natgillin/translations-raw huggingface dataset:
This means that it helps to prevent cells in the blood called platelets sticking together (aggregating).
To znači da pomaže u sprečavanju sljepljivanja (agregacije) stanica u krvi koje se nazivaju trombociti.
What are the benefits and risks of Eptifibatide Accord?
Koje su koristi i rizici lijeka Eptifibatide Accord?
For practical information about using Eptifibatide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o korištenju lijeka Eptifibatide Accord pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
Therefore, the CHMP's view was that, as for Integrilin, the benefit outweighs the identified risk.
Stoga je stajalište Odbora da koristi nadmašuju utvrđene rizike, kao i kod Integrilina.
Why is Eptifibatide Accord approved?
Zašto je Eptifibatide Accord odobren?
How does Eptifibatide Accord work?
Kako djeluje Eptifibatide Accord?
How is Eptifibatide Accord used?
Kako se Eptifibatide Accord koristi?
How has Eptifibatide Accord been studied?
Kako je Eptifibatide Accord ispitivan?
Skilarence is available as tablets (30 and 120 mg).
Skilarence je dostupan u obliku tableta (30 i 120 mg).
Tablets should be swallowed whole during or immediately after a meal.
Tablete se moraju progutati cijele tijekom ili neposredno nakon obroka.
The full EPAR for Skilarence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Skilarence nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity.
Glavna mjera djelotvornosti bio je udio bolesnika u kojih je postignuto smanjenje od 75 % u pogledu težine bolesti.
Psoriasis results from over-activity of the body's immune (defence) system.
Psorijaza je posljedica prekomjerne aktivnosti imunosnog (obrambenog) sustava.
Skilarence dimethyl fumarate
Skilarence dimetilfumarat
Other information about Skilarence
Ostale informacije o lijeku Skilarence
What measures are being taken to ensure the safe and effective use of Skilarence?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Skilarence?
The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk.
Tvrtka koja stavlja na tržište lijek Skilarence osigurat će zdravstvenim radnicima obrazovne materijale o riziku od ozbiljnih infekcija, uključujući PML, te o tome kako minimizirati taj rizik.
The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day.
Početna doza od 30 mg jedanput dnevno povećava se svaki tjedan u skladu s rasporedom navedenim u uputi o lijeku sve dok se stanje prouzročeno psorijazom ne poboljša ili dok bolesnik ne dostigne maksimalnu dozu od 240 mg triput dnevno.
What is Skilarence and what is it used for?
Što je Skilarence i za što se koristi?
It is not intended to provide practical advice on how to use Skilarence.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Skilarence.
After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm .
Nakon 16 tjedana liječenja, takvo je smanjenje postignuto u 37 % bolesnika koji su uzimali Skilarence, u odnosu na 15 % bolesnika koji su uzimali placebo i 40 % bolesnika koji su uzimali Fumaderm.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skilarence have also been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Skilarence nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches.
Skilarence je lijek koji se upotrebljava za liječenje plak psorijaze, bolesti koja uzrokuje zadebljana, crvena i upaljena područja na koži pokrivena ljuskama.
Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary.
Budući da lijek Skilarence smanjuje aktivnost imunosnog sustava, postoji rizik od ozbiljnih infekcija i progresivne multifokalne leukoencefalopatije (PML, infekcija mozga), ali taj se rizik može minimizirati redovitim mjerenjem broja bijelih krvnih stanica i prekidom liječenja ako je to potrebno.
What are the risks associated with Skilarence?
Koji su rizici povezani s lijekom Skilarence?
Skilarence must not be used in patients who have severe problems of the digestive system, liver or kidneys.
Skilarence ne smiju uzimati bolesnici koji imaju teške probleme s probavnim sustavom, jetrom ili bubrezima.
The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system.
Djelatna tvar lijeka Skilarence, dimetilfumarat, smanjuje aktivnost imunosnog sustava.
The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use.
