natgillin/translations-raw huggingface dataset:
50 mg/ 12, 5 mg filmovertrukne tabletter - blister
Outer carton for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets blister
50 mg/ 12, 5 mg filmovertrukne tabletter
Cozaar Comp 50 mg/ 12.5 mg mg film-coated tablets
Hver tablet indeholder 50 mg losartankalium og 12, 5 mg hydrochlorthiazid
Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 eller 280 filmovertrukne tabletter.
4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 film-coated tablets.
[Udfyldes nationalt]
[To be completed nationally] [For referral procedures]
37 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 mg/ 12, 5 mg filmovertrukne tabletter
Blister for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets
50 mg/ 12, 5 mg
Cozaar Comp 50 mg/ 12.5 mg
[Se Annex I – Udfyldes nationalt]
[See Annex I - To be completed nationally] [For referral procedures]
38 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 mg/ 12, 5 mg filmovertrukne tabletter - HDPE- beholder
Outer carton for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets HDPE Bottle
Hver tablet indeholder 50 mg losartankalium og 12, 5 mg hydrochlorthiazid.
Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
50 mg/ 12, 5 mg filmovertrukne tabletter – HDPE- beholder
Bottle label for Cozaar Comp 50 mg/ 12.5 mg film-coated tablets HDPE Bottle
Hver tablet indeholder 50 mg losartan og 12, 5 mg hydrochlorthiazid.
Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
100 filmovertrukne tabletter
100 film-coated tablets.
42 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 mg/ 12, 5 mg filmovertrukne tabletter - blister
Outer carton for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets blister
100 mg/ 12, 5 m filmovertrukne tabletter
Cozaar Comp 100 mg/ 12.5 mg mg film-coated tablets
Hver tablet indeholder 100 mg losartankalium og 12, 5 mg hydrochlorthiazid
Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Lactosemonohydrat.
Lactose-monohydrate.
14, 15, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter.
14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 film coated-tablets.
[Udfyldes nationalt]
[To be completed nationally][For referral procedures]
44 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
100 mg/ 12, 5 mg filmovertrukne tabletter
Blister for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets
100 mg/ 12, 5 mg
Cozaar Comp 100 mg/ 12.5 mg
45 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 mg/ 12, 5 mg filmovertrukne tabletter - HDPE- beholder
Outer carton for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets HDPE bottle
100 mg/ 12, 5 mg filmovertrukne tabletter
Cozaar Comp 100 mg/ 12.5 mg mg film-coated tablets
Hver tablet indeholder 100 mg losartankalium og 12, 5 mg hydrochlorthiazid.
Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
100 filmovertrukne tabletter.
100 film coated-tablets.
100 mg/ 12, 5 mg filmovertrukne tabletter – HDPE- beholder
Bottle label for Cozaar Comp 100 mg/ 12.5 mg film-coated tablets HDPE bottle
Hver tablet indeholder 100 mg losartan og 12, 5 mg hydrochlorthiazid.
Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
100 filmovertrukne tabletter
100 film coated-tablets.
[Udfyldes nationalt].
[To be completed nationally]
100 mg/ 25 mg filmovertrukne tabletter - blister
Outer carton for Cozaar Comp 100 mg/ 25 mg film-coated tablets blister
100 mg/ 25 mg filmovertrukne tabletter
Cozaar Comp 100 mg/ 25 mg mg film-coated tablets
Hver tablet indeholder 100 mg losartankalium og 25 mg hydrochlorthiazid
Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter.
7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
50 11.
51 11.
51 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
100 mg/ 25 mg filmovertrukne tabletter
Blister for Cozaar Comp 100 mg/ 25 mg film-coated tablets
100 mg/ 25 mg
Cozaar Comp 100 mg/ 25 mg
52 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 mg/ 25 mg filmovertrukne tabletter - HDPE- beholder
Outer carton for Cozaar Comp 100 mg/ 25 mg film-coated tablets HDPE bottle
Hver tablet indeholder 100 mg losartankalium og 25 mg hydrochlorthiazid.
Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
100 mg/ 25 mg filmovertrukne tabletter – HDPE- beholder
Outer carton for Cozaar Comp 100 mg/ 25 mg film-coated tablets HDPE bottle
Hver tablet indeholder 100 mg losartan og 25 mg hydrochlorthiazid.
Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
[Udfyldes nationalt]
N/ A
Læs denne indlægssseddel grundigt, inden De begynder at tage medicinen. • Gem indlægssedlen.
• Keep this leaflet.
De kan få brug for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, De vil vide. • Lægen har ordineret Cozaar Comp. til Dem personligt.
You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you.
Cozaar Comp. 's virkning og hvad De skal bruge det til 2.
What Cozaar Comp is and what it is used for 2.
3.
Before you take Cozaar Comp 3.
Sådan skal De tage Cozaar Comp.
How to take Cozaar Comp 4.
6.
How to store Cozaar Comp 6.
COZAAR COMP. 'S VIRKNING OG HVAD DE SKAL BRUGE DET TIL
WHAT COZAAR COMP IS AND WHAT IT IS USED FOR
Cozaar Comp. er en kombination af en angiotensin II- receptorantagonist (losartan) og et vanddrivende lægemiddel (hydrochlorthiazid).
Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
• hvis De er overfølsom (allergisk) over for losartan, hydrochlorthiazid eller et af de øvrige indholdsstoffer • hvis De er overfølsom (allergisk) over for andre sulfonamidafledte stoffer (f. eks. andre thiazider, nogle antibakterielle stoffer, f. eks. cotrimoxazol, spørg lægen hvis De er i tvivl om hvad det er). • hvis De er gravid, tror De kan være gravid eller planlægger at blive gravid (se også "Graviditet og amning") • hvis De ammer • hvis De har alvorligt nedsat leverfunktion • hvis De har alvorligt nedsat nyrefunktion, eller hvis Deres nyrer ikke danner urin • hvis De har lavt indhold af kalium, lavt indhold af natrium eller højt indhold af kalcium, som ikke kan forbedres ved behandling • hvis De har urinsur gigt.
• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine. • if you are allergic (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure) • if you are, think you may be or are planning to become pregnant (see also “ Pregnancy and breast-feeding”) • if you are breast-feeding • if you have severely impaired liver function • if you have severely impaired kidney function or your kidneys are not producing any urine. • if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment • if you are suffering from gout
Vær ekstra forsigtig med at tage Cozaar Comp.
Take special care with Cozaar Comp
• hvis De tidligere har haft hævelse af ansigt, læber, svælg eller tunge • hvis De tager vanddrivende medicin • hvis De er på saltbegrænset diæt • hvis De kaster/ har kastet voldsomt op eller har/ har haft kraftig diarré • hvis De har nedsat hjertefunktion
• if you have previously suffered from swelling of the face, lips, throat or tongue
58 • hvis De har forsnævring af de blodkar, der fører til nyrerne (nyreateriestenose), eller hvis De kun har en fungerende nyre, eller de for nylig har fået nyretransplantation, • hvis De har forsnævring af arterierne (atherosclerose), angina pectoris (smerter i brystet pga dårlig hjertefunktion) • hvis De har "aorta - eller mitralklapstenose" (forsnævring af hjerteklapperne) eller "hypertrofisk kardiomyopati" (en sygdom der medfører fortykkelse af hjertemusklen) • hvis De har diabetes • hvis De har urinsur gigt • hvis De har eller har haft en allergisk tilstand, astma eller en tilstand som kan medføre ledsmerter, hududslæt og feber (systemisk lupus erythematosus) • hvis De har højt indhold af kalcium eller lavt indhold af kalium eller De er på en diæt med lavt kalium • hvis De skal have bedøvelse (også hos tandlægen), eller De skal opereres, eller hvis De skal have foretaget prøver af parathyroideafunktionen, skal De fortælle Deres læge eller sundhedspersonalet, at De tager losartankalium og hydrochlorthiazid tabletter • hvis De har primær hyperaldosteronisme (et syndrom der er forbundet med øget udskillelse af hormonet aldosteron fra binyrerne, som skyldes en abnormitet i kirtlen).
