natgillin/translations-raw huggingface dataset:
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.
- juuksekadu, nahakuivus, ekseem, soomuseline nahk, madal punane lööve vistrike ja laikudega,
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.
küünte kahjustus, sügelemine, rasuse naha soomusjad kogumid, naha värvus muutus, nahahaavand, näoturse, higistamine, striiad;
HOW TO STORE KALETRA
- healoomuline nahakasvaja, tsüst;
− Keep out of the reach and sight of children. − Do not use Kaletra after the expiry date which is stated on the bottle.
- kõrge vererõhk, veenipõletik, mis on tingitud verehüübest, veresoonte põletik, varikoosne
The expiry date refers to the last day of that month.
veen, süvaveenipõletik, mis on tingitud verehüübest, veresoonte häire.
How should I store Kaletra and for how long?
KUIDAS KALETRA’ T SÄILITADA
− Store in a refrigerator (2°C - 8°C). − In use storage:
- Ńagu kõikide ravimite puhul, hoida laste eest varjatud ja kättesaamatus kohas.
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
- Ärge kasutage Kaletra’ t pärast kõlblikkusaega, mis on märgitud pakendil.
It is advised to write the date of removal from the refrigerator on the package. − Avoid exposure to excessive heat. − It is important to keep Kaletra in the bottle it came in.
- See ravimpreparaat ei vaja säilitamisel eritingimusi.
Do not transfer it to any other container.
Kuidas ma peaksin ära viskama kasutamata jäänud Kaletra?
How should I dispose of any unused Kaletra?
- Ravimeid ei tohi ära visata kanalisatsiooni kaudu ega koos majapidamisprügiga.
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Küsige oma apteekrilt, kuidas hävitatakse ravimeid, mida enam ei vajata.
What Kaletra contains
Mida Kaletra sisaldab:
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Abiained on:
The other ingredients are:
Tablett: kopovidoon, sorbitaanlauraat, kolloidne veevaba räni, naatriumstearüülfumaraat.
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.
Tableti kate: hüpromelloos, titaandioksiid, tüüp 400 makrogoolid (polüetüleenglükool 400), hüdroksüpropüültselluloos, talk, kolloidne veevaba räni, tüüp 3350 makrogoolid (polüetüleenglükool 3350), kollane raudoksiid E172, polüsorbaat 80.
What Kaletra look like and contents of the pack
144 Kuidas Kaletra välja näeb ja pakendi sisu
− 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 õhukese polümeerikattega tabletid on saadaval plastikpurgis, mis sisaldab 120 tabletti.
Marketing Authorisation Holder
Kaletra on saadaval ka suukaudse lahusena.
България Т.П.
България Т. П.
H-1139 Budapest Tel.: +36 1 465 2100
H- 1139 Budapest Tel.: + 36 1 465 2100
133 Danmark Abbott Laboratories A/S Emdrupvej 28C DK-2100 København Ø Tlf: + 45 39 77-00-00
Danmark Abbott Laboratories A/ S Emdrupvej 28C DK- 2100 København Ø Tlf: + 45 39 77- 00- 00
Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
145 Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Läti Tel: + 371 67605580
Perfektastrasse 84A A-1230 Wien Tel: + 43 1 891-22
Perfektastrasse 86 A- 1230 Wien Tel: + 43 1 891- 22
134 Italia Abbott S.r.l.
Italia Abbott S. r. l.
I-04010 Campoverde di Aprilia (Latina) Tel: + 39 06 928921
I- 04010 Campoverde di Aprilia (Latina) Tel: + 39 06 928921
Latvija Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Tel: + 371 67605580
146 Latvija Abbott Laboratories Baltics Vienības 87h Rīga, LV- 1004 Tel: + 371 67605580
135 PACKAGE LEAFLET – INFORMATION FOR THE USER
INFORMATSIOON KASUTAJALE
KALETRA 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Kaletra 100 mg/ 25 mg õhukese polümeerikattega tabletid Lopinaviir/ ritonaviir
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
Enne ravimi võtmist lugege hoolikalt infolehte.
