natgillin/translations-raw huggingface dataset:
Your doctor will decide whether you can take Losec if you are breastfeeding.
Zdravnik bo presodil, ali lahko jemljete zdravilo Losec, če dojite.
56 x 1 tablets (10 mg and 20 mg only) 100 x 1 (20 mg only)
56 x 1 tableta (samo 10 mg in 20 mg) 100 x 1 tableta (samo 20 mg)
10 mg: Each gastro-resistant tablet contains 19-20 mg sucrose.
10 mg: ena gastrorezistentna tableta vsebuje 19-20 mg saharoze.
• if you are taking a medicine containing nelfinavir (for HIV infection).
• če jemljete kakšno zdravilo, ki vsebuje nelfinavir (za okužbo s HIV).
Do not take Losec if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Ne jemljite zdravila Losec, če jemljete kakšno zdravilo, ki vsebuje nelfinavir (uporablja se za zdravljenje okužbe s HIV).
40 mg 7, 14, 15, 28, 30 capsules.
40 mg 7, 14, 15, 28, 30 kapsul.
PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant tablets
FARMACEVTSKA OBLIKA gastrorezistentna tableta
BOTTLE LABEL
NALEPKA PLASTENKE
Carton for blister and wallet: Store in the original package in order to protect from moisture.
Škatla za pretisni omot in ovojnino: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
affects 1 to 10 users in 10,000
pojavijo se pri 1 do 10 od 10.000 uporabnikov
84 tablets (10 mg and 20 mg only) 90 tablets (10 mg and 20 mg only) 98 tablets (20 mg only) 100 tablets
84 tablet (samo 10 mg in 20 mg) 90 tablet (samo 10 mg in 20 mg) 98 tablet (samo 20 mg) 100 tablet
Vial of active substance
SEZNAM POMOŽNIH SNOVI
Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk For the prevention of NSAID associated gastric ulcers or duodenal ulcers in patients at risk (age> 60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is Losec 20 mg once daily.
Za preprečevanje razjed na želodcu ali razjed na dvanajstniku, povezanih z uporabo NSAID pri ogroženih bolnikih (starost > 60 let, anamneza razjed na želodcu ali dvanajstniku, anamneza krvavitev v zgornjem delu prebavil) je priporočeni odmerek 20 mg zdravila Losec enkrat na dan.
140 tablets (10 mg and 20 mg only) 200 tablets (20 mg only) 280 tablets (20 mg only)
140 tablet (samo 10 mg in 20 mg) 200 tablet (samo 20 mg) 280 tablet (samo 20 mg)
Pack sizes: Vials 1x40 mg, 5x40 mg and 10x40 mg.
Velikosti pakiranj: viale 1 x 40 mg, 5 x 40 mg, 10 x 40 mg.
The plasma elimination half-life of omeprazole is usually shorter than one hour both after single and repeated once-daily dosing.
Eliminacijski razpolovni čas omeprazola v plazmi je po navadi krajši od ene ure, tako po enkratni kot po večkratni uporabi enkrat na dan. Omeprazol se med odmerki popolnoma odstrani iz plazme.
Losec 20 mg gastro-resistant tablets: Pink, oblong, biconvex, film-coated tablets, engraved with or on one side and 20 mg on the other side containing enteric coated pellets.
Losec 20 mg gastrorezistentne tablete: rožnate, podolgovate, bikonveksne filmsko obložene tablete z vtisnjeno oznako ali na eni strani in 20 mg na drugi strani; tablete vsebujejo gastrorezistentne kroglice.
HOW TO TAKE LOSEC
KAKO JEMATI ZDRAVILO LOSEC
5 vials x40 mg
5 vial x 40 mg
20 mg: Each gastro-resistant tablet contains 19-20 mg sucrose.
20 mg: ena gastrorezistentna tableta vsebuje 19-20 mg saharoze.
• if you are taking a medicine containing nelfinavir (used for HIV infection).
• če jemljete kakšno zdravilo, ki vsebuje nelfinavir (uporablja se pri okužbi s HIV).
• The usual dose is 20 mg once a day for 4-8 weeks.
