natgillin/translations-raw huggingface dataset:
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Ako je bubrežna funkcija oštećena, bubrežni klirens se smanjuje razmjerno smanjenju klirensa kreatinina i stoga se poluvrijeme eliminacije produžuje što dovodi do povećanih razina metformina u plazmi.
Elimination Following oral administration of [
Nakon peroralne primjene [
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
U kliničkim je ispitivanjima incidencija hipoglikemije bila česta u bolesnika koji su primali 100 mg vildagliptina na dan u kombinaciji s metforminom (1%) te manje česta u bolesnika koji su primali placebo uz metformin (0,4%).
Table 1 Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)
Tablica 1 Nuspojave zabilježene u bolesnika koji su primali 100 mg vildagliptina na dan kao dodatak metforminu u usporedbi s palcebom uz metformin u dvostruko slijepim ispitivanjima (N=208)
All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.
Nakon ukidanja ispitivanog lijeka, svi su se simptomi i abnormalne laboratorijske vrijednosti povukli bez liječenja.
Gastrointestinal disorders Very common Nausea, vomiting, diarrhoea, abdominal pain and loss of appetite Hepatobiliary disorders Very rare
Mučnina, povraćanje, proljev, bol u abdomenu i gubitak apetita
- if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems.
Simptomi uključuju bol u trbuhu, ubrzano i duboko disanje, pospanost ili Vam dah ima neobičan voćni miris. - ako ste nedavno imali srčani udar ili imate zatajivanje srca ili ozbiljne probleme s cirkulacijom krvi ili poteškoće pri disanju koje mogu biti znak srčanih problema.
What Zomarist looks like and contents of the pack Zomarist 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Zomarist 50 mg/850 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR” na jednoj strain i „SEH” na drugoj strani.
Nasopharyngitis Metabolism and nutrition disorders Uncommon
Nazofaringitis Poremećaji metabolizma i prehrane Manje često
Musculoskeletal and connective tissue disorders Not known
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Nepoznato
Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Zomarist 50 mg/1000 mg filmom obložene tablete su tamnožute, ovalne tablete s oznakom „NVR” na jednoj strain i „FLO” na drugoj strani.
Maximum daily dose is 2000 mg.
Maksimalna dnevna doza je 2000 mg.
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side.
Žuta, ovalna filmom obložena tableta sa zaobljenim rubovima, s utisnutom oznakom „NVR” na jednoj strani i „SEH” na drugoj strani.
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Metformin ima korisne učinke na metabolizam lipida u ljudi, neovisno od svom učinku na glikemiju.
Table 4 Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
Tablica 4 Nuspojave zabilježene u bolesnika koji su primali 100 mg vildagliptina na dan kao monoterapiju u dvostruko slijepim ispitivanjima (N=1855)
Skin reactions such as erythema, pruritus and urticaria *A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin.
B12 uz pad razine u serumu vrlo je rijetko zamijećena u bolesnika koji su dugotrajno liječeni metforminom.
Zomarist 50 mg/1000 mg film-coated tablets
Zomarist 50 mg/1000 mg filmom obložene tablete
Zomarist 50 mg/850 mg film-coated tablets
Zomarist 50 mg/850 mg filmom obložene tablete
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Zomarist in order to avoid low blood glucose (hypoglycaemia).
Da bi izbjegao nisku koncentraciju glukoze u krvi (hipoglikemija), Vaš će liječnik možda htjeti smanjiti Vašu dozu sulfonilureje kad je uzimate zajedno s Zomaristom.
After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h.. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Nakon oralne doze metformina najveća koncentracija u plazmi (Cmax) se postiže nakon otprilike 2,5 sata.
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment-), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Liječenje vildagliptinom u dozi od 50 do 100 mg na dan u bolesnika sa šećernom bolešću tipa 2 značajno je poboljšalo markere funkcije beta stanica, uključujući HOMA- (engl.
Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity.
U konvencionalnim in vitro i in vivo testovima genotoksičnosti vildagliptin nije bio mutagen.
DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Na osnovu in vivo ispitivanja u kojem su korišteni štakori s manjkom DPP-4 otkriveno je da DPP-4 djelomično doprinosi hidrolizi vildagliptina.
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Tamnožuta, ovalna filmom obložena tableta sa zaobljenim rubovima, s utisnutom oznakom „NVR” na jednoj strani i „FLO” na drugoj strani.
- Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
- Jedna Zomarist 50 mg/850 mg filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration.
Nakon peroralne primjene 23% doze izlučuje se putem bubrega kao nepromijenjeni vildagliptin.
- Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
- Jedna Zomarist 50 mg/1000 mg filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
WIN MEDICA ΦΑΡΜΑΚΕΥΤΙΚΗ A.E. Tηλ: +30 210 74 88 821
Tηλ: +30 210 74 88 821
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets
Zomarist 50 mg/850 mg filmom obložene tablete Zomarist 50 mg/1000 mg filmom obložene tablete
Constipation Musculoskeletal and connective tissue disorders Uncommon
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često
Gastrointestinal disorders Not known
Poremećaj probavnog sustava Nepoznato
- The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.
- Drugi sastojci su: hidroksipropilceluloza, magnezijev stearat, hipromeloza, titanijev dioksid
The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
Pri liječenju vildagliptinom nije zapažen poznati učinak odgođenog pražnjenja želuca uslijed povišene razine GLP-1.
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/850 mg filmom obložene tablete Zomarist 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Značajke laktacidoze su acidozna dispneja, bol u abdomenu, grčevi u mišićima, astenija i hipotermija nakon koje slijedi koma.
Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Jedna tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Jedna tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
Svaka filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Svaka filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
No severe hypoglycaemic events were reported in the vildagliptin arms.
U dijelu bolesnika koji su primali vildagliptin nisu zabilježeni teški hipoglikemijski događaji.
Asthenia
Liječenje
Lactic acidosis
Hiperhidroza
Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/850 mg filmom obložene tablete vildagliptin/metforminklorid
Nausea
Mučnina
EU/1/08/483/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/030 360 film-coated tablets (PCTFE/PVC/Alu)
EU/1/08/483/007 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/008 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/009 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/010 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/011 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/012 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/025 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/026 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/027 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/028 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/029 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/030 360 filmom obloženih tableta (PCTFE/PVC/Al)
Accumulation of foamy alveolar macrophages in the lung was observed in rats and mice.
U štakora i miševa zapaženo je nakupljanje pjenastih alveolarnih makrofaga u plućima.
EU/1/08/483/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/024 360 film-coated tablets (PCTFE/PVC/Alu)
EU/1/08/483/001 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/002 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/003 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/004 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/005 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/006 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/019 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/020 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/021 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/022 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/023 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/024 360 filmom obloženih tableta (PCTFE/PVC/Al)
EU/1/08/483/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/036 360 film-coated tablets (PCTFE/PVC/Alu)
EU/1/08/483/016 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/017 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/018 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/034 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/035 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/036 360 filmom obloženih tablet (PCTFE/PVC/Al)
EU/1/08/483/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/033 360 film-coated tablets (PCTFE/PVC/Alu)
EU/1/08/483/013 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/014 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/015 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/031 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/032 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/033 360 filmom obloženih tableta (PCTFE/PVC/Al)
DPP-4 inhibition by vildagliptin is not affected by age.
Ove se promjene ne smatraju klinički značajnim, međutim dob ne utječe na inhibiciju DPP-4 vildagliptinom.
Oedema peripheral
Prijavljivanje nuspojava
Talk to your doctor, pharmacist or nurse before taking Zomarist if you have or have had a disease of the pancreas.
Ako imate ili ste imali bolest gušterače, obratite se svom liječniku, ljekarniku ili medicinskoj prije nego uzmete Zomarist.
