natgillin/translations-raw huggingface dataset:
Parenteral medicines must be inspected visually for particulate matter and discolouration prior to administration.
Videz parenteralnih zdravil moramo pred dajanjem vizualno pregledati, da ne vsebujejo trdnih delcev ali da nimajo spremenjene barve.
Common Neuropathysensory
Nevropatijasenzorična
Irritation of the skin and itching Chest pain
Draženje kože in srbenje
Table 2.
PRILOGA II
Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed.
Če opazimo nevrološko toksičnost stopnje 3 ali 4, zdravljenje prekinemo.
Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Občasno so v kliničnih študijah pemetrekseda, običajno ob sočasnem dajanju z drugo citotoksično učinkovino, poročali o resnih srčnožilnih dogodkih, vključno z miokardnim infarktom in možganskožilnimi dogodki.
Read the package leaflet for the shelf life of the reconstituted product.
EXP Za informacije o roku uporabnosti rekonstituiranega zdravila preberite navodilo za uporabo.
NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Pfizer 1.000 mg prašek za koncentrat za raztopino za infundiranje
Uncommon cases of oedema have been reported in patients treated with pemetrexed.
Pri bolnikih, zdravljenih s pemetreksedom, so poročali o občasnih primerih edema.
Creatinine elevation
Povišanje
Immunodepressed status is common in cancer patients.
Pri bolnikih z rakom je delovanje imunskega sistema pogosto oslabljeno.
The active substance is pemetrexed.
Zdravilna učinkovina je pemetreksed.
Reconstituted and infusion solutions
za intravensko uporabo po rekonstituciji in redčenju
NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Pfizer 100 mg prašek za koncentrat za raztopino za infundiranje
Pemetrexed at a dose of 500 mg/m2 was studied as a single agent in 64 chemonaive patients with malignant pleural mesothelioma.
Pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m2 pri
Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
V kliničnih preskušanjih s pemetreksedom so pogosto poročali o sepsi, ki je bila včasih usodna.
Pemetrexed Pfizer.
Shranjevanje zdravila Pemetreksed Pfizer
NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje
Rash/ desquamation Common Pruritus Alopecia
Pogosto Srbenje Alopecija
Table 3.
PRILOGA III
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 1,000 mg
Nalepka na viali 1.000 mg
Kidney failure
Odpoved ledvic
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1,000 mg
Zunanja škatla 1.000 mg
Breast-feeding
Stomatitis/ faringitis
GENERAL CLASSIFICATION FOR SUPPLY 15.
- Navodilo shranite.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 mg
Zunanja škatla 500 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg
Zunanja škatla 100 mg
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Pain in the abdomen
Bolečina v trebuhu
Common Dyspepsia
Diareja Bruhanje
Pemetrexed as a single agent
Pemetreksed kot samostojno zdravilo
Renal Disorders Common Renal disorders****
Pogosto Bolezni sečil****
(Invented) name Strength Pharmaceutical Form
(Izmišljeno) ime Jakost Farmacevtska oblika
Pack size
matriks z lepilom za
This summary was last updated in 01-2013.
Povzetek je bil nazadnje posodobljen 01-2013.
106 volunteers completed the study and were included in the results.
Študijo je zaključilo 106 prostovoljcev, ki so bili vključeni v rezultate.
Doctors will therefore need to use the scans in conjunction with clinical evaluation.
Zdravniki bodo zato morali uporabiti posnetke skupaj s kliničnim vrednotenjem.
The European Commission granted a marketing authorisation valid throughout the European Union for Amyvid on 14 January 2013.
Evropska komisija je dovoljenje za promet z zdravilom Amyvid, veljavno po vsej Evropski uniji, odobrila dne 14 januarja 2013.
This is a summary of the European public assessment report (EPAR) for Amyvid.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Amyvid.
The most common side effect with Amyvid (seen in between 1 and 10 patients in 100) is headache.
Najpogostejši neželeni učinek zdravila Amyvid (opažen pri 1 do 10 bolnikih od 100) je glavobol.
A main study was conducted in 226 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died.
Glavna študija je bila opravljena z 226 prostovoljci, ki so bili razdeljeni v dve skupini: v skupino zdravih mladih oseb in v skupino bolnikov ob koncu življenja, ki so privolili v obdukcijo.
