qanastek/EMEA-V3 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;
- paaugstināts asinsspiediens, vēnu iekaisums, kas saistīts ar asiņu recekli, asinsvadu iekaisums,
140 − 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; − 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.
varikozas vēnas, dziļo vēnu iekaisums, kas saistīts ar asiņu recekli, asinsvadu slimība.
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.
Ja novērojat jebkādas blakusparādības, kas šajā instrukcijā nav minētas, vai kāda no minētajām blakusparādībām Jums izpaužas smagi, lūdzam par tām izstāstīt ārstam vai farmaceitam.
− 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.
- Nelietot Kaletra pēc derīguma termiņa beigām, kas norādīts uz iepakojuma.
How should I dispose of any unused Kaletra?
Kā ir jāatbrīvojas no neizlietotās Kaletra?
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Zāles nedrīkst izmest kopā ar saimniecības atkritumiem vai kanalizācijā.
The active substances are lopinavir and ritonavir.
Aktīvās vielas ir lopinavirs un ritonavirs.
Each tablet of Kaletra contains 200 mg of lopinavir and 50 mg of ritonavir
Katra Kaletra tablete satur 200 mg lopinavira un 50 mg ritonavira.
141 The other ingredients are:
Citas sastāvdaļas ir:
Tablet Copovidone, sorbitan laurate, colloidal anhydrous silica, sodium stearyl fumarate.
Tablete Koloidāls bezūdens silīcija dioksīds, kopovidons, nātrija stearilfumarāts, sorbitāna laurāts.
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.
Tabletes apvalks Hipromeloze, titāna dioksīds, makrogols, tips 400 (polietilēnglikols 400), hidroksipropilceluloze, talks, koloidāls bezūdens silīcija dioksīds, makrogols, tips 3350 (polietilēnglikols 3350), dzeltenais dzelzs oksīds E172, polisorbāts 80.
− 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.
- Kaletra apvalkotās tabletes iepakotas plastmasas pudelēs pa 120 tabletēm.
− 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).
- Kaletra apvalkotās tabletes ir pieejamas arī blisteros.
Marketing Authorisation Holder
- Katra kastīte satur 5 folijas blisterus ar 8 tabletēm katrā (40 tabletes).
Manufacturer
- Katrs iepakojums satur 3 kastītes (120 tabletes).
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
Reģistrācijas apliecības īpašnieks Abbott Laboratories Limited Queenborough Kent ME11 5EL Lielbritānija
Aesica Queenborough Ltd Queenborough Kent ME11 5EL United Kingdom
Ražotājs Aesica Queenborough Ltd Queenborough Kent ME11 5EL Lielbritānija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Lai iegūtu papildus informāciju par šīm zālēm, lūdzam īpašnieka vietējo pārstāvniecību.
Italia Abbott S.r.l.
144 Italia Abbott S. r. l.
{MM/YYYY}
Šī lietošanas instrukcija akceptēta {MM/ GGGG}
144 PACKAGE LEAFLET – INFORMATION FOR THE USER
INFORMĀCIJA ZĀĻU LIETOTĀJAM
Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir
KALETRA 100 mg/ 25 mg apvalkotās tabletes Lopinavir/ ritonavir
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
Ārsts noteiks, kādas
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.
- ja Jums ir alerģija (paaugstināta jutība) pret lopinaviru, ritonaviru vai kādu citu 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).
- ja Jums ir smagi aknu darbības traucējumi.
Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
Nelietojiet Kaletra kopā ar kādām no tālāk minētajām zālēm:
145 If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
- astemizolu vai terfenadīnu (parasti lieto, lai ārstētu alerģijas simptomus - šīs zāles var iegādāties
Take special care with Kaletra
arī bez receptes);
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.
- perorāli (iekšķīgi) lietotu midazolāmu, triazolāmu (lieto trauksmes un/ vai miega traucējumu
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.
