FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products added to the insulin solution may cause degradation of the insulin, e.g. if the medicinal products contain thiols or sulphites.
Romanian: Medicamentele ad ugate la solu ia de insulin pot produce degradarea acesteia, de exemplu, dac con in tioli sau sulfi i.
English: Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Romanian: Verifica i eticheta pentru a v asigura c ave i tipul corect de insulin ; Dezinfecta i membrana de cauciuc cu un tampon cu alcool medicinal.
English: After delivery, insulin requirements return rapidly to pre-pregnancy values.
Romanian: Dup na tere, necesarul de insulin revine rapid la valorile anterioare perioadei de sarcin .
English: Before use: store in a refrigerator (2°C - 8°C).
Romanian: Înainte de utilizare: a se p stra la frigider (2°C - 8°C).
English: 1 vial contains 10 ml equivalent to 1000 IU.
Romanian: 1 flacon con ine 10 ml echivalent cu 1000 UI.
English: It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials.
Romanian: Este disponibil în cutii cu 1 sau 5 flacoane a câte 10 ml sau în ambalaj multiplu cu 5 cutii cu câte 1 flacon a 10 ml.
English: Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
Romanian: Înainte de o c l torie în zone cu diferen e de fus orar, pacientul trebuie sf tuit s se adreseze unui medic, deoarece, aceasta presupune administrarea insulinei i a meselor la alte ore.
English: 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.
Romanian: Trecerea unui pacient pe o alt marc sau alt tip de insulin trebuie f cut numai sub supraveghere medical strict . Schimb rile survenite în concentra ie, marc (produc tor), tip (insulin cu ac iune 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 necesitatea modific rii dozei.
English: When combination with long-acting insulin is necessary it is only possible to mix Velosulin with isophane or premixed insulin products.
Romanian: Când este necesar asocierea cu o insulin cu ac iune prelungit , Velosulin se va amesteca doar cu insulin izofan sau cu insuline preamestecate.
English: A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
Romanian: O defec iune a pompei sau o obstruc ie a setului de perfuzie poate avea ca rezultat o cre tere rapid a glicemiei.
English: To get the benefit of insulin infusion, and to detect possible malfunction of the pump, the patient should measure his blood glucose level regularly.
Romanian: Pentru a beneficia de perfuzia de insulin i pentru a detecta posibilele disfunc ionalit i ale pompei, trebuie s v verifica i cu regularitate glicemia.
English: If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
Romanian: Dac ave i retinopatie diabetic i glicemia dumneavoastr se îmbun t e te foarte repede, retinopatia se poate înr ut i.
English: 1 ml contains 100 IU of insulin human.
Romanian: 1 ml solu ie injectabil con ine insulin uman 100 UI.
English: Use only teflon-coated or stainless steel needles.
Romanian: Se vor utiliza doar ace acoperite cu teflon sau din o el inoxidabil.
English: Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to the infusion material.
Romanian: Dup amestecarea Velosulin cu lichidele de perfuzie, o cantitate de insulin care nu poate fi apreciat va fi adsorbit pe materialul de perfuzie.
English: PARTICULARS TO APPEAR ON THE PACKAGING OUTER WRAPPER LABLE ON MULTIPACKS
Romanian: INFORMA II CARE TREBUIE S APAR PE AMBALAJ ETICHETA COLECTIV A AMBALAJELOR MULTIPLE
English: Patients administering Velosulin by CSII must have injection syringes and alternative insulin readily available in case of emergency or pump interruption or failure, in order that insulin can be administered by subcutaneous injection.
Romanian: Pacien ii care î i administreaz Velosulin prin PCSI trebuie s aib seringi de insulin la îndemân ca alternativ , în caz de urgen sau a unei eventuale întreruperi sau defec iuni ale pompei, pentru ca insulina s poat fi administrat prin injectare subcutanat .
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Romanian: Pacien ii trebuie sf tui i s ia m suri de precau ie pentru a evita hipoglicemia în timpul conducerii de vehicule.