58 • if you take diuretics (water pills) • if you are on a salt-restricted diet • if you have or have had severe vomiting and/ or diarrhoea • if you have heart failure • if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant • if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function) • if you have ‘ aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘ hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle) • if you are diabetic • if you have had gout • if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus). • if you have high calcium or low potassium levels or you are on a low potassium diet • if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking Losartan potassium and Hydrochlorothiazide tablets. • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland).
Særlige forholdsregler (f. eks. blodprøver) kan være hensigtsmæssige, hvis De tager kaliumtilskud, salterstatninger med kalium eller kaliumbesparende medicin, anden vanddrivende medicin, visse afføringsmidler, medicin til behandling af urinsur gigt, medicin til at kontrollere hjerterytmen eller diabetesmedicin (medicin til at tage gennem munden eller insulin).
Special precautionary measures (e. g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“ water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).
Det er også vigtigt for lægen at vide, om de tager anden medicin til at nedsætte Deres blodtryk, steroider, medicin til behandling af cancer, smertestillende medicin, medicin mod svampeinfektioner, eller medicin mod ledbetændelse, resiner mod forhøjet kolesterol, f. eks. colestyramin, medicin til muskelafslapning, sovemedicin; opioid medicin, f. eks. morfin, "pressoraminer", f. eks. adrenalin eller andre lægemidler fra samme gruppe; (diabetesmedicin til at tage gennem munden eller insulin).
It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, drugs for treatment of fungal infections, or arthritis medicines, resins used for high cholesterol, such as colestyramine, medicines which relax your muscles, sleeping tablets; opioid medicines such as morphine, ‘ pressor amines’ such as adrenaline or other drugs from the same group; (oral agents for diabetes or insulins).
De skal helst ikke drikke alkohol, når De tager disse tabletter; alkohol og Cozaar Comp. kan medføre gensidig øget virkning.
Taking Cozaar Comp with food and drink You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other’ s effects.
59 Børn og unge
59 Use in children and adolescents
Ældre
Use in elderly patients
Når De starter behandling med denne medicin, bør De ikke udføre opgaver, som kræver særlig opmærksomhed (f. eks. køre bil eller betjene farlige maskiner), indtil De ved, hvordan medicinen påvirker Dem.
When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.
SÅDAN SKAL DE TAGE COZAAR COMP.
HOW TO TAKE COZAAR COMP
50 mg/ 12, 5 mg daligt til kontrol af blodtrykket over en 24- timers periode.
High Blood Pressure The usual dose of Cozaar Comp for most patients with high blood pressure is 1 tablet of Cozaar Comp 50 mg/ 12.5 mg per day to control blood pressure over the 24-hour period.
Dosis kan øges til 2 tabletter af losartan/ hydrochlorthiazid 50 mg/ 12, 5 mg filmovertrukne tabletter én gang dagligt, eller dosis kan ændres til 1 tablet af losartan/ hydrochlorthiazid 100 mg/ 25 mg filmovertrukne tabletter (en højere styrke) pr. dag.
This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/ 12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/ 25 mg Film-Coated Tablets (a stronger strength) per day.
Den højeste daglige dosis er 2 tabletter af losartan/ hydrochlorthiazid 50 mg/ 12, 5 mg filmovertrukne tabletter eller 1 tablet dagligt af losartan/ hydrochlorthiazid 100 mg/ 25 mg filmovertrukne tabletter.
The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/ 12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/ 25 mg Film-Coated Tablets
Hvis De har taget for meget Cozaar Comp.
If you take more Cozaar Comp than you should
Hvis De har glemt at tage Cozaar Comp.
