natgillin/translations-raw huggingface dataset:
Fuzeon powder for solution for injection comes in a carton containing 60 vials of your medicine.
Prašek za raztopino za injiciranje zdravila Fuzeon je v škatli, ki vsebuje 60 vial vašega zdravila.
67 Marketing Authorisation Holder
67 Imetnik dovoljenja za promet z zdravilom
Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380
Eesti Roche Eesti OÜ Tel: + 372 6 177 380
Tel: +353 (0) 1 469 0700
68 Slovenija Ireland Roche farmacevtska družba d. o. o.
Detailed information on this medicine 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.
HOW TO USE FUZEON
KAKO UPORABLJATI ZDRAVILO FUZEON
The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection into the upper arm, anterior thigh or abdomen.
Običajen odmerek je 90 mg dvakrat na dan, dan kot 1- ml subkutana (tik pod kožo) injekcija v nadlaket, sprednjo stran stegna ali trebuh.
Each injection should be given at a site different from the last place you injected and never where there is still an injection site reaction from an earlier dose.
Vsako injekcijo dajte na drugo mesto kot prejšnjo injekcijo in nikoli tja, kjer je še vedno reakcija na mestu injiciranja od prejšnjega odmerka.
How long should you take Fuzeon For?
69 Kako dolgo morate jemati zdravilo Fuzeon?
This is when your
Virus HIV v vaši krvi lahko postane odporen proti zdravilu Fuzeon in ravni virusa v vaši krvi začnejo naraščati.
69 doctor may decide to no longer keep treating you with Fuzeon.
Takrat se bo lahko vaš zdravnik odločil za ukinitev zdravljenja z zdravilom Fuzeon.
● When handling syringes, do not touch the needle.
● Ko držite injekcijsko brizgo, se ne dotikajte igle.
● Make sure none of the items that you need for your injection have been opened.
● Prepričajte se, da nobena stvar, ki jo potrebujete za injiciranje ni bila odprta.
● Discard used syringes into your dedicated container with a lid for the safe disposal of waste materials.
● Uporabljene injekcijske brizge zavrzite v za to določeni vsebnik za odpadke s pokrovom za varno odstranjevanje odpadnih snovi.
STEP 1:
KORAK:
Gather all of the following supplies that you will need to prepare and give yourself an injection.
Pripravite si vse spodaj naštete potrebščine, ki jih boste potrebovali za pripravo in dajanje injekcije.
You need to ask your pharmacist or doctor if you need to find out where to get the water for injections, the 3 ml and 1 ml syringes, alcohol swabs and dedicated waste container with a lid:
Vprašajte vašega farmacevta ali zdravnika, kje lahko dobite vodo za injekcije, 3 ml in 1 ml injekcijske brizge, alkoholne blazinice in vsebnik za odpadke s pokrovom.
● One vial of Fuzeon
● eno vialo zdravila Fuzeon,
● One vial of water for injections
● eno vialo vode za injekcije,
● One 1 ml syringe (smaller syringe) with a 13 mm needle
● eno 1- ml injekcijsko brizgo (manjša injekcijska brizga) s 13- mm iglo,
● 3 alcohol swabs
70 ● 3 alkoholne blazinice,
70 ● Place syringes and vials onto a clean surface.
● Odložite injekcijske brizge in viale na čisto površino.
Remove the plastic cap and draw back 1.1 ml of air.
Odstranite plastični pokrov in zajemite 1, 1 ml zraka v brizgo.
Make sure the tip of the needle is always below the surface of the sterile water to help keep any air bubbles from entering the syringe.
Prepričajte se, da je vrh igle vedno pod gladino sterilne vode za injekcije, da preprečite vstop zračnih mehurčkov v injekcijsko brizgo.
Slowly pull back the plunger until the water for injection reaches the 1.1 ml mark.
Počasi izvlecite bat, dokler voda ne doseže oznake 1, 1 ml.
If excess air enters the syringe, gently press the plunger to force any air back into the vial and withdraw the water for injections again, making sure you have 1.1 ml of water for injections in the syringe.