What Kaletra is and what it is used for 2.
- Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
How to take Kaletra 4.
- Kui teil on lisaküsimusi, pidage nõu oma arsti või apteekriga.
Possible side effects 5.
- Ravim on välja kirjutatud teile.
How to store Kaletra 6.
Ärge andke seda kellelegi teisele.
Further information
Ravim võib olla neile
WHAT KALETRA IS AND WHAT IT IS USED FOR
kahjulik, isegi kui haigussümptomid on sarnased.
− Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
- Kui ükskõik milline kõrvaltoimetest muutub tõsiseks või kui te märkate mõnda kõrvaltoimet,
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.
mida selles infolehes ei ole nimetatud, palun rääkige sellest oma arstile või apteekrile.
Kaletra should not be administered to children younger than 2 years of age unless specifically directed by their doctor. − Kaletra is an antiretroviral medicine.
Mis ravim on Kaletra ja milleks seda kasutatakse 2.
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
Kuidas Kaletra’ t võtta 4.
Your doctor will determine which medicines are best for you.
Lisainfo
BEFORE YOU TAKE KALETRA
MIS RAVIM ON KALETRA JA MILLEKS SEDA KASUTATAKSE
Do not take Kaletra
- Arst on määranud Kaletra teile selleks, et hoida inimese immuunpuudulikkuse viiruse (HIV)
− if you are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra.
Kaletra aeglustab haigustekitaja levikut teie organismis.
− if you have severe liver problems
- Kaletra’ t kasutatakse üle 2- aastastel lastel ja täiskasvanutel, kes on nakatunud AIDSi põhjustava
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).
Kaletra’ t ei kasutata alla 2- aastastel lastel, kui arst ei ole spetsiaalselt nii määranud.
136 Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
- Kaletra on retroviirusevastane ravim, mis kuulub ravimite gruppi, mida nimetatakse proteaasi
If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
Arst määrab teile
Take special care with Kaletra
sellised ravimid, mis teile kõige rohkem sobivad.
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
MIDA ON VAJA TEADA ENNE KALETRA VÕTMIST
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.
Ärge võtke Kaletra’ t
On rare occasions these muscle disorders have been serious.
- kui te olete allergiline (ülitundlik) lopinaviiri, ritonaviiri või Kaletra mõne koostisosa suhtes.
Taking other medicines
- kui teil on tõsiseid probleeme maksaga.
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);
Ärge võtke Kaletra’ t, kui te kasutate mõnda alljärgnevatest ravimitest
137 − Antifungals (e.g. ketoconazole, itraconazole, voriconazole); − Erectile dysfunction medicines (e.g. sildenafil and tadalafil); − Heart medicines including:
- astemisool või terfenadiin (kasutatakse tavaliselt allergianähtude raviks – need ravimid võivad
− − −
olla saadaval ka käsimüügiravimitena);
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
- peroraalne (suu kaudu manustatav) midasolaam, triasolaam (kasutatakse ärevuse vähendamiseks
− 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.
ja/ või unehäirete korral);
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.
- pimosiid (kasutatakse skisofreenia raviks);
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- tsisapriid (kasutatakse teatud maokaebuste leevendamiseks);
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
- ergotamiin, dihüdroergotamiin, ergonoviin, metüülergonoviin (kasutatakse peavalude
Contraceptives
leevendamiseks);
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
- amiodaroon (kasutatakse südame rütmihäirete raviks);
Taking Kaletra with food and drink
- vardenafiil (kasutatakse erektsioonihäirete raviks);
Kaletra tablets can be taken with or without food.
- lihtnaistepuna (Hypericum perforatum) sisaldavad preparaadid.
Pregnancy and breast-feeding
148 Lugege ravimite nimekirja lõigus “ Võtmine koos teiste ravimitega ” informatsiooniks teatud teiste ravimite kohta, mis nõuavad erilist tähelepanu.
− 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.