English: Eat a meal or snack containing carbohydrates within 30 minutes of administration.
Romanian: Mânca i sau lua i o gustare care con ine glucide în decurs de 30 minute de la injectare.
English: 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.
Romanian: 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 .
English: Dosage is individual and determined by the physician in accordance with the needs of the patient.
Romanian: Dozajul este individual i stabilit de medic în concordan cu necesit ile pacientului.
English: You can keep it in the pump reservoir for 6 days at up to 37°C (close to the body).
Romanian: Îl pute i p stra în rezervorul pompei timp de 6 zile, la temperaturi de pân la 37°C (lâng corp).
English: Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Romanian: Men ine i acul sub piele cel pu in 6 secunde, pentru a v asigura c întreaga doz a fost
English: Keep out of the reach and sight of children
Romanian: A nu se l sa la îndemâna i vederea copiilor
English: 6.6 Special precautions for disposal and other handling
Romanian: 6.6 Precau ii speciale pentru eliminarea reziduurilor i alte instruc iuni de manipulare
English: No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Romanian: Nu s-a observat formarea de leg turi puternice cu proteinele plasmatice, cu excep ia anticorpilor insulinici circulan i (dac sunt prezen i).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Romanian: ATEN IONARE SPECIAL PRIVIND FAPTUL C MEDICAMENTUL NU TREBUIE
English: If your blood sugar gets too high
Romanian: Dac zah rul din sânge cre te prea mult
English: Velosulin is a fast-acting insulin and may be used in combination with certain long-acting insulin products.
Romanian: Velosulin este o insulin cu ac iune rapid i se poate utiliza în asociere cu insuline cu ac iune prelungit .
English: Velosulin may also be administered intravenously in special situations by medical professionals.
Romanian: Velosulin poate fi administrat i intravenos în situa ii speciale, numai de c tre personal medical calificat.
English: 10 ml glass vial (type 1) closed with a bromobutyl/polyisoprene rubber stopper and a protective tamper-proof cap.
Romanian: Flacon din sticl tip I a 10 ml, închis cu un dop din cauciuc bromobutilic/poliizoprenic i etan at cu capac protector.
English: Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
Romanian: De aceea, se recomand supravegherea atent a pacientelor cu diabet zaharat atât în timpul sarcinii, cât i în perioada de concep ie.
English: Keep out of the reach and sight of children.
Romanian: A nu se l sa la îndemâna i vederea copiilor.
English: If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain.
Romanian: Dac glicemia dumneavoastr se îmbun t e te foarte repede, aceasta poate provoca o durere cu senza ie de arsur , furnic turi sau oc electric.
English: 6 HOW TO STORE VELOSULIN
Romanian: 6 CUM SE P STREAZ VELOSULIN
English: If you are going abroad: travelling over time zones may affect your insulin needs and the
Romanian: Dac c l tori i în str in tate: c l toriile în zone cu diferen de fus orar pot influen a necesarul dumneavoastr de insulin i momentul injec iilor.
English: Novo Allé, DK-2880 Bagsværd, Denmark
Romanian: Novo Allé, DK-2880 Bagsværd, Danemarca Acest prospect a fost aprobat în
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
Romanian: Dac vreuna dintre reac iile adverse devine grav sau dac observa i orice reac ii adverse, inclusiv cele nemen ionate în acest prospect, v rug m s -i spune i medicului dumneavoastr , personalului medical specializat în tratarea diabetului zaharat sau farmacistului.
English: Side effects reported uncommonly (in less than 1 patient in 100)
Romanian: Reac ii adverse raportate mai pu in frecvent (la mai pu in de 1 pacient din 100)
English: Pharmacotherapeutic group: insulins and analogues for injection, fast-acting, insulin (human).
Romanian: Grupa farmacoterapeutic : insulin (uman ) i analogi injectabili cu ac iune rapid . Cod ATC: A10AB01.
