natgillin/translations-raw huggingface dataset:
Rygsmerter, muskelspasmer, myalgi Artralgi, muskelkramper, smerter i ekstremiteter
Back pain, muscle spasms myalgia Arthralgia, muscle cramps, pain in limb
Brystsmerter
Uncommon:
Influenzalignende symptomer, smerter
Chest pain Influenza-like illness, pain
Forhøjet urinsyre i blodet Forhøjet serumkreatinin, forhøjet kreatininkinase i blodet, forhøjede leverenzymer
Blood uric acid increased Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Yderligere oplysninger om de enkelte komponenter Tidligere rapporterede bivirkninger for de enkelte indholdsstoffer kan også være potentielle bivirkninger i forbindelse med Kinzalkomb, selvom de ikke er observeret i kliniske forsøg med dette produkt.
8 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with Kinzalkomb, even if not observed in clinical trials with this product.
Bivirkningerne forekom med samme hyppighed hos patienterne i placebo - og i telmisartangruppen.
Undesirable effects occurred with similar frequency in placebo and telmisartan treated patients.
I placebo- kontrollerede forsøg var den samlede forekomst af bivirkninger, som blev rapporteret i forbindelse med telmisartan (41, 4%) sædvanligvis sammenlignelig med placebo (43, 9%).
The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials.
Følgende bivirkninger er samlet fra alle kliniske forsøg med 5788 hypertensive patienter behandlet med telmisartan.
The following adverse drug reactions listed below have been accumulated from all clinical trials including 5788 hypertensive patients treated with telmisartan.
Følgende bivirkninger af ukendt hyppighed er rapporteret ved brug af telmisartan alene:
Adverse reactions of unknown frequency reported with the use of telmisartan alone include:
Infektion i øvre luftveje, urinvejsinfektion herunder cystitis,
Upper respiratory tract infection, urinary tract infection including cystitis
Eosinofili, anæmi, trombocytopeni
Eosinophilia, anaemia, thrombocytopenia
Gastrointestinalt ubehag
Stomach discomfort
subkutane væv Ikke kendt:
Not known:
Artrose, senesmerter
Arthrosis, tendon pain
Nyreinsufficiens, nedsat nyrefunktion (inklusive akut nyresvigt)
Renal dysfunction, renal impairment (including acute renal failure)
9 Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions
Asteni, udebleven effekt
Asthenia, drug ineffective
4. 4).
Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see section 4.4).
Sialoadenit
Sialoadenitis
lymfesystem
9 Blood and lymphatic system disorders
Aplastisk anæmi, hæmolytisk anæmi, knoglemarvssvigt, leukopeni, neutropeni, trombocytopeni, agranulocytose
Anaemia aplastic, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis, thrombocytopenia
Svimmelhed
Light-headedness
Xantopsi
Xanthopsia
subkutant væv Ikke kendt:
Not known:
Lupus- lignende syndrom, lysfølsomhedsreaktion, kutan vaskulit, toksisk epidermal nekrolyse
Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis
10 Nyre og urinveje
Renal and urinary disorders
Interstitiel nefrit, nedsat nyrefunktion, glukosuri
Nephritis interstitial, renal dysfunction, glycosuria
De mest udtalte symptomer ved telmisartan- overdosering var hypotension og takykardi; også bradykardi, svimmelhed, opkastning, forhøjelse i serum- kreatinin og akut nyresvigt er set.
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
Overdosering med hydrochlorthiazid medfører elektrolytforstyrrelser (hypokaliæmi, hypokloræmi) og hypovolæmi pga. overdreven diurese.
Overdose with hydrochlorothiazide is associated with electrolyte depletion
Hypokaliæmi kan ved samtidig brug af digitalisglykosider eller visse antiarytmika resultere i muskelkramper og/ eller accentueret arytmi.
Hypokalaemia may result in muscle spasms and/ or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Provokeret opkastning og/ eller maveudskylning er mulige behandlinger.
Suggested measures include induction of emesis and/ or gastric lavage.
Ved hypotension skal patienten lægges i rygleje, og der skal hurtigt gives salt - og væskesubstitution.
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
ATC- kode:
Angiotensin II receptor antagonists and diuretics, ATC code:
C09D A07
C09DA07
Kinzalkomb er en kombination af en angiotensin II- receptorantagonist, telmisartan og thiazidet hydrochlorthiazid.
Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Telmisartan er en oralt administreret effektiv specifik angiotensin II- receptorsubtype 1( AT1) - antagonist.
Telmisartan is an orally effective and specific angiotensin II receptor subtype 1 (AT1) antagonist.
