qanastek/EMEA-V3 huggingface dataset:
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.
- Ebusija fil- ġogi, weġgħat u uġigħ (speċjalment tal- ġenbejn, ta ’ l- irkoppa u ta ’ l- ispallejn) u
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.
It- tul tat- terapija antiretrovirali kombinata, l- użu tal- kortikosterojdi, il- konsum ta ’ l- alkoħol, l- immuno - soppressjoni severa (tnaqqis fl- attività tas- sistema immunitarja), indiċi tal- massa tal- ġisem aktar għoli, fost l- oħrajn, jistgħu jkunu xi wħud mill- ħafna fatturi li jżidu r- riskju għall- iżvilupp ta ’ din il- marda.
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.
- Uġigħ fil- muskoli, sensittività jew dgħjufija, partikolarment meta jkunu qegħdin jittieħdu dawn
The cause and long-term health effects of these conditions are not known at this time.
F’ każi rari, dawn id- disturbi fil- muskoli kienu serji.
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
161 Meta tieħu mediċini oħra Għid lit- tabib tiegħek jekk qiegħed tieħu xi waħda mill- mediċini mniżżla hawn taħt, peress li għandha tingħata attenzjoni speċjali:
UNCOMMON side effects (affects 1 to 10 users in 1,000):
- Anti- bijotiċi (eż. rifabutin, rifampicin, clarithromycin);
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- Mediċini għal kontra l- kanċer (eż. vincristine, vinblastine);
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;
- Anti- dipressanti (eż. trazodone, bupropion);
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.
- Mediċini għal kontra l- epilessija (eż. carbamazepine, phenytoin, phenobarbital);
HOW TO STORE KALETRA
- Mediċini għal kontra l- fungu (eż.
− As with all medicines, keep Kaletra 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.
- Mediċini ġħad- disfunzjoni erettili (eż. sildenafil and tadalafil);
How should I dispose of any unused Kaletra?
- Mediċini tal- qalb, li jinkludu:
These measures will help protect the environment.
Digoxin; Mediċini li huma antagonisti tal- kanali tal- kalċju (eż. felodipine, nifedipine, nicardipine); Mediċini użati biex jirregolarizzaw ir- rittmu tal- qalb (eż. bepridil, systemic lidocaine, quinidine);
FURTHER INFORMATION
- Mediċini użati biex ibaxxu l- kolesterol fid- demm (eż. atorvastatin, lovastatin, rosuvastatin jew
What Kaletra contains
simvastatin);
The active substances are lopinavir and ritonavir.
- Mediċini li jaffetwaw is- sitema immunitarja (eż. cyclosporin, sirolimus (rapamycin), tacrolimus);
Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
- Mediċini użati biex wieħed iwaqqaf it- tipjip (eż. bupropion);
141 The other ingredients are:
- Mediċini bħall- morfina (eż. methadone);
Tablet Copovidone, sorbitan laurate, colloidal anhydrous silica, sodium stearyl fumarate.
- Inibituri non- nucleoside reverse transcriptase (NNRTIs) (eż. efavirenz, nevirapine);
Tablet coating Hypromellose, titanium dioxide, macrogols type 400 (polyethylene glycol 400), hydroxypropyl cellulose, talc, colloidal anhydrous silica, macrogols type 3350 (polyethylene glycol 3350), yellow ferric oxide E172, polysorbate 80.
- Kontraċettivi li jittieħdu mill- ħalq jew l- użu ta ’ kontraċettiv f’ forma ta ’ ġarża li terħi l- mediċina
What Kaletra looks like and contents of the pack
biex tiġi evitata t- tqala (ara s- sezzjoni bl- isem Kontraċettivi imniżżla hawn taħt);
− Kaletra film-coated tablets come in a plastic bottle containing 120 tablets. − The tablets are yellow embossed with [Abbott logo] and “KA”. − One bottle of 120 tablets is provided in one package.
- Impedituri protejaż (eż. amprenavir, fosamprenavir, indinavir, nelfinavir, ritonanvir, saquinavir);
− Kaletra film-coated tablets are also supplied in blisters. − Each carton contains 5 foil blisters of 8 tablets (40 tablets). − Each pack contains 3 cartons (120 tablets).
- Sedattivi (eż. midazolam mgħoti b’ injezzjoni);
Marketing Authorisation Holder
- Sterojdi (eż. dexamethasone, fluticasone propionate, ethinyl oestradiol);
Manufacturer
- Warfarin.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
Jekk jogħġbok għid lit- tabib jew lill- iżpiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Aesica Queenborough Ltd Queenborough Kent ME11 5EL United Kingdom
Mediċini għad- disfunzjoni erettili (vardenafil, sildenafil, tadalafil)
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
- Tiħux Kaletra jekk bħalissa qiegħed tieħu vardenafil.