Če je v injekcijski brizgi preveč zraka, narahlo pritisnite bat, da iztisnete zrak nazaj v vialo in ponovno odvzemite vodo za injekcije, tako da imate v injekcijski brizgi 1, 1 ml vode za injekcije.
● Remove the needle from the vial, making sure you never touch the needle with your fingers or any other object.
71 ● Odstranite iglo z viale, pazite, da se igle nikoli ne dotaknete s prsti ali čim drugim.
● Throw away the water for injections vial into the rubbish.
● Vialo vode za injekcije vrzite v smeti.
The water for injections vial is intended for single use only.
Viala z vodo za injekcije je namenjena samo za enkratno uporabo.
Injecting Water for Injections Into the Fuzeon Powder
Vbrizganje vode za injekcije v prašek zdravila Fuzeon
71 ● Gently tap the vial of Fuzeon to loosen the powder.
● Narahlo potrkajte na vialo zdravila Fuzeon, da zrahljate prašek.
Hold the water-filled syringe by the barrel and push the needle through the rubber top of the Fuzeon vial at a slight angle.
Injekcijsko brizgo napolnjeno z vodo držite za tulec in potisnite iglo narahlo pod kotom skozi gumijasti zamašek viale.
● After all of the water for injections has been added to the vial of Fuzeon, throw the syringe into a dedicated waste container.
● Potem ko ste v vialo zdravila Fuzeon dodali vso vodo za injekcije, zavrzite injekcijsko brizgo v za to določeni vsebnik za odpadke.
Mixing the Water For Injections with the Fuzeon Powder
Mešanje vode za injekcije s praškom zdravila Fuzeon
● Make sure the powder has dissolved completely, allowing any bubbles that may have formed to settle.
● Prepričajte se, da se je prašek popolnoma raztopil, da so mehurčki, ki so morda nastali, popolnoma izginili.
Start again with a new vial of Fuzeon Powder.
Začnite z novo vialo praška zdravila Fuzeon.
● Once a dose is mixed with water for injections, it must be used immediately or stored in a refrigerator and used within 24 hours.
● Ko ste odmerek raztopili z vodo za injekcije, ga morate uporabiti takoj ali shraniti v hladilnik in uporabiti v 24 urah.
● If you are preparing both of your daily doses at one time, be sure to use new syringes, water for injections and Fuzeon for each dose.
● Če sočasno pripravljate oba dnevna odmerka, poskrbite, da za vsak odmerek uporabite novo injekcijsko brizgo, novo vodo za injekcije in novo zdravilo Fuzeon.
STEP 3:
KORAK:
72 Choose a different area from where you last injected yourself, and then check for any places where you may have a reaction (press the skin to see if there are any hard bumps).
Izberite drugo mesto, kjer ste nazadnje injicirali in nato preglejte mesta, kjer bi lahko imeli reakcijo (pritisnite na kožo, da vidite ali imate otrdela mesta).
Drawing Up Fuzeon into the 1 ml syringe
Odvzem zdravila Fuzeon v 1- ml injekcijsko brizgo
Pick up the 1 ml small syringe.
Vzemite malo, 1- ml injekcijsko brizgo.
Remove the plastic cap and draw back 1 ml of air.
Odstranite plastični pokrov in zajemite 1 ml zraka.
Make sure the tip of the needle is always below the surface of the solution to help keep air bubbles from entering the syringe.
Prepričajte se, da je konica igle vedno pod površino raztopine, da preprečite vstop zračnih mehurčkov v brizgo.
● Pierce the skin at a 45-degree angle.
73 ● Vbodite v kožo pod kotom 45 stopinj.
73 When the needle is in, release the skin, and using the same hand, hold on to the syringe barrel to help steady it and prevent shifting.
Ko ste iglo vbodli, spustite kožo in z isto roko primite tulec brizge, da ga lažje držite pri miru in preprečite premikanje.
● Using the thumb, depress the plunger in to inject the medicine.
