natgillin/translations-raw huggingface dataset:
Very rare side effects These may affect up to 1 in 10,000 people: • hallucinations (‘ seeing’ or ‘ hearing’ things that aren’ t really there) • confusion or agitation • feeling ‘ wobbly’ or unsteady when you move about • uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness • a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis) • in people who already have epilepsy, seizures happening more often • changes in liver function, which will show up in blood tests, or liver failure • changes which may show up in blood tests — including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia • a disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation)
Zelo redki neželeni učinki Pojavijo se lahko pri največ 1 od 10. 000 oseb: • halucinacije ("videnje" ali "slišanje" stvari, ki jih v resnici ni) • zmedenost ali vznemirjenost • občutek "majavosti" ali negotovosti, ko se gibljete naokoli • neobvladljivi gibi telesa (tiki), neobvladljivi mišični spazmi, ki prizadenejo oči, glavo in trup (horeoatetoza), ali drugi nenavadni gibi telesa, npr. trzanje, tresenje ali togost
110
•
a high temperature (fever) swell ing around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy)
pogostejši epileptični napadi pri bolnikih, ki imajo epilepsijo spremenjeno delovanje jeter, ki se kaže s spremenjenimi izvidi preiskav krvi, odpoved jeter spremembe, ki se lahko pokažejo pri preiskavah krvi, med njimi zmanjšano število rdečih krvnih celic (anemija), zmanjšano število belih krvnih celic (levkopenija, nevtropenija, agranulocitoza), zmanjšano število krvnih ploščic (trombocitopenija), zmanjšano število vseh teh vrst celic (pancitopenija) in bolezen kostnega mozga, ki jo imenujemo aplastična anemija
in people who already have Parkinson’s disease, worsening of the symptoms.
motnja strjevanja krvi, ki lahko povzroči nepričakovane krvavitve ali podplutbe (diseminirana intravaskularna koagulacija)
If you get side effects If any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
zvišana telesna temperatura (vročina) oteklost (edem) obraza ali oteklost bezgavk na vratu, v pazduhah ali dimljah (limfadenopatija) poslabšanje simptomov pri bolnikih, ki imajo Parkinsonovo bolezen
Keep Lamictal out of the sight and reach of children.
Zdravilo shranjujte nedosegljivo otrokom!
If you have any unwanted Lamictal tablets, don’t dispose of them in your waste water or your household rubbish.
Če vam ostanejo tablete Lamictal, ki jih ne potrebujete več, jih ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Take them back to your pharmacist, who will dispose of them in a way that won’t harm the environment.
Vrnite jih farmacevtu, ki jih bo odstranil tako, da ne bo škodovalo okolju.
What Lamictal tablets contain The active substance is lamotrigine.
Kaj vsebujejo tablete Lamictal Zdravilna učinkovina je lamotrigin.
What Lamictal dispersible/chewable tablets contain The active substance is lamotrigine.
Kaj vsebujejo Lamictal disperzibilne/ žvečljive tablete Zdravilna učinkovina je lamotrigin.
Each dispersible/chewable tablet contains 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
Ena disperzibilna/ žvečljiva tableta vsebuje 2 mg, 5 mg, 25 mg, 50 mg, 100 mg ali 200 mg lamotrigina.
What Lamictal tablets look like and contents of the pack Lamictal tablets (all strengths) are square with rounded corners, and pale, yellowish brown in colour.
Izgled tablet Lamictal in vsebina pakiranja Tablete Lamictal (vse jakosti) so kvadratne oblike z zaobljenimi vogali in so blede rumeno- rjave barve.
Lamictal 25 mg tablets are marked ‘GSEC7’ on one side and ‘25’ on the other.
Tablete Lamictal 25 mg imajo na eni strani oznako 'GSEC7' in na drugi strani '25'.
Lamictal 50 mg tablets are marked ‘GSEE1’ on one side and ‘50’ on the other.
107 Tablete Lamictal 50 mg imajo na eni strani oznako 'GSEE1' in na drugi strani '50'.
Lamictal 100 mg tablets are marked ‘GSEE5’ on one side and ‘100’ on the other.
Tablete Lamictal 100 mg imajo na eni strani oznako 'GSEE5' in na drugi strani '100'.
Lamictal 200 mg tablets are marked ‘GSEE7’ on one side and ‘200’ on the other.