• Običajen odmerek je 20 mg enkrat na dan od 4 do 8 tednov.
20 mg: Each capsule contains 8 mg lactose.
20 mg: ena kapsula vsebuje 8 mg laktoze.
50 tablets (10 mg and 20 mg only) 56 tablets (20 mg only) 100 tablets
50 tablet (samo 10 mg in 20 mg) 56 tablet (samo 20 mg) 100 tablet
• The usual dose is 60 mg daily.
• Običajen odmerek je 60 mg enkrat na dan.
• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.
• Če se vam razjeda ne pozdravi povsem, je odmerek mogoče povečati na 40 mg enkrat na dan za
40 mg: Each capsule contains 9 mg lactose.
40 mg: ena kapsula vsebuje 9 mg laktoze.
Losec 40 mg gastro-resistant tablets: Dark red-brown, oblong, biconvex, film-coated tablets, engraved with or on one side and 40 mg and a score on the other side containing enteric coated pellets.
Losec 40 mg gastrorezistentne tablete: temnordečerjave, podolgovate, bikonveksne filmsko obložene tablete z vtisnjeno oznako ali na eni strani ter 40 mg in prelomno zarezo na drugi strani; tablete vsebujejo gastrorezistentne kroglice.
20 mg 7, 14, 15, 28, 30, 50, 60, 84 capsules.
20 mg 7, 14, 15, 28, 30, 50, 60, 84 kapsul.
In patients with poorly responsive duodenal ulcer Losec 40 mg once daily is recommended and healing is usually achieved within four weeks.
Za bolnike, pri katerih se razjeda na dvanajstniku slabo odzove, je priporočeni odmerek 40 mg zdravila Losec enkrat na dan in ozdravitev je navadno dosežena v štirih tednih.
10 mg: Each gastro-resistant tablet contains 10.3 mg omeprazole magnesium equivalent to 10 mg omeprazole.
10 mg: ena gastrorezistentna tableta vsebuje 10,3 mg magnezijevega omeprazolata, kar ustreza 10 mg omeprazola.
In patients with poorly responsive gastric ulcer Losec 40 mg once daily is recommended and healing is usually achieved within eight weeks.
Za bolnike, pri katerih se razjeda na želodcu slabo odzove, je priporočeni odmerek 40 mg zdravila Losec enkrat na dan in ozdravitev je navadno dosežena v osmih tednih.
Losec gastro-resistant tablets contain omeprazole magnesium corresponding to 10 mg, 20 mg or 40 mg omeprazole.
Gastrorezistentne tablete Losec vsebujejo magnezijev omeprazolat, ki ustreza 10 mg, 20 mg ali 40 mg omeprazola.
Losec 10 mg gastro-resistant tablets: Light-pink, oblong, biconvex, film-coated tablets engraved with or on one side and 10 mg on the other side containing enteric coated pellets.
Losec 10 mg gastrorezistentne tablete: svetlorožnate, podolgovate, bikonveksne filmsko obložene tablete z vtisnjeno oznako ali na eni strani in 10 mg na drugi strani; tablete vsebujejo gastrorezistentne kroglice.
Combination with two antibiotics: Losec 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administrated two times daily for one week.
Kombinacija dveh antibiotikov: Losec 20 mg, amoksicilin 1 g in klaritromicin 500 mg se vsi uporabljajo dvakrat na dan en teden.
This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach.
Kapsul ne grizite in ne drobite: vsebujejo namreč obložene kroglice, ki preprečijo, da bi kislina v želodcu razgradila zdravilo.
• Losec 10 mg capsules have a pink body, marked 10 and a pink cap marked A/OS.
• Kapsule Losec 10 mg imajo rožnato telo, na katerem je oznaka 10, in rožnat pokrovček, na katerem je oznaka A/OS.
What Losec contains
DODATNE INFORMACIJE Kaj vsebuje zdravilo Losec
20 mg: Each capsule contains 20 mg omeprazole.
20 mg: ena kapsula vsebuje 20 mg omeprazola.