● S palcem pritisnite bat za injiciranje zdravila.
After the dose is fully delivered remove the needle from the skin.
Ko ste injicirali celoten odmerek, izvlecite iglo iz kože.
● Discard the syringe into a dedicated waste container with a lid.
● Injekcijsko brizgo zavrzite v za to določeni vsebnik za odpadke s pokrovom.
Keep the cover of this container tight and keep the container out of the reach of children.
Ta vsebnik naj bo vedno tesno zaprt in na mestu, nedosegljivem otrokom.
The vials of Fuzeon are intended for single use only.
Viale zdravila Fuzeon so namenjene enkratni uporabi.
If blood is visible, dispose of the items into the dedicated waste container with a lid.
Če je na njih kri, predmete zavrzite v za to določeni vsebnik za odpadke s pokrovom.
If you have any questions or concerns about the safe disposal of these materials, please call your doctor or pharmacist.
Če imate vprašanja ali skrbi v zvezi z varnim odstranjevanjem teh materialov, se, prosimo, posvetujte s svojim zdravnikom ali farmacevtom.
Galvus is a medicine containing the active substance vildagliptin.
Galvus je zdravilo, ki vsebuje zdravilno učinkovino vildagliptin.
It is available as round, pale yellow tablets (50 mg).
Na voljo je v obliki okroglih, bledo rumenih tablet.
Galvus is used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes).
Zdravilo Galvus se uporablja za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni).
It is used together with another antidiabetes medicine (as ‘ dual therapy’) when the patient ’ s diabetes is insufficiently controlled by this other medicine taken alone.
Uporablja se skupaj z drugim zdravilom za sladkorno bolezen (kot dvotirno zdravljenje), ko sladkorna bolezen bolnika ni zadostno urejena z uporabo zgolj tega drugega zdravila.
Galvus can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
Zdravilo Galvus se lahko uporablja z metforminom, tiazolidindionom ali sulfonilsečnino, vendar pa se pri bolnikih, ki ne morejo jemati metformina, uporablja zgolj v kombinaciji s sulfonilsečnino.
In adults, the recommended dose of Galvus is: • one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione, • one tablet in the morning when taken with a sulphonylurea.
Pri odraslih znaša priporočeni odmerek zdravila Galvus: • ena tableta zjutraj in druga zvečer pri uporabi z metforminom ali tiazolidindionom; • ena tableta zjutraj pri jemanju s sulfonilsečnino.
Galvus can be taken with or without food.
Zdravilo Galvus je mogoče jemati s hrano ali brez nje.
Galvus is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Zdravilo Galvus ni priporočljivo za bolnike, ki imajo zmerno ali hudo okvaro ledvic, vključno z bolniki na hemodializi (tehniki čiščenja krvi) s končno ledvično odpovedjo.
Galvus is not recommended for patients with liver problems.
Zdravilo Galvus ni priporočljivo za bolnike z okvaro jeter.
It should be used with caution in patients aged over 75 years.
Pri bolnikih, starejših od 75 let, je zdravilo treba uporabljati previdno.
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 koncentracije glukoze (sladkorja) v krvi ali pri kateri telo ne more insulina učinkovito izrabljati.
The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Zdravilna učinkovina v zdravilu Galvus, vildagliptin, je zaviralec dipeptidil peptidaze 4 (DPP- 4).
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Deluje tako, da zavira razgradnjo hormonov inkretinov v telesu.
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 vildagliptin vzpodbuja trebušno slinavko, da tvori več insulina, ko je raven glukoze v krvi visoka.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin zmanjšuje tudi tvorbo glukoze v jetrih, in sicer s zviševanjem koncentracije insulina in zniževanjem koncentracije hormona glukagona.
The effects of Galvus were first tested in experimental models before being studied in humans.
Učinki zdravila Galvus so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Galvus has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Zdravilo Galvus so preučevali tudi v sedmih glavnih študijah, v katere je bilo vključenih skupno več kot 4000 bolnikov s sladkorno boleznijo tipa 2 in nezadostnim nadzorom nad koncentracijo glukoze v krvi.
