natgillin/translations-raw huggingface dataset:
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduction in the activity of the immune system), higher body mass index, among others, may be some of the many risk factors for developing this disease. − Muscle pain, tenderness or weakness, particularly in combination with these medicines.
Durata tratamentului antiretroviral asociat, utilizarea corticosteroizilor, consumul de alcool, imunosupresia severă (reducerea funcţiei sistemului imun), indice mare al masei corporale, printre altele, pot fi unii din numeroşii factori de risc de apariţie a acestei boli.
On rare occasions these muscle disorders have been serious.
Aceste tulburări musculare pot fi rareori grave.
Taking other medicines
141 Folosirea altor medicamente
Tell your doctor if you are taking any of the medicines listed below, as special care should then be taken: − Antibiotics (e.g. rifabutin, rifampicin, clarithromycin); − Anticancer medicines (e.g. vincristine, vinblastine); − Antidepressants (e.g. trazodone, bupropion); − Anti-epilepsy medicines (e.g. carbamazepine, phenytoin, phenobarbital);
Spuneţi medicului dumneavoastră dacă luaţi oricare din medicamentele enumerate mai jos, deoarece sunt necesare precauţii speciale:
127 − Antifungals (e.g. ketoconazole, itraconazole, voriconazole); − Erectile dysfunction medicines (e.g. sildenafil and tadalafil); − Heart medicines including:
- Medicamente pentru disfuncţia erectilă (de exemplu sildenafil şi tadalafil);
− − −
- Digoxin
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
- Inhibitori de protează (de exemplu amprenavir, fosamprenavir, indinavir, nelfinavir, ritonavir,
− Medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin or simvastatin); − Medicines affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus); − Medicines used for smoking cessation (e.g. bupropion); − Morphine-like medicines (e.g. methadone); − Oral contraceptive or using a patch contraceptive to prevent pregnancy (see section below titled Contraceptives); − Protease inhibitors (e.g. amprenavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir); − Sedatives (e.g. midazolam administered by injection); − Steroids (e.g. dexamethasone, fluticasone propionate, ethinyl oestradiol); − Warfarin. − Medicines that cause a reaction with alcohol (e.g. disulfiram).
Pentru informaţii privind medicamentele pe care nu trebuie să le luaţi concomitent cu Kaletra, citiţi lista medicamentelor din capitolul ‘ Nu luaţi Kaletra concomitent cu oricare dintre următoarele medicamente ’.
Read the list of medicines under ‘Do not take Kaletra with any of the following medicines’ for information on medicines that you must not take with Kaletra.
Vă rugăm să spuneţi medicului dumneavoastră sau farmacistului dacă luaţi sau aţi luat recent orice alte medicamente, inclusiv dintre cele eliberate fără prescripţie medicală.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- Dacă luaţi sildenafil sau tadalafil împreună cu Kaletra, puteti prezenta riscul de reacţii adverse
Erectile dysfunction medicines (vardenafil, sildenafil, tadalafil) − Do not take Kaletra if you are currently taking vardenafil. − If you take sildenafil or tadalafil and Kaletra together, you may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours.
cum sunt tensiune arterială mică, tulburări de vedere şi erecţie prelungită cu durata de peste 4 ore.
− If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives. − Kaletra does not reduce the risk of passing HIV to others.
trebuie să utilizaţi un contraceptiv suplimentar sau diferit (de exemplu prezervativul), deoarece Kaletra poate să reducă eficacitatea contraceptivelor orale şi a celor sub formă de plasture.
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
adecvate (de exemplu utilizarea prezervativului) pentru a preveni transmiterea bolii prin contact sexual.
Taking Kaletra with food and drink
Utilizarea Kaletra cu alimente şi băuturi
It is important that Kaletra is taken with food.
Kaletra comprimate poate fi luat cu sau fără alimente.
Pregnancy and breast-feeding
142 Sarcina şi alăptarea
− Tell you doctor immediately if you are pregnant, think you may be pregnant or if you are breast-feeding. − Pregnant or breast-feeding mothers should not take Kaletra unless specifically directed by the doctor. − It is recommended that HIV-infected women do not breast-feed their infants because there is a possibility that the baby can be infected with HIV through your breast milk.
- Spuneţi imediat medicul dumneavoastră dacă sunteţi gravidă, credeţi că s- ar putea să fiţi
128 Driving or using machines
gravidă sau dacă vă alăptaţi copilul.
