natgillin/translations-raw huggingface dataset:
OUTER CARTON (1 VIAL)
ZUNANJA OVOJNINA (1 VIALA)
ATryn 1750 IU powder for solution for infusion Antithrombin alfa
ATryn 1. 750 i. e. prašek za pripravo raztopine za infundiranje Antitrombin alfa
STATEMENT OF ACTIVE SUBSTANCE(S)
NAVEDBA ENE ALI VEC ZDRAVILNIH UCINKOVIN
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI.
Približno 175 i. e. / ml antitrombina alfa po rekonstituciji z 10 ml sterilne vode za injekcije.
Excipients:
Pomozne snovi:
Glycine Sodium chloride Sodium citrate
Glicin Natrijev klorid Natrijev citrat
EXP {MM/YYYY)
UPORABNO DO:
Any unused solution should be discarded.
Neporabljeno raztopino zavrzite.
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma A/ S Industriparken 55 DK- 2750 Ballerup Danska
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKASERIJE
OUTER CARTON (10 VIALS)
ZUNANJA OVOJNINA (10 VIAL)
10 Vials
10 vial
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
LEO Pharma A/ S Inudstriparken 55 DK- 2750 Ballerup Danska
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
17 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (25 VIALS)
ZUNANJA OVOJNINA (25 VIAL)
25 Vials
25 vial
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STICNIH OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT( I) UPORABE
ATryn 1750 IU powder for solution for infusion Antithrombin alfa For intravenous use.
ATryn 1750 i. e. prašek za pripravo raztopine za infundiranje Antitrombin alfa Za intravensko uporabo.
Approximately 175 IU/ml antithrombin alfa when reconstituted with 10 ml of WFI
Približno 175 i. e. / ml antitrombina alfa po rekonstituciji z 10 ml sterilne vode za injekcije.
LEO Pharma A/S, DK-2750 Ballerup, Denmark.
LEO Pharma A/ S, DK- 2750 Ballerup, Danska.
21 PACKAGE LEAFLET:
21 NAVODILO ZA UPORABO
ATryn 1750 IU powder for solution for infusion Antithrombin alfa.
ATryn 1750 i. e. prašek za pripravo raztopine za infundiranje Antitrombin alfa.
Read all of this leaflet carefully before you start using this medicine.
Pred uporabo natancno preberite navodilo!
- If you have any further questions, ask your doctor.
- Ce imate dodatna vprašanja, se posvetujte z zdravnikom.
- If any of the side effects get serious or if you notice any side effects not listed in the
- Ce katerikoli neželeni ucinek postane resen ali ce opazite kateri koli neželeni ucinek, ki ni
leaflet, please tell your doctor.
omenjen v tem navodilu, obvestite svojega zdravnika.
What ATryn is and what it is used for 2.
Kaj je zdravilo ATryn in za kaj ga uporabljamo 2.
Before you use ATryn 3.
Kaj morate vedeti preden boste uporabili zdravilo ATryn 3.
How to use ATryn 4.
Kako uporabljati zdravilo ATryn 4.
Possible side effects 5 How to store ATryn 6.
Možni neželeni ucinki 5 Shranjevanje zdravila ATryn 6.
WHAT ATryn IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ATryn IN ZA KAJ GA UPORABLJAMO
ATryn is an anti-clotting agent and contains antithrombin alfa which is similar to human antithrombin.
ATryn je zdravilo proti strjevanju krvi in vsebuje antitrombin alfa, ki je podoben humanemu antitrombinu.
Antithrombin alfa is produced by recombinant DNA technology from the milk of goats.
Antitrombin alfa se izdeluje iz kozjega mleka z rekombinantno DNA tehnologijo.
If you have congenital antithrombin deficiency, your blood level of antithrombin is lower than normal, which may result in a reduced anti-clotting capacity of your blood.
Ce imate prirojeno pomanjkanje antitrombina, je raven antitrombina v krvi nižja od obicajne, kar lahko povzroci manjšo zmožnost preprecevanja strjevanja krvi.
If your anti-clotting capacity is reduced, there is an increased risk of the formation of clots in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism) during major surgery.
Ce se zmožnost preprecevanja strjevanja zmanjša, obstaja povecana nevarnost tvorbe strdkov v žilah nog (tromboza globokih ven) ali drugih žilah v telesu (tromboembolizem) med vecjimi operacijami.
BEFORE YOU USE ATryn
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ATryn
Do not use ATryn If you are allergic (hypersensitive) to antithrombin alfa or any of the other ingredients of ATryn.
