FrancophonIA/ELRC3.0 huggingface dataset:
English: Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Danish: Bivirkninger, hvor hyppigheden ikke er kendt: hovedpine, ringen for ørerne, hoste, smagsforstyrrelser, forstoppelse, led- og muskelsmerter, leversygdom og nedsat nyrefunktion, øget mængde af kalium i blodet og allergiske reaktioner, såsom udslæt, nældefeber, opsvulmet ansigt, læber, mund, tunge og hals.
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Danish: I to epidemiologiske studier baseret på det danske Cancerregister er der observeret øget risiko for nonmelanom hudkræft (basalcellekarcinom og pladecellekarcinom) ved en stigende kumulativ dosis af hydrochlorthiazid.
English: Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 x 1 film coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Danish: Irbesartan/Hydrochlorthiazid Teva er tilgængelige i pakningsstørrelser med 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 og 100 filmovertrukne i ikke perforerede blisterpakninger; pakningsstørrelser med 50x1 filmovertrukken tablet i enhedsblisterpakninger og pakningsstørrelse med 28 filmovertrukne tabletter i ikke perforerede kalenderblisterpakninger.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets EU/1/09/583/049-072
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter EU/1/09/583/049-072
English: Indigotine (Indigo carmine aluminium lake FD&C blue #2) Iron Oxide Black
Danish: Indigotin (Indigocarmin) Sort jernoxid
English: The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p < 0.0001).
Danish: Faldet i SeSBT/SeDBT ved 5 uger var henholdsvis 30,8/24,0 mm Hg og 21,1/19,3 mm Hg for irbesartan/hydrochlorthiazid og irbesartan (p < 0,0001).
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
Danish: Dosering 1 gang dagligt med 150 mg irbesartan og 12,5 mg hydrochlorthiazid gav en systolisk/diastolisk gennemsnitlig placebojusteret blodtryksreduktion ved laveste måling (24 timer efter dosis) på 12,9/6,9 mm Hg hos patienter med let til moderat hypertension.
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution.
Danish: Dog skal denne faste dosiskombination gives med forsigtighed til patienter med mild til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min).
English: The administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Danish: Non-steroide antiinflammatoriske lægemidler Administration af et non-steroidt antiinflammatorisk lægemiddel kan reducere den diuretiske,
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg
English: The other side of the tablet debossed with the number "7238".
Danish: Den anden side af tabletten er præget med tallet "7238".
English: (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Danish: Stort forbrug af hydrochlorthiazid (≥ 50.000 mg kumulativt) var forbundet med en justeret OR-værdi på 1,29 (95 %KI: 1,23-1,35) for basalcellekarcinom og på 3,98 (95 %-KI: 3,68-4,31) for pladecellekarcinom.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets EU/1/09/583/025-048
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter EU/1/09/583/025-048
English: Therefore, the use of Irbesartan/Hydrochlorothiazide Teva is not recommended.
Danish: Derfor frarådes brug af Irbesartan/Hydrochlorthiazid Teva.
English: In patients with creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Danish: Halveringstiden for hydrochlorthiazid forlænges til 21 timer hos patienter med kreatininclearance < 20 ml/min.
English: No dosage adjustment of Irbesartan/Hydrochlorothiazide Teva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Danish: Dosisjustering af Irbesartan/Hydrochlorthiazid Teva til patienter med mild eller moderat leverfunktionsnedsættelse er ikke nødvendig (se pkt.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Danish: Non-melanom hudkræft: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft.
English: Swelling extremity Arthralgia, myalgia
Danish: Artralgi, myalgi
English: Respiratory, thoracic and mediastinal disorders:
Danish: Luftveje, thorax og mediastinum
English: Hyperkalaemia
Danish: Hyperkaliæmi
English: The use of Irbesartan/Hydrochlorothiazide Teva during breast feeding is not recommended.
Danish: Anvendelse af Irbesartan/Hydrochlorothiazide Teva i ammeperioden frarådes.
English: Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Danish: Virkningen af pressoraminer kan nedsættes, men ikke tilstrækkeligt til at udelukke deres anvendelse;
English: The trough to peak effects measured by cuff during office visits were 68 % and 76 % for irbesartan/hydrochlorothiazide 150 mg/12.5 mg and irbesartan/hydrochlorothiazide 300 mg/12.5 mg, respectively.
Danish: Forholdet mellem den laveste og den maksimale effekt var henholdsvis 68 % og 76 % for irbesartan/hydrochlorthiazid 150 mg /12,5 mg og irbesartan/hydrochlorthiazid 300 mg /12,5 mg, når effekten blev målt med blodtryksmanchet ved kontrolbesøg.