Tablete Lamictal 200 mg imajo na eni strani oznako 'GSEE7' in na drugi strani '200'.
111 What Lamictal dispersible/chewable tablets look like and contents of the pack Lamictal dispersible/chewable tablets (all strengths) are white to off-white, and may be slightly mottled.
Izgled Lamictal disperzibilnih/ žvečljivih tablet in vsebina pakiranja Lamictal disperzibilne/ žvečljive tablete (vse jakosti) so bele do umazano bele barve in so lahko rahlo lisaste.
Lamictal 2 mg dispersible/chewable tablets are round.
Lamictal 2 mg disperzibilne/ žvečljive tablete so okrogle oblike.
They are marked ‘LTG’ above the number ‘2’ on one side; and with two ovals overlapping at right angles on the other.
Na eni strani imajo oznako 'LTG' nad številko '2', na drugi pa dve elipsi, ki se prekrivata pod pravim kotom.
Lamictal 5 mg dispersible/chewable tablets are elongated with curved sides.
Lamictal 5 mg disperzibilne/ žvečljive tablete so podolgovate oblike in imajo ukrivljene robove.
They are marked ‘GS CL2’ on one side; and ‘5’ on the other.
Na eni strani imajo oznako ‘ GS CL2 ’, na drugi strani pa oznako ‘ 5 ’.
Lamictal 25 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 25 mg disperzibilne/ žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
They are marked ‘GSCL5’ on one side; and ‘25’ on the other.
Na eni strani imajo oznako ‘ GSCL5 ’, na drugi strani pa oznako ‘ 25 ’.
Lamictal 50 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 50 mg disperzibilne/ žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
They are marked ‘GSCX7’ on one side; and ‘50’ on the other.
Na eni strani imajo oznako ‘ GSCX7 ’, na drugi strani pa oznako ‘ 50 ’.
Lamictal 100 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 100 mg disperzibilne/ žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
They are marked ‘GSCL7’ on one side; and ‘100’ on the other.
Na eni strani imajo oznako ‘ GSCL7 ’, na drugi strani pa oznako ‘ 100 ’.
Lamictal 200 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 200 mg disperzibilne/ žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
They are marked ‘GSEC5’ on one side; and ‘200’ on the other.
Na eni strani imajo oznako ‘ GSEC5 ’, na drugi strani pa oznako ‘ 200 ’.
{Name and address} < {tel} > < {fax} > < {e-mail} >
{Ime in naslov} < {tel.} > < {faks} > < {e- pošta} >
Manufacturer: < Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom. >
Izdelovalec: < Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Velika Britanija. >
Grunwaldzka 189, 60-322 Poznan, Poland. >
Grunwaldzka 189, 60- 322 Poznan, Poljska. >
< Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Germany. >
< Glaxo Wellcome GmbH & Co., Industriestrasse 32- 36, 23843 Bad Oldesloe, Nemčija. >
< GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgaria. >
< GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bolgarija. >
< Glaxo Wellcome S.A., Avda.
108 < Glaxo Wellcome S. A., Avda.
Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spain. >
Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Španija. >
This leaflet was last approved in {MM/YYYY}.
LLLL}.
112 ANNEX IV
109 DODATEK IV
CONDITION OF THE MARKETING AUTHORISATION(S)
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
113 CONDITIONS CONSIDERED ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT INCLUDING PHARMACOVIGILANCE
110 POGOJI, KI SO BISTVENI ZA VARNO IN UČINKOVITO UPORABO
The Marketing Authorisation Holder commits to timely submission of MR/national variations to implement labelling changes, which may be agreed following Pharmacovigilance Working Party (PhVWP) recommendation concerning suicidal ideation and behaviour with anti-epileptic drugs.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo pravočasno predložil vloge za spremembe v zvezi s postopkom medsebojnega priznavanja/ nacionalnim postopkom zaradi uvedbe spremenjenega označevanja, ki se lahko odobrijo na podlagi priporočila Delovne skupine za farmakovigilanco (PhVWP) glede samomorilnega razmišljanja in vedenja pri zdravilih proti epilepsiji.
114
111
Ref.
London, 23. julij 2008 Dok. ref.