Odbor za lijekove za humanu uporabu (CHMP) smatra da se u glavnom ispitivanju dokazala kratkoročna djelotvornost lijeka Skilarence, a u objavljenim ispitivanjima sličnih lijekova pokazalo se da se djelotvornost zadržava stalnom uporabom.
This is a summary of the European public assessment report (EPAR) for Skilarence.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Skilarence.
A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate).
U glavnom ispitivanju koje je obuhvatilo 704 bolesnika s umjerenom do teškom plak psorijazom Skilarence se pokazao djelotvornijim u liječenju bolesti od placeba (prividno liječenje) i jednako djelotvornim kao Fumaderm (lijek za psorijazu koji sadržava dimetilfumarat i monoetilfumarat).
It is used in patients with moderate or severe disease for whom treatments applied direct to the skin do not work well enough.
Upotrebljava se u bolesnika s umjerenom ili teškom bolešću koji nisu dovoljno dobro reagirali na lijekove koji se primjenjuju izravno na kožu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Skilarence nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
It must also not be used by women during pregnancy or if breast-feeding.
Osim toga, ne smiju ga uzimati žene koje su trudne ili koje doje.
Skilarence can only be obtained with a prescription and it should be used under the supervision of a doctor who has experience in diagnosing and treating psoriasis.
Skilarence se izdaje samo na recept i namijenjen je za primjenu pod nadzorom liječnika iskusnog u dijagnosticiranju i liječenju psorijaze.
The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general.
Najčešće nuspojave lijeka Skilarence (koje se mogu javiti u više od 1 na 10 osoba) jesu učinci na probavni sustav (proljev, napuhnutost, bol u želucu i mučnina), navale crvenila (crvenilo kože) i smanjen broj limfocita (vrsta bijelih krvnih stanica) ili bijelih krvnih stanica općenito.
It is thought to act on T cells (a type of white blood cell that forms part of the immune system) to prevent the cells from producing substances that cause inflammation and lead to psoriasis.
Smatra se da lijek djeluje na Tstanice (vrsta bijelih krvnih stanica koje čine imunosni sustav) i sprečava da stanice stvaraju tvari koje uzrokuju upalu i dovode do psorijaze.
Why is Skilarence approved?
Zašto je lijek Skilarence odobren?
The doctor may reduce the dose when the psoriasis has been brought under control.
Liječnik može smanjiti dozu kad se postigne dobra kontrola stanja prouzročenog psorijazom.
How does Skilarence work?
Kako djeluje Skilarence?
Skilarence contains the active substance dimethyl fumarate.
Skilarence sadržava djelatnu tvar dimetilfumarat.
For more information about treatment with Skilarence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Skilarence pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
What benefits of Skilarence have been shown in studies?
Koje su koristi lijeka Skilarence dokazane u ispitivanjima?
For practical information about using Skilarence, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Skilarence bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
Most side effects are mild or moderate.
Većina nuspojava bila je blaga do umjerena.
How is Skilarence used?
Kako se Skilarence koristi?
For the full list of all side effects reported with Skilarence, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Skilarence potražite u uputi o lijeku.
"ARAC" At Regulatory Affairs Consulting GmbH
Njemačka "ARAC" At Regulatory Affairs Consulting GmbH
FAES FARMA, S.A. Maximo Aguirre, 14.
Španjolska FAES FARMA, S.A. Maximo Aguirre, 14.
JANSSEN-CILAG 1 rue Camille Desmoulins TSA 91003
Francuska Janssen-Cilag 1 rue Camille Desmoulins TSA 91003
1 28700 San Sebastián de los ReyesMadrid
28700 San Sebastián de los Reyes
Slovak Republic Stada Arzneimittel AG, Stadastrasse 2-8,
Nizozemska Stada Arzneimittel AG, Stadastrasse 2-8,
STRAGEN France SAS 52 rue de la République 69002 Lyon France
Francuska STRAGEN France SAS 52 rue de la République 69002 Lyon
Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K703
Njemačka Zentiva Pharma GmbH Industriepark FrankfurtHöchst, Gebäude K703
CHEMICAL FARMA 3, Quai Louis Blériot 75016 PARIS FRANCE
Francuska CHEMICAL FARMA 3, Quai Louis Blériot 75016 Paris
Bayer Sante 220 avenue de la Recherche 59120 Loos France
Francuska Bayer Sante 220 avenue de la Recherche 59120 Loos
Slovak Republic Johnson & Johnson, s. r. o.
