qanastek/EMEA-V3 huggingface dataset:
120 Psychiatric disorders: abnormal dreams, agitation, anxiety, confusion, depression, dyskinesia, emotional lability, decreased libido, nervousness, abnormal thinking;
likwidu fil- marrara), bidla fil- livell ta ’ l- ormoni, riżultati mhux normali tat- testijiet li jsiru fil - laboratorju;
Nerve disorders: dizziness, amnesia, ataxia, encephalopathy, facial paralysis, hypertonia, neuropathy, peripheral neuritis, somnolence, tremor, taste perversion, migraine, extrapyramidal syndrome;
- Ħaġra fil- kliewi, awrina mhux normali, albumina fl- awrina, livelli għoljin tal- kalċju fl- awrina,
Eye disorders: abnormal vision, eye disorder;
aċidu uriku eċċessiv fid- demm;
Ear disorders: tinnitus;
xaħam fil- fwied, sensittività tal- fwied;
Cardiac disorders: palpitation, lung oedema, myocardial infarct;
- Nuqqas ta ’ vitamina essenzjali jew ta ’ aktar minn waħda, deidratazzjoni, akkumulazzjoni ta ’
Vascular disorders: hypertension, thrombophlebitis, vasculitis, varicose vein, deep thrombophlebitis, vascular disorder;
- Uġigħ fil- ġogi, infjammazzjoni tal- ġogi, uġigħ fil- muskoli, uġigħ fid- dahar, disturbi fil- ġogi;
Respiratory, thoracic and mediastinal disorders: dyspnoea, rhinitis, increased cough;
- Sturdament, telf tal- memorja jew indeboliment tal- memorja, nuqqas ta’ abbiltà li tikkoordina l -
Gastrointestinal disorders: enlarged abdomen, constipation, dry mouth, dysphagia, enterocolitis, eructation, oesophagitis, faecal incontinence, gastritis, gastroenteritis, haemorrhagic colitis, mouth ulcerations, pancreatitis, sialadenitis, stomatitis, ulcerative stomatitis, periodontitis;
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 -
Liver disorders: cholecystitis, hepatitis, hepatomegaly, liver fatty deposit, liver tenderness;
- Ħolm mhux normali, aġitazzjoni, ansjetà, konfużjoni, depressjoni, indeboliment fl- abbiltà li
Skin disorders: alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, nail disorder, pruritis, seborrhoea, skin discoloration, skin ulcer, face oedema, sweating, skin striae;
tikkontrolla l- movimenti, nuqqas ta ’ stabbilità emozzjonali, tnaqqis fl- aptit sesswali, nervożità, taħseb b’ mod mhux normali;
Muscle disorders: arthralgia, arthrosis, myalgia, back pain, joint disorder;
- Ħruġ mhux normali tas- semen mill- ġisem, żieda fid- daqs tas- sider, żieda fid- daqs tas- sider ta ’ l -
Renal and urinary disorders: kidney calculus, urine abnormality, albuminuria, hypercalcinuria, hyperuricemia;
irġiel, impotenza, menstrwazzjoni esaġerata jew li ddum għaddejja għal tul ta ’ żmien;
Reproductive system disorders: abnormal ejaculation, breast enlargement, gynecomastia, impotence, menorrhagia;
- Qtugħ ta ’ nifs, irritazzjoni u infjammazzjoni ta ’ l- imnieħer, żieda fis- sogħla;
General disorders: chest pain, chest pain substernal, chills, fever, flu syndrome, malaise, peripheral oedema, drug interaction,
- Taqa ’ x- xagħar, ġilda xotta, ekżema, qoxra fil- ġilda, raxx aħmar ċatt bil- ponot jew marki ħomor
Investigations: decreased glucose tolerance, weight gain, weight loss, increased bilirubin, hormone level altered, lab test abnormal.
fil- ġilda, disturbi fid- dwiefer, ħakk, akkumulazzjoni ta ’ qoxra ta ’ ġilda żejtnija, telf tal- kulur tal - ġilda, ulċeri tal- ġilda, nefħa fil- wiċċ, ħruġ ta ’ għaraq, sinjali fil- ġilda li normalment jidhru wara li wieħed ikun ħxien;
Inform your doctor promptly about these or any other symptoms.
- Tumur tal- ġilda beninn, ċesta;
If the condition persists or worsens, seek medical attention.
- Pressjoni għolja, infjammazzjoni tal- vini relatata ma ’ embolu, disturbi vaskulari.
HOW TO STORE KALETRA
KIF TAĦŻEN KALETRA
As with all medicines, keep Kaletra out of the reach and sight of children.
- Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use Kaletra after the expiry date which is stated on the pack.
- Tużax Kaletra wara d- data ta ’ skadenza li tidher fuq il- flixkun.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal
121 How should I store Kaletra and for how long
Kif għandi naħżen Kaletra u għal kemm żmien?
Store in a refrigerator (2°C - 8°C).
- Aħżen fi friġġ (2°C – 8°C).
In use storage:
- Ħażna waqt l- użu:
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
Jekk miżmum barra mill- friġġ, taħżinx f’ temperatura 'l fuq minn 25°C u armi
Avoid exposure to excessive heat.
- Evita l- esponiment għall- sħana eċċessiva.
It is important to keep Kaletra in the original package.
- Huwa importanti li żżomm Kaletra fil- flixkun oriġinali.
Do not transfer it to any other container.
Titrassferihx għal kontenitur ieħor.
Medicines should not be disposed of via wastewater or household waste.
- Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
- Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures will help protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta ’ l- ambjent.
What Kaletra contains
X’ fih Kaletra:
− The active substance is lopinavir, the capsules also contain ritonavir which acts to increase the blood levels of lopinavir by inhibiting enzymes which metabolise it.
Is- sustanzi attivi huma lopinavir u ritonavir.
Each capsule of Kaletra contains 133.3 mg of lopinavir and 33.3 mg of ritonavir (pharmacokinetic enhancer).
Kull ml ta ’ Kaletra fih lopinavir 80 mg u ritonavir 20 mg.
− The other ingredients are: oleic acid, propylene glycol, polyoxyl 35 castor oil, purified water.
Alkoħol (42% v/ v), high fructose corn syrup, propylene glycol, ilma ppurifikat, glycerol, povidone, magnasweet- 110 flavour (taħlita ta ’ monoammonium glycyrrhizinate u glycerol), vanilla flavour (fih p - hydroxybenzoic acid, p- hydroxybenzaldehyde, vanillic acid, vanillin, heliotrope, ethyl vanillin),
− The capsule shell components are: gelatine, anhydrized liquid sorbitol (mixture of sorbitol, sorbitol anhydrides and mannitol), glycerol, titanium dioxide (white colour), sunset yellow (E110), medium-chain triglycerides, lecithin and black ink containing: propylene glycol, black iron oxide, polyvinyl acetate phthalate, polyethylene glycol 400 and ammonium hydroxide.
146 polyoxyl 40 hydrogenated castor oil, cotton candy flavour (fih ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol), acesulfame potassium, saccharin sodium, sodium chloride, peppermint oil, sodium citrate, citric acid, menthol.
What Kaletra looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakket:
The capsules are orange with a black ink imprint of the [Abbott logo] and “PK”.
- Is- soluzzjoni orali Kaletra tiġi fi fliexken kulur ambra għal dożi multipli, ta ’ daqs ta ’ 60 ml.
Each pack contains 5 cartons (180 capsules).
- Kull pakket fih 5 fliexken ta ’ 60 ml.
Kaletra is also supplied as an oral solution and as film-coated tablets.
- Kull ml ta ’ Kaletra fih 80 mg lopinavir u 20 mg ritonavir.
Aesica Queenborough Ltd Queenborough Kent ME11 5EL United Kingdom
Aesica Queenborough Ltd Queenborough Kent ME11 5EL Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lirrappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Deutschland Abbott GmbH & Co.