Other information about Amyvid
Druge informacije o zdravilu Amyvid
What measures are being taken to ensure the safe use of Amyvid?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Amyvid?
Amyvid is for diagnostic use only.
Zdravilo Amyvid je namenjeno samo za diagnostično uporabo.
The type of scan used with Amyvid is called positron emission tomography (PET).
Vrsta slikanja, ki se uporablja z zdravilom Amyvid, se imenuje pozitronska emisijska tomografija (PET).
β-amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease, Lewy body dementia and Parkinson's disease dementia) and some elderly people with no symptoms.
β-amiloidne lehe so obloge, ki so včasih prisotne v možganih oseb z demencami (kot so Alzheimerjeva bolezen, demenca z Lewyjevimi telesci in demenca pri Parkinsonovi bolezni) ter pri nekaterih asimptomatskih starejših osebah.
In addition, the usefulness of Amyvid in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Poleg tega uporabnost zdravila Amyvid pri napovedovanju razvoja Alzheimerjeve bolezni pri bolnikih, ki imajo težave s spominom, ali pri spremljanju odzivov bolnikov na zdravljenje ni bila ugotovljena.
Amyvid must not be used in people who are hypersensitive (allergic) to florbetapir (18F) or any of the other ingredients.
Zdravila Amyvid ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) florbetapir (18F) ali katero koli drugo sestavino zdravila.
The specificity of the PET scans was 100% in 47 healthy volunteers, which means that all of their scans were rated as negative after being read by experts who were not aware if the scans belonged to healthy people or to patients.
Specifičnost preiskav PET je bila pri 47 zdravih prostovoljcih 100-odstotna, kar pomeni, da so bili vsi njihovi posnetki ocenjeni kot negativni, ko so jih odčitali strokovnjaki, ki niso vedeli, ali gre za posnetke zdravih oseb ali bolnikov.
When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 92% and a specificity of 100%.
Ko so primerjali rezultate obdukcij s preiskavami PET, so ugotovili 92odstotno občutljivost in 100-odstotno specifičnost preiskav.
The effects of Amyvid were first tested in experimental models before being studied in humans.
Učinki zdravila Amyvid so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The study looked at sensitivity and specificity of the scans (how reliable they were at differentiating volunteers who had significant amounts of plaques in the brain from those who did not).
V študiji so proučevala občutljivost in specifičnost posnetkov (s kakšno zanesljivostjo ločijo prostovoljce z večjimi količinami leh v možganih od tistih prostovoljcev, ki jih nimajo).
What benefit has Amyvid shown during the studies?
Kakšne koristi je zdravilo Amyvid izkazalo med študijami?
Patients should discuss the results of their PET scan with their doctor.
Bolniki naj se o rezultatih svoje preiskave PET pogovorijo z zdravnikom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Amyvid.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Amyvid, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Amyvid is a solution for injection that contains the active substance florbetapir (
Amyvid je raztopina za injiciranje, ki vsebuje zdravilno učinkovino florbetapir (
PET scans with Amyvid should only be requested by doctors skilled in the clinical management of patients with neurodegenerative diseases such as Alzheimer's and other dementias.
Preiskave PET z zdravilom Amyvid lahko naročijo le zdravniki, ki so usposobljeni za klinično obravnavo bolnikov z nevrodegenerativnimi boleznimi, kot so Alzheimerjeva in druge demence.
This means that the PET scans were able to correctly identify as positive 92% of the patients who had significant amounts of plaques, and that all patients without significant plaques were correctly rated as negative.
To pomeni, da so s preiskavami PET kot pozitivne pravilno identificirali 92 % bolnikov, ki so imeli večje količine leh, in da so bili vsi bolniki brez večjih količin leh pravilno ocenjeni negativno.
Amyvid is given by injection into a vein about 30 to 50 minutes before obtaining an image from a PET scan.
Zdravilo Amyvid se injicira intravensko približno 30 do 50 minut pred izdelavo slike z aparatom za pozitronsko emisijsko tomografijo.
The company that markets Amyvid will provide access to a training course for all nuclear medicine physicians expected to use this product in the EU in order to ensure accurate and reliable reading of the PET scan images.
