FrancophonIA/ELRC3.0 huggingface dataset:
English: In general, when patients are transferred from injection to infusion therapy, it may be advisable to reduce the dosage by initiating the patient at 90% of the previous total daily dosage, with 40% as basal rate and 50% as boluses divided between the three main meals.
Romanian: În general, când pacien ii sunt transfera i de pe tratament injectabil pe tratament perfuzabil, se poate recomanda reducerea dozajului prin ini ierea pacientului la 90% din doza zilnic anterioar cu 40% ca rat bazal i 50% ca bolusuri împ r ite între cele trei mese principale.
English: Velosulin should not be disposed of via wastewater or household waste.
Romanian: Velosulin nu trebuie aruncat pe calea apei menajere sau a reziduurilor menajere.
English: When filling a new syringe, no large air bubbles should be left in either the syringe or the catheter.
Romanian: La umplerea unei noi seringi nu trebuie l sate bule mari de aer, atât în sering , cât i în cateter.
English: 6 weeks when used or stored at room temperature (below 25°C).
Romanian: 6 s pt mâni când este utilizat sau p strat la temperatura camerei (sub 25°C).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Romanian: COMPOZI IA CALITATIV I CANTITATIV Insulin uman , ADNr (ob inut prin tehnologie ADN recombinant pe Saccharomyces cerevisiae).
English: A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Romanian: 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.
English: If an adjustment is needed when switching the patients to Velosulin, it may occur with the first dose or during the first several weeks or months.
Romanian: Dac este necesar modificarea dozei când pacien ii sunt transfera i pe Velosulin, aceasta se poate face de la prima doz sau în timpul primelor s pt mâni sau luni de tratament.
English: If repeated or severe low blood glucose levels occur, the patient should notify the health care professional and the need to reduce or stop the insulin administration should be considered.
Romanian: Dac se constat în mod repetat valori sc zute ale glicemiei, pacientul trebuie s anun e personalul medical de specialitate, iar nevoia de a reduce sau întrerupe administrarea insulinei trebuie luat în considerare.
English: Before using Velosulin
Romanian: Înainte de a utiliza Velosulin
English: Fast improvement in blood glucose control may be associated with a condition termed “acute painful neuropathy”, which is usually reversible.
Romanian: Controlul glicemic îmbun t it rapid poate fi asociat cu o afec iune denumit „neuropatie acut dureroas ”, care este, de obicei, reversibil .
English: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Romanian: Omiterea unei mese sau un exerci iu fizic intens, neplanificat poate s conduc la hipoglicemie.
English: Like all medicines, Velosulin can cause side effects, although not everybody gets them.
Romanian: Ca toate medicamentele, Velosulin poate poate provoca reac ii adverse, cu toate c nu apar la toate persoanele.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Romanian: CLASIFICARE GENERAL PRIVIND MODUL DE ELIBERARE Medicament eliberat pe baz de prescrip ie medical
English: If you don't treat it, this could lead to diabetic coma and death.
Romanian: Dac nu sunte i tratat pentru aceast stare, ea poate duce la com diabetic i moarte.
English: Keep the vials in the original package.
Romanian: P stra i flacoanele în ambalajul original.
English: However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Romanian: Totu i, au fost înregistrate diferen e ale Cmax între grupele de vârst , ceea ce subliniaz importan a stabilirii individuale a dozei insulinei umane.
English: In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved.
Romanian: În eventualitatea unui episod hipoglicemic, perfuzia de insulin trebuie întrerupt , pân la rezolvarea episodului.
English: When Velosulin is administered as a bolus injection onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours.
Romanian: Prin administrare în bolus, debutul ac iunii apare în ½ or , atinge un efect maxim în 1,5-3,5 ore i are o durat de aproximativ 7-8 ore.
English: Novo Nordisk A/S Novo Nordisk A/S Novo Allé Hallas Allé DK-2880 Bagsværd DK-4400 Kalundborg Denmark Denmark
Romanian: Novo Nordisk A/S Novo Nordisk A/S Novo Allé Hallas Allé DK-2880 Bagsværd DK-4400 Kalundborg Danemarca Danemarca
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Romanian: A. PRODUC TORUL SUBSTAN EI BIOLOGIC ACTIVE I DE IN TORII AUTORIZA IEI DE FABRICA IE RESPONSABILI PENTRU ELIBERAREA SERIEI
English: Use only syringes made of polyethylene, polypropylene or glass.
Romanian: Se vor utiliza doar seringi din polietilen , polipropilen sau sticl .
English: Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia.
Romanian: Folosirea unor doze inadecvate sau întreruperea tratamentului, în special în diabetul zaharat de tip 1, poate duce la hiperglicemie.
English: If the patient suspects an interruption to insulin flow the patient should notify the health care professional.