- pimozīdu (lieto šizofrēnijas ārstēšanai);
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
- cisaprīdu (lieto, lai mazinātu noteiktus kuņģa darbības traucējumus);
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.
- ergotamīnu, dihidroergotamīnu, ergonovīnu, metilergonovīnu (lieto galvassāpju ārstēšanai);
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.
- amiodaronu (lieto sirdsdarbības traucējumu ārstēšanai);
On rare occasions these muscle disorders have been serious.
- vardenafilu (lieto erektīlās disfunkcijas ārstēšanai);
Taking other medicines
- zāles, kuru sastāvā ir divšķautņu asinszāle (Hypericum perforatum).
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);
Informāciju par dažām citām zālēm, kuru lietošanas gadījumā jāievēro īpaša piesardzība, lasiet zāļu sarakstā „ Citu zāļu lietošana ”.
146 − Heart medicines including:
146 Ja pašlaik lietojat kādas no šīm zālēm, jautājiet ārstam par nepieciešamību lietot citas zāles Kaletra terapijas laikā.
− − −
HIV infekciju un AIDS.
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
ar inficētām asinīm Jums jāievēro atbilstoši piesardzības pasākumi, lai nepieļautu slimības pārnešanu (piemēram, jāizmanto prezervatīvi).
− 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.
Kaletra var palielināt asiņošanas risku;
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.
- cukura diabēts, jo pacientiem, kuri lietojuši Kaletra, ziņots par paaugstinātu glikozes līmeni
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
- aknu slimības, jo pacientiem ar pārciestām aknu slimībām, piemēram, hronisku B vai
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.
- slikta dūša, vemšana, sāpes vēderā, apgrūtināta elpošana un izteikts muskuļu vājums kājās un
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
- slāpes, bieža urinēšana, apmiglota redze vai ķermeņa masas samazināšanās, jo tas var liecināt
Your doctor can explain these symptoms to you.
par paaugstinātu glikozes līmeni asinīs;
Contraceptives
Var būt tauku slāņa
− 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.
Šādu pārmaiņu cēlonis un ilgstoša ietekme uz veselību nav zināma;
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
- locītavu stīvums, smeldze un sāpes (īpaši gūžās, ceļos un plecos) un apgrūtinātas kustības, jo
Taking Kaletra with food and drink
Retos gadījumos šie
Kaletra tablets can be taken with or without food.
muskuļu traucējumi var būt nopietni.
Pregnancy and breast-feeding
Citu zāļu lietošana
− 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.
Izstāstiet savam ārstam, ja lietojat kādas no tālāk minētajām zālēm, jo šādā gadījumā jāievēro īpaša piesardzība:
Driving or using machines
- antidepresanti (piemēram, trazodons, bupropions);
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- pretepilepsijas līdzekļi (piemēram, karbamazepīns, fenitoīns, fenobarbitāls);
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.
- zāles erektīlās disfunkcijas ārstēšanai (piemēram, sildenafils un tadalafils);
Instead, contact your doctor.
- sirds zāles, to vidū:
147 3.
147
HOW TO TAKE KALETRA
hinidīns);
How should Kaletra be taken?
rosuvastatīns vai simvastatīns);
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed.
- steroīdi (piemēram, deksametazons, flutikazona propionāts, etinilestradiols);
− 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.
Informāciju par zālēm, kuras nedrīkst lietot kopā ar Kaletra, lasiet nodaļā „ Nelietojiet Kaletra kopā ar kādām no tālāk minētajām zālēm ”.
How much Kaletra should be taken and when?
- Nelietojiet Kaletra, ja pašlaik lietojat vardenafilu.
− The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- Ja lietojat sildenafilu vai tadalafilu kopā ar Kaletra, Jums var rasties tādas blakusparādības kā
Your doctor will advise on the number of tablets to be taken. − For children, your doctor will decide the right dose (number of tablets) based on the child’s height and weight. − Kaletra is also supplied as an oral solution for patients who cannot take tablets and as 200 mg/50 mg film-coated tablets.