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- Gravidele sau mamele care alăptează nu trebuie să ia Kaletra fără recomandarea strictă a
Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safety.
Kaletra nu a fost studiat specific pentru efectele posibile asupra capacităţii de a conduce vehicule sau de a folosi utilaje.
Instead, contact your doctor.
CUM SĂ LUAŢI KALETRA
Kaletra contains 42% v/v alcohol.
Cum trebuie utilizat Kaletra?
Important information about some of the ingredients of Kaletra
Este important să înghiţiţi comprimatele de Kaletra întregi, fără să le mestecaţi, sparge sau sfărâmaţi.
Kaletra contains 42% v/v alcohol.
- Kaletra comprimate poate fi luat cu sau fără alimente.
Each dose contains up to 1.7 g of alcohol.
- Întotdeauna luaţi Kaletra exact cum v- a spus medicul dumneavoastră.
Potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
- Trebuie să întrebaţi medicul dumneavoastră sau farmacistul dacă nu sunteţi sigur cum trebuie să
May modify or increase the effect of other medicines.
Cât şi când trebuie să luaţi Kaletra?
This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
- Doza uzuală pentru adulţi este de 400 mg/ 100 mg de două ori pe zi, la intervale de 12 ore, în
Unsuitable in hereditary fructose intolerance.
asociere cu alte medicamente anti- HIV.
Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a physician.
Medicul dumneavoastră vă indică numărul de comprimate care trebuie utilizat.
Kaletra contains glycerol which is harmful in high doses.
- Pentru copii, medicul dumneavoastră decide doza exactă (numărul de comprimate) în funcţie de
Can cause headache and stomach upset and diarrhoea.
înălţimea şi greutatea copilului.
Kaletra contains polyoxyl 40 hydrogenated castor oil.
asemenea, Kaletra sub formă de soluţie orală.
This may cause nausea, vomiting, colic, severe purgation at high doses.
Pot să nu mai iau Kaletra sau să schimb doza?
It should not be given when intestinal obstruction is present.
- Nu întrerupeţi sau modificaţi doza zilnică de Kaletra fără a discuta mai întâi cu medicul
Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet.
- Kaletra trebuie să fie luat de două ori pe zi, în fiecare zi pentru a permite controlul infecţiei cu
High potassium in the blood can cause stomach upset and diarrhoea.
HIV, indiferent de cât de bine vă simţiţi.
Kaletra contains sodium as saccharin sodium, sodium chloride and sodium citrate, which may be harmful to people on a low sodium diet.
- Utilizarea Kaletra, aşa cum vi s- a recomandat, asigură cea mai bună şansă de a întârzia
HOW TO TAKE KALETRA
dezvoltarea rezistenţei la medicament.
Kaletra is recommended for use in adults and children 2 years of age or older who are infected with HIV.
- În cazul în care o reacţie adversă vă împiedică să luaţi Kaletra aşa cum v- a fost recomandat,
Take care when dosing children.
informaţi imediat medicul dumneavoastră.
Dosing should be less that 5 ml twice daily for children weighing less that 40 kg.
În
− It is important that all doses of Kaletra oral solution are taken with food. − Always take Kaletra exactly as your doctor has told you. − You should check with your doctor or pharmacist if you are not sure how you should take your medicine.
timpul călatoriilor sau când aveţi nevoie de spitalizare, asiguraţi- vă că aveţi suficientă Kaletra, cel puţin până când v- o puteţi procura din nou.
How much Kaletra should be taken and when?
Dacă luaţi mai mult decât trebuie din Kaletra
− The usual adult dose is 5 ml of the oral solution twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- Dacă v- aţi dat seama că aţi luat mai mult decât trebuie Kaletra, adresaţi- vă imediat medicului
Your doctor will advise on the amount of Kaletra to be taken. − For children, your doctor will decide the right dose based on the child’s height and weight. − Kaletra is also supplied as film-coated tablets containing 200 mg of lopinavir and 50 mg of ritonavir and film-coated tablets containing 100 mg of lopinavir and 25 mg of ritonavir.
- Dacă nu puteţi anunţa medicul, mergeţi la spital.
Can I stop taking Kaletra or change my dose?
143 Dacă uitaţi să luaţi Kaletra
− Do not stop or change the daily dose of Kaletra without first consulting with your doctor. − Kaletra should always be taken twice every day to help control your HIV infection, no matter how much better you feel.
