natgillin/translations-raw huggingface dataset:
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.
kot npr. nizek krvni tlak, omedlevica, motnje vida in erekcija, ki traja več kot 4 ure.
− 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.
uporabiti dodatno ali drugačno kontracepcijsko zaščito (npr. kondom), kajti zdravilo Kaletra lahko zmanjša učinkovitost peroralnih kontraceptivov ali kontraceptivov v obližu.
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
Upoštevati morate ustrezne
It is important that Kaletra is taken with food.
Tablete Kaletra lahko vzamete s hrano ali brez nje.
− 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.
- Nosečnice ali doječe matere ne smejo jemati zdravila Kaletra, razen če jim tega posebej ne naroči
128 Driving or using machines
Vpliv na sposobnost upravljanja vozil in strojev
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.
Ne vozite in ne upravljajte s stroji, če se vam pojavi katerikoli neželeni učinek (npr.
Kaletra contains 42% v/v alcohol.
KAKO JEMATI ZDRAVILO KALETRA
Important information about some of the ingredients of Kaletra
Pomembno je, da tablete Kaletra zaužijete cele in jih ne žvečite, ne lomite in ne drobite.
Kaletra contains 42% v/v alcohol.
- Tablete Kaletra lahko vzamete s hrano ali brez nje.
Each dose contains up to 1.7 g of alcohol.
- Pri jemanju zdravila Kaletra natančno upoštevajte zdravnikova navodila.
Potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
- Če ste negotovi o jemanju vašega zdravila, se posvetujte z zdravnikom ali s farmacevtom.
May modify or increase the effect of other medicines.
Koliko zdravila Kaletra naj uporabim in kdaj
This medicinal product contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
- Običajni odmerek za odrasle je 400 mg/ 100 mg dvakrat na dan, to je vsakih 12 ur, v kombinaciji z
Unsuitable in hereditary fructose intolerance.
Zdravnik vam bo svetoval, koliko tablet morate vzeti.
Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a physician.
- Pravi odmerek (število tablet) za otroka bo zdravnik določil na temelju otrokove višine in telesne
Kaletra contains glycerol which is harmful in high doses.
- Zdravilo Kaletra je na voljo tudi kot peroralna raztopina za bolnike, ki ne morejo zaužiti tablet, in
Can cause headache and stomach upset and diarrhoea.
v obliki 100 mg/ 25 mg filmsko obloženih tablet.
Kaletra contains polyoxyl 40 hydrogenated castor oil.
Ali lahko preneham z jemanjem zdravila Kaletra ali spremenim odmerek
This may cause nausea, vomiting, colic, severe purgation at high doses.
- Dnevnega odmerka zdravila Kaletra ne spreminjajte in ne opuščajte, ne da bi se prej posvetovali z
It should not be given when intestinal obstruction is present.
- Da bo zdravilo Kaletra pomagalo obvladovati okužbo s HIV, ga morate vzeti vsak dan dvakrat, ne
Kaletra contains potassium as acesulfame potassium, which may be harmful to people on a low potassium diet.
- Uporaba zdravila Kaletra po navodilih zagotavlja najboljšo možnost za odložitev pojava
High potassium in the blood can cause stomach upset and diarrhoea.
odpornosti proti temu zdravilu.
Kaletra contains sodium as saccharin sodium, sodium chloride and sodium citrate, which may be harmful to people on a low sodium diet.
- Če vam neželen učinek prepreči, da bi zdravilo Kaletra jemali, kot je naročeno, to takoj povejte
HOW TO TAKE KALETRA
zdravniku.
Kaletra is recommended for use in adults and children 2 years of age or older who are infected with HIV.
- Vedno imejte pri roki dovolj zdravila Kaletra, da vam ga ne bo zmanjkalo.
Take care when dosing children.
Če greste na potovanje
Dosing should be less that 5 ml twice daily for children weighing less that 40 kg.
ali v bolnišnico, imejte s seboj vedno toliko zdravila Kaletra, da bo trajalo, dokler ne dobite nove zaloge.
− 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.
- To zdravilo jemljite, dokler vam zdravnik ne naroči drugače.
How much Kaletra should be taken and when?
Če ste vzeli večji odmerek zdravila Kaletra, kot bi smeli
− 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.
- Če ugotovite, da ste vzeli več zdravila Kaletra, kot bi bilo treba, se takoj posvetujte s svojim
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.
- Če ne morete kontaktirati svojega zdravnika, pojdite v bolnišnico.
Can I stop taking Kaletra or change my dose?
Če ste pozabili vzeti zdravilo 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.
- Če ste pozabili vzeti zdravilo Kaletra, vzemite izpuščeni odmerek čim je mogoče, potem pa
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.