Ārsts var Jums izskaidrot šos simptomus.
Can I stop taking Kaletra or change my dose?
Pretapaugļošanās līdzekļi
− 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. − 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.
grūtniecības, Jums jāizmanto papildus vai cita veida pretapaugļošanās metode (piemēram, prezervatīvs), jo Kaletra var mazināt perorālo un plākstera veida pretapaugļošanās līdzekļu efektivitāti.
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.
atbilstoši piesardzības pasākumi, lai nepieļautu slimības pārnešanu (piemēram, jāizmanto prezervatīvi).
If you take more Kaletra than you should
Kaletra lietošana kopā ar uzturu
− 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.
- Sievietes grūtniecības vai zīdīšanas laikā nedrīkst lietot Kaletra, ja vien ārsts nav īpaši norādījis.
If you forget to take Kaletra
inficēt ar HIV.
− 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.
Nevadiet transportlīdzekļus un neapkalpojiet mehānismus, ja izjūtat kādas blakusparādības
POSSIBLE SIDE EFFECTS
Kā jālieto Kaletra?
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
Vai es drīkstu pārtraukt Kaletra lietošanu vai mainīt devu?
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.
- Kaletra jālieto divreiz dienā katru dienu, lai palīdzētu kontrolēt HIV infekciju, neatkarīgi no tā,
You should tell your doctor promptly about these or any other symptoms.
- Lietojot Kaletra saskaņā ar ieteikumiem, Jums būs labākas izredzes aizkavēt rezistences
If the condition persists or worsens, seek medical attention.
- Ja kāda blakusparādība traucē lietot Kaletra kā norādīts, nekavējoties informējiet ārstu.
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).
- Rūpējieties, lai vienmēr būtu pieejams pietiekams Kaletra daudzums un Jums nevajadzētu izlaist
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.
Pirms ceļojuma vai pirms uzturēšanās slimnīcā pārliecinieties, ka Jums pietiks Kaletra, līdz varēsiet saņemt jaunu iepakojumu.
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.
Ja esat lietojis vairāk Kaletra nekā noteikts
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.
- Ja aptverat, ka esat ieņēmis vairāk Kaletra nekā nepieciešams, nekavējoties sazinieties ar ārstu. -
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.
- Ja aizmirstat ieņemt devu, izdariet to pēc iespējas ātrāk un tad turpiniet regulāri lietot parasto
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’).
Var būt grūti atšķirt blakusparādības, ko izraisījusi Kaletra, un blakusparādības, ko var izraisīt citas vienlaikus lietotas zāles un HIV infekcijas komplikācijas.
The cause and long-term health effects of these conditions are not known at this time.
Ir svarīgi, lai Jūs informētu ārstu par šiem vai jebkādiem citiem simptomiem.
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
Ja blakusparādības neizzūd vai pat pastiprinās, meklējiet medicīnisku palīdzību.
UNCOMMON side effects (affects 1 to 10 users in 1,000):
ĻOTI BIEŽI sastopamas blakusparādības (skar vairāk nekā 1 no 10 zāļu lietotājiem):
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- paaugstināts triglicerīdu (taukvielu paveida) līmenis.
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.
- nespēks un enerģijas trūkums;
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.
- slikta dūša, vemšana, sāpes vēderā, izkārnījumu izskata izmaiņas, gremošanas traucējumi kuņģī,
5.
- sāpes;
HOW TO STORE KALETRA
- izsitumi, pinnes;
− 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.
Ķermeņa apveida pārmaiņa tauku pārsadales dēļ Kombinēta ārstēšana ar pretretrovīrusu medikamentiem tauku sadalījuma izmaiņu dēļ var izraisīt ķermeņa formas pārmaiņas.
How should I dispose of any unused Kaletra?
