natgillin/translations-raw huggingface dataset:
- You have a gastric ulcer or you take medicines that can irritate your stomach such as medicines against inflammations, since gastric reactions have been reported with Wakix.
Kaj je zdravilo Wakix in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Wakix Kako jemati zdravilo Wakix Možni neželeni učinki
Microcrystalline cellulose Crospovidone type A Talc
6.1 Seznam pomožnih snovi Jedro tablete mikrokristalna celuloza krospovidon tipa A smukec magnezijev stearat koloidni brezvodni silicijev dioksid
White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side.
Wakix 4,5 mg filmsko obložene tablete bela okrogla bikonveksna filmsko obložena tableta s premerom 3,7 mm in oznako „5“ na eni strani
Asthenia Chest Pain Feeling Abnormal Malaise Oedema Peripheral oedema
Splošne težave in spremembe na mestu aplikacije utrujenost astenija bolečina v prsnem košu nenormalno počutje splošno slabo počutje edem periferni edem bolečina nočno potenje občutek pobitosti
Nausea Vomiting Dyspepsia
Bolezni sečil polakisurija
Gastrooesophageal reflux disease Gastritis Gastrointestinal pain Hyperacidity Paraesthesia oral Stomach discomfort
Bolezni prebavil navzea bruhanje dispepsija suha usta bolečina v trebuhu driska neugodje v trebuhu bolečina v zgornjem delu trebuha zaprtost gastroezofagealna refluksna bolezen gastritis bolečina v prebavilih čezmerna želodčna kislina oralna parestezija neugodje v želodcu napihnjenost trebuha disfagija flatulenca odinofagija enterokolitis
- Are breastfeeding.
- Navodilo shranite.
Decreased appetite Increased appetite Fluid retention
Presnovne in prehranske motnje zmanjšan tek povečan tek zastajanje tekočine anoreksija hiperfagija motnje teka
Wakix 4.5 mg film-coated tablet
Wakix 4,5 mg tableta
Toxic skin eruption Photosensitivity
Bolezni kože in podkožja eritem srbenje izpuščaj hiperhidroza potenje toksični kožni izbruh občutljivost na svetlobo
Musculoskeletal and connective tissue disorders
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica tinitus
The applicant presented data on experimental models from the scientific literature.
Predlagatelj je predstavil podatke o poskusnih modelih iz znanstvene literature.
It is available as white round tablets (10 and 20 mg).
Na voljo je v obliki belih, okroglih tablet (10 in 20 mg).
The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Priporočeni vzdrževalni odmerek znaša od 10 do 20 mg enkrat na dan pri bolnikih z revmatoidnim artritisom ter 20 mg enkrat na dan pri bolnikih s psoriatičnim artritisom.
The full EPAR for Leflunomide ratiopharm can be searched for 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 Leflunomide ratiopharm je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide ratiopharm on 29 November 2010.
Evropska komisija je dovoljenje za promet z zdravilom Leflunomide ratiopharm, veljavno po vsej Evropski uniji, izdala 29. novembra 2010.
This means that Leflunomide ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Arava.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leflunomide ratiopharm.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Leflunomide ratiopharm treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Zdravljenje z zdravilom Leflunomide ratiopharm se začne z „udarnim odmerkom“ 100 mg enkrat na dan tri dni zapored, čemur sledi jemanje vzdrževalnega odmerka.
This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Leflunomide ratiopharm.
For more information about treatment with Leflunomide ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Leflunomide ratiopharm preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.
Zdravnik mora opraviti krvne preiskave za pregled delovanja jeter, števila belih krvnih celic in krvnih ploščic, preden predpiše zdravilo Leflunomide ratiopharm in nato v rednih časovnih presledkih med zdravljenjem.
With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Zaradi manjšega števila prisotnih limfocitov je manjše tudi vnetje, kar pomaga pri nadzoru simptomov artritisa.
Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Zdravilo Leflunomide ratiopharm se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča nastajanje rdečih in luskinastih zaplat na koži ter vnetje sklepov).
Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Leflunomid to doseže z zaviranjem encima, imenovanega „dihidroorotat-dehidrogenaza“, ki je potreben za razmnoževanje limfocitov.
Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Ker je zdravilo Leflunomide ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Zdravljenje z zdravilom Leflunomide ratiopharm mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega artritisa in psoriatičnega artritisa.