If you forget to take Cozaar Comp Try to take Cozaar Comp daily as prescribed.
Forsøg at tage Cozaar Comp. dagligt som foreskrevet.
However, if you miss a dose, do not take an extra dose.
60 En alvorlig allergisk reaktion (udslæt, kløe, hævelse af ansigt, læber, mund eller svælg, som gør det svært at synke eller trække vejret).
60 A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
Dette er en alvorlig men sjælden bivirkning, som rammer mere end 1 ud af 10. 000 patienter men færre end 1 ud af 1. 000 patienter.
This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients.
Almindelige (berører færre end én person ud af 10 men flere end én person ud af 100): • Hoste, infektion i øvre luftveje, tilstoppet næse, bihulebetændelse, lidelser i bihulerne • Diarré, mavesmerter, kvalme, fordøjelsesbesvær • Muskelsmerter eller muskelkramper, smerter i benene, rygsmerter • Søvnløshed, hovedpine, svimmelhed • Svaghed, træthed, smerter i brystet • Øget indhold af kalium (som kan medføre unormal hjerterytme), nedsat hæmoglobin.
Common (affecting less than one person in 10 but more than one person in 100): • Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder, • Diarrhoea, abdominal pain, nausea, indigestion, • Muscle pain or cramps, leg pain, back pain, • Insomnia, headache, dizziness, • Weakness, tiredness, chest pain, • Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.
Sjælden (berører mere end én person ud af 10. 000 og færre end én person ud af 1. 000): • Hepatitis (betændelse i leveren), unormale leverfunktionsprøver
Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients) • Hepatitis (inflammation of the liver), abnormal liver function tests
50 mg/ 12, 5 mg indeholder 50 mg losartankalium og 12, 5 mg hydrochlorthiazid som aktive indholdsstoffer.
Cozaar Comp 50 mg/ 12.5 mg > contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
100 mg/ 12, 5 mg indeholder 100 mg losartankalium og 12, 5 mg hydrochlorthiazid som aktive indholdsstoffer.
Cozaar Comp100 mg/ 12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
100 mg/ 25 mg indeholder 100 mg losartankalium og 25 mg hydrochlorthiazid som aktive indholdsstoffer.
Cozaar Comp 100 mg/ 25 mg > contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Mikrokrystallinsk cellulose, lactosemonohydrat, prægelatineret majsstivelse, magnesiumstearat, hydroxypropylcellulose, hypromellose.
Cozaar Comp 50 mg/ 12.5 mg, Cozaar Comp 100 mg/ 12.5 mgand Cozaar Comp 100 mg/ 25 mg contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.
100 mg/ 25 mg indeholder 8, 48 mg (0, 216 mEq) kalium.
Cozaar Comp 100 mg/ 12.5 mg mg and Cozaar Comp 100 mg/ 25 mg contain 8.48 mg (0.216 mEq) of potassium.
100 mg/ 25 mg indeholder også titandioxid (E171), quinolingult (E104) og carnaubavoks (E903).
Cozaar Comp 50 mg/ 12.5 mg and Cozaar Comp 100 mg/ 25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Hydroxypropylcellulose (E463), hypromellose (E464) og titandioxid (E171)] samt carnaubavoks (E903).
Cozaar Comp 100 mg/ 12.5 mg also contain: white color concentrate [or the individual ingredients of the concentrate: hydroxypropyl cellulose (E463), hypromellose (E464) and titanium dioxide (E171)] and carnauba wax (E903).
Cozaar Comp. 's udseende og pakningsstørrelse
What Cozaar Comp looks like and contents of the pack
50 mg/ 12, 5 mg fås som filmovertrukne tabletter med eller uden delekærv.
Cozaar Comp 50 mg/ 12.5 mg is supplied as scored or unscored film-coated tablets.
100 mg/ 12, 5 mg fås som filmovertrukne tabletter uden delekærv.