Romanian: Dac pacien ul suspecteaz o întrerupere a fluxului de insulin , acesta trebuie s anun e personalul medical de specialitate.
English: Nervous system disorders
Romanian: Tulbur ri ale sistemului nervos
English: A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 - 6.1 mmol/l) induced by intravenous treatment with another fast acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%).
Romanian: Un studiu clinic efectuat într-o singur unitate de terapie intensiv unde se trateaz hiperglicemia (glicemie peste 10 mmol/l) la 204 pacien i cu diabet zaharat i 1344 pacien i f r diabet zaharat la care s-au efectuat interven ii chirurgicale majore, a eviden iat c glicemia normal (4,4-6,1 mmol/l) indus prin administrarea intravenoas de Actrapid a redus mortalitatea cu 42% (8% fa de 4,6%).
English: The frequencies are defined as: uncommon (≥ <1/100).
Romanian: Frecven a este definit astfel: mai pu in frecvente ( 1/1000 i < 1/100).
English: Your blood sugar may get too high (this is called hyperglycaemia).
Romanian: Zah rul din sânge poate cre te prea mult (aceasta se nume te hiperglicemie).
English: A number of medicinal products are known to interact with glucose metabolism.
Romanian: Se cunoa te faptul c unele medicamente interac ioneaz cu metabolismul glucozei.
English: • 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.
Romanian: • Episoadele hipoglicemice severe, 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.
English: Talk about your insulin needs with your doctor and diabetes nurse.
Romanian: Discuta i despre necesarul de insulin cu medicul dumneavoastr sau cu asistenta medical .
English: Renal or hepatic impairment may reduce insulin requirement.
Romanian: Insuficien a renal sau hepatic poate reduce necesarul de insulin al pacien ilor.
English: Do not use Velosulin after the expiry date which is stated on the label and the carton.
Romanian: Nu utiliza i Velosulin dup data de expirare înscris pe etichet i cutie.
English: Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Romanian: Schimbarea continu prin rota ie a locurilor de injectare în cadrul aceleia i regiuni anatomice poate ajuta la reducerea sau prevenirea acestor reac ii.
English: Swollen joints.
Romanian: Umflarea încheieturilor.
English: One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Romanian: O UI (Unitate Interna ional ) corespunde la 0,035 mg insulin uman anhidr .
English: However, hypoglycaemia may develop over sequential stages:
Romanian: Totu i, hipoglicemia se poate dezvolta pe parcursul unor etape secven iale:
English: This might happen:
Romanian: Aceasta se poate întâmpla în urm toarele situa ii:
English: The relatively fast absorption of soluble insulin ensures a constant supply of insulin to the blood from a relatively small pool under the skin.
Romanian: Absorb ia relativ rapid a insulinei solubile asigur o distribu ie constant a acesteia în sânge de la nivelul rezervorului relative mic de sub piele.
English: If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Romanian: Dac medicul dumneavoastr v-a trecut de pe un tip sau marc de insulin pe un alt tip sau marc , atunci s-ar putea ca doza de insulin s fie ajustat de c tre medic.
English: 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).
Romanian: 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).
English: Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C May be kept in an infusion pump at up to 37°C for 6 days
Romanian: A se ine flaconul în cutie pentru a fi protejat de lumin În timpul utiliz rii: a nu se p stra la frigider sau la temperaturi peste 25°C Poate fi inut în pompa de insulin la temperaturi de peste 37°C timp de 6 zile
English: Velosulin is a fast-acting insulin.
Romanian: Velosulin este o insulin cu ac iune rapid .
English: Each vial has a protective, tamper-proof plastic cap.
Romanian: Fiecare flacon are un capac protector din plastic.
English: The vial may be kept at room temperature (not above 25°C) for 6 weeks after first opening.
Romanian: Flaconul poate fi p strat la temperatura camerei (nu peste 25ºC) timp de 6 s pt mâni de la prima utilizare.
English: Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Romanian: Injectarea într-un pliu cutanat reduce riscul inject rii intramusculare accidentale.
English: Velosulin is accompanied by a package leaflet with detailed instruction for use to be followed.
Romanian: Velosulin este înso it de prospectul pentru pacient care con ine instruc iuni detaliate pentru folosire, care trebuie urmate.
English: WHAT TO DO IN AN EMERGENCY
Romanian: Ce este de f cut în cazuri de urgen .
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S
Romanian: De in torul autoriza iei de punere pe pia i produc torul Novo Nordisk A/S
English: Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Romanian: De asemenea, dac pacientul nu r spunde la glucagon în decurs de 10-15 minute trebuie
English: Use only catheters where the material in contact with the insulin is made of polyethylene or polypropylene.
Romanian: Se vor utiliza doar catetere al c ror material care intr în contact cu insulina este din polietilen sau polipropilen .
