natgillin/translations-raw huggingface dataset:
Frequencies of adverse drug reactions from clinical trials that are considered related to Insulatard are listed below.
Frecven a reac iilor adverse din studii clinice, considerate ca având leg tur cu Insulatard, este prezentat mai jos.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Frecven a este definit astfel: mai pu in frecvente (1/ 1000 i < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Cazuri 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.
În cadrul fiec rei grupe de frecven, reac iile adverse sunt prezentate în ordinea descresc toare a gravit ii.
Nervous system disorders Very 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 Mai pu in frecvente – neuropatie periferic Controlul glicemic îmbun t it rapid poate fi asociat cu o afec iune denumit „ neuropatie acut dureroas ”, care este, de obicei, reversibil.
Eye disorders Very rare - Refraction disorders 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.
These symptoms are usually of transitory nature.
De regul, aceste simptome sunt tranzitorii.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Foarte rare – retinopatie diabetic Controlul glicemic îmbun t it pe termen lung scade riscul progresiei retinopatiei diabetice.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Afec iuni cutanate i ale esutului subcutanat Mai pu in frecvente – lipodistrofie Lipodistrofia poate s apar la locul inject rii ca o consecin a omiterii rot rii locului de injectare în cadrul aceleia i regiuni anatomice.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Tulbur ri generale i la locul administr rii Mai pu in frecvente – reac ii la locul inject rii Reac ii la locul inject rii (ro ea, tumefac ie, prurit, durere i hematom la locul inject rii) pot s apar în timpul tratamentului cu insulin.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
5 La ini ierea terapiei insulinice pot s apar edeme.
These symptoms are usually of transitory nature.
Obi nuit, aceste simptome sunt tranzitorii.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Tulbur ri ale sistemului imunitar Mai pu in frecvente – urticarie, erup ii cutanate tranzitorii 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 de respira ie, palpita ii, sc derea tensiunii arteriale i le in/ pierderea con tien ei.
Generalised hypersensitivity reactions are potentially life- threatening.
Reac iile de hipersensibilitate generalizat pot fi poten ial letale.
5 A specific overdose of insulin cannot be defined.
Un supradozaj specific cu insulin nu poate fi definit.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Totu i, hipoglicemia se poate dezvolta pe parcursul unor etape secven iale: • Episoadele hipoglicemice u oare pot fi tratate prin administrarea oral de glucoz sau produse ce con in zah r.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • 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 person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
De aceea, se recomand ca pacien ii cu diabet zaharat s aib întotdeauna asupra lor buc ele de zah r, dulciuri, biscui i sau suc de fructe cu zah r. • Episoadele hipoglicemice grave, când pacientul devine incon tient, pot fi tratate fie prin administrarea intramuscular sau subcutanat de glucagon (0, 5- 1 mg) de c tre o persoan instruit adecvat, fie prin administrarea intravenoas de glucoz de c tre personal medical.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
De asemenea, dac pacientul nu r spunde la glucagon în decurs de 10- 15 minute trebuie administrat glucoz intravenos.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Dup rec p tarea con tien ei, pentru a preveni rec derile este recomandat administrarea oral de carbohidra i.
PHARMACOLOGICAL PROPERTIES
PROPRIET
5.1 Pharmacodynamic properties
I FARMACOLOGICE
Pharmacotherapeutic group:
5. 1 Propriet i farmacodinamice
Insulins and analogues for injection, intermediate-acting, insulin (human).
Grupa farmacoterapeutic: insulin (uman) i analogi injectabili, cu ac iune intermediar.
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
Debutul ac iunii apare în ½ or, atinge un efect maxim în 4- 12 ore i are o durat de ac iune de pân la 24 ore.
5.2 Pharmacokinetic properties
5. 2 Propriet i farmacocinetice
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Acest proces este influen at de mai mul i factori (de exemplu doza de insulin, calea i locul administr rii, grosimea stratului adipos subcutanat, tipul diabetului zaharat).
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
De aceea, farmacocinetica preparatelor de insulin prezint varia ii considerabile intra - i interindividuale.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
Absorb ie Concentra ia plasmatic maxim a insulinei este atins în 2- 18 ore de la administrarea subcutanat.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribu ie Nu s- a observat formarea de leg turi puternice cu proteinele plasmatice, cu excep ia anticorpilor insulinici circulan i (dac sunt prezen i).