Cozaar Comp 100 mg/ 12.5 mg mg is supplied as unscored film-coated tablets.
100 mg/ 25 mg fås som filmovertrukne tabletter uden delekærv.
Cozaar Comp 100 mg/ 25 mg is supplied as unscored film-coated tablets.
50 mg/ 12, 5 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 eller 280 tabletter.
62 Cozaar Comp 50 mg/ 12.5 mg > - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
100 mg/ 12, 5 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 14, 15, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
Cozaar Comp 100 mg/ 12.5 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
100 mg/ 25 mg - PVC/ PE/ PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
Cozaar Comp 100 mg/ 25 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Indehaveren af markedsføringstilladelsen
Marketing Authorisation Holder and Manufacturer
< Udfyldes nationalt >
< To be completed nationally >
Belgien Belgien Belgien Belgien Bulgarien Cypern Cypern Danmark Danmark Danmark Danmark Estland Estland Finland Finland Frankrig
Austria Austria Belgium Belgium Belgium Belgium Bulgaria Cyprus Cyprus Denmark Denmark Denmark Denmark Estonia
COZAAR PLUS FORTE 100 mg/ 25 mg COZAAR PLUS 50 mg/ 12, 5 mg LOORTAN PLUS FORTE 100 mg/ 25 mg LOORTAN PLUS 50 mg/ 12, 5 mg Hyzaar FORTZAAR HYZAAR Cozaar Comp.
Cosaar Plus - Filmtabletten Fortzaar-Filmtabletten COZAAR PLUS FORTE 100 MG/ 25 MG COZAAR PLUS 50 MG/ 12,5 MG LOORTAN PLUS FORTE 100 MG/ 25 MG LOORTAN PLUS 50 MG/ 12,5 MG Hyzaar FORTZAAR HYZAAR Cozaar Comp.
100 mg/ 12, 5 mg Fortzaar HYZAAR FORTZAAR Cozaar Comp Cozaar Comp Forte Fortzaar 100 mg/ 25 mg film- coated tablets
FORTZAAR Cozaar Comp Cozaar Comp Forte Fortzaar 100 mg/ 25 mg film-coated tablets
Grækenland Grækenland Holland Holland Holland Irland Irland Italien Italien Italien Italien Italien Italien Italien Letland Letland
Germany Germany Germany Germany Germany Germany Greece
HYZAAR HYZAAR 100/ 25 Cozaar Plus 100/ 12, 5 Fortzaar 100/ 25 Hyzaar 50/ 12, 5 "Cozaar" Comp 50 mg/ 12, 5 mg film- coated tablets "Cozaar" Comp 100 mg/ 25 mg film- coated tablets HIZAAR 50 mg + 12, 5 mg compresse rivestite con film HIZAAR 100 mg + 25 mg compresse rivestite con film FORZAAR 100 mg + 25 mg compresse rivestite con film NEO- LOTAN PLUS 50 mg + 12, 5 mg compresse rivestite con film NEO- LOTAN PLUS 100 mg + 25 mg compresse rivestite con film LOSAZID 50 mg + 12, 5 mg compresse rivestite con film LOSAZID 100 mg + 25 mg compresse rivestite con film HYZAAR 50 mg/ 12, 5 mg Fortzaar 100 mg/ 25 mg
LORZAAR PLUS 50/ 12,5 mg Filmtabletten CARDOPAL PLUS 50/ 12,5 mg Filmtabletten LORZAAR VARIPHARM PLUS 50/ 12,5 mg Filmtabletten FORTZAAR 100/ 25 mg Filmtabletten FORTZAAR VARIPHARM 100/ 25 mg Filmtabletten LORZAAR PLUS forte 100/ 12,5 mg Filmtabletten HYZAAR
