natgillin/translations-raw huggingface dataset:
Talk to your doctor for advice on how to minimize the risk of bleeding. • Weight loss and loss of appetite (anorexia); tiredness; weakness; feeling unwell • Feeling sick (nausea), being sick (vomiting); stomach pain; constipation • Inflammation and ulcers of the mouth, tongue or gums • High body temperature (fever) • Hair loss.
Posvetujte se z zdravnikom, kako lahko zmanjšate tveganje za pojav krvavitev. • Hujšanje in neješčnost (anoreksija), utrujenost, šibkost, slabo počutje • Siljenje na bruhanje, bruhanje, bolečine v trebuhu, zaprtje • Vnetje in razjede na jeziku ali dlesnih • Zvišana telesna temperatura • Izpadanje las
Common side effects These may affect up to 1 in 10 people treated with Hycamtin • Allergic or hypersensitivity reactions (including rash) • Yellow skin • Itching sensation • Muscle pain.
Pogosti neželeni učinki Pojavijo se lahko pri največ 1 od 10 oseb, ki se zdravijo z zdravilom Hycamtin. • Alergijske ali preobčutljivostne reakcije (vključno z izpuščajem) • Rumena koža • Srbenje • Bolečine v mišicah
Rare side effects These may affect up to 1 in 1000 people treated with Hycamtin. • Severe allergic or anaphylactic reactions • Swelling caused by fluid build up (angioedema) • Itchy rash (or hives).
Redki neželeni učinki Pojavijo se lahko pri največ 1 od 1000 oseb, ki se zdravijo z zdravilom Hycamtin. • Hude alergijske ali anafilaktične reakcije • Otekanje zaradi kopičenja tekočine (angioedem)
73 If you get side effects → Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet,
73 • Srbeč izpuščaj (ali koprivnica)
Each capsule contains topotecan hydrochloride equivalent to 0.25 mg or 1 mg of topotecan. • The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172).
1 mg topotekana. • Pomožne snovi so: hidrogenirano rastlinsko olje, glicerilmonostearat, želatina, titanov dioksid (E171), samo v 1- mg kapsulah tudi rdeči železov oksid (E172).
Hycamtin 0.25 mg capsules are white to yellowish white and imprinted with ‘ Hycamtin’ and ‘ 0.25 mg’.
0, 25- mg kapsule Hycamtin so bele do rumenkasto bele in označene s ‘ Hycamtin ’ in ‘ 0. 25 mg ’.
Hycamtin 1 mg capsules are pink and imprinted with ‘ Hycamtin’ and ‘ 1 mg’.
1- mg kapsule Hycamtin so rožnate barve in označene s ‘ Hycamtin ’ in ‘ 1 mg ’.
Hycamtin is available in packs containing 10 capsules of 0.25 mg or 1 mg topotecan.
Zdravilo Hycamtin je na voljo v pakiranjih, ki vsebujejo po 10 kapsul z 0, 25 mg ali 1 mg topotekana.
74 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
74 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Danmark GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00 info@glaxosmithkline. dk
GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00 info@ glaxosmithkline. dk
Detailed information on this medicine product is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
Icandra is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Icandra je zdravilo, ki vsebuje zdravilni učinkovini vildagliptin in metforminijev klorid.
It is available as oval tablets (light yellow:
Na voljo je v obliki ovalnih tablet (svetlo rumenih:
50 mg vildagliptin and 850 mg metformin hydrochloride; dark yellow:
50 mg vildagliptina in 850 mg metforminijevega klorida; temno rumenih:
50 mg vildagliptin and 1,000 mg metformin hydrochloride).
50 mg vildagliptina in 1 000 mg metforminijevega klorida).
The company that makes Eucreas has agreed that its scientific data can be used for Icandra.
Družba, ki proizvaja zdravilo Eucreas, soglaša, da se lahko njeni znanstveni podatki uporabijo tudi za zdravilo Icandra.
Icandra is used to treat type 2 diabetes (non-insulin-dependent diabetes).
Zdravilo Icandra se uporablja za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisna sladkorna bolezen).
It is used in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.
Uporablja se pri bolnikih, katerih bolezen ni zadostno nadzorovana samo z metforminom v največjem odmerku, ki ga še prenašajo, ali pri bolnikih, ki že jemljejo kombinacijo vildagliptina in metformina v obliki ločenih tablet.
The choice of tablet strength to start with depends on the dose of metformin the patient is currently taking, but the recommended dose is 50 mg vildagliptin and 1,000 mg metformin twice a day.
