii anafilactice Simptomele hipersensibilit ii generalizate pot include erup ii cutanate generalizate, prurit, transpira ii, tulbur ri gastro- intestinale, edem angioneurotic, dificult i în respira ie, palpita ii i sc derea tensiunii arteriale.
Generalised hypersensitivity reactions are potentially life threatening.
Reac iile de hipersensibilitate generalizat sunt poten ial letale.
5 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
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.
Eye disorders Uncommon - Refraction disorder Refraction anomalies may occur upon initiation of insulin therapy.
Tulbur ri oculare Mai pu in frecvente – tulbur ri de refrac ie Anomalii de refrac ie pot s apar la ini ierea tratamentului cu insulin.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Mai pu in frecvente – retinopatie diabetic Controlul glicemic îmbun t it pe termen lung scade riscul progresiei retinopatiei diabetice.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
Cu toate acestea, intensificarea terapiei insulinice cu îmbun t irea rapid a controlului glicemic poate fi asociat cu agravarea retinopatiei diabetice.
Uncommon - Local hypersensitivity Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Mai pu in frecvente – reac ii de hipersensibilitate local În timpul tratamentului cu insulin pot s apar reac ii de hipersensibilitate local (eritem, tumefac ie i prurit la locul inject rii).
These reactions are usually transitory and normally they disappear during continued treatment.
De regul, aceste reac ii sunt tranzitorii i dispar pe parcursul tratamentului.
General disorders and administration site conditions Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Tulbur ri generale i la nivelul locului de administrare Mai pu in frecvente – edem La ini ierea terapiei insulinice pot s apar edeme.
Oedema and weight increase may occur when NovoMix 30 is used in combination with OADs.
Atunci când NovoMix 30 este utilizat în asociere cu ADO, pot ap rea edeme i cre tere în greutate.
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 stadii dac sunt administrate doze prea mari comparativ cu necesarul pacien ilor:
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• Episoade hipoglicemice u oare, care se trateaz prin ingestie de glucoz sau produse care con in zah r.
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
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 must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Dac pacien ii nu r spund la glucagon în decurs de 10 - 15 minute, trebuie administrat i glucoz intravenos.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Dup rec p tarea cuno tin ei, pentru a preveni rec derea, se recomand administrarea oral de glucide.
Drugs used in diabetes.
Grupa farmacoterapeutic: medicament antidiabetic.
Insulins and analogues for injection, intermediate-acting combined with fast-acting.
Insuline i analogi injectabili cu ac iune intermediar combinat cu ac iune rapid.
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 30 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).
6 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
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 30 is a biphasic insulin, which contains 30% soluble insulin aspart.
NovoMix 30 este o insulin bifazic care con ine 30% insulin aspart solubil.
This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Aceasta are un debut rapid al ac iunii, permi ând administrarea mai aproape de mas (între 0 i 10 minute înainte/ dup mas), comparativ cu insulina uman solubil.
The crystalline phase (70%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin (Figure 1).
Faza cristalin (70%) este reprezentat de protamin insulina aspart cristalizat, care are un profil de ac iune similar cu cel al insulinei umane NPH (figura 1).
When NovoMix 30 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Când NovoMix 30 se injecteaz subcutanat, debutul ac iunii survine în decurs de 10- 20 minute de la injectare.
The maximum effect is exerted between 1 and 4 hours after injection.
Efectul maxim se manifest între 1 i 4 ore dup injectare.
The duration of action is up to 24 hours.
Durata de ac iune este de pân la 24 ore.
Glucose infusion rate
Rata de perfuzie a glucozei
Activity profile of NovoMix 30 (___) and biphasic human insulin 30 (---) in healthy subjects.
Profilul activit ii NovoMix 30 (___) i insulina uman bifazic 30 (---) la subiec i s n to i.
In a 3 month trial in patients with type 1 and type 2 diabetes NovoMix 30 showed equal control of glycosylated haemoglobin compared to treatment with biphasic human insulin 30.
