natgillin/translations-raw huggingface dataset:
Xiliarx should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them.
Zdravilo Xiliarx naj bi torej uporabljali samo bolniki, za katere metformin ni primeren bodisi zaradi neželenih učinkov, ki se pojavijo zaradi jemanja metformina, bodisi ker imajo bolezen, pri kateri jemanje metformina zanje ni ustrezno.
Other information about Xiliarx
Druge informacije o zdravilu Xiliarx
The CHMP also considered the use of Xiliarx on its own and concluded that it was effective in reducing blood glucose but less so than metformin.
CHMP je proučil tudi samostojno uporabo zdravila Xiliarx in zaključil, da je sicer učinkovito pri zniževanju glukoze v krvi, a manj kot metformin.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja dovolj insulina za vzdrževanje primerne ravni glukoze (sladkorja) v krvi ali pri kateri ga telo ne more učinkovito izrabiti.
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba koncentracije snovi, imenovane glikozilirani hemoglobin (HbA1c), v krvi, ki kaže, kako dobro je krvni sladkor uravnan.
Xiliarx has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Zdravilo Xiliarx so proučevali v 11 glavnih študijah, v katere je bilo vključenih skupno več kot 5 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih koncentracija glukoze v krvi ni bila zadostno uravnana.
Xiliarx is a medicine that contains the active substance vildagliptin.
Xiliarx je zdravilo, ki vsebuje zdravilno učinkovino vildagliptin.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Xiliarx and at regular intervals during treatment.
Ker vildagliptin povezujejo z okvaro jeter, morajo bolniki pred začetkom zdravljenja z zdravilom Xiliarx opraviti preiskave jeter in nato v rednih presledkih med zdravljenjem.
A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
Morda bo treba odmerek sulfonilsečnine znižati, da se zmanjša tveganje za pojav hipoglikemije (nizkih ravni krvnega sladkorja).
• one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
• ena tableta zjutraj in druga zvečer (100 mg na dan), kadar se uporablja samostojno, z metforminom ali tiazolidindionom, z metfominom v kombinaciji s sulfonilsečnino ali z insulinom (z metforminom ali brez njega);
Xiliarx is used to treat type 2 diabetes mellitus.
Zdravilo Xiliarx se uporablja za zdravljenje sladkorne bolezni tipa 2.
It works by blocking the breakdown of ‘incretin' hormones in the body.
Deluje tako, da zavira razgradnjo hormonov inkretinov v telesu.
Four studies compared the effects of Xiliarx, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
V štirih študijah so primerjali učinke zdravila Xiliarx v odmerku 50 ali 100 mg na dan v obdobju 24 tednov z učinki placeba, kadar je bilo uporabljeno kot dodatek k obstoječemu zdravljenju z metforminom (544 bolnikov), pioglitazonom (tiazolidindionom, 463 bolnikov), glimepiridom (sulfonilsečnino, 515 bolnikov) ali insulinom (296 bolnikov).
The CHMP noted that Xiliarx was effective as an add-on to metformin, a thiazolidinedione, or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
CHMP je ugotovil, da je bilo zdravilo Xiliarx učinkovito kot dodatek zdravljenju z metforminom, tiazolidindionom ali sulfonilsečnino (zdravljenje z dvema zdraviloma), kot dodatek sulfonilsečnini in metforminu (zdravljenje s tremi zdravili) ali insulinu z metforminom ali brez njega, ter zaključil, da so koristi dodatnega zdravljenja večje od tveganj.
For the full list of all side effects reported with Xiliarx, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Xiliarx, glejte navodilo za uporabo.
In the study involving 296 patients taking insulin, adding Galvus caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect was small possibly due to the fact that the study included long-term patients who were less likely to show improvement..
V študiji, v kateri je sodelovalo 296 bolnikov, ki so jemali insulin, je dodajanje zdravila Xiliarx povzročilo večje znižanje ravni HbA1c kot dodajanje placeba, vendar je bila razlika zelo majhna, kar je verjetno posledica dejstva, da je študija vključevala dolgotrajne bolnike, pri katerih je bilo izboljšanje stanja manj verjetno.
In the study comparing Xiliarx with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Xiliarx.
V študiji, v kateri so zdravilo Xiliarx primerjali z metforminom, so bili opaženi občutno boljši rezultati z metforminom: znižanje HbA1c za 1,5 odstotne točke po 52 tednih v primerjavi z znižanjem za okoli 1 odstotno točko pri bolnikih, ki so prejemali zdravilo Xiliarx.
However, in another study involving 449 patients taking insulin, the size of this effect was significant.
Vendar pa je bila v drugi študiji, v kateri je sodelovalo 449 bolnikov, razlika precej pomembnejša.
What is the risk associated with Xiliarx?
Kakšna tveganja so povezana z zdravilom Xiliarx?
