natgillin/translations-raw huggingface dataset:
Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day; Sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001).
Metformin ≥ 1500 mg/dan Sitagliptin 100 mg/dan LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] S placebom kontrolirana 16-tedenska študija Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik Vrednost p < 0,05 v primerjavi s kombinacijo placebo + peroralni antidiabetik Odstotek spremembe telesne mase so analizirali kot sekundarni opazovani dogodek (p < 0,0001); absolutno spremembo telesne mase (v kg) so analizirali z nominalno vrednostjo p (p < 0,0001).
Ebymect has been demonstrated to be bioequivalent with coadministered dapagliflozin and metformin (see section 5.2).
Zdravilo Ebymect je dokazano bioekvivalentno s sočasno uporabljenima dapagliflozinom in metforminom (glejte poglavje 5.2).
In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Pri bolnikih z normalnim delovanjem ledvic ali blago okvaro ledvic (izhodiščna ocenjena hitrost glomerularne filtracije [eGFR] ≥ 60 ml/min/1,73 m2) je bila ta skupina učinkov opisana pri 1,3 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 0,8 % tistih,
Ebymect should be discontinued prior to, or at the time of, the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.5).
Zdravilo Ebymect je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.5.
• a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017;
• značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 dogodka/1000 bolnik-let, dieta sama 12,7 dogodka/1000 bolnik-let, p = 0,017;
Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A
Jedro tablete: hidroksipropilceluloza (E463) mikrokristalna celuloza (E460(i)) magnezijev stearat (E470b) natrijev karboksimetilškrob, vrsta A
How to take Ebymect
Kako jemati zdravilo Ebymect
Hypoglycaemia (when used with SU or insulin)
Presnovne in prehranske motnje hipoglikemija (med uporabo s sulfonilsečninami ali insulinom)
• Ebymect 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets.
• Zdravilo Ebymect 5 mg/1000 mg so 10,5 x 21,5 mm velike, ovalne, rumene filmsko obložene tablete.
• a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
• značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 dogodkov/1000 bolnik-let, dieta sama 18 dogodkov/1000 bolnik-let (p = 0,01).
EU/1/15/1051/009 5 mg/1000 mg 56 tablets EU/1/15/1051/010 5 mg/1000 mg 60 tablets EU/1/15/1051/011 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/15/1051/012 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Ebymect 5 mg/1000 mg filmsko obložene tablete EU/1/15/1051/007 5 mg/1000 mg 14 tablet EU/1/15/1051/008 5 mg/1000 mg 28 tablet EU/1/15/1051/009 5 mg/1000 mg 56 tablet EU/1/15/1051/010 5 mg/1000 mg 60 tablet EU/1/15/1051/011 5 mg/1000 mg 60 x 1 tableta (enkratni odmerek) EU/1/15/1051/012 5 mg/1000 mg 196 (2 x 98) tablet (skupno pakiranje)
Ebymect 5 mg/850 mg film-coated tablets and Ebymect 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister.
Filmsko obložene tablete Ebymect 5 mg/850 mg in Ebymect 5 mg/1000 mg so na voljo v pretisnih omotih iz PVC/PCTFE/Alu.
Ebymect 5 mg/850 mg film-coated tablets
Ebymect 5 mg/850 mg filmsko obložene tablete
An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing longterm, clinical studies with another SGLT2 inhibitor.
V dolgoročnih kliničnih študijah z drugim zaviralcem SGLT2, ki še potekajo, so opazili povečano število primerov amputacij na spodnjih okončinah (predvsem prstov na nogah).
Ebymect 5 mg/1,000 mg film-coated tablets
Ebymect 5 mg/1000 mg filmsko obložene tablete
Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side.
Ebymect 5 mg/1000 mg filmsko obložene tablete Rumene, bikonveksne, 10,5 x 21,5 mm velike, ovalne filmsko obložene tablete z vtisnjeno oznako "5/1000" na eni strani in "1069" na drugi strani.
•Ebymect5mg/850mg are 9.5x20mm oval, brown film-coated tablets.
