natgillin/translations-raw huggingface dataset:
A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Bolniki brez okužbe s HIV, ki so imeli različne stopnje motenj v delovanju jeter po klasifikaciji Child- Pugh- Turcotte (CPT), so vzeli enkratni 245 mg odmerek tenofovirdizoproksilata.
The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/ ml and 2,050 (50.8%) ng• h/ ml, respectively, in normal subjects compared with 289 (46.0%) ng/ ml and 2,310 (43.5%) ng• h/ ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ ml and 2,740 (44.0%) ng• h/ ml in subjects with severe hepatic impairment.
Pri osebah brez motenj v delovanju jeter je bila srednja (% koeficienta variacije) vrednost Cmax 223 (34, 8%) ng/ ml in AUC0- ∞ 2. 050 (50, 8%) ng• h/ ml tenofovirja, v primerjavi z 289 (46, 0%) ng/ ml in 2. 310 (43, 5%) ng• h/ ml tenofovirja pri osebah z zmernimi motnjami ter 305 (24, 8%) ng/ ml in 2. 740 (44, 0%) ng• h/ ml pri osebah s hudimi motnjami v delovanju jeter.
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki o emtricitabinu na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Preclinical studies of tenofovir disoproxil fumarate conducted in rats, dogs and monkeys revealed target organ effects in gastrointestinal tract, kidney, bone and a decrease in serum phosphate concentration.
14 Predklinične študije tenofovirdizoproksil fumarata izvedene na podganah, psih in opicah so pokazale učinke na tarčnih organih v prebavnem traktu, ledvicah, kosteh in zmanjšanje koncentracije serumskega fosfata.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in bone mineral density.
Odkritja študij izvedenih na podganah in opicah so pokazala z učinkovino povezano zmanjšanje absorpcije fosfata v črevesju s potencialno sekundarnim zmanjšanjem mineralne gostote kosti.
The mechanisms of these toxicities are not completely understood.
Mehanizmi, ki vodijo do pojava teh toksičnosti, še niso popolnoma znani.
Conventional reproductive/ developmental toxicity studies with emtricitabine and tenofovir disoproxil fumarate reveal no special hazard for humans.
Običajne študije reproduktivne/ razvojne toksičnosti z emtricitabinom in tenofovirdizoproksil fumaratom ne kažejo posebnega tveganja za človeka.
Tenofovir disoproxil fumarate was positive in two out of three in vitro genotoxicity studies but negative in the in vivo micronucleus assay.
Tenofovirdizoproksil fumarat je bil pozitiven v dveh od treh in vitro študijah genotoksičnosti, toda negativen pri in vivo testu na mikronukleusu.
Tenofovir disoproxil fumarate did not show any carcinogenic potential in a long-term oral carcinogenicity study in rats.
Tenofovirdizoproksil fumarat ni pokazal kancerogenega potenciala v dolgotrajni peroralni kancerogenetski raziskavi na podganah.
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at a dose of 600 mg/ kg/ day.
Dolgoročna peroralna kancerogenetska raziskava na miših je pokazala nizko incidenco tumorjev na dvanajstniku, ki so verjetno povezani z visokimi lokalnimi koncentracijami v prebavnem traktu pri odmerku 600 mg/ kg/ dan.
While the mechanism of tumour formation is uncertain, the findings are unlikely to be of relevance to humans.
Mehanizem nastanka tumorjev je nejasen, te ugotovitve pa za ljudi verjetno niso relevantne.
14 The combination of emtricitabine and tenofovir disoproxil fumarate was positive in the in vitro mouse lymphoma assay, with comparable results to those obtained for tenofovir disoproxil fumarate alone.
Kombinacija emtricitabina in tenofovirdizoproksil fumarata je bila pozitivna pri in vitro testu mišjega limfoma, rezultati pa primerljivi s tistimi, ki so jih pridobili za sam tenofovirdizoproksil fumarat.