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Ti se sproščajo po obroku in spodbujajo trebušno slinavko k tvorjenju insulina.
• together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient's diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
• skupaj z metforminom, tiazolidindionom ali sulfonilsečnino (zdravljenje z dvema zdraviloma), kadar sladkorna bolezen ni zadostno urejena samo s tem drugim zdravilom, vendar se v kombinaciji s sulfonilsečnino uporablja samo pri bolnikih, ki ne morejo jemati metformina;
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Vildagliptin s povečanjem koncentracije hormonov inkretinov v krvi spodbuja trebušno slinavko, da tvori več insulina, ko je raven glukoze v krvi visoka.
In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6 percentage points.
Pri njegovi uporabi v kombinaciji z glimepiridom sta 50-miligramski in 100-miligramski dnevni odmerek povzročila znižanje za približno 0,6 odstotne točke.
When used as an add-on to existing treatment for type 2 diabetes, Xiliarx was more effective than placebo in reducing HbA1c levels.
Pri njegovi uporabi kot dodatna terapija k obstoječemu zdravljenju sladkorne bolezni tipa 2 je bilo pri zniževanju koncentracije HbA1c učinkovitejše od placeba.
Why has Xiliarx been approved?
Zakaj je bilo zdravilo Xiliarx odobreno?
Xiliarx used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Kadar se je zdravilo Xiliarx uporabljalo samostojno, je bilo sicer učinkovito pri zniževanju ravni HbA1c, a manj kot primerjalna zdravila.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Zmanjšuje tudi tvorbo glukoze v jetrih, in sicer z zviševanjem koncentracije insulina in zniževanjem koncentracije hormona glukagona.
In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.
Nasprotno pa je bila pri bolnikih, ki so poleg obstoječega zdravljenja prejemali placebo, sprememba koncentracije HbA1c manjša in je znašala od znižanja za 0,3 odstotne točke do povečanja za 0,2 odstotne točke.
In combination with metformin and glimepiride, 50 mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.
V kombinaciji z metforminom in glimepiridom je zdravilo Xiliarx v odmerku 50 mg dvakrat na dan znižalo ravni HbA1c za eno odstotno točko v primerjavi z znižanjem za 0,3 odstotne točke pri bolnikih, ki so jemali placebo.
Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.
Pri bolnikih, ki so zdravilo Xiliarx jemali kot dodatek insulinu z metforminom ali brez njega, se je raven HbA1c znižala za 0,77 odstotne točke, medtem ko se je pri bolnikih, ki so kot dodatek insulinu jemali placebo, znižala le za 0,05 odstotne točke.
• together with a sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise;
• skupaj s sulfonilsečnino in metforminom (zdravljenje s tremi zdravili) pri bolnikih, pri katerih sladkorna bolezen ni zadostno urejena s temi zdravili, dieto in telesno vadbo;
• together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
• skupaj z insulinom (z metforminom ali brez njega) pri bolnikih, pri katerih sladkorna bolezen ni zadostno urejena z dieto in telesno vadbo ter ustaljenim odmerkom insulina.
Five of these studies looked at the effects of Xiliarx taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
V petih študijah so pri skupno 3 644 bolnikih proučevali učinke zdravila Xiliarx, uporabljenega samostojno, ter jih primerjali z učinki placeba (zdravila brez zdravilne učinkovine), metformina, rosiglitazona (tiazolidindiona) ali gliklazida (sulfonilsečnine).
With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0 percentage points.
Pri njegovi uporabi z metforminom in pioglitazonom je bil 100-miligramski dnevni odmerek učinkovitejši od 50-miligramskega, pri čemer se je koncentracija HbA1c znižala za 0,8 do 1,0 odstotne točke.
• on its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin;
• samostojno (zdravljenje z enim zdravilom) pri bolnikih, pri katerih sladkorna bolezen ni zadostno urejena s prehrano in telesno vadbo ter ki ne morejo jemati metformina;
How has Xiliarx been studied?
Kako je bilo zdravilo Xiliarx raziskano?
What is Xiliarx used for?
Za kaj se zdravilo Xiliarx uporablja?
What is Xiliarx?
Kaj je zdravilo Xiliarx?
How does Xiliarx work?
Kako zdravilo Xiliarx deluje?
A further study compared Galvus with placebo as an add-on treatment in 318 patients who were already taking metformin and glimepiride.
V nadaljnji študiji so pri 318 bolnikih, ki so že jemali metformin ali glimepirid, zdravilo Xiliarx primerjali s placebom, kadar sta bila uporabljena kot dodatek zdravljenju.
How is Xiliarx used?
Kako se zdravilo Xiliarx uporablja?
A further study compared Galvus with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin.