147 Deutschland Abbott GmbH & Co.
Κύπρος Lifepharma (Z.A.M.) Ltd Aγ.
148 Κύπρος Lifepharma (Z. A. M.) Ltd Aγ.
{MM/YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ [data]
125 PACKAGE LEAFLET:
149 FULJETT TA ’ TAGĦRIF:
KALETRA (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
KALETRA 200 mg/ 50 mg pilloli miksija b’ rita lopinavir/ ritonavir
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
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.
TAGĦTIHIEX lil persuni oħra.
Do not pass it onto others.
Tista ’ tagħmlilhom il- ħsara,
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.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
− Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
- - It- tabib tiegħek tak Kaletra biex jgħinek biex l- infezzjoni tiegħek ta ’ l- immunodeficiency virus
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.
Kaletra jintuża minn tfal ta ’ sentejn jew ikbar u minn adulti li huma infettati bl- HIV, il - virus li jikkawża l- AIDS.
Kaletra should not be administered to children younger than 2 years of age unless specifically directed by their doctor. − Kaletra is an antiretroviral medicine.
Kaletra m’ għandux jingħata lil tfal li għandhom inqas minn sentejn sakemm it- tabib tagħhom ma jkunx ordna dan speċifikament.
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
It- tabib tiegħek
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.
- jekk int allerġiku/ a (għandek sensittività eċċessiva) għal lopinavir, ritonavir jew sustanzi oħra 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).
mediċini jistgħu ikunu disponibli mingħajr riċetta);
126 Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
- Midazolam orali (mittieħed mill- ħalq), triazolam (użati għas- soljiev ta ’ anzjetà u/ jew problemi ta ’
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.
Għalhekk, huwa importanti li int tibqa ’ taħt l - osservazzjoni tat- tabib tiegħek waqt li tkun qiegħed tieħu 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.
Għandhom jittieħdu l -
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
riġlejn u fid- dirgħajn għax dawn is- sintomi jistgħu jindikaw żieda fil- livelli ta ’ l- aċidu laktiku.
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.
ikkunsidrati bħala fattur ta ’ riskju għall- pankreatite (infjammazzjoni tal- frixa) u dawn is- sintomi jistgħu jissuġġerixxu din il- kondizzjoni.
Tell your doctor if you experience: − Nausea, vomiting, abdominal pain, difficulty breathing and severe weakness of the muscles in the legs and arms as these symptoms may indicate raised lactic acid levels. − Thirst, frequent urination, blurred vision or weight loss as this may indicate raised sugar levels in the blood. − Nausea, vomiting, abdominal pain as large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas) and these symptoms may suggest this condition. − Changes in body shape due to changes in fat distribution.
Il - kawża u l- effetti dejjiema ta ’ dawn il- kundizzjonijiet fuq is- saħħa għadhom m’ humiex magħrufa.
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’).
Huwa maħsub li dawn is- sintomi huma riżultat ta ’ titjib fir- rispons immunitarju tal - ġisem, li jgħin lill- ġisem biex jiġġieled kontra l- infezzjonijiet li setgħu kienu preżenti u li ma kellhomx sintomi ovvji.
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.
- Ebusija fil- ġogi, weġgħat u uġigħ (speċjalment tal- ġenbejn, ta ’ l- irkoppa u ta ’ l- ispallejn) u
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).
diffikultà biex wieħed jiċċaqlaq, peress li xi pazjenti li jkunu qegħdin jieħdu dawn il- mediċini jistgħu jiżviluppaw marda ta ’ l- għadam li tissejjaħ nekrosi ta ’ l- għadam (mewt tat- tessut ta ’ l - għadam ikkaġunat permezz tan- nuqqas ta ’ supplixximent tad- demm fl- għadam).
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.
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
On rare occasions these muscle disorders have been serious.
F’ każi rari, dawn id- disturbi fil- muskoli kienu serji.