The combination of emtricitabine and tenofovir disoproxil fumarate was negative in the bacterial reverse mutation assay (Ames assay).
Kombinacija emtricitabina in tenofovirdizoproksil fumarata je bila negativna pri bakterijskem testu reverzne mutacije (Ames test).
A one month dog study using the combination of emtricitabine and tenofovir disoproxil fumarate, found no exacerbation of toxicological effects compared to the separate components.
Uporaba kombinacije emtricitabina in tenofovirdizoproksil fumarata v enomesečni študiji na psih ni pokazala poslabšanja toksikoloških učinkov v primerjavi z ločenima učinkovinama.
Glycerol triacetate (E1518) Hypromellose (E464) Indigo carmine aluminium lake (E132) Lactose monohydrate Titanium dioxide (E171)
Filmska obloga: triacetin (E1518) hipromeloza (E464) barvilo indigotin (E132) laktoza monohidrat titanov dioksid (E171)
HDPE bottle with a child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Plastenka iz polietilena velike gostote (HDPE), z za otroke varno zaporko, ki vsebuje 30 filmsko obloženih tablet in silikagelsko sušilno sredstvo.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
Na voljo so naslednje velikosti pakiranj: škatle z 1 plastenko ali s 3 plastenkami po 30 filmsko obloženih tablet.
Cork, Ireland
Cork, Irska
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
20 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
BOTTLE AND CARTON LABELLING
OZNAČEVANJE NA ŠKATLI IN NALEPKI PLASTENKE
Truvada 200 mg/ 245 mg film-coated tablets Emtricitabine/ tenofovir disoproxil
Truvada 200 mg/ 245 mg filmsko obložene tablete emtricitabin/ tenofovirdizoproksilat
3 x 30 film-coated tablets.
3 x 30 filmsko obloženih tablet.
EU/ 1/ 04/ 305/ 001 30 film-coated tablets EU/ 1/ 04/ 305/ 002 3 x 30 film-coated tablets
EU/ 1/ 04/ 305/ 001 30 filmsko obloženih tablet EU/ 1/ 04/ 305/ 002 3 x 30 filmsko obloženih tablet
What Truvada is and what it is used for 2.
Kaj je zdravilo Truvada in za kaj ga uporabljamo 2.
Before you take Truvada 3.
Kaj morate vedeti, preden boste vzeli zdravilo Truvada 3.
How to take Truvada 4.
Kako jemati zdravilo Truvada 4.
How to store Truvada 6.
Shranjevanje zdravila Truvada 6.
WHAT TRUVADA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TRUVADA IN ZA KAJ GA UPORABLJAMO
Truvada is a treatment for Human Immunodeficiency Virus (HIV) infection in adults over 18 years of age.
Zdravilo Truvada se uporablja za zdravljenje okužbe z virusom HIV (virus človeške imunske pomanjkljivosti) pri odraslih, starejših od 18 let.
Truvada contains two active substances, emtricitabine and tenofovir disoproxil.
Zdravilo Truvada vsebuje dve zdravilni učinkovini, emtricitabin in tenofovirdizoproksilat.
Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Zdravilo Truvada se lahko jemlje namesto emtricitabina in tenofovirdizoproksilata, ki se uporabljata ločeno v enakih odmerkih.
While taking Truvada you may still develop infections or other illnesses associated with HIV infection.
Med jemanjem zdravila Truvada se lahko še naprej razvijejo okužbe ali druge bolezni povezane s HIV infekcijo.
You can also pass on the virus to others, so it is important to take precautions to avoid infecting other people.
Virus lahko prenesete tudi na druge, zato je pomembno, da uporabljate zaščitne ukrepe, ki preprečujejo okužbo drugih oseb.
BEFORE YOU TAKE TRUVADA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TRUVADA
Do not take Truvada
Ne jemljite zdravila Truvada
• If you are allergic (hypersensitive) to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of Truvada listed at the end of this leaflet.