Družba, ki trži zdravilo Amyvid, bo vsem zdravnikom specialistom nuklearne medicine, za katere se pričakuje, da bodo zdravilo uporabljali v EU, omogočila dostop do programa usposabljanja, da se bo tako zagotovilo natančno in zanesljivo odčitavanje slik preiskav PET.
The active substance in Amyvid, florbetapir (
Zdravilna učinkovina v zdravilu Amyvid, florbetapir (
F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
F), je radiofarmak, ki oddaja majhne količine sevanja in deluje tako, da se veže na β-amiloidne lehe v možganih.
A negative scan indicates sparse or no β-amyloid plaques, which means that the patient is unlikely to have Alzheimer's disease.
Negativen rezultat preiskave kaže na redke ali odsotne β-amiloidne lehe, kar pomeni, da je malo verjetno, da ima bolnik Alzheimerjevo bolezen.
This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other neurodegenerative diseases.
To ocenjujemo kot bistveno izboljšavo diagnostike bolnikov, ki imajo težave s spominom in pri katerih ugotavljamo morebitno Alzheimerjevo bolezen in druge nevrodegenerativne bolezni.
What is the risk associated with Amyvid?
Kakšna tveganja so povezana z zdravilom Amyvid?
Amyvid delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Zdravilo Amyvid povzroča majhne količine sevanja, povezanega z najmanjšim tveganjem za razvoj raka ali dednih nenormalnosti.
A positive scan on its own, however, is not sufficient to make a diagnosis in patients with memory problems, as plaque deposition may be seen in patients with different types of neurodegenerative dementias as well as in elderly people with no symptoms.
Pozitiven rezultat preiskave sam po sebi ne zadošča za postavitev diagnoze pri bolnikih, ki imajo težave s spominom, saj je odlaganje leh lahko prisotno pri bolnikih z različnimi vrstami nevrodegenerativnih demenc in tudi pri asimptomatskih starejših osebah.
Why has Amyvid been approved?
Zakaj je bilo zdravilo Amyvid odobreno?
After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Amyvid.
Ko dobimo sliko, jo odčitajo zdravniki specialisti nuklearne medicine, ki so posebej usposobljeni za tolmačenje slik preiskav PET z zdravilom Amyvid.
It is used for brain scans in adult patients with memory problems so that doctors can see whether or not they have significant amounts of β-amyloid plaques in the brain.
Uporablja se pri slikanju možganov odraslih bolnikov, ki imajo težave s spominom, tako da lahko zdravniki vidijo, ali imajo bolniki morda v možganih znatne količine β-amiloidnih leh.
For the full list of all side effects reported with Amyvid, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Amyvid, glejte navodilo za uporabo.
The CHMP did, however, note that, partly due to the limited effects of current treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Amyvid.
Odbor CHMP je navedel še, da po preiskavah PET z zdravilom Amyvid - deloma zaradi omejenih učinkov trenutnih zdravljenj Alzheimerjeve bolezni - ne obstajajo trdni dokazi o takojšnjem izboljšanju obravnave bolnikov ali izidov za bolnike.
When it attaches to the plaques, the radiation it emits is then seen on the PET scan, enabling doctors to know whether or not significant amount of plaques are present.
Ko se zdravilo veže na lehe, oddaja sevanje, ki ga je mogoče videti na sliki preiskave PET, na podlagi katerega zdravniki ugotovijo, ali je morda prisotna večja količina leh.
The Committee noted the good safety profile and non-invasive nature of the PET scans with Amyvid and concluded that
Odbor je upošteval ugoden varnostni profil in neinvazivno naravo preiskav PET z zdravilom Amyvid ter zaključil, da so koristi zdravila Amyvid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Among the patients, 59 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Pri bolnikih je bilo opravljenih 59 obdukcij, ki so dokončno potrdile, ali so imeli večje količine βamiloidnih leh v možganih.
PET scans with Amyvid were shown to have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Preiskave PET z zdravilom Amyvid so pokazale veliko občutljivost in specifičnost pri zaznavi β-amiloidnih leh v možganih, njihovi rezultati pa so ustrezali ugotovitvam obdukcij.