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);
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);
127 − Antifungals (e.g. ketoconazole, itraconazole, voriconazole); − Erectile dysfunction medicines (e.g. sildenafil and tadalafil); − Heart medicines including:
- Kontraċettivi li jittieħdu mill- ħalq jew l- użu ta ’ kontraċettiv f’ forma ta ’ garża li terħi l- mediċina
− − −
- Warfarin.
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
Għal tagħrif fuq mediċini li m’ għandekx tieħu ma ’ Kaletra, aqra l- lista tal- mediċini taħt ‘ Tieħux Kaletra ma ’ xi waħda mill- mediċini li ġejjin ’.
− 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).
Mediċini għad- disfunzjoni erettili (vardenafil, sildenafil, tadalafil)
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.
- Tiħux Kaletra jekk bħalissa qiegħed tieħu vardenafil.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- Jekk inti tieħu sildenafil jew tadalafil u Kaletra flimkien, int tista ’ tkun qiegħed f’ riskju ta ’ effetti
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.
sekondarji bħal pressjoni baxxa, tintilef minn sensik, tibdil viżwali u erezzjoni tal- pene li ddum aktar minn 4 siegħat.
Contraceptives
Kontraċettivi
− 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.
f’ forma ta ’ garża li terħi l- mediċina biex tevita t- tqala, għandek tibda tuża kontraċettiv addizzjonali jew tip differenti ta ’ kontraċettiv (eż. kondom) għax Kaletra jista ’ jnaqqas l - effettività tal- kontraċettivi li jittieħdu mill- ħalq jew dawk f’ forma ta ’ garża li terħi l- mediċina.
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
Għandhom jittieħdu l -
It is important that Kaletra is taken with food.
Il- pilloli Kaletra jistgħu jittieħdu ma ’ l- ikel jew waħedhom
− 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.
- Huwa rrakkomandat li nisa nfettati bl- HIV ma jreddgħux lit- trabi tagħhom minħabba l- possibilità
128 Driving or using machines
Sewqan u tħaddim ta ’ magni
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
Kaletra ma ġiex studjat speċifikament għall- effetti possibli fuq il- ħila li issuq karozza jew li tħaddem magni.
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.
Issuqx jew tħaddimx magni jekk inti tesperjenza xi effetti sekondarji (eż. nawseja) li jaffetwaw l - ħila tiegħek li tagħmel dan mingħajr periklu.
Instead, contact your doctor.
KIF GĦANDEK TIEĦU KALETRA
Kaletra contains 42% v/v alcohol.
Kif u meta għandek tieħu Kaletra
Important information about some of the ingredients of Kaletra
Huwa importanti li l- pilloli Kaletra jinbelgħu sħaħ u ma jiġux mimgħuda, imkissra jew mgħaffġa.
Kaletra contains 42% v/v alcohol.
- Il- pilloli Kaletra jistgħu jittieħdu ma ’ l- ikel jew waħedhom.
Each dose contains up to 1.7 g of alcohol.
- Dejjem ħu Kaletra eżatt kif qallek it- tabib tiegħek.
Potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
- Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju dwar kif
May modify or increase the effect of other medicines.
Kemm għandek tieħu Kaletra u fi x’ ħin?
This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
- Id- doża li ssoltu tingħata għall- adulti hija 400 mg/ 100 mg darbtejn kuljum, jiġifieri kull 12 - il
Unsuitable in hereditary fructose intolerance.
siegħa, flimkien ma ’ mediċini oħra għal kontra l- 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.
It- tabib tiegħek jinfurmak dwar in- numru ta ’ pilloli li għandek tieħu.
Kaletra contains glycerol which is harmful in high doses.
- Fil- każ tat- tfal, it- tabib tiegħek jiddeċiedi d- doża t- tajba li għandha tingħata (numru ta ’ pilloli)
Can cause headache and stomach upset and diarrhoea.
ibbażata fuq it- tul u l- piż tat- tifel/ tifla.