To prevent the duodenal and stomach ulcers from coming back:
Za preprečitev ponovitve razjede na dvanajstniku ali želodcu:
40 mg: 25 x 1, 28 x 1, 50 x 1 tablets.
40 mg: 25 x 1, 28 x 1, 50 x 1 tablet.
• Do not use Losec after the expiry date which is stated on the label and carton after EXP.
• Zdravila Losec ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP .
Losec gastro-resistant tablets contain omeprazole magnesium corresponding to 10 mg or 20 mg omeprazole.
Gastrorezistentne tablete Losec vsebujejo magnezijev omeprazolat, ki ustreza 10 mg ali 20 mg omeprazola.
10 mg: hard gelatine capsules with an opaque pink body, marked 10 and an opaque pink cap marked A/OS, containing enteric coated pellets.
10 mg: trde želatinske kapsule z neprosojnim rožnatim telesom, označenim z 10, in neprosojnim rožnatim pokrovčkom, označenim z A/OS, ki vsebujejo gastrorezistentne kroglice.
• The usual dose is 20 mg once a day for 2 weeks.
• Običajen odmerek je 20 mg enkrat na dan 2 tedna.
20 mg: hard gelatine capsules with an opaque pink body, marked 20 and an opaque reddish-brown cap marked A/OM, containing enteric coated pellets.
20 mg: trde želatinske kapsule z neprosojnim rožnatim telesom, označenim z 20, in neprosojnim rdečkastorjavim pokrovčkom, označenim z A/OM, ki vsebujejo gastrorezistentne kroglice.
This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach.
Tablet ne grizite in jih ne drobite: vsebujejo namreč obložene kroglice, ki preprečijo, da bi kislina v želodcu razgradila zdravilo.
NOTE: Steps 1 to 5 must be performed in immediate sequence:
OPOZORILO: Korake od 1 do 5 je treba opraviti takoj enega za drugim: Z brizgo potegnite ves vehikel iz ampule (10 ml).
Losec gastro-resistant tablets contains the active substance omeprazole.
Zdravilo Losec gastrorezistentne tablete vsebuje zdravilno učinkovino omeprazol.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
• Losec 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each twice daily for one week or
• Losec 20 mg + 250 mg (alternativno 500 mg) klaritromicina + 400 mg metronidazola (ali
10 mg: Each capsule contains 10 mg omeprazole.
10 mg: ena kapsula vsebuje 10 mg omeprazola.
10 mg: Each capsule contains 4 mg lactose.
10 mg: ena kapsula vsebuje 4 mg laktoze.
Therefore, if any of the following happen to you before you start taking Losec or while you are taking it, talk to your doctor straight away:
Zato se morate takoj posvetovati s svojim zdravnikom, če se vam kaj od naštetega zgodi pred začetkom jemanja zdravila Losec ali medtem, kot jemljete to zdravilo:
40 mg: Each capsule contains 40 mg omeprazole.
40 mg: ena kapsula vsebuje 40 mg omeprazola.
Losec and associated names (see Annex I) 10 mg Losec and associated names (see Annex I) 20 mg
Losec in povezana imena (glejte Dodatek I) 10 mg Losec in povezana imena (glejte Dodatek I) 20 mg
If needed the dose can be increased to Losec 40 mg once daily.
Če je treba, je odmerek mogoče povečati na 40 mg zdravila Losec enkrat na dan.
• You are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• Če 4 tedne ali več stalno jemljete zdravila za ublažitev simptomov težav z želodcem ali zgage.
Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together.
Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je povprečno zavrtje agregacije trombocitov (IPA) zmanjšalo za 47 % (24 ur) oz. 30 % (5. dan).
• The usual dose is 20 mg Losec twice a day for one week.
• Običajen odmerek je 20 mg zdravila Losec dvakrat na dan en teden.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.
• Zdravnik vam bo predpisal tudi dva izmed naslednjih treh antibiotikov: amoksicilin,
Each capsule contains 40 mg omeprazole.
Ena kapsula vsebuje 40 mg omeprazola.
Each gastro-resistant tablet contains 20 mg omeprazole.