English: Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Romanian: Discuta i cu medicul dumneavoastr dac este recomandabil s conduce i vehicule sau s folosi i utilaje în cazul în care ave i episoade frecvente de hipoglicemie sau simptome de avertizare a hipoglicemiei reduse sau absente.
English: Follow their advice carefully.
Romanian: Urma i-le sfatul cu aten ie.
English: Patients using CSII may be more prone to infection at the site of infusion.
Romanian: Pacien ii care utilizeaz PCSI sunt mai expu i la infec ii la locul de perfuzare.
English: Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective betablocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.
Romanian: Antidiabetice orale (AO), inhibitori ai monoaminooxidazei (IMAO), blocante beta-adrenergice neselective, inhibitori ai enzimei de conversie a angiotensinei (IECA), salicila i, alcool etilic, steroizi anabolizan i i sulfonamide.
English: Look out for the signs of allergy in 5 Possible side
Romanian: Pentru semnele alergiei vezi pct. 5.
English: Causes of a hypo
Romanian: Cauze de hipoglicemie
English: Close blood glucose monitoring is therefore recommended.
Romanian: De aceea, se recomand monitorizarea atent a glicemiei.
English: Use the injection technique advised by your doctor or diabetes nurse
Romanian: Urma i tehnica de injectare recomandat de medicul
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to medical prescription
Romanian: • CONDI II SAU RESTRIC II PRIVIND FURNIZAREA I UTILIZAREA IMPUSE
English: Use in syringes
Romanian: Utilizarea în seringi
English: Read all of this leaflet carefully before you start using your insulin.
Romanian: Citi i cu aten ie i în întregime acest prospect înainte de a începe s utiliza i acest medicament.
English: Read and follow carefully the instructions that accompany your insulin pump.
Romanian: Citi i i urma i cu aten ie instruc iunile care înso esc pompa dumneavoastr de insulin .
English: Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Romanian: Atât hipoglicemia, cât i hiperglicemia care apar în condi ii de control inadecvat al terapiei diabetului zaharat cresc riscurile de malforma ii congenitale i deces intrauterin.
English: Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section
Romanian: În ceea ce prive te compatibilitatea cu pompe de perfuzie cu insulin , rezervoare, catetere i ace, se va consulta seciunea 6.6.
English: The patient should follow the instructions from the physician about the basal infusion rate and the mealtime insulin boluses to be taken.
Romanian: Pacientul trebuie s urmeze instruc iunile medicului despre rata de perfuzie bazal i bolusurile ce trebuie administrate la momentul meselor.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Romanian: MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
English: Dosage is individual and determined in accordance with the needs of the patient.
Romanian: Dozajul este individual i stabilit în concordan cu necesit ile pacientului.
English: Patients started on CSII must receive comprehensive instruction in the use of the pump, and the necessary actions in case of illness, hypoglycaemia, hyperglycaemia or pump failure.
Romanian: Pacien ii care utilizeaz pompe de insulin trebuie instrui i corespunz tor privind utilizarea pompei i ac iunile necesare ce trebuie întreprinse în caz de îmboln vire, hipoglicemie, hiperglicemie sau defec iune a pompei.
English: The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Romanian: Cele mai indicate locuri pentru injectare sunt: peretele abdominal, fesele, fa a anterioar a coapselor sau regiunea superioar a bra ului.
English: - If you have any further questions, ask your doctor, diabetes nurse or your pharmacist.
Romanian: - Dac ave i orice întreb ri suplimentare, adresa i-v medicului dumneavoastr , personalului medical specializat în tratarea diabetului zaharat sau farmacistului.
English: 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.
Romanian: 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.
English: Upon regaining consciousness, administration of oral carbohydrate is recommended for the
Romanian: Dup rec p tarea con tien ei, pentru a preveni rec derile este recomandat administrarea oral
English: Insulin in the blood stream has a half-life of a few minutes.
Romanian: Insulina are un timp de înjum t ire plasmatic de câteva minute.