English: Electrolyte imbalance
Danish: Elektrolytforstyrrelser
English: • Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg.
Danish: • Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg.
English: Vascular disorders:
Danish: Ortostatisk svimmelhed
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets EU/1/09/583/001-024
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter EU/1/09/583/001-024
English: • Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg.
Danish: • Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg.
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Danish: Yderligere information om irbesartaninteraktioner Irbesartans farmakokinetik er i kliniske forsøg ikke blevet påvirket af hydrochlorthiazid.
English: The other side of the tablet debossed with the number "7239".
Danish: Den anden side af tabletten er præget med tallet "7239".
English: Contents of the pack and other information What Irbesartan/Hydrochlorothiazide Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Irbesartan/hydrochlorthiazid Teva indeholder:
English: Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
Danish: Lægen vil sandsynligvis starte behandling med Irbesartan/Hydrochlorthiazid Teva, hvis den tidligere behandling for forhøjet blodtryk ikke har haft tilstrækkelig effekt.
English: Nervous system disorders:
Danish: Nervesystemet
English: Irbesartan/hydrochlorothiazide combination
Danish: Kombination af irbesartan/hydrochlorthiazid
English: Each film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide
Danish: Hver filmovertrukket tablet indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, der planlægger at blive gravide, bør skifte til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA'er skønnes nødvendig.
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, der planlægger at blive gravide, bør skifte til anden antihypertensiv behandling, hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig.
English: Special Populations
Danish: Særlige patientgrupper
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Tablet coating for 150 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
Danish: Tabletovertræk for styrken 150 mg/12,5 mg: Hypromellose, titandioxid, polyethylenglycol 6000 (macrogol), polyethylenglycol 400 (macrogol), rød jernoxid, gul jernoxid og sort jernoxid.
English: The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Danish: Tillæg af 12,5 mg hydrochlorthiazid til 300 mg irbesartan 1 gang dagligt hos patienter, der ikke er tilstrækkeligt behandlede med 300 mg irbesartan alene, medførte yderligere placebo-korrigeret diastolisk blodtryksreduktion ved laveste måling (24 timer efter dosis) på 6,1 mm Hg. Kombinationen af 300 mg irbesartan og 12,5 mg hydrochlorthiazid medførte en total placebo-korrigeret systolisk/diastolisk reduktion på op til 13,6/11,5 mm Hg.
English: Lithium The combination of lithium and Irbesartan/Hydrochlorothiazide Teva is not recommended (see section 4.5).
Danish: Lithium Kombination af lithium og Irbesartan/Hydrochlorthiazid Teva frarådes (se pkt.
English: Tablet coating for 300 mg/25 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, Indigotine (Indigo carmine aluminium lake FD&C blue #2) and iron oxide black.
Danish: Tabletovertræk for styrken 300 mg/25 mg: Hypromellose, titandioxid, polyethylenglycol 6000 (macrogol), polyethylenglycol 400 (macrogol), rød jernoxid, Indigotin (Indigocarmin) og sort jernoxid.
English: Efficacy and safety of irbesartan/hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomised, double-blind, active-controlled, 8-week, parallel-arm study.
Danish: Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af irbesartan/hydrochlorthiazid som initial behandling ved svær hypertension (defineret som SeDBT ≥ 110 mm Hg).
English: Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
Danish: Samtidig administration af irbesartan ændrer det kalium-tab, der er forbundet med disse diuretika, formodentligt ved at blokere renin-angiotensin-aldosteronsystemet.
English: Therefore, the combination of lithium and Irbesartan/Hydrochlorothiazide Teva is not recommended (see section 4.4).
Danish: Derfor frarådes kombination af lithium og Irbesartan/Hydrochlorthiazid Teva (se pkt.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Danish: Non-melanom hudkræft: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft (se også pkt.
English: Other medicines and Irbesartan/Hydrochlorothiazide Teva
Danish: Brug af anden medicin sammen med Irbesartan/Hydrochlorthiazid Teva
English: Tablet coating for 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
Danish: Tabletovertræk for styrken 300 mg/12,5 mg: Hypromellose, titandioxid, polyethylenglycol 6000 (macrogol), polyethylenglycol 400 (macrogol), rød jernoxid, gul jernoxid og sort jernoxid.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in the irbesartan and hydrochlorothiazide combination, minimal or no effects were reported.
