natgillin/translations-raw huggingface dataset:
Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
În
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
timpul călatoriilor sau când aveţi nevoie de spitalizare, asiguraţi- vă că aveţi suficientă Kaletra, cel puţin până când v- o puteţi procura din nou.
You may need to read it again. − If you have any further questions, please ask your doctor or pharmacist − This medicine has been prescribed for you.
- Continuaţi să luaţi medicamentul până când medicul dumneavoastră vă recomandă altceva.
Do not pass it onto others.
Dacă luaţi mai mult decât trebuie din Kaletra
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Dacă v- aţi dat seama că aţi luat mai mult decât trebuie Kaletra, adresaţi- vă imediat medicului
In this leaflet:
dumneavoastră.
What Kaletra is and what it is used for 2.
- Dacă nu puteţi anunţa medicul, mergeţi la spital.
Before you take Kaletra 3.
152 Dacă uitaţi să luaţi Kaletra
Possible side effects 5.
- Dacă aţi omis o doză, luaţi- o cât mai curând posibil şi continuaţi după programul stabilit
How to store Kaletra 6.
anterior de medicul dumneavoastră.
Further information
- Nu luaţi o doză dublă pentru a compensa doza uitată.
WHAT KALETRA IS AND WHAT IT IS USED FOR
REACŢII ADVERSE POSIBILE
− Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
Ca toate medicamentele, Kaletra poate provoca reacţii adverse, cu toate că acestea nu apar la toate persoanele.
Kaletra does this by slowing down the spread of the infection in your body. − Kaletra is used by children 2 years of age or older and adults who are infected with HIV, the virus which causes AIDS.
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.
Kaletra should not be administered to children younger than 2 years of age unless specifically directed by their doctor. − Kaletra is an antiretroviral medicine.
Trebuie să spuneţi medicului dumeavoastră imediat despre aceste sau oricare alte simptome.
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
Dacă simptomele persistă sau se înrăutăţesc, solicitaţi consult medical.
Your doctor will determine which medicines are best for you.
Reacţii adverse FOARTE FRECVENTE (întâlnite la mai mult de 1 din 10 persoane tratate):
2.
- Diaree;
BEFORE YOU TAKE KALETRA
- Creşterea colesterolului;
Do not take Kaletra: − If you are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra. − If you have severe liver problems.
- Creşterea TGP (un tip de enzime hepatice)
Do not take Kaletra with any of the following medicines: − Astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription); − Midazolam taken orally (taken by mouth), triazolam (used to relieve anxiety and/or trouble sleeping); − Pimozide (used to treat schizophrenia); − Cisapride (used to relieve certain stomach problems); − Ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); − Amiodarone (used to treat abnormal heart beat); − Vardenafil (used to treat erectile dysfunction); − Products that contain St John’s wort (Hypericum perforatum).
- Creşterea trigliceridelor.
Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
Informaţii suplimentare privind creşterea colesterolului şi a trigliceridelor
145 If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
- Riscul complicaţiilor pe termen lung cum sunt crize cardiace sau accident vascular datorită
Take special care with Kaletra
creşterii trigliceridelor şi a colesterolului nu este cunoscut încă.
It is therefore important that you remain under the supervision of your doctor while taking Kaletra. − Kaletra does not reduce the risk of passing HIV to others.
- Medicul dumneavostră vă va monitoriza şi vă va prescrie alte medicamente la nevoie.
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
- Creşterea mare a trigliceridelor (grăsimi în sânge) este considerată un risc crescut pentru
Tell your doctor if you have/had: − Haemophilia type A and B as Kaletra might increase the risk of bleeding. − Diabetes as increased blood sugars have been reported in patients receiving Kaletra. − A history of liver problems as patients with a history of liver disease, including chronic hepatitis B or C are at increased risk of severe and potentially fatal liver side effects.
pancreatită.
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’).
Reacţii adverse FRECVENTE (întâlnite la 1 până la 10 din 100 persoane tratate):
The cause and long-term health effects of these conditions are not known at this time. − Signs and symptoms of inflammation from previous infections soon after anti-HIV treatment is started.
- Modificări ale formei corpului, datorită redistribuiţiei grăsimii;
It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. − Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement as some patients taking these medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
- Dureri de cap;
On rare occasions these muscle disorders have been serious.
- Creşterea glucozei serice, creşterea amilazei serice (o enzimă pentru digestie), enzime hepatice
Taking other medicines
crescute;
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); − Antifungals (e.g. ketoconazole, itraconazole, voriconazole); − Erectile dysfunction medicines (e.g. sildenafil and tadalafil);
- Tulburări ale somnului;
146 − Heart medicines including:
- Slăbiciune şi pierderea energiei;
− − −
digestiv;
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
- Dureri;
− 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); − Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine); − 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.
