natgillin/translations-raw huggingface dataset:
Liv Mathison (Norge) 24. april 2008 20. oktober 2008 20. november 2008
Dr Alar Irs (Estonia) Dr Liv Mathison (Norway) 24 April 2008 20 October 2008 20 November 2008
1/ 26 Medlemsstat
1/ 25
Særnavn
Member State
Det Forenede Kongerige Tlf.:
UK Tel:
oral anvendelse
oral
Generics [UK] Ltd., Station Close, Potters Bar, Herts, EN6 1TL.
Generics [UK] Ltd.,
4mg 4mg
tablet
2/ 26 BILAG II
2/ 25 ANNEX II
3/ 26 FAGLIGE KONKLUSIONER
3/ 25 SCIENTIFIC CONCLUSIONS
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF Doxagamma 4 mg depottabletter og de tilknyttede navne (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxagamma 4 mg prolonged release tablets and associated names (see Annex I)
CHMP var af den opfattelse, at bioækvivalensen efter indgivelse af en enkelt dosis i to forskellige bioækvivalensundersøgelser (undersøgelse 463/ 04 og 1995/ 04- 05) og indgivelse af flere doser (undersøgelse 5208/ 02- 3) var blevet tilstrækkeligt påvist i overensstemmelse med CHMP’ s retningslinjer.
CHMP was of the opinion that the bioequivalence was sufficiently established after single dose administration in two different bioequivalence studies (study 463/ 04 and 1995/ 04-05) and after multiple dose administration (study5208/ 02-3) according to the CHMP guidelines.
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ( ER), ETIKETTERING OG INDLÆGSSEDDEL
OF THE SUMMARY(IES) OF
- hensigten med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for
- The scope of the referral was to agree whether Doxagamma 4mg prolonged release tablets
Doxagamma 4mg depottabletter og de tilknyttede navne afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom hypotension og svimmelhed, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995, hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP’ s retningslinjer, navnlig når det gælder virkningen af fødevarer, og spørgsmålet om, hvorvidt denne afvigelse medfører, at undersøgelserne ikke er tilstrækkeligt følsomme til at kunne registrere forskelle mellem præparaterne,
differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food with concern regarding the adequate sensitivity of to detect a difference between products,
Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxagamma 4 mg prolonged release tablets and associated names (see Annex I).
4/ 26 BILAG III
4/ 25 ANNEX III
5/ 26 PRODUKTRESUME
5/ 25 SUMMARY OF PRODUCT CHARACTERISTICS
6/ 26 1 LÆGEMIDLETS NAVN
6/ 25 1 NAME OF THE MEDICINAL PRODUCT
Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I]
Doxagamma 4 mg prolonged release tablets and associated names [See Annex I]
Én depottablet indeholder 4 mg doxazosin (som mesilat).
One prolonged-release tablet contains 4 mg doxazosin (as mesilate).
Depottablet Hvide, runde bikonvekse tabletter med påtrykt “ DL ” på den ene side.
White, round, biconvex tablets with bossing “ DL”
Essentiel hypertension.
- Essential hypertension
Symptomatisk behandling af benign prostatahyperplasi.
- Symptomatic treatment of benign prostatic hyperplasia.
Voksnes:
Adults:
Sædvanligvis 4 mg doxazosin én gang daglig.
Usually 4 mg doxazosin once daily.
Om nødvendigt kan dosis øges til 8 mg én gang daglig.
If necessary, the dosage may be increased to 8 mg doxazosin once daily.
Doxagamma 4 mg depottabletter og dermed forbundne navne kan anvendes som monoterapi eller i kombination med andre lægemidler, f. eks. et thiaziddiuretikum, et beta- adrenoreceptorblokerende middel, en calciumantagonist eller en ACE- hæmmer.
Doxagamma 4 mg prolonged release tablets and associated names can be used as sole agent or in combination with another medicinal product e. g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Sædvanligvis 4 mg én gang daglig.
Usually 4 mg doxazosin once daily.
