natgillin/translations-raw huggingface dataset:
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in z oportunistično okužbo v anamnezi se lahko kmalu po začetku anti- HIV zdravljenja pojavijo znaki in simptomi vnetja povezani s prejšnjimi okužbami.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Menijo, da so ti simptomi posledica izboljšanja telesnega imunskega odgovora, ki omogoča telesu, da se brani pred okužbami, ki so bile prej prisotne brez očitnih simptomov.
Please speak with your doctor if you have a history of liver disease.
Če imate ali ste kdaj imeli jetrno bolezen, se posvetujete s svojim zdravnikom.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.
Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo z protiretrovirusnimi zdravili, obstaja večje tveganje za resne in potencialno smrtne neželene učinke na jetrih, zato bodo morda pri njih potrebne krvne preiskave za nadzorovanje jetrne funkcije.
If you have a chronic hepatitis B infection, you should not stop your treatment without instructions from your doctor, as you may have a recurrence of your hepatitis.
Če imate kronično okužbo z virusom hepatitisa B, zdravljenja ne smete prekiniti, ne da bi se pred tem posvetovali s svojim zdravnikom, saj bi se lahko hepatitis ponovil.
This recurrence may be more severe if you have serious liver disease.
Ponovni pojav hepatitisa je lahko še hujši, če ste hud jetrni bolnik.
You will need to take Combivir every day.
Zdravilo Combivir boste morali jemati vsak dan.
This medicine helps to control your condition and delay disease progression, but it is not a cure for HIV infection.
To zdravilo pomaga nadzorovati stanje in upočasni napredovanje bolezni, vendar ne ozdravi okužbe s HIV.
You may continue to develop other infections and other illnesses associated with HIV disease.
Še naprej obstaja možnost pojava drugih okužb in drugih obolenj, povezanih s HIV boleznijo.
You should keep in regular contact with your doctor.
Redno boste morali biti v stiku s svojim zdravnikom.
Do not stop taking your medicine without first talking to your doctor.
Brez predhodnega posvetovanja s svojim zdravnikom ne smete prenehati jemati zdravila.
Treatment with Combivir has not been shown to reduce the risk of passing HIV infection on to others by unprotected sexual contact or by blood transfer (for example, blood transfusions or sharing needles).
Pokazalo se je, da zdravljenje z zdravilom Combivir ne zmanjša tveganja za prenos okužbe z virusom HIV na druge med nezaščitenim spolnim odnosom ali s krvjo (npr. transfuzije krvi ali uporaba iste igle za več oseb).
You should continue to use appropriate precautions to prevent this.
Da boste preprečili prenos okužbe na druge, se morate še naprej obnašati odgovorno in skrbeti za ustrezne varnostne ukrepe.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Težave s kostmi Pri nekaterih bolnikih, ki jemljejo kombinirano protiretrovirusno zdravljenje, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself.
31 Jemanje drugih zdravil Pomembno je, da svojemu zdravniku poveste za vsa zdravila, ki jih jemljete, vključno s tistimi, ki ste jih dobili brez recepta.
These may affect the action of Combivir, or Combivir may affect their action.
Le- ta lahko vplivajo na delovanje zdravila Combivir oziroma lahko zdravilo Combivir vpliva na njihovo delovanje.
Combivir should not be taken with high doses of co-trimoxazole, or injections of ganciclovir or foscarnet, as lamivudine, one of the active substances in Combivir may interact with these.
Zdravila Combivir ne smete jemati skupaj z velikimi odmerki kotrimoksazola ali z injekcijami ganciklovirja ter foskarneta zaradi možnih interakcij med njimi in lamivudinom, eno izmed zdravilnih učinkovin zdravila Combivir.
Combivir should also not be taken with stavudine, as zidovudine the other active substance in Combivir may reduce the action of this medicinal product.
Prav tako zdravila Combivir ne smete uporabljati skupaj s stavudinom, ker zidovudin, druga učinkovina zdravila Combivir, lahko zmanjša učinek tega zdravila.
Phenytoin, probenecid, rifampicin, atovaquone, valproic acid, methadone, dapsone, pentamidine, pyrimethamine, co-trimoxazole, fluconazole, amphotericin, flucytosine, ganciclovir, interferon, clarithromycin, vincristine, vinblastine and doxorubicin.