Kaletra contains polyoxyl 40 hydrogenated castor oil.
- Kaletra jiġi fornut ukoll bħala soluzzjoni orali għal dawk pazjenti li ma jistgħux jieħdu pilloli u
This may cause nausea, vomiting, colic, severe purgation at high doses.
bħala pilloli miksija b’ rita ta ’ 100 mg/ 25 mg.
It should not be given when intestinal obstruction is present.
Nista ’ nieqaf nieħu Kaletra jew inbiddel id- doża?
Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet.
- Twaqqafx Kaletra u tbiddilx id- doża ta ’ Kaletra li tieħu kuljum qabel ma l- ewwel tikkonsulta
High potassium in the blood can cause stomach upset and diarrhoea.
- Dejjem għandek tieħu Kaletra darbtejn kuljum biex il- mediċina tgħin biex tikkontrollalek l -
Kaletra contains sodium as saccharin sodium, sodium chloride and sodium citrate, which may be harmful to people on a low sodium diet.
infezzjoni ta ’ l- HIV, irrispettivament minn kemm tkun qiegħed tħossok tajjeb.
3.
153
HOW TO TAKE KALETRA
tiżviluppa r- reżistenza għall- prodott.
Kaletra is recommended for use in adults and children 2 years of age or older who are infected with HIV.
- Jekk inti m’ intix tieħu Kaletra kif qallek it- tabib tiegħek minħabba li qiegħed tesperjenza xi effett
Take care when dosing children.
sekondarju, informa lit- tabib tiegħek immedjatament.
Dosing should be less that 5 ml twice daily for children weighing less that 40 kg.
- Dejjem żomm biżżejjed Kaletra biex ma tispiċċax mingħajr il- mediċina.
− 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.
ikollok bżonn tmur l- isptar, kun ċert li għandek biżżejjed Kaletra biex iservik sakemm tkun tista ’ terġa tixtri.
How much Kaletra should be taken and when?
Jekk tieħu Kaletra aktar milli suppost
− 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.
- Jekk tirrealliża li ħadt iżjed Kaletra milli suppost għandek tieħu, kellem lit- tabib tiegħek
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.
- Jekk ma tistax tkellem lit- tabib tiegħek, mur l- isptar.
Can I stop taking Kaletra or change my dose?
Jekk tinsa tieħu 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.
- Jekk tinsa tieħu doża, ħu d- doża li qbist mill- aktar fis possibbli, u mbagħad kompli bid- doża
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.
Bħal kull mediċina oħra, Kaletra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd. Tista tkun diffiċli li tinnota liema effetti sekondarji huma ikkawżati minn Kaletra u dawk li jistgħu iseħħu minħabba mediċini oħra li qed tieħu fl- istess ħin jew minn kumplikazzjonjiet ta ’ l- infezzjoni ta ’ l- 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.
Jekk il - kundizzjoni tibqa ’ l- istess jew tiggrava, fittex għajnuna medika.
How do I measure the correct dose of the solution?
- Żieda fil- GGT (tip ta ’ enżima tal- fwied);
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.
- Ir- riskji dejjiema li jistgħu jwasslu għall- kumplikazzjonijiet, bħal attakki tal- qalb jew attakk ta ’
Talk to you pharmacist if you have difficulty opening the bottle.
puplesija minħabba żieda fit- trigliċeridi u fil- kolesterol, għadhom m’ humiex magħrufa.
5 dosing syringes are included in each carton of Kaletra oral solution.
Effetti sekondarji KOMUNI (jaffetwaw minn 1 sa 10 persuni minn kull 100 persuna li jieħdu Kaletra):
Ask your pharmacist for instructions on how to use the syringe correctly.
- Riżultati mhux normali ta ’ testijiet tal- funzjoni tal- fwied;
After each dose of Kaletra separate the plunger and the syringe.
- Tibdil fil- forma tal- ġisem minħabba tibdil fid- distribuzzjoni tax- xaħam;
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.