It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Zdravilo zmanjšuje vnetje tako, da zmanjša tvorjenje imunskih celic, imenovanih „limfociti“, ki so vzrok za vnetje.
The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharm has been shown to have comparable quality and to be bioequivalent to Arava.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Leflunomide ratiopharm primerljivo raven kakovosti kot zdravilo Arava ter da mu je biološko enakovredno.
Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Arava, odtehtajo znana tveganja.
What are the benefits and risks of Leflunomide ratiopharm?
Kakšne so koristi in tveganja, povezani z zdravilom Leflunomide ratiopharm?
Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Ker je zdravilo Leflunomide ratiopharm generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Arava.
Leflunomide ratiopharm is a ‘generic medicine'.
Leflunomide ratiopharm je „generično zdravilo“.
The Committee recommended that Leflunomide ratiopharm be given marketing authorisation.
Priporočil je, da se za zdravilo Leflunomide ratiopharm izda dovoljenje za promet.
Leflunomide ratiopharm is a medicine that contains the active substance leflunomide.
Leflunomide ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino leflunomid.
Other information about Leflunomide ratiopharm
Druge informacije o zdravilu Leflunomide ratiopharm
The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant.
Zdravilna učinkovina zdravila Leflunomide ratiopharm, leflunomid, je zdravilo za zaviranje imunske odzivnosti.
Why has Leflunomide ratiopharm been approved?
Zakaj je bilo zdravilo Leflunomide ratiopharm odobreno?
How has Leflunomide ratiopharm been studied?
Kako je bilo zdravilo Leflunomide ratiopharm raziskano?
How is Leflunomide ratiopharm used?
Kako se zdravilo Leflunomide ratiopharm uporablja?
What is Leflunomide ratiopharm used for?
Za kaj se zdravilo Leflunomide ratiopharm uporablja?
What is Leflunomide ratiopharm?
Kaj je zdravilo Leflunomide ratiopharm?
How does Leflunomide ratiopharm work?
Kako zdravilo Leflunomide ratiopharm deluje?
The name of the medicine was changed to Adcirca on 21 October 2009.
Ime zdravila je bilo 21. oktobra 2009 spremenjeno v Adcirca.
What measures are being taken to ensure the safe and effective use of Adcirca?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Adcirca?
What benefit has Adcirca shown during the studies?
Kakšne koristi je zdravilo Adcirca izkazalo med študijami?
Before treatment, the patients could walk an average of 343 metres in six minutes.
Pred zdravljenjem so bolniki v šestih minutah povprečno lahko prehodili 343 metrov.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom potrebi lahko poveča glede na njihov odziv.
Previously known as Tadalafil Lilly.
Prej znano kot Tadalafil Lilly.
The full EPAR for Adcirca 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 Adcirca je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly on 1 October 2008.
Evropska komisija je dovoljenje za promet z zdravilom Tadalafil Lilly, veljavno po vsej Evropski uniji, izdala 1. oktobra 2008.
Other information about Adcirca
Druge informacije o zdravilu Adcirca
Adcirca is taken as two tablets (40 mg) once a day, with or without food.
Zdravilo se jemlje v odmerku dveh tablet (40 mg) enkrat na dan s hrano ali brez nje.
The main measure of effectiveness was the change in exercise capacity (the ability to carry out physical activity) measured by the distance the patients could walk in six minutes after 16 weeks of treatment.
Glavno merilo učinkovitosti je bilo izboljšanje telesne zmogljivosti (sposobnosti opravljanja telesne dejavnosti), izmerjeno na podlagi razdalje, ki so jo bolniki lahko prehodili v šestih minutah po 16 tednih zdravljenja.
What is the risk associated with Adcirca?
Kakšna tveganja so povezana z zdravilom Adcirca?
The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Razred odraža resnost bolezni: razred II pomeni rahlo omejitev telesne zmogljivosti, razred III pa znatno omejitev telesne zmogljivosti.
Adcirca is used in patients with class II or III disease.
Zdravilo se uporablja pri bolnikih z boleznijo razreda II ali III.
The CHMP decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Adcirca večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
A risk management plan has been developed to ensure that Adcirca is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Adcirca je bil pripravljen načrt obvladovanja tveganj.
Adcirca was more effective than placebo at improving exercise capacity.
Zdravilo Adcirca je bilo pri izboljšanju telesne zmogljivosti učinkovitejše od placeba.