Zidovudin lahko tudi medsebojno deluje in poslabša kateri koli neželeni učinek naslednjih zdravil: fenitoina, probenecida, rifampicina, atovakvona, valprojske kisline, metadona, dapsona, pentamidina, pirimetamina, kotrimoksazola, flukonazola, amfotericina, flucitozina, ganciklovirja, interferona, klaritromicina, vinkristina, vinblastina in doksorubicina.
If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Nosečnost in dojenje Če zanosite ali načrtujete zanositev, se morate s svojim zdravnikom posvetovati o možnih neželenih učinkih ter koristih in tveganjih protiretrovirusnega zdravljenja za vas in vašega otroka.
If you have taken Combivir during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Če ste zdravilo Combivir jemali med nosečnostjo, vas lahko vaš zdravnik naroča na redne preglede, da bo spremljal razvoj vašega otroka.
Such visits may include blood tests and other diagnostic tests.
Takšni pregledi lahko vključujejo preiskave krvi in druge diagnostične preiskave.
In children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
Pri otrocih, katerih matere so med nosečnostjo jemale nukleozidne in nukleotidne analoge, je korist zaradi zmanjšane nevarnosti okužbe z virusom HIV večja od tveganja zaradi neželenih učinkov.
If you are breast-feeding please inform your doctor before taking any medicines.
Če dojite, obvestite svojega zdravnika, preden vzamete katero koli zdravilo.
Combivir is not recommended if you are breast-feeding.
Zdravilo Combivir za uporabo med dojenjem ni priporočljivo.
It is recommended that HIV infected women do not breast- feed their infants under any circumstances in order to avoid transmission of HIV.
Priporočeno je, naj z virusom HIV okužene matere pod nobenim pogojem ne dojijo svojih otrok, da ne bi prenesle okužbe nanje.
HOW TO TAKE COMBIVIR
KAKO JEMATI ZDRAVILO COMBIVIR
Always take Combivir exactly as your doctor has told you.
Pri jemanju zdravila Combivir natančno upoštevajte zdravnikova navodila.
Swallow Combivir tablets with water.
Combivir tablete pogoltnite skupaj z vodo.
The tablets can be taken with or without food.
Tablete lahko jemljete skupaj s hrano ali brez nje.
If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Če tablete (tablet) ne morete pogoltniti, lahko tableto (tablete) zdrobite in dodate v manjšo količino redkega živila ali hrane ter nato takoj v celoti zaužijte.
The usual dose of Combivir for adults and adolescents weighing at least 30 kg is one tablet twice a day.
Običajni predpisani odmerek za odrasle in mladostnike s telesno maso 30 kg ali več je ena tableta dvakrat na dan.
For children weighing between 21 kg and 30 kg the recommended oral dose of Combivir is one-half tablet taken in the morning and one whole tablet taken in the evening.
Priporočeni peroralni odmerek zdravila Combivir za otroke s telesno maso od 21 do 30 kg je polovica tablete zjutraj in ena cela tableta zvečer.
For children weighing 14 kg to 21 kg the recommended oral dose of Combivir is one-half tablet taken twice daily.
Priporočeni peroralni odmerek zdravila Combivir za otroke s telesno maso od 14 do 21 kg je polovica tablete dvakrat na dan.
Each dose of Combivir should be taken approximately 12 hours apart.
Med vsakim posameznim odmerkom zdravila Combivir mora miniti približno 12 ur.
For children weighing less than 14 kg, lamivudine and zidovudine should be taken as separate formulations according to the prescribed dosing for these products.
Otroci s telesno maso manjšo od 14 kg morajo jemati lamivudin in zidovudin kot ločeni zdravilni učinkovini v skladu z navodili za jemanje teh zdravil.
A liquid formulation is available for both lamivudine and zidovudine for the treatment of patients unable to take tablets.
Za zdravljenje bolnikov, ki ne morejo jemati tablet, sta lamivudin in zidovudin na voljo v obliki tekoče farmacevtske oblike.
31 If your doctor wishes to reduce your dose of Combivir, for example if you have kidney problems, then your medicine may be changed to lamivudine and zidovudine taken as separate medicines, which are available as tablets or liquid.
Če želi vaš zdravnik odmerek zdravila Combivir zmanjšati, na primer, kadar imate ledvične težave,
If you take more Combivir than you should Accidentally taking too much Combivir is unlikely to cause any serious problems.