• Če ste alergični na (preobčutljivi za) emtricitabin, tenofovir, tenofovirdizoproksil fumarat ali na katerokoli sestavino zdravila Truvada, ki so navedene na koncu tega navodila.
Take special care with Truvada
Bodite posebno pozorni pri uporabi zdravila Truvada
• Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
• Če ste kdaj prej imeli bolezni ledvic ali če so preiskave kazale na težave z ledvicami, obvestite o tem zdravnika.
Your doctor may also order blood tests during treatment to monitor your kidneys.
Pred začetkom zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic in vam
24 Truvada is not usually taken with other medicines that can damage your kidneys (see Taking other medicines).
24 morda svetoval, da jemljete tablete manj pogosto.
If this is unavoidable, your doctor will monitor your kidney function once a week.
Vaš zdravnik bo morda naredil krvne preiskave v času zdravljenja, da bo nadzoroval stanje vaših ledvic.
Truvada has not been studied in patients over 65 years of age.
Zdravila Truvada niso proučevali pri bolnikih starejših od 65 let.
If you are older than this and are prescribed Truvada, your doctor will monitor you carefully.
Če ste starejši in so vam predpisali zdravilo Truvada, vas bo zdravnik skrbno nadzoroval.
• Do not give Truvada to children and adolescents under 18 years of age.
• Zdravila Truvada ne dajajte otrokom in mladostnikom mlajšim od 18 let.
Both active substances in Truvada show some activity against hepatitis B virus although they are not approved for the treatment of hepatitis B infection.
Obe zdravilni učinkovini v zdravilu Truvada kažeta določeno aktivnost proti virusu hepatitisa B, čeprav nista odobreni za zdravljenje okužbe s hepatitisom B.
• Once you start taking Truvada, look out for possible signs of lactic acidosis.
• Ko začnete jemati zdravilo Truvada, bodite pozorni na možne simptome laktacidoze.
Medicines containing nucleoside analogues, including Truvada, can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
Zdravila, ki vsebujejo analoge nukleozidov, vključno z zdravilom Truvada, lahko povzročijo laktacidozo (preveliko količino mlečne kisline v krvi) skupaj s povečanimi jetri.
Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.
Globoko, naglo dihanje, zaspanost in nespecifični simptomi kot npr. slabost, bruhanje in bolečine v trebuhu, lahko nakazujejo razvoj laktacidoze.
This rare but serious side effect has occasionally been fatal.
Ta redek, vendar resen neželeni učinek je lahko včasih usoden.
Lactic acidosis occurs more often in women, particularly if they are very overweight.
Laktacidoza se pogosteje pojavlja pri ženskah, še posebej, če so občutno pretežke.
If you have liver disease you may also be more at risk of getting this condition.
Če imate obolenje jeter, je verjetnost večja, da bi se enaki simptomi pojavili tudi pri vas.
While you are being treated with Truvada, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
V času zdravljenja z zdravilom Truvada bo vaš zdravnik pozorno spremljal znake, ki bi pri vas lahko nakazovali razvoj laktacidoze.
Combination antiretroviral therapies (including Truvada) may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
Kombinirane protiretrovirusne terapije (vključno z zdravilom Truvada) lahko povišajo nivo sladkorja in količino maščob v krvi (hiperlipidemija) ter povzročijo spremembe v telesnih maščobah in odpornost na insulin (glejte poglavje 4, Možni neželeni učinki).
If you are diabetic, overweight or have high cholesterol, talk to your doctor.
Če ste sladkorni bolnik, imate prekomerno telesno težo ali visok holesterol, se posvetujte z zdravnikom.
If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Truvada is started.
Če imate napredovalo okužbo s HIV (AIDS) in imate kakšno okužbo, se lahko ob uvedbi zdravljenja z zdravilom Truvada pri vas razvijejo simptomi okužbe in vnetja ali poslabšanje simptomov že obstoječe okužbe.