Johnson & Johnson, s. r. o.
Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Njemačka Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Mylan dura gmbH Wittstichstr.
Njemačka Mylan dura gmbH Wittstichstr.
Aktiengesellschaft Industriestr.
Njemačka Hexal Aktiengesellschaft Industriestr.
Luxembourg JANSSEN-CILAG N.V. Antwerpseweg 15-17
Luksemburg JANSSEN-CILAG N.V. Antwerpseweg 15-17
BAYER HISPANIA, S.L Avda.
Španjolska BAYER HISPANIA, S.L Avda.
28027 Madrid Spain
28027 Madrid
Temapharm Sp. z o.o.
Temapharm Sp. z o.o. ul.
C/ Anabel Segura, 11 Edificio Albatros B 1ª planta
C/ Anabel Segura, 11
28108 Alcobendas Madrid
28108 Alcobendas
Lagedijk 1-3;
Nizozemska WeCare, Lagedijk 1-3;
Stadapharm GmbH Stadastr.
Njemačka Stadapharm GmbH Stadastr.
Famy Care Europe Ltd. One Wood Street EC2V 7WS
Famy Care Europe Ltd. 1 Wood Street EC2V7WS London United Kingdom
Aliud Pharma GmbH Gottlieb-Daimler-Str.
Njemačka Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1
Njemačka MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung
Navatejera,
Ind., Navatejera
Teva The Netherlands B.V.
Nizozemska Teva Nederland B.V.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Combined hormonal contraceptives
Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja u državama članicama
Belgium L.F. WILL & CIE SA Rue du Manil 80
L.F. WILL & CIE SA Rue du Manil 80 1301 Wavre Belgium
Ethinylestradiol Dienogest maxim
Dienogest Etinilestradiol maxim
Czech Republic LadeePharma Kft Lajos utca 48-66.
Rumunjska LadeePharma Kft Lajos utca 48-66
Aristo Pharma GmbH Wallenroder Straße 8
Njemačka Aristo Pharma GmbH Wallenroder Straße 8-10
de Burgos, 16-D 28036 Madrid Spain
Španjolska ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D 28036 Madrid
Janssen-Cilag GmbH Johnson & Johnson Platz 1
Njemačka Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss
Rowex Ltd Bantry Co. Cork Ireland
Rowex Ltd Bantry Co.
La Vallina s/n,
C/ La Vallina s/n, Pol.
Germany betapharm Arzneimittel GmbH Kobelweg 95
Njemačka betapharm Arzneimittel GmbH Kobelweg 95
49 avenue Georges Pompidou 92593 LEVALLOISPERRET Cedex FRANCE
Francuska SANDOZ 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Talafusova 970
WH-Pharma s.r.o. Talafusova 970
Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy
Boccioni, 1 21040 Origgio (VA) Italy
The Netherlands betapharm Arzneimittel GmbH Kobelweg 95
Nizozemska betapharm Arzneimittel GmbH Kobelweg 95
Merck Sharp and Dohme de España, S.A Josefa Valcárcel, 38 28027 Madrid Spain
Španjolska Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38
BIOGARAN 15 Bd Charles de Gaulle
Francuska BIOGARAN 15 Bd Charles de Gaulle 92700 Colombes France
1-13 boulevard Romain Rolland 75014 PARIS FRANCE
Francuska SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland 75014 Paris
LABORATOIRES CRISTERS 22, quai Galliéni 92150 SURESNES FRANCE
Francuska LABORATOIRES CRISTERS 22, quai Galliéni
Berlipharm B.V.