Doxagamma 4 mg depottabletter og dermed forbundne navne kan anvendes til ved benign prostatahyperplasi (BPH) patienter, der er enten hypertensive eller normotensive, da ændringer i
Doxagamma 4 mg prolonged release tablets and associated names may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure
7/ 26 blodtrykket hos normotensive patienter er klinisk usignifikant.
7/ 25 changes in normotensive patients are clinically insignificant.
Da der ikke er nogen ændring i farmakokinetikken hos patienter med nedsat nyrefunktion, og da der ikke er nogen tegn på, at doxazosin forværrer eksisterende nedsat nyrefunktion, kan normal dosering generelt anvendes til disse patienter.
Since there is no change in pharmacokinetics in patients with impaired renal function, and since there are no signs that doxazosin aggravates existing renal impairment, the usual dose can be used in these patients.
Doxazosin bør gives med særlig forsigtighed til patienter med tegn på nedsat leverfunktion.
Doxazosin should be given with particular caution to patients with evidence of impaired liver function.
Da der ikke findes klinisk erfaring fra patienter med svær leverinsufficienss, anbefales anvendelsen ikke til disse patienter (se pkt 4. 4).
(see section 4.4).
Doxagamma 4 mg depottabletter og dermed forbundne navne anbefales ikke til patienter under 18 år gamle.
Doxagamma 4 mg prolonged release tablets and associated names are not recommended for patients under the age of 18 years.
- Overfølsomhed over for det aktive stof, andre quinazoliner (f. eks. prazosin, terazosin) eller
- Hypersensitivity to the active substance, other quinazolines (e. g. prazosin, terazosin), or to any
over for hjælpestofferne.
of the excipients
- Benign prostatahyperplasi og samtidig obstruktion af øvre urinveje, kroniske
- Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary ract
urinvejsinfektioner eller blæresten.
infections or bladder stones
- Overflow af blæren, anuri eller progressiv nyreinsufficiens
- Overflow bladder, anuria or progressive renal insufficiency
- Anamnese med øsofageal eller gastrointestinal obstruktion eller bedømt som værende udsat
History of esophageal or gastrointestinal obstruction or decreased lumen gastrointestinal tract.
for øget risiko for sådanne obstruktioner
diameter of the
- Amning
Lactation
Doxazosin bør gives med forsigtighed til patienter med følgende akutte hjertesygdomme:
Doxazosin should be administered with caution in patients with the following acute heart diseases:
Lungeødem som et resultat af aorta - eller mitralstenose, hjertesvigt ved højt output, højresidig hjertesvigt som et resultat af lungeemboli, perikardial effusion og venstresidig ventrikulær hjerteinsufficiens med lavt fyldningstryk.
Pulmonary oedema as a result of aortic or mitral stenosis, heart failure at high output, right sided heart failure as a result of pulmonary embolism or pericardiac effusion and left sided ventricular heart insufficiency with low filling pressure.
Ved indledningen af behandlingen eller øgning af dosis bør patienten overvåges for at minimere muligheden for posturale virkninger, f. eks. hypotension og synkope.
On initiation of therapy or increasing of dose the patient should be monitored to minimise the potential for postural effects, e. g. hypotension and syncope.
Hos patienter behandlet for benign prostatahyperplasi og uden hypertension er ændringer i middelblodtrykket små, men hypotension, svimmelhed, træthed forekommer hos 10 - 20% af patienterne, og ødem og dyspnøe forekommer hos mindre end 5% af patienterne.
In patients treated for benign prostatic hyperplasia and without hypertension mean blood pressure changes are small, but hypotension, dizziness, fatigue occur in 10 – 20% of the patients and oedema and dyspnoea occur in less than 5% of patients.
5. 2).
Doxazosin should be administered with caution in patients with signs of mild to moderate hepatic impairment (see section 5.2).
Der anbefales også forsigtighed, når doxazosin gives somtidig med lægemidler, der kan øve indflydelse på levermetabolismen (f. eks. cimetidin).
Caution is also recommended when doxazosin is administered concomitantly with medicinal products, which may influence hepatic metabolism (e. g. cimetidine).