This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Cialis, ki je bilo izdano leta 2002 (uporaba dokumentacije s soglasjem).
After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.
Po 16 tednih se je pri bolnikih, ki so jemali 40-miligramski odmerek zdravila Adcirca, ta razdalja povečala za 26 metrov več kot pri tistih, ki so jemali placebo.
The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).
Najpogostejši neželeni učinki zdravila Adcirca (opaženi pri več kot 1 bolniku od 10) so glavobol, zardevanje (pordelost kože), nazofaringitis (vnetje nosu in grla), vključno z zamašenim nosom ali izcedkom iz nosu in zamašenimi sinusi, navzeja (slabost), dispepsija (zgaga), vključno z bolečinami v želodcu, mialgija (bolečine v mišicah), bolečine v hrbtu in okončinah (rokah, dlaneh, nogah in stopalih).
For more information about treatment with Adcirca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Adcirca preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Adcirca is a medicine that contains the active substance tadalafil.
Adcirca je zdravilo, ki vsebuje zdravilno učinkovino tadalafil.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adcirca, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
This is a summary of the European public assessment report (EPAR) for Adcirca.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Adcirca.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adcirca.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Adcirca is not recommended for patients with severe kidney or liver problems.
Zdravilo Adcirca ni priporočeno za bolnike z resnimi težavami z ledvicami ali jetri.
Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Zdravilo Adcirca se uporablja za zdravljenje odraslih bolnikov s pljučno arterijsko hipertenzijo (PAH) za izboljšanje telesne zmogljivosti (sposobnosti izvajanja telesne dejavnosti).
Why has Adcirca been approved?
Zakaj je bilo zdravilo Adcirca odobreno?
The active substance in Adcirca, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Zdravilna učinkovina v zdravilu Adcirca, tadalafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5), kar pomeni, da zavira encim PDE5.
Adcirca must not be used in patients who have had an acute myocardial infarction (sudden heart attack) within the last three months, or who have severe hypotension (low blood pressure).
Zdravilo se ne sme se uporabljati pri bolnikih, ki so v zadnjih treh mesecih doživeli akutni miokardni infarkt (nenaden srčni napad) ali ki imajo hudo hipotenzijo (nizek krvni tlak).
This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Povečan tlak zniža količino kisika, ki lahko pride v kri v pljučih, zaradi česar je telesna dejavnost otežena.
Patients with mild or moderate kidney or liver problems should start with a lower dose, but this can be increased if
Bolniki z blagimi ali zmernimi težavami z ledvicami ali jetri naj začnejo zdravljenje z nižjim odmerkom, ki pa se po
Adcirca treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Zdravljenje z zdravilom Adcirca sme uvesti in nadzorovati le zdravnik, ki ima izkušnje z zdravljenjem pljučne arterijske hipertenzije.
Adcirca must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (another medicine to treat pulmonary hypertension).
Zdravilo Adcirca se ne sme jemati z nitrati (skupino zdravil za zdravljenje angine pektoris) ali z zdravili razreda spodbujevalcev gvanilat ciklaze, kot je riocigvat (drugo zdravilo za zdravljenje pljučne hipertenzije).
For the full list of all side effects and restrictions with Adcirca, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Adcirca glejte navodilo za uporabo.
Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) have been compared with placebo (a dummy treatment) in one main study involving 406 patients with PAH, most of whom had class II or class III disease that was of unknown cause or caused by collagen vascular disease.
Štiri odmerke zdravila Adcirca (2,5, 10, 20 in 40 mg enkrat na dan) so primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v katero je bilo vključenih 406 bolnikov s pljučno arterijsko hipertenzijo.
It must not be used in patients who have ever had loss of vision because of a problem called nonarteritic anterior ischaemic optic neuropathy (NAION) that affects the blood flow to the nerve in the eye.
Zdravilo se ne sme uporabljati pri bolnikih, ki so v preteklosti izgubili vid zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), ki vpliva na dotok krvi v očesni živec.
In patients with PAH, Adcirca widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Pri bolnikih s pljučno arterijsko hipertenzijo zdravilo Adcirca razširi krvne žile v pljučih, kar zmanjša krvni tlak in izboljša simptome.
Adcirca has been shown to be effective in PAH with no identified cause and in PAH caused by collagen vascular disease.