PET scans with Amyvid were shown to have high specificity and sensitivity when used for identifying which patients had significant amounts of β-amyloid plaques in the brain.
Preiskave PET z zdravilom Amyvid so pokazale visoko specifičnost in občutljivost pri identifikaciji bolnikov z večjimi količinami β-amiloidnih leh v možganih.
What is Amyvid?
Kaj je zdravilo Amyvid?
What is Amyvid used for?
Za kaj se zdravilo Amyvid uporablja?
How has Amyvid been studied?
Kako je bilo zdravilo Amyvid raziskano?
How does Amyvid work?
Kako zdravilo Amyvid deluje?
How is Amyvid used?
Kako se zdravilo Amyvid uporablja?
As of week 144:
V 144. tednu:
Your doctor will test for these changes.
Zdravnik bo opravil preiskave glede teh sprememb.
Such changes may in part be linked to disease control and life style.
Takšne spremembe so deloma lahko povezane z obvladanjem bolezni in načinom življenja.
• Risk management plan (RMP)
• Načrt za obvladovanje tveganja (RMP)
NC = not calculated
n/i = ni izračuna
Then take the next dose at your usual time.
Nato vzemite naslednji odmerek ob svojem običajnem času.
Staggered administration (12 hours apart) provided similar results.
Odmerjanje z zamikom (12 ur narazen) je dalo podobne rezultate.
Do not change the dose unless your doctor tells you to.
Ne spreminjajte odmerka, razen če vam to naroči zdravnik.
Other effects in children
Drugi učinki pri otrocih
• Always take the dose recommended by your doctor.
• Vedno vzemite odmerek, ki vam ga je priporočil zdravnik.
- this may cause the child to be tired or breathless.
- To lahko povzroči utrujenost ali zasoplost otroka.
This medicine should not be given to adolescents with existing kidney problems.
Tega zdravila se ne sme dajati mladostnikom z obstoječimi ledvičnimi težavami.
The 144 week secondary endpoint data are also presented in Table 4.
Tudi podatki za sekundarni cilj po 144 tednih so predstavljeni v preglednici 4.
URAI Within 12 Weeks Prior to Screening, mITT Analysis
URAI v 12 tednih pred presejanjem, analiza mITT
Interaction not studied.
Interakcij niso preučevali.
• Many HIV tests can miss a recent infection.
• Mnogi testi za HIV lahko spregledajo nedavno okužbo.
People who do have HIV must take this medicine in combination with other drugs.
Ljudje, ki imajo HIV, morajo to zdravilo jemati v kombinaciji z drugimi zdravili.
If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.
Če imate hepatitis B ali C, bo vaš zdravnik skrbno razmislil o najboljšem režimu zdravljenja za vas.
ATC code: J05AR03
Oznaka ATC: J05AR03
Patients were followed for a median of 71 weeks and 87 weeks, respectively.
Bolnike so spremljali povprečno 71 oziroma 87 tednov.
They may want to do more tests to make sure you are still HIV negative.
Morda bo želel opraviti več testov, da se prepriča, da ste še vedno HIV-negativni.
You do not need to take another tablet if you were sick more than 1 hour after taking this medicine.
Še ene tablete vam ni treba vzeti, če ste bruhali več kot 1 uro po zaužitju tega zdravila.
These tumours are unlikely to be of relevance to humans.
Ti tumorji za ljudi verjetno niso relevantni.
You may require blood tests for several months after stopping treatment.
Morda bodo pri vas potrebne krvne preiskave še več mesecev po prenehanju zdravljenja.
Keep the tablet bottle or package with you so that you can easily describe what you have taken.
S seboj imejte plastenko ali škatlico tablet, da boste lahko opisali, kaj ste zaužili.
• Get tested for HIV regularly.
• Redno se testirajte za HIV.
• Reminders for evaluations/counselling at the initial visit and follow-up.
• opozorila za oceno/svetovanje pri prvem obisku in v fazi spremljanja.
• That a multidisciplinary approach is recommended for the management of paediatric patients
• da se za vodenje pediatričnih bolnikov priporoča multidisciplinarni pristop;
Importance of adherence:
Pomembnost adherence:
Not recommended for use in this population.