- Dacă aţi omis o doză, luaţi- o cât mai curând posibil şi continuaţi după programul stabilit
129 − Using Kaletra as recommended should give you the best chance of delaying the development of resistance to the product. − If a side effect is preventing you from taking Kaletra as directed tell your doctor right away. − Always keep enough Kaletra on hand so you don’t run out.
Este dificil să deosebiţi reacţiile adverse provocate de Kaletra de cele ale altor medicamente luate concomitent sau de cele determinate de complicaţii ale infecţiei cu HIV.
When you travel or need to stay in the hospital make sure you will have enough Kaletra to last until you can get a new supply. − Continue to take this medicine until your doctor tells you otherwise.
Dacă simptomele persistă sau se înrăutăţesc, solicitaţi consult medical.
How do I measure the correct dose of the solution?
- Creşterea TGP (un tip de enzime hepatice)
Open the child-proof cap by pushing down on it with your palm and twisting it counter clockwise, or in the direction of the arrow.
Informaţii suplimentare privind creşterea colesterolului şi a trigliceridelor
Talk to you pharmacist if you have difficulty opening the bottle.
- Riscul complicaţiilor pe termen lung cum sunt crize cardiace sau accident vascular datorită
5 dosing syringes are included in each carton of Kaletra oral solution.
creşterii trigliceridelor şi a colesterolului nu este cunoscut încă.
Ask your pharmacist for instructions on how to use the syringe correctly.
- Medicul dumneavostră vă va monitoriza şi vă va prescrie alte medicamente la nevoie.
After each dose of Kaletra separate the plunger and the syringe.
- Creşterea mare a trigliceridelor (grăsimi în sânge) este considerată un risc crescut pentru
Wash the plunger and the syringe with dish soap and warm water as soon as you can; you may soak both in soapy water for up to 15 minutes.
Efecte adverse FRECVENTE (întâlnite la 1 până la 10 din 100 persoane tratate):
Rinse the syringe and plunger with clean water.
- Valori anormale ale testelor funcţiei hepatice;
Put the syringe back together and draw up and expel tap water a few times to rinse.
- Modificări ale formei corpului, datorită redistribuiţiei grăsimii;
Let the syringe dry completely before you use that syringe for dosing.
- Creşterea glucozei serice, creşterea amilazei serice (o enzimă pentru digestie), enzime hepatice
If you take more Kaletra than you should
- Slăbiciune şi pierderea energiei;
− If you realise you have taken more Kaletra than you were supposed to, contact you doctor right away. − If you cannot contact your doctor, go to the hospital.
- Greaţă, vărsături, dureri abdominale, scaune modificate, indigestie, gaze, tulburări ale aparatului
If you forget to take Kaletra
- Erupţii pe piele, acnee;
− If you miss a dose, take the missed dose as soon as possible together with some food, and then continue with your normal dose on the regular schedule as prescribed by your doctor. − Do not take a double dose to make up for a forgotten dose.
Informaţii suplimentare privind greaţa, vărsăturile sau durerile abdominale Spuneţi medicului dumneavostră dacă aveţi greaţă, vărsături sau dureri abdominale deoarece acestea pot fi sugestive pentru apariţia pencreatitei.
POSSIBLE SIDE EFFECTS
Cauzele şi efectul pe termen lung ale acestor modificări nu sunt cunoscute încă.
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
144 Reacţii adverse MAI PUŢIN FRECVENTE (întâlnite la 1 până la 10 din 1000 persoane tratate):
It may be difficult to tell which side effects have been caused by Kaletra and which may occur due to other medicines you take at the same time or by the complications of the HIV infection.
- Număr scăzut de globule roşii din sânge, număr scăzut de globule albe din sânge, mărirea
You should tell your doctor promptly about these or any other symptoms.
- Zgomote în ureche sau în ambele urechi, cum sunt zumzet, ţiuit sau şuierătură;
If the condition persists or worsens, seek medical attention.
transpiraţii şi/ sau acumulare de lichid în plămâni;
130 VERY COMMON side effects (affects more than 1 user in 10): − Diarrhoea; − Increased cholesterol; − Increased GGT (a type of liver enzyme); − Increased triglycerides (a form of fat).
