natgillin/translations-raw huggingface dataset:
Kinzalkomb bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelig dokumentation for sikkerhed og virkning.
Kinzalkomb is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
• Overfølsomhed over for de aktive stoffer eller ét eller flere af hjælpestofferne (se pkt.
• Hypersensitivity to any of the active substances or to any of the excipients (see section 6.1).
4. 6) • Galdeophobning i galdegange og galdeobstruktion • Svært nedsat leverfunktion • Svært nedsat nyrefunktion (kreatinin- clearance < 30 ml/ min) • Refraktær hypokaliæmi, hyperkalcæmi.
2 • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). • Second and third trimester of pregnancy and lactation (see sections 4.4 and 4.6). • Cholestasis and biliary obstructive disorders. • Severe hepatic impairment. • Severe renal impairment (creatinine clearance < 30 ml/ min). • Refractory hypokalaemia, hypercalcaemia.
Graviditet Angiotensin II- receptorantagonister bør ikke anvendes under graviditet.
Pregnancy Angiotensin II receptor antagonists should not be initiated during pregnancy.
Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, medmindre fortsat behandling med angiotensin II- receptorantagonist er påkrævet.
Unless continued angiotensin II receptor antagonist 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.
4. 3 og 4. 6).
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
4. 3), idet telmisartan overvejende udskilles med galden.
Kinzalkomb 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 Kinzalkomb anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske - og elektrolytbalancen kan udløse hepatisk coma.
In addition, Kinzalkomb 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.
Der er øget risiko for alvorlig hypotension og nyreinsufficiens, når patienter med bilateral nyrearteriestenose eller stenose af arterien til en enkelt fungerende nyre behandles med lægemidler, som påvirker renin- angiotensin- aldosteronsystemet.
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
4. 3).
Kinzalkomb should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Hos patienter med nedsat nyrefunktion kan thiazid medføre azotæmi.
Thiazide diuretic- associated azotaemia may occur in patients with impaired renal function.
Intravaskulær hypovolæmi:
Intravascular hypovolaemia:
Specielt efter første dosis kan der forekomme symptomatisk hypotension hos patienter, som har for lavt volumen i blodbanen eller natriummangel på grund af kraftig diuretisk behandling, saltfattig diæt, diarré eller opkastning.
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Sådanne tilstande bør korrigeres før behandling med Kinzalkomb.
Such conditions should be corrected before the administration of Kinzalkomb.
Andre tilstande med stimulering af renin- angiotensin- aldosteronsystemet:
Other conditions with stimulation of the renin-angiotensin-aldosterone system:
4. 8).
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin- aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
3 Primær aldosteronisme:
Primary aldosteronism:
Patienter med primær aldosteronisme vil generelt ikke respondere på antihypertensiva, som virker ved at hæmme renin- angiotensinsystemet.
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Som ved brug af andre vasodilatatorer bør særlig forsigtighed udvises hos patienter, der lider af aorta - eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Metaboliske og endokrine virkninger:
3 Metabolic and endocrine effects:
Hos diabetikere kan det være nødvendigt med dosisjusteringer af insulin eller perorale antidiabetika.
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Der er dog kun rapporteret om minimal eller ingen påvirkning ved den mængde thiazid (12, 5 mg), som findes i Kinzalkomb.
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Kinzalkomb, minimal or no effects were reported.
Thiazider, herunder hydrochlorthiazid, kan forårsage forstyrrelser i væske - eller elektrolytbalancen (bl. a. hypokaliæmi, hyponatriæmi og hypochloræmisk alkalose).
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis).
4. 8).
Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting (see section 4.8).
Hypokaliæmi kan forkomme ved anvendelse af thiaziddiuretika, men samtidig behandling med telmisartan kan reducere den diuretika- inducerede hypokaliæmi.
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia.
4. 5).
The risk of hypokalaemia is greater in patients with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or Adrenocorticotropic hormone (ACTH) (see section 4.5).