V nadaljnji študiji so pri 449 bolnikih, ki so že jemali ustaljen odmerek insulina z dolgotrajnim delovanjem, zdravilo Xiliarx primerjali s placebom, kadar sta bila uporabljena kot dodatek zdravljenju.
This medicine is the same as Galvus, which is already authorised in the European Union (EU).
Ta odobritev je temeljila na dovoljenju za promet, odobrenemu za zdravilo Galvus leta 2007 (uporaba dokumentacije s soglasjem).
The physician information should contain the following key messages:
Informacije za zdravnika morajo vsebovati naslednje pomembne informacije:
• The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
• Potreba po testiranju bolnikov za aktivno in neaktivno tuberkulozo pred zdravljenjem, vključno z uporabo ustreznih presejalnih testov.
• The role and use of patient alert card.
• Uporaba in namen bolnikove opozorilne kartice.
• Physician information
• Informacije za zdravnika
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo izpolniti vse pogoje za zagotovitev varnosti in učinkovitosti uporabe zdravila, ki so opisani spodaj:
• Patient Alert Card
• Bolnikovo opozorilno kartico
• The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Simponi,
• Možnost za tveganje hudih okužb vključno z oportunističnimi bakterijami, virusnimi okužbami in glivičnimi okužbami pri bolnikih, ki prejemajo zdravilo Simponi.
• The contraindication of Simponi in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Simponi,
• Kontraindicirano zdravljenje za bolnike s preteklo zmerno do hudo boleznijo srca (NYHA III/IV) in z možnostjo tveganja za poslabšanje kongestivne srčne bolezni po zdravljenju z zdravilom Simponi.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Simponi are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet z zdravilom mora pred prihodom zdravila na trg zagotoviti, da bodo vsi možni predpisovalci zdravila prejeli informacije namenjene zdravnikom, ki bodo vsebovale:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE GLEDE VARNOSTI IN ČINKOVITOSTI UPORABE ZDRAVILA, KI JIH MORAJO IZPOLNITI DRŽAVE ČLANICE
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
DODATEK POGOJI ALI OMEJITVE GLEDE VARNOSTI IN ČINKOVITOSTI UPORABE ZDRAVILA, KI JIH MORAJO IZPOLNITI DRŽAVE ČLANICE
• The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Potrebo po informiranju bolnika o tehniki dajanja zdravila in izobraževanu bolniškeg osebja kako poročati o napakah pri dajanju zdravila.
The MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of the medicinal product in any indication.
Imetnik dovoljenja za promet z zdravilom mora predložiti ustrezne znanstvene dokaze, ki bodo pokazali pozitivno razmerje med tveganji in koristmi uporabe zdravila pri kateri koli indikaciji.
For the suspension of medicinal products containing nalidixic acid, flumequine, pipemidic acid and cinoxacin to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holders
Za preklic začasnega umika dovoljenj za promet z zdravili, ki vsebujejo nalidiksno kislino, flumekvin, pipemidno kislino in cinoksacin, morajo pristojni organi zagotoviti, da so imetniki dovoljenj za promet z zdravilom izpolnili spodnje pogoje.
Annex IV Conditions for lifting the suspension of the marketing authorisations
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
{Name and address} {Tel} {fax} {e-mail}
{Ime in naslov} {tel.} {faks} {e-pošta}
This is so the doctor knows what you have taken.
Tako bo zdravnik lahko vedel, kaj ste vzeli.
If this happens, do not drive or use any tools or machines.
Če se vam to zgodi, ne vozite in ne uporabljajte orodij oziroma strojev.
1000 Ljubljana Slovenia
1000 Ljubljana Slovenija
This leaflet does not contain all the information about your medicine.
To navodilo ne vsebuje vseh informacij o vašem zdravilu.
They are used together when treatment with just one did not work.
Skupaj se uporabljata, če zdravljenje z eno samo od njiju ni učinkovito.
(Invented) name
Izmišljeno ime
The patient should be closely monitored and the treatment should be symptomatic and supportive.
Bolnika je treba natančno nadzirati; zdravljenje mora biti simptomatsko in podporno.
This is because the drug has never been used in these age groups.
Zdravilo namreč v teh starostnih skupinah še ni bilo nikoli uporabljeno.
This could be Raynaud's phenomenon
To je lahko Raynaudov pojav.
• Ringing in your ears
• zvonjenje v ušesih
2740-244 Porto Salvo Portugal
2740-244 Porto Salvo Portugalska
However, the effect of multiple doses is not known.
Toda učinek večkratnih odmerkov ni znan.
This can happen especially at the start of treatment, or when changing over from other preparations.
To se lahko zgodi zlasti na začetku zdravljenja ali po prehodu z drugih zdravil.
Empreendimento Lagoas Park, Edifício 7 - 3º Piso
Empreendimento Lagoas Park, Edifício 7 - 3ş Piso
• Reduced sexual desire in men or women
• zmanjšano spolno poželenje pri moških ali ženskah
• If you have ever had a serious allergic reaction called “angioedema”.