These symptoms may indicate that your body’ s improved immune system is fighting infection.
Ti simptomi lahko nakazujejo, da se izboljšani imunski sistem vašega telesa bojuje proti okužbi.
Look out for signs of inflammation or infection soon after you start taking Truvada.
Bodite pozorni na simptome vnetja ali okužbe kmalu po začetku jemanja zdravila Truvada.
Bone problems.
Težave s kostmi.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
25 Težave s kostmi (včasih zlom) se lahko pojavijo tudi zaradi okvare celic ledvičnih tubulov (glejte poglavje 4, Možni neželeni učinki).
25 Taking other medicines
Jemanje drugih zdravil
You should not take Truvada if you are already taking other medicines that contain emtricitabine, tenofovir disoproxil, lamivudine or zalcitabine.
Zdravila Truvada ne smete jemati, če že jemljete druga zdravila, ki vsebujejo emtricitabin, tenofovirdizoproksilat, lamivudin ali zalcitabin.
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
• It is especially important to tell your doctor if you are taking other medicines which may damage your kidneys.
• Posebno pomembno je, da svojega zdravnika obvestite, če jemljete druga zdravila, ki bi lahko poškodovala vaše ledvice.
aminoglycosides (for bacterial infection) amphotericin B (for fungal infection) foscarnet (for viral infection) ganciclovir (for viral infection) pentamidine (for infections) vancomycin (for bacterial infection) interleukin-2 (to treat cancer) cidofovir (for viral infection)
aminoglikozidi (za bakterijsko okužbo) amfotericin B (za glivično okužbo) foskarnet (za virusno okužbo) ganciklovir (za virusno okužbo) pentamidin (za okužbe) vankomicin (za bakterijsko okužbo) interlevkin- 2 (za zdravljenje raka) cidofovir (za virusno okužbo)
• Other medicines containing didanosine (for HIV infection):
• Druga zdravila, ki vsebujejo didanozin (za okužbe z virusom HIV):
Taking Truvada with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Jemanje zdravila Truvada z drugimi protivirusnimi zdravili, ki vsebujejo didanozin, lahko zviša nivoje didanozina v krvi in zmanjša število celic CD4.
Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil fumarate and didanosine were taken together.
Pri sočasnem jemanju zdravil, ki vsebujejo tenofovirdizoproksil fumarat in didanozin, so redko poročali o vnetju trebušne slinavke in laktoacidozi (zvišanju mlečne kisline v krvi), ki je bila včasih smrtna.
Taking Truvada with food and drink
Jemanje zdravila Truvada skupaj s hrano in pijačo
• Truvada should be taken with food (for example, a meal or a snack).
• Zdravilo Truvada je treba jemati s hrano (na primer pri obroku ali prigrizku).
• You must not take Truvada during pregnancy unless specifically discussed with your doctor.
• Zdravila Truvada ne smete jemati med nosečnostjo, razen če ste se o tem posebej dogovorili s svojim zdravnikom.
There are no clinical data on the use of Truvada in pregnant women and it is not usually used unless absolutely necessary.
Klinični podatki o uporabi zdravila Truvada pri nosečnicah niso na voljo in zdravila Truvada se običajno ne uporablja, razen če to ni nujno potrebno.
• If you are a woman who could get pregnant during treatment with Truvada, you must use an effective method of contraception to avoid becoming pregnant.
• Če ste ženska, ki bi lahko med zdravljenjem z zdravilom Truvada zanosila, morate uporabljati učinkovito kontracepcijsko metodo, da bi s tem preprečili zanositev.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of antiretroviral therapy to you and your child.
• Če zanosite ali načrtujete zanositev, se posvetujte z zdravnikom o možnih koristih in tveganjih protiretrovirusnega zdravljenja za vas in vašega otroka.
• Do not breast-feed during treatment with Truvada.
