natgillin/translations-raw huggingface dataset:
Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat, kolloid silica, prægelatineret majsstivelse, poloaxamer 188.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Blandt diabetiske, hypertensive patienter med kronisk nyreinsufficiens og udtalt proteinuri sås hyperkalæmi (≥5,5 mEq/l) hos 46,3% af patienterne i irbesartangruppen og 26,3% af patienterne i placebogruppen.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Efter enten oral eller intravenøs administration af 14C irbesartan, genfindes ca. 20% radioaktivitet i urinen og resten i afføringen.
C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Hos 1.715 hypertensive patienter med type 2-diabetes, proteinuri ≥ 900 mg/dag og serumkreatininværdier i intervallet 1,0-3,0 mg/dl, evalueredes langtidseffekterne (median 2,6 år) ved Irbesartan BMS med henblik på progression af nyresygdom og totalmortalitet.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Irbesartan BMS on the progression of renal disease and all-cause mortality were examined.
I Dyrestudier med irbesartan sås forbigående toksisk effekt (øget nyrebækken kavitation, hydroureter eller subkutant ødem) hos rottefostre.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Dokumentationen for forbedring af nyresygdom ved brug af Irbesartan BMS hos hypertensive type 2-diabetikere er baseret på studier, hvor irbesartan blev brugt efter behov med tillæg af andre antihypertensive lægemidler, for at nå det ønskede blodtryk (se pkt.
The demonstration of renal benefit of Irbesartan BMS in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Du bør ikke tage Irbesartan BMS i begyndelsen af graviditeten, og du må ikke tage det, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis du tager det efter tredje måned af graviditeten.
Irbesartan BMS is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Irbesartan BMS anvendes til at behandle forhøjet blodtryk (hypertension) til at beskytte nyrerne hos patienter med for højt blodtryk, type 2-diabetes og blodprøver, der
Irbesartan BMS is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Luftveje, thorax og mediastinum: Ualmindelig:
Respiratory, thoracic and mediastinal disorders: Uncommon: cough
Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silicondioxid, magnesiumstearat, titandioxid (E171), macrogol 3000,
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Kaliumtilskud og kalium-besparende diuretika: Erfaringer med brug af andre lægemidler, der indvirker på renin-angiotensin systemet, viser at samtidig brug af kalium-besparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre lægemidler, som kan øge serumkaliumniveauet (fx heparin), kan medføre øget serum-kalium, Derfor frarådes samtidig brug med sådanne lægemidler (se pkt.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Nyrefunktionsnedsættelse og nyretransplantation: Der anbefales periodisk kontrol af serum-kalium- og serum-kreatinin, hvis Irbesartan BMS anvendes til patienter med nedsat nyrefunktion.
Renal impairment and kidney transplantation: when Irbesartan BMS is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Indholdsstoffer: indeholder også lactosemonohydrat.
LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Hver Irbesartan BMS-tablet 75 mg indeholder 75 mg irbesartan.
Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.
Almindeligvis påvirker eller påvirkes Irbesartan BMS ikke af anden medicin.
Irbesartan BMS does not usually interact with other medicines.
Det reproduktive system og mammae: Ualmindelig:
Reproductive system and breast disorders: Uncommon: sexual dysfunction
Hypertensive patienter med type 2 diabetes og nefropati: I en undersøgelse med patienter med fremskreden nyresygdom var effekten af irbesartan på nyrer og kardiovaskulære hændelser ikke den sammei alle sub-grupper.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Hver Irbesartan BMS-tablet 300 mg indeholder 300 mg irbesartan.
Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.
INFORMATION I BRAILLE-SKRIFT Irbesartan BMS 75 mg
INFORMATION IN BRAILLE Irbesartan BMS 75 mg
Som det er tilfældet med ACE-hæmmere, kan samtidig anvendelse af antiotensin II- antagonister og NSAID medføre øget risiko for forværring af nyrefunktionen, herunder muligt akut nyresvigt samt øgning af serum-kalium.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Hver Irbesartan BMS-tablet 150 mg indeholder 150 mg irbesartan.
Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.
INFORMATION I BRAILLE-SKRIFT Irbesartan BMS 300 mg
INFORMATION IN BRAILLE Irbesartan BMS 300 mg
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: irbesartan 75 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg
Irbesartan BMS skal tages gennem munden.