Zdravilo Adcirca se je izkazalo za učinkovito pri pljučni hipertenziji brez opredeljenega vzroka in pri pljučni hipertenziji, katere vzrok je sistemska bolezen veziva.
It causes high blood pressure in the vessels taking blood from the heart to the lungs.
To povzroči zelo visok krvni tlak v žilah, po katerih se kri pretaka iz srca v pljuča.
How has Adcirca been studied?
Kako je bilo zdravilo Adcirca raziskano?
What is Adcirca used for?
Za kaj se zdravilo Adcirca uporablja?
How is Adcirca used?
Kako se zdravilo Adcirca uporablja?
What is Adcirca?
Kaj je zdravilo Adcirca?
How does Adcirca work?
Kako zdravilo Adcirca deluje?
Under these conditions the ability to react may be decreased.
V takih pogojih je zmožnost reagiranja lahko zmanjšana.
Rare (0.01-0.1%)
Redki (0,01-0,1 %)
Common (>1%)
Pogosti (> 1 %)
This should be taken into account when driving or using machines.
Pri vožnji in uporabi strojev je treba to upoštevati.
Titanium dioxide (E 171)
Titanov dioksid (E 171)
(see section 4.8 Undesirable effects).
(glejte poglavje 4.8 Neželeni učinki).
Aluminium/Aluminium blister (Alu/OPA/PVC/PE)
Pretisni omot iz aluminija/aluminija (Alu/OPA/PVC/PE)
However, in order to avoid treatment failure, local antibacterial resistance patterns and local guidelines should be considered.
Za preprečitev neuspešnega zdravljenja je treba upoštevati lokalne vzorce antibakterijske rezistence in lokalne smernice.
Consideration should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.
Bodite pozorni na uradne smernice (npr. državna priporočila) glede bakterijske rezistence in ustrezne uporabe ter predpisovanja antibakterijskih sredstev.
Each hard capsule contains 15 or 30 mg lansoprazole.
Vsaka trda kapsula vsebuje 15 ali 30 mg lansoprazola.
The capsules may be emptied, but the contents may not be chewed or ground.
Kapsule se lahko izpraznijo, vendar se njihove vsebine ne sme žvečiti ali zdrobiti.
dry mouth or throat,
suha usta ali žrelo,
Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough benefit risk assessment should regularly be performed in these patients (see “5.3 Preclinical safety data”).
Zaradi omejenih podatkov o varnosti bolnikov na vzdrževalnem zdravljenju, ki traja dlje kot eno leto, je treba redno ocenjevati zdravljenje in opraviti temeljito oceno tveganja in koristi (glejte 5.3 Predklinični podatki o varnosti).
Interaction with Other Medicinal Products and Other Forms of Interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 and 250 capsules
7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 in 250 kapsul
If visual disturbances occur during long-term use (>1 year), an ophthalmologist should be consulted.
Če se pri dolgotrajni uporabi (> 1 leto) pojavijo motnje vida, se je treba posvetovati z okulistom.
2, 7, 10, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 and 250 capsules
2, 7, 10, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 in 250 kapsul
Bioavailability after a single dose of 30 mg and after repeated daily administration is 80-90%.
Biološka razpoložljivost po enkratnem 30-miligramskem odmerku in po ponavljajoči se dnevni uporabi je 80-90 %.
The dose should be individually adjusted and the treatment should be continued for as long as necessary.
Odmerek je treba prilagoditi vsakemu bolniku posebej in zdravljenje nadaljevati, dokler je potrebno.
15 mg once daily.
15 mg enkrat dnevno.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, VLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Eradication of Helicobacter pylori:
Eradikacija Helicobacter pylori:
Preliminary data suggest that lansoprazole-based eradication therapy is effective in children and the elderly.
Predhodni podatki nakazujejo, da je eradikacijsko zdravljenje na osnovi lansoprazola učinkovito pri otrocih in starostnikih.
Lansoprazole is not recommended in children as safety and efficacy have not been established in this population.
Uporabo lansoprazola pri otrocih odsvetujemo, saj njegova varnost in učinkovitost v tej populaciji še ni ugotovljena.
Undesirable Effects
Neželeni učinki).
Elderly: Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements.
Starejše osebe: Zaradi podaljšanega izločanja lansoprazola, bo pri starejših osebah morda treba zdravljenje razdeliti v odmerke po 15-30 mg, glede na potrebe posameznika.