•Zdravilo Ebymect5 mg/850 mg so 9,5 x 20 mm velike, ovalne, rjave filmsko obložene tablete.
Hepatic impairment
Zelo redki hepatitis
Talc (E553b) Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Filmska obloga: polivinilalkohol (E1203) makrogol 3350 (E1520(iii)) smukec (E553b) titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
Each Ebymect 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Ena filmsko obložena tableta (tableta) zdravila Ebymect 5 mg/850 mg vsebuje dapagliflozinpropandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 850 mg metforminijevega klorida.
Lactic acidosis Vitamin B1
pomanjkanje volumna b,e žeja diabetična ketoacidoza laktacidoza pomanjkanje vitamina B12
Ebymect 5 mg/850 mg film-coated tablets Ebymect 5 mg/1,000 mg film-coated tablets
Ebymect 5 mg/850 mg filmsko obložene tablete Ebymect 5 mg/1000 mg filmsko obložene tablete
Reported in ≥ 2 % of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Glejte poglavje 4.4 Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
Uncommon Rare
Neraziskane kombinacije
Each Ebymect 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.
Ena filmsko obložena tableta (tableta) zdravila Ebymect 5 mg/1000 mg vsebuje dapagliflozinpropandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 1.000 mg metforminijevega klorida.
How to store Ebymect
Shranjevanje zdravila Ebymect
Ebymect 5 mg/850 mg film-coated tablets Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Ebymect 5 mg/850 mg filmsko obložene tablete Ebymect 5 mg/1000 mg filmsko obložene tablete dapagliflozin/metforminijev klorid
Liver function disorders Hepatitis
Bolezni jeter, žolčnika in žolčevodov motnje delovanja jeter
Ebymect 5 mg/850 mg tablets dapagliflozin/metformin HCl
Ebymect 5 mg/850 mg tablete dapagliflozin/metforminijev klorid
Ebymect 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Ebymect 5 mg/1000 mg tablete dapagliflozin/metforminijev klorid
• a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034;
• značilno zmanjšanje absolutnega tveganja vseh zapletov sladkorne bolezni v skupini z metforminom (29,8 dogodka/1000 bolnik-let) v primerjavi z dieto samo (43,3 dogodka/1000
Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Ebymect 5 mg/1000 mg filmsko obložene tablete dapagliflozin/metforminijev klorid
Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5 % versus 0.0 %; HDL cholesterol 6.0 % versus 2.7 %; LDL cholesterol 2.9 % versus -1.0 %; triglycerides -2.7 % versus -0.7 %.
Povprečni odstotek spremembe od izhodišča za 10 mg dapagliflozina v primerjavi s placebom je bil: celotni holesterol 2,5 % v prim.
Ebymect 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Ebymect 5 mg/850 mg filmsko obložene tablete dapagliflozin/metforminijev klorid
• by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis;
Metformin lahko deluje po treh mehanizmih: • z zmanjšanjem nastajanja glukoze v jetrih z zavrtjem glukoneogeneze in glikogenolize,
suicidal thoughts or suicide attempts.
samomorilnih misli ali poskusa samomora.
The marketing authorisation was renewed on 9 March 2005.
Dovoljenje za promet je bilo podaljšano 9. marca 2005.
The main measure of effectiveness was response rates.
Glavno merilo učinkovitosti je bila stopnja odziva.
These contain from 1 to 50 million IU (international units) per millilitre.
Te oblike vsebujejo od 1 do 50 milijonov mednarodnih enot na mililiter.
The most common side effects with Viraferon in adults (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), anxiety, agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, nausea (feeling sick) or vomiting, abdominal (tummy) pain, diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (indigestion), alopecia (hair loss), increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, fatigue (tiredness), rigors (shaking chills), fever, flulike symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Najpogostejši neželeni učinki zdravila Viraferon pri odraslih (opaženi pri več kot 1 bolniku od 10) so levkopenija (majhno število belih krvnih celic), anoreksija (izguba teka), depresija, nespečnost (težave s spanjem), anksioznost, vznemirjenost, živčnost, omotica, glavobol, motnje koncentracije, suha usta, zamegljen vid, navzeja (občutek slabosti) ali bruhanje, bolečine v trebuhu, driska, stomatitis (vnetje ustne sluznice), dispepsija (slaba prebava), alopecija (izpadanje las), prekomerno potenje, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišičnoskeletne bolečine (bolečine v mišicah in kosteh), vnetje na mestu injiciranja, utrujenost, mrzlica (drgetanje), povišana telesna temperatura, gripi podobni simptomi, astenija (šibkost), razdražljivost, bolečine v prsih, oslabelost (slabo počutje) in izguba telesne mase.