Kui te kasutate mõnda loetletud ravimitest, küsige oma arstilt nõu nende väljavahetamise suhtes mõne teise ravimi vastu Kaletra- ravi perioodil.
138 Driving or using machines
Oluline informatsioon
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- Kaletra ei ravi teid HIV infektsioonist või AIDSist terveks.
Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safety.
- Kaletra- ravi saavatel patsientidel võivad tekkida HIV infektsiooni või AIDSiga seotud
HOW TO TAKE KALETRA
infektsioonid ja teised haigused.
How should Kaletra be taken?
- Kaletra ei vähenda riski nakatada teisi HIV- ga.
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
ettevaatusmeetmeid, et vähendada riski nakatada teisi seksuaalkontaktil (nt kasutama kondoomi) või vere kaudu.
− 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.
Rääkige oma arstile, kui teil esineb/ on esinenud:
How much Kaletra should be taken and when?
- A - ja B- tüüpi hemofiilia, kuna Kaletra võib suurendada veritsuse riski.
− The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- suhkurtõbi, kuna Kaletra’ t saavatel patsientidel on teatatud suurenenud veresuhkru tasemest.
Can I stop taking Kaletra or change my dose?
- maksaprobleemid, kuna varem esinenud maksahaigusega patsientidel, sh krooniline B - või C -
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.
hepatiit, on suurenenud risk raskete ja potentsiaalselt eluohtlike maksa kõrvaltoimete tekkeks.
If you take more Kaletra than you should
Rääkige oma arstile, kui teil esineb:
− 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.
- iiveldus, oksendamine, kõhuvalu, hingamisraskused ja tõsine jalgade ja käte lihaste nõrkus,
If you forget to take Kaletra
kuna need sümptomid võivad osutada suurenenud piimhappe tasemele.
− 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.
- janu, sage urineerimine, hägune nägemine või kaalukaotus, kuna see võib osutada suurenenud
POSSIBLE SIDE EFFECTS
veresuhkru tasemele.
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- iiveldus, oksendamine, kõhuvalu, kuna triglütseriidide taseme suurt tõusu (rasvad veres)
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.
peetakse pankreatiidi riskifaktoriks (kõhunäärme põletik) ja need sümptomid võivad sellele seisundile viidata.
139 You should tell your doctor promptly about these or any other symptoms.
- muutused kehakujus tänu muutustele rasvade jaotumises.
If the condition persists or worsens, seek medical attention.
See võib väljenduda jalgade, käte ja
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).
näopiirkonna rasvkoe vähenemises, rasva ladestumise suurenemises kõhupiirkonnas ja siseoganites, rindade suurenemises ja rasvamügarate tekkimises kaelapiirkonda (kuklapoolel).
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.
- eelmiste infektsioonide põletiku nähud ja sümptomid kohe pärast HIV- vastase ravi alustamist.
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.
Arvatakse, et need sümptomid tekivad tänu organismi immuunvastuse paranemisele, võimaldades kehal võidelda infektsioonidega, mis on esinenud ilma silmnähtavate sümptomiteta.
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.
- liigesjäikus ja valud (eriti puusas, põlves ja õlas) ning liikumisraskused, kuna mõnedel neid
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.
ravimeid võtvatel patisentidel võib areneda luuhaigus nimega osteonekroos (luukoe surm, mille põhjuseks on kahjustunud luu verevarustus).
The cause and long-term health effects of these conditions are not known at this time.
Paljude muude tegurite hulgas võivad haiguse arenemise riskifaktoriteks olla kombineeritud retroviirusevastase ravi pikkus, kortikosteroidide kasutamine, alkoholi tarvitamine, raske immunosupressioon (immuunsüsteemi aktiivsuse vähenemine) ja kõrgem kehamassi indeks.
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
Harvadel juhtudel
UNCOMMON side effects (affects 1 to 10 users in 1,000):
võivad lihashaigused olla tõsised.
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
Võtmine koos teiste ravimitega
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;
Informeerige oma arsti kui te kasutate mõnda allnimetatud ravimitest, kuna sel juhul peate olema eriti tähelepanelik: