natgillin/translations-raw huggingface dataset:
for livstruende komplikationer på kort sigt (herunder patienter med massivt ukontrolleret ekssudat [pleural, perikardiel, peritoneal], pulmonal lymfangitis samt mere end 50 % leverpåvirkning), var ikke egnede til deltagelse i studiet.
massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Et åben-label fase-2-studie undersøgte sikkerhed og virkning samt farmakokinetiske egenskaber ved fulvestrant hos 30 piger i alderen 1 til 8 år med progressiv pubertas præcox i forbindelse med McCune Albright-syndrom (MAS).
An open-label phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
• Forhøjet mængde bilirubin (galdefarvestof, der dannes i leveren)
• Increase of bilirubin (bile pigment produced by the liver)
Hos rotter sås reversibel nedsat kvindelig fertilitet og embryo-overlevelse, dyctocia samt en øget forekomst af fosterabnormaliteter inkl.
In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml injektionsvæske, opløsning) skal administreres med 2 fyldte injektionssprøjter, se afsnit 3.
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Fulvestrant Mylan anvendes enten
Fulvestrant Mylan is used either:
Perifer neuropatie, iskiase
Neuropathy peripherale, sciaticae
Hazard ratio for fulvestrant 250 mg i forhold til anastrozol for tid til død, var 1,01 (95% konfidensinterval, 0,86 til 1,19).
The hazard ratio of fulvestrant 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Anvend kun dette lægemiddel til børn, gravide eller ammende kvinder og patienter i højrisikogruppe såsom patienter med epilepsi og leversygdomme efter aftale med lægen.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Temperaturer under 2°C vil ikke beskadige produktet, forudsat at det ikke opbevares ved temperaturer under -20°C.
Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Fulvestrant skal anvendes med forsigtighed til patienter med meget nedsat nyrefunktion (kreatininclearance < 30 ml/min).
Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Fulvestrant Mylan indeholder: - Aktivt stof: fulvestrant.
What Fulvestrant Mylan contains - The active substance is fulvestrant.
6.6 Regler for bortskaffelse og anden håndtering Administrationsinstruktion
6.6 Special precautions for disposal and other handling
- Øvrige indholdsstoffer (hjælpestoffer): benzylbenzoat, benzylalkohol, vandfri ethanol, renset ricinusolie.
- The other ingredients (excipients) are benzyl benzoate, benzyl alcohol, ethanol, anhydrous, castor oil, refined.
I alt 521 præ-/peri- og postmenopausale kvinder, som havde progredieret under eller inden for 12 måneder efter fuldførelse af adjuverende endokrin behandling, under eller inden for 1 måned efter tidligere endokrin behandling mod fremskreden sygdom, blev randomiseret 2:1 til fulvestrant plus palbociclib eller fulvestrant plus placebo og stratificeret efter dokumenteret følsomhed over for tidligere hormonbehandling, menopausalstatus ved studiets start (præ-/peri- versus postmenopausal) og forekomst af viscerale metastaser.
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to fulvestrant plus palbociclib or fulvestrant plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Der bør udvises forsigtighed, hvis Fulvestrant Mylan injiceres i det dorsogluteale område på grund af den nært underliggende iskiasnerve.
Caution should be taken if injecting Fulvestrant Mylan at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Et to-årigt onkogenicitetsstudie med rotter (intramuskulær administration af fulvestrant) viste øget forekomst af godartede ovarietumorer i granulosa-celler hos hunrotter ved den høje dosis på 10 mg/rotte/15 dage og en øget forekomst af Leydigs tumorer i testiklerne hos hanrotter.
A two-year oncogenicity study in rats (intramuscular administration of fulvestrant) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
For brugervenlighed vendes kanylens skråspids opad mod vippearmen (se figur 4).
For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4).
Benzylbenzoat Benzylalkohol Ethanol, vandfri Ricinusolie, renset
Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined
-AI-undergruppe (n=313)a
-AI subgroup (n=313)a
Benzylbenzoat
Benzyl benzoate
Studiet omfattede 423 patienter med recidiverende eller progredierende sygdom under antiøstrogen-behandlingen (AE-undergruppe), og 313 patienter med recidiverende eller progredierende sygdom under aromatasehæmmer-behandlingen (AI-undergruppe).
The study included 423 patients whose disease had recurred or progressed during anti-estrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
Ved niveauet ”ingen effekt” for disse fund var den systemiske eksponering (AUC) cirka 1,5 gange niveauet af den forventede humane eksponeringer hos hunrotter og 0,8 gange hos hanrotter.
At the no-effect level for these findings, systemic exposure levels (AUC) were, in rats, approximately 1.5-fold the expected human exposure levels in females and 0.8-fold in males, and in mice, approximately 0.8fold the expected human exposure levels in both males and females.
Sammenligning melle grupper (Fulvestrant 500 mg/Fulvestrant 250 mg)
Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Du må ikke amme, mens du behandles med Fulvestrant Mylan.
You must not breast-feed while on treatment with Fulvestrant Mylan.
Interferens med estradiol-antistofanalyser
Interference with estradiol antibody assays
Meget almindelig Astenia, reaktioner ved injektionsstedetb
Very common Astheniaa, injection site reactionsb Common
Fulvestrant er indiceret til patienter med recidiverende eller progredierende sygdom under antiøstrogenbehandling.
Fulvestrant is indicated in patients whose disease had recurred or progressed on an anti-estrogen therapy.
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Fulvestrant skal anvendes med forsigtighed til patienter med let til moderat nedsat leverfunktion (se pkt.
4.4 Special warnings and precautions for use Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
• som monoterapi til behandling af østrogen-receptor-positiv, lokal fremskreden eller metastatisk brystkræft hos postmenopausale kvinder: - der ikke tidligere har modtaget endokrin behandling, eller - med sygdomstilbagefald under eller efter adjuverende behandling med antiøstrogen, eller sygdomsprogression under antiøstrogenbehandling.
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Opbevar den fyldte sprøjte i den originale pakning for at beskytte mod lys.
Keep the pre-filled syringe in the original package in order to protect from light.
Temperaturudsving har en kumulativ virkning på produktkvaliteten, og perioden på 28 dage må ikke overskrides i løbet af Fulvestrant Mylans opbevaringstid (se pkt.
Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the shelf life of Fulvestrant Mylan (see section 6.3).
55% af patienterne havde viscerale metastaser ved studiets udgangspunkt.
Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
Neoadjuverende behandling af brystkræftpatienter i op til 16 uger, med enten fulvestrant 500 mg eller fulvestrant 250 mg, viste ingen klinisk signifikante ændringer i endometriets tykkelse, hvilket indikerer manglende agonistvirkning.
Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Det skal du vide, før du begynder at bruge Fulvestrant Mylan
What you need to know before you use Fulvestrant Mylan
Hold fast i låget (A) med den anden hånd og vip forsigtigt frem og tilbage, indtil låget brækkes af og kan trækkes af.
With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure 1).
I de poolede datasæt med fulvestrant som monoterapi var de hyppigst rapporterede bivirkninger reaktioner ved injektionsstedet, asteni, kvalme og forhøjede leverenzymer (ALAT, ASAT, ALP).
In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Stomatitisg Diarré Opkastning Hud og subkutane væv Meget almindelig Alopeci Udslæth Almindelig Tør hud Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed Feber Almindelig Asteni Undersøgelser Almindelig Forhøjet ASAT Forhøjet ALAT
Stomatitisg Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rashh Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Efter temperaturudsving skal produktet straks igen opbevares ved de anbefalede opbevaringsforhold (opbevares i køleskab og transporteres nedkølet ved 2°C - 8°C).
After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C).
Der blev udført et randomiseret, dobbeltblindet, dobbelt-dummy, fase 3-multicenterstudie med fulvestrant 500 mg versus anastrozol 1 mg med postmenopausale kvinder med ER-positiv og/eller PgR-positiv lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere havde fået hormonbehandling.
A Phase 3, randomised, double-blind, double-dummy, multicentre study of fulvestrant 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Patienter med fremskreden/metastatisk, symptomatisk, visceral spredning, som havde risiko
Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Der blev udført et internationalt, randomiseret, dobbeltblindet, fase 3-multicenterstudie med parallelgrupper med fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 500 mg plus placebo med kvinder med HR-positiv, HER2-negativ lokalt fremskreden brystkræft, der ikke var modtagelig for resektion eller strålebehandling med henblik på helbredelse, eller metastatisk brystkræft, uanset menopausalstatus, hvis sygdom progredierede efter tidligere endokrin behandling i (neo)adjuverende eller metastatisk regi.
A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
Figur 1 Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intentto-treat-population) ─ FALCON-studiet
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
• Anafylaktisk reaktion
• Anaphylactic reactions
Det reproduktive system og mammae
Reproductive system and breast disorders Common
Neoadjuverende behandling med enten fulvestrant 500 mg eller fulvestrant 250 mg til brystkræftpatienter i op til 16 uger resulterede ikke i klinisk signifikante ændringer af knogle-turnover-markører i serum.
Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in serum bone-turnover markers.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En fyldt injektionssprøjte indeholder 250 mg fulvestrant i 5 ml opløsning.
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Sådan skal du bruge Fulvestrant Mylan
How to use Fulvestrant Mylan
To kliniske fase 3-studier blev gennemført med i alt 851 postmenopausale kvinder med fremskreden brystkræft, som havde sygdomstilbagefald under, eller efter, adjuvant endokrin behandling, eller progression efter endokrin behandling for fremskreden sygdom.
Two phase-3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
En fyldt injektionssprøjte (5 ml) indeholder 250 mg fulvestrant.
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
ORR-odds ratio (95% CI) og pværdi
ORR Odds Ratio (95% CI) and p-value
To klare type 1 fyldte glas-injektionssprøjter med et polystyren pumpestempel, der er lukket med sikkerhedsforsegling, hver indeholdende 5 ml Fulvestrant Mylan injektionsvæske, opløsning.
Two clear type 1 glass pre-filled syringes with polypropylene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Fulvestrant Mylan solution for injection.
For undergruppen af patienter med sygdom, der var begrænset til ikkeviscerale metastaser (n=208), var hazard ratio 0,592 (95% CI: 0,419; 0,837) for fulvestrant-armen sammenlignet med anastrozol-armen.
For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the fulvestrant arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the fulvestrant arm compared to the anastrozole arm.
Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intent-to-treat-population) - PALOMA-3-studiet
Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study
-AE-undergruppe (n=423) -AI-undergruppe (n=313)a a
-AE subgroup (n=423) -AI subgroup (n=313)a a
e Anæmi inkluderer de følgende PTs: anæmi, nedsat hæmoglobin, nedsat hæmatokrit.
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
assisterede vippearm for at aktivere beskyttelsesmekanismen (se figur 5).
• After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab og transporteres nedkølet.
Store and transport refrigerated.
I forbindelse med administration af fulvestrant er bivirkninger, relateret til injektionsstedet, herunder iskias, neuralgi, neuropatiske smerter og perifer neuropati, observeret og rapporteret.
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Progressionsfri overlevelse Antal PFS-hændelser (%) PFS-hazard ratio (95% CI) og pværdi
Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue
Den fyldte injektionssprøjte opbevares i den originale yderpakning for at beskytte mod lys.
Store the pre-filled syringe in the original package in order to protect from light.
Blandt de vigtigste sekundære effektendepunkter var objektiv responsrate (ORR), klinisk gevinstrate (CBR) og total overlevelse (OS).
Progression-free survival (PFS) was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Der vedlægges også en beskyttet kanyle (BD SafetyGlideTM) til montering på sprøjten.
A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
Fulvestrant Mylan er en klar, farveløs til gul, viskøs væske i en fyldt injektionssprøjte lukket med en sikkerhedsforsegling indeholdende 5 ml injektionsvæske, opløsning.
What Fulvestrant Mylan looks like and contents of the pack Fulvestrant Mylan is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.