Doxazosin bør anvendes med forsigtighed til patienter med diabetisk autonom neuropati.
8/ 25 Doxazosin should be used with care in patients with Diabetic Autonomic Neuropathy.
Doxazosin er stærkt bundet til plasmaproteiner (98%).
4.5 Interactions with other medicinal products and other forms of interaction Doxazosin is highly bound to plasma proteins (98%).
Doxazosin er blevet administreret sammen med thiaziddiuretika, furosemid, beta- blokerende midler, antibiotika, orale hypoglykæmiske midler, urikosuriske midler eller antikoagulantia uden bivirkningersreaktioner.
Doxazosin has been administered together with thiazide diuretics, furosemide, beta-blocking agents, antibiotics, oral hypoglycaemic agents, uricosuric agents, or anticoagulants without adverse drug interactions.
Non- steroide antirheumatika eller østrogener kan nedsætte den antihypertensive virkning af doxazosin.
Non- steroidal antirheumatics or estrogens may reduce the antihypertensive effect of doxazosin.
Der foreligger ikke tilstrækkelige data om brugen af doxazosin hos gravide kvinder.
4.6 Pregnancy and lactation There are no adequate data from the use of doxazosin in pregnant women.
5. 3).
Animal studies have shown reduced foetal survival at high doses (see section 5.3).
5. 3), og der er ingen oplysninger om udskillelsen af lægemidlet i human modermælk.
Doxagamma 4 mg prolonged release tablets and associated names is contraindicated during lactation as the medicinal product accumulates in the milk of lactating rats (see section 5.3) and there is no information about the excretion of the medicinal product into human breast milk.
Alternativt skal amning stoppes, hvis behandling med Doxagamma 4 mg depottabletter og dermed forbundne navne er uundgåelig.
Alternatively, breast- feeding must be stopped, if treatment with Doxagamma 4 mg prolonged release tablets and associated names is unavoidable.
9/ 26 Bivirkningerne, der betragtes som mindst muligvis relateret til behandlingen, er angivet nedenfor efter legemets organklassesystem og absolutte hyppighed.
The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency.
Hyppigheder er defineret som meget almindelig (≥1/ 10); almindelig (> 1/ 100 til < 1/ 10); usædvanlig (> 1/ 1000 til < 1/ 100); sjælden (> 1/ 10. 000 til < 1/ 1000); meget sjælden (< 1/ 10. 000).
Frequencies are defined as very common (≥ 1/ 10); common (> 1/ 100 to< 1/10); uncommon (> 1/1000 to< 1/100); rare (> 1/10 000 to < 1/ 1000); very rare (< 1/10 000).
Reduktion i erythrocytter, leukocytter og thrombocytter
Reduction of erythrocytes, leucocytes and thrombocytes
Tørst, hypokaliæmi, podegra Sjælden:
Metabolism and nutrition disorders:
Stigning i serum urea.
Uncommon: thirst, hypokalaemia, gout Rare: hypoglycaemia Very rare: increase in serum urea.
Apati Usædvanlig:
Psychiatric disorders:
Depression, agitation
9/ 25 Common: apathia Uncommon: nightmares, amnesia, emotional instability Rare: depression, agitation
Paræstesi
Common: muscle cramps, fatigue, malaise, headache, somnolence Uncommon: tremor, muscular stiffness Rare: paraesthesia
Sløret syn
Common: accomodation disturbances Uncommon: lacrimation, photophobia Rare: blurred vision
Sygdomme i det ydre og indre øre:
Ear and labyrinth disorders:
Tinnitus
Uncommon: tinnitus
Arytmi, angina pectoris, bradykardi, takykardi, myokardieinfarkt
Common: palpitations, chest pain Uncommon: arrhythmia, angina pectoris, bradycardia, tachycardia, myocardial infarction
Almindelig:
Vascular disorders:
Cerebrovaskulære forstyrrelser
Common: giddiness, dizziness, oedema, orthostatic dysregulation Uncommon: postural hypotension, peripheral ischaemia, syncope Rare: cerebrovascular disturbances
Larynxødem
Common: dyspnoea, rhinitis Uncommon: epistaxis, broncho spasms, cough, pharyngitis Rare: oedema of larynx
Abdominalt ubehag, diaré, opkastning
Common: constipation, dyspepsia Uncommon: anorexia, increased appetite, taste disturbances Rare: abdominal discomfort, diarrhoea, vomiting
Ikterus, forhøjede levertal
Rare: icterus, increased liver values
Udslæt, pruritus, purpura
Uncommon: alopecia, oedema of the face/ general oedema Rare: rash, pruritus, purpura
Usædvanlig:
Musculoskeletal, connective tissue and bone disorders:
Muskelsmerter, arthralgi, muskelsvaghed
Uncommon: muscular pain, arthralgia, muscle weakness
Stigning i serum creatinin.