Izbira začetne jakosti tablet je odvisna od odmerka metformina, ki ga bolnik trenutno jemlje, vendar je priporočeni odmerek 50 mg vildagliptina in 1 000 mg metformina dvakrat dnevno.
Patients already taking vildagliptin and metformin should switch to Icandra containing the same amounts of each active substance.
Bolniki, ki že jemljejo vildagliptin in metformin, bi morali preiti na zdravilo Icandra, ki vsebuje enaki količini obeh zdravilnih učinkovin.
Doses of vildagliptin above 100 mg are not recommended.
Odmerki vildagliptina, ki presegajo 100 mg, niso priporočljivi.
Taking Icandra with or just after food may reduce any stomach problems caused by metformin.
Jemanje zdravila Icandra skupaj s hrano ali takoj po obroku lahko zmanjša trebušne težave, ki jih povzroča metformin.
Icandra should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Zdravila Icandra ne smejo uporabljati bolniki, ki imajo zmerne ali hude težave z ledvicami ali težave z jetri.
Elderly patients taking Icandra should have their kidney function monitored regularly.
Pri starejših bolnikih, ki jemljejo zdravilo Icandra, je treba redno nadzorovati delovanje ledvic.
Icandra is not recommended for use in patients aged over 75 years.
Jemanje zdravila Icandra ni priporočljivo pri bolnikih, starejših od 75 let.
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 tvori dovolj insulina za nadzor koncentracije glukoze (sladkorja) v krvi ali kadar telo insulina ne more izkoriščati učinkovito.
Icandra contains two active substances, which each have a different mode of action.
Zdravilo Icandra vsebuje dve zdravilni učinkovini, ki delujeta vsaka na drugačen način.
Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘ incretin’ hormones in the body.
Vildagliptin, ki je zaviralec dipeptidil peptidaze 4 (DPP- 4), deluje tako, da zavira razgradnjo hormonov inkretinov v telesu.
By increasing
Z večanjem koncentracije hormonov inkretinov v krvi vildagliptin spodbuja trebušno slinavko k
1 Previously known as Vildagliptin/ Metformin Hydrochloride Novartis.
1 Prvotno znano kot Vildagliptin/ Metformin Hydrochloride Novartis.
Reproduction is authorised provided the source is acknowledged. levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Reproduction is authorised provided the source is acknowledged. ustvarjanju večje količine insulina, če so koncentracije krvne glukoze visoke.
Vildagliptin does not work when the blood glucose is low.
Vildagliptin ne deluje, kadar so koncentracije glukoze v krvi nizke.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin prav tako zmanjša koncentracijo glukoze, ki jo tvorijo jetra, tako da poveča koncentracijo insulina in zmanjša koncentracijo hormona glukagona.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Metformin deluje predvsem z zaviranjem tvorjenja glukoze in zmanjšanjem njene absorpcije v črevesju.
As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Kot posledica delovanja obeh snovi se koncentracija glukoze v krvi zniža, kar pomaga nadzorovati sladkorno bolezen tipa 2.
Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Vildagliptin je kot samostojna učinkovina v EU odobren od septembra 2007 pod imenom Galvus, metformin pa je v EU na voljo od leta 1959.
Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Vildagliptin se lahko uporablja z metforminom pri bolnikih s sladkorno boleznijo tipa 2, ki je samo z metforminom ni mogoče ustrezno nadzorovati.
The studies of Galvus as an add-on to metformin were used to support the use of Icandra in the same indication.
V podporo uporabi zdravila Icandra za isto indikacijo so uporabili študije zdravila Galvus, uporabljenega kot dodatek metforminu.
The studies measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V študijah so merili vrednosti snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je koncentracija glukoze v krvi nadzorovana.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Icandra were absorbed in the body in the same way as when they were taken as separate tablets.
Predlagatelj je predstavil tudi rezultate dveh študij, v katerih je dokazal, da sta se zdravilni učinkovini dveh jakosti zdravila Icandra absorbirali v telesu na enak način kot v primeru, ko sta se jemali kot ločeni tableti.
Vildagliptin was more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Vildagliptin je bil učinkovitejši od placeba (zdravila brez zdravilne učinkovine) pri zniževanju vrednosti HbA1c, ko je bil dodan metforminu.
Patients adding vildagliptin had a fall in HbA1c levels of 0.88% after 24 weeks from a starting level of 8.38%.
Pri bolnikih, ki so kot dodatno zdravilo jemali vildagliptin, se je po 24 tednih vrednost HbA1c znižala za 0, 88% z začetne ravni 8, 38%.
In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23% from a starting level of 8.30%.