Nizozemska Berlipharm B.V.
via Messina 38 20154 Milano Italy
Teva Italia S.r.l. via Messina 38 20154 Milano Italy
Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78
Španjolska Actavis Group PTC ehf Reykjavikurvegi 76-78
Apothecon B.V.
Nizozemska Apothecon B.V.
S.C. SANDOZ S.R.L.
Rumunjska S.C. SANDOZ S.R.L.
Pfizer Pharma GmbH Linkstr.
Njemačka Pfizer Pharma GmbH Linkstr. 10
Slovak Republic Ratiopharm GmbH Graf-Arco-Strasse 3
Njemačka Ratiopharm GmbH Graf-Arco-Strasse 3
Bayer B.V.
Nizozemska Bayer B.V.
Paseo Pintor Rosales,
Španjolska QUALITEC EUROPA, S.L Paseo Pintor Rosales, 42
Sun-Farm Sp. z o.o.
Sun-Farm Sp. z o.o. Człekówka 75
Czech Republic Jenapharm GmbH & Co. KG
Njemačka Jenapharm GmbH & Co.
Pfizer B.V.
Nizozemska Pfizer B.V.
ARROW GENERIQUES 26 avenue Tony Garnier
Francuska Arrow Generiques 26 avenue Tony Garnier 69007 Lyon
25 Rue des peuliers 92752 NANTERRE CEDEX
Francuska ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
TEVA PHARMA S.L.U.
Španjolska TEVA PHARMA S.L.U.
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3
Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - 50131 Florence
Chemical Works of Gedeon Richter Plc., Gyömrői ut 19-21, H-1103 Budapest, Hungary
Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary
Slovak Republic Ivowen Limited 3, Anglesea Street Clonmel
Rumunjska Ivowen Limited 3 Anglesa St
Pharmaceuticals GmbH Raiffeisenstr.
Njemačka Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11
Belgium Madaus GmbH Colonia Allee 15
Španjolska MADAUS GmbH Colonia Allee 15
Jenapharm GmbH & Co. KG
Rumunjska Jenapharm GmbH & Co.
Šmartinska cesta 53 1000 Ljubljana Slovenija
Johnson & Johnson d.o.o. Šmartinska cesta 53 1000 Ljubljana Slovenija
WYETH FARMA, S.A. Ctra.
Španjolska WYETH FARMA, S.A. Ctra. de Burgos, Km 23.
Czech Republic Pharbil Waltrop GmbH Im Wirrigen 25
Njemačka Pharbil Waltrop GmbH Im Wirrigen 25
Luxembourg Gedeon Richter Plc.
Chemical Works of Gedeon Richter Plc.,
Luxembourg Teva Pharma Belgium N.V.
Luksemburg Teva Pharma Belgium N.V. Laarstraat 16
Frederic Mompou, 5 08960 Sant Just Desvern
08960 Sant Just Desvern Barcelona
Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse Belgium
JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340 Beerse Belgium
Teva Pharmaceuticals S.R.L.
Rumunjska Teva Pharmaceuticals S.R.L.
Slovak Republic Sandoz Pharmaceuticals d.d.
Sandoz Pharmaceuticals d.d. Verovškova 57
LABORATOIRES EUROGENERICS Le Quintet - bâtiment A
Le Quintet - bâtiment
Luxembourg Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Luksemburg Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Plom, 2-4, 5ª planta 08038 Barcelona Spain
Plom, 2-4, 5ª planta
Norgestimat Ethinylestradiol
Norgestimat Etinilestradiol
Alkotás street 53 MOM Park F, Budapest
Alkotás street 53 Budapest 1123
Johnson & Johnson d.o.o.
Rumunjska Johnson & Johnson d.o.o. Šmartinska cesta 53
Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul.
Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19
Slovak Republic mibe GmbH Arzneimittel
Slovačka Republika mibe GmbH Arzneimittel Münchener Str. 15
TEVA SANTE 110 Esplanade du Général de Gaulle 92931 PARIS LA DEFENSE CEDEX FRANCE
Francuska TEVA SANTE 110 Esplanade du Général de Gaulle
LABORATORIOS EFFIK, S.A.