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 Kinzalkomb, hyperkalaemia might occur.
Skønt der ikke er set nogen klinisk signifikant hyperkaliæmi i forbindelse med Kinzalkomb, 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 Kinzalkomb, 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 Kinzalkomb (see section 4.5).
- Hyponatriæmi og hypochloræmisk alkalose
- Hyponatraemia and hypochloraemic alkalosis
4. 5).
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia (see section 4.5).
Sorbitol og lactosemonohydrat:
Sorbitol and Lactose Monohydrate:
Det bør derfor ikke indtages af patienter med sjælden arvelig fructoseintolerans og/ eller sjælden arvelig galactoseintolerans, Lapp Lactasemangel (særlig form for arvelig lactasemangel) eller glucose - / galactosemalabsorption.
Patients with rare hereditary problems of fructose intolerance and/ or with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4 Etniske forskelle:
Ethnic differences:
Dette skyldes muligvis en hyppigere forekomst af lavt reninniveau i den hypertensive negroide population.
As with all other angiotensin II receptor antagonists, telmisartan is apparently less effective in lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
Andet:
4 Other:
Dog er de mere sandsynlige hos førstnævnte patientgruppe.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Forværring eller aktivering af systemisk lupus erythematosus er rapporteret ved anvendelsen af thiaziddiuretika.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
4. 8).
Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8).
Der er rapporteret reversible stigninger i serum- lithiumkoncentrationerne samt toksicitet ved samtidig behandling med lithium og ACE- hæmmere.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
I sjældne tilfælde er dette også set ved behandling med angiotensin II- receptorantagonister (som Kinzalkomb).
Rare cases have also been reported with angiotensin II receptor antagonists (including Kinzalkomb).
Hvis denne kombination skønnes nødvendig, tilrådes tæt monitorering af serum- lithiumniveauet.
If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Lægemidler, der forbindes med kaliumtab og hypokaliæmi (fx andre kaliuretiske diuretika, laksantia, kortikosteroider, ACTH, amphotericin, carbenoxolon, G- penicillin, salicylsyre og derivater):
Medicinal products associated with potassium loss and hypokalaemia (e. g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives):
Hvis disse stoffer gives sammen med hydrochlorthiazid- telmisartan- kombinationen, tilrådes monitorering af kalium- plasmaniveauet.
If these substances are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
4. 4).
These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).
Lægemidler, som kan øge kaliumniveauet eller udløse hyperkaliæmi (fx ACE- hæmmere, kaliumbesparende diuretika, kaliumtilskud, saltsubstituter der indeholder kalium, ciclosporin eller andre lægemidler, fx heparin- natrium):
ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium):
Hvis disse medikamenter gives sammen med hydrochlorthiazid- telmisartan- kombinationen, tilrådes monitorering af kalium- plasmaniveauet.
If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
4. 4).
Based on the experience with the use of other medicinal products that blunt the renin- angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Lægemidler, som påvirkes af serumkaliumforstyrrelser:
Medicinal products affected by serum potassium disturbances:
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 Kinzalkomb 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.
- klasse 1a- antiarytmika, (fx kinidin, hydrokinidin, disopyramid)
- class Ia antiarrythmics (e. g. quinidine, hydroquinidine, disopyramide)
- klasse 3- antiarytmika, (fx amiodaron, sotalol, doftilid, ibutilid)
- class III antiarrythmics (e. g. amiodarone, sotalol, dofetilide, ibutilide)
- visse antipsykotika (fx thioridazin, chlorpromazin, levomepromazin, trifluoperazin,
- some antipsychotics (e. g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
- andre (fx bepridil, cisaprid, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidin,
- others (e. g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
sparfloxacin, terfenadin, vincamin IV)
pentamidine, sparfloxacine, terfenadine, vincamine IV.)
Digitalisglykosider:
Digitalis glycosides:
4. 4).
Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
5 Andre antihypertensiva:
Other antihypertensive agents:
Antidiabetika (perorale midler og insuliner):
Antidiabetic medicinal products (oral agents and insulin):
4. 4).
Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Risikoen for lactoacididose forårsaget af et muligt funktionelt nyresvigt i forbindelse med hydrochlorthiazid.
Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
Cholestyramin og colestipolresiner:
Cholestyramine and colestipol resins:
Non- steroide anti- inflammatoriske lægemidler (NSAID):
Non-steroidal anti-inflammatory medicinal products:
NSAID (f. eks. acetylsalicylsyre (ASA) i doser beregnet til anti- inflammatorisk behandling, COX- 2- hæmmere og ikke- selektive NSAID) kan hos nogle patienter nedsætte den diuretiske, natriuretiske og antihypertensive virkning af thiaziddiuretika og den antihypertensive virkning af angiotensin II- receptorantagonister.
NSAIDs (i. e. acetylsalicylic acid at anti- inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
Samtidig behandling med angiotensin II- receptorantagonister og stoffer der hæmmer cyclo - oxygenasen, kan medføre en yderligere svækkelse hos nogle patienter, der allerede har nedsat nyrefunktion (dehydrering, alder).
In some patients with compromised renal function (e. g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Der kan opstå akut nyresvigt, som i de fleste tilfælde er reversibelt. Derfor bør samtidig behandling foregå under nøje overvågning, især af ældre patienter.
Therefore the combination should be administered with caution, especially in the elderly.
Pressor- aminer (fx noradrenalin):
Pressor amines (e. g. noradrenaline):
Virkningen af pressor- aminer kan være forringet.
The effect of pressor amines may be decreased.
Ikke- depolariserende muskelrelaksantia (fx tubocurarin):
Nondepolarizing skeletal muscle relaxants (e. g. tubocurarine):
Virkningen af ikke- depolariserende muskelrelaksantia kan forstærkes af hydrochlorthiazid.
The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
Lægemidler, der anvendes til behandling af urinsyregigt (fx probenecid, sulfinpyrazon og allopurinol):
Medicinal products used in the treatment for gout (e. g. probenecid, sulfinpyrazone and allopurinol):
Øgning af probenecid - eller sulfinpyrazondosis kan være nødvendig.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Kalciumsalte:
Calcium salts:
Hvis der gives kalciumsupplement, skal serumkalcium monitoreres og kalciumdoseringen justeres herefter.
If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.
Betablokkere og diazoxid:
Beta-blockers and diazoxide:
Anticholinergika kan øge biotilgængeligheden af diuretika af thiazid- typen ved at nedsætte den gastrointestinale motilitet og mavetømningshastigheden.
Anticholinergic agents (e. g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Cytotoksiske lægemidler (fx cyclophosphamid, methotrexat):
Cytotoxic agents (e. g. cyclophosphamide, methotrexate):
Følgende præparater har farmakologiske egenskaber, der kan forventes at forstærke den hypotensive effekt af alle antihypertensiva, herunder telmisartans:
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan:
Baclofen, amifostin.
Baclofen, amifostine.
4. 4.).
The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
4. 3 og 4. 4).
The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
6 Graviditet (se pkt.
6 Pregnancy (see section 4.3):
4. 3) Der foreligger ikke tilstrækkelige data om brugen af Kinzalkomb hos gravide kvinder.
There are no adequate data from the use of Kinzalkomb in pregnant women.
Det kan dog ikke udelukkes, at der er en lille risiko.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, med mindre fortsat behandling med angiotensin II- receptorantagonister er påkrævet.
Unless continued angiotensin II receptor antagonist 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.
Behandling i andet og tredje trimester med angiotensin II- receptorantagonister kan medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, forsinkelse af knogledannelsen i kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi).
Angiotensin II receptor antagonist therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
(Se også pkt.
(See also section 5.3).