English: Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
Romanian: De asemenea, ajustarea dozei poate fi necesar dac pacien ii î i intensific activitatea fizic sau î i modific dieta obi nuit .
English: Name and address of the manufacturer of the biological active substance
Romanian: Numele i adresa produc torului substan ei biologic active
English: If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Romanian: Dac observa i c pielea dumneavoastr cap t aspect neregulat sau se îngroa la locul inject rii, informa i medicul sau asistenta deoarece aceste reac ii se pot agrava sau pot modifica absorb ia insulinei injectat în astfel de locuri.
English: Velosulin may cause hypoglycaemia (low blood sugar).
Romanian: Velosulin poate cauza hipoglicemie (cantitate mic a zah rului în sânge).
English: For a full list of excipients, see section 6.1.
Romanian: Pentru lista tuturor excipien ilor, vezi pct. 6.1 Lista excipien ilor.
English: Side effects reported very rarely (in less than 1 patient in 10,000)
Romanian: Reac ii adverse raportate foarte rar (la mai pu in de 1 pacient din 10000)
English: • If you exercise more than usual.
Romanian: • Dac depune i un efort fizic mai mare decât de obicei.
English: If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
Romanian: Dac sunte i gravid , dori i s r mâne i gravid sau al pta i: v rug m s v adresa i medicului dumneavoastr pentru sfat.
English: Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Romanian: Blocantele beta-adrenergice pot masca simptomele hipoglicemiei i pot întârzia revenirea din starea de hipoglicemie.
English: On rare occasions, injection site reactions may require discontinuation of Velosulin.
Romanian: În cazuri rare, reac iile la locul de injectare pot necesita întreruperea administr rii Velosulin.
English: Velosulin is for injection under the skin (subcutaneously).
Romanian: Velosulin se folose te pentru injectare sub piele (subcutanat ).
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Romanian: De obicei, afec iunile concomitente, în special infec iile i st rile febrile, cresc necesarul de insulin al pacien ilor.
English: Velosulin should not be mixed with insulin zinc suspensions since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way.
Romanian: Velosulin nu trebuie amestecat cu suspensii de insulin cu zinc, întrucât tamponul fosfat poate interac iona cu ionii de zinc din suspensie, modificând profilul de ac iune al insulinei într-un mod imprevizibil.
English: Continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps is usually administered in the abdominal wall.
Romanian: Perfuzia continu subcutanat cu insulin (PCSI) în pompe externe pentru perfuzia de insulin se administreaz , de obicei, în peretele abdominal.
English: Do not use Velosulin
Romanian: Nu utiliza i Velosulin
English: Draw air into the syringe, in the same amount as the dose of insulin you need Inject the air into the vial: push the needle through the rubber stopper and press the plunger Turn the vial and syringe upside down
Romanian: Trage i în sering un volum de aer egal cu doza de insulin care trebuie injectat Introduce i aerul în flacon: împinge i acul prin dopul de cauciuc i ap sa i pistonul Întoarce i invers flaconul i seringa
English: This is part of a multipack and not for sale of individual vials
Romanian: Aceast form de ambalare este parte integrant dintr-un ambalaj multiplu i nu se comercializeaz separat
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Romanian: Controlul glicemic îmbun t it pe termen lung scade riscul progresiei retinopatiei diabetice.
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).
Romanian: Dac doza de insulin este prea mare fa de necesar poate s apar hipoglicemia (vezi pct 4.8 i 4.9).
English: Monitoring of the patient's blood glucose during infusion is therefore recommended.
Romanian: De aceea, se recomand monitorizarea glicemiei pacientului în timpul perfuziei.
English: If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Romanian: Dac prezenta i oricare dintre aceste semne, mânca i tablete de glucoz sau gust ri bogate în zah r (dulciuri, biscui i, suc de fructe), apoi odihni i-v .
English: However, the Velosulin dosage may need to be adjusted.
Romanian: Totu i, poate fi necesar o ajustare a dozei de Velosulin.
English: The vials that is not being used is to be stored in a refrigerator (2°C - 8°C).
Romanian: Flacoanele care nu sunt utilizate trebuie p strate la frigider (2°C - 8°C).
English: In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Romanian: În diabetul zaharat de tip 1, evenimentele hiperglicemice netratate duc eventual la cetoacidoz diabetic , poten ial letal .
English: The advisability of driving should be considered in these circumstances.
Romanian: În aceste circumstan e, recomandarea privind conducerea vehiculelor sau folosirea utilajelor trebuie reconsiderat .
English: When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin.
Romanian: Când se administreaz prin PCSI, nu se va ad uga nici un alt medicament sau insulin în rezervorul pompei de perfuzie cu Velosulin .
English: Generalised hypersensitivity reactions are potentially lifethreatening.
Romanian: Reac iile de hipersensibilitate generalizat pot pune via a în pericol.