Telmisartan udviser ingen partiel agonistaktivitet ved AT1- receptoren.
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Telmisartan bindes selektivt til AT1 - receptoren.
Telmisartan selectively binds the AT1 receptor.
Telmisartan udviser ikke affinitet til andre receptorer, herunder AT2 og andre mindre karakteriserede AT- receptorer.
Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Telmisartan hæmmer ikke "angiotensin- converting - enzyme" (kininase- II- enzymet), som også nedbryder bradykinin.
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
11 En dosis på 80 mg telmisartan givet til raske frivillige hæmmer næsten fuldstændigt en angiotensin II - provokeret blodtryksforhøjelse.
An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the angiotensin II evoked blood pressure increase.
Den maksimale reduktion i blodtrykket opnås generelt 4- 8 uger, efter behandlingen er påbegyndt og fastholdes gennem langtidsbehandling.
The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of treatment and is sustained during long-term therapy.
Dette er bekræftet ved målinger, der blev foretaget på tidspunktet for maksimal effekt og umiddelbart forud for den næste dosis (trough/ peak ratio var over 80% efter dosering af 40 mg og 80 mg telmisartan i alle placebokontrollerede kliniske forsøg).
This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80% after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Ved pludselig seponering af telmisartan, vil blodtrykket gradvist returnere til værdierne fra før behandlingsstart over en periode på flere dage, uden at der ses tegn på "rebound" - hypertension.
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Forekomsten af tør hoste var signifikant lavere hos de patienter, der blev behandlet med telmisartan end hos dem, der blev behandlet med ACE- hæmmere i kliniske forsøg, som direkte sammenlignede disse to antihypertensive behandlinger.
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Effekten af telmisartan på dødelighed og kardiovaskulær morbiditet er i øjeblikket ukendt.
11 The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
Sandsynligvis pga. blokering af renin- angiotensin - aldosteronsystemet synes telmisartan at modvirke det kaliumtab, der er forbundet med disse diuretika.
Presumably through blockade of the renin- angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Effekten af en fastdosiskombination af telmisartan/ HCTC på dødelighed og kardiovaskulær morbiditet er indtil videre ukendt.
The effects of Fixed Dose Combination of telmisartan/ HCTZ on mortality and cardiovascular morbidity are currently unknown.
Ved peroral administration opnås peak- koncentrationerne af telmisartan i løbet af 0, 5- 1, 5 time efter indgift.
Following oral administration peak concentrations of telmisartan are reached in 0.5 – 1.5 h after dosing.
42% og 58%.
The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42% and 58%, respectively.
19% ved en dosis på 160 mg.
Food slightly reduces the bioavailability of telmisartan with a reduction in the area under the plasma concentration time curve (AUC) of about 6% with the 40 mg tablet and about 19% after a 160 mg dose.
Farmakokinetikken ved peroralt indgivet telmisartan er ikke- lineær ved doser på 20- 160 mg, idet der ved stigende doser ses overproportionale stigninger af plasmakoncentrationen (Cmax og AUC).
The pharmacokinetics of orally administered telmisartan are non- linear over doses from 20 – 160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses.
Ved peroral administration af Kinzalkomb nås peak- koncentrationerne af hydrochlorthiazid i løbet af 1, 0- 3, 0 time efter indgift.
Following oral administration of Kinzalkomb peak concentrations of hydrochlorothiazide are reached in approximately 1.0 – 3.0 hours after dosing.
60%.
Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60%.
12 Distribution:
Distribution:
Telmisartan er i høj grad bundet til plasmaproteiner (> 99, 5%), hovedsagelig albumin og alfa- I- syre glycoprotein.
Telmisartan is highly bound to plasma proteins (> 99.5%) mainly albumin and alpha l- acid glycoprotein.
500 l, hvilket tyder på ekstra vævsbinding.
The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
68% af hydrochlorthiazidet er bundet i plasma, og det tilsyneladende fordelingsvolumen er 0, 83- 1, 14 l/ kg.
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83 – 1.14 l/ kg.
Biotransformation og eliminering:
Biotransformation and elimination:
Efter enten intravenøs eller oral administration af 14C - mærket telmisartan blev størstedelen af den indgivne dosis (> 97%) udskilt i fæces via biliær ekskretion.
Following either intravenous or oral administration of 14 C-labelled telmisartan most of the administered dose (> 97%) was eliminated in faeces via biliary excretion.
11% af den målte radioaktivitet i plasma.
After a single dose of 14C-labelled telmisartan the glucuronide represents approximately 11% of the measured radioactivity in plasma.
