natgillin/translations-raw huggingface dataset:
Behandling af NSAID-associerede gastriske og duodenale ulcera Til behandling af NSAID-associerede gastriske og duodenale ulcera er den anbefalede dosis Losec 20 mg en gang dagligt. 
For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is Losec 20 mg once daily.
• Behandling af gastriske ulcera 
• Treatment of gastric ulcers
Enterogranulaterne må ikke tygges. 
The entericcoated pellets must not be chewed.
Agranulocytose, pancytopeni 
Agranulocytosis, pancytopenia Immune system disorders Rare:
• Behandling af refluksøsofagitis 
• Treatment of reflux esophagitis
10 mg: 7, 14, 15, 28, 30, 35, 50, 56, 84 kapsler. 
10 mg: 7, 14, 15, 28, 30, 35, 50, 56, 84 capsules.
20 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 enterotabletter. 
20 mg: 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets.
Til patienter med dårligt responderende gastrisk ulcus anbefales 40 mg omeprazol en gang dagligt, og heling opnås sædvanligvis inden for 8 uger. 
In patients with poorly responsive gastric ulcer Losec 40 mg once daily is recommended and healing is usually achieved within eight weeks.
28 enterotabletter 
28 tablets
Losec enterotabletter indeholder omeprazol magnesium svarende til 10 mg eller 20 mg omeprazol. 
Losec gastro-resistant tablets contain omeprazole magnesium corresponding to 10 mg or 20 mg omeprazole.
Losec 10 mg enterotabletter: En lys pink, aflang, bikonveks, filmovertrukket tablet indeholdende enterogranulat, mærket med eller på den ene side og 10 mg på den anden side. 
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.
5 enterotabletter 
5 tablets
Når du får Losec 
BEFORE YOU TAKE LOSEC
20 mg: Hård gelatinekapsel med en uigennemsigtig lyserød hoveddel mærket 20 og en uigennemsigtig rødbrun hætte mærket A/OM indeholdende enterogranulat. 
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.
Patienter, der har svært ved at synke, og børn, der kan drikke eller synke halvfast føde Patienterne kan åbne kapslen og synke indholdet med et halvt glas vand. 
For patients with swallowing difficulties and for children who can drink or swallow semi-solid food Patients can open the capsule and swallow the contents with half a glass of water or after mixing the contents in a slightly acidic fluid e.g., fruit juice or applesauce, or in non-carbonated water.
20 mg: Hver enterotablet indeholder 19-20 mg saccharose. 
20 mg: Each gastro-resistant tablet contains 19-20 mg sucrose.
Opløsningen skal altid omrøres umiddelbart før den drikkes. 
The dispersion should always be stirred just before drinking and rinsed down with half a glass of water.
≥ 2 år >20 kg 20 mg en gang dagligt. 
The dose can be increased to 20 mg once daily if needed ≥ 2 years of age > 20 kg 20 mg once daily.
10 mg: Hver enterotablet indeholder 10,3 mg omeprazolmagnesium svarende til 10 mg omeprazol. 
10 mg: Each gastro-resistant tablet contains 10.3 mg omeprazole magnesium equivalent to 10 mg omeprazole.
40 mg: 25 x 1, 28 x 1, 50 x 1 enterotabletter. 
40 mg: 25 x 1, 28 x 1, 50 x 1 tablets.
• Den sædvanlige dosis er 20 mg én gang dagligt i 2 uger. 
• The usual dose is 20 mg once a day for 2 weeks.
40 mg: 7, 14, 15, 28, 30 kapsler. 
40 mg 7, 14, 15, 28, 30 capsules.
10 enterotabletter (kun 10 mg) 14 enterotabletter 
10 tablets (10 mg only) 14 tablets
Leversvigt, encefalopati hos patienter med præeksisterende leversygdom 
Hepatic failure, encephalopathy in patients with pre-existing liver disease Skin and subcutaneous tissue disorders Uncommon:
Svimmelhed, paræstesi, døsighed 
Dizziness, paraesthesia, somnolence
Om nødvendigt kan dosis øges til 40 mg en gang dagligt. 
