natgillin/translations-raw huggingface dataset:
Brug ikke Pritor efter den udløbsdato, der står på pakningen efter ” EXP ”.
Do not use Pritor after the expiry date which is stated on the carton after “ EXP”.
Du kan opbevare Pritor ved almindelig temperatur.
This medicine does not require any special storage conditions.
Du bør opbevare Pritor i den originale yderpakning for at beskytte tabletterne mod fugt.
You should store your medicine in the original package in order to protect the tablets from moisture.
Pritor indeholder
What Pritor contains
Pritor’ s udseende og pakningsstørrelse
What Pritor looks like and contents of the pack
53 Pritor 20 mg tabletter er hvide runde tabletter, hvorpå firmaets logo og koden 50H er præget.
Pritor 20 mg tablets are white, round and engraved with the code number '50H 'on one side and the company logo on the other side.
Pritor er pakket i blisterpakninger med 14, 28, 30, 56, 90 eller 98 tabletter.
52 Pritor is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets.
Indehaver af markedsføringstilladelse Bayer HealthCare AG D- 51368 Leverkusen Tyskland
Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Fremstiller Bayer HealthCare AG D- 51368 Leverkusen Tyskland
Manufacturer Bayer HealthCare AG D-51368 Leverkusen Germany
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ England
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ United Kingdom
54 Hvis du vil have yderligere oplysninger om Pritor, skal du henvende dig til den lokale repræsentant:
53 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Du kan finde yderligere information om Pritor på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Pritor 40 mg tabletter Telmisartan
INFORMATION FOR THE USER Pritor 40 mg tablets Telmisartan
Telmisartan er en angiotensin II- receptorantagonist.
Pritor belongs to a group of medicines known as angiotensin II receptor antagonists.
56 Vær ekstra forsigtig med at tage Pritor
Take special care with Pritor
Fortæl det til lægen, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande: • Nyresygdom eller du har fået en nyre transplantation • Nedsat blodtilstrømning til en eller begge nyrer / nyrearteriestenose) • Leversygdom • Hjerteproblemer • Aldosteronnisme (vand eller saltophobning i kroppen samtidig med ubalance i mineral sammensætningen) • For lavt blodtryk (hypotension), som kan forekomme, hvis du er dehydreret (overdrevent tab af kropsvæske) eller er i saltunderskud efter anvendelse af vanddrivende medicin, er på saltfattig kost, har diarré eller ved opkastning. • Har et højt kaliumindhold i blodet (de hyppigste årsager til dette er sukkersyge, nedsat nyrefunktion, alder over 70 år og kaliumtilskud, eller medicin, der påvirker blodets indhold af kalium) • Diabetes
55 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
57 Graviditet og amning
Pregnancy and breast-feeding
Normalt vil lægen anbefale, at du straks stopper med at tage Pritor, hvis du bliver gravid.
56 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
Pritor kan også bruges i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Pritor.
Alternatively, Pritor may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Pritor.
BIVIRKNINGER 58 Pritor kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Pritor can cause side effects, although not everybody gets them.
Forekommer hos 1 til 10 patienter ud af 1. 000 • Sjældne:
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100
Hyppigheden kan ikke bestemmes ud fra de kendte data.
57 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
59 Pritor 40 mg tabletter er hvide aflange tabletter, hvorpå firmaets logo og koden 51H er præget.
Pritor 40 mg tablets are white, oblong-shaped and engraved with the code '51H 'on one side.
Pritor er pakket i blisterpakninger med 14, 28, 28x1, 30, 56, 90, 98 eller 280 tabletter.
58 Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
60 Hvis du vil have yderligere oplysninger om Pritor, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
61 INDLÆGSSEDDEL:
60 PACKAGE LEAFLET:
Pritor 80 mg tabletter Telmisartan
INFORMATION FOR THE USER Pritor 80 mg tablets Telmisartan
Vær ekstra forsigtig med at tage Pritor
Take special care with Pritor
Fortæl det til lægen, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande: • Nyresygdom eller du har fået en nyre transplantation
• Kidney disease or kidney transplant.
