natgillin/translations-raw huggingface dataset:
In an update to this retrospective analysis that included 10 further studies that met the criteria for inclusion, but were not available at the time of the original analysis, the overall incidence of events typically associated with cardiac ischaemia was not statistically different for rosiglitazone containing regimens, 2.21% versus combined active and placebo comparators, 2.08% [HR 1.098 (95% CI 0.809 - 1.354)].
Ta posodobitev je pokazala, da se celotna incidenca dogodkov, tipično povezanih s srčno ishemijo pri bolnikih, ki so prejemali rosiglitazon (2,21 %) ni statistično značilno razlikovala od incidence pri bolnikih, ki so prejemali primerjalno učinkovino ali placebo (2,08 %) [razmerje ogroženosti 1,098 (95 % IZ 0,809-1,354)].
HOW TO STORE AVANDIA
SHRANJEVANJE ZDRAVILA AVANDIA
7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets, unit dose pack.
7, 28, 56, 84, 90 ali 112 filmsko obloženih tablet v neprozornih pretisnih omotih (PVC/aluminij) ali 56 filmsko obloženih tablet v pakiranju po enoti odmerka.
Any unused product should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets.
IME ZDRAVILA AVANDIA 8 mg filmsko obložene tablete
Red-brown film-coated tablets debossed with “GSK” on one side and "8" on the other side.
Filmsko obložena tableta Rdeče-rjave filmsko obložene tablete, označene z “GSK” na eni in “8” na drugi strani.
United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Tel: + 44 (0)800 221441 customercontactuk@gsk.com
In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Po pridobitvi dovoljenja za uporabo rosiglitazona so poleg neželenih učinkov, odkritih med kliničnimi preskušanji poročali še o neželenih učinkih, ki so navedeni v preglednici2.
EU/1/00/137/004 56 tablet unit dose pack
EU/1/00/137/004 56 tablet, pakiranje po enoti odmerka
Preclinical data
Predklinični podatki
NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets.
IME ZDRAVILA AVANDIA 4 mg filmsko obložene tablete
• liver doesn't function as well as it should (increase in liver enzymes).
• oteklina mrežnice na očesnem ozadju (makularni edem) • okvara delovanja jeter (zvišana vrednost jetrnih encimov).
NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets.
IME ZDRAVILA AVANDIA 2 mg filmsko obložene tablete
Triple oral therapy
Peroralno zdravljenje s tremi zdravili
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 8 mg rosiglitazona.
SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
SmithKline Beecham Ltd, 980 Great West Road Brentford, Middlesex, TW8 9GS Velika Britanija
SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 4 mg rosiglitazona.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 2 mg rosiglitazona.
Common Common Common myalgia*
mialgija*
New or worse cases of macular oedema have occurred on rare occasions in people taking Avandia and similar medicines.
V redkih primerih so pri bolnikih, ki so se zdravili z zdravilom Avandia in podobnimi zdravili poročali o novem pojavu ali poslabšanju že obstoječega makularnega edema.
EU/1/00/137/005 7 tablets EU/1/00/137/006 28 tablets EU/1/00/137/007 56 tablets EU/1/00/137/014 84 tablets EU/1/00/137/017 90 tablets EU/1/00/137/008 112 tablets EU/1/00/137/009 56 tablet unit dose pack
EU/1/00/137/008 112 tablet EU/1/00/137/009 56 tablet, pakiranje po enoti odmerka
NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg tablets rosiglitazone
IME ZDRAVILA AVANDIA 2 mg tablete rosiglitazon
NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg tablets rosiglitazone
IME ZDRAVILA AVANDIA 8 mg tablete rosiglitazon
Film coating (Opadry pink OY-L-24803): Hypromellose 6cP
Filmska obloga (Opadry pink OY-L-24802): hipromeloza 6cP titanov dioksid E171 makrogol 3000 laktoza monohidrat triacetin rdeči železov oksid E172
NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg tablets rosiglitazone
IME ZDRAVILA AVANDIA 4 mg tablete rosiglitazon
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu
(EMEA) http://www.ema.europa.eu
PHARMACEUTICAL FORM AND CONTENTS
Izgled zdravila Avandia in vsebina pakiranja
In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
Pred tem je treba opraviti ustrezen klinični pregled in oceniti bolnikovo ogroženost za pojav neželenih učinkov, povezanih z zastajanjem tekočine (glejte poglavji 4.4 in 4.8).
MARKETING AUTHORISATION HOLDER SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
IMETNIK DOVOLJENJA ZA PROMET SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija
NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets rosiglitazone
AVANDIA 8 mg filmsko obložene tablete rosiglitazon
• rapid increase in your weight
hitro povečanje telesne mase.
NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets rosiglitazone
AVANDIA 4 mg filmsko obložene tablete rosiglitazon
NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets rosiglitazone
AVANDIA 2 mg filmsko obložene tablete rosiglitazon
Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Pri njuni sočasni uporabi se lahko poveča tveganje za pojav edemov in ishemične bolezni srca.