The dose can be increased to 40 mg once daily if needed
84 enterotabletter (kun 10 mg og 20 mg) 90 enterotabletter (kun 10 mg og 20 mg) 98 enterotabletter (kun 20 mg) 100 enterotabletter 
84 tablets (10 mg and 20 mg only) 90 tablets (10 mg and 20 mg only) 98 tablets (20 mg only) 100 tablets
Losec enterotabletter indeholder omeprazolmagnesium svarende til 10 mg, 20 mg eller 40 mg omeprazol. 
Losec gastro-resistant tablets contain omeprazole magnesium corresponding to 10 mg, 20 mg or 40 mg omeprazole.
Det tørre pulver i hætteglasset vil blive opblandet til en opløsning, før du får det. Pakningsstørrelser: Hætteglas 1 x 40 mg, 5 x 40 mg og 10 x 40 mg. Ikke alle pakningsstørrelser er nødvendigvis markedsført. 
Pack sizes: Vials 1x40 mg, 5x40 mg, 10x40 mg. Not all pack sizes may be marketed.
• Hvis du har haft fordøjelsesbesvær eller halsbrand i 4 uger eller mere. 
• You continuously suffer from indigestion or heartburn for 4 or more weeks.
o Blisterpakninger med 7, 14, 15, 28, 30, 35, 50, 56 og 84 kapsler 
o Blisters of 7, 14, 15, 28, 30, 35, 50, 56 and 84 capsules.
Derfor skal du straks tale med din læge, hvis noget af det følgende sker for dig, før du begynder at tage Losec, eller mens du tager det: 
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:
Et randomiseret, dobbeltblindet klinisk forsøg (Héliot-studiet) konkluderede, at omeprazol i kombination med to antibiotika (amoxicillin og clarithromycin) var sikkert og effektivt i behandlingen af H. pylori-infektion hos børn fra 4 år med gastritis. 
A randomised, double blind clinical study (Héliot study) concluded that omeprazole, in combination with two antibiotics (amoxicillin and clarithromycin), was safe and effective in the treatment of H. pylori infection in children age 4 years old and above with gastritis: H. pylori eradication rate: 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin.
20 mg: 7, 14, 15, 28, 30, 50, 60, 84 kapsler. 
20 mg 7, 14, 15, 28, 30, 50, 60, 84 capsules.
YDRE KARTON TIL BLISTER YDRE KARTON TIL BEHOLDER BEHOLDERETIKET 
CARTON FOR BLISTER CARTON FOR BOTTLE BOTTLE LABEL
Dinatriumedetat. 
wheezing.
40 mg: 7, 14, 15, 28, 30, 100 enterotabletter. 
40 mg: 7, 14, 15, 28, 30, 100 tablets.
PRODUKTRESUME Receptpligtige lægemiddelformer 
SUMMARY OF PRODUCT CHARACTERISTICS For medicinal products available on prescription
• Den sædvanlige dosis er 20 mg én gang dagligt i 4 uger. 
• The usual dose is 20 mg once a day for 4 weeks.
Virkning på mavesyresekretionen: 
Effect on gastric acid secretion
40 mg: Hård gelatinekapsel med en uigennemsigtig rødbrun hoveddel mærket 40 og en uigennemsigtig rødbrun hætte mærket A/OL indeholdende enterogranulat. 
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.
Nyrer og urinveje Sjælden: 
Muscular weakness Renal and urinary disorders Rare:
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til opløsning af Losec og tilhørende navne (se Bilag I) injektionsvæske, opløsning [Se Bilag I - Udfyldes nationalt] iv 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for reconstitution of Losec and associated names (see Annex I) solution for injection [See Annex I - To be completed nationally] iv
Den indeholder vigtige informationer. 
Read all of this leaflet carefully because it contains important information for you.
Dette kan forårsage svaghed, blå mærker eller øget modtagelighed overfor infektioner. 
bruising or make infections more likely.
• Ledsmerter eller muskelsmerter. 