- Mărirea abdomenului, constipaţie, gură uscată, dificultăţi la înghiţire, inflamaţia intestinului
Further information about increased cholesterol and triglycerides − The long-term risks for complications such as heart attacks or stroke due to increased triglycerides and cholesterol are not known at this time. − Your doctor will monitor you and may prescribe other medicines if needed. − Large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis.
subţire şi gros, arsuri, inflamaţia faringelui, incapacitatea de a vă controla intestinele, inflamaţia stomacului şi a intestinului, diaree cu sânge, ulceraţii ale gurii, inflamaţia pancreasului; inflamaţia glandelor salivare, inflamaţia mucoasei gurii, ulcer bucal, inflamaţia gingiilor;
COMMON side effects (affects 1 to 10 users in 100): − Abnormal liver function tests; − Changes in body shape due to changes in fat distribution; − Headache; − Increased glucose, increased amylase (a digestive enzyme), increased liver enzymes; − Difficulty in sleeping; − Lack of strength and energy; − Nausea, vomiting, abdominal pain, abnormal stools, indigestion, wind, problems with your digestive system; − Pain; − Rash, acne; − Tingling, prickling or numbness of the skin.
gripă, senzaţie vagă de discomfort, acumularea de lichide la nivelul picioarelor sau în jurul gleznelor, interacţiuni cu alte medicamente;
Further information about nausea, vomiting or abdominal pain Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis.
- Funcţionare redusă a testiculelor, sindrom Cushing (o afecţiune cauzată de valori mari ale
Changes in body shape due to changes in fat distribution Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
- Inflamaţia urechii medii, inflamaţia bronşiilor, inflamaţia sinusurilor, furunculi frecvenţi,
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’).
- Scăderea toleranţei la glucoză, creşterea în greutate, scăderea în greutate, creşterea bilirubinei
The cause and long-term health effects of these conditions are not known at this time.
(un pigment biliar), modificări ale concentraţiei hormonilor, teste de laborator modificate;
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
- Litiază renală, urini anormale, albumină în urină, niveluri crescute ale calciului în urină, acid
UNCOMMON side effects (affects 1 to 10 users in 1,000):
uric în exces în sânge;
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- Inflamaţia vezicii biliare, inflamaţia ficatului, ficat mărit, depozite grase la nivelul ficatului,
nodes; − A sound in one ear or both ears, such as buzzing, ringing or whistling; − Abnormal vision, eye disorder; − Feeling the heart racing, ‘skipping a beat’ or pounding, heart attack, swelling and/or fluid accumulation in the lungs; − Enlarged abdomen, constipation, dry mouth, difficulty swallowing, inflammation of the small and large intestine, burping, inflammation of the food pipe, inability to control your bowels, inflammation of the stomach and intestine, bloody diarrhoea, mouth ulcerations, inflammation of the pancreas; inflammation of a salivary gland, inflammation in the mouth, mouth ulcer, inflammation of the gums; − Chest pain, chest pain beneath the sternum, chills, fever, flu-like symptoms, vague feeling of bodily discomfort, accumulation of fluid in your legs or around your ankles, interactions with other medicines; − Lack of functioning of the testes, Cushing syndrome (a condition caused by high levels of cortisol in the blood), under-active thyroid gland; − Inflammation of the middle ear, inflammation of the bronchi, inflammation of the sinuses, recurring boils, bacterial infection, viral infection; 131 − Decreased glucose tolerance, weight gain, weight loss, increased bilirubin (a bile pigment), hormone level altered, lab test abnormal; − Kidney stones, urine abnormality, albumin in the urine, high levels of calcium in the urine, excess uric acid in the blood; − Inflammation of the gall bladder, inflammation of the liver, enlarged liver, fatty deposits in the liver, liver tenderness; − Deficiency of one or more essential vitamins, dehydration, accumulation of fluid in the cells or tissues, increased appetite, excess lactic acid in the blood, obesity, anorexia, diabetes mellitus, high glucose in the blood, low cholesterol in the blood; − Painful joints, inflammation in the joints, muscle pain, back pain, joint disorder; − Dizziness, loss or impairment of memory, loss in the ability to co-ordinate muscular movement, degenerative brain disease, loss of power of voluntary movement in the facial muscles, increased muscle tension, disease or abnormality of the nervous system, damage to nerves of the peripheral nervous system, sleepiness, tremor, altered sense of taste, migraine, abnormal involuntary movements; − Abnormal dreams, agitation, anxiety, confusion, depression, impairment in the ability to control movements, emotional instability, decreased sexual desire, nervousness, abnormal thinking; − Abnormal ejaculation, breast enlargement, enlargement of male breasts, impotence, abnormally heavy or extended menstrual flow; − Shortness of breath, irritation and inflammation of the nose, increased cough; − Hair loss, dry skin, eczema, scaling of the skin, flat red rash with pimples or spots, nail disorder, itching, accumulation of scales of greasy skin, skin discoloration, skin ulcer, facial swelling, sweating, stretch marks; − Benign skin tumour, cyst; − High blood pressure, vein inflammation related to a blood clot, inflammation of the blood vessels, varicose vein, deep vein inflammation related to a blood clot, vascular disorder.