62 • Nedsat blodtilstrømning til en eller begge nyrer / nyrearteriestenose) • Leversygdom • Hjerteproblemer • Aldosteronnisme (vand eller saltophobning i kroppen samtidig med ubalance i mineral sammensætningen) • For lavt blodtryk (hypotension), som kan forekomme, hvis du er dehydreret (overdrevent tab af kropsvæske) eller er i saltunderskud efter anvendelse af vanddrivende medicin, er på saltfattig kost, har diarré eller ved opkastning. • Har et højt kaliumindhold i blodet (de hyppigste årsager til dette er sukkersyge, nedsat nyrefunktion, alder over 70 år og kaliumtilskud, eller medicin, der påvirker blodets indhold af kalium) • Diabetes
61 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
Pritor er, som alle andre angiotensin II- receptorantagonister, mindre effektiv til at sænke blodtrykket hos sorte mennesker.
As with all other angiotensin antagonists, Pritor may be less effective in lowering the blood pressure in black patients.
Pritor kan forårsage alvorlig fosterskade, hvis det tages mere
Usually, your doctor will advise you to take another medicine instead of Pritor, as Pritor is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalt vil lægen anbefale, at du straks stopper med at tage Pritor, hvis du bliver gravid.
62 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
Den normale dosering af Pritor til kontrol af blodtrykket i 24 timer er én tablet á 40 mg én gang daglig.
The usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Pritor kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Pritor can cause side effects, although not everybody gets them.
Forekommer hos færre en 1 patient ud af 10. 000 Ukendt hyppighed:
63 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Pritor 80 mg tabletter er hvide aflange tabletter, hvorpå firmaets logo og koden 52H er præget.
Pritor 80 mg tablets are white, oblong-shaped and engraved with the code '52H 'on one side.
Pritor er pakket i blisterpakninger med 14, 28, 28x1, 30, 56, 90, 98 eller 280 tabletter.
64 Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
65 Indehaver af markedsføringstilladelse Bayer HealthCare AG D- 51368 Leverkusen Tyskland
Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
66 Hvis du vil have yderligere oplysninger om Pritor, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
40 mg eller 80 mg telmisartan og 12, 5 mg hydrochlorothiazid; gule og hvide:
40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; yellow and white:
PritorPlus anvendes til patienter med essentiel hypertension (højt blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af telmisartan alene. ” Essentiel ” betyder, at det høje blodtryk ikke er forårsaget af nogen anden sygdomstilstand.
PritorPlus is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Det er ikke påvist, at PritorPlus er sikkert og effektivt hos patienter under 18 år.
The safety and effectiveness of PritorPlus have not been established in patients below 18 years of age.
Den dosis af PritorPlus, som skal anvendes, afhænger af den dosis af telmisartan, som patienten tog tidligere: patienter, som fik 40 mg telmisartan, skal tage 40/ 12, 5 mg- tabletterne, og patienter, der fik 80 mg telmisartan, skal tage 80/ 12, 5 mg- tabletterne.
The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/ 12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/ 12.5 mg tablets.
Tabletterne med 80/ 25 mg anvendes til patienter, hvis blodtryk ikke kan kontrolleres med 80/ 12, 5 mg- tabletterne, eller som er blevet stabiliseret ved hjælp af de to aktive stoffer indtaget separat, inden de skiftede til PritorPlus.
The 80/ 25 mg tablets are used in patients whose blood pressure is not controlled using the 80/ 12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to PritorPlus.
Ved at blokere de receptorer, som angiotensin II normalt binder til, forhindrer telmisartan hormonet i at have nogen effekt, hvorved blodkarrene udvider sig.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Det virker ved at fremkalde øget urinproduktion, således at væskemængden i blodet nedsættes, og blodtrykket nedsættes.
It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Kombinationen af de to aktive stoffer har en ekstra effekt, hvorved blodtrykket sænkes mere end ved et lægemiddel anvendt alene.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Ved en sådan blodtryksnedsættelse reduceres risikoen for skader på grund af højt blodtryk, såsom slagtilfælde.
By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
I fire af disse undersøgelser (2 272 patienter) blev PritorPlus sammenlignet med placebo (en uvirksom behandling) og med telmisartan taget alene.
In four of these studies (2,272 patients), PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone.
PritorPlus var mere effektivt end placebo samt telmisartan alene til at reducere det diastoliske blodtryk.