26 • Med zdravljenjem z zdravilom Truvada ne dojite.
It is not yet known whether the active substances in this medicine pass into human breast milk.
Ni še znano, ali zdravilni učinkovini tega zdravila prehajata v materino mleko.
26 • If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
• Če ste ženska, okužena z virusom HIV, je priporočljivo, da ne dojite, da s tem preprečite prenos virusa preko mleka na dojenčka.
Important information about some of the ingredients of Truvada
Pomembne informacije o nekaterih sestavinah zdravila Truvada
If you know you are lactose-intolerant, or if you have been told that you have an intolerance to any other sugars, talk to your doctor before taking this medicine.
Če veste, da imate intoleranco za laktozo ali so vam povedali, da imate intoleranco za katerekoli druge sladkorje, se pred uporabo tega zdravila posvetujete z zdravnikom.
HOW TO TAKE TRUVADA
KAKO JEMATI ZDRAVILO TRUVADA
• Always take Truvada exactly as your doctor has told you.
• Pri jemanju zdravila Truvada vedno natančno upoštevajte zdravnikova navodila.
The usual dose:
Običajen odmerek:
• Adults: one tablet each day with food (for example, a meal or a snack). • Not for children and adolescents
• Odrasli: ena tableta vsak dan s hrano (na primer pri obroku ali prigrizku). • Zdravilo ni za otroke in mladostnike
• If you have problems with your kidneys, your doctor may advise you to take Truvada less frequently.
• Če imate ledvične težave, vam bo zdravnik morda svetoval, da jemljete zdravilo Truvada manj pogosto.
• If your doctor decides to stop one of the components of Truvada or change the dose of Truvada, you may be given emtricitabine and/or tenofovir separately instead of the combined medicine or other medicines for the treatment of HIV infection.
• Če zdravnik odloči, da boste prenehali jemati eno od učinkovin zdravila Truvada, ali da bo spremenil odmerek zdravila Truvada, boste morda namesto kombiniranega zdravila ali drugih zdravil za zdravljenje okužbe s HIV dobivali emtricitabin in/ ali tenofovir ločeno.
• Your doctor will prescribe Truvada with other antiretroviral medicines.
• Zdravnik vam bo predpisal zdravilo Truvada skupaj z drugimi protiretrovirusnimi zdravili.
If you accidentally take too many Truvada tablets, contact your doctor or nearest emergency department for advice.
Če ste pomotoma zaužili preveč tablet zdravila Truvada, se posvetujte z zdravnikom ali poiščite najbližjo urgentno ambulanto.
If you forget to take Truvada
Če ste pozabili vzeti zdravilo Truvada
It is important not to miss a dose of Truvada.
Pomembno je, da ne pozabite vzeti nobenega odmerka zdravila Truvada.
If you do miss a dose of Truvada, take it as soon as you can, and then take your next dose at its regular time.
Če ste pozabili vzeti odmerek zdravila Truvada, ga vzemite čim prej in nato vzemite naslednji odmerek ob običajnem času.
27 If it is almost time for your next dose anyway, forget about the missed dose.
27 Če je že skoraj čas za vaš naslednji odmerek, pozabljenega odmerka ne vzemite.
If you throw up less than 1 hour after taking Truvada, take another tablet.
Če nastopi bruhanje manj kot 1 uro po zaužitju zdravila Truvada, vzemite še eno tableto.
If you stop taking Truvada
Če ste prenehali jemati zdravilo Truvada
• Stopping treatment with Truvada may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
• Prenehanje zdravljenja z zdravilom Truvada lahko zmanjša učinkovitost zdravljenja okužbe s HIV, ki vam ga je predpisal zdravnik.
Speak with your doctor before you stop taking Truvada for any reason, particularly if you are experiencing any side effects or you have another illness.
