natgillin/translations-raw huggingface dataset:
Моля информирайте Вашия лекар или фармацевт, ако приемате или наскоро сте приемали други лекарства, включително и такива, отпускани без рецепта.
− 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).
- Не вземайте Kaletra, ако в момента приемате варденафил.
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.
- Ако приемате едновременно силденафил или тадалафил с Kaletra, може да сте изложени
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
на риск от нежелани реакции като понижено кръвно налягане, припадък, промени в зрението и ерекция, траеща повече от 4 часа.
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.
предотвратяване на бременност, трябва да използвате допълнителен или различен метод за контрацепция (напр. презерватив), тъй като Kaletra може да намали ефективността на пероралните контрацептиви или контрацептивните пластири.
− 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.
Вие трябва да вземете
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
147 Прием на Kaletra с храна и напитки
Taking Kaletra with food and drink
Kaletra таблетки може да се приема с или без храна.
It is important that Kaletra is taken with food.
- Ако сте бременна или мислите, че може да сте бременна, или кърмите, незабавно
− 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.
уведомете Вашия лекар.
128 Driving or using machines
- Бременните или кърмещите жени, не трябва да вземат Kaletra, освен ако не е изрично
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
- Препоръчва се на инфектираните с HIV жени да не кърмят, тъй като има възможност от
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.
КАК ДА ПРИЕМАТЕ KALETRA
Instead, contact your doctor.
- Kaletra таблетки може да се приема с или без храна.
Kaletra contains 42% v/v alcohol.
- Винаги приемайте Kaletra точно както Ви е казал Вашият лекар.
Important information about some of the ingredients of Kaletra
фармацевт.
Kaletra contains 42% v/v alcohol.
Колко Kaletra трябва да се приема и кога
Each dose contains up to 1.7 g of alcohol.
- Обичайната доза за възрастни е 400 mg/ 100 mg два пъти дневно, т. е на всеки 12 часа, в
Potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
комбинация с други анти- ХИВ лекарства.
May modify or increase the effect of other medicines.
- За деца, Вашият лекар ще определи подходящата доза (броя таблетки), въз основа на
This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
височината и теглото на детето.
Unsuitable in hereditary fructose intolerance.
- Kaletra се предлага също под формата на перорален разтвор за пациенти, които не могат
Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a physician.
Допустимо ли е да прекратите приема на Kaletra или да промените дозата си
Kaletra contains glycerol which is harmful in high doses.
консултирате с Вашия лекар.
Can cause headache and stomach upset and diarrhoea.
- Kaletra винаги трябва да се взема два пъти дневно, всеки ден, за да подпомага контрола на
Kaletra contains polyoxyl 40 hydrogenated castor oil.
HIV инфекцията, без значение колко по- добре се чувствате.
This may cause nausea, vomiting, colic, severe purgation at high doses.
възможност за забавяне на развитието на резистентност към продукта.
It should not be given when intestinal obstruction is present.
- Ако някоя нежелана реакция Ви пречи да приемате Kaletra, както е предписано, веднага
Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet.
кажете на Вашия лекар.
High potassium in the blood can cause stomach upset and diarrhoea.
Когато
Kaletra contains sodium as saccharin sodium, sodium chloride and sodium citrate, which may be harmful to people on a low sodium diet.
препоръча друго.
HOW TO TAKE KALETRA
148 Ако сте приели повече от необходимата доза Kaletra
Kaletra is recommended for use in adults and children 2 years of age or older who are infected with HIV.
Вашия лекар.
Take care when dosing children.
Ако сте пропуснали да приемете Кaletra
Dosing should be less that 5 ml twice daily for children weighing less that 40 kg.
- Ако сте пропуснали доза, вземете пропуснатата доза възможно най- скоро, след което
− 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.
ВЪЗМОЖНИ НЕЖЕЛАНИ РЕАКЦИИ
How much Kaletra should be taken and when?