Španjolska LABORATORIOS EFFIK, S.A. San Rafael, 3
Czech Republic Bayer Pharma AG Müllerstraße 178
Rumunjska Bayer Pharma AG Muellerstrasse 170-178
Belgium mibe GmbH Arzneimittel
Belgija mibe GmbH Arzneimittel Münchener Str. 15
Czech Republic Medico Uno Pharma Kft.
Rumunjska Medico Uno Pharma Kft.
Polígono Industrial Colón II
Polígono Industrial Colón II 08228 Tarrasa
SymPhar Sp. z o.o.
SymPhar Sp. z o.o. ul. Włoska 1
Slovak Republic Zentiva, k.s.
Španjolska Zentiva, k.s.
Etonogestrel Ethinylestradiol
Etonogestrel Etinilestradiol
Luxembourg N.V. Organon Kloosterstraat 6
N.V. Organon Kloosterstraat 6 P.O.
Cloromadinona + Etinilestradiol Actavis
Klormadinonacetat Etinilestradiol
FARMACEUTICA, S.A. Avda.
Španjolska SANDOZ FARMACEUTICA, S.A. Avda.
UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany
Njemačka UCB Pharma GmbH Alfred-Nobel-Str. 10
Czech Republic Zentiva, k.s.
Nizozemska Zentiva, k.s.
MSD France 34 avenue Léonard de Vinci
Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France
Czech Republic mibe GmbH Arzneimittel
Češka Republika mibe GmbH Arzneimittel Münchener Str. 15
Chlormadinone Ethinylestradiol
Klormadinon Etinilestradiol
Ethinylestradiol Dienogest vatrice 0,03 mg/2 mg Filmtabletten
Dienogest Etinilestradiol vatrice 0,03 mg/2 mg Filmtabletten
BRILL PHARMA, S.L.
Španjolska BRILL PHARMA, S.L. Mandri
Ethinylestradiol Drospirenon
Etinilestradiol Drospirenon
DK-2300 København S Denmark
Edward Thomsens Vej 14 DK-2300 København
Ethinylestradiol Chlormadinon acetate beatrice 0,03 mg/2 mg Filmtabletten
Klormadinon Etinilestradiol beatrice 0,03 mg/2 mg Filmtabletten
23-25 avenue du Docteur Lannelongue 75668 PARIS Cedex
75668 PARIS Cedex 14
0,02 m 0,075 mg
GESTODELLE 20 0,02 mg 0,075 mg
Ethinylestradiol Gestoden
Etinilestradiol Gestoden
Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary gestodene ethinylestradiol
28B III/5 1095 Budapest Hungary
Pfizer Hellas S.A. 243 Messoghion Avenue,
243 Messoghion Avenue, 154 51 N.
Ethinylestradiol Chlormadinon acetate eufem 2 mg/0,03 mg Filmtabletten
Klormadinon Etinilestradiol eufem 2 mg/0,03 mg Filmtabletten
1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Njemačka 1 A Pharma GmbH Keltenring 1 + 3
Germany mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany
Njemačka mibe GmbH Arzneimittel Münchener Str. 15
PHARMACEUTICALS S.L.
Španjolska MYLAN PHARMACEUTICALS S.L.
Ethinylestradiol Desogestrel
Etinilestradiol Dezogestrel
LABORATORIO STADA, S.L.
Španjolska LABORATORIO STADA, S.L. Frederic Mompou, 5
Ethinylestradiol Dienogest ladonna sanol 2 mg /0,03 mg Filmtabletten
Dienogest Etinilestradiol ladonna sanol 2 mg /0,03 mg
0,040 mg
3 mg 0,02 mg
Marszałka J.
Mester u.
Dienogest Ethinylestradiol
Dienogest Etinilestradiol
Generis Farmacêutica, S.A.