šķidruma uzkrāšanās plaušās;
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
nepatīkama ķermeņa sajūta, šķidruma uzkrāšanās kājās un ap potītēm, mijiedarbība ar citām zālēm;
These measures will help protect the environment.
asinīs), nepietiekama vairogdziedzera darbība;
150 6.
150
FURTHER INFORMATION
KĀ UZGLABĀT KALETRA
Each tablet of Kaletra contains 100 mg of lopinavir and 25 mg of ritonavir
Katra Kaletra tablete satur 100 mg lopinavira un 25 mg ritonavira.
Tablet Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Tablete Koloidāls bezūdens silīcija dioksīds, kopovidons, nātrija stearilfumarāts, sorbitāna laurāts.
Tablet coating Polyvinyl alcohol, talc, titanium dioxide, macrogols type 3350, yellow ferric oxide E172.
Tabletes apvalks Polivinilspirts, talks, titāna dioksīds, 3350 tipa makrogols, dzeltenais dzelzs oksīds E172.
− Kaletra film-coated tablets come in a plastic bottle containing 60 tablets. − The tablets are pale yellow debossed with [Abbott logo] and “KC”. − One bottle of 60 tablets is provided in one package.
- Kaletra apvalkotās tabletes iepakotas plastmasas pudelēs pa 60 tabletēm.
Marketing Authorisation Holder
- Tabletes ir gaiši dzeltenas ar iespiedumu [Abbott logo] un “ KC ”.
Manufacturer
- Vienā iepakojumā ir viena pudele ar 60 tabletēm.
France Abbott France 10, rue d’Arcueil BP 90233 F-94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
Abbott France 10, rue d’ Arcueil BP 90233 F- 94528 Rungis Cedex Tél: + 33 (0) 1 45 60 25 00
153
153 Šī lietošanas instrukcija akceptēta {MM/ GGGG}
What is Karvea?
Kas ir Karvea?
Karvea is a medicine that contains the active substance irbesartan.
Karvea ir zāles, kas satur aktīvo vielu – ibesartānu.
It is available as white, oval tablets (75, 150 and 300 mg).
Tās pieejamas kā baltas, iegarenas tabletes (75 mg, 150 mg un 300 mg)
What is Karvea used for?
Kāpēc lieto 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.
Vārds „ esenciālā ” nozīmē, ka paaugstināto asinsspiedienu nav izraisījusi cita slimība.
Karvea is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Karvea lieto arī nieru slimību ārstēšanai, ja slimniekiem ir hipertensija un 2. tipa cukura diabēts (insulīnneatkarīgs diabēts).
Karvea is not recommended for use in patients below 18 years of age.
Karvea nav ieteicams pacientiem, kas jaunāki par 18 gadiem.
How is Karvea used?
Kā lieto Karvea?
Karvea is taken by mouth, with or without food.
Karvea lieto iekšķīgi kopā ar ēdienu vai atsevišķi.
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.
Ja asisnsspiedienu nevar pietiekami labi kontrolēt, devu var palielināt līdz 300 mg dienā vai var pievienot citas zāles hipertensijas ārstēšanai, piemēram, hidrohlortiazīdu.
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.
Slimniekiem, kam veic hemodialīzi (asins attīrīšanu) vai kas ir vecāki par 75 gadiem, sākumdeva var būt 75 mg.
In patients with hypertension and type 2 diabetes, Karvea is added to other treatments for hypertension.
Slimnieki ar hipertensiju un 2. tipa diabēta slimnieki var lietot Karvea kopā ar citām zālēm hipertensijas ārstēšanai.
How does Karvea work?
Kā Karvea darbojas?
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.
Tas pārtrauc hormona, ko dēvē par angiotenzīnu II, darbību organismā.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Bloķējot receptorus, ar kuriem parasti saistās angiotenzīns II, ibesartāns pārtrauc šī hormona iedarbību, izraisot asinsvadu paplašināšanos.
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Tādā veidā asinsspiediens pazeminās, samazinot veselības risku, kas rodas augsta asinsspiediena dēļ un izpaužas kā, piemēram, insults.