English: The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Romanian: Efectul insulinei de sc dere a glicemiei se datoreaz facilit rii p trunderii glucozei în celule prin legarea insulinei de receptorii de pe celulele musculare i adipoase, precum i inhib rii simultane a form rii glucozei în ficat.
English: zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
Romanian: clorur de zinc, glicerol, metacrezol, fosfat disodic dihidrat, hidroxid de sodiu, acid clorhidric i ap pentru preparate injectabile
English: Refraction anomalies may occur upon initiation of insulin therapy.
Romanian: Anomalii de refrac ie pot s apar la ini ierea tratamentului cu insulin .
English: Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
Romanian: Pacien ii la care controlul glicemiei este net îmbun t it, de exemplu prin tratament intensiv cu insulin , pot prezenta o modificare a simptomelor de avertizare obi nuite i trebuie sf tui i în acest sens.
English: Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Romanian: Este recomandabil s ave i asupra dumneavoastr tablete de glucoz , dulciuri, biscui i sau suc de fructe pentru a preveni o hipoglicemie.
English: Many medicines affect the way glucose works in your body and they may influence your insulin dose.
Romanian: Multe medicamente influen eaz modul în care glucoza este utilizat în organismul dumneavoastr i aceasta v poate influen a doza de insulin . Medicamentele cel mai des utilizate care pot influen a tratamentul dumneavoastr cu insulin sunt enumerate mai jos.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Romanian: • CONDI II SAU RESTRIC II CU PRIVIRE LA SIGURAN A I EFICACITATEA Nu este cazul.
English: - Keep this leaflet.
Romanian: - P stra i acest prospect.
English: Most reactions are transitory and disappear during continued treatment.
Romanian: Obi nuit, aceste reac ii sunt tranzitorii i dispar pe parcursul tratamentului.
English: Due to the lack of long-acting insulin, patients receiving continuous subcutaneous insulin infusion via an insulin pump are at risk of fast development of ketoacidosis in case of prolonged interruption of continuous subcutaneous insulin infusion.
Romanian: Datorit absen ei insulinei cu ac iune prelungit , pacien ii care i i administreaz PCSI utilizând pompe de insulin , prezint riscul de a manifesta rapid cetoacidoz în cazul unei întreruperi prelungite a perfuziei continue subcutanate cu insulin .
English: 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
Romanian: 1 ml solu ie con ine 100 UI (3,5 mg) insulin uman (ADNr)
English: General disorders and administration site conditions Uncommon - Injection site reactions
Romanian: Tulbur ri generale i la nivelul locului de administrare Mai pu in frecvente - reac ii la locul inject rii
English: MARKETING AUTHORISATION NUMBERS EU/1/02/232/001 1 x 10 ml
Romanian: NUM RUL(ELE) AUTORIZA IEI DE PUNERE PE PIA EU/1/02/232/001 1 x 10 ml
English: The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Romanian: Timpul de înjum t ire plasmatic prin eliminare este determinat de viteza absorb iei din esutul subcutanat.
English: Solusion for injection or infusion 1 x 10 ml
Romanian: Solu ie injectabil sau perfuzabil 1 x 10 ml
English: The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Romanian: Necesarul individual zilnic de insulin este cuprins, de regul , între 0,3 i 1,0 UI/kg i zi i poate fi mai mare la pacien ii insulinorezisten i (de exemplu în perioada pubert ii sau datorit obezit ii) sau mai mic la pacien ii cu produc ie de insulin endogen rezidual .
English: Follow the instructions of your doctor or diabetes nurse concerning the correct mixing procedure.
Romanian: Amestecarea Velosulin cu insuline cu ac iune prelungit Urma i instruc iunile medicului dumneavoastr sau ale asistentei medicale privind procedura corect de amestecare.
English: Ask your doctor about this.
Romanian: Adresa i-v medicului dumneavoastr în leg tur cu acest lucru.