Pri bolnikih, ki so kot dodatno zdravilo jemali placebo, pa je bila sprememba vrednosti HbA1c manjša, saj se je ta povečala za 0, 23% z začetne ravni 8, 30%.
The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Najpogostejši neželeni učinki zdravila Icandra (opaženi pri več kot 1 bolniku izmed 10) so bili navzeja (slabost), bruhanje, driska, bolečine v trebuhu in izguba apetita.
For the full list of all side effects reported with Icandra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Icandra, glejte navodilo za uporabo.
It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Zdravila ne smejo uporabljati bolniki z diabetično ketoacidozo (visoke ravni ketonov in kislin v krvi), diabetično predkomo, težavami z ledvicami ali jetri, bolezenskimi stanji, ki lahko vplivajo na ledvice, ali boleznijo, ki povzroča zmanjšano oskrbo tkiv s kisikom, kot na primer odpoved srca ali pljuč ali nedavni srčni napad.
It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast-feeding.
Zdravila prav tako ne smejo uporabljati bolniki, zastrupljeni z alkoholom (čezmerno uživanje alkohola), ali alkoholiki oziroma doječe matere.
The Committee for Medicinal Products for Human Use (CHMP) concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da vildagliptin skupaj z metforminom zmanjša koncentracijo glukoze v krvi, kombinacija obeh zdravilnih učinkovin v eni tableti pa lahko bolnikom pomaga, da se držijo predpisanega načina zdravljenja.
Therefore, the Committee decided that the benefits of Icandra are greater than its risks for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Zato je Odbor zaključil, da so koristi zdravila Icandra pri zdravljenju bolnikov s sladkorno boleznijo tipa 2, pri katerih samo z največjim peroralnim odmerkom metformina, ki ga še prenašajo, ni mogoče doseči zadostnega glikemičnega nadzora, ali pri tistih, ki se že zdravijo z vildagliptinom in metforminom v obliki ločenih tablet, večje od z njim povezanih tveganj.
The Committee recommended that Icandra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Icandra odobri dovoljenje za promet.
Other information about Icandra:
Druge informacije o zdravilu Icandra:
The European Commission granted a marketing authorisation valid throughout the EU for Vildagliptin/ Metformin Hydrochloride Novartis to Novartis Europharm Limited on 1 December 2008.
Evropska komisija je dovoljenje za promet z zdravilom Vildagliptin/ Metformin Hydrochloride Novartis, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 1. decembra 2008.
The name of the medicine was changed to Icandra on 6 February 2009.
Ime zdravila je bilo spremenjeno v Icandra dne 6. februarja 2009.
The full EPAR for Icandra can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Icandra je na voljo tukaj.
EU Number EU/ 1/ 08/ 484/ 001 EU/ 1/ 08/ 484/ 002 EU/ 1/ 08/ 484/ 003 EU/ 1/ 08/ 484/ 004 EU/ 1/ 08/ 484/ 005 EU/ 1/ 08/ 484/ 006 EU/ 1/ 08/ 484/ 007 EU/ 1/ 08/ 484/ 008 EU/ 1/ 08/ 484/ 009 EU/ 1/ 08/ 484/ 010 EU/ 1/ 08/ 484/ 011 EU/ 1/ 08/ 484/ 012 EU/ 1/ 08/ 484/ 013 EU/ 1/ 08/ 484/ 014 EU/ 1/ 08/ 484/ 015 EU/ 1/ 08/ 484/ 016 EU/ 1/ 08/ 484/ 017 EU/ 1/ 08/ 484/ 018
Številka EU EU/ 1/ 08/ 484/ 001 EU/ 1/ 08/ 484/ 002 EU/ 1/ 08/ 484/ 003 EU/ 1/ 08/ 484/ 004 EU/ 1/ 08/ 484/ 005 EU/ 1/ 08/ 484/ 006 EU/ 1/ 08/ 484/ 007 EU/ 1/ 08/ 484/ 008 EU/ 1/ 08/ 484/ 009 EU/ 1/ 08/ 484/ 010 EU/ 1/ 08/ 484/ 011 EU/ 1/ 08/ 484/ 012 EU/ 1/ 08/ 484/ 013 EU/ 1/ 08/ 484/ 014 EU/ 1/ 08/ 484/ 015 EU/ 1/ 08/ 484/ 016 EU/ 1/ 08/ 484/ 017 EU/ 1/ 08/ 484/ 018
Invented name Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra
Izmišljeno ime Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra
Strength 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg
Jakost 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Farmacevtska oblika filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Pot uporabe peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Packaging blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al)
Ovojnina pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al) pretisni omot (PA/ Al/ PVC // Al)
Package size 10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets
Velikost pakiranja 10 tablet 30 tablet 60 tablet 120 tablet 180 tablet 360 tablet 10 tablet 30 tablet 60 tablet 120 tablet 180 tablet 360 tablet 120 (2x60) tablet 180 (3x60) tablet 360 (6x60) tablet 120 (2x60) tablet 180 (3x60) tablet 360 (6x60) tablet
Icandra 50 mg/ 850 mg film-coated tablets
Icandra 50 mg/ 850 mg filmsko obložene tablete
Icandra is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Zdravilo Icandra je indicirano za zdravljenje bolnikov z diabetesom tipa 2, pri katerih diabetesa ni mogoče urediti samo z metforminom v največjem peroralnem odmerku, ki ga še prenašajo, ali pri tistih, ki že prejemajo zdravljenje z vildagliptinom in metforminom v obliki ločenih tablet.