How has Karvea been studied?
Kā noritēja Karvea izpēte?
Karvea was originally studied in 11 trials for its effects on blood pressure.
Karvea sākotnēji pētīja 11 pētījumos, noskaidrojot tā ietekmi uz asinsspiedienu.
Karvea was compared with placebo (a dummy treatment) in 712 patients, and with other medicines for hypertension (atenolol, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Turklāt šo zāļu lietošana kopā ar 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. enalapril or amlodipine) in 823 patients.
Reproduction is authorised provided the source is acknowledged. hidrohlortiazīdu tika pētīta, iesaistot 1736 slimniekus.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Galvenais iedarbīguma rādītājs bija asinsspiediena pazemināšana diastolē (asinsspiediena mērījumi starp diviem sirdspukstiem).
For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Nieru slimības gadījumā Karvea papildus pētīja divos lielos pētījumos, iesaistot kopumā 2326 nieru slimniekus ar 2. tipa diabētu.
Karvea was used for two years or more.
Karvea tika lietotas ilgstoši – divus gadus vai ilgāk.
One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Vienā pētījumā pārbaudīja nieru bojājumu marķierus, novērtējot, vai nieres izvada albumīnu urīnā.
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.
Otrā pētījuma mērķis bija noskaidrot, vai Karvea paildzina laikposmu, kurā divkāršojas kreatinīna koncentrācija (nieru slimības marķieris) serumā, kā arī laikposmu, pēc kura pacientam nepieciešama nieru pārstādīšana vai dialīze, vai iestājas nāve.
In this study, Karvea was compared with placebo and with amlodipine.
Šajā pētījumā Karvea salīdzināja ar placebo un amlodipīnu
What benefit has Karvea shown during the studies?
Kāds ir Karvea iedarbīgums šajos pētījumos?
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.
Asinsspiediena pētījumos Karvea labāk nekā placebo samazināja asinsspiedienu diastolē un pēc iedarbības bija līdzīgas citām zālēm hipertensijas ārstēšanai.
When used with hydrochlorothiazide, the effects of the two medicines were additive.
Lietojot Karvea kopā ar hidrohlortiazīdu, divu zāļu veidu iedarbība summējās.
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.
Pirmajā nieru slimības pētījumā, vērtējot pēc olbaltumvielas izvadīšanas, Karvea labāk nekā placebo samazināja nieru bojājumu risku.
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.
Otrajā nieru slimības pētījumā Karvea samazināja relatīvo risku — kas izpaužas kā seruma kreatinīna koncentrācijas divkāršošanās, nepieciešamība veikt nieres pārstādīšanu vai dialīzi, kā arī letāls iznākums pētījuma laikā, — par 20%, salīdzinot ar placebo.
The main benefit was on the effect on blood creatinine levels.
Galvenais ieguvums bija iedarbīgums uz seruma kreatinīna koncentrāciju.
What is the risk associated with Karvea?
Kāds pastāv risks, lietojot 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).
Visbiežāk novērotās Karvea nevēlamās blakusparādības (vienam līdz desmit pacientiem no simts) bija reibonis (slikta dūša) vai vemšana, nespēks (nogurums) un asins kreatīnkināzes (muskuļos atrodama fermenta) līmeņa palielināšanās.
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).
Turklāt vairāk nekā vienam pacientam no simts ar 2. tipa cukura diabētu un aknu slimību novēro šādas nevēlamās blakusparādības: hiperkalēmiju (augstu kālija līmeni), ortostatiskus reiboņus (reiboņi, kas parādās, pieceļoties), sāpes muskuļos un kaulos un ortostatisku hipertensiju (pazemināto asinsspiedienu, pieceļoties).
For the full list of all side effects reported with Karvea, see the Package Leaflet.
Pilns visu Karvea izraisīto blakusparādību saraksts ir atrodams zāļu lietošanas pamācībā.