Ne uporabljajte zdravila ATryn Ce ste alergicni na (preobcutljivi za) antitrombin alfa ali katero koli sestavino zdravila ATryn.
Take special care with ATryn If you are allergic to goat products, please tell your treating physician since you should not use ATryn.
Ce ste alergicni na izdelke iz kozjega mleka, to povejte zdravniku, ker zdravila v tem primeru ne smete uporabljati.
As with any intravenous protein product, allergic reactions are possible.
Kot pri vsakem intravenskem beljakovinskem izdelku so možne alergicne reakcije.
If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Ce se pojavijo izpušcaji, srbece maroge ali gnojni mehurcki po vsej koži, tišcanje v prsih, sopihanje (težko dihanje), se morate takoj obrniti na zdravnika, ker gre lahko za simptome hude alergicne reakcije.
To test for the occurrence of an allergic reaction, blood will be collected and tested before and some time after you have been treated with ATryn.
Za preverjanje pojava alergicne reakcije je treba zbrati in preveriti kri pred in vcasih po zdravljenju z zdravilom ATryn.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika, ce jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi ce ste ga dobili brez recepta.
When ATryn is used together with heparin (an anti-clotting drug), or some other anti-clotting drugs, this may increase the risk of bleeding.
Ko zdravilo ATryn uporabljate skupaj s heparinom (zdravilo proti strjevanju krvi) ali kakšnimi drugimi zdravili proti strjevanju krvi, to lahko poveca nevarnost krvavitve.
Therefore your doctor will carefully monitor the use of ATryn when administered together with these anti-clotting drugs.
Zdravnik bo skrbno spremljal uporabo zdravila ATryn, ce ga boste uporabljali skupaj s temi antikoagulanti.
22 Using ATryn with food and drink No special precautions should be taken while eating or drinking.
Uporaba zdravila ATryn skupaj s hrano in pijaco 22 Pri uporabi skupaj s hrano ali pijaco niso potrebni posebni previdnostni ukrepi.
Pregnancy ATryn is not indicated for use in pregnant patients.
Nosecnost Zdravilo ATryn ni indicirano za nosecnice.
Breast-feeding It is unknown whether ATryn is present in breast milk.
Dojenje Ni znano, ali se zdravilo ATryn izloca v materino mleko.
Therefore it is not recommended to breastfeed whilst being treated with ATryn.
Zato med zdravljenjem z zdravilom ATryn dojenje ni priporocljivo.
Driving and using machines Not relevant.
Vpliv na sposobnost vožnje in upravljanja s stroji Podatek ni pomemben.
Important information about some of the ingredients of ATryn Not relevant.
Pomembne informacije o nekaterih sestavinah zdravila ATryn Podatek ni pomemben.
HOW TO USE ATryn
KAKO UPORABLJATI ZDRAVILO ATryn
Your health care provider will prepare a solution of ATryn to be administered through an infusion directly into a blood vessel.
Zdravnik bo pripravil raztopino zdravila ATryn za infundiranje v žilo.
Blood levels of antithrombin will be regularly checked in the blood and a change of dose may be necessary.
Raven antitrombina v krvi se bo redno preverjala in morda bo potrebna sprememba odmerka.
If you use more ATryn than you should
Ce ste vzeli vecji odmerek zdravila Atryn, kot bi smeli
The doctor will treat you, as appropriate, if you have any particular ill effects.
Ce imate kakršne koli posebne neugodne ucinke, vas bo zdravnik ustrezno zdravil.
If you stop using ATryn
Ce ste prenehali jemati zdravilo ATryn
If you have any further questions on the use of this product, ask your doctor.
Ce imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
Like all medicines, ATryn may cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ATryn neželene ucinke, ki pa se ne pojavijo pri vseh bolnikih.
Some side effects such as bleeding, bruises, redness, or pain at the site of injection, nausea, headache, feeling hot, dizziness, bruising and increased bleeding may occur during treatment with ATryn.
Med zdravljenjem z zdravilom ATryn se lahko pojavijo nekateri neželeni ucinki, kot so krvavitev, modrice, rdecica ali bolecina na mestu injiciranja, slabost, glavobol, obcutek vrocice, omotica, modrice in povecana krvavitev.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Ce katerikoli neželeni ucinek postane resen ali ce opazite katerikoli neželeni ucinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE ATryn
SHRANJEVANJE ZDRAVILA ATryn
Do not use ATryn after the expiry date stated on the labelling after the letters EXP.