België/Belgique/Belgien Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Louvain-la-Neuve Tél/Tel: + 32 10 475311
- Jekk inti tieħu sildenafil jew tadalafil u Kaletra flimkien, int tista ’ tkun qiegħed f’ riskju ta ’ effetti
Luxembourg/Luxemburg Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Louvain-la-Neuve Belgique/Belgien Tél/Tel: + 32 10 475311
Jekk erezzjoni tal- pene ddum aktar minn 4 siegħat, għandek tfittex l - għajnuna medika immedjatament biex tevita dannu permanenti fil- pene.
България Т.П.
Kontraċettivi
Бизнес Парк София, сгр.8С ет.7 София 1766 Teл: + 359 2 489 1950
- Jekk int bħalissa qiegħda tuża kontraċettiv li jittieħed mill- ħalq jew jekk qiegħda tuża kontraċettiv
1/a-c.
- Kaletra ma tnaqqasx ir- riskju li inti tgħaddi l- HIV lil ħaddieħor.
H-1139 Budapest Tel.: + 36 1 465 2100
Għandhom jittieħdu l -
Česká republika Abbott Laboratories s. r. o.
prekawzjonijiet xierqa (eż. agħmel użu mill- kondom) biex jiġi evitat li l- marda tgħaddiha lil ħaddieħor permezz ta ’ kuntatt sesswali.
Hadovka Office Park Evropská 2590/33d CZ-160 00 Praha 6 Tel: + 420 267 292 111
162 Meta tieħu Kaletra ma ’ l- ikel u max- xorb
Malta V.J.Salomone Pharma Limited 79, Simpson Street, Marsa HMR 14, Malta.
Il- pilloli Kaletra jistgħu jittieħdu ma ’ l- ikel jew waħedhom.
Tel: + 356 22983201
Tqala u Treddigħ
Danmark Abbott Laboratories A/S Emdrupvej 28C DK-2100 København Ø Tlf: + 45 39 77-00-00
- Għarraf lit- tabib tiegħek immedjatament jekk inti tqila, taħseb li int tqila jew jekk qiegħda
Nederland Abbott B.V.
tredda ’.
Siriusdreef 51 NL-2132 WT Hoofddorp Tel: + 31 (0) 88 8222 688
- Nisa tqal jew ommijiet li jkunu qegħdin ireddgħu ma jistgħux jieħdu Kaletra, sekemm ma jkunx
KG Max-Planck-Ring 2 D-65205 Wiesbaden Tel: + 49 (0) 6122 58-0
speċifikament indikat mod ieħor mit- tabib tagħhom.
Norge Abbott Norge AS PO Box 1, N-1330 Fornebu Martin Linges vei 25, N-1367 Snarøya Tlf: + 47 81 55 99 20
- Huwa rrakkomandat li nisa nfettati bl- HIV ma jreddgħux lit- trabi tagħhom minħabba l- possibilità
Eesti Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
li t- tarbija tiġi nfettata bl- HIV mill- ħalib tas- sider.
Österreich Abbott Ges.m.b.H.
Sewqan u tħaddim ta ’ magni
Perfektastrasse 86 A-1230 Wien Tel: + 43 1 891-22
Minflok, ikkuntattja lit- tabib tiegħek.
Ελλάδα Abbott Laboratories (ΕΛΛΑΣ) Α.Β.Ε.Ε.
KIF GĦANDEK TIEĦU KALETRA
Λεωφόρος Βουλιαγμένης 512 GR 174 56 Άλιμος, Αθήνα Τηλ: +30 21 0 9985-222
Huwa importanti li l- pilloli Kaletra jinbelgħu sħaħ u ma jiġux mimgħuda, imkissra jew mgħaffġa.
Polska Abbott Laboratories Poland Sp. z o.o.
- Il- pilloli Kaletra jisgħu jittieħdu ma ’ l- ikel jew waħedhom.
Postępu 18A PL - 02-676 Warszawa Tel.: + 48 22 606-10-50
- Dejjem ħu Kaletra eżatt kif qallek it- tabib tiegħek.
Avenida de Burgos, 91 E-28050 Madrid Tel: + 34 9 1 337-5200
- Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju dwar
Portugal Abbott Laboratórios, Lda.
kif għandek tieħu l- mediċina tiegħek.
Estrada de Alfragide, nº 67 Alfrapark, Edifício D, P-2610-008 Amadora Tel: + 351 (0) 21 472 7100
Kemm għandek tieħu Kaletra u fi x’ ħin?