Common: frequent desire to micturate, increased micturation, delayed ejaculation Uncommon: incontinence, micturation disturbances, dysuria Rare: impotence, priapism Very rare: increase of serum creatinine.
Almindelig:
General disorders and administration site conditions:
Lav legemstemperatur hos ældre
Common: asthenia Uncommon: flushing, fever/ shiver, paleness 10/ 25 Rare: low body temperature in elderly
Alfa- adrenoreceptorantagonister ATC- kode:
Alpha-adrenoceptor antagonists, ATC code:
Denne virkning menes at være et resultat af selektiv blokade af alfa - 1- adrenoreceptorer lokaliseret i vaskulaturen.
This effect is thought to result from selective blockade of the alpha-1- adrenoceptors located in the vasculature.
11/ 26 Patienter behandlet med doxazosin tabletter med umiddelbar frigivelse mod hypertension kan overføres til Doxagamma 4 mg depottabletter og dermed forbundne navne, og dosis titreret opad efter behov, mens virkning og tolerans bibeholdes
Patients treated with immediate release doxazosin tablets against hypertension can be transferred to Doxagamma 4 mg prolonged release tablets and associated names and the dose titrated upwards as needed, while maintaining effect and tolerability.
Doxazosin har en gavnlig virkning på blodlipider med signifikant øgning af HDL/ total cholesterol ratio (ca.
Doxazosin has a beneficial effect on blood lipids with significant increase of HDL/ total cholesterol ratio (app.
4- 13% af base line værdierne) og signifikant reduktion af totale glycerider og total cholesterol.
4-13% of base line values), and significant reduction in total glycerides and total cholesterol.
Behandling med doxazosin har vist sig at resultere i regression af venstre ventrikulær hypertrofi, hæmning af thrombocytophobning såvel som forbedret kapacitet af vævsplasminogen- aktivator.
Treatment with doxazosin has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation as well as enhanced capacity of tissue plasminogen-activator.
Administration af Doxagamma 4 mg depottabletter og dermed forbundne navne til patienter med prostatahyperplasi resulterer i en signifikant forbedring af urodynamikken og symptomer som et resultat af en selektiv blokade af alfa- adrenoreceptorer lokaliseret prostatas muskelstroma, kapsel og hals.
11/ 25 Administration of Doxagamma 4 mg prolonged release tablets and associated names to patients with prostatic hyperplasia results in a significant improvement in urodynamics and symptoms as a result of a selective blockade of alpha-adrenoceptors located in the prostatic muscular stroma, capsule and bladder neck.
Doxazosin har vist sig at være en effektiv blokker af 1A undertype af alfa- adrenoreceptorer, der udgør mere end 70% af de adrenerge undertyper i prostata.
Doxazosin has shown to be an effective blocker of 1A subtype of alpha-adrenoceptors which make up more than 70% of the adrenergic subtypes in prostate.
Peak/ bølgedalsratio for Doxagamma 4 mg depottabletter og dermed forbundne navne er mindre end halvdelen af den for doxazosin tabletter med umiddelbar frigivelse.