Karvea should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Karvea nedrīkst lietot cilvēki, kam ir paaugstināta jutība (alerģija) pret irbesartānu vai kādu citu šo zāļu sastāvdaļu.
Its use during the first three months of pregnancy is not recommended.
Šo zāļu lietošana sievietēm pirmo trīs grūtniecības mēnešu laikā nav ieteicama.
Why has Karvea been approved?
Kāpēc Karvea tika apstiprinātas?
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.
Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka pacienta ieguvumi, ar Karvea ārstējot hipertensiju, kā arī nieru slimniekus ar hipertensiju un 2. tipa cukura diabētu, pārsniedz šo zāļu radīto risku.
The Committee recommended that Karvea be given marketing authorisation.
Komiteja ieteica izsniegt Karvea reģistrācijas apliecību.
The European Commission granted a marketing authorisation valid throughout the European Union for Karvea to Bristol-Myers Squibb Pharma EEIG on 27 August 1997.
Cita informācija par Karvea Eiropas Komisija 1997. gada 27. augustā izsniedza Karvea reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam Bristol- Myers Squibb Pharma EEIG.
The marketing authorisation was renewed on 27 August 2002 and on 27 August 2007.
Reģistrācijas apliecība tika atjaunota 2002. gada 27. augustā un 2007. gada 27. augustā.
The full EPAR for Karvea is available here.
Pilns Karvea EPAR teksts ir atrodams šeit.
Route of Administration
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Karvea 75 mg tablets.
Karvea 75 mg tabletes.
Each tablet contains 75 mg of irbesartan.
Tablete satur 75 mg irbesartāna (Irbesartan).
Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Karvea 150 mg lietošana reizi dienā parasti nodrošina labāku asinsspiediena kontroli 24 h nekā 75 mg deva.
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.
Pacientiem, kuru stāvokli neizdodas pietiekami kontrolēt ar 150 mg reizi dienā, Karvea devu var palielināt līdz 300 mg vai pievienot citu antihipertensīvo līdzekli.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).
Pierādīts, ka Karvea iedarbību īpaši pastiprina diurētiskā līdzekļa, piemēram, hidrohlortiazīda pievienošana (skatīt apakšpunktu 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).
Karvea labvēlīgā ietekme uz nierēm 2. tipa cukura diabēta pacientiem ar hipertensiju pierādīta pētījumos, kuros irbesartānu lietoja papildus citiem antihipertensīviem līdzekļiem, lai sasniegtu mērķa asinsspiedienu (skatīt apakšpunktu 5. 1).
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
Pacientiem, kam veic hemodialīzi, jāapsver mazākas sākumdevas (75 mg) lietošana (skatīt apakšpunktu 4. 4)..
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.
Gados veci pacienti: kaut gan par 75 gadiem vecākiem pacientiem jāapsver sākumterapija ar 75 mg, gados veciem cilvēkiem deva parasti nav jāpielāgo.
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).
Lietošana bērniem: irbesartānu nav ieteicams lietot bērniem un pusaudžiem, jo nav pietiekošu datu par drošību un efektivitāti (skatīt apakšpunktu 4. 8, 5. 1 un 5. 2).
Such conditions should be corrected before the administration of Karvea.
Šie traucējumi jānovērš pirms Karvea lietošanas.
While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Kaut gan šāda iedarbība nav konstatēta, lietojot Karvea, angiotensīna- II receptoru antagonisti var to izraisīt.
Renal impairment and kidney transplantation: when Karvea is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Pavājināta nieru darbība un nieru transplantācija: lietojot Karvea pacientiem ar pavājinātu nieru darbību, ieteicams periodiski kontrolēt kālija un kreatinīna līmeni serumā.
There is no experience regarding the administration of Karvea in patients with a recent kidney transplantation.