Če ste uporabili večji odmerek zdravila Combivir, kot bi smeli Ni verjetno, da bi nenamerno zaužitje prevelikih odmerkov zdravila Combivir povzročilo resnejše težave.
However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Kljub temu se v primeru, da ste uporabili večji odmerek zdravila, kot bi smeli, takoj posvetujte z zdravnikom ali farmacevtom ali pa se po nadaljnji nasvet obrnite na urgentni oddelek najbližje bolnišnice.
If you forget to take Combivir If you forget to take a dose of Combivir, take it as soon as you remember and then continue as before.
Če ste pozabili vzeti zdravilo Combivir Če ste pozabili vzeti predpisani odmerek zdravila Combivir, ga vzemite takoj, ko se spomnite, nato pa nadaljujte z jemanjem kot običajno.
Like all medicines, Combivir can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo Combivir neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Combivir, by other medicines you are taking at the same time or by the HIV disease.
Med zdravljenjem okužbe z virusom HIV nekaterih neželenih učinkov, ki se pojavijo, ni mogoče vselej pripisati zdravilu Combivir, lahko jih povzročajo druga zdravila, ki jih sočasno jemljete, ali bolezen (HIV) sama.
For this reason it is very important that you inform your doctor about any changes in your health.
Zato je zelo pomembno, da svojega zdravnika obvestite o kakršni koli spremembi vašega zdravstvenega stanja.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Kombinirano zdravljenje s protiretrovirusnimi zdravili lahko povzroči spremembe v obliki telesa zaradi sprememb v porazdelitvi maščevja.
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’).
To lahko vključuje izgubo maščevja na nogah, rokah in obrazu, nalaganje maščob v abdomnu (trebuh) in drugih notranjih organih, povečanje prsi in pojav maščobnih izboklin na zadnji strani vratu (bivolja grba).
The cause and long-term health effects of these conditions are not known at this time.
Vzrok in dolgoročni vpliv teh pojavov dandanes nista znana.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Kombinirano zdravljenje s protiretrovirusnimi zdravili lahko tudi povzroči povišanje mlečne kisline in sladkorja v krvi, hiperlipidemijo (povišana količina maščob v krvi) in odpornost proti insulinu.
Very common side effects.
Zelo pogosti neželeni učinki.
These may affect more than than 1 user in 10.
Pojavijo se lahko pri več kot 1 od 10 bolnikov.
Headache and nausea.
Glavobol in siljenje na bruhanje
Common side effects.
Pogosti neželeni učinki.
These may affect 1 to 10 users in 100.
Pojavijo se lahko pri 1 do 10 od 100 bolnikov.
Vomiting, stomach pain, diarrhoea, increase in certain liver enzymes, joint pain, muscle pain and other muscle disorders, dizziness, tiredness, difficulty sleeping, hair loss, anaemia (low red blood cell count) and neutropenia (low white blood cell count).
Bruhanje, bolečine v trebuhu, driska, zvišanje določenih jetrnih encimov, bolečine v sklepih, bolečine v mišicah in druge mišične motnje, vrtoglavica, utrujenost, težave s spanjem, izguba las, anemija (zmanjšano število rdečih krvnih celic) in nevtropenija (zmanjšano število belih krvnih celic).
If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness and a reduction in your white blood cell count can make you more prone to infection.
V primeru zmanjšanega števila rdečih krvnih celic boste morda utrujeni ali zasopli, zmanjšano število belih krvnih celic pa lahko vodi v povečano dovzetnost za okužbe.
Uncommon side effects.
Občasni neželeni učinki.
These may affect 1 to 10 users in 1,000.
Pojavijo se lahko pri 1 do 10 od 1. 000 bolnikov.
Flatulence, breathlessness, rash (red, raised or itchy), fever, general aches and pains and reduction in platelets (blood cells important for blood clotting).
Napenjanje, zasoplost, izpuščaj (rdeč, privzdignjen ali srbeč), zvišana telesna temperatura, splošne bolečine in zmanjšanje števila trombocitov (krvnih celic, pomembnih za strjevanje krvi).
If you have a low platelet count you may notice that you bruise more easily.
Če imate zmanjšano število trombocitov, boste morda opazili, da se vam hitreje pojavljajo modrice.