Viraferon is given three times per week (every other day) by subcutaneous injection (under the skin).
Zdravilo Viraferon se daje trikrat tedensko (vsak drugi dan) s subkutano injekcijo (pod kožo).
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferoni so naravne snovi, ki jih proizvaja telo za obrambo proti napadi, kot so okužbe, ki jih povzročajo virusi.
The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 3 to 10 million IU per square metre of body surface area.
Odmerek in trajanje zdravljenja sta odvisna od zdravljene bolezni in odziva bolnika, pri čemer se odmerki gibljejo v razponu od 3 do 10 milijonov mednarodnih enot na kvadratni meter telesne površine.
Viraferon has to be stored in a refrigerator (2°C-8°C).
Zdravilo Viraferon je treba hraniti v hladilniku (2 °C-8 ºC).
The exact way alpha interferons work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the body's defence system, works).
Natančen način delovanja interferonov alfa pri virusnih boleznih ni v celoti znan, vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema, obrambnega sistema telesa).
The European Commission granted a marketing authorisation valid throughout the EU for Viraferon to SP Europe on 9 March 2000.
Evropska komisija je dovoljenje za promet z zdravilom Viraferon, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 9. marca 2000.
Because Viraferon can be associated with side effects such as depression, patients must be closely monitored during treatment.
Ker je mogoče zdravilo Viraferon povezati z neželenimi učinki, kot je depresija, je treba bolnike med zdravljenjem pozorno spremljati.
Alpha interferons may also block the multiplication of viruses.
Interferoni alfa utegnejo tudi blokirati razmnoževanje virusov.
• children and adolescents with a history of severe mental illness, particularly severe depression,
• otrocih in mladostnikih z anamnezo hude duševne bolezni, še posebej hude depresije,
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VIRAFERON EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) VIRAFERON Povzetek EPAR za javnost
In children it is used with ribavirin.
Pri otrocih se uporablja v kombinaciji z ribavirinom.
Treatment with Viraferon should be initiated by a doctor who has experience in the management of the disease it is being used for.
Zdravljenje z zdravilom Viraferon mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katero se uporablja.
Viraferon should not be used in:
Zdravila Viraferon se ne sme uporabljati pri:
It is available as a powder and solvent to be made up into a solution for injection or infusion, as a ready-to-use solution for injection and as a multidose pen for injection.
Na voljo je kot prašek in vehikel za pripravo raztopine za injiciranje ali infundiranje, kot predhodno pripravljena raztopina za injiciranje ter kot večodmerni peresnik za injiciranje.
Other information about Viraferon:
Druge informacije o zdravilu Viraferon:
Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes Viraferon supplied data from the scientific literature and from studies of its use in children with chronic hepatitis B. The company also supplied information from a number of studies of Viraferon used alone or with ribavirin for the treatment of chronic hepatitis C. These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345 patients whose disease had relapsed (returned) after previous treatment with interferon.
Ker se je interferon alfa-2b že prej uporabljal za zdravljenje številnih bolezni v Evropski uniji (EU), je podjetje, ki izdeluje zdravilo Viraferon, predložilo podatke iz znanstvene literature in študij o njegovi uporabi pri otrocih s kroničnim hepatitisom B. Podjetje je predložilo tudi podatke iz številnih študij zdravila Viraferon, uporabljenega samostojno ali v kombinaciji z ribavirinom pri zdravljenju kroničnega hepatitisa C. V teh študijah je sodelovalo skupno 2552 predhodno nezdravljenih bolnikov (ki dotlej še niso prejemali zdravil) in skupno 345 bolnikov, pri katerih se je bolezen ponovila po predhodnem zdravljenju z interferonom.