- Lipsa uneia sau a mai multor vitamine esenţiale, deshidratare, acumularea de lichid în celulele
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
ţesuturilor, creşterea apetitului, acid lactic în exces în sânge, obezitate, anorexie, diabet zaharat, hiperglicemie, colesterol scăzut în sânge;
HOW TO STORE KALETRA
articulaţiilor;
− Keep out of the reach and sight of children. − Do not use Kaletra after the expiry date which is stated on the bottle.
- Vertij, pierderea memoriei, pierderea capacităţii de a coordona mişcările, boală degenerativă a
The expiry date refers to the last day of that month.
- Coşmaruri, agitaţie, anxietate, confuzie, depresie, tulburări în capacitatea de a controla
How should I store Kaletra and for how long?
ale cantităţii şi duratei ciclului menstrual.
− Store in a refrigerator (2°C - 8°C). − In use storage:
- Respiraţie scurtă, iritaţie şi inflamaţie a nasului, accentuarea tusei;
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
- Căderea părului, tegumente uscate, eczeme, dermatită exfoliativă, erupţii pe piele cu pustule şi
It is advised to write the date of removal from the refrigerator on the package. − Avoid exposure to excessive heat. − It is important to keep Kaletra in the bottle it came in.
pete, afecţiuni ale unghiilor, mâncărimi, acumulări de cruste cutanate grase, depigmentări cutante, seboree, ulceraţii ale pielii, edem facial, transpitaţii, vergeturi cutanate;
Do not transfer it to any other container.
- Tumori benigne cutanate, chist;
How should I dispose of any unused Kaletra?
de sânge, varice, inflamaţia venelor profunde datorită unui cheag de sânge, tulburări vasculare;
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
Dacă vreuna dintre reacţiile adverse devine gravă sau dacă observaţi orice reacţie adversă nemenţionată în acest prospect, vă rugăm să spuneţi medicului dumneavoastră sau farmacistului.
These measures will help protect the environment.
- A nu se lăsa la îndemâna şi vederea copiilor.
132 6.
necesare.
The active substances are lopinavir and ritonavir.
Substanţele active sunt lopinavirul şi ritonavirul.
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Fiecare comprimat de Kaletra conţine 200 mg lopinavir şi 50 mg ritonavir.
The other ingredients are:
Alţi componenţi sunt: copovidonă, laurat de sorbitan, siliciu coloidal anhidru, fumarat stearil de sodiu.
Alcohol, high fructose corn syrup, propylene glycol, purified water, glycerol, povidone, magnasweet- 110 flavour (mixture of monoammonium glycyrrhizinate and glycerol), vanilla flavour (containing p- hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotrope, ethyl vanillin), polyoxyl 40 hydrogenated castor oil, cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, menthol.
Componentele filmului sunt: hipromeloză, dioxid de titan, macrogol 400 (propilenglicol 400), hidroxipropil celuloză, talc, siliciu coloidal anhidru, macrogol 3350 (propilenglicol 3350), oxid galben de fer (E172), polisorbat 80.
− Kaletra oral solution comes in a multiple-dose 60 ml amber bottle. − Five bottles containing 60 ml are provided in one package. − Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
- Comprimatele filmate Kaletra sunt ambalate în flacoane din plastic conţinând 120 comprimate
Marketing Authorisation Holder
- Fiecare cutie conţine 1 flacon a 120 comprimate.
България Т.П.
146 България Т. П.
Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
Eesti Österreich Abbott Laboratories Baltics Vienibas 87h LV- 1004 Rīga Läti Tel: + 371 67605580