Както всички лекарства, Kaletra може да предизвика нежелани реакции, въпреки че не всеки ги получава.
− 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.
Може да се окаже трудно да се разграничат нежеланите реакции, предизвикани от Kaletra и тези, които са причинени от други лекарства, приемани по същото време или от усложненията на HIV- инфекцията.
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.
- повишен холестерол;
Can I stop taking Kaletra or change my dose?
Допълнителна информация относно повишени нива на холестерола и триглицеридите
− 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.
- Към момента не са известни дългосрочните рискове от усложнения като инфаркт или
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.
удар, поради повишеното ниво на триглицеридите и холестерола.
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.
- Вашият лекар ще Ви проследява и при необходимост ще Ви предпише други лекарства.
How do I measure the correct dose of the solution?
- Значителното повишаване на количеството на триглицеридите (масти в кръвта) се счита
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.
също за рисков фактор за панкреатит.
Talk to you pharmacist if you have difficulty opening the bottle.
ЧЕСТИ нежелани реакции:
5 dosing syringes are included in each carton of Kaletra oral solution.
(засягат от 1 до 10 на 100 пациенти):
Ask your pharmacist for instructions on how to use the syringe correctly.
- отклонения в показателите за функцията на черния дроб при лабораторни изследвания;
After each dose of Kaletra separate the plunger and the syringe.
- промени във формата на тялото, поради промени в разпределението на мазнините в
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.
- главоболие;
Rinse the syringe and plunger with clean water.
- повишено ниво на кръвната захар, повишена амилаза (храносмилателен ензим) и
Put the syringe back together and draw up and expel tap water a few times to rinse.
повишени чернодробни ензими;
Let the syringe dry completely before you use that syringe for dosing.
- проблеми със съня;
If you take more Kaletra than you should
- гадене, повръщане, болка в корема, промяна в изпражненията, нарушено храносмилане,
− 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.
- обриви, акне;
If you forget to take Kaletra
Информирайте вашия лекар, ако забележите някакви промени във формата на тялото поради промени в разпределението на мазнините в тялото.
− 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.
лимфните възли;
POSSIBLE SIDE EFFECTS
- проблеми със зрението, нарушения на очите;
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- сърцебиене, "прескачане ” или „ блъскане ” на сърцето, сърдечен удар, оток и/ или
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.
натрупване на течност в белия дроб;
You should tell your doctor promptly about these or any other symptoms.
- подуване на корема, запек, сухота в устата, затруднено преглъщане, възпаление на
If the condition persists or worsens, seek medical attention.
- болка в областта на гърдия кош, болка зад гръдната кост, студени тръпки, треска,
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).
грипоподобни симптоми, чувство на физически дискомфорт, отоци на краката и около глезените, взаимодействие с други лекарства;
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.
апетит, повишени на млечната киселина в кръвта, затлъстяване, безапетитие, захарен диабет, повишена кръвна захар, ниски нива на холестерол в кръвта;
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.
- замаяност, загуба или нарушение на паметта, загуба на способността за координиране на
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.
- необичайни сънища, възбуда, тревожност, обърканост, депресия, нарушаване на
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.
способността за контрол на движенията, емоционална лабилност, намалено сексуално желание, нервност, нарушен мисловен процес;
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’).
- нарушена еякулация, уголемяване на гърдите, гинекомастия, импотентност, менорагия
The cause and long-term health effects of these conditions are not known at this time.
(необичайно силно или продължително менструално кървене);
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
- задух, дразнене и възпаление на носа, засилена кашлицата;
UNCOMMON side effects (affects 1 to 10 users in 1,000):
- кожни доброкачествени новообразувания, кисти;
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- повишено кръвно налягане, възпаление на вените, водещо до образуването на тромб,
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.
възпаление на кръвоносните съдове, възпаление на дълбоките вени, водещо да образуването на тромб, съдови нарушения.
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.