Peak/ trough ratio of Doxagamma 4 mg prolonged release tablets and associated names is less than half that of immediate release doxazosin tablets.
Ved steady- state var den relative biotilgængelighed for doxazosin fra Doxagamma 4 mg depottabletter og dermed forbundne navne sammenlignet med den umiddelbare frigivelsesform 54% ved 4 mg dosis og 59% ved 8 mg dosis.
At steady-state, the relative bioavailability of doxazosin from Doxagamma 4 mg prolonged release tablets and associated names compared to immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
Cirka 98% af doxazosin er proteinbundet i plasma.
98% of doxazosin is protein-bound in plasma.
Doxazosin bliver omfattende metaboliseret med < 5% udskilt som uændret produkt Doxazosin bliver primært metaboliseret ved O- demethylering og hydroxylering.
Doxazosin is primarily metabolised by O-demethylation and hydroxylation.
12/ 26 Plasmaeliminationen er bifasisk med den terminale eliminationshalveringstid værende 22 timer, og dette giver derfor basis for doseringen én gang daglig.
The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing
Der er kun begrænsede data vedrørende patienter med nedsat leverfunktion og om virkningerne af lægemidler, der vides at have indflydelse på levermetabolismen (f. eks. cimetidin).
There are only limited data in patients with liver impairment and on the effects of medicinal products known to influence hepatic metabolism (e. g. cimetidine).
I en klinisk undersøgelse af 12 forsøgspersoner med moderat nedsat leverfunktion resulterede en administration af en enkeltdosis doxazosin i en øgning af AUC på 43% og et fald i oral clearance på cirka 40%.
40%.
4. 4)
Doxazosin therapy in patients with hepatic impairment should be performed with caution (see section 4.4).
Undersøgelse af gravide kaniner og rotter ved daglige doseringer, der resulterede i plasmakoncentrationer på henholdsvis 4 og 10 gange den humane eksponering (Cmax og AUC), afslørede ikke bevis for skade på føtus.
12/ 25 Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity Studies in pregnant rabbits and rats at daily doses resulting in plasma concentrations 4 and 10 times the human exposure (Cmax and AUC), respectively, revealed no evidence of harm to the foetus.
Et dosisregime på 82 mg/ kg/ dag (8 gange den humane eksponering) var forbundet med nedsat føtal overlevelse.
A dosage regime of 82mg/ kg/ day (8 times the human exposure) was associated with reduced foetal survival.
Makrogol Mikrokrystallinsk cellulose Povidon K 29- 32 Butylhydroxytoluen (E321) α- Tocopherol Kolloidalt vandfrit silica Natriumstearylfumarat
Macrogol Cellulose, microcrystalline Povidone K 29-32 Butylhydroxytoluene (E321) α -Tocopherol Silica, colloidal anhydrous Sodium stearyl fumarate
Methacrylsyre - ethylakrylat copolymer (1: 1) Dispersion 30 procent Kolloidalt vandfrit silica Makrogol 1300- 1600 Titaniumdioxid (E171)
Methacrylic acid - ethyl acrylate copolymer (1:1) Dispersion 30 per cent Silica, colloidal anhydrous Macrogol 1300-1600 Titanium dioxide (E171)
13/ 26 6. 2 Uforligeligheder
6.2 Incompatibilities
Blister (PVC/ PVDC/ aluminium)
PVC/ PVDC/ aluminium blisters Pack sizes:
Æsker med 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) tabletter Kalenderpakninger med 28 og 98 depottabletter
10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10 x 14) tablets Calendar packs of 28 and 98
Enhedsdoseringspakning med 50 x 1
Unit dose 50 x 1
HDPE tabletbeholder Pakningsstørrelser:
HDPE tablet container 13/ 25 Pack sizes:
100, 250 tabletter
100, 250 tablets
8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
8 MARKETING AUTHORISATION NUMBER
[Udfyldes national]
[To be completed nationally]
14/ 26 10 DATO FOR ÆNDRING AF TEKSTEN
10 DATE OF REVISION OF THE TEXT
15/ 26 ETIKETTERING
14/ 25 LABELLING
16/ 26 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
15/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Oral anvendelse Tages efter lægens anvisninger.