Cytokrom P450 - isoenzymer er ikke involveret i metaboliseringen af telmisartan.
The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Telmisartans totale plasmaclearance efter oral administration er > 1500 ml/ min.
Total plasma clearance of telmisartan after oral administration is > 1500 ml/ min.
Den terminale eliminationshalveringstid var > 20 timer.
Terminal elimination half-life was > 20 hours.
Hydrochlorthiazid metaboliseres ikke hos mennesker og udskilles næsten fuldstændigt uforandret i urinen.
Hydrochlorothiazide is not metabolised in man and is excreted almost entirely as unchanged substance in urine.
60% af den perorale dosis udskilles uforandret i løbet af 48 timer.
About 60% of the oral dose is eliminated as unchanged substance within 48 hours.
250- 300 ml/ min.
Renal clearance is about 250 – 300 ml/ min.
Den terminale eliminationshalveringstid for hydrochlorthiazid er 10- 15 timer.
The terminal elimination half-life of hydrochlorothiazide is 10 – 15 hours.
Specielle populationer
12 Special populations
Telmisartans plasmakoncentration er generelt 2- 3 gange højere hos kvinder end hos mænd.
Plasma concentrations of telmisartan are generally 2 – 3 times higher in females than in males.
50 ml/ min).
Based on modest experience in patients with mild to moderate renal impairment (creatinine clearance of 30 – 60 ml/ min, mean about 50 ml/ min) no dosage adjustment is necessary in patients with decreased renal function.
I et typisk forsøg med patienter med en middel kreatinin- clearance på 90 ml/ min, var elimineringshalveringstiden for hydrochlorthiazid øget.
In a typical study in patients with a mean creatinine clearance of 90 ml/ min the elimination half-life of hydrochlorothiazide was increased.
34 timer.
In functionally anephric patients the elimination half-life is about 34 hours.
I farmakokinetiske forsøg med patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100%.
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100%.
I prækliniske sikkerhedsforsøg med samtidig indgift af telmisartan og hydrochlorthiazid i normotensive rotter og hunde i doser, der gav en eksponering sammenlignelig med den i det klinisk - terapeutiske område, fandt man ikke andre resultater end dem, der allerede var set ved indgift af de to stoffer hver for sig.
In preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, doses producing exposure comparable to that in the clinical therapeutic range caused no additional findings not already observed with administration of either substance alone.
Fald i røde blodcelleparametre (erytrocytter, hæmoglobin, hæmatokrit), ændringer i den renale hæmodynamik (forhøjet urea N i serum (BUN) og kreatinin), forøget plasmareninaktivitet, hypertrofi/ hyperplasi af de juxtaglomerulære celler og gastriske slimhindelæsioner.
Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/ hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Gastriske læsioner kunne forhindres/ afhjælpes ved peroral salttilførsel og
Gastric lesions could be prevented/ ameliorated by oral saline supplementation and group housing of animals.
Telmisartan viste intet tegn på mutagenicitet og relevant klastogen aktivitet ved in vitro- forsøg, og ingen tegn på karcinogenicitet i rotter og mus.
Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
4. 6.
For the foetotoxic potential of the telmisartan/ hydrochlorothiazide combination see section 4.6.
Lactosemonohydrat Magnesiumstearat Majsstivelse Meglumin Mikrokrystallinsk cellulose Povidon (K25) Rød jernoxid (E172) Natriumhydroxid Natriumstivelsesglycolat (type A) Sorbitol (E420)
13 Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Opbevares i original emballage for at beskytte mod fugt 6. 5 Emballagetype og pakningsstørrelser
Store in the original package in order to protect from moisture.
Aluminium/ aluminium blister (PA/ Al/ PVC/ Al eller PA/ PA/ Al/ PVC/ Al).
Aluminium/ aluminium blisters (PA/ Al/ PVC/ Al or PA/ PA/ Al/ PVC/ Al).
Blister med 14, 28, 56, eller 98 tabletter eller perforeret enkeltdosis blister med 28 x 1 tabletter.
Blister with 14, 28, 56, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
19. april 2002 Dato for forlængelse af markedsføringstilladelse:
Date of first authorisation:19 April 2002 Date of last renewal:
Kinzalkomb 80 mg/ 12, 5 mg tabletter
Kinzalkomb 80 mg/ 12.5 mg tablets
Én tablet indeholder 80 mg telmisartan og 12, 5 mg hydrochlorthiazid.
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Ovale tabletter i to lag, et rødt og et hvidt, hvori koden ” H8 ” er præget.
Red and white oval shaped two layer tablet engraved with the code number'H8 '.