- Съхранявайте на място, недостъпно за деца.
− Keep out of the reach and sight of children. − Do not use Kaletra after the expiry date which is stated on the bottle.
- Не използвайте Kaletra след срока на годност, отбелязан върху опаковката.
How should I store Kaletra and for how long?
- Този лекарствен продукт не изисква специални условия на съхранение.
− Store in a refrigerator (2°C - 8°C). − In use storage:
Как да се изхвърлят неизползваните количества Kaletra
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
- Лекарствата не трябва да се изхвърлят в канализацията или в контейнера за домашни
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.
отпадъци.
How should I dispose of any unused Kaletra?
Тези мерки ще
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
спомогнат за опазване на околната среда.
These measures will help protect the environment.
6.
132 6.
Какво съдържа Kaletra
What Kaletra contains
Всяка таблетка Kaletra съдържа 200 mg лопинавир и 50 mg ритонавир.
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
сорбитанов
The other ingredients are:
Обвивка на таблетката Хипромелоза, титанов диоксид, макроголи тип 400 (полиетилен гликол 400), хидроксипропил целулоза, талк, колоидален силициев диоксид, макроголи тип 3350 (полиетилен гликол 3350), жълт железен оксид Е172, полисорбат 80.
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.
- Kaletra филмирани таблетки са поставени в пластмасова бутилка, съдържаща 120
− 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.
таблетки.
Marketing Authorisation Holder
- Таблетките са жълти с вдлъбнато релефно означение [Abbott лого] и ” КА ”.
Manufacturer
България Т. П.
България Т.П.
Danmark Abbott Laboratories A/ S Emdrupvej 28C DK- 2100 København Ø Tlf: + 45 39 77- 00- 00
133 Danmark Abbott Laboratories A/S Emdrupvej 28C DK-2100 København Ø Tlf: + 45 39 77-00-00
152 Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Läti Tel: + 371 67605580
Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
Italia Abbott S. r. l.
134 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
153 Latvija Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Tel: + 371 67605580
Latvija Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Tel: + 371 67605580
Дата на последно одобрение на листовката {ММ/ ГГГГ}.
This leaflet was last approved in:
154 ЛИСТОВКА:
{MM/YYYY}
- Запазете тази листовка.
135 PACKAGE LEAFLET – INFORMATION FOR THE USER
- Ако имате допълнителни въпроси, моля попитайте Вашия лекар или фармацевт.
KALETRA 200 mg/50 mg film-coated tablets lopinavir/ritonavir
- Това лекарство е предписано лично на Вас.
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Kaletra е антиретровирусно лекарство.
It belongs to a group of medicines called protease inhibitors. − Kaletra is prescribed for use in combination with other antiviral medicines.
Принадлежи към група лекарства наречени
Your doctor will determine which medicines are best for you.
протеазни инхибитори.
BEFORE YOU TAKE KALETRA
Вашият лекар ще
Do not take Kaletra
определи кои лекарствени продукти са най- подходящи за Вас.
− if you are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra.
ПРЕДИ ДА ПРИЕМЕТЕ KALETRA
− if you have severe liver problems
Не приемайте Kaletra:
136 Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
- ако сте алергични (свръхчувствителни) към лопинавир, ритонавир или някоя от другите
If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
съставки на Kaletra.
Take special care with Kaletra
- ако имате тежки чернодробни проблеми.
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.
Не приемайте Kaletra с някое от следните лекарства:
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.
- астемизол или терфенадин (често използвани за лечение на симптомите на алергии - тези
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.
лекарствени продукти може да са достъпни и без рецепта);
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’).
- мидазолам, приеман перорално (приеман през устата), триазолам (използвани за
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.
намаляване на тревожността и/ или при смущения на съня);
On rare occasions these muscle disorders have been serious.
- пимозид (използван за лечение на шизофрения);
Taking other medicines
- цизаприд (използван за облекчаване на някои стомашни проблеми);
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);