France Abbott France 10, rue d’Arcueil BP 90233 F-94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
- Id- doża li ssoltu tingħata għall- adulti hija 400 mg/ 100 mg darbtejn kuljum, jiġifieri kull 12 - il
Bucharest Business Park Şos.
siegħa, flimkien ma ’ mediċini oħra għal kontra l- HIV.
Bucureşti-Ploieşti 1A Corp B, etaj 3, sector 1 013681 Bucureşti Tel: +40 21 529 30 00
It- tabib tiegħek jinfurmak dwar in- numru ta ’ pilloli li għandek tieħu.
Ireland Abbott Laboratories, Ireland, Ltd 4051 Kingswood Drive Citywest Business Campus IRL – Dublin 24, Tel: + 353 (0) 1 469-1500
- Fil- każ tat- tfal, it- tabib tiegħek jiddeċiedi d- doża t- tajba li għandha tingħata (numru ta ’ pilloli)
Slovenija Abbott Laboratories d.o.o.
ibbażata fuq it- tul u l- piż tat- tifel/ tifla.
Dolenjska cesta 242c SI-1000 Ljubljana Tel: + 386 (1) 23 631 60
- Kaletra jiġi formut ukoll bħala soluzzjoni orali għal dawk il- pazjenti li ma jistgħux jieħdu pilloli,
Hörgatún 2 IS-210 Garðabær Sími: +354 535 7000
u bħala pilloli miksija b’ rita ta ’ 200 mg/ 50 mg.
Slovenská republika Abbott Laboratories Slovakia s.r.o.
Nista ’ nieqaf nieħu Kaletra jew inbiddel id- doża?
Karadžičova 10 SK- 821 08 Bratislava 2 Tel: + 421 (0) 2 4445 4176
- Twaqqafx Kaletra u tbiddilx id- doża ta ’ Kaletra li tieħu kuljum qabel ma l- ewwel tikkonsulta
Italia Abbott S.r.l.
mat- tabib tiegħek.
Suomi/Finland Abbott OY Pihatörmä 1B/Gårdsbrinken 1B FIN-02240 Espoo/Esbo Puh/Tel: + 358 (0) 9 7518 4120
- Dejjem għandek tieħu Kaletra darbtejn kuljum biex il- mediċina tgħin biex tikkontrollalek l -
Νικολάου 8 1055, Λευκωσία Τηλ.: +357 22 34 74 40
infezzjoni ta ’ l- HIV, irrispettivament minn kemm tkun qiegħed tħossok tajjeb.
Sverige Abbott Scandinavia AB Box 509/Gårdsvägen 8 SE-169 29 Solna/SE-169 70 Solna Tel: + 46 (0) 8 5465 67 00
- Bl- użu ta ’ Kaletra kif irrakkomandat għalik, int għandek l- aħjar ċans li tnaqqas ir- rittmu li bih
Latvija Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Tel: + 371 67605580
tiżviluppa r- reżistenza għall- prodott.
United Kingdom Abbott Laboratories Ltd Abbott House Vanwall Business Park Maidenhead Berkshire SL6 4XE-UK Tel: + 44 (0) 1628 773355
- Jekk inti m’ intix tieħu Kaletra kif qallek it- tabib tiegħek minħabba li qiegħed tesperjenza xi effett
Lietuva Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Latvija Tel: + 371 67605580
sekondarju, informa lit- tabib tiegħek immedjatament.
This leaflet was last approved on:
- Dejjem żomm biżżejjed Kaletra biex ma tispiċċax mingħajr il- mediċina.
{MM/YYYY}
Meta tivjaġġa jew
144 PACKAGE LEAFLET – INFORMATION FOR THE USER
- Kompli ħu din il- mediċina sakemm it- tabib tiegħek jindikalek mod ieħor.
Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
163 Jekk tieħu Kaletra aktar milli suppost
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Jekk tirrealizza li ħadt iżjed Kaletra milli sippost għandek tieħu, kellem lit- tabib tiegħek
In this leaflet:
minnufih.
What Kaletra is and what it is used for 2.
- Jekk ma tistax tkellem lit- tabib tiegħek, mur l- isptar.
Before you take Kaletra 3.
Jekk tinsa tieħu Kaletra
Possible side effects 5.
normali skond l- iskeda regolari, kif qallek it- tabib tiegħek.
Further information
- M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu
WHAT KALETRA IS AND WHAT IT IS USED FOR
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
− Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
Bħal kull mediċina oħra, Kaletra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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.
Tista ’ tkun diffiċli li tinnota liema effetti sekondarji huma kkawżati minn Kaletra u huma dawk li jistgħu iseħħu minħabba mediċini oħra li qed tieħu fl- istess ħin jew minn kumplikazzjonjiet ta ’ l- infezzjoni ta ’ l- 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.