Rare side effects.
Redki neželeni učinki.
These may affect 1 to 10 users in 10,000.
Pojavijo se lahko pri 1 do 10 od 10. 000 bolnikov.
Cough, nasal symptoms, patchy colour changes inside the mouth, heartburn, chest pain (possibly indicating a heart muscle disease called cardiomyopathy), breakdown of muscle tissue, liver disorders such as enlarged liver, fatty liver, inflammation of the liver (hepatitis), inflammation of the pancreas, nail and skin colour changes, sweating, flu-like feeling, drowsiness, passing urine more frequently, breast enlargement in male patients, chest pain, chills, loss of appetite, taste changes, tingling in the limbs, seizures, inability to concentrate, depression and feeling anxious, increase of lactic acid in the body known as lactic acidosis (see Take special care with Combivir).
Kašelj, nosni simptomi, lisaste barvne spremembe v ustih, pekoča bolečina pri srcu, bolečina v prsih (kar lahko nakazuje obolenje srčne mišice, imenovano kardiomiopatija), oslabelost mišičnega tkiva, motnje v delovanju jeter, kot so povečana jetra, zamaščena jetra, vnetje jeter (hepatitis), vnetje trebušne slinavke, barvne spremembe na koži in nohtih, potenje, gripi podobno počutje, omotičnost, pogostejše odvajanje vode, povečanje prsi pri bolnikih moškega spola, bolečina v prsih, mrzlica, izguba apetita, sprememba okusa, mravljinčenje udov, krči, nesposobnost koncentracije, depresija in občutek tesnobe, povečana koncentracija mlečne kisline v telesu, poznana pod imenom laktacidoza (glejte Bodite posebno pozorni pri uporabi zdravila Combivir).
32 While many of the side effects that have been reported occur with both lamivudine and zidovudine when given as separate medicines, some are more likely to occur with one of the medicines only.
33 Mnogi izmed navedenih neželenih učinkov se ob ločenem jemanju lamivudina in zidovudina lahko pojavijo pri lamivudinu in pri zidovudinu, nekateri pa se pogosteje pojavljajo samo pri eni od obeh učinkovin.
Your doctor may decide that you need to stop taking Combivir and take lamivudine and zidovudine separately.
Odločitev o tem, ali morate prenehati z jemanjem zdravila Combivir in začeti ločeno jemati lamivudin in zidovudin, sprejme vaš zdravnik.
This will allow your doctor to vary the dose or stop one of the active substances if it is considered that this will help manage any side effects.
Na ta način bo vaš zdravnik lahko spreminjal odmerek ali ustavil dajanje ene izmed učinkovin, če bo presodil, da bo tako mogoče odpravil neželene učinke.
HOW TO STORE COMBIVIR
SHRANJEVANJE ZDRAVILA COMBIVIR
Do not use Combivir after the expiry date which is stated on the container.
Zdravila Combivir ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The expiry date refers to the last day of that month.
Datum izteka uporabnosti se nanaša na zadnji dan navedenega meseca.
What Combivir contains
Kaj vsebuje zdravilo Combivir
The active substances are lamivudine 150 mg and zidovudine 300 mg.
- Zdravilni učinkovini sta 150 mg lamivudina in 300 mg zidovudina.
The other ingredients are: - tablet core; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide - tablet film-coat; hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
- jedro tablete; mikrokristalna celuloza, natrijev karboksimetilškrob (brez glutena), magnezijev
What Combivir looks like and contents of the pack
- filmska obloga tablete; hipromeloza, titanov dioksid, makrogol 400, polisorbat 80.
Combivir film-coated tablets are provided in tamper evident blister packs containing 60 tablets.
Zdravilo Combivir filmsko obložene tablete so na voljo v škatlah, z varovalom, da še niso bile odprte, v katerih so pretisni omoti s 60 tabletami.
They are white to off-white, capsule-shaped scored tablets marked with the code GXFC3 on both sides.
So bele do sivobele tablete v obliki kapsule z zarezo in oznako GXFC3 na obeh straneh.