Decreased blood glucose
*Smanjena apsorpcija vitamina
- For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Zomarist should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Uobičajena početna doza Zomariste mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) plus dosadašnja doza metformina.
Fatigue
Konstipacija
LIST OF EXCIPIENTS
Opis odabarnih nuspojava
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Popis naziva, farmaceutskih oblika, jačina lijekova, puta primjene, nositelja odobrenja u državama članicama
Co. Tipperary Ireland
Tipperary Ireland
ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona.
Španjolska ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona.
LABORATORIOS CINFA, S.A. OlazChipi, 10.
Španjolska LABORATORIOS CINFA, S.A. OlazChipi, 10.
S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România
Rumunjska S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România
BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor.
Španjolska BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor.
Sweden sanofi-aventis AB Box 14142
Švedska sanofi-aventis AB Box 14142
Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Latvija sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid).
Španjolska LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid).
Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark
Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense
FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid).
Španjolska FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid).
Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Danska sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid.
Španjolska RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid.
Czech Republic Krka, d.d., Novo mesto Šmarješka cesta 6
Rumunjska Krka, d.d., Novo mesto Šmarješka cesta 6
Areos 103 and Ag. Triados 36, Palaio Faliro 17562
Triados 36, Palaio Faliro 17562
Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Austrija sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Austria ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Austrija ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Marszałka J. Piłsudskiego 5 95-200 Pabianice
Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice
MYLAN PHARMACEUTICALS, S.L.
Španjolska MYLAN PHARMACEUTICALS, S.L.
B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România
Rumunjska LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România
Frederic Mompou, 5 , Sant Just Desvern (Barcelona).
Španjolska LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona).
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C7.3 e 7.4
João II, Lote 1.06.2.2 C - 7.3 e 7.4
SANOFI AVENTIS, S.A. Josep Plá, 2, Barcelona.
Španjolska SANOFI AVENTIS, S.A. Josep Plá, 2,
Farma-Projekt Sp. z o.o.
Farma-Projekt Sp. z o.o. ul. Józefińska 2
Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia
ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia
Baarnsche Dijk 1 3741 LN BAARN The Netherlands
3741 LN BAARN The Netherlands
Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano - Italy
LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano - Italy
Rowex Ltd, Bantry, Co. Cork, Ireland
Rowex Ltd, Bantry, Co.
Czech Republic sanofi-aventis, s.r.o.
Češka Republika sanofi-aventis, s.r.o.
Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
Španjolska GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980
- via Messina 3820154 Milano Italy
Teva Italia S.r.l. - via Messina 3820154 Milano Italy
Slovak Republic
Slovačka Republika
Chile, 8 - 2ª planta.
Španjolska GERMED FARMACEUTICA S.L. Chile, 8 - 2ª planta.
PHARMAGENUS, S.A. Avda.
Španjolska PHARMAGENUS, S.A. Avda.
Genthon BV Microweg, 22
Nizozemska Genthon BV Microweg, 22
The Netherlands ratiopharm Nederland B.V. Swensweg 5
Nizozemska ratiopharm Nederland B.V.
Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303
Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd.
Meda Pharma Hungary Kft Váci út 91.
Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary
C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
Španjolska TEVA GENERICOS ESPAÑOLA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
Mylan B.V.
Nizozemska Mylan B.V.
Sandoz B.V.
Nizozemska Sandoz B.V.
SANDOZ FARMACÉUTICA, S.A. Avda.
Španjolska SANDOZ FARMACÉUTICA, S.A. Avda.
Sanofi Malta Ltd. St. Julian's Rd.
Sanofi Malta Ltd.
Veluwezoom 22 1327 AH ALMERE The Netherlands
1327 AH ALMERE The Netherlands
Slovak Republic sanofi-aventis Slovakia s.r.o.
Slovačka Republika sanofi-aventis Slovakia s.r.o. Einsteinova 24
Meda Pharma B.V.
Nizozemska Meda Pharma B.V.