Zdravila ATryn ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
Diluted solutions:
Razredcene raztopine:
The product should be used immediately.
Zdravilo porabite takoj.
What ATryn contains
Kaj vsebuje zdravilo ATryn
- The active substance is antithrombin alfa
- Zdravilna ucinkovina je antitrombin alfa
- The other ingredients are: glycine, sodium chloride, sodium citrate
- Pomožne snovi so: glicin, natrijev klorid, natrijev citrat
White to off-white powder.
Prašek za pripravo raztopine za infundiranje.
1, 10 or 25 vials per carton.
Bel do sivkastobel prašek.
Each vial of ATryn contains a nominal value of 1750 IU of recombinant antithrombin alfa.
Velikost pakiranja: škatla z 1, 10 ali 25 vialami. Vsaka viala zdravila ATryn vsebuje nominalno vrednost 1750 i. e. rekombinantnega antitrombina alfa.
The powder will be dissolved before it can be infused.
Prašek je treba pred infundiranjem raztopiti.
Marketing authorisation Holder LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Imetnik dovoljenja za promet z zdravilom LEO Pharma A/ S, Industriparken 55, DK- 2750 Ballerup, Danska.
Manufacturer authorisation holder responsible for batch release LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
Imetnik dovoljenja za izdelavo zdravila, odgovoren za sprošcanje serije LEO Pharma A/ S, Industriparken 55, DK- 2750 Ballerup, Danska.
This medicinal product has been authorized under “Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v “ izjemnih okolišcinah ”.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
To pomeni, da zaradi redkosti bolezni ni bilo mogoce pridobiti popolnih informacij o tem zdravilu.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo pregledala vse nove informacije, ki bodo morda na voljo vsako leto, SPC pa bo po potrebi posodobljen.
Detailed information is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu --------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
------------------------------------------------------------------------------------------------------------------------------ Naslednje informacije so namenjene le zdravstvenim in farmacevtskim delavcem:
Each vial of ATryn contains a lyophilised powder of 1750 IU antithrombin alfa and is intended for single use only.
Vsaka viala zdravila ATryn vsebuje 1750 i. e. liofiliziranega praška antitrombina alfa in je namenjena le enkratni uporabi.
Vials should be brought to room temperature prior to reconstitution and kept no longer than 3 hours.
Viale morajo pred rekonstituiranjem doseci sobno temperaturo, hraniti pa se jih sme najvec 3 ure.
The powder should be reconstituted with 10 ml of Sterile Water for Injection (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
Prašek je treba rekonstituirati z 10 ml sterilne vode za injekcije (WFI), ki jo vbrizgamo vzdolž stene viale in rahlo zavrtimo (ne pretresemo), da preprecimo penjenje.
The reconstituted product should be inspected visually for particulate matter and discolouration prior to administration.
Rekonstituiran izdelek je treba pred uporabo preveriti zaradi morebitnih delcev v snovi in spremembe barve.
Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
Ko se povsem raztopi, lahko z rekonstituiranim zdravilom napolnimo sterilno brizgo za enkratno uporabo.
The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with an in-line filter e.g. a methylcellulose filter with a 0.2 micron pore size.
Rekonstituirano zdravilo se uporablja za intravensko infuzijo s sterilno brizgo za enkratno uporabo ali infuzijsko vrecko s filtrom, npr. metilceluloznim filtrom z velikostjo odprtinice 0, 22 mikrona.
Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for administration.
Da bo raztopina primerna za uporabo, jo lahko razredcite z obicajno raztopino natrijevega klorida 9 mg/ ml (0, 9%).
The contents of infusion syringes on diluted solution prepared in infusion bags should be administered within 8 hours of preparation.
Vsebino v brizgalkah ali razredceno raztopino, pripravljeno v infuzijskih vreckah, je treba uporabiti v 8- ih urah po pripravi.
Compatibility with PVC infusion lines with in-line filters has been established.
Dokazana je bila združljivost s PVC cevkami za infuzije s filtri.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
The therapeutic goal of treatment with ATryn is to increase to, and maintain antithrombin activity between 80 – 120% (0.8 – 1.2 IU/ml) for the duration of treatment.
24 Terapevtski namen zdravljenja z zdravilom ATryn je povecati in vzdrževati aktivnost antitrombina med 80 – 120% (0, 8 – 1, 2 i. e. / ml) v casu zdravljenja.
Initial treatment starts with a loading dose of ATryn targeting an antithrombin activity level of 100%.