Danish: Der er dog rapporteret minimal eller ingen effekt ved en dosis på 12,5 mg, som findes i kombinationen af irbesartan og hydrochlorthiazid.
English: Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide
Danish: Hver filmovertrukket tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid
English: In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Danish: Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/moderat cirrhose.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: Each film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide
Danish: Hver filmovertrukket tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Danish: Hvis du drikker alkohol, mens du er i behandling med dette produkt, kan du opleve, at du bliver mere svimmel, især når du rejser dig op fra siddende stilling.
English: For oral use.
Danish: Administration Til oral brug.
English: caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Danish: ≥ 100 mg/kg/dag hos makakaber) en reduktion i røde blodlegemeparametre (erytrocytter, hæmoglobin, hæmatokrit).
English: Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.
Danish: Hydrochlorthiazids fotosensibiliserende virkning kan være en mulig mekanisme i forhold til non-melanom hudkræft.
English: How to take Irbesartan/Hydrochlorothiazide Teva
Danish: Sådan skal du tage Irbesartan/Hydrochlorthiazid Teva
English: Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan / hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter irbesartan / hydrochlorthiazid
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid.
English: If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.
Danish: Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage
English: Common:
Danish: NN:
English: Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg.
Danish: Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er regulerede med 300 mg/12,5 mg-kombinationen, kan respondere ved dosisøgning til 300/25 mg. Der er hos disse patienter observeret en øgning i blodtryksreduktionen for såvel systolisk blodtryk (SBP) som diastolisk blodtryk (DBP) (henholdsvis 13,3 mm Hg og 8,3 mm Hg).
English: Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
Danish: Thiaziddiuretika øger urinudskillelse og sænker derved blodtrykket.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter irbesartan / hydrochlorthiazid
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: Teva Nederland B.V. Tel: +31 8000228400
Danish: Tel: +31 8000228400
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: What Irbesartan/Hydrochlorothiazide Teva is and what it is used for What you need to know before you take Irbesartan/Hydrochlorothiazide Teva How to take Irbesartan/Hydrochlorothiazide Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Irbesartan/Hydrochlorthiazid Teva Sådan skal du tage Irbesartan/Hydrochlorthiazid Teva Bivirkninger
English: Although not specifically studied with irbesartan/hydrochlorothiazide, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Danish: Der er hverken observeret rebound-hypertension for irbesartan eller hydrochlorthiazid.
English: Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter irbesartan / hydrochlorthiazid
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of irbesartan/hydrochlorothiazide 150 mg/12.5 mg were 100 %.
Danish: Forholdet mellem den laveste og den maksimale effekt af irbesartan/hydrochlorthiazid 150 mg/12,5 mg var 100 %, når blodtrykket blev monitoreret ambulant.
English: Irbesartan/Hydrochlorothiazide Teva is for oral use.
Danish: Irbesartan/Hydrochlorthiazid Teva skal tages gennem munden.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Pink to dark pink, film-coated capsule shaped tablet.
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter Pink til mørk pink filmovertrukne kapselformede tabletter.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/12,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Iron Oxide Black
Danish: Sort jernoxid
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets are pink to dark pink, film coated capsule shaped tablet.
Danish: Irbesartan/Hydrochlorthiazid Teva 300 mg/25 mg filmovertrukne tabletter er pink til mørke pink, filmovertrukne kapselformede tabletter.
English: In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Danish: Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Danish: Dosisjustering er ikke nødvendig til patienter med nedsat nyrefunktion, hvis den renale kreatininclearance er > 30 ml/min (se pkt.
English: Adverse reactions reported with the use of hydrochorothiazide alone Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia; bradycardia might also occur.
Danish: Hypotension og takykardi forventes at være de mest sandsynlige symptomer på irbesartanoverdosering.
English: Increases in blood urea nitrogen (BUN), creatinine and creatine kinase Decreases in serum potassium and sodium
Danish: Øget serumcarbamid, kreatinin og kreatinkinase
English: Musculoskeletal and connective tissue disorders:
Danish: Svækkelse, muskelspasmer bindevæv Vaskulære sygdomme
English: Method of Administration
Danish: Systemorganklasse
English: Flushing
Danish: Amning
English: When necessary, Irbesartan/HydrochlorothiazideTeva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Om nødvendigt kan Irbesartan/Hydrochlorthiazid Teva kombineres med andre antihypertensiva (se pkt.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Light pink to pink, film-coated capsule shaped tablet.
Danish: Irbesartan/Hydrochlorthiazid Teva 150 mg/12,5 mg filmovertrukne tabletter Lys pink til pink, filmovertrukne kapselformede tabletter.