• Joint pains (arthralgia) or muscle pains (myalgia).
15 enterotabletter 
15 tablets
Losec indeholder: 
What Losec contains
Hver kapsel indeholder 40 mg omeprazol 
Each capsule contains 40 mg omeprazole.
Hver kapsel indeholder 20 mg omeprazol 
Each capsule contains 20 mg omeprazole.
50 enterotabletter (kun 10 mg og 20 mg) 56 enterotabletter (kun 20 mg) 100 enterotabletter 
50 tablets (10 mg and 20 mg only) 56 tablets (20 mg only) 100 tablets
• Hvis du er blevet behandlet for fordøjelsesbesvær eller halsbrand uafbrudt i 4 uger eller mere. 
• You are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
YDRE KARTON TIL BEHOLDER YDRE KARTON TIL BLISTER BREV 
OTC CARTON FOR BOTTLE CARTON FOR BLISTER WALLET
Inden du tager Losec, skal du fortælle din læge, hvis du er gravid eller prøver at blive det. Din læge vil tage stilling til, om du kan tage Losec i denne periode. 
Before taking Losec, tell your doctor if you are pregnant or trying to get pregnant.
30 enterotabletter 
30 tablets
Povidon, krydsbundet Natriumhydroxid (til pH-justering) Natriumstearylfumarat Talcum 
sodium stearyl fumarate, talc, triethyl citrate, iron oxide, titanium dioxide
Inden du får Losec, skal du fortælle din læge, hvis du er gravid eller prøver at blive det. Din læge vil tage stilling til, om du må få Losec i denne periode. 
Before you are given Losec, tell your doctor if you are pregnant or trying to get pregnant.
Symptomatisk behandling af halsbrand og syreregurgitation ved gastroøsofageal reflukssygdom Dosisanbefalinger: 
Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease The posology recommendations are as follows:
Ydre karton til blister: Opbevares i den originale yderpakning for at beskytte mod fugt. 
Carton for blister: Store in the original package in order to protect from moisture.
Losec og tilhørende navne (se Bilag I) 40 mg pulver og solvens til injektionsvæske, opløsning (I+II) [Se Bilag I - Udfyldes nationalt] omeprazol 
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
Indehaver af markedsføringstilladelsen og fremstiller [Se Bilag I - Udfyldes nationalt] 
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
50 enterotabletter 
50 tablets
Derfor skal du straks tale med din læge, hvis noget af det følgende sker for dig, før eller efter du får Losec: 
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:
Dosisanbefalinger: Alder Vægt 
The posology recommendations are as follows: Age
10 mg: 7, 14, 15, 28, 30, 50, 100 enterotabletter; hospitalspakning med 140 enterotabletter. 
10 mg: 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets.
• Din læge vil kombinere behandlingen med to af følgende tre antibiotika: amoxicillin, 
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.
Frekvens for eradikation af H. pylori: 74,2 % (23/31 patienter) med omeprazol + amoxicillin + clarithromycin versus 9,4 % (3/32 patienter) med amoxicillin + clarithromycin. 
A randomised, double blind clinical study (Héliot study) concluded that omeprazole in combination with two antibiotics (amoxicillin and clarithromycin), was safe and effective in the treatment of H. pylori infection in children age 4 years old and above with gastritis: H. pylori eradication rate: 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin.
10 mg: Hver kapsel indeholder 4 mg lactose 20 mg: Hver kapsel indeholder 8 mg lactose 40 mg: Hver kapsel indeholder 9 mg lactose 
20 mg: Each capsule contains 8 mg lactose.
SÅDAN SKAL DU TAGE LOSEC 
HOW TO TAKE LOSEC
BEMÆRK: Trin 1 til 5 skal udføres umiddelbart efter hinanden: Med en sprøjte optrækkes al opløsningsmidlet fra ampullen (10 ml). 
With a syringe draw all of the solvent from the ampoule (10 ml).
• 10 mg: o HDPE-beholdere med 7, 14, 15, 28, 30, 50, 100 enterotabletter; hospitalspakning med 140 enterotabletter. 