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
6 Metabolism S- a raportat c insulina uman este degradat de insulin- proteaz sau enzime de degradare a insulinei i posibil de izomeraza protein- disulfit.
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
A fost propus pentru molecula de insulin uman un num r de locuri de clivaj (hidroliz); nici unul dintre metaboli ii forma i în urma hidrolizei nu sunt activi.
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminare Timpul de înjum t ire plasmatic prin eliminare este determinat de viteza absorb iei din esutul subcutanat.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of
De aceea, timpul de înjum t ire plasmatic prin eliminare (t1/ 2) este o m sur a absorb iei mai mult decât eliminarea per se a insulinei din plasm (în sânge insulina are un t1/ 2 de câteva minute).
Trials have indicated a t½ of about 5-10 hours.
Studiile au eviden iat un t1/ 2 de aproximativ 5- 10 ore.
5.3 Preclinical safety data
5. 3 Date preclinice de siguran
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Datele non- clinice 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, carcinogenitatea, toxicitatea asupra func iei de reproducere.
PHARMACEUTICAL PARTICULARS
I FARMACEUTICE
6.1 List of excipients
6. 1 Lista excipien ilor
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
Clorur de zinc Glicerol Metacrezol Fenol Hidrogenofosfat de disodiu dihidrat Hidroxid de sodiu (pentru ajustarea pH- ului) Acid clorhidric (pentru ajustarea pH- ului) Sulfat de protamin Ap pentru preparate injectabile
6.2 Incompatibilities
6. 2 Incompatibilit i
Insulin suspensions should not be added to infusion fluids.
Suspensiile de insulin nu trebuie ad ugate în solu iile perfuzabile.
4 weeks when used or stored at room temperature (below 25°C).
4 s pt mâni când este utilizat sau p strat la temperatura camerei (sub 25°C).
6.4 Special precautions for storage
6. 4 Precau ii speciale pentru p strare
During use: do not refrigerate.
În timpul utiliz rii: a nu se congela.
Do not store above 25°C.
A se p stra la temperaturi sub 25°C.
Keep the vial in the outer carton in order to protect from light.
A se p stra flaconul în ambalajul original pentru a fi protejat de lumin.
Protect from excessive heat and sunlight.
A se feri de c ldur excesiv i de expunerea la soare.
6.5 Nature and contents of container
6. 5 Natura i con inutul ambalajului
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
7 Flacon din sticl (tip I) a 10 ml, închis cu un dop de bromobutil/ poliizopren i asigurat cu capac protector de plastic.
Pack sizes:
M rimea ambalajului:
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 i 5 flacoane a câte 10 ml i ambalaj multiplu cu 5 cutii cu câte 1 flacon a 10 ml.
Not all pack sizes may be marketed.
Este posibil ca nu toate m rimile de ambalaj s fie comercializate.
6.6 Special precautions for disposal and other handling
6. 6 Precau ii speciale pentru eliminarea reziduurilor i alte instruc iuni de manipulare
7 After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Dup scoaterea din frigider a flaconului de Insulatard, este recomandat s l sa i flaconul s ajung la temperatura camerei (nu peste 25°C) înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
Nu se utilizeaz suspensiile de insulin care nu sunt uniform albicioase i opalescente dup omogenizarea suspensiei.
Any unused product or waste material should be disposed of in accordance with local requirements.
Orice produs neutilizat sau material rezidual trebuie eliminat în conformitate cu reglement rile locale.
MARKETING AUTHORISATION HOLDER
DE IN TORUL AUTORIZA IEI DE PUNERE PE PIA
MARKETING AUTHORISATION NUMBER(S)
NUM RUL( ELE) AUTORIZA IEI DE PUNERE PE PIA
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA PRIMEI AUTORIZ RI SAU A REÎNNOIRII AUTORIZA IEI
Date of first authorisation:
Data primei autoriz ri:
Insulatard 100 IU/ ml suspension for injection in a vial.