Jekk il- kundizzjoni tibqa ’ l- istess jew tiggrava, fittex għajnuna medika.
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
Effetti sekondarji KOMUNI ĦAFNA (jaffetwaw aktar minn persuna 1 minn kull 10 persuni li jieħdu Kaletra):
Your doctor will determine which medicines are best for you.
- Żieda fil- GGT (tip ta ’ enżima tal- fwied);
BEFORE YOU TAKE KALETRA
- Żieda fit- trigliċeridi (forma ta ’ xaħam).
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.
- Ir- riskji dejjiema li jistgħu jwasslu għall- kumplikazzjonijiet, bħal attakki tal- qalb jew attakk ta ’
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).
puplesija minħabba zieda fit- trigliċeridi u fil- kolesterol, għadhom m’ humiex magħrufa.
Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
- It- tabib tiegħek iżommok taħt osservazzjoni, u jista ’ jagħtik mediċini oħra jekk ikun hemm il -
145 If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
- Żidiet kbar fl- ammont tat- trigliċeridi (xaħmijiet fid- demm) ġew ikkunsidrati bħala fattur ta ’ riskju
Take special care with Kaletra
għall- pankreatite.
Important information − Kaletra is not a cure for HIV infection or AIDS. − People taking Kaletra may still develop infections or other illnesses associated with HIV disease and AIDS.
Effetti sekondarji KOMUNI (jaffetwaw minn 1 sa 10 persuni minn kull 100 persuna li jieħdu Kaletra):
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.
- Riżultati mhux normali ta ’ testijiet tal- funzjoni tal- fwied;
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
- Tibdil fil- forma tal- ġisem minħabba tibdil fid- distribuzzjoni tax- xaħam;
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.
- Uġigħ ta ’ ras;
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.
- Żieda fil- glukosju, żieda fl- amylase (enżima fis- sistema diġestiva), żieda fl- enżimi tal- fwied;
On rare occasions these muscle disorders have been serious.
- Diffikultà biex torqod;
Taking other medicines
- Nuqqas ta ’ saħħa u enerġija;
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);
- Nawseja, rimettar, uġigħ addominali, skart tal- ġisem mhux normali, indiġestjoni, gass, problemi
146 − Heart medicines including:
fis- sistema diġestiva tiegħek;
− − −
- Uġigħ;
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
- Raxx, akne;
− 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.
- Tnemnim, tingiż jew tittarrax il- ġilda.
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.
Aktar tagħrif dawr in- nawseja, rimettar, u uġigħ addominali Għarraf lit- tabib tiegħek jekk tesperjenza nawseja, rimettar jew uġigħ addominali għax dawn jistgħu jkunu sinjali ta ’ pankreatite.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
164 Tibdil fil- forma tal- ġisem minħabba tibdil fid- distribuzzjoni tax- xaħam It- terapija antiretrovirali kombinata tista ’ tikkawża tibdil fil- forma tal- ġisem minħabba tibdil fid - distribuzzjoni tax- xaħam.
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.
Dan jista jinkludi telf ta ’ xaħam mir- riġlejn, dirgħajn u mill- wiċċ, żieda ta ’ xaħam fiż- żaqq u organi interni oħra, żieda fid- daqs tas- sider u ċapep tax- xaħam fuq wara ta ’ l- għonq (‘ buffalo hump ’).
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Il- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kundizzjonijiet għadhom m’ humiex magħrufa.
Your doctor can explain these symptoms to you.
Għarraf lit- tabib tiegħek jekk tinnota xi tibdil fil- forma ta ’ ġismek kkawżat mid - distribuzzjoni tax- xaħam.
Contraceptives
Effetti sekondarji MHUX KOMUNI (jaffetwaw minn 1 sa 10 persuni minn kull 1, 000 persuna li jieħdu Kaletra):
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
- Numru baxx ta ’ ċelloli ħomor tad- demm, numru baxx ta ’ ċelloli bojod tad- demm, żieda fid- daqs
Taking Kaletra with food and drink
tal- glandoli limfatiċi;
Kaletra tablets can be taken with or without food.
- Tisma ’ ħsejjes f’ widna waħda jew fiż- żewġ widnejn, bħal żanżin, ċempil jew tisfir;
Pregnancy and breast-feeding
- Viżjoni mhux normali, disturbi fl- għajnejn;
− 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.