Zacetno zdravljenje se zacne z odmerkom zdravila ATryn, ki dvigne raven aktivnosti antitrombina na 100%.
This initial loading dose is based on body weight and on the pretreatment antithrombin activity level.
Zacetni odmerek se doloci glede na telesno težo in raven aktivnosti antitrombina pred zdravljenjem.
Loading Dose (IU) = [(100 – patient’s pre -treatment AT activity level in%) /2.28] x Body Weight in kg
Zacetni odmerek (i. e.) = [(100 – raven aktivnosti antitrombina pri bolniku pred zdravljenjem v%) / 2, 28] x telesna teža v kilogramih
The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Obicajni zacetni odmerek pri operiranih bolnikih (prvotna aktivnost antitrombina 50%, telesna teža 75 kg) s prirojenim pomanjkanjem antitrombina v klinicno nevarnih razmerah znaša 20- 25 i. e. / kg telesne teže.
The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Zacetni odmerek je treba dati kot 15 minut trajajoco infuzijo, kateri takoj sledi infuzija vzdrževanja ravni.
Maintenance Dose (IU/hour) = [(100 – patient’s pre -treatment AT activity level in%) /10.22] x Body Weight in kg
Vzdrževalni odmerek (i. e. / uro) = [(100 – raven aktivnosti antitrombina pri bolniku pred zdravljenjem v%) / 10, 22] x telesna teža v kilogramih
The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Obicajni vzdrževalni odmerek pri operiranih bolnikih s prirojenim pomanjkanjem antitrombina v klinicno nevarnih razmerah znaša 4- 5 i. e. / kg/ h.
During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
Med vecjo porabo (npr. vecje operacije, hkratna uporaba heparina) je lahko dejanski odmerek višji.
After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Po zacetku infundiranja vzdrževalnega odmerka je treba vzeti kri za preverjanje ravni aktivnosti antitrombina 45 minut po infundiranju zacetnega odmerka.
In case the AT activity level is between 80% and 120% (0.8- 1.2 IU/ml), no dose adjustment is needed.
Ce je raven aktivnosti antitrombina med 80% in 120% (0, 8 - 1, 2 i. e. / ml), ni potrebno prilagajanje odmerka.
In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
Ce je raven aktivnosti antitrombina manjša od 80%, povecajte hitrost vzdrževalne infuzije za 50%.
In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
Ce je raven aktivnosti antitrombina vecja od 120%, zmanjšajte hitrost infuzije za 30%.
Subsequently, antithrombin activity should be checked 1 times a day and dose -2 adjustments made accordingly.
Aktivnost antitrombina morate nato preverjati 1- 2 dnevno in odmerek ustrezno prilagajati.
In case the activity level is below 80% a 15 minutes bolus infusion of AT can be given to quickly restore the AT activity level.
V primeru, da je raven aktivnosti pod 80%, lahko opravite 15- minutno bolusno infundiranje antitrombina, da se povrne raven aktivnosti antitrombina.
The dose can be calculated utilizing the p loading dose formula above.
Odmerek se da izracunati s pomocjo pooperacijske aktivnosti antitrombina v zgornji formuli za zacetni odmerek.
ost-surgical AT activity in the
Izkušenj pri otrocih ni.
EU/ 1/ 06/ 349/ 001
Številka EU EU/ 1/ 06/ 349/ 001 EU/ 1/ 06/ 349/ 002 EU/ 1/ 06/ 349/ 003 EU/ 1/ 06/ 349/ 004 EU/ 1/ 06/ 349/ 005 EU/ 1/ 06/ 349/ 006 EU/ 1/ 06/ 349/ 007 EU/ 1/ 06/ 349/ 008
blister (PVC/ PVdC/ alu)
Zaščiteno ime Avaglim Avaglim Avaglim Avaglim Avaglim Avaglim Avaglim Avaglim
4 mg/ 4 mg
jakost 4 mg/ 4 mg 4 mg/ 4 mg 4 mg/ 4 mg 4 mg/ 4 mg 8 mg/ 4 mg 8 mg/ 4 mg 8 mg/ 4 mg 8 mg/ 4 mg
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
Oral use
pot uporabe Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
blister (PVC/ PVdC/ alu)
ovojnina Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij) Pretisni omot (PVC/ PVDC/ aluminij)
112 tablets
velikost pakiranja 14 28 56 112 14 28 56 112
blister (PVC/ PVdC/ alu)
Pretisni omot (PVC/ PVDC/ aluminij)
Avaglim is a medicine containing two active substances, rosiglitazone and glimepiride.