Včasih je težko ločiti neželene učinke zaradi zdravila Kaletra od neželenih učinkov zaradi drugih sočasno uporabljanih zdravil ali od zapletov okužbe 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.
Če stanje traja ali se poslabša, poiščite zdravniško pomoč.
How do I measure the correct dose of the solution?
143 Najpogostejši neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov):
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.
- zvišana GGT (gama- glutamil transferaza, to je tip jetrnih encimov);
Talk to you pharmacist if you have difficulty opening the bottle.
- zvišani trigliceridi (vrsta maščobe).
5 dosing syringes are included in each carton of Kaletra oral solution.
Dodatne informacije o zvišanem holesterolu in trigliceridih
Ask your pharmacist for instructions on how to use the syringe correctly.
- Dolgotrajna tveganja za zaplete zaradi zvišanih trigliceridov in holesterola, npr. za srčne napade
After each dose of Kaletra separate the plunger and the syringe.
- Zdravnik bo spremljal vaše stanje in vam bo lahko predpisal druga zdravila, če bo potrebno.
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.
- Močno zvečanje nivoja trigliceridov (vrste maščob v krvi) velja za dejavnik tveganja za
Rinse the syringe and plunger with clean water.
- nenormalni jetrni funkcijski testi;
Put the syringe back together and draw up and expel tap water a few times to rinse.
- sprememba telesne oblike zaradi spremenjene porazdelitve maščevja;
Let the syringe dry completely before you use that syringe for dosing.
- zvišana glukoza, zvišana amilaza (prebavni encim), zvišani jetrni encimi;
If you take more Kaletra than you should
- pomanjkanje moči in energije;
− 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.
- občutek siljenja na bruhanje, bruhanje, bolečine v trebuhu, nenormalno blato, motnje prebavne
If you forget to take Kaletra
funkcije po jedi, vetrovi, prebavne motnje;
− 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.
- bolečine;
POSSIBLE SIDE EFFECTS
- izpuščaji, akne;
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- ščemenje, zbadanje ali otrplost kože.
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.
To lahko obsega izginotje maščevja na nogah, rokah in obrazu, zvečanje maščevja v trebuhu in drugih notranjih organih, zvečanje dojk in kopičenje na hrbtu in vratu ("bivolja grba").
You should tell your doctor promptly about these or any other symptoms.
Vzrok in dolgotrajne zdravstvene posledice teh sprememb trenutno niso znane.
If the condition persists or worsens, seek medical attention.
Občasni neželeni učinki (pojavijo se pri 1 do 10 od 1000 bolnikov):
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).
- zmanjšano število rdečih krvnih celic, zmanjšano število belih krvnih celic, zvečanje bezgavk;
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.
- šumenje v enem ali obeh ušesih, kot je brnenje, zvenenje, piskanje;
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.
- nenormalen vid, očesne bolezni;
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.
- občutki hitrega, neenakomernega ali močnega utripanja srca, srčni infarkt, otekanje in/ ali nabiranje
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.
- zvečanje trebuha, zaprtje, suha usta, težave pri požiranju, vnetje tankega in debelega črevesa,
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’).
spahovanje, vnetje požiralnika, nezmožnost kontroliranja izločanja blata, vnetje želodca in črevesja, krvava driska, razjede v ustih, vnetje trebušne slinavke, vnetje žleze slinavke, vnetje v ustih, vnetje dlesni;
The cause and long-term health effects of these conditions are not known at this time.
- bolečine v prsih, bolečine v prsih pod prsnico, mrzlica, zvišana telesna temperatura, simptomi,
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
- zmanjšano delovanje testisov, Cushingov sindrom (stanje, ki ga povzroči visok nivo kortizola v
UNCOMMON side effects (affects 1 to 10 users in 1,000):
krvi), zmanjšano delovanje ščitnice;
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- vnetje srednjega ušesa, vnetje bronhijev, vnetje sinusov, turavost, bakterijska okužba, virusna
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.
okužba;
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.
- zmanjšana toleranca na glukozo, zvečanje telesne mase, hujšanje, zvišan bilirubin (žolčno
5.
144
HOW TO STORE KALETRA
presežek sečne kisline v krvi;
− Keep out of the reach and sight of children. − Do not use Kaletra after the expiry date which is stated on the bottle.
- vnetje žolčnika, vnetje jeter, povečanje jeter, nalaganje maščobe v jetrih, občutljivost jeter;
The expiry date refers to the last day of that month.