- Erupţii pe piele, acnee;
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.
- Furnicături, mâncărimi sau amorţeli ale pielii.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
153 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 pancreatitei.
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.
Modificări ale formei corpului, datorită redistribuiţiei grăsimii Tratamentul antiretroviral combinat poate provoca modificări ale formei corpului, datorită redistribuiţiei grăsimii.
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Acestea pot include pierderea ţesutului gras de la nivelul picioarelor, braţelor şi feţei, creşterea cantităţii de grăsime la nivelul abdomenului şi organelor interne, mărirea sânilor şi îngroşarea cefei (“ ceafă de bizon ”).
Your doctor can explain these symptoms to you.
Cauzele şi efectul pe termen lung ale acestor modificări nu sunt cunoscute încă.
Contraceptives
Reacţii adverse MAI PUŢIN FRECVENTE (întâlnite la 1 până la 10 din 1000 persoane tratate):
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
- Număr scăzut de globule roşii din sânge, număr scăzut de globule albe din sânge, mărirea
Taking Kaletra with food and drink
ganglionilor limfatici;
Kaletra tablets can be taken with or without food.
- Zgomote în ureche sau în ambele urechi, cum sunt zumzet, ţiuit sau şuierătură;
Pregnancy and breast-feeding
- Vedere anormală, afecţiuni oculare;
− 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.
- Perceperea unui ritm cardiac accelerat, ‘ lipsa unei bătăi ’ sau izbitură, infarct
Driving or using machines
miocardic, transpiraţii şi/ sau acumulare de lichid în plămâni;
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- Mărirea abdomenului, constipaţie, gură uscată, dificultăţi la înghiţire, inflamaţia intestinului
HOW TO TAKE KALETRA
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;
How should Kaletra be taken?
- Dureri în piep, dureri în piept în spatele sternului, temperatură scăzută, febră, simptome de tip
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
gripă, senzaţie vagă de discomfort, acumularea de lichide la nivelul picioarelor sau în jurul gleznelor, interacţiuni cu alte medicamente;
− Kaletra tablets can be taken with or without 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.
- Funcţionare redusă a testiculelor, sindrom Cushing (o afecţiune cauzată de valori mari
How much Kaletra should be taken and when?
alecortizonului în sânge), activitate redusă a glandei tiroide;
− The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- Inflamaţia urechii medii, inflamaţia bronşiilor, inflamaţia sinusurilor, furunculi frecvenţi,
Can I stop taking Kaletra or change my dose?
infecţii bacteriene, infecţii virale;
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.
- Scăderea toleranţei la glucoză, creşterea în greutate, scăderea în greutate, creşterea bilirubinei
If you take more Kaletra than you should
(un pigment biliar), modificări ale concentraţiei hormonilor, teste de laborator modificate;
− 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.
- Litiază renală, urini anormale, albumină în urină, niveluri crescute ale calciului în urină, acid
If you forget to take Kaletra
uric în exces în sânge;
− If you miss a dose, take the missed dose as soon as possible, 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.
- Inflamaţia vezicii biliare, inflamaţia ficatului, ficat mărit, depozite grase la nivelul ficatului,
POSSIBLE SIDE EFFECTS
sensibilitate hepatică;
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- Lipsa uneia sau a mai multor vitamine esenţiale, deshidratare, acumularea de lichid în celulele
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.
ţesuturilor, creşterea apetitului, acid lactic în exces în sânge, obezitate, anorexie, diabet zaharat, hiperglicemie, colesterol scăzut în sânge;
You should tell your doctor promptly about these or any other symptoms.
- Dureri articulare, inflamaţia articulaţiilor, dureri musculare, dureri lombare, afecţiuni ale
If the condition persists or worsens, seek medical attention.
articulaţiilor;
148 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).
- Vertij, pierderea memoriei, pierderea capacităţii de a coordona mişcările, boală degenerativă a
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.
creierului, pierderea capacităţii de control a contracţiilor voluntare ale muşchilor feţii, creşterea tensiunii musculare, boli sau modificări ale sistemului nervos, afectarea nervilor din sistemul nervos periferic, somnolenţă, tremor, alterări ale gustului, migrenă, mişcări involuntare modificate;
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.
- Coşmaruri, agitaţie, anxietate, confuzie, depresie, tulburări în capacitatea de a controla
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.
mişcările, labilitate emoţională, scăderea libidoului, nervozitate, tulburări de gândire;
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.