Nav pieredzes par Karvea lietošanu pacientiem, kam nesen pārstādīta niere.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Karvea, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Hiperkaliēmija: tāpat kā lietojot citas renīna- angiotensīna- aldosterona sistēmu ietekmējošas zāles, ārstēšanas laikā ar Karvea var attīstīties hiperkaliēmija, īpaši pavājinātas nieru darbības, diagnosticētas proteinūrijas gadījumā diabētiskas nieru slimības dēļ un/ vai sirds mazspējas gadījumā.
Lithium: the combination of lithium and Karvea is not recommended (see section 4.5).
Litijs: nav ieteicams lietot litija un Karvea kombināciju (skatīt apakšpunktu 4. 5).
Therefore, the use of Karvea is not recommended.
Primārs aldosteronisms: pacientiem ar primāru aldosteronismu parasti nebūs atbildreakcijas pret antihipertensīviem līdzekļiem, kas darbojas, nomācot renīna- angiotensīna sistēmu, tādēļ Karvea lietošana nav ieteicama.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Kā novērots, lietojot angiotensīnu konvertējošā enzīma inhibitorus, irbesartāns un citi angiotensīna antagonisti melnādainiem cilvēkiem pazemina asinsspiedienu mazāk efektīvi nekā ne- melnādainiem cilvēkiem, iespējams, tādēļ, ka starp melnādaniem hipertensijas slimniekiem ir vairāk pacientu ar zemu renīna līmeni (skatīt apakšpunktu 5. 1).
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be
Pacientēm, kas plāno grūtniecību, jāveic pāreja uz alternatīvu ārstēšanu ar
3 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
3 artihipertensīviem līdzekļiem, kuriem ir vispāratzīts drošības profils grūtniecības laikā, ja vien AIIRA terapijas turpināšana nav būtiski pamatota.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pacientiem ar retu iedzimtu galaktozes nepanesamību, Lapp laktāzes deficītu vai glikozes- galaktozes malabsorbciju šīs zāles nav ieteicams lietot.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Karvea has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Diurētiskie līdzekļi un citi antihipertensīvie līdzekļi: citi antihipertensīvie līdzekļi var pastiprināt irbesartāna hipotensīvo darbību, tomēr Karvea ir droši lietots kopā ar citiem antihipertensīviem līdzekļiem, piemēram, beta blokatoriem, ilgstošas darbības kalcija kanālu blokatoriem un tiazīdu grupas diurētiskiem līdzekļiem.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Karvea (see section 4.4).
Iepriekšēja ārstēšana ar lielām diurētisko līdzekļu devām var izraisīt šķidruma deficītu un radīt hipotensijas risku, sākot ārstēšanu ar Karvea (skatīt apakšpunktu 4. 4).
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Nesteroīdie pretiekaisuma līdzekļi: ja angiotesīna II antagonistus lieto vienlaikus ar nesteroīdiem pretiekaisuma līdzekļiem (tostarp, selektīviem COG- 2 inhibitoriem, acetilsalicilskābi (> 3 g/ dienā) un neselektīviem NSPL, antihipertensīvā iedarbība var pavājināties.
4 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
4 turpināšana nav būtiski pamatota.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Tiklīdz grūtniecība ir apstiprināta, ārstēšana ar AIIRA jāpārtrauc nekavējoties, un nepieciešamības gadījumā jāuzsāk alternatīva terapija.
Karvea is contraindicated (see section 4.3) during breast-feeding.
Karvea ir kontrindicēts (skatīt apakšpunktu 4. 3) laikā, kad bērnu baro ar krūti.
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i. e., uncommon) but in excess of placebo.
0, 5% cukura diabēta pacientu ar mikroalbuminūriju un normālu nieru darbību (t. i., retāk), bet biežāk nekā lietojot placebo, novēroja ortostatisku reiboni un ortostatisku hipotensiju.
The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Zemāk sekojošā tabula atspoguļo nevēlamās blakusparādības, kuras novēroja ar placebo kontrolētos pētījumos, kuros 1965 pacienti saņēma irbesartānu.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Bieži:
5 Common:
5