Three of these studies looked at the effects of Galvus taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
V treh od teh študij so preučevali učinke zdravila Galvus, uporabljenega samostojno, pri skupno 2198 bolnikih, ki predhodno niso bili zdravljeni zaradi sladkorne bolezni, ter jih primerjali z učinki placeba (zdravila brez zdravilne učinkovine), metformina ali rosiglitazona (tiazolidindion).
The other four studies compared the effects of Galvus, 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 preostalih štirih študijah so primerjali učinke zdravila Galvus, dajanega v odmerku 50 ali 100 mg dnevno v obdobju 24 tednov, z učinki placeba, pri čemer je bilo zdravilo Galvus uporabljeno kot dodatna terapija k obstoječemu zdravljenju z metforminom (544 bolnikov), pioglitazonom (tiazolidindion, 463 bolnikov), glimepiridom (sulfonilsečnina, 515 bolnikov) ali insulinom (296 bolnikov).
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 okviru vseh študij je bilo glavno merilo učinkovitosti sprememba koncentracije snovi, imenovane glikozilirani hemoglobin (HbA1c), v krvi, ki kaže, kako dobro je krvni sladkor uravnan.
What benefit has Galvus shown during the studies?
Kakšne koristi je zdravilo Galvus izkazalo med raziskavami?
Galvus reduced levels of HbA1c in all studies.
Zdravilo Galvus je v vseh študijah znižalo koncentracijo HbA1c.
When used alone, it caused a reduction in HbA1c levels by approximately 1% from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.
Pri njegovi samostojni uporabi je po 24 tednih privedlo do znižanja koncentracije HbA1c za približno 1% glede na izhodiščno raven, ki je znašala okrog 8%, vendar pa ni bilo tako učinkovito kot metformin ali rosiglitazon.
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%.
Pri njegovi uporabi z metforminom in pioglitazonom je bil 100 mg dnevni odmerek učinkovitejši od 50 mg dnevnega odmerka, pri čemer se je koncentracija HbA1c znižala za 0, 8 do 1, 0 odstotka.
In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6%.
Pri njegovi uporabi v kombinaciji z glimepiridom sta 50 mg in 100 mg dnevni odmerek povzročila znižanje za približno 0, 6%.
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%.
V nasprotju s tem so bolniki, ki so poleg svojega obstoječega zdravljenja prejemali placebo, izkazovali manjše spremembe koncentracije HbA1c, ki so znašale od znižanja za 0, 3% do povišanja za 0, 2%.
Although adding Galvus to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.
Čeprav je dodajanje zdravila Galvus k obstoječemu zdravljenju z insulinom privedlo do večjega zmanjšanja koncentracije HbA1c kot placebo, je bil ta učinek premajhen, da bi ga bilo mogoče obravnavati kot bistvenega za bolnike.
The company withdrew its application for the use of Galvus on its own and as an add-on to insulin during the assessment of the medicine.
Med vrednotenjem zdravila je podjetje umaknilo svojo vlogo za uporabo zdravila Galvus kot samostojnega zdravila in njegovo uporabo kot dodatek k insulinu.
For the full list of all side effects reported with Galvus, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Galvus, glejte Navodilo za uporabo.
Galvus should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Zdravila Galvus ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vildagliptin ali katero koli drugo sestavino zdravila.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Galvus and at regular intervals during treatment.
Ker vildagliptin povezujejo z okvaro jeter, morajo bolniki opraviti preiskave jeter pred začetkom zdravljenja z zdravilom Galvus in nato v rednih presledkih med zdravljenjem.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Galvus’ s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Galvus pri zdravljenju sladkorne bolezni tipa 2, pri čemer se zdravilo Galvus uporablja v okviru dvotirnega peroralnega zdravljenja v kombinaciji z metforminom, sulfonilsečnino ali tiazolidindionom, večje od z njim povezanih tveganj.