English: Name and address of the manufacturers responsible for batch release
Romanian: Numele i adresa produc torilor responsabili pentru eliberarea seriei
English: Velosulin contains metacresol, which may cause allergic reactions.
Romanian: Velosulin con ine metacrezol, care poate determina reac ii alergice.
English: Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Romanian: Informa i-v rudele, prietenii i colegii apropia i c în cazul în care v pierde i con tien a trebuie s v a eze pe o parte i s v acorde imediat asisten medical .
English: As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Romanian: Ca în orice tratament cu insulin , pot ap rea reac ii la locul de injectare, care includ: durere, prurit, urticarie, tumefac ie i inflama ie.
English: Insulin products should only be added to compounds with which it is known to be compatible.
Romanian: Preparatele de insulin pot fi ad ugate numai acelor compu i cu care se tie c sunt compatibile.
English: The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
Romanian: De aceea, farmacocinetica preparatelor de insulin prezint varia ii intra- i interindividuale semnificative.
English: Velosulin should never be mixed with any other insulin when used in a pump.
Romanian: Velosulin nu trebuie amestecat niciodat cu alt tip de insulin când este utilizat în pompele de insulin .
English: These usually disappear after a few weeks of taking your insulin.
Romanian: De obicei, acestea dispar dup câteva s pt mâni de tratament cu insulin .
English: Use in infusion pump
Romanian: Utilizarea în pompe pentru perfuzie
English: Inject the insulin straight away under the skin.
Romanian: Injecta i imediat insulina subcutanat.
English: Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Romanian: V rug m s discuta i cu medicul dumneavoastr sau farmacistul dac utiliza i sau a i utilizat de curând orice alt medicament, chiar i dintre cele care se elibereaz f r prescrip ie medical .
English: If you drive or use tools or machines: watch out for signs of a hypo.
Romanian: Dac conduce i vehicule sau folosi i utilaje: fi i aten i la semnele hipoglicemiei.
English: In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
Romanian: La pacien ii cu diabet zaharat, optimizarea controlului glicemic întârzie debutul complica iilor diabetice tardive.
English: Usually, 40-60% of the total daily dose is given as a continuous basal rate and the remaining 40-60% as boluses divided between the three main meals.
Romanian: În mod obi nuit, 40-60% din doza zilnic este administrat în rat bazal continu i diferen a de 4060% este administrat în bolusuri împ r ite între cele trei mese principale.
English: Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Romanian: Fosfat disodic dihidrat Hidroxid de sodiu (pentru ajustarea pH-ului) Acid clorhidric (pentru ajustarea pH-ului) Ap pentru preparate injectabile
English: This phosphate-buffered soluble insulin is intended for continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps.
Romanian: Aceast insulin solubil tamponat cu fosfat este destinat pentru administrarea subcutanat continu (PCSI) în pompe de insulin externe.
English: A hypo means your blood sugar level is too low.
Romanian: O hipoglicemie înseamn un nivel prea mic al zah rului în sânge.
English: Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Romanian: Schimba i mereu locul inject rii pentru a evita formare de noduli (vezi pct. 5.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
Romanian: A. PRODUC TORUL SUBSTAN EI BIOLOGIC ACTIVE I
English: The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Romanian: Semnele de avertizare a hipoglicemiei pot s apar brusc i pot include: transpira ii reci, piele palid i rece, dureri de cap, b t i rapide ale inimii, senza ie de r u, senza ie intens de foame, tulbur ri de vedere trec toare, somnolen , oboseal i sl biciune neobi nuite, nervozitate sau tremor, stare de nelini te, confuzie, dificult i de concentrare.
English: The following substances may reduce insulin requirement:
Romanian: Urm toarele substan e pot reduce necesarul de insulin :
English: If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Romanian: Dac v injecta i insulina prea des în acela i loc, esutul gras de sub piele din acest loc se poate sub ia (lipoatrofie) sau îngro a (lipohipertrofie).
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Romanian: Totu i, intensificarea terapiei insulinice cu îmbun t irea rapid a controlului glicemic poate fi asociat cu agravarea temporar a retinopatiei diabetice.
English: Changes at the injection site (Lipodystrophy).
Romanian: Modific ri la nivelul locului de injectare (Lipodistrofie).
English: Insulin infusion (CSII):
Romanian: Perfuzia cu insulin (PCSI):
English: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Romanian: Contraceptive orale, tiazide, glucocorticoizi, hormoni tiroidieni i simpatomimetice beta-adrenergice, hormon de cre tere i danazol.
English: Octreotide/lanreotide may both decrease and increase insulin requirement.
Romanian: Octreotidul/lanreotidul poate atât reduce cât i cre te necesarul de insulin .
English: If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Romanian: Dac vi se injecteaz glucagon ve i avea nevoie de glucoz sau de o gustare dulce cât mai curând posibil dup ce v rec p ta i con tien a.