63
63 Greece Hungary
Litauen
Hungary Ireland Ireland
FORTZAAR (Losartan/ Hydrochlorthiazide)
HYZAAR 50 mg/ 12,5 mg; Fortzaar 100 mg/ 25 mg FORTZAAR (Losartan/ Hydrochlorothiazide)
Litauen Luxemburg Luxemburg Luxemburg Luxemburg Malta
Lithuania Luxembourg Luxembourg Luxembourg Luxembourg Malta
HYZAAR (Losartan/ Hydrochlorthiazide) COZAAR PLUS FORTE 100 mg/ 25 mg COZAAR PLUS 50 mg/ 12, 5 mg LOORTAN PLUS FORTE 100 mg/ 25 mg LOORTAN PLUS 50 mg/ 12, 5 mg "Cozaar Comp" 50/ 12. 5 mg Pilloli miksija b' rita
HYZAAR (Losartan/ Hydrochlorothiazide) COZAAR PLUS FORTE 100 MG/ 25 MG COZAAR PLUS 50 MG/ 12,5 MG LOORTAN PLUS FORTE 100 mg/ 25 mg LOORTAN PLUS 50 mg/ 12,5 mg "Cozaar Comp" 50/ 12.5 mg pilloli miksija b’ rita
"Cozaar Comp" 100/ 25 mg Pilloli miksija b' rita
"Cozaar Comp" 100/ 25 mg pilloli miksija b’ rita
"Cozaar Comp" 100/ 12, 5 mg Pilloli miksija b' rita
"Cozaar Comp" 100/ 12,5 mg pilloli miksija b’ rita
Polen Polen Portugal Portugal Portugal Portugal Portugal Rumænien Rumænien Slovenien Slovenien Spanien Spanien Storbritannien Storbritannien Storbritannien
Netherlands Netherlands Netherlands Poland Poland Portugal Portugal Portugal Portugal Portugal Romania Romania Slovenia Slovenia Spain Spain Sweden Sweden
HYZAAR HYZAAR FORTE COZAAR Plus FORTZAAR SIAARA LOORTAN Plus Losartan + Hidroclorotiazida Frosst HYZAAR® 50 mg/ 12, 5 mg, comprimate filmate FORTZAAR® 100 mg/ 25 mg, comprimate filmate HYZAAR FORTZAAR Cozaar Plus Fortzaar COZAAR- COMP 50/ 12. 5 mg FILM- COATED TABLETS COZAAR- COMP 100/ 25 mg FILM- COATED TABLETS COZAAR- Comp 100 mg/ 12. 5 mg Film- coated tablets
Cozaar Plus 100/ 12,5 Fortzaar 100/ 25 Hyzaar 50/ 12,5 HYZAAR HYZAAR FORTE COZAAR Plus FORTZAAR SIAARA LORTAAN Plus Losartan + Hidroclorotiazida Frosst HYZAAR® 50 mg/ 12,5 mg, comprimate filmate FORTZAAR® 100/ 25 mg,, comprimate filmate HYZAAR FORTZAAR Cozaar Plus Fortzaar Cozaar Comp 50 mg/ 12,5 mg filmdragerade tabletter Cozaar Comp 100 mg/ 12,5 mg filmdragerade tabletter
64
64 Sweden United Kingdom United Kingdom United Kingdom
London, den 3. september 2008 Ref. dok.
Ref.
EMEA/ CHMP/ 494917/ 2008
EMEA/ CHMP/ 494914/ 2008
UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 30 Cozaar Comp og tilknyttede navne
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar Comp and associated names
Internationalt fællesnavn (INN): losartan + hydrochlorothiazid
International Non-Proprietary Name (INN): losartan + hydrochlorothiazide
Cozaar Comp og tilknyttede navne, 50/ 12, 5 mg, 100/ 12, 5 mg, 100/ 25 mg, filmovertrukne tabletter er en fastdosiskombination af losartan and hydrochlorothiazid.
Cozaar Comp and associated names, 50/ 12.5 mg; 100/ 12.5 mg; 100/ 25 mg, film coated tablets is a fixed dose combination of losartan and hydrochlorothiazide.