Ena gastrorezistentna tableta vsebuje 20 mg omeprazola.
Intravenous omeprazole produces a dose dependent inhibition of gastric acid secretion in humans.
Intravenski omeprazol pri človeku povzroči od odmerka odvisno zavrtje izločanja želodčne kisline.
Each capsule contains 20 mg omeprazole.
Ena kapsula vsebuje 20 mg omeprazola.
• The usual dose is 20 mg once a day for 4 weeks.
• Običajen odmerek je 20 mg enkrat na dan 4 tedne.
Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.
Zdravljenje simptomatske gastroezofagealne refluksne bolezni Priporočeni odmerek je 20 mg zdravilaLosec na dan. Bolniki se lahko ustrezno odzovejo na odmerek 10 mg na dan, zato je treba odmerek prilagoditi individualno.
Each gastro-resistant tablet contains 40 mg omeprazole.
Ena gastrorezistentna tableta vsebuje 40 mg omeprazola.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product not subject to medical prescription.
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
• Losec 40 mg capsules have a reddish-brown body marked 40 and a reddish-brown cap marked A/OL.
• Kapsule Losec 40 mg imajo rdečkastorjavo telo, na katerem je oznaka 40, in rdečkastorjav pokrovček, na katerem je oznaka A/OL.
PACKAGE LEAFLETs For medicinal products available on prescription
NAVODILA ZA UPORABO Za zdravila, ki se izdajajo na zdravniški recept
Each vial of powder for solution for injection contains omeprazole sodium equivalent to 40 mg of omeprazole.
Ena viala praška za raztopino za injiciranje vsebuje natrijev omeprazolat, ki ustreza 40 mg omeprazola.
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - izpolni država članica]
o Blisters of 7, 14, 15, 28 or 30 capsules.
o Pretisni omoti s 7, 14, 15, 28 ali 30 kapsulami.
• They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
• 4 tedne ali več stalno jemljejo zdravila za ublažitev simptomov težav z želodcem ali zgage
20 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets.
20 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablet.
Each vial of powder for solution for infusion contains omeprazole sodium equivalent to 40 mg of omeprazole.
Ena viala praška za raztopino za infundiranje vsebuje natrijev omeprazolat, ki ustreza 40 mg omeprazola.
40 mg: hard gelatine capsules with an opaque reddish-brown body, marked 40 and an opaque reddishbrown cap marked A/OL, containing enteric coated pellets.
40 mg: trde želatinske kapsule z neprosojnim rdečkastorjavim telesom, označenim s 40, in neprosojnim rdečkastorjavim pokrovčkom, označenim z A/OL, ki vsebujejo gastrorezistentne kroglice.
Therefore, if any of the following happen to you before you are given Losec or after you are given it, talk to your doctor straight away:
Zato se morate takoj posvetovati s svojim zdravnikom, če se vam kaj od naštetega zgodi, preden dobite zdravilo Losec ali potem, ko ste ga dobili:
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Omeprazole like other proton pump inhibitors must not be used concomitantly with nelfinavir (see section 4.5).
Tako kot drugih zaviralcev protonske črpalke se tudi omeprazola ne sme uporabljati hkrati z nelfinavirjem (glejte poglavje 4.5).
Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
Če se razjeda še ni pozdravila, vam zdravnik lahko naroči, da jemljite enak odmerek še nadaljnja 2 tedna.
10 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets.
10 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablet.
Prevention of relapse of duodenal ulcers
Preprečevanje ponovitve razjed na želodcu
• Losec 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tinidazole 500 mg), both three times a day for one week.
• Losec 40 mg se odmerja enkrat na dan, 500 mg amoksicilina in 400 mg metronidazola (ali
20 mg: 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140, 200, 280 tablets.
20 mg: 7, 14, 15, 28, 30, 50, 56, 100 tablet, bolnišnično pakiranje 140, 200, 280 tablet.
• Saquinavir (used to treat HIV infection)
• sakvinavir (uporablja se za zdravljenje okužbe s HIV)
Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
Če se razjeda še ni pozdravila, vam zdravnik lahko naroči, da jemljite enak odmerek še nadaljnje 4 tedne.