• 10 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 100 tablets; hospital pack of 140 tablets.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 42,6 mg omeprazolnatrium svarende til 40 mg omeprazol. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for solution for injection contains omeprazole sodium 42.6 mg, equivalent to omeprazole 40 mg. After reconstitution, 1 ml contains omeprazole sodium 4.26 mg, equivalent to omeprazole 4 mg.
o Perforeret enkeltdosis-blisterpakning (hospitalspakning) med 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 enterotabletter. 
o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1, 100 x 1 tablets.
5 hætteglas x 40 mg 
5 vials x40 mg
Nervesystemet Almindelig: 
Aggression, hallucinations Nervous system disorders Common:
Nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt. 
Dose adjustment is not needed in patients with impaired renal function.
40 mg: 5, 7, 14, 15, 28, 30, 50, 56, 60, 100 enterotabletter; hospitalspakning med 560 enterotabletter. 
40 mg: 5, 7, 14, 15, 28, 30, 50, 56, 60, 100 tablets; hospital pack of 560 tablets.
Som andre protonpumpehæmmere må omeprazol ikke anvendes samtidigt med nelfinavir (se pkt. 
Omeprazole like other proton pump inhibitors must not be used concomitantly with nelfinavir (see section 4.5).
Losec og tilhørende navne (se Bilag I) 10 mg hårde kapsler Losec og tilhørende navne (se Bilag I) 20 mg hårde kapsler Losec og tilhørende navne (se Bilag I) 40 mg hårde kapsler 
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
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Losec og tilhørende navne (se Bilag I) 40 mg pulver til injektionsvæske [Se Bilag I - Udfyldes nationalt] omeprazol 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Losec and associated names (see Annex I) 40 mg powder for injection [See Annex I - To be completed nationally] omeprazole iv
INDLÆGSSEDDEL Receptpligtige lægemiddelformer 
PACKAGE LEAFLETs For medicinal products available on prescription
• Recidivprofylaktisk mod gastriske ulcera 
• Prevention of relapse of gastric ulcers
BEMÆRK: Trin 1 til 5 skal udføres umiddelbart efter hinanden: Med en sprøjte optrækkes opløsningsmidlet fra ampullen (10 ml). 
NOTE: Steps 1 to 5 must be performed in immediate sequence:
10 hætteglas x 40 mg 
10 vials x40 mg
• Blister: Opbevares i den originale yderpakning for at beskytte mod fugt. 
• Store this blister in the original package in order to protect from moisture.
• Følelse af, det hele drejer rundt (svimmelhed). 
• Feeling sick (nausea) or being sick (vomiting).
• Smagsforstyrrelser 
• Taste changes.
Fortæl din læge eller dit apotek, hvis du er gravid eller prøver at blive det, før du tager Losec. 
Before taking Losec, tell your doctor or pharmacist if you are pregnant or trying to get pregnant.
Profylaktisk mod recidiverende gastriske ulcera 
Prevention of relapse of gastric ulcers
Hver enterotablet indeholder 20 mg omeprazol 
Each gastro-resistant tablet contains 20 mg omeprazole.
Hvert hætteglas indeholder natriumhydroxid 
I. Powder for injection Each vial contains sodium hydroxide.
Hver enterotablet indeholder 40 mg omeprazol 
Each gastro-resistant tablet contains 40 mg omeprazole.
40 mg: 5, 7, 14, 15, 28, 30, 60 kapsler; hospitalspakninger med 140, 280 eller 700 kapsler. 
40 mg: 5, 7, 14, 15, 28, 30, 60 capsules; hospital packs of 140, 280 or 700 capsules.
Losec og tilhørende navne (se Bilag I) 10 mg hårde kapsler Losec og tilhørende navne (se Bilag I) 20 mg hårde kapsler Losec og tilhørende navne (se Bilag I) 40 mg hårde kapsler [Se Bilag I - Udfyldes nationalt] 
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 [See Annex I - To be completed nationally]
Losec og tilhørende navne (se Bilag I) 40 mg, pulver og solvens til injektionsvæske, opløsning [Se Bilag I - Udfyldes nationalt] 
Losec and associated names (see Annex I) 40 mg powder and solvent for solution for injection [See Annex I - To be completed nationally]
De synkes hele med et halvt glas vand. 