• raised and itchy rash (hives)
• privzdignjen in srbeč kožni izpuščaj (koprivnica)
Avandia 8 mg tablets are red-brown, marked "GSK" on one side and "8" on the other.
Na eni strani imajo oznako "gsk", na drugi pa "8".
7, 28, 84, 90 or 112 film-coated tablets.
7, 28, 84, 90 ali 112 filmsko obloženih tablet v neprozornih pretisnih omotih (PVC/aluminij).
BEFORE YOU TAKE AVANDIA
Če ste pozabili vzeti zdravilo Avandia
Excipient
Presnova
Film coating (Opadry orange OY-L-23028): Hypromellose 6cP
Filmska obloga (Opadry orange OY-L-23028): hipromeloza 6cP titanov dioksid E171 makrogol 3000 smukec laktoza monohidrat triacetin rdeči železov oksid E172 rumeni železov oksid E172
POSSIBLE SIDE EFFECTS
Neželeni učinki
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES) št. 470/2009.
**Haemolytic units For the full list of excipients, see section 6.1.
**Hemolizne enote Za celoten seznam pomožnih snovi glejte poglavje 6.1.
a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
Revaccination Annual.
Ponovno cepljenje Letno.
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ UNITED KINGDOM
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Velika Britanija
Any person intending to manufacture, import, possess, sell, supply and use BTVPUR AlSap 2-4 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati BTVPUR AlSap 2-4, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena pod posebnimi pogoji, ki jih predpisuje zakonodaja Evropske Skupnosti za nadzor nad boleznijo modrega jezika.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member States may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri mladičih imunih ovc).
The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 2-4 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba BTVPUR AlSap 2-4 je lahko prepovedana v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
The duration of immunity is 1 year after primary vaccination course.
Trajanje imunosti je 1 leto po osnovnem cepljenju.
The marketing authorization holder should provide a suitable system for quantifying active ingredient at blending stage as soon as feasible.
Imetnik dovoljenja za promet mora takoj ko bo to mogoče, predložiti zadovoljiv sistem za kvantitativno določanje vsebnosti zdravilne učinkovine na stopnji mešanja v proizvodnem postopku.
Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest FRANCE
Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Francija
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6, niso bili opaženi po dajanju dvakratnega odmerka cepiva.
In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Pri tej kategoriji živali je treba cepivo uporabljati glede na presojo odgovornega veterinarja glede razmerja korist/tveganje oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
*Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10).
*Infektivni odmerek za celično kulturo 50%, ekvivalent titru pred inaktivacijo (log10) **Hemolizne enote.
The safety and the efficacy of the vaccine have not been established in breeding males.
Varnost in učinkovitost cepiva nista bili ugotovljena pri plemenjakih.
Vaccination may be followed by a small local swelling at the injection site (at most 24 cm2) for a short period (at most 14 days).
Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 24 cm ki hitro izgine (v največ 14 dneh).
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)
*(pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml ni prenosa virusa)
Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.
Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer Aluminijev hidroksid Saponin
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
Avoid bubble formation, as this can be irritating at the site of injection.
Izogibajte se nastanku zračnih mehurčkov, saj ti lahko povzročijo draženje na mestu dajanja.
*below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
*pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml, ni prenosa virusa
Do not mix with any other veterinary medicinal products.
Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/005
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/108/005
NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI BTVPUR AlSap 2-4 suspenzija za injiciranje za ovce
The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with aluminium hydroxide and saponin adjuvants.
Cepivo vsebuje inaktiviran virus modrega jezika, serotip 2 in 4, z aluminijevim hidroksidom in saponini kot adjuvansi.
No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine.
Drugi učinki, razen tistih ki so navedeni v poglavju neželeni učinki, niso bili opaženi po dajanju dvojnega odmerka cepiva.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Vaccination may be followed by a small local swelling at the injection site (at most 24 cm²) for a short A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 24 cm Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1,1 °C.
Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.
Imunost nastopi tri tedne po osnovnem cepljenju za serotip 4 in 5 tednov po osnovnem cepljenju za serotip 2.
Once broached, use immediately.
Po odprtju uporabite takoj.
PACKAGE LEAFLET FOR: BTVPUR AlSap 2-4 suspension for injection for sheep
NAVODILO ZA UPORABO BTVPUR AlSap 2-4 suspenzija za injiciranje za ovce
A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1,1 °C.
The periodic safety update report (PSUR) cycle should be re-started for submission of 6 monthly reports (covering all authorised presentations of this product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
PSUR ciklus je potrebno za trajanje 2 leti ponovno vzpostaviti tako, da se PSUR predaja vsakih 6 mesecev (vključevati mora vsa registrirana pakiranja zdravila).
Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
Aktivna imunizacija ovc proti virusu modrega jezika, serotip 2 in 4, za preprečitev viremije* in zmanjšanje kliničnih znakov.