Irbesartan BMS is for oral use.
Almindeligt: svimmelhed, kvalme/opkastning, træthed og blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinin-kinase-enzym).Der er hos patienter med forhøjet blodtryk og type 2-diabetes med nyresygdom også indberettet svimmelhed, når man rejser sig op fra liggende eller siddende stilling, lavt blodtryk når man rejser sig op fra liggende eller siddende stilling, led- og muskelsmerter og en nedsat mængde protein i de røde blodlegemer (hæmoglobin).
In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
INFORMATION I BRAILLE-SKRIFT Irbesartan BMS 150 mg
INFORMATION IN BRAILLE Irbesartan BMS 150 mg
Æsker med 56 x 1 filmovertrukne tabletter; 7 blisterkort med 8 x 1 filmovertrukken tablet i hvert perforeret PVC/PVDC/aluminiumblister med éngangsdoser.
Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/PVDC/Aluminium perforated unit dose blisters.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: irbesartan 150 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/375/028-033
MARKETING AUTHORISATION NUMBERS EU/1/06/375/028-033
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder: irbesartan 300 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg
På trods af dette er Irbesartan BMS uden risiko blevet administreret sammen med andre antihypertensive lægemidler som beta-blokkere, langtidsvirkende calciumantagonister samt diuretika af thiazidtypen.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan BMS has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/375/016-021
MARKETING AUTHORISATION NUMBERS EU/1/06/375/016-021
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/375/022-027
MARKETING AUTHORISATION NUMBERS EU/1/06/375/022-027
SÅDAN SKAL DU BRUGE IRBESARTAN BMS Tag altid Irbesartan BMS nøjagtigt efter lægens anvisning.
Always take Irbesartan BMS exactly as your doctor has told you.
Knogler, led, muskler og bindevæv : Almindelig:
Musculoskeletal and connective tissue disorders: Common:
On
OTHER
Nyrefunktionsnedsættelse: Det er ikke nødvendigt at dosisjustere patienter med nedsat nyrefunktion.
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
LÆGEMIDLETS NAVN Irbesartan BMS 75 mg tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets.
Hjælpestof: 61,50 mg lactosemonohydrat per tablet.
Excipient: 61.50 mg of lactose monohydrate per tablet.
LÆGEMIDLETS NAVN Irbesartan BMS 75 mg tabletter irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets irbesartan
LÆGEMIDLETS NAVN Irbesartan BMS 150 mg tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets.
Hjælpestof: 15,37 mg lactosemonohydrat per tablet.
Excipient: 15.37 mg of lactose monohydrate per tablet.
LÆGEMIDLETS NAVN Irbesartan BMS 300 mg tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets.
Hjælpestof: 30,75 mg lactosemonohydrat per tablet.
Excipient: 30.75 mg of lactose monohydrate per tablet.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan BMS 75 mg tabletter irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg tablets irbesartan
4.3 og 4.4).
(18 - 40 years).
LÆGEMIDLETS NAVN Irbesartan BMS 300 mg tabletter irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets irbesartan
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan BMS 300 mg tabletter irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg tablets irbesartan
LÆGEMIDLETS NAVN Irbesartan BMS 150 mg tabletter irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets irbesartan
LÆGEMIDLETS NAVN Irbesartan BMS 75 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan BMS 150 mg tabletter irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets irbesartan
Æsker med 14 tabletter: 1 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 14 tablets: 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters.
LÆGEMIDLETS NAVN Irbesartan BMS 75 mg filmovertrukne tabletter irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets irbesartan
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan BMS 75 mg filmovertrukne tabletter irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets irbesartan
Der er set fald i hæmoglobin, som ikke var klinisk signifikant, hos 1,7% (dvs almindelig) af de hypertensive patienter med fremskreden diabetisk nyresygdom
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been
Irbesartan BMS 75 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 300 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE IRBESARTAN BMS
BEFORE YOU TAKE IRBESARTAN BMS
Æsker med 56 tabletter: 4 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 56 tablets: 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Æsker med 28 tabletter: 2 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 28 tablets: 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
LÆGEMIDLETS NAVN Irbesartan BMS 150 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets.