Într- un studiu efectuat timp de 3 luni la pacien i cu diabet zaharat de tip 1 i 2 NovoMix 30 a dovedit un control similar al nivelului hemoglobinei glicozilate comparativ cu insulina uman bifazic 30.
Insulin aspart is equipotent to human insulin on a molar basis.
Insulina aspart este echipotent molar cu insulina uman.
Compared to biphasic human insulin 30, administration of NovoMix 30 before breakfast and dinner resulted in lower postprandial blood glucose after both meals (breakfast and dinner).
În compara ie cu insulina uman bifazic 30, administrarea NovoMix 30 înaintea micului dejun i a cinei a avut ca rezultat valori mai mici ale glicemiei postprandiale dup cele dou mese (mic dejun i cin).
A meta-analysis including nine trials in patients with type 1 and type 2 diabetes showed that fasting blood glucose was higher in patients treated with NovoMix 30, than in patients treated with biphasic human insulin 30.
O meta- analiz care a inclus nou studii clinice la pacien i cu diabet zaharat de tip 1 i 2 a demonstrat c valorile glicemiei á jeun au fost mai mari în cazul pacien ilor trata i cu NovoMix 30 decât în cazul celor c rora li s- a administrat insulin uman bifazic 30.
In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix 30 either alone or in combination with metformin, or to metformin together with sulfonylurea.
Într- un studiu clinic randomizat, 341 pacien i cu diabet zaharat tip 2 au fost trata i cu NovoMix 30 în monoterapie sau în asociere cu metformin sau cu metformin i sulfoniluree.
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 7 trata i cu NovoMix 30 în asociere cu metformin si pacien ii trata i cu metformin i sulfoniluree.
In this trial 57% of the patients had baseline HbA1c above 9%; in these patients treatment with NovoMix 30 in combination with metformin resulted in significantly lower HbA1c than metformin in combination with sulfonylurea.
În acest studiu 57% dintre pacien i au avut o valoare ini ial a HbA1c peste 9%; la ace ti pacien i tratamentul cu NovoMix 30 în asociere cu metformin a avut ca rezultat valori semnificativ mai mici ale HbA1c decât la pacien ii trata i cu metformin i sulfoniluree.
In one study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycaemic agents alone, were randomised to treatment with twice daily NovoMix 30 (117 patients) or once daily insulin glargine (116 patients).
Într- un studiu clinic randomizat, din totalul de pacien i cu diabet zaharat tip 2 insuficient controla i doar cu medicamente hipoglicemiante orale, 117 au fost trata i cu NovoMix 30 de dou ori pe zi, iar 116 au fost trata i cu insulin glargine o dat pe zi.
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%).
4. 2, media reducerii HbA1c a fost de 2, 8% cu NovoMix 30 (media la momentul ini ial = 9, 7%).
With NovoMix 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/ L (from 14.0 mmol/ L at baseline to 7.1 mmol/ L).
Cu NovoMix 30, 66% i respectiv 42% dintre pacien i au atins nivele HbA1c sub 7% i respectiv 6, 5%, iar media FPG a fost redus cu 7 mmol/ l (de la 14, 0 mmol / - ini ial la 7, 1 mmol/ l).
7 In patients with type 2 diabetes a meta-analysis showed a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia with NovoMix 30 compared to biphasic human insulin 30.
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.
The risk of overall daytime hypoglycaemic episodes was increased in patients treated with NovoMix 30
Riscul global al episoadelor hipoglicemice diurne a fost mai crescut la pacien ii trata i cu NovoMix 30.
Children and adolescents:
Copii i adolescen i:
A 16-week clinical trial comparing postprandial glycaemic control of meal- related NovoMix 30 with meal-related human insulin/ biphasic human insulin 30 and bedtime NPH insulin was performed in 167 subjects aged 10 to 18 years.
Într- un studiu clinic de 16 s pt mâni efectuat la 167 de subiec i cu vârsta cuprins între 10 i 18 ani s- a comparat controlul glicemiei post- prandiale ob inut cu NovoMix 30 fa de insulina uman / insulina bifazic uman 30 administrate la mas i insulina NPH administrat la culcare.