- Tħoss qalbek tgħaġġel, tħoss qalbek tieqaf jew tħabbat ħafna, attakk ta ’ qalb, nefħa u/ jew
Driving or using machines
akkumulazzjoni ta ’ fluwidu fil- pulmuni;
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- Nefħa fiż- żaqq, stitikezza, nixfa fil- ħalq, diffikultà biex tibla ’, infjammazzjoni tal- musrana ż -
HOW TO TAKE KALETRA
żgħira u l- kbira, tifwiq, infjammazzjoni tal- pajp ta ’ l- ikel, ma tkunx tista ’ tikkontrolla l- għamil ta ’ l- awrina, infjammazzjoni ta ’ l- istonku u l- musrana, dijarea bid- demm, tiġriħ fil- ħalq, infjammazzjoni tal- frixa, infjammazzjoni tal- glandola tal- bżieq, infjammazzjoni fil- ħalq, ulċeri fil- ħalq, infjammazzjoni tal- ħanek;
How should Kaletra be taken?
- Uġigħ fis- sider, uġigħ fis- sider taħt l- isternu, tħoss id- dehxiet, deni, sintomi li jixbhu lil dawk ta ’
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
l- influwenza, tħossok m’ intix f’ sikktek, akkumulazzjoni ta ’ fluwidu f’ riġlejk jew madwar l - għekieżi, interazzjoni ma ’ mediċini oħra;
− 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.
- Nuqqas ta ’ funzjoni tat- testikoli, is- sindromu Cushing (Cushing syndrome) (kundizzjoni
How much Kaletra should be taken and when?
kkawżata minn livell għoli ta ’ cortisol fid- demm), il- glandola tat- tirojde ma taħdimx kemm sippost;
− The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- Infjammazzjoni tal- widna tan- nofs, infjammazzjoni tal- bronki, infjammazzjoni tas- sinus,
Can I stop taking Kaletra or change my dose?
imsiemer li jerġgħu ifeġġu, infezzjoniji tal- batterji, infezzjoni virali;
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.
- Tnaqqis fit- tolleranza tal- glukosju, żieda fil- piż, tnaqqis fil- piż, żieda fil- bilirubin (kulur tal -
If you take more Kaletra than you should
likwidu fil- marrara), bidla fil- livell ta ’ l- ormoni, riżultati mhux normali tat- testijiet li jsiru fil - laboratorju;
− 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.
- Ħaġra fil- kliewi, awrina mhux normali, albumina fl- awrina, livelli għoljin tal- kalċju fl- awrina,
If you forget to take Kaletra
aċidu uriku eċċessiv fid- demm;
− 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.
- Infjammazzjoni tal- bużżieq tal- marrara, infjammazzjoni tal- fwied, nefħa fil- fwied, depożitu tax -
POSSIBLE SIDE EFFECTS
xaħam fil- fwied, sensittività tal- fwied;
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- Nuqqas ta ’ vitamina essenzjali jew ta ’ aktar minn waħda, deidratazzjoni, akkumulazzjoni ta ’
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.
fluwidu fiċ- ċelloli jew fit- tessuti, żieda fl- aptit, aċidu laktiku eċċessiv fid- demm, obesità, anoressija, dijabete mellitus, glukosju għoli fid- demm, kolesterol baxx fid- demm;
If the condition persists or worsens, seek medical attention.
- Uġigħ fil- ġogi, infjammazzjoni tal- ġogi, uġigħ fil- muskoli, uġigħ fid- dahar, disturbi fil- ġogi;
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).
- Sturdament, telf tal- memorja jew indeboliment tal- memorja, nuqqas ta’ abbiltà li tikkoordina l -
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.
movimenti tal- muskoli, mard tal- moħħ deġenerattiv, telf ta ’ l- abbiltà li tagħmel movimenti volontarji bil- muskoli tal- wiċċ, żieda fit- tensjoni tal- muskoli, mard jew abnormalitajiet fis - sistema nervuża, ħsara fin- nervituri tas- sistema nervuża periferali, ngħas, tregħid, bidla fis- sens tat- togħma, migranja, movimenti involontarji mhux normali;
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.
- Ħolm mhux normali, aġitazzjoni, ansjetà, konfużjoni, depressjoni, indeboliment fl- abbiltà li
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.
tikkontrolla l- movimenti, nuqqas ta ’ stabbilità emozzjonali, tnaqqis fl- aptit sesswali, nervożità, taħseb b’ mod mhux normali;
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.
- Ħruġ mhux normali tas- semen mill- ġisem, żieda fid- daqs tas- sider, żieda fid- daqs tas- sider ta ’ l -
The cause and long-term health effects of these conditions are not known at this time.
irġiel, impotenza, menstrwazzjoni esaġerata jew li ddum għaddejja għal tul ta ’ żmien;
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
- Qtugħ ta ’ nifs, irritazzjoni u infjammazzjoni ta ’ l- imnieħer, żieda fis- sogħla;
UNCOMMON side effects (affects 1 to 10 users in 1,000):
- Taqa ’ x- xagħar, ġilda xotta, ekżema, qoxra fil- ġilda, raxx aħmar ċatt bil- ponot jew marki ħomor
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- Tumur tal- ġilda beninn, ċesta;
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.