EMEA/ CHMP/ 212114/ 2008
EMEA/ 476648/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Lamictal and associated names
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA ZDRAVILO Lamictal in z njim povezana imena
International Non-Proprietary Name (INN): lamotrigine
Mednarodno nelastniško ime (INN): lamotrigin
BACKGROUND INFORMATION Lamictal and associated names, 25 mg, 50 mg, 100 mg, 200 mg tablet and 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, dispersible / chewable tablet, is an antiepileptic drug, used for the treatment of epilepsy and Bipolar Disorder.
OSNOVNE INFORMACIJE Zdravilo Lamictal in z njim povezana imena, tablete v odmerkih po 25 mg, 50 mg, 100 mg, 200 mg ter disperzibilne/ žvečljive tablete v odmerkih po 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, je antiepileptik za zdravljenje epilepsije in bipolarne motnje.
On 1 March 2007, GlaxoSmithKline Research & Development Limited presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Lamictal and associated names.
Družba GlaxoSmithKline Research & Development Limited je 1. marca 2007 pri Evropski agenciji za zdravila (EMEA) sprožila napotitveni postopek v skladu s členom 30 Direktive 2001/ 83/ ES, kakor je bila spremenjena, za uskladitev nacionalno odobrenih povzetkov glavnih značilnosti zdravila (SPC), označevanj in navodil za uporabo, vključno z vidikom kakovosti zdravila Lamictal in z njim povezanih imen.
Adults and children above 12 years Lamictal is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Epilepsija Odrasli in otroci, starejši od 12 let Zdravilo Lamictal je indicirano kot dodatno zdravljenje ali monoterapija za zdravljenje epilepsije za delne ali generalizirane napade, vključno s tonično- kloničnimi napadi in napadi, povezanimi s sindromom Lennox- Gastaut.
Children 2 to 12 years Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Otroci od 2 do 12 let Zdravilo Lamictal je indicirano kot dodatna terapija za zdravljenje epilepsije za delne ali generalizirane napade, vključno s tonično- klončnimi napadi in napadi, povezanimi sindromom Lennox- Gastaut.
Adults 18 years and above Lamictal is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes.
Odrasli, stari 18 let in več Zdravilo Lamictal je indicirano za preprečevanje razpoloženjskih epizod pri bolnikih z bipolarnimi motnjami, predvsem za preprečevanje depresivnih epizod.
The list of product names concerned is given in Annex I.
Seznam zadevnih imen zdravila je naveden v Dodatku I.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Znanstveni zaključki so podani v Dodatku II, dopolnjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo pa v Dodatku III.
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansopon 15 mg and 30 mg International Non-Proprietary Name (INN):
MNENJE V ZVEZI Z NAPOTITVIJO IZ LENA 29( 2) 1 ZA Lansopon 15 mg in 30 mg Mednarodno nelastniško ime (INN):
Lansopon (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Lansopon (lansoprazol) je zaviralec protonske rpalke, ki zavira izločanje želodčne kisline in se č uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega vnetja požiralnika, Zollinger - Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve peptične razjede pri bolnikih z razjedami, povezanimi s H. pylori.
A Marketing Authorisation for Lansopon (15 mg and 30 mg) was previously granted to Hexal AG in Finland on 7 November 2003.
Dovoljenje za promet z zdravilom Lansopon (15 mg in 30 mg) je bilo prvotno dodeljeno družbi Hexal AG iz Finske 7. novembra 2003.
The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.
Referenčna država lanica je bila Finska, zadevne države lanice pa so bile Belgija, Nemčija,
The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Zadevne države lanice niso mogle doseči soglasja v zvezi z č medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je podelila referenčna država lanica.
The application was withdrawn in the Netherlands and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Vloga je bila umaknjena na Nizozemskem in Nemčija je 15. decembra 2004 Evropski agenciji č za zdravila podala razloge za nesoglasje.
The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/ Tomas Salmonson, Gottfried Kreutz/ Julia Dunne respectively.
Za poročevalca in soporočevalca so bili imenovani Sif Ormarsdottir/ Tomas Salmonson, Gottfried Kreutz/ Julia Dunne.
During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Lansopon.
Na sestanku v juniju 2005, je CHMP glede na vse predložene podatke ter znanstveno razpravo znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansopon ugodno.
Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “ Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 23 June 2005.