The Committee recommended that Galvus be given marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Galvus.
Other information about Galvus:
Druge informacije o zdravilu Galvus:
The European Commission granted a marketing authorisation valid throughout the European Union for Galvus to Novartis Europharm Limited on 26 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom Galvus, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 26. septembra 2007.
The full EPAR for Galvus can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Galvus je na voljo tukaj.
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
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)
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)
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets 336 (3x112) tablets
7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 60 tablet 90 tablet 112 tablet 180 tablet 336 tablet 336 (3x112) tablet
Each tablet contains 50 mg of vildagliptin.
Vsaka tableta vsebuje 50 mg vildagliptina.
Each tablet contains 47.82 mg anhydrous lactose.
Vsaka tableta vsebuje 47, 82 mg brezvodne laktoze.
One side is debossed with “ NVR”, and the other side with “ FB”.
Bela do svetlo rumenkasta, okrogla (premera 8 mm) tableta z ravnima ploskvama in zaobljenim robom ter oznakama “ NVR ” na eni strani in “ FB ” na drugi.
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus:
Vildagliptin je indiciran za zdravljenje sladkorne bolezni tipa 2:
- metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of
- z metforminom pri bolnikih s slabo urejeno sladkorno boleznijo kljub monoterapiji z
monotherapy with metformin,
metforminom v največjih odmerkih, ki jih bolnik še prenaša;
- a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose
- s sulfonilureo pri bolnikih s slabo urejeno sladkorno boleznijo kljub zdravljenju s sulfonilureo v
of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
največjih odmerkih, ki jih bolnik še prenaša, pri tem pa zdravljenje z metforminom za te bolnike ni primerno zaradi neprenašanja ali kontraindikacij;
- a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a
- s tiazolidindionom pri bolnikih, za katere je zdravljenje s tiazolidindioni primerno, njihova
thiazolidinedione is appropriate.
sladkorna bolezen pa je slabo urejena.
Adults When used in dual combination with metformin or a thiazolidinedione, the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Odrasli V kombinaciji z metforminom ali s tiazolidindionom je priporočeni dnevni odmerek vildagliptina 100 mg, ki ga vzamete kot en odmerek 50 mg zjutraj in en odmerek 50 mg zvečer.
The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione or with metformin and a sulphonylurea has not been established.
Varnost in učinkovitost vildagliptina v trotirnem zdravljenju v kombinaciji z metforminom in tiazolidindionom ali z metforminom in sulfonilureo ni bila ugotovljena.
Galvus can be administered with or without a meal (see also section 5.2).
Zdravilo Galvus se lahko jemlje z obrokom ali brez njega (glejte tudi poglavje 5. 2).
2 Additional information on special populations Renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/ min).
2 Drugi podatki o posebnih skupinah bolnikov Okvara ledvic Za bolnike z blago okvaro ledvic (očistek kreatinina ≥ 50 ml/ min) prilagajanje odmerkov ni potrebno.
The use of Galvus is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD) (see also sections 4.4 and 5.2).
Uporaba zdravila Galvus ni priporočljiva za bolnike z zmerno ali hudo okvaro ledvic in bolnike s končno ledvično odpovedjo (end- stage renal disease - ESRD) na hemodializi (glejte poglavji 4. 4 in 5. 2).
Hepatic impairment Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Okvara jeter Zdravila Galvus 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 poglavji 4. 4 in 5. 2).
Elderly (≥ 65 years) No dose adjustments are necessary in elderly patients.
Starejše osebe (≥ 65 let) Za starejše bolnike prilagajanje odmerkov ni potrebno.
Experience in patients aged 75 years and older is limited and caution should be exercised when treating this population (see also sections 5.1 and 5.2).
Pri zdravljenju te skupine bolnikov je potrebna previdnost (glejte tudi poglavji 5. 1 in 5. 2).
Paediatric population (< 18 years) Galvus is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Pediatrična populacija (< 18 let) Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Galvus pri otrocih in mladostnikih ni priporočljiva.