Irbesartan BMS 150 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Æsker med 98 tabletter: 7 blisterkort med 14 tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 98 tablets: 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Æsker med 84 filmovertrukne tabletter: 6 blisterkort med 14 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 84 film-coated tablets: 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
LÆGEMIDLETS NAVN Irbesartan BMS 300 mg filmovertrukne tabletter.
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets.
Æsker med 14 filmovertrukne tabletter: 1 blisterkort med 14 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 14 film-coated tablets: 1 blister card of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Hjælpestof: 102,00 mg lactosemonohydrat per tablet.
Excipient: 102.00 mg of lactose monohydrate per film-coated tablet.
Hjælpestof: 25,50 mg lactosemonohydrat per tablet.
Excipient: 25.50 mg of lactose monohydrate per film-coated tablet.
Æsker med 28 filmovertrukne tabletter: 2 blisterkort med 14 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 28 film-coated tablets: 2 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Æsker med 56 filmovertrukne tabletter: 4 blisterkort med 14 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 56 film-coated tablets: 4 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan BMS 150 mg filmovertrukne tabletter irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan
Æsker med 98 filmovertrukne tabletter: 7 blisterkort med 14 filmovertrukne tabletter i PVC/PVDC/aluminiumblistere.
Cartons of 98 film-coated tablets: 7 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Irbesartan BMS 150 mg filmovertrukne tabletter leveres i blisterpakninger á 14, 28, 56, 84 eller 98 filmovertrukne tabletter.
Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Lad derfor være med at give Irbesartan BMS til andre.
Do not pass it on to others.
Irbesartan BMS 300 mg filmovertrukne tabletter leveres i blisterpakninger á 14, 28, 56, 84 eller 98 filmovertrukne tabletter.
Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
LÆGEMIDLETS NAVN Irbesartan BMS 150 mg filmovertrukne tabletter irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets irbesartan
LÆGEMIDLETS NAVN Irbesartan BMS 300 mg filmovertrukne tabletter irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets irbesartan
Irbesartan BMSs udseende og pakningstørrelse Irbesartan BMS 75 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2771 på den anden side.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Irbesartan BMS 300 mg filmovertrukne tabletter irbesartan
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan
Irbesartan BMS 75 mg filmovertrukne tabletter leveres i blisterpakninger á 14, 28, 56, 84 eller 98 filmovertrukne tabletter.
Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter recept.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription
EU/1/06/375/011 - 14 tabletter EU/1/06/375/012 - 28 tabletter EU/1/06/375/013 - 56 tabletter EU/1/06/375/014 - 56 x 1 tabletter EU/1/06/375/015 - 98 tabletter
EU/1/06/375/011 - 14 tablets EU/1/06/375/012 - 28 tablets EU/1/06/375/013 - 56 tablets EU/1/06/375/014 - 56 x 1 tablets EU/1/06/375/015 - 98 tablets
Irbesartan BMSs udseende og pakningstørrelse Irbesartan BMS 300 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2873 på den anden side.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Irbesartan BMSs udseende og pakningstørrelse Irbesartan BMS 75 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2871 på den anden side.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Irbesartan BMSs udseende og pakningstørrelse Irbesartan BMS 300 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2773 på den anden side.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Irbesartan BMSs udseende og pakningstørrelse Irbesartan BMS 150 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2872 på den anden side.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Irbesartan BMSs udseende og pakningstørrelse Irbesartan BMS 150 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2772 på den anden side.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
CONDITIONS OF THE MARKETING AUTHORISATION
EU/1/06/375/016 - 14 tabletter EU/1/06/375/017 - 28 tabletter EU/1/06/375/018 - 56 tabletter EU/1/06/375/019 - 56 x 1 tabletter EU/1/06/375/020 - 84 tabletter EU/1/06/375/021 - 98 tabletter
EU/1/06/375/016 - 14 tablets EU/1/06/375/017 - 28 tablets EU/1/06/375/018 - 56 tablets EU/1/06/375/019 - 56 x 1 tablets EU/1/06/375/020 - 84 tablets EU/1/06/375/021 - 98 tablets
EU/1/06/375/022 - 14 tabletter EU/1/06/375/023 - 28 tabletter EU/1/06/375/024 - 56 tabletter EU/1/06/375/025 - 56 x 1 tabletter EU/1/06/375/026 - 84 tabletter EU/1/06/375/027 - 98 tabletter
EU/1/06/375/022 - 14 tablets EU/1/06/375/023 - 28 tablets EU/1/06/375/024 - 56 tablets EU/1/06/375/025 - 56 x 1 tablets EU/1/06/375/026 - 84 tablets EU/1/06/375/027 - 98 tablets
Hjælpestof: 51,00 mg lactosemonohydrat per tablet.