PritorPlus was more effective than placebo and than telmisartan alone in reducing diastolic blood pressure.
De hyppigste bivirkninger ved PritorPlus (som optræder hos mellem 1 og 10 patienter ud af 100) er bronkitis (inflammation i lungerne), pharyngitis (ondt i halsen), sinusitis (inflammation i bihulerne, luftfyldte passageveje i knoglerne rundt om næse og øjne), infektioner i de øvre luftveje (forkølelse), urinvejsinfektioner, hypercholesteroliæmi (højt kolesterolniveau i blodet), hypokalæmi (for lavt indhold af kalium i blodet), angst, svimmelhed, mavesmerter, diarré, dyspepsi (halsbrand), gastritis (betændelse i mundslimhinden), eksem (kløende, skællende hud), artralgi (ledsmerter), osteoartritis (hævelse og smerte i leddene), muskeltrækninger, smerter i arme og ben, myalgi (muskelsmerter), erektil dysfunktion (manglende evne til at opnå eller vedligeholde en rejsning), influenzalignende sygdom og smerter.
The most common side effects with PritorPlus (seen in between 1 and 10 patients in 100) are bronchitis (inflammation of the lungs), pharyngitis (sore throat), sinusitis (inflammation of the sinuses, air-filled passageways in the bones around the nose and eyes), upper respiratory tract infections (colds), urinary tract infections (infections of the structures that carry urine), hypercholesterolaemia (high blood cholesterol levels), hypokalaemia (low blood potassium levels), anxiety, dizziness, vertigo (a spinning sensation), abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn), gastritis (inflammation of the stomach lining), eczema (itchy, scaly skin), arthralgia (joint pain), osteoarthritis (swelling and pain in the joints), muscle spasms, pain in the extremities (arms and legs), myalgia (muscle pain), erectile dysfunction (inability to get or keep an erection), flu-like illness and pain.
Den fuldstændige liste over indberettede bivirkninger ved PritorPlus fremgår af indlægssedlen.
For the full list of all side effects reported with PritorPlus, see the Package Leaflet.
PritorPlus må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for telmisartan, hydrochlorothiazid, sulfonamid eller nogen af indholdsstofferne (herunder sorbitol).
PritorPlus should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients (including sorbitol).
PritorPlus må heller ikke anvendes hos personer, der har alvorlige lever -, nyre - eller galdesygdomme, eller som har for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
PritorPlus should also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede, at fordelene ved PritorPlus er større end risiciene til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
The Committee for Medicinal Products for Human Use (CHMP) decided that PritorPlus’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Andre oplysninger om PritorPlus:
Other information about PritorPlus:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for PritorPlus den 22. april 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
Indehaveren af markedsføringstilladelsen er Bayer Healthcare AG.
The marketing authorisation holder is Bayer Healthcare AG.
Markedsføringstilladelsen blev fornyet den 22. april 2007.
The marketing authorisation was renewed on 22 April 2007.
Den fuldstændige EPAR for PritorPlus findes her.
The full EPAR for PritorPlus is available here.
EU/ 1/ 02/ 215/ 009 EU/ 1/ 02/ 215/ 010 EU/ 1/ 02/ 215/ 011 EU/ 1/ 02/ 215/ 012 EU/ 1/ 02/ 215/ 013 EU/ 1/ 02/ 215/ 014 EU/ 1/ 02/ 215/ 015 EU/ 1/ 02/ 215/ 016 EU/ 1/ 02/ 215/ 017
EU/ 1/ 02/ 215/ 001 EU/ 1/ 02/ 215/ 002 EU/ 1/ 02/ 215/ 003 EU/ 1/ 02/ 215/ 004 EU/ 1/ 02/ 215/ 005 EU/ 1/ 02/ 215/ 006 EU/ 1/ 02/ 215/ 007 EU/ 1/ 02/ 215/ 008 EU/ 1/ 02/ 215/ 009 EU/ 1/ 02/ 215/ 010 EU/ 1/ 02/ 215/ 011 EU/ 1/ 02/ 215/ 012 EU/ 1/ 02/ 215/ 013 EU/ 1/ 02/ 215/ 014 EU/ 1/ 02/ 215/ 015 EU/ 1/ 02/ 215/ 016 EU/ 1/ 02/ 215/ 017 EU/ 1/ 02/ 215/ 018 EU/ 1/ 02/ 215/ 019 EU/ 1/ 02/ 215/ 020 EU/ 1/ 02/ 215/ 021
PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus
PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus PritorPlus
80 mg/ 12, 5 mg 80 mg/ 12, 5 mg 40 mg/ 12, 5 mg 80 mg/ 12, 5 mg 40 mg/ 12, 5 mg 80 mg/ 12, 5 mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg
40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
56 tabletter 98 tabletter 90 tabletter 90 tabletter 30 tabletter 30 tabletter 14 tabletter 28 tabletter 28 x 1 tabletter
14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 90 tablets 90 tablets 30 tablets 30 tablets 14 tablets 28 tablets 28 x 1 tablets 30 tablets 56 tablets 90 tablets 98 tablets
PritorPlus 40 mg/ 12, 5 mg tabletter
PritorPlus 40 mg/ 12.5 mg tablets
Ovale tabletter i to lag, et rødt og et hvidt, hvori koden ” H4 ” er præget på.