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.
Pe toat durata studiului media HbA1c a r mas similar fa de valoarea ini ial în ambele grupe de tratament i nu a fost nicio diferen în rata hipoglicemiilor cu NovoMix 30 sau insulina bifazic uman 30.
In a smaller (54 subjects) and younger (age range 6 to 12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycaemic episodes and the postprandial glucose increase was significantly lower with NovoMix 30 compared to biphasic human insulin 30.
Într- un alt studiu cu 54 de subiec i cu vârsta cuprins între 6 i 12 ani, dublu orb, încruci at (cu durata de 12 s pt mâni în fiecare grup de tratament), rata episoadelor hipoglicemice i cre terea glicemiei post- prandiale a fost mai mic pe NovoMix 30 comparativ cu insulina bifazic uman 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with NovoMix 30.
În finalul studiului HbA1c a fost semnificativ mai mic în grupul tratat cu insulin bifazic uman 30 comparativ cu NovoMix 30.
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 30, as compared with soluble human insulin.
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 30, comparativ cu insulina uman solubil.
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.
Insulina aspart din faza solubil a NovoMix 30 reprezint 30% din totalul de insulin: aceasta este absorbit mai repede din esutul subcutanat decât componenta solubil a insulinei umane bifazice.
The remaining 70% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Restul de 70% 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.
The maximum serum insulin concentration is, on average, 50% higher with NovoMix 30 than with biphasic human insulin 30.
Concentra ia seric maxim de insulin este în medie cu 50% mai mare pentru NovoMix 30 decât pentru insulina uman bifazic 30.
The time to maximum concentration is, on average, half of that for biphasic human insulin 30.
Timpul de realizare a concentra iei maxime este, în medie, jum tate din cel corespunz tor insulinei umane bifazice 30.
In healthy volunteers a mean maximum serum concentration of 140 ± 32 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.20 U/ kg body weight.
La voluntari s n to i valoarea medie a concentra iei plasmatice maxime, de 140 ± 32 pmol/ l, a fost realizat dup circa 60 minute de la injectarea subcutanat a 0, 2 U/ kg.
The mean half life (t½) of NovoMix 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hours.
Timpul mediu de înjum t ire (t½) al NovoMix 30, care reflect viteza de absorb ie a frac iunii legat de protamin, a fost de aproximativ 8- 9 ore.
Serum insulin levels returned to baseline 15-18 hours after a subcutaneous dose.
Nivelele de insulin seric au revenit la valorile ini iale dup 15- 18 ore de la injectarea subcutanat.
In type 2 diabetic patients, the maximum concentration was reached about 95 minutes after dosing, and concentrations well above zero for not less than 14 hours post-dosing were measured.
La pacien ii cu diabet zaharat de tip 2, concentra ia maxim a fost realizat dup 95 minute de la administrare i concentra ii evident mai mari decât zero au fost eviden iate i la 14 ore de la administrare.
The pharmacokinetics of NovoMix 30 has not been investigated in children or adolescents.
Farmacocinetica NovoMix 30 nu a fost investigat la copii i adolescen i.
However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6– 12 years) and adolescents (13– 17 years) with type 1 diabetes.
Totu i, propriet ile farmacocinetice i farmacodinamice ale insulinei solubile aspart au fost investigate la copii (6- 12 ani) i adolescen i (13- 17 ani) cu diabet tip 1.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults.
Insulina aspart a fost absorbit rapid la ambele grupe de vârst, cu tmax similar ca i la adul i.
However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Totu i, Cmax a fost diferit în ambele grupe de vârst, subliniind importan a titr rii individualizate a insulinei aspart.
The pharmacokinetics of NovoMix 30 has not been investigated in elderly, or patients with impaired renal or liver function.