• Prevention of relapse of duodenal ulcers
• preprečevanje ponovitve razjed na želodcu
10 mg: 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets.
10 mg: 7, 14, 15, 28, 30, 50, 100 tablet, bolnišnično pakiranje 140 tablet.
• Do not use Losec after the expiry date which is stated on the vial and carton after EXP.
• Zdravila Losec ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP .
• 10 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets.
• 10 mg: o Plastenke iz HDPE s 7, 14, 15, 28, 30, 50, 100 tabletami, bolnišnično pakiranje s 140 tabletami.
• The usual dose once the gullet has healed is 10 mg once a day.
• Potem, ko se požiralnik pozdravi, je običajen odmerek 10 mg enkrat na dan.
• Losec 20 mg capsules have a pink body, marked 20 and a reddish-brown cap marked A/OM.
• Kapsule Losec 20 mg imajo rožnato telo, na katerem je oznaka 20, in rdečkastorjav pokrovček,
Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets
Losec in povezana imena (glejte Dodatek I) 10 mg gastrorezistentne tablete Losec in povezana imena (glejte Dodatek I) 20 mg gastrorezistentne tablete
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.
• zdravila za redčenje krvi, npr. varfarin ali druge antagoniste vitamina K. Zdravnik vas bo morda moral kontrolirati, ko boste začeli ali nehali jemati zdravilo Losec.
o Blisters of 7, 14, 15, 28, 30, 50, 60 or 84 capsules.
o Pretisni omoti s 7, 14, 15, 28, 30, 50, 60 ali 84 kapsulami.
The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing.
V programu kliničnih preskušanj omeprazola in med njegovo postmarketinško uporabo so ugotovili (ali so posumili na) naslednje neželene učinke zdravila.
The dose can be increased to 40 mg once daily if needed
Če je treba, je odmerek mogoče povečati na 40 mg enkrat na dan.
10 mg: 7, 14, 28 tablets
Aluminijski pretisni omot 10 mg: 7, 14, 28 tablet 20 mg: 7, 14 tablet
Gastric ECL-cell hyperplasia and carcinoids, have been observed in life-long studies in rats treated with omeprazole.
V vseživljenjskih študijah na podganah, ki so dobivale omeprazol, so opažali hiperplazijo želodčnih celic ECL in karcinoide.
• Shelf life after reconstitution: The reconstituted solution should not be stored at temperatures above 25°C and should be used within 4 hours after preparation.
Pripravljeno raztopino je treba shranjevati pri temperaturi do 25 °C in jo je treba uporabiti v 4 urah po pripravi.Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če je bilo pripravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
Carton for blister: Store in the original package in order to protect from moisture.
Škatla za pretisni omot: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains omeprazole sodium 42.6 mg, equivalent to omeprazole 40 mg. After reconstitution, 1 ml contains omeprazole sodium 0.426 mg, equivalent to omeprazole 0.4 mg.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 42,6 mg natrijevega omeprazolata, kar ustreza 40 mg omeprazola.
o Blisters of 7, 14, 15, 28, 30, 35, 50, 56 and 84 capsules.
o Pretisni omoti s 7, 14, 15, 28, 30, 35, 50, 56 in 84 kapsulami.
Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5).
Atazanavirja ni priporočljivo uporabljati hkrati z zaviralci protonske črpalke (glejte poglavje 4.5).
o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets.
o Perforirani pretisni omoti za enkratni odmerek (bolnišnično pakiranje) s 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tableto.
Losec contains lactose.
Zdravilo Losec vsebuje laktozo.
Dry mouth, stomatitis, gastrointestinal candidiasis Hepatobiliary disorders Uncommon:
suha usta, stomatitis, kandidoza prebavil Bolezni jeter, žolčnika in žolčevodov Občasni:
Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets Losec and associated names (see Annex I) 40 mg gastro-resistant tablets
Losec in povezana imena (glejte Dodatek I) 10 mg gastrorezistentne tablete Losec in povezana imena (glejte Dodatek I) 20 mg gastrorezistentne tablete Losec in povezana imena (glejte Dodatek I) 40 mg gastrorezistentne tablete
• Losec 10 mg gastro-resistant tablets are light-pink with or on one side and 10 mg on the other side.