Odbor za zdravila za uporabo v humani medicini je izrazil strinjanje s spremembami v razdelku 4. 2 (Odmerjanje in način uporabe) Povzetka glavnih značilnosti zdravila, ki navajajo natančna priporočila glede odmerjanja za antibiotike v skladu s “ Točkami, ki jih je treba upoštevati pri sestavi besedila za zdravljenje z eradikacijo Helicobacter pylori v izbranih poglavjih Povzetka glavnih značilnosti zdravila ”, in 23. junija 2005 sprejel pozitivno mnenje.
1 Article 29(2) of Directive 2001/ 83/ EC, as amended.
1 len 29( 2) of Direktive 2001/ 83/ ES, kot je bila spremenjena.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, VLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH LANICAH Č
Invented name Lansoprazole BEXAL 15 mg
Lansoprazole BEXAL 15 mg
gélules gastro-resistantes
gélules gastro- resistantes Lansoprazole BEXAL 30 mg
Gastro-resistant capsule, hard
Gastrorezistentna kapsula, trda Peroralna uporaba
Lansoprazole BEXAL 30 mg gélules gastro-resistantes
gélules gastro- resistantes
Lansopon 15 mg, 30 mg, gastro-resistant capsules, hard were referred for arbitration according to Article 29 of Council Directive 2001/ 83/ EC, as amended, following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
Zdravilo Lansopon, 15- mg, 30- mg, gastrorezistentne kapsule, trde, je bilo napoteno na arbitražni postopek v skladu s lenom 29 Direktive Sveta 2001/ 83/ ES, kakor je bila spremenjena, zaradi zadržkov, č ki jih je predložila Nemčija v okviru postopka medsebojnega priznavanja s Finsko, ki je bila referenčna država lanica.
The concerns rose referred to discrepancies in comparison to the reference products on posology.
Zadržki so bili predloženi zaradi neskladnosti pri primerjavah z referenčnimi zdravili v č zvezi z odmerjanjem.
Lansoprazole 30 mg combined with amoxicillin 1g, clarithromycin 250 or 500 mg, or metronidazole 400 mg twice daily was associated with eradication rates ranging from 71 to 94%, and ulcer healing rates were generally > 80% in well designed studies.
V dobro zasnovanih raziskavah so z uporabo lansoprazola 30 mg v kombinaciji z amoksicilinom 1 g, klaritromicinom 250 ali 500 mg ali metronidazolom 400 mg dvakrat dnevno dokazali 71 - do 94 - odstotno stopnjo eradikacije ter običajno > 80- odstotno stopnjo zaceljenja razjede.
Triple therapies with a proton pump inhibitor, clarithromycin and either amoxycillin or metronidazole are the most widely accepted treatment for Helicobacter pylori infection.
Najbolj razširjeno zdravljenje okužbe s Helicobacter pylori je trotirno zdravljenje z zaviralcem protonske rpalke, klaritromicinom in amoksicilinom ali metronidazolom.
Combinations of lansoprazole with one or two antibiotics produced equivalent eradication of H. pylori.
S kombinacijo lansoprazola z č enim ali dvema antibiotikoma so dosegli enakovredno eradikacijo H. pylori.
Fourteen-day, proton pump inhibitor-based triple therapy achieves better results than 7-day schedules.
Štirinajstdnevno trotirno zdravljenje z zaviralcem protonske rpalke je imelo boljše rezultate kot sedemdnevno zdravljenje. č
A meta-analysis of studies comparing twice daily, one-week triple therapy with a proton pump inhibitor, clarithromycin (C) and amoxycillin (A) (PCA) vs. those using proton pump inhibitor, clarithromycin and a nitroimidazole (N) (PCN) for H. pylori eradication provided evidence in support of similar H. pylori eradication efficacy.
V meta- analizi raziskav, ki so primerjale enotedensko trotirno zdravljenje s kombinacijo zaviralca protonske rpalke, klaritromicina (C) in amoksicilina (A) (PCA) ter kombinacijo zaviralca protonske č rpalke, klaritromicina in nitroimidazola (N) (PCN) za eradikacijo H. pylori z odmerki dvakrat dnevno, č so ugotovili podobno učinkovitost eradikacije H. pylori.
The combination of lansoprazole with antibiotics either as double or triple therapy has demonstrated an H. pylori eradication rate of between 80 and 90%.