Španjolska BIAL INDUSTRIAL FARMACEUTICA, S.A.
Belgium Teva Pharma Belgium N.V.
Teva Pharma Belgium N.V. Laarstraat 16
154 51 N. Psychiko, Greece
Psychiko, Greece
Gedeon Richter România S.A.
Rumunjska Gedeon Richter România S.A. Str. Cuza-Vodă, nr. 99-105
Velvian Germany GmbH
Nizozemska Velvian Germany GmbH Carl-Zeiss-Ring 9
Teva Pharmaceuticals Polska Sp. z o.o.
Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53
ANTIN DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG
DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG
69007 LYON FRANCE
75009 Paris
Gustav III's Boulevard
Edificio Albatros B
CT Arzneimittel GmbH Graf-Arco-Str. 3
Njemačka TEVA GmbH Graf-Arco-Str.
LABORATOIRES GRUNENTHAL 19, rue Ernest Renan Immeuble Eureka 92000 Nanterre FRANCE
Nizozemska EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Włoska 1
1ª planta
Desogestrel Ethinylestradiol
Dezogestrel/ Etinylestradiol
0.03 mg / 0.04 mg 0.01mg / 0.05mg / 0.07mg
0.05 mg/0.03 mg 0.07 mg/ 0.04 mg 0.1 mg/ 0.03 mg
This was also supported by the SAG AI.
To je također podržao SAG AI.
No new safety risk was identified and the safety profile remains overall unchanged for these products.
Nije utvrđen novi sigurnosni rizik i sigurnosni profil ostaje općenito nepromijenjen za te lijekove.
However, no definite conclusion can be drawn on the efficacy in this indication.
Međutim, ne može se donijeti konačan zaključak o djelotvornosti u ovoj indikaciji.
Further in view of the size of the Buccalin tablet, it should not be used in children below 2 years of age; the indication should be revised accordingly.
Nadalje, s obzirom na veličinu tableta Buccalina, ne bi ih trebalo primjenjivati u djece mlađe od dvije godine; u skladu s tim trebalo bi revidirati indikaciju.
Depending on MS, the paediatric indication covers children from 1 year, 6 months, or without restrictions.
Ovisno o državi članici, pedijatrijska indikacija obuhvaća djecu od jedne godine, šest mjeseci ili bez ograničenja.
It is noted that serious hypersensitivity reactions may occur.
Zabilježeno je da se mogu pojaviti ozbiljne reakcije preosjetljivosti.
No robust study was conducted for Polyvaccinum and no data in adults was identified.
Za Polyvaccinum nije provedeno pouzdano ispitivanje i nisu utvrđeni podatci za odrasle.
The composition, the manufacturing, the formulation, the administered dose, the treatment schedule and the route of administration of different bacterial lysates available in human therapy are heterogeneous.
Sastav, proizvodnja, formulacija, primijenjena doza, raspored liječenja i put primjene različitih bakterijskih lizata dostupnih u liječenju ljudi raznoliki su.
Of note, the Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases does not recommend oral bacterial lysates for the management of adult LRTI (Woodhead, 2011).
Valja napomenuti da radna skupina Europskog društva za plućne bolesti i Europskog društva za kliničku mikrobiologiju i infektivne bolesti ne preporučuje oralne bakterijske lizate za upravljanje infekcijom donjeg dišnog sustava u odraslih (Woodhead, 2011).
Having reviewed the appropriateness of the formulations and pharmaceutical forms for use in the authorised paediatric populations up to 5 years of age, the CHMP considered that acceptability studies in children below the age of 5 years should be performed for Respivax, Buccalin, Ismigen, Polyvaccinum suspension for injection.
Nakon provjere prikladnosti formulacija i farmaceutskih oblika za primjenu kod odobrenih pedijatrijskih populacija u dobi do pet godina, CHMP je smatrao da bi trebalo provesti ispitivanja prihvatljivosti za djecu mlađu od pet godina za Respivax, Buccalin, Ismigen, Polyvaccinum otopinu za injekciju.