Avaglim je zdravilo, ki vsebujejo dve zdravilni učinkovini, rosiglitazon in glimepirid.
It is available as triangular tablets (pink:
Na voljo je v obliki tablet trikotne oblike (roza:
4 mg rosiglitazone and 4 mg glimepiride; red:
4 mg rosiglitazona in 4 mg glimepirida; rdeče:
8 mg rosiglitazone and 4 mg glimepiride).
8 mg rosiglitazona in 4 mg glimepirida).
Avaglim is used to treat adult patients who have type 2 diabetes (non-insulin-dependent diabetes).
Zdravilo Avaglim se uporablja za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2 (od insulina neodvisna sladkorna bolezen).
Avaglim is used in patients who cannot satisfactorily control their blood glucose (sugar) when using an adequate dose of a sulphonylurea (a type of antidiabetes medicine) on its own, and for whom metformin (another antidiabetes medicine) is not suitable.
Zdravilo Avaglim se uporablja pri bolnikih, pri katerih ni mogoče zadovoljivo uravnavati ravni glukoze (sladkorja) z ustreznim odmerkom sulfonilsečnine (vrsta zdravila proti sladkorni bolezni), dajane samostojno, in za katere metformin (druga vrsta zdravila proti sladkorni bolezni) ni primeren.
Avaglim is taken once a day, just before or during a meal, generally breakfast.
Zdravilo Avaglim se jemlje enkrat na dan, tik pred obrokom ali med njim (običajno je to zajtrk).
Doctors must be careful when switching patients who are at risk of developing hypoglycaemia (low blood sugar) to Avaglim, such as elderly patients, patients with low weight or those who have been taking certain other medicines.
Zdravniki morajo biti previdni, kadar preidejo na zdravilo Avaglim pri bolnikih, pri katerih obstaja nevarnost hipoglikemije (nizek krvni sladkor), kot so na primer starejši bolniki, bolniki z nizko telesno maso ali bolniki, ki jemljejo določena druga zdravila.
The patient can start with separate tablets containing only rosiglitazone or a sulphonylurea, before switching to the combination tablet once control is achieved.
Bolnik lahko najprej začne jemati ločene tablete, ki vsebujejo samo rosiglitazon ali samo sulfonilsečnino, in nato preidejo na kombinirane tablete, ko je nadzor dosežen.
The dose should start with the 4 mg/ 4 mg tablet.
Odmerjanje naj se začne s 4 mg/ 4 mg tableto.
The dose can be increased to the 8 mg/ 4 mg tablets after eight weeks if needed, but this should be done with caution, due to the risk of fluid retention.
Po osmih tednih zdravljenja se lahko odmerek poveča na 8 mg/ 4 mg, če je potrebno, vendar je potrebna previdnost zaradi tveganja za zastajanje tekočine.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose 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 uravnavanje koncentracije glukoze v krvi ali pri kateri telo ne more učinkovito izrabiti insulina.
Avaglim contains two active substances, which have different modes of action.
Zdravilo Avaglim vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
Rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Rosiglitazon poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
It stimulates the pancreas to produce more insulin.
Glimepirid je sulfonilsečnina; spodbuja trebušno slinavko, da proizvede več
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. insulina.
As rosiglitazone has been approved on its own in the European Union (EU) since 2000 as Avandia, studies of rosiglitazone on its own were used as the basis for Avaglim.
Ker je rosiglitazon kot samostojno zdravilo v Evropski uniji (EU) že odobren od leta 2000 pod imenom Avandia, so bile študije samega rosiglitazona uporabljene kot podlaga za zdravilo Avaglim.
Glimepiride has also been available in the EU since 1995.
Tudi glimepirid je v EU na voljo od leta 1995 dalje.
For glimepiride, information from scientific publications was used.
Za glimepirid so bile uporabljene informacije iz znanstvenih publikacij.
In addition, four studies were carried out, comparing the combination of both active substances to each substance on its own, in patients who had never been treated, as well as in patients whose blood glucose levels were not controlled when treated with only one of the substances.
Poleg tega so bile izvedene štiri študije, v katerih so primerjali kombinacijo obeh zdravilnih učinkovin z vsako od njiju posebej pri bolnikih, ki še niso bili zdravljeni, ter pri bolnikih, pri katerih raven glukoze v krvi ni bila nadzorovana, kadar so prejemali samo eno od obeh učinkovin.