• Gastrorezistentne tablete Losec 10 mg so svetlorožnate z oznako ali na eni strani in
o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets.
o Perforirani pretisni omoti za enkratni odmerek (bolnišnično pakiranje) s 25 x 1, 28 x 1, 50 x 1, 56 x 1 tableto.
Losec and associated names (see Annex I) 40 mg powder and solvent for solution for injection (I+II) [See Annex I - To be completed nationally] omeprazole
Losec in povezana imena (glejte Dodatek I) 40 mg prašek in vehikel za raztopino za injiciranje (I+II) [Glejte Dodatek I - izpolni država članica] omeprazol
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - izpolni država članica]
40 mg: 5, 7, 14, 15, 28, 30, 50, 56, 60, 100 tablets; hospital pack of 560 tablets.
40 mg: 5, 7, 14, 15, 28, 30, 50, 56, 60, 100 tablet, bolnišnično pakiranje 560 tablet.
Losec and associated names (see Annex I) 10 mg hard capsules Losec and associated names (see Annex I) 20 mg hard capsules Losec and associated names (see Annex I) 40 mg hard capsules
Losec in povezana imena (glejte Dodatek I) 10 mg trde kapsule Losec in povezana imena (glejte Dodatek I) 20 mg trde kapsule Losec in povezana imena (glejte Dodatek I) 40 mg trde kapsule
31-40 kg Combination with two antibiotics: Losec 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administrated two times daily for one week.
31 do 40 kg Kombinacija dveh antibiotikov: Losec 20 mg, amoksicilin 750 mg in klaritromicin 7,5 mg/kg telesne mase se vsi uporabljajo dvakrat na dan en teden.
40 mg: 5, 7, 14, 15, 28, 30, 60 capsules; hospital packs of 140, 280 or 700 capsules.
40 mg: 5, 7, 14, 15, 28, 30, 60 kapsul; bolnišnična pakiranja s 140, 280 ali 700 kapsulami.
The other ingredients are disodium hydrogen phosphate dihydrate, hydroxypropylcellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid co-polymer, microcrystalline cellulose, macrogol (polyethylene glycol), sodium lauryl sulphate, iron oxide, titanium dioxide, gelatine, printing ink (containing shellac, ammonium hydroxide, potassium hydroxide and black iron oxide).
- Pomožne snovi so natrijev hidrogenfosfat dihidrat, hidroksipropilceluloza, hidroksipropilmetilceluloza, brezvodna laktoza, magnezijev stearat, manitol, kopolimer metakrilne kisline, mikrokristalna celuloza, makrogol (polietilenglikol), natrijev lavrilsulfat, železov oksid, titanov dioksid, želatina, barva za napis (vsebuje šelak, amonijev hidroksid, kalijev hidroksid in črni železov oksid).
• 20 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140 , 200, 280 tablets.
• 20 mg: o Plastenke iz HDPE s 7, 14, 15, 28, 30, 50, 56, 100 tabletami, bolnišnično pakiranje s 140 , 200, 280 tabletami.
Losec and associated names (see Annex I) 10 mg capsules Losec and associated names (see Annex I) 20 mg capsules Losec and associated names (see Annex I) 40 mg capsules [See Annex I - To be completed nationally]
Losec in povezana imena (glejte Dodatek I) 10 mg kapsule Losec in povezana imena (glejte Dodatek I) 20 mg kapsule Losec in povezana imena (glejte Dodatek I) 40 mg kapsule [Glejte Dodatek I - izpolni država članica]
15-30 kg Combination with two antibiotics: Losec 10 mg, amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administrated together two times daily for one week.
15 do 30 kg Kombinacija dveh antibiotikov: Losec 10 mg, amoksicilin 25 mg/kg telesne mase in klaritromicin 7,5 mg/kg telesne mase se vsi uporabljajo hkrati, dvakrat na dan en teden.