Preden prenehate jemati zdravilo Truvada iz kateregakoli razloga, se pogovorite z zdravnikom, še zlasti če imate kakršnekoli neželene učinke ali kakšno drugo bolezen.
Contact your doctor before you restart taking Truvada tablets.
Preden začnete ponovno jemati zdravilo Truvada, se posvetujte z zdravnikom.
• If you have HIV infection and hepatitis B, it is especially important not to stop your Truvada treatment without talking to your doctor first.
• Če ste okuženi z virusom HIV in hepatitisom B, je še zlasti pomembno, da ne prenehate z zdravljenjem z zdravilom Truvada, ne da bi se prej posvetovali z zdravnikom.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Truvada.
Krvne preiskave ali simptomi pri nekaterih bolnikih so kazali, da se je njihov hepatitis poslabšal po prenehanju zdravljenja z zdravilom Truvada.
In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis.
Pri nekaterih bolnikih z napredovalim obolenjem jeter ali cirozo prenehanje zdravljenja ni priporočeno, saj lahko to povzroči poslabšanje hepatitisa.
Like all medicines, Truvada can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Truvada neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Tell your doctor about any of the following side effects:
Obvestite zdravnika o, če imate kateregakoli od naslednjih neželenih učinkov:
Very common side effects (These can affect at least 10 in every 100 patients treated)
Zelo pogosti neželeni učinki (Prizadenejo lahko najmanj 10 od 100 bolnikov, ki se zdravijo)
• dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
• omotičnost, glavobol, driska, slabost, bruhanje
Common side effects (These can affect 1 to 10 in every 100 patients treated)
Pogosti neželeni učinki (Prizadenejo lahko od 1 do 10 na 100 bolnikov, ki se zdravijo)
• problems with digestion resulting in discomfort after meals, flatulence
• prebavne motnje, ki privedejo do slabega počutja po zaužitem obroku, flatulenca (napihnjenost)
28 • other allergic reactions, such as wheezing, swelling or feeling light-headed
• izpuščaji (vključno z rdečimi pikami ali ogrci, včasih z mehurjasto in oteklo kožo), kar je lahko alergična reakcija, srbečica, sprememba obarvanosti kože, vključujoč temne lise 28 • druge alergijske reakcije, kot so piskanje, otekanje ali omotičnost
• liver and pancreas problems
• težave z jetri in pankreasom
Uncommon side effects (These can affect at least 1 in every 1,000 patients treated, but less than 1 in every 100 patients treated)
Občasni neželeni učinki (Prizadenejo lahko najmanj 1 bolnika od 1. 000 bolnikov, ki se zdravijo, vendar manj kot 1 bolnika od 100 bolnikov, ki se zdravijo)
Rare side effects (These can affect at least 1 in every 10,000 patients treated, but less than 1 in every 1,000 patients treated)
Redki neželeni učinki (Prizadenejo lahko najmanj 1 bolnika od 10. 000 bolnikov, ki se zdravijo, vendar manj kot 1 bolnika od 1. 000 bolnikov, ki se zdravijo)
• lactic acidosis (excess lactic acid in the blood, a serious side effect that can be fatal).
• laktacidoza (preveč mlečne kisline v krvi, resen neželeni učinek, ki je lahko usoden).
deep rapid breathing drowsiness feeling sick (nausea), being sick (vomiting) and stomach pain
globoko, hitro dihanje omotica slabost, bruhanje in bolečine v trebuhu
think you may have lactic acidosis, contact your doctor immediately.
Če menite, da bi lahko imeli laktacidozo, se nemudoma posvetujte z zdravnikom.
• pain in the abdomen (tummy) caused by inflammation of the pancreas
• bolečine v trebuhu zaradi vnetja pankreasa
Very rare side effects (These can affect less than 1 in every 10,000 patients treated)
Zelo redki neželeni učinki (Prizadenejo lahko manj kot 1 bolnika na vsakih 10. 000 bolnikov, ki se zdravijo)