- Ejaculare anormală, creşterea sânilor, creşterea sânilor la bărbaţi, impotenţă sexuală, modificări
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’).
- Respiraţie scurtă, iritaţie şi inflamaţie a nasului, accentuarea tusei;
The cause and long-term health effects of these conditions are not known at this time.
- Căderea părului, tegumente uscate, eczeme, dermatită exfoliativă, erupţii pe piele cu pustule şi
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
pete, afecţiuni ale unghiilor, mâncărimi, acumulări de cruste cutanate grase, depigmentări cutante, seboree, ulceraţii ale pielii, edem facial, transpitaţii, vergeturi cutanate;
UNCOMMON side effects (affects 1 to 10 users in 1,000):
- Tumori benigne cutanate, chist;
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- Tensiune arterială crescută, inflamaţia venelor datorită unui cheag de sânge, inflamaţia vaselor
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; 149 − 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.
de sânge, varice, inflamaţia venelor profunde datorită unui cheag de sânge, tulburări vasculare;
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.
154 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.
− Keep out of the reach and sight of children. − Do not use Kaletra after the expiry date which is stated on the pack. − This medicinal product does not require any special storage conditions.
- Nu utilizaţi Kaletra după data de expirare înscrisă pe cutie.
How should I dispose of any unused Kaletra?
Cum trebuie să îndepărtez Kaletra neutilizat?
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Întrebaţi farmacistul dumneavoastră cum să eliminaţi medicamentele care nu vă mai sunt
The other ingredients are:
Alţi componenţi sunt:
Tablet Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Comprimatul Siliciu coloidal anhidru, copovidonă, fumarat stearil de sodium, laurat de sorbitan.
Tablet coating Polyvinyl alcohol, talc, titanium dioxide, macrogols type 3350, yellow ferric oxide E172.
Învelişul comprimatului Polivinil alcool, talc, dioxid de titan, macrogol 3350, oxid galben de fer (E172).
− Kaletra film-coated tablets come in a plastic bottle containing 60 tablets. − The tablets are pale yellow debossed with [Abbott logo] and “KC”. − One bottle of 60 tablets is provided in one package.
- Comprimatele filmate Kaletra sunt ambalate în flacoane din plastic conţinând 60 comprimate.
Marketing Authorisation Holder
- Fiecare cutie conţine 1 flacon a 60 comprimate.
България Т.П.
155 България Т. П.
Ireland Abbott Laboratories, Ireland, Ltd 4051 Kingswood Drive Citywest Business Campus IRL – Dublin 24, Tel: + 353 (0) 1 469-1500
156 Ireland Abbott Laboratories, Ireland, Ltd 4051 Kingswood Drive Citywest Business Campus IRL – Dublin 24, Tel: + 353 (0) 1 469- 1500
Νικολάου 8 1055, Λευκωσία Τηλ.: +357 22 34 74 40
Νικολάου 8 1055, Λευκωσία Τηλ: + 357 22 34 74 40
153
157
Karvea is used in patients who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Prin „ esenţială ” se înţelege că hipertensiunea nu este cauzată de nicio altă afecţiune.
Karvea is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Karvea se utilizează, de asemenea, în tratarea afecţiunilor renale (la rinichi) la pacienţii cu hipertensiune şi diabet zaharat de tip 2 (diabet neinsulinodependent).
Karvea is not recommended for use in patients below 18 years of age.
Karvea nu este recomandat pacienţilor cu vârsta sub 18 ani.
Karvea is taken by mouth, with or without food.
Karvea se administrează pe cale orală, cu sau fără alimente.
The usual recommended dose is 150 mg once a day.
Doza uzuală recomandată este de 150 mg administrată o dată pe zi.
If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Dacă tensiunea arterială nu este suficient ţinută sub control, doza poate fi mărită la 300 mg/ zi sau pot fi asociate la tratament alte medicamente pentru hipertensiune, cum ar fi hidroclorotiazida.
In patients with hypertension and type 2 diabetes, Karvea is added to other treatments for hypertension.
La pacienţii cu hipertensiune şi diabet zaharat de tip 2, Karvea se asociază cu alte tratamente pentru hipertensiune.
Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Tratamentul se începe cu o doză de 150 mg, administrată o dată pe zi şi se măreşte de obicei până la 300 mg o dată pe zi.
The active substance in Karvea, irbesartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Substanţa activă din Karvea, irbesartanul, este un „ antagonist al receptorilor de angiotensină II ” ceea ce înseamnă că blochează acţiunea în organism a unui hormon numit angiotensină II.