- nenormalne sanje, huda tesnoba, anksioznost, zmedenost, depresija, motena sposobnost
How should I store Kaletra and for how long?
podaljšana menstruacija;
− Store in a refrigerator (2°C - 8°C). − In use storage:
- oteženo dihanje z občutkom napora dihalnih mišic, vzdraženost in vnetje nosne sluznice, povečan
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
- plešavost, suha koža, ekcem, vnetje kože z luščenjem tkiva, ploščat rdeč izpuščaj z aknami ali
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.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Do not transfer it to any other container.
SHRANJEVANJE ZDRAVILA KALETRA
How should I dispose of any unused Kaletra?
- Zdravilo shranjujte nedosegljivo otrokom!
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Zdravila Kaletra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na
These measures will help protect the environment.
Kako naj zavržem neporabljeno zdravilo Kaletra
132 6.
Takšni
What Kaletra contains
Kaj vsebuje zdravilo Kaletra
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Ena tableta Kaletre vsebuje 200 mg lopinavirja in 50 mg ritonavirja.
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.
Filmska obloga Hipromeloza, titanov dioksid, makrogol 400, hidroksipropilceluloza, smukec, brezvodni koloidni silicijev dioksid, makrogol 3350, rumeni železov oksid E172, polisorbat 80.
What Kaletra look like and contents of the pack
145 Izgled zdravila Kaletra in vsebina pakiranja
− 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.
- Tablete so rumene in imajo vtisnjeni oznaki [Abbottov logo] in "KA".
Marketing Authorisation Holder
- Eno pakiranje vsebuje 3 škatle (120 tablet).
Manufacturer
Imetnik dovoljenja za promet z zdravilom
Deutschland Abbott GmbH & Co.
146 Deutschland Abbott GmbH & Co.
Κύπρος Lifepharma (Z.A.M.) Ltd Aγ.
147 Κύπρος Lifepharma (Z. A. M.) Ltd Aγ.
135 PACKAGE LEAFLET – INFORMATION FOR THE USER
148 NAVODILO ZA UPORABO
KALETRA 200 mg/50 mg film-coated tablets lopinavir/ritonavir
KALETRA 100 mg/ 25 mg filmsko obložene tablete lopinavir/ ritonavir
− if you have severe liver problems
- če imate hude težave z jetri.
136 Read the list of medicines under ‘Taking other medicines’ for information on certain other medicines which require special care.
Ne jemljite zdravila Kaletra, če trenutno jemljete katero od naslednjih zdravil
If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
- astemizol ali terfenadin (pogosto se uporabljata za zdravljenje simptomov alergije – ti zdravili
Take special care with Kaletra
sta lahko na voljo brez recepta);
Appropriate precautions should be taken to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination.
- peroralni (zaužiti) midazolam, triazolam (uporabljata se za lajšanje tesnobnosti in/ ali težav s
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.
spanjem);
On rare occasions these muscle disorders have been serious.
- pimozid (uporablja se za zdravljenje shizofrenije);
Taking other medicines
- cisaprid (uporablja se za lajšanje določenih težav z želodcem);
137 − Antifungals (e.g. ketoconazole, itraconazole, voriconazole); − Erectile dysfunction medicines (e.g. sildenafil and tadalafil); − Heart medicines including:
- ergotamin, dihidroergotamin, ergonovin, metilergonovin (uporabljajo se za zdravljenje
− − −
glavobolov);
Digoxin; Calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine); Medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
- amiodaron (uporablja se za zdravljenje motenj srčnega ritma);
− 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.
- vardenafil (uporablja se za zdravljenje erektilne disfunkcije);
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.
- izdelke, ki vsebujejo šentjanževko (Hypericum perforatum).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
149 Za informacije o drugih zdravilih, ki zahtevajo posebno pozornost, preberite seznam zdravil v poglavju “ Jemanje drugih zdravil ”.
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Če trenutno jemljete katero od teh zdravil, se za čas, ko jemljete zdravilo Kaletra, z zdravnikom pogovorite o zamenjavi s kakšnim drugim zdravilom.
Your doctor can explain these symptoms to you.
Bodite posebno pozorni pri uporabi zdravila Kaletra
Contraceptives
Pomembni podatki
Appropriate precautions (e.g. use of a condom) should be taken to prevent passing on the disease through sexual contact.
- Zdravilo Kaletra ne ozdravi okužbe s HIV ali AIDS- a.
Taking Kaletra with food and drink
- Osebe, ki jemljejo zdravilo Kaletra, lahko še vedno zbolijo za okužbami ali drugimi boleznimi,
Kaletra tablets can be taken with or without food.
Zato je pomembno, da med jemanjem zdravila Kaletra ostanete pod nadzorstvom svojega zdravnika.
Pregnancy and breast-feeding
Upoštevati morate ustrezne
− 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.
previdnostne ukrepe, da ne pride do prenosa s spolnim stikom (npr. uporaba kondoma) ali kontaminacijo s krvjo.