Insulatard 100 UI/ ml suspensie injectabil în flacon
1 ml contains 100 IU of insulin human.
1 ml suspensie injectabil con ine insulin uman 100 UI.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
9 De asemenea, ajustarea dozei poate fi necesar dac pacien ii î i intensific activitatea fizic sau î i modific dieta obi nuit.
9 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4).
The vials are for use with insulin syringes with a corresponding unit scale.
Flacoanele sunt destinate utiliz rii împreun cu seringile de administrare a insulinei cu scal de unit i corespunz toare.
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
10 transfera i pe Insulatard, aceasta se poate face de la prima doz sau în timpul primelor s pt mâni sau luni de tratament.
10 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Câ iva pacien i care au avut reac ii hipoglicemice dup ce au fost transfera i de pe insulin de origine animal pe insulin uman au raportat simptome precoce de avertizare a hipoglicemiei mai pu in pronun ate sau diferite fa de cele avute sub tratamentul cu insulin de origine animal.
Insulin treatment of the nursing mother presents no risk to the baby.
11 Tratamentul cu insulin al mamei care al pteaz nu prezint riscuri pentru sugar.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Pacien ii trebuie sf tui i s ia m suri de precau ie pentru a evita hipoglicemia în timpul conducerii de vehicule, mai ales pentru cei care au simptome de avertizare a hipoglicemiei absente sau de intensitate mic sau care au episoade frecvente de hipoglicemie.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Mai pu in frecvente – edem
12 4.9 Overdose
12 La ini ierea terapiei insulinice pot s apar edeme.
Insulins and analogues for injection, intermediate-acting, insulin (human).
Grupa farmacoterapeutic: insulin (uman) i analogi injectabili cu ac iune intermediar.
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
13 Metabolism S- a raportat c insulina uman este degradat de insulin- proteaz sau enzime de degradare a insulinei i posibil de izomeraza protein- disulfit.
13 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminare Timpul de înjum t ire plasmatic prin eliminare este determinat de viteza absorb iei din esutul subcutanat.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
De aceea, timpul de înjum t ire plasmatic prin eliminare (t1/ 2) este o m sur a absorb iei mai mult decât eliminarea per se a insulinei din plasm (în sânge insulina are un t1/ 2 de câteva minute).
Insulin products should only be added to compounds with which it is known to be compatible.
Preparatele de insulina pot fi ad ugate numai acelor compu i cu care se tie c sunt compatibile.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
14 Flacon din sticl (tip I) a 10 ml, închis cu un dop de bromobutil/ poliizopren i asigurat cu capac protector de plastic.
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 i 5 flacoane a câte 10 ml i ambalaj multiplu cu 5 cutii cu câte 1 flacon a câte 10 ml.
14 Insulin preparations which have been frozen must not be used.
Preparatele de insulin care au fost congelate nu mai trebuie folosite.
After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Dup scoaterea din frigider a flaconului de Insulatard, este recomandat s l sa i flaconul s ajung la temperatura camerei (nu peste 25°C) înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge.
Insulatard Penfill 100 UI/ ml suspensie injectabil în cartu
1 cartridge contains 3 ml equivalent to 300 IU.
1 cartu con ine 3 ml echivalent cu 300 UI.
Suspension for injection in a cartridge.
Suspensie injectabil în cartu.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
16 De asemenea, ajustarea dozei poate fi necesar dac pacien ii î i intensific activitatea fizic sau î i modific dieta obi nuit.
16 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4).
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
Cartu ele sunt destinate utiliz rii împreun cu dispozitivele Novo Nordisk de administrare a insulinei (dispozitive durabile pentru uz repetat) i acele NovoFine.
Detailed instruction accompanying the delivery system must be followed.
Trebuie urmate instruc iunile detaliate care înso esc dispozitivul de administrare.
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
17 transfera i pe Insulatard, aceasta se poate face de la prima doz sau în timpul primelor s pt mâni sau luni de tratament.
17 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Câ iva pacien i care au avut reac ii hipoglicemice dup ce au fost transfera i de pe insulin de origine animal pe insulin uman au raportat simptome precoce de avertizare a hipoglicemiei mai pu in pronun ate sau diferite fa de cele avute sub tratamentul cu insulin de origine animal.