Red and white oval shaped two layer tablet engraved with the code number'H4 '.
Fastdosiskombinationen PritorPlus (40 mg telmisartan/ 12, 5 mg hydrochlorthiazid) er indiceret til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med telmisartan alene.
PritorPlus fixed dose combination (40 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
Voksne PritorPlus gives, hvis blodtrykket ikke kan reguleres tilfredsstillende med telmisartan alene.
Adults PritorPlus should be taken once daily with liquid, with or without food in patients whose blood pressure is not adequately controlled by telmisartan alone.
• PritorPlus 40 mg/ 12, 5 mg er til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med Pritor 40 mg • PritorPlus 80 mg/ 12, 5 mg er til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med Pritor 80 mg.
• PritorPlus 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 40 mg • PritorPlus 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 80 mg
Hos patienter med let eller moderat nedsat leverfunktion bør dosis ikke overskride PritorPlus 40 mg/ 12, 5 mg én gang daglig.
In patients with mild to moderate hepatic impairment the posology should not exceed PritorPlus 40 mg/ 12.5 mg once daily.
PritorPlus bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelig dokumentation for sikkerhed og virkning.
PritorPlus is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
4. 3), idet telmisartan overvejende udskilles med galden.
PritorPlus should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
Desuden skal PritorPlus anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske - og elektrolytbalancen kan udløse hepatisk coma.
In addition, PritorPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
4. 3).
PritorPlus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Sådanne tilstande bør korrigeres før behandling med PritorPlus.
Such conditions should be corrected before the administration of PritorPlus.
Der er dog kun rapporteret om minimal eller ingen påvirkning ved den mængde thiazid (12, 5 mg), som findes i PritorPlus.
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in PritorPlus, minimal or no effects were reported.
Omvendt kan hyperkaliæmi optræde på grund af telmisartans antagonistiske effekt på angiotensin II (AT1) - receptorerne.
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of PritorPlus, hyperkalaemia might occur.
Skønt der ikke er set nogen klinisk signifikant hyperkaliæmi i forbindelse med PritorPlus, så omfatter risikofaktorerne for udvikling af hyperkaliæmi blandt andet nyreinsufficiens og/ eller hjertesvigt samt diabetes mellitus.
Although clinically significant hyperkalaemia has not been documented with PritorPlus, risk factors for the development of hyperkalaemia include renal insufficiency and/ or heart failure, and diabetes mellitus.
4. 5).
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with PritorPlus (see section 4.5).
I sjældne tilfælde er dette også set ved behandling med angiotensin II- receptorantagonister (som PritorPlus).
Rare cases have also been reported with angiotensin II receptor antagonists (including PritorPlus).
Samme anbefaling gælder for nedenstående ” torsades de pointes ” inducerende lægemidler (herunder visse antiarrytmika), hvor hypokaliæmi er en prædisponerende faktor.
Periodic monitoring of serum potassium and ECG is recommended when PritorPlus is administered with these medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
4. 3) Der foreligger ikke tilstrækkelige data om brugen af PritorPlus hos gravide kvinder.
There are no adequate data from the use of PritorPlus in pregnant women.