• Swallow your tablets whole with half a glass of water.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver enterotablet indeholder 10 mg omeprazol 
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains omeprazole sodium equivalent to 40 mg omeprazole
o Perforeret enkeltdosis-blisterpakning (hospitalspakning) med 25 x 1, 28 x 1, 50 x 1 enterotabletter. 
o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1 tablets.
10 mg: 7, 14, 28 enterotabletter 20 mg: 7, 14 enterotabletter 
10 mg: 7, 14, 28 tablets
Som andre protonpumpehæmmere, bør omeprazol ikke anvendes samtidigt med nelfinavir (se pkt. 
Omeprazole like other proton pump inhibitors (PPIs) should not be used concomitantly with nelfinavir (see section 4.5).
Den anbefalede profylaktiske dosis til recidiverende gastriske ulcera hos patienter med dårligt responderende gastrisk ulcus er Losec 20 mg en gang dagligt. 
For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is Losec 20 mg once daily.
10 mg: 5, 7, 10, 14, 15, 28, 30, 50, 56, 60, 100 kapsler; hospitalspakninger med 140, 280 eller 700 kapsler. 
10 mg: 5, 7, 10, 14, 15, 28, 30, 50, 56, 60, 100 capsules; hospital packs of 140, 280 or 700 capsules.
Losec og tilhørende navne (se Bilag I) 10 mg enterotabletter Losec og tilhørende navne (se Bilag I) 20 mg enterotabletter 
Losec and associated names (see Annex I) 10 mg Losec and associated names (see Annex I) 20 mg
• 10 mg: o HDPE-beholdere med 5, 7, 10, 14, 15, 28, 30, 50, 56, 60, eller 100 kapsler; hospitalspakninger med 140, 280 eller 700 kapsler. 
• 10 mg: o HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 56, 60 or 100 capsules; hospital packs of 140, 280 or 700 capsules.
INDLÆGSSEDDEL Ikke receptpligtige lægemiddelformer 
PACKAGE LEAFLET For medicinal products available without prescription
o Perforeret enkeltdosis-blisterpakning (hospitalspakninger) med 25 x 1, 28 x 1, 50 x 1, 56 x 1 enterotabletter. 
o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets.
• Hvis du har blod i afføringen (sort/mørk afføring). 
• You pass black stools (blood-stained faeces).
10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 enterotabletter; hospitalspakning med 560 enterotabletter. 
10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
PRODUKTRESUME Ikke receptpligtige lægemiddelformer 
SUMMARY OF PRODUCT CHARACTERISTICS For medicinal products available without prescription
≥ 1 år 10-20 kg 10 mg en gang dagligt. 
Weight Posology ≥ 1 year of age 10-20 k g
• 20 mg: o HDPE-beholdere med 7, 14, 15, 28, 30, 50, 56, 100 enterotabletter; hospitalspakninger med 140, 200, 280 enterotabletter. 
• 20 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140 , 200, 280 tablets.
o Blisterpakning med 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 100 enterotabletter; hospitalspakning med 560 enterotabletter. 
o Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 100 tablets; hospital pack of 560 tablets.
20 mg: 7, 14, 15, 28, 30, 50, 56, 100 enterotabletter; hospitalspakninger med 140, 200, 280 enterotabletter. 
20 mg: 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140, 200, 280 tablets.
20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 enterotabletter; hospitalspakning med 560 enterotabletter. 
20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of, 560 tablets.
Tilsæt resten af opløsningsmidlet til hætteglasset. 
Add the remaining solvent into the vial, make sure the syringe is empty.
Psykiske forstyrrelser Ikke almindelig: 
Hypomagnesaemia Psychiatric disorders Uncommon:
• Svimmelhed, prikken eller snurren som f.eks. når benet sover, træthedsfølelse. 