Insulin treatment of the nursing mother presents no risk to the baby.
18 Tratamentul cu insulin al mamei care al pteaz nu prezint riscuri pentru sugar.
19 4.9 Overdose
19 La ini ierea terapiei insulinice pot s apar edeme.
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
20 Metabolism S- a raportat c insulina uman este degradat de insulin- proteaz sau enzime de degradare a insulinei i posibil de izomeraza protein- disulfit.
20 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminare Timpul de înjum t ire plasmatic prin eliminare este determinat de viteza absorb iei din esutul subcutanat.
6 weeks when used or carried as a spare (below 30°C).
6 s pt mâni când este utilizat sau transportat ca rezerv (sub 30°C).
Do not store above 30°C.
A se p stra la temperaturi sub 30°C.
Keep the cartridge 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.
3 ml glass cartridge (type 1) with a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
21 Cartu din sticl (tip I) a 3 ml, cu piston din cauciuc bromobutilic i cu dop de cauciuc bromobutilic/ poliizoprenic.
The cartridge contains a glass ball to facilitate the re-suspension.
Cartu ul con ine o bil din sticl care faciliteaz omogenizarea suspensiei.
1, 5 and 10 cartridges x 3 ml.
1, 5 i 10 cartu e a câte 3 ml.
21 Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
Cartu ele trebuie utilizate numai în combina ie cu produse cu care sunt compatibile i permit func ionarea sigur i eficace a cartu ului.
Insulatard Penfill is for single person use only.
Insulatard Penfill este de folosin individual.
After removing Insulatard Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Dup scoaterea din frigider a Insulatard Penfill, este recomandat s l sa i cartu ul s ajung la temperatura camerei (nu peste 25°C) înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard NovoLet 100 UI/ ml suspensie injectabil în stilou injector (pen) preumplut
1 pre-filled pen contains 3 ml equivalent to 300 IU.
1 stilou injector (pen) preumplut con ine 3 ml echivalent cu 300 UI.
Suspension for injection in a pre-filled pen.
Suspensie injectabil în stilou injector (pen) preumplut.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
23 De asemenea, ajustarea dozei poate fi necesar dac pacien ii î i intensific activitatea fizic sau î i modific dieta obi nuit.
23 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4).
Insulatard NovoLet is designed to be used with NovoFine needles.
Insulatard NovoLet este destinat utiliz rii împreun cu acele NovoFine.
NovoLet delivers 2-78 units in increments of 2 unitsThe pens should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle top.
Stiloul injector (pen- ul) preumplut trebuie preg tit înainte de injectare, astfel încât selectorul dozei s fie în pozi ia zero i o pic tur de insulin s apar la vârful acului.
The dose is set by turning the selector, which returns to zero during the injection.
Doza este fixat prin rotirea selectorului, care revine la pozi ia zero în timpul inject rii
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
24 rapid, cu ac iune intermediar, cu ac iune prelungit, etc.), specie (animal, uman sau analog de insulin) i/ sau metod de fabrica ie (tehnologie ADN recombinant fa de insulina de origine animal) pot duce la modific ri ale dozei.
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
Dac este necesar modificarea dozei când pacien ii sunt transfera i pe Insulatard, aceasta se poate face de la prima doz sau în timpul primelor s pt mâni sau luni de tratament.
Continuous rotation of the injection site within a given area may help to
Schimbarea continu prin rota ie a locurilor de injectare în cadrul aceleia i regiuni anatomice, poate ajuta la reducerea sau prevenirea acestor reac ii.
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Câ iva pacien i care au avut reac ii hipoglicemice dup ce au fost transfera i de pe insulin de origine animal pe insulin uman au raportat simptome precoce de avertizare a hipoglicemiei mai pu in pronun ate sau diferite fa de cele avute sub tratamentul cu insulin de origine animal.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
25 Dup na tere, necesarul de insulin revine rapid la valorile anterioare perioadei de sarcin.
25 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Capacitatea de concentrare i de reac ie a pacientului poate fi afectat ca urmare a hipoglicemiei.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
26 Mai pu in frecvente – edem La ini ierea terapiei insulinice pot s apar edeme.