- Żieda fil- glukosju, żieda fl- amylase (enżima fis- sistema diġestiva), żieda fl- enżimi tal- fwied;
Rinse the syringe and plunger with clean water.
- Nuqqas ta ’ saħħa u enerġija;
Put the syringe back together and draw up and expel tap water a few times to rinse.
- Nawseja, rimettar, uġigħ addominali, skart tal- ġisem mhux normali, indiġestjoni, gass, problemi
Let the syringe dry completely before you use that syringe for dosing.
fis- sistema diġestiva tiegħek;
If you take more Kaletra than you should
- Tnemnim, tingiż jew tittarrax il- ġilda.
− 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.
Effetti sekondarji MHUX KOMUNI (jaffetwaw minn 1 sa 10 persuni minn kull 1, 000 persuna li jieħdu Kaletra):
If you forget to take Kaletra
tal- glandoli limfatiċi;
− 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.
- Tħoss qalbek tgħaġġel, tħoss qalbek tieqaf jew tħabbat ħafna, attakk ta ’ qalb, nefħa u/ jew
POSSIBLE SIDE EFFECTS
akkumulazzjoni ta ’ fluwidu fil- pulmuni;
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- Nefħa fiż- żaqq, stitikezza, nixfa fil- ħalq, diffikultà biex tibla ’, infjammazzjoni tal- musrana ż -
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.
l- influwenza, tħossok m’ intix f’ sikktek, akkumulazzjoni ta ’ fluwidu f’ riġlejk jew madwar l - għekieżi, interazzjoni ma ’ mediċini oħra;
You should tell your doctor promptly about these or any other symptoms.
- Nuqqas ta ’ funzjoni tat- testikoli, is- sindromu Cushing (Cushing syndrome) (kundizzjoni
If the condition persists or worsens, seek medical attention.
imsiemer li jerġgħu ifeġġu, infezzjoniji tal- batterji, infezzjoni virali;
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).
likwidu fil- marrara), bidla fil- livell ta ’ l- ormoni, riżultati mhux normali tat- testijiet li jsiru fil - laboratorju;
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.
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;
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.
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 -
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.
155 sistema nervuża, ħsara fin- nervituri tas- sistema nervuża periferali, ngħas, tregħid, bidla fis- sens tat- togħma, migranja, movimenti involontarji 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.
- Ħolm mhux normali, aġitazzjoni, ansjetà, konfużjoni, depressjoni, indeboliment fl- abbiltà li
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’).
tikkontrolla l- movimenti, nuqqas ta ’ stabbilità emozzjonali, tnaqqis fl- aptit sesswali, nervożità, taħseb b’ mod mhux normali;
The cause and long-term health effects of these conditions are not known at this time.
- Ħruġ mhux normali tas- semen mill- ġisem, żieda fid- daqs tas- sider, żieda fid- daqs tas- sider ta ’ l -
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
irġiel, impotenza, menstrwazzjoni esaġerata jew li ddum għaddejja għal tul ta ’ żmien;
UNCOMMON side effects (affects 1 to 10 users in 1,000):
- Qtugħ ta ’ nifs, irritazzjoni u infjammazzjoni ta ’ l- imnieħer, żieda fis- sogħla;
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- Taqa ’ x- xagħar, ġilda xotta, ekżema, qoxra fil- ġilda, raxx aħmar ċatt bil- ponot jew marki ħomor
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.
- 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 bottle.
- Bħall - kull mediċina oħra żomm Kaletra fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal.
How should I store Kaletra and for how long?
- Tużax Kaletra wara id- data ta ’ l- iskadenza li tidher fuq il- pakkett.
− Store in a refrigerator (2°C - 8°C). − In use storage:
- Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
Do not transfer it to any other container.
Kif għandi narmi Kaletra li ma jkunx intuża?
How should I dispose of any unused Kaletra?
- Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
The active substances are lopinavir and ritonavir.
Is- sustanzi attivi huma lopinavir u ritonavir.