- Pressjoni għolja, infjammazzjoni tal- vini relatata ma ’ embolu, disturbi vaskulari.
− 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.
- Tużax Kaletra wara d- data ta ’ skadenza li tidher fuq il- kartuna.
How should I dispose of any unused Kaletra?
Kif għandi narmi Kaletra li ma jkunx intuża?
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Kaletra contains
X’ fih Kaletra
Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir
Kull pillola Kaletra fiha 100 mg lopinavir u 25 mg ritonavir.
Tablet Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Pillola Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Tablet coating Polyvinyl alcohol, talc, titanium dioxide, macrogols type 3350, yellow ferric oxide E172.
Ir- rita tal- pillola Polimer ta ’ l- alkoħol, talkum, dijossidu tat- titanju, macrogols tat- tip 3350, ossidu isfar tal- ħadid E172.
What Kaletra looks like and contents of the pack
Id- Dehra ta ’ Kaletra u l- kontenut tal- pakkett:
− 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.
- Il- pilloli miksija b’ rita Kaletra jiġu fi flixkun tal- plastik li fih 60 pillola.
Marketing Authorisation Holder
- Pakkett wieħed ikun fih flixkun wieħed ta ’ 60 pillola.
Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
166 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Tel: + 356 22983201
Tel: + 356 21220174
España Abbott Laboratories, S.A.
167 España Abbott Laboratories, S. A.
Lietuva Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Latvija Tel: + 371 67605580
168 Lietuva Abbott Laboratories Baltics Vienības 87h Rīga, LV- 1004 Latvija Tel: + 371 67605580
{MM/YYYY}
Dan il- fuljett kien approvat l- aħħar f ’
153
169
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Karvea?
X’ inhu Karvea?
Karvea is a medicine that contains the active substance irbesartan.
Karvea hija mediċina li fiha s- sustanza attiva irbesartan.
It is available as white, oval tablets (75, 150 and 300 mg).
Huwa disponibbli bħala pillola bajda ovali (75, 150 u 300 mg).
What is Karvea used for?
Għal x' hiex jintuża Karvea?
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.
Karvea huwa wżat għall- pazjenti li jbatu minn pressjoni għolja essenzjali (pressjoni għolja tad- demm). ‘ Essenzjali ’ tfisser li l- pressjoni għolja fid- demm ma tkunx ikkawżata minn xi kundizzjoni oħra.
Karvea is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Karvea huwa użat ukoll fit- trattament tal- mard renali (tal- kliewi) f’ pazjenti li jbatu minn ipertensjoni u d- dijabete tat- tip 2 (dijabete li mhix dipendenti fuq l- insulina).
Karvea is not recommended for use in patients below 18 years of age.
Karvea m’ għandux jintuża fuq pazjenti ta ’ anqas minn 18 - il sena.
How is Karvea used?
Kif jintuża Karvea?
Karvea is taken by mouth, with or without food.
Karvea jittieħed b’ mod orali, ma ’ l- ikel jew fuq stonku vojt.
The usual recommended dose is 150 mg once a day.
Id- doża normalment rakkomandata hija ta ’ 150 mg darba kuljum.
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.
Jekk il- pressjoni tad- demm ma tkunx ikkontrollata b’ mod suffiċjenti, id - doża tista ’ tiġi miżjuda sa 300mg kull jum jew inkella jistgħu jiġu miżjuda mediċini oħra g] all - ipertensjoni, bħal ma ’ hu hydrochlorothiazide (dijuretiku).
A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Doża tal- bidu ta ’ 75 mg tista ’ tiġi użata fuq pazjenti li qed jirċievu l- emodijaliżi (teknika għat- tisfija tad- demm) jew f’ pazjenti li għandhom iktar minn 75 sena.
In patients with hypertension and type 2 diabetes, Karvea is added to other treatments for hypertension.
F ’ pazjenti li jbatu b’ ipertenzjoni u dijabete tat- tip 2, Karvea huwa miżjud mat- trattamenti l- oħra għall- ipertensjoni.
Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
It- trattament jinbeda b’ doża ta ’ 150mg darba kuljum u normalment jiġi miżjud għall- 300mg darba kuljum.
How does Karvea work?
Kif jaħdem Karvea?
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.