Belgium Eurogenerics S.A. Esplanade Heysel, b22
Nizozemska Eurogenerics S.A. Esplanade Heysel, b22
- Viale Bodio 37/b, 20158 Milano Italy
ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, 20158 Milano Italy
Denmark
S Denmark
Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten šumeća tableta
Synthon B.V.
Nizozemska Synthon B.V.
Centrafarm B.V.
Nizozemska Centrafarm B.V.
Stilnoct, tabletten 10 mg tablet oral use
Stilnoct, tabletten 10 mg tableta
Biochemiestrasse 10 Kundli
Sandoz GmbH ul. Biochemiestrasse 10 Kundli
LEK farmacevtska družba d.d.
LEK farmacevtska družba d.d. Verovškova 57
Heumann Pharma GmbH & Co. Generica KG
Heumann Pharma GmbH & Co.
Zolpidem Genthion coated tablet oral use
Zolpidem Genthion obložena tableta kroz usta
Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Takeda GmbH Byk-Gulden-Str.
Actavis B.V.
Nizozemska Actavis B.V.
Viale Fulvio Testi 330, 20126 Milano, Italia
Viale Fulvio 330 20126 Milano Italy
Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Stilnoct 5mg fiilm-coated tablets obložena tableta kroz usta
ADOH B.V.
Nizozemska ADOH B.V.
Šlandrova ulica 4
Rumunjska ALKALOID-INT d.o.o. Šlandrova ulica 4
Stilnoct tablet oral use
Stilnoct tableta
Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Njemačka neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str.
Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Edluar 10 mg, tablet voor sublinguaal gebruik sublingvalna tableta pod jezik
Zolsana 5 mg coated tablets coated tablet oral use
Zolsana 5 mg coated tablets obložena tableta kroz usta
Zolpitop coated tablet oral use
Zolpitop obložena tableta kroz usta
Dodorest coated tablet oral use
Dodorest obložena tableta kroz usta
Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Edluar 5 mg, tablet voor sublinguaal gebruik sublingvalna tableta pod jezik
EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingvalna tableta pod jezik
ul.
Co.
Zolpeduar sublingual tablet sublingual use
Zolpeduar sublingvalna tableta pod jezik
10 mg/ml oral drops, solution oral use
10 mg/ml oralne kapi, otopina kroz usta
INSOM 10 mg pezsgőtabletta effervescent tablet oral use
INSOM 10 mg pezsgőtabletta šumeća tableta
Novo Mesto 8501 Slovenia
Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia
Stilnoct 10mg film-coated tablets coated tablet oral use
Stilnoct 10mg film-coated tablets obložena tableta kroz usta
Zolsana 10 mg coated tablets coated tablet oral use
Zolsana 10 mg coated tablets obložena tableta kroz usta
Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Zolpidemtartaat Actavis 5 mg, tabletten tableta
Józefińska 2
Veluwezoom 22
Czech Republic Apotex Europe B.V. Darwinweg 20
Nizozemska Apotex Europe B.V.
Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet sublingual use
Edluar 10 mg Sublingualtabletten 10 mg sublingvalna tableta pod jezik
Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Zolpidemtartraat Actavis 10 mg, tabletten tableta
tablet oral use
šumeća tableta
EDLUAR 5 mg nyelvalatti tabletta sublingual tablet sublingual use
EDLUAR 5 mg nyelvalatti tabletta sublingvalna tableta pod jezik
SANOFI-AVENTIS ROMÂNIA S.R.L.
Rumunjska SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et.
13 24941 Flensburg Germany
23 40764 Langenfeld Germany
Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
Edluar 10 mg Sublingualtabletten 10 mg sublingvalna tableta kroz usta
Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Švedska ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Stilnoct coated tablet oral use
Stilnoct obložena tableta kroz usta
Zolpeduar sublingual tablet oral use
Zolpeduar sublingvalna tableta kroz usta
Edluar 10 mg sublingual tablets sublingual tablet sublingual use
Edluar 10 mg sublingual tablets sublingvalna tableta pod jezik