• patients with thyroid disease unless it is controlled,
• bolnikih z boleznijo ščitnice, razen če je obvladana,
• patients with epilepsy or other central nervous system problems,
• bolnikih z epilepsijo ali drugimi motnjami delovanja centralnega živčnega sistema,
The studies showed that Viraferon is effective in the diseases for which it can be used.
Študije so pokazale, da je zdravilo Viraferon učinkovito pri zdravljenju bolezni, za katere je namenjeno.
It was also effective in children when used with ribavirin, with 46% of the children having responded to treatment at the six-month follow up visit following a year's treatment.
V kombinaciji z ribavirinom je bilo učinkovito tudi pri otrocih, saj je bilo ob pregledu po šestmesečnem obdobju spremljanja, ki je sledilo enoletnemu zdravljenju, ugotovljeno, da se je na zdravljenje odzvalo 46 % otrok.
• patients with severe kidney or liver disease including that caused by cancer,
• bolnikih s hudo boleznijo ledvic ali jeter, vključno s takšno, ki jo povzroča rak,
The use of Viraferon in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between three and 16 years.
Uporabo zdravila Viraferon v kombinaciji z ribavirinom so preučevali tudi pri 118 predhodno nezdravljenih otrocih s hepatitisom C, starimi med tri in 16 let.
Viraferon can be used on its own but is best used in combination with ribavirin (an antiviral medicine).
Pri odraslih je zdravilo Viraferon mogoče uporabljati samostojno, vendar je bolje, če se uporablja v kombinaciji z ribavirinom (protivirusnim zdravilom).
The interferon alfa-2b in Viraferon is produced by a method known as ‘recombinant DNA technology': the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Interferon alfa-2b, ki ga vsebuje zdravilo Viraferon, se proizvaja po metodi, imenovani „rekombinantna DNA tehnologija“: proizvaja ga bakterija, ki je prejela gen (DNA), kar ji omogoča njegovo tvorjenje.
For more information, see the Package Leaflet.
Za več informacij glejte Navodilo za uporabo.
• hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system,
• bolnikih s hepatitisom, ki imajo cirozo jeter, ki povzroča simptome, ali ki so nedavno prejemali zdravila, ki vplivajo na imunski sistem,
What is the risk associated with Viraferon?
Kakšna tveganja so povezana z zdravilom Viraferon?
What benefit has Viraferon shown during the studies?
Kakšne koristi je zdravilo Viraferon izkazalo med raziskavami?
The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
Nadomestni interferon alfa-2b deluje na enak način kot naravno proizvedeni interferon alfa.
• chronic hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
• kroničnega hepatitisa C (bolezni jeter, ki je posledica okužbe z virusom hepatitisa C).
Similar side effects have been seen in children receiving Viraferon, as well as inhibition of growth.
Podobni neželeni učinki so bili opaženi pri otrocih, ki so prejemali zdravilo Viraferon, kakor tudi zavirana rast.
Viraferon should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or any of the other ingredients.
Zdravilo Viraferon se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) interferon alfa-2b ali katero koli drugo sestavino.
• patients with a history of certain disorders of the immune system, or who have had an organ transplant and are taking medicines that suppress the immune system,
• bolnikih, ki imajo določene motnje imunskega sistema v anamnezi ali so imeli presaditev organa in jemljejo zdravilo za zaviranje delovanja imunskega sistema,
Viraferon is used for the treatment of:
Zdravilo Viraferon se uporablja za zdravljenje:
• patients with a history of severe heart disease,
• bolnikih z anamnezo hudega obolenja srca,
Viraferon is a medicine containing the active substance interferon alfa-2b.
Viraferon je zdravilo, ki vsebuje zdravilno učinkovino interferon alfa-2b.
For the full list of all side effects reported with Viraferon, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Viraferon, glejte Navodilo za uporabo.