Oral use The tablets should be swallowed whole.
17/ 26 10.
16/ 25 10.
18/ 26 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
17/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] Doxazosin
Doxagamma 4 mg prolonged release tablets and associated names [See Annex I] doxazosin
19/ 26 MINDSTEKRAV TIL DEN UMIDDELBARE EMBALLAGE
18/ 25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
HDPE TABLET BEHOLDER
HDPE TABLET CONTAINER
Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] doxazosin
Doxagamma 4 mg prolonged release tablets and associated names doxazosin
100 depottabletter 250 depottabletter
100 prolonged-release tablets 250 prolonged-release tablets
Oral anvendelse Tabletter skalæ sluges hele.
Oral use The tablets should be swallowed whole.
[Udfyldes nationalt]
[To be completed nationally] 12.
[Udfyldes nationalt]
[To be completed nationally] PACKAGE LEAFLET PACKAGE LEAFLET:
Doxagamma 4 mg depottabletter og dermed forbundne navne [se Bilag I] (Doxazosin)
Doxagamma 4 mg prolonged release tablets and associated names [See Annex I] (Doxazosin)
Hvad Doxagamma 4 mg depottabletter og dermed forbundne navne er, og hvad de anvendes til 2.
What Doxagamma 4 mg prolonged release tablets and associated names is and what it is used for 2.
Hvad De skal gøre, før De begynder at tage Doxagamma 4 mg depottabletter og dermed forbundne navne 3.
Before you take Doxagamma 4 mg prolonged release tablets and associated names 3.
Hvordan De tager Doxagamma 4 mg depottabletter og dermed forbundne navne 4.
How to take Doxagamma 4 mg prolonged release tablets and associated names 4.
Hvilke mulige bivirkninger Doxagamma 4 mg depottabletter og dermed forbundne navne har 5.
Possible side effects 5.
Hvordan De opbevarer Doxagamma 4 mg depottabletter og dermed forbundne navne 6.
How to store Doxagamma 4 mg prolonged release tablets and associated names 6.
Deres medicin er i form af en ’ depottablet.
Your medicine is in the form of a ‘ prolonged-release’ tablet.
Den indeholderdoxazosin, der hører til en gruppe af lægemidler, der kaldes alfa- blokkere.
It contains Doxazosin, which belongs to a group of medicines called alpha-blockers.
De bør ikke tage Doxagamma 4 mg depottabletter og dermed forbundne navne • hvis De har taget et lægemiddel indeholdende Doxazosin eller et lignende lægemiddel, f. eks.
Do not take Doxagamma 4 mg prolonged release tablets and associated names • if you have taken medicine containing Doxazosin or a similar medicine eg.
Prazosin, og De har fået en allergisk reaktion • hvis De er overfølsom over for nogen af indholdsstofferne i tabletten • hvis De har eller har haft nogen form for obstruktion af fordøjelseskanalen • hvis De har nyreproblemer, såsom blæresten, vandladningsbesvær eller lider af hyppige urinvejsinfektioner
Prazosin, and you suffered an allergic reaction • if you are allergic to any of the tablet ingredients • if you have or have had a blockage in your gut • if you have kidney problems such as bladder stones, difficulty passing urine or suffer from frequent urine infections.
Vær særlig forsigtig med at anvende Doxagamma 4 mg depottabletter og dermed forbundne navne • hvis De har en hjertesygdom eller en hjertetilstand • hvis De har problemer med leveren 23/ 26 • hvis De har sukkersyge • Hvis De skal have taget en blodprøve, da Doxagamma 4 mg depottabletter og dermed forbundne navne kan påvirke visse testresultater
Take special care with Doxagamma 4 mg prolonged release tablets and associated names • if you have heart disease or a heart condition • if you have liver problems • if you have diabetes • if you need a blood test as Doxagamma 4 mg prolonged release tablets and associated names can affect some test results.