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Kull pillola Kaletra fiha lopinavir 200 mg u ritonavir 50 mg.
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.
Ir- rita tal- pillola 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.
What Kaletra look like and contents of the pack
156 Id- dehra tal- prodott u d- daqs tal- pakket:
− 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.
- Kaletra pilloli miksija b’ rita jiġu fi flixkun tal- plastik li fih 120 pillola.
Marketing Authorisation Holder
- Kaletra pilloli miksija b’ rita jiġu wkoll f’ folji.
Manufacturer
- Kull pakkett fih 3 kartuniet (120 pillola).
Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
157 Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Läti Tel: + 371 67605580
Latvija Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Tel: + 371 67605580
158 Latvija Abbott Laboratories Baltics Vienības 87h Rīga, LV- 1004 Tel: + 371 67605580
135 PACKAGE LEAFLET – INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
KALETRA 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Kaletra 100 mg/ 25 mg pilloli miksija b’ rita lopinavir/ ritonavir
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.
M’ għandekx tgħaddiha lil persuni oħra.
Do not pass it onto others.
Tista ’ tagħmlilhom
What Kaletra is and what it is used for 2.
X’ inhu Kaltera u għalxiex jintuża 2.
− Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
- It- tabib tiegħek tak Kaletra biex jgħinek biex l- infezzjoni tiegħek ta ’ l- immunodeficiency virus
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.
- Kaletra jintuża minn tfal ta ’ sentejn jew ikbar u minn adulti li huma nfettati bl- HIV, il- virus li
Kaletra should not be administered to children younger than 2 years of age unless specifically directed by their doctor. − Kaletra is an antiretroviral medicine.
Kaletra m’ għandux jingħata lil tfal li għandhom inqas minn sentejn sakemm it - tabib tagħhom ma jkunx ordna dan speċifikament.
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
Kaletra jagħmel parti mill- grupp ta ’ mediċini msejħa
− if you are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal lopinavir, ritonavir jew sustanzi oħra
− if you have severe liver problems
ta ’ Kaletra.
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).
- jekk għandek problemi serji ħafna tal- fwied.
136 Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
Tieħux Kaletra ma ’ xi waħda mill- mediċini li ġejjin:
If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
- Astemizole jew terfenadine (kommunement użati biex jittrattaw sintomi t ’ llerġija – dawn il -
Take special care with Kaletra
mediċini jistgħu ikunu disponibbli mingħajr riċetta);
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
- Midazolam orali (mittieħed mill- ħalq), triazolam (użati għas- soljiev ta ’ anzjetà u/ jew problemi ta ’
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.
l- irqad);
On rare occasions these muscle disorders have been serious.
- Pimozide (użati biex jittrattaw skizofrenija);
Taking other medicines
- Cisapride (użati għas- soljiev ta ’ ċerti problemi ta ’ l- istonku);
137 − Antifungals (e.g. ketoconazole, itraconazole, voriconazole); − Erectile dysfunction medicines (e.g. sildenafil and tadalafil); − Heart medicines including:
- Ergotamine, dihydroergotamine, ergonovine, methylergonovine (użati biex jittrattaw l- uġigħ ta ’
− − −
ras);
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
- Amiodarone (użat biex jittratta taħbita mhux normali tal- qalb);
− 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.
160
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.
- Vardenafil (użat biex jittratta disfunzjoni erettili);
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- Prodotti li fihom il- fexfiex tar- raba ’ (St John’ s wort) (Hypericum perforatum).
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.
Għal tagħrif dwar ċerti mediċini oħra li jeħtieġu attenzjoni speċjali qabel tibda toħodhom, aqra l- lista ta ’ mediċini li ssib taħt ‘ Meta tieħu mediċini oħra ’.
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Jekk f’ dan il- waqt qed tieħu kwalinkwe minn dawn il- mediċini, saqsi lit- tabib tiegħek biex taqleb għall - mediċina oħra waqt li qed tieħu Kaletra.