Marketing Authorisation Holder and Manufacturer
34 Imetnik dovoljenja za promet z zdravilom in izdelovalec
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street Ware Herts SG12 0DJ Velika Britanija
Glaxo Group Ltd Greenf ord Road Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Velika Britanija
33 For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
35 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
34 Italia GlaxoSmithKline S.p.A.
36 Italia GlaxoSmithKline S. p. A.
Competact are white oblong tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Zdravilo Competact so bele podolgovate tablete, ki vsebujejo dve zdravilni učinkovini, pioglitazonijev (15 mg) in metforminijev hidroklorid (850 mg).
Competact is used in patients (particularly those who are overweight) who have non insulin-dependent diabetes (type 2 diabetes).
Competact se uporablja pri bolnikih (zlasti tistih s čezmerno telesno maso) s sladkorno boleznijo, ki ni odvisna od insulina (sladkorna bolezen tipa 2).
Competact is used in patients who are not satisfactorily controlled on metformin (an anti-diabetes medicine) used on its own and at the maximum possible dose.
Zdravilo Competact se uporablja pri bolnikih, pri katerih z uporabo metformina (zdravila proti sladkorni bolezni) samega, tudi v največjem možnem odmerku, ni mogoče doseči zadovoljivega nadzora.
Competact can only be obtained with a prescription.
Zdravilo Competact se dobi samo na recept.
Patients changing from metformin only to Competact may need to slowly introduce pioglitazone until a dose of 30 mg per day is reached.
Pri bolnikih, ki prehajajo z metformina na samo Competact, je treba pioglitazon uvajati počasi, dokler se ne doseže odmerek 30 mg na dan.
It is possible to change to Competact directly from metformin if appropriate.
Možen je tudi neposreden prehod z metformina na Competact, če je to ustrezno.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Metformin pa učinkuje predvsem tako, da zavira nastajanje glukoze in zmanjšuje njeno absorpcijo v črevesju.
Pioglitazone on its own has been approved by the EU under the name Actos, can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Pioglitazon sam je bil pod imenom Actos odobren s strani EU in se lahko uporablja skupaj z metforminom pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni mogoče doseči zadovoljivega nadzora.
Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication.
Raziskave z zdravilom Actos, uporabljenim skupaj z metforminom v obliki ločenih tablet, so bile uporabljene v podporo uporabi zdravila Competact za enako indikacijo.
The studies lasted from 4 months to 2 years and involved 1,305 patients who took the combination.
Raziskave so trajale od 4 mesecev do 2 leti in so vključevale 1305 bolnikov, ki so prejemali omenjeno
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Competact shown during the studies?
V raziskavah so merili raven tiste snovi v krvi (HbA1c), ki kaže, kako dobro je raven glukoze v krvi uravnana.
In all studies, adding pioglitazone 30 mg to metformin gave an improvement in the control of blood sugar, with levels of HbA1c which were further decreased by 0.64 to 0.89% compared to the levels on metformin alone.
V vseh raziskavah je dodajanje 30 mg pioglitazona k metforminu prineslo izboljšanje nadzora sladkorja v krvi, pri čemer so se ravni HbA1c nadalje znižale za 0, 64 do 0, 89% v primerjavi z ravnmi, doseženimi samo z metforminom.
The most common side effects of Competact (seen in between 1 and 10 patients in 100) are anaemia (low red blood cells), visual disturbance, weight increase, arthralgia (joint pain), headache, haematuria (blood in the urine), erectile dysfunction (problems getting an erection).
Najpogostejši stranski učinki zdravila Competact (opaženi pri 1 do 10 bolnikih od 100) so slabokrvnost (nizko število rdečih krvnih celic), motnje vida, povečanje telesne mase, artralgija (bolečine v sklepih), glavobol, hematurija (kri v urinu), erektilna disfunkcija (težave z doseganjem erekcije).
For the full list of side effects reported with Competact, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Competact, najdete v Navodilih za uporabo.
Competact should not be used in people who may be hypersensitive (allergic) to pioglitazone, metformin or any of the other ingredients, and in patients who have heart failure, or problems with their liver or their kidneys.
Zdravila Competact ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pioglitazon, metformin ali katerokoli drugo sestavino, kakor tudi ne bolniki s srčnim popuščanjem ali težavami z jetri ali ledvicami.
Competact should not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Zdravila Compteact prav tako ne smejo uporabljati bolniki z boleznijo, ki povzroča pomanjkanje kisika v tkivih, kot je denimo nedavni srčni napad ali šok.