Viraferon was also shown to have a benefit in children with chronic hepatitis B. Viraferon, with or without ribavirin, was shown to be effective in treating hepatitis C in both treatment-naïve and relapsed adults.
Zdravilo Viraferon je izkazalo koristi tudi pri otrocih s kroničnim hepatitisom B. Zdravilo Viraferon v kombinaciji z ribavirinom ali brez njega je bilo učinkovito pri zdravljenju hepatitisa C pri predhodno nezdravljenih odraslih in odraslih s ponovitvijo bolezni.
• chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus)
• kroničnega (dolgotrajnega) hepatitisa B (bolezni jeter, ki je posledica okužbe z virusom hepatitisa B) pri odraslih;
The Committee for Medicinal Products for Human Use (CHMP) decided that Viraferon's benefits are greater than its risks for the treatment of chronic hepatitis B and C. The Committee recommended that Viraferon be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Viraferon pri zdravljenju kroničnega hepatitisa B in C večje od z njim povezanih tveganj.
The full EPAR for Viraferon is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Viraferon je na voljo tukaj.
Why has Viraferon been approved?
Zakaj je bilo zdravilo Viraferon odobreno?
The active substance in Viraferon, interferon alfa-2b, belongs to the group ‘interferons'.
Zdravilna učinkovina zdravila Viraferon, interferon alfa-2b, spada v skupino interferonov.
For a list of all restrictions with Viraferon, see the Package Leaflet.
Za celoten seznam omejitev za zdravilo Viraferon glejte Navodilo za uporabo.
How has Viraferon been studied?
Kako je bilo zdravilo Viraferon raziskano?
What is Viraferon used for?
Za kaj se zdravilo Viraferon uporablja?
What is Viraferon?
Kaj je zdravilo Viraferon?
How is Viraferon used?
Kako se zdravilo Viraferon uporablja?
How does Viraferon work?
Kako zdravilo Viraferon deluje?
• Not drink Grapefruit Juice
• ne sme piti soka grenivke;
The PAC must include the following key messages:
Kartica OKB mora vsebovati naslednja ključna sporočila:
• Have ever had an abnormal electrocardiogram (ECG)
• je kadar koli imel nenormalen elektrokardiogram (EKG);
• Is taking allergy medicines
• jemlje zdravila proti alergiji.
• Is taking medications to treat epilepsy, bacterial or fungal infections, HIV infection, depression or heart rhythm disorders
• jemlje zdravila proti epilepsiji, bakterijskim ali glivičnim okužbam, okužbi z virusom HIV, depresiji ali motnjam srčnega ritma;
• A dose reduction of Ranexa may be needed in combination with:
• Zmanjšanje odmerka zdravila Ranexa bo morda potrebno v kombinaciji z:
• Call their doctor if they feel dizzy or sick, become sick or experience any unexpected symptoms after starting Ranexa.
• mora poklicati zdravnika, če je omotičen ali če mu je slabo, če bruha ali če ima kakršne koli nepričakovane simptome po začetku jemanja zdravila Ranexa.
• That the card should be shown to any doctor involved in their treatment
• Bolnik mora kartico pokazati vsakemu zdravniku, ki sodeluje v njegovem zdravljenju.
• Inform the patient about the potential for an interaction with other prescribed medicinal products and to contact his/her doctor in case of dizziness, nausea or vomiting.
• Bolnika je treba obvestiti o možnosti interakcij z drugimi predpisanimi zdravili in mu naročiti, naj obvesti svojega zdravnika, če se pojavijo omotica, navzeja ali bruhanje.
• With certain other risk factors listed in the product information
• z nekaterimi drugimi dejavniki tveganja, navedenimi v informacijah o zdravilu.
• Taking certain other drugs mentioned in the product information
• ki jemljejo nekatera druga zdravila, omenjena v informacijah o zdravilu;
• Ranexa is contraindicated in patients taking:
• Zdravilo Ranexa je kontraindicirano pri bolnikih, ki jemljejo:
• Caution should be exercised when prescribing Ranexa to patients:
• Previdnost je potrebna pri predpisovanju zdravila Ranexa bolnikom:
• Liver problems
• ima težave z jetri;