Your doctor can explain these symptoms to you.
Oqgħod attent ħafna b’ Kaletra
Contraceptives
Informazzjoni importanti
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
- Kaletra mhuwiex kura għall- infezzjoni ta ’ l- HIV jew għall- AIDS.
Taking Kaletra with food and drink
- Persuni li jkunu qegħdin jieħdu Kaletra xorta jistgħu jiżviluppaw infezzjonijiet jew mard ieħor
Kaletra tablets can be taken with or without food.
assoċjat mal- marda ta ’ l- HIV u ta ’ l- AIDS.
Pregnancy and breast-feeding
Għandhom jittieħdu l -
− 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.
prekawzjonijiet xierqa biex jiġi evitat li l- marda tgħaddiha lil ħaddieħor permezz ta ’ kuntatt sesswali (eż. agħmel użu mill- kondom) jew ta ’ kontaminazzjoni tad- demm.
138 Driving or using machines
Għid lit- tabib tiegħek jekk inti għandek/ kellek:
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- Emofilja tip A u B, peress li Kaletra jista ’ iżid ir- riskju ta- telf ta ’ demm.
HOW TO TAKE KALETRA
- Dijabete, peress li kien hemm rapporti ta ’ żieda fiz- zokkor fid- demm f’ pazjenti li jirċievu
How should Kaletra be taken?
Kaletra.
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
- Storja ta ’ problemi tal- fwied, peress li pazjenti bi storja ta ’ mard tal- fwied, inkluża l- epatite
− 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.
kronika tat- tip B u Ċ huma f’ riskju akbar ta ’ effetti sekondarji serji ħafna u li jistgħu jkunu fatali.
How much Kaletra should be taken and when?
Għid lit- tabib tiegħek jekk int tesperjenza:
− The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- Nawseja, rimettar, uġigħ addominali, diffikultà biex tieħu n- nifs u dgħufija severa tal- muskoli tar -
Can I stop taking Kaletra or change my dose?
riġlejn u d- dirgħajn, peress li dawn is- sintomi jistgħu jindikaw żidiet fil- livelli ta ’ l- aċidu laktiku.
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.
- Għatx, tagħmel l- awrina aktar ta ’ spiss, tara mċajpar jew titlef il- piż, peress li dan jista ’ jindika
If you take more Kaletra than you should
żieda fil- livelli taz- zokkor fid- demm.
− 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.
- Nawseja, rimettar, uġigħ addominali, peress li żidiet kbar fl- ammont ta ’ trigliċeridi (xaħmijiet fid -
− 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.
demm) ġew ikkunsidrati bħala fattur ta ’ riskju għall- pankreatite (infjammazzjoni tal- frixa) u dawn is- sintomi jistgħu jkunu indikazzjoni ta ’ din il- kundizzjoni.
4.
- Tibdil fl- għamla tal- ġisem ikkawżati minn tibdil fid- distribuzzjoni tax- xaħam.
POSSIBLE SIDE EFFECTS
Dawn jistgħu
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.
jinkludu telf ta ’ xaħam mir- riġlejn, dirgħajn u mill- wiċċ, żieda fix- xaħam taż- żaqq u organi interni oħra, żieda fid- daqs tas- sider u ċapep tax- xaħam fuq wara ta ’ l- għonq (‘ buffalo hump ’).
139 You should tell your doctor promptly about these or any other symptoms.
Il - kawża u l- effetti dejjiema ta ’ dawn il- kundizzjonijiet fuq is- saħħa għadhom m’ humiex magħrufa.
If the condition persists or worsens, seek medical attention.
- Sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet li kellek, li jfeġġu kif tibda l- kura għal
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).
Huwa maħsub li dawn is- sintomi huma riżultat ta ’ titjib fir- rispons immunitarju tal - ġisem, li jgħin lill- ġisem biex jiġġieled kontra l- infezzjonijiet li setgħu kienu preżenti u li ma kellhomx sintomi ovvji.