Excipient: 51.00 mg of lactose monohydrate per film-coated tablet.
Irbesartan BMS forebygger at angiotensin-II binder sig til disse receptorer.
Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
EU/1/06/375/006 - 14 tabletter EU/1/06/375/007 - 28 tabletter EU/1/06/375/008 - 56 tabletter EU/1/06/375/009 - 56 x 1 tabletter EU/1/06/375/010 - 98 tabletter
EU/1/06/375/006 - 14 tablets EU/1/06/375/007 - 28 tablets EU/1/06/375/008 - 56 tablets EU/1/06/375/009 - 56 x 1 tablets EU/1/06/375/010 - 98 tablets
EU/1/06/375/028 - 14 tabletter EU/1/06/375/029 - 28 tabletter EU/1/06/375/030 - 56 tabletter EU/1/06/375/031 - 56 x 1 tabletter EU/1/06/375/032 - 84 tabletter EU/1/06/375/033 - 98 tabletter
EU/1/06/375/028 - 14 tablets EU/1/06/375/029 - 28 tablets EU/1/06/375/030 - 56 tablets EU/1/06/375/031 - 56 x 1 tablets EU/1/06/375/032 - 84 tablets EU/1/06/375/033 - 98 tablets
EU/1/06/375/001 - 14 tabletter EU/1/06/375/002 - 28 tabletter EU/1/06/375/003 - 56 tabletter EU/1/06/375/004 - 56 x 1 tabletter EU/1/06/375/005 - 98 tabletter
EU/1/06/375/001 - 14 tablets EU/1/06/375/002 - 28 tablets EU/1/06/375/003 - 56 tablets EU/1/06/375/004 - 56 x 1 tablets EU/1/06/375/005 - 98 tablets
EU/1/06/375/001-005
MARKETING AUTHORISATION NUMBERS EU/1/06/375/001-005
Ti
Sun
Emballage
Pack size
0,2 mg Granulat til oral suspension
Strength Pharmaceutical Form Route of Administration Immediate Packaging
Beskyttelsen begynder at virke 25 dage efter den sidste injektion og holder et år.
Protection starts from 25 days after the last injection and lasts for at least a year.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ZULVAC 8 Bovis den 15. januar 2010.
The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Bovis on 15 January 2010.
Efter den anden injektion kan der forekomme en forbigående, mindre stigning i dyrenes kropstemperatur på 0,4 ºC inden for 24 timer efter vaccinationen.
After the second injection, animals may show a slight, temporary increase in body temperature of 0.4 ºC, in the 24 hours after vaccination.
ZULVAC 8 Bovis blev oprindeligt godkendt under "særlige omstændigheder".
ZULVAC 8 Bovis was initially authorised under ‘exceptional circumstances'.
Den første injektion gives, når dyret er tre måneder gammelt, og den anden injektion gives tre uger senere.
The first injection is given from three months of age and the second injection is given three weeks later.
Tilbageholdelsestiden for ZULVAC 8 Bovis for kød og mælk er nul dage.
The withdrawal period for ZULVAC 8 Bovis for meat and milk is zero days.
Vaccinen gives til dyr ved injektion i musklerne.
The vaccine is given to animals as an injection in the muscle.
Hvis dyrene efterfølgende udsættes for bluetongue-vira, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
In the future, if the animals are exposed to the bluetongue virus the immune system will be able to produce antibodies more quickly.
I 2013 konkluderede CVMP, at de forelagte oplysninger var tilstrækkelige for at kunne omdanne godkendelsen af ZULVAC 8 Bovis til en normal godkendelse.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Bovis to convert to a normal status.