Hvis angiotensin II - receptorantagonister har været anvendt fra andet trimester, bør nyrefunktionen og kraniet kontrolleres ved hjælp af ultralyd.
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
4. 3 og 4. 4.).
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see also sections 4.3 and 4.4).
Thiazider krydser placentabarrieren og kan ses i navlestrengsblod.
Thiazides cross the placental barrier and appear in cord blood.
De kan forårsage elektrolytforstyrrelser hos fostret og muligvis også andre reaktioner, som er set hos voksne.
They may cause foetal electrolyte disturbances and possibly other reactions that have occurred in the adults.
Der er rapporteret om tilfælde af neonatal trombocytopeni og af gulsot hos fostret og den nyfødte, hvor moderen har været i behandling med thiazider.
Cases of neonatal thrombocytopenia, of foetal or neonatal jaundice have been reported with maternal thiazide therapy.
4. 3):
Lactation (see section 4.3):
Kinzalkomb er kontraindiceret ved amning, da det ikke vides, om telmisartan udskilles i modermælken.
Kinzalkomb is contraindicated during lactation since it is not known whether telmisartan is excreted in human milk.
Thiazider ses i modermælken og kan hæmme mælkedannelsen.
Thiazides appear in human milk and may inhibit lactation.
Ved kørsel af befordringsmiddel eller betjening af maskiner bør man dog være opmærksom på, at der ved antihypertensiv behandling lejlighedsvis kan forekomme svimmelhed eller døsighed.
However, when driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy.
Fastdosiskombination I randomiserede, kontrollerede forsøg med alt i alt 1471 patienter, var den totale rapporterede forekomst af bivirkninger ved brug af Kinzalkomb (835 patienter) sammenlignelig med forekomsten for telmisartan alene (636 patienter).
Fixed Dose Combination The overall incidence of adverse events reported with Kinzalkomb was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Hyppigheden af bivirkninger var ikke dosisrelateret og der var ingen korrelation med patienternes køn, alder eller race.
Dose-relationship of undesirable effects was not established and they showed no correlation with gender, age or race of the patients.
Tabellen nedenfor viser de bivirkninger, der forekom hyppigere (p ≤ 0, 05) for telmisartan plus hydrochlorthiazid end for placebo i de kliniske forsøg.
Adverse reactions reported in all clinical trials and occurring more frequently (p ≤ 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Bivirkningerne er opdelt efter organklasse og opført efter hyppighed ud fra følgende konvention: meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
De alvorligste bivirkninger er angivet først.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
7 Infektioner og parasitære sygdomme
Infections and infestations
Bronkit Faryngit, sinuit
Bronchitis Pharyngitis, sinusitis
Ikke almindelig:
and nutrition disorders
Hypokaliæmi Hyperuricæmi, hyponatræmi
Hypokalaemia, Hyperuricaemia, hyponatraemia
Svimmelhed Synkope, paræstesi Søvnløshed, søvnforstyrrelser
Dizziness Syncope, paraesthesia Insomnia, sleep disorders
Takykardi, arytmi
Tachycardia, arrhythmias
Hypotension, ortostatisk hypotension
Hypotension, orthostatic hypotension
Dyspnø Åndedrætsbesvær (inklusive pneumonit og lungeødem)
Dyspnoea Respiratory distress (including pneumonitis and pulmonary oedema)
Diarré, mundtørhed, flatulens Abdominalsmerter, forstoppelse, dyspepsi, opkastning Gastrit
Diarrhoea, dry mouth, flatulence, Abdominal pain, constipation, dyspepsia, vomiting Gastritis
Unormal leverfunktion/ leversygdom
Abnormal hepatic function/ liver disorder
Hud og
Skin and subcutaneous tissue disorders
subkutane væv Sjælden:
Rare:
Angioødem, erytem, prutitus, udslæt, hyperhidrose, urticaria
Angioedema, erythema, pruritus, rash, hyperhidrosis, urticaria