Adults Based on the patient’ s current dose of metformin, Icandra may be initiated at either the 50 mg/ 850 mg or 50 mg/ 1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Odrasli Glede na odmerek metformina, ki ga je bolnik uporabljal do tedaj, je mogoče začeti z uporabo zdravila Icandra bodisi jakosti 50 mg/ 850 mg ali 50 mg/ 1000 mg dvakrat dnevno in sicer eno tableto zjutraj, drugo pa zvečer.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Icandra containing the same doses of each component.
Bolniki, ki prejemajo vildagliptin in metformin v ločenih tabletah, lahko preidejo na zdravljenje z zdravilom Icandra, ki vsebuje enake odmerke posameznih zdravilnih učinkovin.
Taking Icandra with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Jemanje zdravila Icandra s hrano ali takoj po njej lahko ublaži gastrointestinalne simptome, ki so povezani z jemanjem metformina (glejte tudi poglavje 5. 2).
Additional information on special populations Renal impairment Icandra should not be used in patients with creatinine clearance < 60 ml/ min (see sections 4.3, 4.4 and 5.2).
Dodatni podatki o posebnih skupinah bolnikov Okvara ledvic Bolniki z očistkom kreatinina < 60 ml/ min ne smejo uporabljati zdravila Icandra (glejte poglavja 4. 3, 4. 4 in 5. 2).
Hepatic impairment Icandra should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
2 Okvara jeter Zdravila Icandra ne smejo uporabljati bolniki z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti alanin- aminotransferaze (ALT) ali aspartat- aminotransferaze (AST) nad 3- kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavja 4. 3, 4. 4 in 4. 8).
2 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see section 4.4).
Starejši (≥ 65 let) Metformin se izloča preko ledvic, pri starejših bolnikih pa je delovanje ledvic pogosto zmanjšano, zato je treba starješim bolnikom, ki jemljejo zdravilo Icandra, redno pregledovati delovanje ledvic (glejte poglavje 4. 4).
Icandra has not been studied in patients older than 75 years.
Uporaba zdravila Icandra pri bolnikih, starejših od 75 let, ni bila proučena.
Therefore the use of Icandra is not recommended in this population.
Zato uporaba zdravila Icandra pri tej skupini bolnikov ni priporočena.
Paediatric population (< 18 years) Icandra is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Pediatrična populacija (< 18 let) Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Icandra pri otrocih in mladostnikih ni priporočljiva.
− Hypersensitivity to the active substances or to any of the excipients − Diabetic ketoacidosis or diabetic pre-coma − Renal failure or renal dysfunction defined as creatinine clearance < 60 ml/ min (see section 4.4) − Acute conditions with the potential to alter renal function, such as:
- ledvična odpoved oziroma moteno delovanje ledvic, opredeljeno z očistkom kreatinina
- - - -
< 60 ml/ min (glejte poglavje 4. 4);
dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
- akutna stanja, ki bi lahko vplivala na delovanje ledvic, kot so:
4.4 Special warnings and precautions for use
akutna zastrupitev z alkoholom, alkoholizem;
General Icandra is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Splošno Zdravilo Icandra ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin, in se ga ne sme uporabljati pri bolnikih z diabetesom tipa 1.
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
3 Okvara ledvic Metformin se izloča preko ledvic, zato je treba koncentracije kreatinina v serumu redno spremljati:
- at least once a year in patients with normal renal function
- vsaj enkrat na leto pri bolnikih z normalnih delovanjem ledvic,
- at least two to four times a year in patients with serum creatinine levels at the upper limit of
- vsaj dvakrat do štirikrat na leto pri bolnikih koncentracijami kreatinina v serumu na zgornji meji
normal and in elderly patients.
normalnih vrednosti in pri starejših bolnikih.