Fastdosiskombinationen Kinzalkomb (80 mg telmisartan12, 5 mg hydrochlorthiazid) er indiceret til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med telmisartan alene.
Kinzalkomb fixed dose combination (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
16 Børn og unge:
Children and adolescents:
4. 6) • Galdeophobning i galdegange og galdeobstruktion • Svært nedsat leverfunktion • Svært nedsat nyrefunktion (kreatinin- clearance < 30 ml/ min) • Refraktær hypokaliæmi, hyperkalcæmi.
15 • 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.
I tilfælde af konstateret graviditet, skal behandling med angiotensin II- receptorantagonister straks seponeres, og alternativ behandling påbegyndes (se pkt.
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).
17 Primær aldosteronisme:
Primary aldosteronism:
Metaboliske og endokrine virkninger:
16 Metabolic and endocrine effects:
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).
18 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:
17 Other:
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 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.
19 Andre antihypertensiva:
Other antihypertensive agents:
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 (eg 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.
20 Graviditet (se pkt.
19 Pregnancy (see section 4.3):
21 Infektioner og parasitære sygdomme
Infections and infestations
Metabolisme og ernæring
20 Metabolism and nutrition disorders
subkutane væv Sjælden:
Rare::
Rygsmerter, muskelspasmer, myalgi Artralgi, muskelkramper, smerter i ekstremiteter
Back pain, muscle spasms, myalgia Arthralgia, muscle cramps, pain in limb
Yderligere oplysninger om de enkelte komponenter Tidligere rapporterede bivirkninger for de enkelte indholdsstoffer kan også være potentielle bivirkninger i forbindelse med Kinzalkomb, selvom de ikke er observeret i kliniske forsøg med dette produkt.
21 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with Kinzalkomb, even if not observed in clinical trials with this product.
23 Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions
Infektioner og parasitære sygdomme
22 Infections and infestations
lymfesystem
Blood and lymphatic system disorders
24 Nyre og urinveje
Renal and urinary disorders
Symptomer:
23 Symptoms:
25 En dosis på 80 mg telmisartan givet til raske frivillige hæmmer næsten fuldstændigt en angiotensin II - provokeret blodtryksforhøjelse.
An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the angiotensin II evoked blood pressure increase.
Ved pludselig seponering af telmisartan, vil blodtrykket gradvist returnere til værdierne fra før behandlingsstart over en periode på flere dage, uden at der ses tegn på "rebound" - hypertension.
24 Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Effekten af telmisartan på dødelighed og kardiovaskulær morbiditet er i øjeblikket ukendt.
The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
26 Distribution:
Distribution:
68% af hydrochlorthiazidet er bundet i plasma, og det tilsyneladende fordelingsvolumen er 0, 83- 1, 14 l/ kg.
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83 – 1.14 1/ kg.
Hydrochlorthiazid:
25 Hydrochlorothiazide:
Lactosemonohydrat Magnesiumstearat Majsstivelse Meglumin Mikrokrystallinsk cellulose Povidon (K25) Rød jernoxid (E172) Natriumhydroxid Natriumstivelsesglycolat (type A) Sorbitol (E420)
26 Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Kinzalkomb 80 mg/ 25 mg tabletter
Kinzalkomb 80 mg/ 25 mg tablets
Gul og hvid farvede ovale tabletter med koden ” H9 ” præget på.
Yellow and white oval shaped tablet engraved with the code'H9 '.
• I fastdosiskombinationen er Kinzalkomb (80 mg telmisartan/ 25 mg hydrochlorthiazid) indiceret til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med Kinzalkomb 80 mg/ 12, 5 mg (80 mg telmisartan/ 12, 5 mg hydrochlorothiazid) eller til patienter, som tidligere er stabiliseret på telmisartan og hydrochlorothiazid givet hver for sig..
Kinzalkomb fixed dose combination (80 mg telmisartan/ 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb 80 mg/ 12.5 mg (80 mg telmisartan/ 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
• Kinzalkomb 80 mg/ 25 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med Kinzalkomb 80 mg/ 12, 5 mg eller til patienter, som tidligere er stabiliseret på telmisartan og hydrochlorothiazid givet hver for sig.
Kinzalkomb 80 mg/ 25 mg may be administered in patients whose blood pressure is not adequately controlled by Kinzalkomb 80 mg/ 12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Kinzalkomb findes i styrkerne 40 mg/ 12, 5 mg og 80 mg/ 12, 5 mg.
Kinzalkomb is also available at the dose strengths 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
30 Børn og unge:
Children and adolescents:
4. 3 Kontraindikationer
29 4.3 Contraindications