Za kombinacijo lansoprazola z antibiotiki v dvotirnem ali trotirnem zdravljenju je bila dokazana stopnja eradikacije H. pylori v razponu med 80 in 90%.
Triple therapy allows the eradication of H. pylori in more than 85% of cases in patients with peptic ulcer.
S trotirnim zdravljenjem dosežemo eradikacijo H. pylori pri več kot 85% bolnikov z želodčno razjedo.
Benefit/ Risk considerations
Obravnavanje razmerja med koristmi in tveganji
Available data support the use of lansoprazole-amoxicillin-clarithromycin as a first-line treatment.
Razpoložljivi podatki podpirajo uporabo kombinacije lansoprazol- amoksicilin- klaritromicin kot prvenstvenega zdravljenja.
In case of clarithromycin resistance, or treatment failure, the combination of lansoprazole-amoxicillin- metronidazole may be used, and in case of beta-lactam allergy the combination of lansoprazole- clarithromycin-metronidazole is advisable.
V primeru odpornosti proti klaritromicinu ali kadar je zdravljenje neuspešno, je priporočljiva uporaba kombinacije lansoprazol- amoksicilin- metronidazol.
The risk/ benefit ratio of Lansopon 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
Razmerje med tveganji in koristmi zdravila Lansopon 15 mg, 30 mg velja za ugodno pod pogojem, da se ustrezni podatki v zvezi z eradikacijskim zdravljenjem H. pylori vključijo v Povzetek glavnih značilnosti zdravila.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas, The scope of the referral was to agree on a Summary of Products Characteristics in view of the posology for eradication therapy for H. pylori The Summary of Products Characteristic proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA Ker je bil namen napotitve uskladiti Povzetek glavnih značilnosti zdravila glede odmerjanja pri eradikacijskem zdravljenju H. pylori je bil Povzetek glavnih značilnosti zdravila, ki ga je predlagal vlagatelj, ovrednoten na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
4 the CHMP has recommended the granting of the Marketing Authorisations with amendments of the Summary of Product Characteristics as set out in Annex III for Lansopon and associated names (see Annex I).
4 je Odbor za zdravila za uporabo v humani medicini priporočil odobritev dovoljenj za promet z zdravilom s spremembami Povzetka glavnih značilnosti zdravila, kakor je opredeljeno v Dodatku III za Lansopon in povezana imena (glejte Dodatek I).
5 ANNEX III
5 DODATEK III
AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
SPREMENJEN POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
This SPC is the one that was Annexed to the Commission Decision on this Article 29 referral for lansoprazole containing medicinal products.
Ta Povzetek glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s lenom 29, za zdravila, ki vsebujejo lansoprazol.
The text was valid at that time.
Besedilo č je bilo takrat veljavno.
After the Commission Decision, the Member State competent authorities will update the product information as required.
Pristojne oblasti držav lanic bodo podatke o izdelku posodobile v skladu z zahtevami, ko bo č podana odločba Komisije.
NAME OF THE MEDICINAL PRODUCT Lansoprazole and associated names (see Annex I), 15 mg gastro-resistant capsule, hard Lansoprazole and associated names (see Annex I), 30 mg gastro-resistant capsule, hard
Lansoprazol in povezana imena (glejte Dodatek I), 15 mg trde gastrorezistentne kapsule Lansoprazol in povezana imena (glejte Dodatek I), 30 mg trde gastrorezistentne kapsule
4.1 Therapeutic Indications
4. 1 Terapevtske indikacije
• Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography. • Treatment of reflux oesophagitis. • Long-term prophylaxis of reflux oesophagitis. • Eradication of Helicobacter pylori concurrently given with appropriate antibiotic therapy and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.. • Zollinger-Ellison syndrome.
• Zdravljenje endoskopsko ali radiografsko potrjenih razjed dvanajstnika in želodca. • Zdravljenje refluksnega ezofagitisa. • Dolgotrajna profilaksa refluksnega ezofagitisa. • Eradikacija Helicobacter pylori pri sočasnem zdravljenju z ustreznimi antibiotiki in preprečevanje ponovitve želodčne razjede pri bolnikih z razjedami, povezanimi s H. pylori. • Zollinger- Ellisonov sindrom.
Posology and Method of Administration
4. 2 Odmerjanje in način uporabe