Is- sustanza attiva f’ Aproval, ibresartan hija ‘ antagonista tar- riċettur l- anġjotensina II ’ li jfisser li jimblokka l- azzjoni ta ’ ormon fil- ġisem imsejjaħ anġjotensina II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
L- angjootensina II hu sustanza qawwija li ddejjaq l- arterji u l- vini (vasoconstrictor).
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Irbesartan iwaqqaf l- effett ta ’ angiotensin billi jimblokka dawk ir- riċetturi li anġjotensina s- soltu jeħel magħhom, dan iwassal għat- twessigħ ta ’ l - arterji u l- vini (vasolidation).
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Dan iwassal sabiex il- pressjoni tad- demm titbaxxa u r- riskju ta ’ dannu ikkawżat minn pressjoni għolja, bħal puplesija, jitbaxxa.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Karvea?
© European Medicines Agency, 2008.
Oriġinarjament Karvea ġie studjat fi 11 – il prova għall- effetti tiegħu fuq il- pressjoni tad- demm.
Reproduction is authorised provided the source is acknowledged. enalapril or amlodipine) in 823 patients.
Karvea tqabbel ma ’ plaċebo (trattament finta) f’ 712 – il pazjent u tqabbel ma ’ mediċini oħra kontra l - ipertensjoni (etenolol, enalapril, amlodipine) f’ 823 pazjent.
Its use in combination with hydrochlorothiazide was also examined in 1,736 patients).
Ġie eżaminat ukoll l- użu tiegħu flimkien ma ’ hydrochlorothiazide f’ 1, 736 pazjent.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- kejl ewlieni ta ’ l- effikaċja kien it- tnaqqis fil- pressjoni tad - demm ‘ dijastolika ’ (mkejjla matul il- fażi bejn taħbita tal- qalb u oħra).
For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Karvea ġie studjat ukoll f’ żewġ studji kbar dwar il- mard tal- kliewi f’ 2, 326 pazjent li għandhom dijabete tat- tip 2.
Karvea was used for two years or more.
Karvea ġie studjat għal sentejn jew aktar.
One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Wieħed mill- istudji ta ħarsa lejn l - indikaturi tal- ħsara fil- kliewi billi kejjel jekk kienx hemm tneħħija tal- proteina albumina fl- awrina.
The second study looked at whether Karvea increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
It - tieni studju ħares lejn jekk Karvea żiedx il- ħin meħud mill- pazjenti biex jesperjenzaw irduppjar tal - livelli tagħhom tal- livell ta ’ krejatinina fid- demm (indikatur ta ’ mard fil- kliewi), sakemm ikollhom bżonn trapjant tal- kliewi jew dijaliżi, jew sakemm mietu.
In this study, Karvea was compared with placebo and with amlodipine.
F’ dan l- istadju Karvea tqabbel mal- plaċebo u ma ’ l- amlodipina.
What benefit has Karvea shown during the studies?
Liema benefiċċju wera Karvea waqt l- istudji li ġew mwettqa?
In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Fl- istudji dwar il- pressjoni għolja, irriżulta li Karvea kien ferm aktar effettiv mill- plaċebo biex inaqqas il- pressjoni tad- demm dijastolika u kellu effetti simili għal mediċini għall- ipertensjoni.
When used with hydrochlorothiazide, the effects of the two medicines were additive.
Meta użat ma hydrochlorothiazide, l- effetti taż- żewġ mediċini kienu addittivi.
In the first kidney disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Fl- ewwel studju dwar il- mard tal- kliewi irriżulta li Karvea kien ferm aktar effettiv mill- plaċebo biex inaqqas ir- riskju li ssir ħsara lill- kliewi kif ġiet imkejla t- tneħħija tal- proteini.
In the second kidney disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo.
Fit- tieni studju dwar il - mard tal- kliewi, Karvea naqqas ir- riskju relattiv b ’ 20% meta mqabbel mal- plaċebo li jintlaħaq fl - irduppjar tal- livelli tal- krejatinina fid- demm, li jeħtieġu li jsir trapjant tal- kliewi jew il- bżonn ta ’ dijaliżi jew li jkunu mietu waqt l- istudju.
There was a 23% relative risk reduction compared with amlodipine.
Kien hemm 23% tnaqqis relattiv fir- riskju meta mqabbel ma ’ amlodipine.
The main benefit was on the effect on blood creatinine levels.
Il- benefiċċju ewlieni kien l- effett fuq il- livelli tal- krejatinina fid- demm.
What is the risk associated with Karvea?
X’ inhu r- riskju assoċjat ma ’ Karvea?
The most common side effects with Karvea (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase (an enzyme found in muscles).