PACKAGE SIZE 10 doses (10 ml)
VELIKOST PAKIRANJA 10 odmerkov (10 ml)
MARKETING AUTHORISATION NUMBER(S) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/108/001 (1plastenka s 100 ml) EU/2/10/108/002 (10 plastenk s 100 ml)
EU/2/10/108/003 (1 bottle of 50 ml) EU/2/10/108/004 (10 bottles of 50 ml) EU/2/10/108/001 (1 bottle of 100 ml) EU/2/10/108/002 (10 bottles of 100 ml)
EU/2/10/108/003 (1 plastenka s 50 ml) EU/2/10/108/004 (10 plastenk s 50 ml) EU/2/10/108/001 (1 plastenka s 100 ml) EU/2/10/108/002 (10 plastenk s 100 ml)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 1 bottle of 50 ml, or of 10 bottles of 50 ml, or of 1 bottle of 100 ml, or of 10 bottles of 100 ml
Škatla z 1 plastenko s 50 ml ali z 10 plastenkami s 50 ml ali z 1 plastenko s 100 ml ali z 10 plastenkami s 100 ml
10 bottles of 50 doses (10 x 50 ml) 100 doses (100 ml) 10 bottles of 100 doses (10 x 100 ml)
50 odmerkov (50 ml) 10 plastenk s 50 odmerki (10 x 50 ml) 100 odmerkov (100 ml) 10 plastenka s 100 odmerki (10 x 100 ml)
Revaccination
Ponovno cepljenje
Bluetongue virus serotype 2 antigen .............................................................................. 6.8-9.5 CCID50*, Bluetongue virus serotype 4 antigen .............................................................................. 7.1-8.5 CCID50*, Aluminium hydroxide
Virus modrega jezika, serotip 2, antigen ....................................................................... 6,8-9,5 CCID50*, Virus modrega jezika, serotip 4, antigen ....................................................................... 7,1-8,5 CCID50*, Aluminijev hidroksid
It induces an active and specific immunity against bluetongue virus serotypes 2 and 4 in the vaccinated animals.
Pri cepljenih živalih sproži nastanek aktivne in specifične imunosti proti virusu modrega jezika, serotip 2 in 4.
Pharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep.
Farmakoterapevtska skupina: inaktivirano cepivo proti virusu modrega jezika za ovce Oznaka ATC vet QI04AA02.
EXPIRY DATE EXP {month/year} Once broached, use immediately.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Bluetongue virus serotype 2 antigen ............................................................................... 6.8-9.5 CCID50* Bluetongue virus serotype 4 antigen ............................................................................... 7.1-8.5 CCID50* * Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10) Adjuvants:
Virus modrega jezika, serotip 2, antigen ....................................................................... 6,8-9,5 CCID50*, Virus modrega jezika, serotip 4, antigen ....................................................................... 7,1-8,5 CCID50*, *Infektivni odmerek za celično kulturo 50%, ekvivalent titru pred inaktivacijo (log10)
BTV 2 antigen ........................................................................................................... 6.8-9.5 CCID50/ml, BTV 4 antigen ........................................................................................................... 7.1-8.5 CCID50/ml.
antigen BTV 2 ........................................................................................................... 6,8-9,5 CCID50/ml, antigen BTV 4 ........................................................................................................... 7,1-8,5 CCID50/ml.
Aluminium hydroxide
Aluminijev hidroksid, Saponin q.s.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Administer one dose of 1 ml subcutaneously according to the following vaccination scheme: Primary vaccination
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1ml of vaccine contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
The name of the medicine was changed to Icandra on 6 February 2009.
Ime zdravila je bilo 6. februarja 2009 spremenjeno v Icandra.
The recommended dose of Icandra is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Priporočeni odmerek zdravila Icandra je ena tableta dvakrat dnevno, pri čemer se ena tableta vzame zjutraj, druga pa zvečer.
The full EPAR for Icandra can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Icandra je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Icandra
Druge informacije o zdravilu Icandra
The European Commission granted a marketing authorisation valid throughout the European Union for Vildagliptin/Metformin Hydrochloride on 1 December 2008.
Evropska komisija je dovoljenje za promet z vildagliptinom/metforminijevim kloridom, veljavno po vsej Evropski uniji, odobrila dne 1. decembra 2008.
For more information about treatment with Icandra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Icandra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Icandra.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Icandra.
Vildagliptin / metformin hydrochloride
Icandra vildagliptin/metforminijev klorid
The company that makes Eucreas has agreed that its scientific data can be used for Icandra.
Družba, ki proizvaja zdravilo Eucreas, se strinja, da se lahko znanstveni podatki tega zdravila uporabijo za zdravilo Icandra.
Therefore, the Committee decided that the benefits of Icandra are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Icandra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 od 10) so slabost, bruhanje, driska, bolečina v trebuhu in izguba teka.
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, ki kažeta, da je telo zdravilni učinkovini v obeh jakostih zdravila Icandra absorbiralo enako, kot pri njunem jemanju v obliki ločenih tablet.
What benefit has Icandra shown during the studies?
Kakšne koristi je zdravilo Icandra izkazalo med študijami?
The choice of tablet strength to start with depends on the patient's current treatment and the expected effects of Icandra, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Icandra, vendar je priporočljivo,da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
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 se ne sme uporabljati pri bolnikih, ki imajo zmerne ali hude težave z ledvicami ali imajo težave z jetri.