• če ste kdaj imeli resno alergijsko reakcijo, imenovano "angioedem”.
It may harm them even if their symptoms are the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
176-74 Kallithea Greece
176-74 Kallithea Grčija
Critical Evaluation
Kritično vrednotenje
This medicinal product is authorised in the Member States of the EEA under the following names:
To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: Avstrija:
• Sleep problems
• težave s spanjem
The elimination half-life is 5 to 6 hours.
Eliminacijski razpolovni čas je od 5 do 6 ur.
TRITAZIDE is not recommended for children and young people under the age of 18 years.
Zdravilo TRITAZIDE ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
This change of the text is to ensure it doesn't suggest an immediate artificial abortion, which is not justified by the clinical experiences collected till now.
Namen te spremembe je zagotoviti, da v besedilu ne bi bil predlagan takojšen umetni splav, saj to ni utemeljeno z dosedanjimi kliničnimi izkušnjami.
This may be a sign of your body holding onto more water than usual
To je lahko znak, da se v telesu zadržuje več vode kot po navadi
This may be given for an operation or any dental work.
Dobite ga lahko za operacijo ali kakšen zobozdravstven poseg.
• If you miss a dose, take your normal dose when it is next due.
• Če ste pozabili vzeti odmerek, vzemite običajen odmerek, ko je čas za naslednjega.
Sulphonamide diuretics should be taken at least one hour before or four to six hours after these medications.
Sulfonamidne diuretike je treba vzeti vsaj eno uro pred temi zdravili ali od štiri do šest ur po teh zdravilih.
Adverse reactions frequency is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so opredeljeni po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
167 14 Bromma Sweden
167 14 Bromma Švedska
In most cases the initial dose is the same, but there are differences with respect to subsequent titration (both in terms of frequency of increase and maximum daily dose).
V večini primerov je začetni odmerek enak, razlike so pri nadaljnjem titriranju (pri pogostosti povečevanja odmerka in največjem dnevnem odmerku).
The list of products which interact or may interact with Tritazide is acceptable.
Seznam zdravil, ki medsebojno delujejo ali lahko medsebojno delujejo z zdravilom Tritazide, je sprejemljiv.
Elderly Your doctor will reduce the initial dose and adjust your treatment more slowly.
Starejši Zdravnik bo zmanjšal začetni odmerek in bo bolj počasi prilagajal vaše zdravljenje.
A-1037 Wien
A-1037 Dunaj
• Sexual inability in men
• spolna nezmožnost pri moških
It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia.
Priporočljivo je kontrolirati belo krvno sliko, da bi odkrili morebitno levkopenijo.
Tritazide was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the abovementioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Zdravilo Tritazide je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila (SPC), ki ga je pripravil CMD(h), v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena, saj zgoraj navedeno zdravilo nima enakega povzetka glavnih značilnosti zdravila v državah članicah EU, na Islandiji in Norveškem.
Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Bolnika je treba opazovati vsaj 12 do 24 ur in ga odpustiti šele po popolnem izginotju simptomov.
POLIFARMA SPA Viale dell'Arte 69 00144 Roma Italy
POLIFARMA SPA Viale dell'Arte 69 00144 Rim Italija
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TRITAZIDE AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA TRITAZIDE IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
• Severe stomach pain which may reach through to your back.
• huda bolečina v želodcu, ki lahko sega v hrbet.
Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients.
Začetni odmerek mora biti manjši, nadaljnja titracija pa bolj postopna, ker obstaja večja možnost neželenih učinkov, zlasti pri zelo starih in slabotnih bolnikih.
Emergency therapy should be instituted promptly.
Nemudoma je treba uvesti nujno zdravljenje.
Zentiva HU Kft Népfürdo u.22 1138 Budapest Hungary
Zentiva HU Kft Népfürdo u.22 1138 Budapest Madžarska
Testing should be more frequent in elderly and cirrhotic patients.
Kontrole morajo biti pogostejše pri starejših bolnikih in bolnikih s cirozo.
The combination product can be considered as bioequivalent to products containing the individual components.
Kombinirano zdravilo lahko obravnavamo kot bioekvivalentno zdraviloma, ki vsebujeta posamezni sestavini.
• Change in the way things smell
• spremembe vonja stvari
Taking TRITAZIDE with food and alcohol
Jemanje zdravila TRITAZIDE s hrano in alkoholom
TRITAZIDE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
TRITAZIDE je mogoče vzeti pred obroki, med njimi ali po njih, ker uživanje hrane ne vpliva na biološko uporabnost (glejte poglavje 5.2).
• TRITAZIDE may be taken with or without food.
• Zdravilo TRITAZIDE lahko vzamete s hrano ali brez nje.