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
INFORMATION I BRAILLE-SKRIFT Ikke relevant (Hospitalspakning) 
Perforated unit dose blister (hospital pack):
20 mg: 5, 7, 14, 15, 28, 30, 50, 60, 100 kapsler; hospitalspakninger med 140, 280 eller 700 kapsler. 
20 mg: 5, 7, 10, 14, 15, 28, 30, 50, 60, 100 capsules; hospital packs of 140, 280 or 700 capsules.
• Mundtørhed. 
• Dry mouth.
Losec og tilhørende navne (se Bilag I) 10 mg enterotabletter Losec og tilhørende navne (se Bilag I) 20 mg enterotabletter Losec og tilhørende navne (se Bilag I) 40 mg enterotabletter 
Losec and associated names (see Annex I) 10 mg Losec and associated names (see Annex I) 20 mg Losec and associated names (see Annex I) 40 mg
Profylaktisk mod recidiverende duodenale ulcera 
Prevention of relapse of duodenal ulcers
Mave-tarm-kanalen Almindelig: 
Perforated unit dose blister:
Losec og tilhørende navne (se Bilag I) 10 mg enterotabletter Losec og tilhørende navne (se Bilag I) 20 mg enterotabletter Losec og tilhørende navne (se Bilag I) 40 mg enterotabletter [Se Bilag I - Udfyldes nationalt] 
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]
• Brug ikke Losec efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
• Do not use Losec after the expiry date which is stated on the pack after EXP.
Farmakodynamiske virkninger 
5.1 Pharmacodynamic properties
Solvens til injektionsvæske 
Increased liver enzymes
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder omeprazolnatrium svarende til 40 mg omeprazol. 
Each vial of powder for solution for injection contains omeprazole sodium equivalent to 40 mg of omeprazole.
o Blisterpakninger med 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 enterotabletter; hospitalspakning med 560 enterotabletter. 
o Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of 560 tablets.
• 10 mg: o Blisterpakninger med 7, 14, 28 enterotabletter 
o Blisters of 7, 14, 28 tablets
o Blisterpakninger med 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 enterotabletter; hospitalspakning med 560 enterotabletter. 
o Blisters of 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
forekommer hos mellem 1 og 10 ud af 100 behandlede Ikke almindelig: forekommer hos mellem 1 og 10 ud af 1.000 behandlede 
affects 1 to 10 users in 1,000
Losec og tilhørende navne (se Bilag I) 40 mg, pulver til infusionsvæske, opløsning [Se Bilag I - Udfyldes nationalt] Omeprazol 
Losec and associated names (see Annex I) 40 mg powder for solution for infusion [See Annex I - To be completed nationally] Omeprazole
For vejledning i tilberedning af injektionsopløsningen, se pkt. 
For instructions on reconstitution of the product before administration, see section 6.6.
Gelatine 
Gynaecomastia
Dette kan være 
If you have this condition,
Hvert hætteglas med pulver til infusionsvæske indeholder omeprazolnatrium svarende til 40 mg omeprazol - Øvrige indholdsstoffer: Dinatriumedetat, natriumhydroxid. 
Each vial of powder for solution for infusion contains omeprazole sodium equivalent to 40 mg of omeprazole.
• Recidivprofylaktisk mod duodenale ulcera 
• Prevention of relapse of duodenal ulcers
udslæt, besvimelse eller besvær med at synke (alvorlig allergisk reaktion). 
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow (severe allergic reaction).
Doseringsanbefalinger: 
Excipient:
50 kapsler (kun 10 mg og 20 mg) 56 kapsler (kun 10 mg) 
50 capsules (10 mg and 20 mg only)
Efter opløsning indeholder 1 ml 0,426 mg omeprazolnatrium svarende til 0,4 mg omeprazol. 
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.
• Brug ikke Losec efter den udløbsdato, der star på etiketten og yderpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
• Do not use Losec after the expiry date which is stated on the label and carton after EXP.
Dinatriumphosphatdihydrat 
• Hypomagnesaemia