English: They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
Romanian: Acestea includ: urinare frecvent , senza ie de sete, pierderea poftei de mâncare, senza ie de r u (grea sau v rs turi), ame eal sau oboseal , piele uscat i ro ie, gur uscat i respira ie cu miros de fructe (aceton ).
English: Frequencies of adverse drug reactions from clinical trials that are considered related to fast-acting ≥1/1,000 to human insulin (Actrapid) are listed below.
Romanian: Frecven a reac iilor adverse din studii clinice, considerate ca având leg tur cu insulina uman cu ac iune rapid , Actrapid, este prezentat mai jos.
English: Pack sizes: 1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
Romanian: M rimea ambalajului: 1 i 5 flacoane a câte 10 ml i ambalaj multiplu cu 5 cutii cu câte 1 flacon a 10 ml.
English: When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Romanian: La începerea tratamentului cu insulin re inerea apei în organism poate produce umfl turi în jurul gleznelor sau a altor articula ii.
English: After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
Romanian: Dup prima utilizare a perfuziei, solu ia de insulin poate fi p strat în rezervorul pompei timp de ase zile, la temperaturi de pâna la 37°C (lâng corp).
English: When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Romanian: Când dou tipuri de insulin se amestec , se introduce în sering insulina cu ac iune rapid , apoi insulina cu ac iune prelungit .
English: Make sure there is no air left in the syringe: point the needle upwards and push the air out Check you have the right dose
Romanian: Asigura i-v c nu a r mas aer în sering : îndrepta i acul în sus i împinge i aerul afar .
English: Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
Romanian: Adresa i-v medicului dumneavoastr sau unui serviciu de urgen dup o injec ie cu glucagon: motivul hipoglicemiei trebuie identificat pentru a preveni alte episoade de hipoglicemie.
English: • Less exercise than usual.
Romanian: • A i depus mai pu in efort fizic decât de obicei.
English: Insulin solutions should not be used if they do not appear water clear and colourless.
Romanian: Solu iile de insulin care nu sunt limpezi i incolore nu trebuie utilizate.
English: Reactions usually resolve in a few days to a few weeks.
Romanian: De regul , aceste reac ii dispar pe parcursul câtorva zile, pân la câteva s pt mâni.
English: If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent)
Romanian: Dac hipoglicemia sever nu este tratat , aceasta poate provoca leziuni ale creierului
English: 4.6 Pregnancy and lactation
Romanian: 4.6 Sarcina i al ptarea
English: To inject Velosulin on its own
Romanian: Cum s v injecta i Velosulin
English: Causes of hyperglycaemia
Romanian: Cauze de hiperglicemie
English: If it isn't in perfect condition when you get the vial, return the vial to your supplier If it hasn't been stored correctly or been frozen (see 6 How to store Velosulin) If it does not appear water clear and colourless.
Romanian: Dac nu a fost p strat corespunz tor sau a fost congelat (vezi pct. 6.
English: Keep the vial in the outer carton in order to protect from light.
Romanian: A se p stra flaconul în cutie pentru a fi protejat de lumin . A se proteja de lumin i c ldur excesiv .
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Romanian: Ele includ sete, poliurie, grea , v rs turi, somnolen , tegumente uscate i eritematoase, xerostomie, pierderea apetitului i respira ie cu miros de aceton .
English: If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin
Romanian: Dac a i f cut un efort fizic mai intens decât de obicei sau dori i s v modifica i dieta
English: If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty
Romanian: Dac a i consumat alcool: aten ie la semnele hipoglicemiei i nu consuma i niciodat alcool
English: Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Romanian: Lipodistrofia poate s apar la locul inject rii ca o consecin a omiterii rot rii locului de injectare în cadrul aceleia i regiuni anatomice.
English: The following substances may increase insulin requirement:
Romanian: Urm toarele substan e pot cre te necesarul de insulin :
English: POSSIBLE SIDE EFFECTS
Romanian: Reac ii adverse posibile).