L- aktar effetti sekondarji komuni b ’ Approvel (dehru f’ madwar pazjent 1 u 10 pazjenti f’ 100) huma sturdament, nawżea (dardir) jew remettar, għejja (ħedla) u żjieda fil- livelli ta ’ kinażju ta ’ krejatinina fid- demm (enzima li tinsab fil- muskoli).
In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease have the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), musculoskeletal (joint) pain and orthostatic hypotension (low blood pressure when standing up).
Barra minn dan, aktar minn pazjent 1 minn kull 100 bid - dijabete tat- tip 2 u mard tal- kliewi jkollhom l- effetti sekondarji li ġejjin: iperkalemija (livelli għoljin ta ’ potassju fid- demm), sturdament ortostatiku (sturdament meta wieħed iqum fuq riġlejh), uġiegħ muskuloskeletali (ġogi) u ipertensjoni ortostatika (pressjoni baxxa meta wieħed iqum fuq riġlejh).
For the full list of all side effects reported with Karvea, see the Package Leaflet.
Għal lista sħiħa ta ’ l- effetti sekondarji rrapportati b’ Karvea, ara l- Fuljett ta ’ Tagħrif.
Karvea should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Karvea m ’ għandux jintuża min- nies li jista ’ jkollhom ipersensittività eċċessiva (allerġiċi) għall - irbesartan jew għal xi sustanzi oħra tiegħu.
It must not be used in women who are more than three months pregnant or who are breast-feeding.
Ma għandux jintuża minn nisa li jkollhom aktar minn tliet xhur tqala jew qed ireddgħu.
Its use during the first three months of pregnancy is not recommended.
L- użu tiegħu matul l- ewwel tliet xhur tat- tqala ma huwiex rakkomandat.
Why has Karvea been approved?
Għaliex ġie approvat Karvea?
The Committee for Medicinal Products for Human Use (CHMP) decided that Karvea’ s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Karvea huma akbar mir- riskji tiegħu għat- trattament ta 'pazjenti għat- trattament ta ’ ipertensjoni essenzjali u għat- trattament ta ’ mard tal- kliewi f ’ pazjenti li jbatu minn pressjoni għolja u dijabete mellitus tat- tip 2.
The Committee recommended that Karvea be given marketing authorisation.
Huma irrakkomandaw li Karvea jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Karvea:
Informazzjoni oħra dwar Karvea:
The European Commission granted a marketing authorisation valid throughout the European Union for Karvea to Bristol-Myers Squibb Pharma EEIG on 27 August 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Karvea lil Sanofi Pharma Bristol- Myers Squibb Pharma EEIG fis- 27 ta ’ Awissu 1997.
The marketing authorisation was renewed on 27 August 2002 and on 27 August 2007.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet aġġornata fis- 27 ta ’ Awissu 2002 u fis- 27 ta ’ Awissu 2007.
The full EPAR for Karvea is available here.
L- EPAR sħiħ dwar Karvea jista ’ jiġi kkonsultat hawnhekk.
This summary was last updated in 06-2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ 06- 2008.
Karvea 75 mg tablets.
Karvea 75 mg pilloli.
Each tablet contains 75 mg of irbesartan.
Kull pillola fiha 75 mg irbesartan.
Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Karvea b’ doża ta ’ 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l- 24 siegħa għall- pressjoni tad- demm minn 75 mg.
In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other anti-hypertensive agents can be added.
F’ pazjenti li mhumiex ikkontrollati biżżejjed b’ 150 mg darba kuljum, id- doża ta ’ Karvea tista ’ tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta ’ kontra l- pressjoni għolja.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).
B' mod partikolari, iż- żjieda ta 'dijuretiku bħal hydrochlorothiazide ntwera li jkollha effett ta' tisħiħ ma 'Karvea (ara sezzjoni 4. 5).
The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Il- benefiċċju renali muri b’ Karvea f’ pazjenti b’ dijabete ta ’ tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja kif meħtieġ, biex jintlaħaq il- livell mixtieq ta ’ pressjoni (ara sezzjoni 5. 1).
Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Anzjani: għalkemm għandha tiġi ikkonsidrata li tinbeda l- kura b' doża fil- bidu ta ’ 75 mg f’ pazjenti ’ il fuq minn 75 sena, ġeneralment m’ hemmx bżonn ta 'aġġustament tad- doża f’ anzjani.
Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
2 Pazjenti pedjatriċi: irbesartan mhux irrakkomandat għall- użu fit- tfal u l- addoloxxenti peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjonijiet 4. 8, 5. 1 u 5. 2).
Such conditions should be corrected before the administration of Karvea.
Dawn il- kondizzjonijiet għandhom jiġu kkoreġuti qabel tinbeda l- kura b’ Karvea.