Farmacocinetica NovoMix 30 nu a fost studiat la vârstnici sau pacien i cu insuficien renal sau
Non-clinical data with insulin aspart reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Datele non- clinice privind insulina aspart nu au eviden iat nici un risc special pentru om pe baza studiilor conven ionale farmacologice privind evaluarea siguran ei, toxicitatea dup doze repetate, genotoxicitatea i toxicitatea asupra func iei de reproducere.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Studii in vitro, care includ legarea de receptorii insulinei i IGF- 1 i efectele asupra cre terii celulare, au demonstrat c insulina aspart se comport foarte asem n tor cu insulina uman.
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Studiile demonstreaz, de asemenea, c disocierea insulinei aspart de receptorul insulinei este echivalent cu cea a insulinei umane.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glicerol Fenol Metacrezol Zinc (sub form de clorur) Clorur de sodiu Fosfat disodic dihidrat Sulfat de protamin Hidroxid de sodiu (pentru ajustarea pH- ului) Acid clorhidric (pentru ajustarea pH- ului) Ap pentru preparate injectabile
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
În absen a unor studii de compatibilitate, acest medicament nu trebuie amestecat cu alte medicamente.
The in-use shelf life is 4 weeks (not above 30°C).
4 s pt mâni dup prima utilizare (la temperaturi sub 30°C).
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
A se p stra la frigider (2°C – 8°C), departe de congelator.
Do not freeze.
Nu se congeleaz.
NovoMix 30 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
Cartu ele de NovoMix 30 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.
Do not refrigerate.
Nu se congeleaz.
Do not store above 30°C.
Nu se p streaz la temperaturi peste 30°C.
Keep the cartridges in the outer carton in order to protect from light.
A se p stra cartu ul în ambalajul original, pentru a fi protejat de lumin.
After removing NovoMix 30 Penfill from the refrigerator it is recommended to allow NovoMix 30 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
Dup scoaterea din frigider a NovoMix 30 Penfill, este recomandat s l sa i NovoMix 30 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
The cartridge contains a glass ball to facilitate resuspension.
Cartu ul con ine o bil de sticl pentru facilitarea refacerii suspensiei.
Each cartridge contains 3 ml suspension.
Fiecare cartu con ine 3 ml suspensie.
Cartons of 5 or 10 cartridges.
Cutii con inând 5 sau 10 cartu e.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
Cartu ele sunt destinate utilizarii împreun cu dispozitivele Novo Nordisk de administrare (dispozitive durabile pentru folosiri repetate) i cu acele NovoFine.
Detailed instruction accompanying the cartridge and delivery system must be followed.
Trebuie urmate instruc iunile detaliate care înso esc dispozitivul de administrare.
NovoMix 30 Penfill is for use by one person only.
NovoMix 30 Penfill este de uz individual.
The cartridge must not be refilled.
Cartu ul nu trebuie reumplut.
9 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.
The resuspended liquid must appear uniformly white and cloudy.
Suspensia trebuie s fie uniform albicioas i opalescent.
NovoMix 30 which has been frozen must not be used.
NovoMix 30 care a fost înghe at nu trebuie utilizat.
The patient should be advised to discard the needle after each injection.
Se va atrage aten ia pacientului c dup fiecare injectare trebuie s îndep rteze acul.
MARKETING AUTHORISATION NUMBERS
NUM RUL( ELE) AUTORIZA IEI DE PUNERE PE PIA
1 August 2000 Date of last renewal:
1 August 2000 Data ultimei reînnoiri:
1 August 2005
1 August 2005
NovoMix 50 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 50 Penfill 100 U/ ml, suspensie injectabil în cartu.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 50/ 50
Insulin aspart solubil * i protamin insulin aspart cristalizat * ……... 100 U/ ml în raport de 50/ 50
NovoMix 50 is a white suspension.
NovoMix 50 este o suspensie de culoare alb.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 50 to be given immediately before a meal.
Datorit debutului s u rapid i a unei activit i maxime precoce, NovoMix 50 poate fi administrat, imediat înainte de mas.
When necessary, NovoMix 50 can be given soon after start of a meal.
Când este necesar, NovoMix 50 poate fi administrat la scurt timp dup începerea mesei.
Dosage of NovoMix 50 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Doza de NovoMix 50 se stabile te individual la recomand rile medicului i în concordan cu nevoile pacientului.