Uporabe se pri tej populaciji ne priporoča.
• swelling of the face, lips, tongue or throat
• oteklost obraza, ustnic, jezika ali grla
 Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
 Nemudoma obvestite zdravnika o vsakem novem ali nenavadnem simptomu potem, ko ste prenehali z zdravljenjem, še posebej o simptomih, ki jih povezujete z okužbo s hepatitisom B.
Opportunistic infections
Oportunistične okužbe
• Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
• priporočen urnik spremljanja delovanja ledvic, pri čemer se upošteva prisotnost ali odsotnost dodatnih dejavnikov tveganja za okvare ledvic;
hepatic steatosis, hepatitis
hepatična steatoza, hepatitis
If you get a flu-like illness, it could mean you have recently been infected with HIV.
Če zbolite za gripi podobno boleznijo, lahko to pomeni, da ste bili nedavno okuženi s HIV.
Whether such neurological disorders are transient or permanent is currently unknown.
Trenutno ni znano, ali so takšne nevrološke motnje prehodne ali trajne.
 Tell your doctor if you are taking any of these medicines.
 Obvestite zdravnika, če jemljete katero koli od teh zdravil.
• Provides safety information on adherence, HIV testing, renal, bone and HBV status.
• nudi varnostne informacije glede adherence, testiranja za HIV, stanja ledvic, kosti in HBV.
• Reminder on the importance of strict adherence to the recommended dosing regimen
• opozorilo glede pomembnosti strogega upoštevanja priporočenega režima odmerjanja;
Wait and take the next dose, preferably with food, at your usual time.
Počakajte in vzemite naslednji odmerek, najbolje s hrano, ob svojem običajnem času.
• Provides information on the possible side effects
• nudi informacije o možnih neželenih učinkih;
This is because the active substances in this medicine pass into human breast milk.
To je zato, ker učinkovini tega zdravila prehajata v materino mleko.
The same recommendations apply as in adults (see Co-administration of other medicinal products below).
Veljajo enaka priporočila kot pri odraslih (glejte spodnje poglavje Sočasno dajanje drugih zdravil).
This indicates that active tubular secretion is an important part of the elimination of tenofovir.
To nakazuje, da ima aktivna tubularna sekrecija pomembno vlogo pri izločanju tenofovirja.
Subjects were followed for 7,830 person-years.
Osebe so spremljali 7.830 človek-let.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kakršnekoli vnetne simptome je treba obravnavati in uvesti zdravljenje, kadar je potrebno.
If available, 90% confidence intervals are shown in parentheses.
90-odstotni intervali zaupanja so prikazani v oklepajih, če so na voljo.
 If this applies to you, tell your doctor immediately.
 Če to velja za vas, o tem nemudoma obvestite zdravnika.
Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
Zdravnik bo skrbno pretehtal, če vas bo zdravil s kombinacijami tenofovirja in didanozina.
Date of first authorisation: 16 December 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. december 2016
• Any signs of inflammation or infection.
• Znaki vnetja ali okužbe.
Tests may also show:
Preiskave lahko kažejo tudi:
• Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
• Testirajte se za druge spolno prenosljive okužbe, kot sta sifilis in gonoreja.
Subjects were followed for 4,237 person-years.
Osebe so spremljali 4.237 človek-let.
This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Tako boste zagotovili polno učinkovitost vašega zdravila in zmanjšali možnost razvoja odpornosti proti zdravljenju.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Pogostnost je definirana kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki neželeni učinki (≥ 1/10.000 do < 1/1.000).
Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice and drink immediately.
Nato zmešajte prašek s približno 100 ml (pol kozarca) vode, pomarančnega ali grozdnega soka in nemudoma popijte.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
 If you think you may have lactic acidosis, get medical help immediately.
 Če menite, da bi lahko imeli laktacidozo, nemudoma poiščite zdravniško pomoč.
If you feel dizzy while taking this medicine, do not drive and do not use any tools or machines.
Če se vam v času zdravljenja s tem zdravilom pojavlja omotičnost, ne vozite avtomobila in ne upravljajte orodij ali strojev.
The frequency of the following side effects is not known.
Pogostnost naslednjih neželenih učinkov je neznana.