En klar type 1 fyldt glas-injektionssprøjte med et polystyren pumpestempel, der er lukket med sikkerhedsforsegling, indeholdende 5 ml Fulvestrant Mylan injektionsvæske, opløsning.
One clear type 1 glass pre-filled syringe with polypropylene plunger rod, fitted with a tamper-evident closure, containing 5 ml Fulvestrant Mylan solution for injection.
Derfor skal patienter, som oplever denne bivirkning, være forsigtige, når de fører motorkøretøj eller betjener maskiner.
However, since asthenia has been reported very commonly with fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
(kreatinin-clearance < 30 ml/min), og derfor anbefales forsigtighed ved behandling af disse patienter (se pkt.
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Fulvestrant Mylan 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte fulvestrant i.m.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En fyldt injektionssprøjte indeholder 250 mg fulvestrant i 5 ml opløsning
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
For instruktioner om administration af lægemidlet se pkt.
For detailed instructions for administration, see section 6.6.
Type af estimat
Variable Type of estimate
(angivet i afsnit 6) - hvis du er gravid eller ammer - hvis du har alvorlige leverproblemer
Do not use Fulvestrant Mylan: - if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant or breast-feeding - if you have severe liver problems
Ricinusolie, renset
Castor oil, refined
BEMÆRK: Der bør udvises forsigtighed ved administration af Fulvestrant Mylan i det dorsogluteale injektionsområde på grund af den nært underliggende iskiasnerve (se pkt.
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Fulvestrant Mylan at the dorsogluteal injection site (see section 4.4).
Fulvestrant Mylan 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte fulvestrant
Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Meget almindelig Smerter i led, muskler og knoglerd Almindelig
Very common Joint and musculoskeletal paind Common
K-M median i måneder; hazard ratio Alle patienter -AE-undergruppe (n=423) -AI-undergruppe (n=313)a
All Patients -AE subgroup (n=423) -AI subgroup (n=313) a
Tabel 1 Bivirkninger rapporteret hos patienter behandlet med fulvestrant monoterapi Bivirkninger efter systemorganklasse og hyppighed Infektioner og parasitære sygdomme
Adverse reactions by system organ class and frequency Infections and infestations
- previous problems with blood clots - knogleskørhed (nedsat mineralindhold i knoglerne) - alkoholisme
- osteoporosis (loss of bone density) - alcoholism
Der bør udvises forsigtighed ved administration af fulvestrant i det dorsogluteale injektionsområde på grund af den nært underliggende iskiasnerve (se pkt.
Caution should be taken while administering fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8).
Meget almindelig Hedeturee Almindelig
Very common Hot flushese Common
Administrationsinstruktion
Instructions for administration
Ikke almindelig Blødning ved injektionsstedetf, hæmatom ved injektionsstedetf, iskias, neuralgic a
Injection site haemorrhage f, injection site haematoma f, neuralgiac,f a
Kombineret analyse for begge studier viste, at hazard ratio for fulvestrant 250 mg i forhold til anastrozol, med henblik på progressionsfri overlevelse var 0,95 (95% konfidensinterval 0,82-1,10).
Combined analysis of both studies showed the hazard ratio of fulvestrant 250 mg to anastrozole for progression-free survival was
Brug af anden medicin sammen med Fulvestrant Mylan Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
LÆGEMIDLETS NAVN Fulvestrant Mylan 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte
NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
Det skal du vide, før du begynder at bruge Fulvestrant Mylan Sådan skal du bruge Fulvestrant Mylan Bivirkninger
What you need to know before you use Fulvestrant Mylan 3.
Se også produktresuméet for palbociclib, når fulvestrant anvendes i kombination med palbociclib.
When fulvestrant is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Vaginal blødninge Ikke almindelig Vaginal candidiasisf, leukoréf
Vaginal moniliasis f, leukorrhea f
Mave-tarm-kanalen
Vaginal haemorrhagee
Meget almindelig Udslæte
Very common Rashe
Nedsat antal blodpladere
Reduced platelet counte
ANVENDELSE
IM use
Dog er asteni rapporteret som meget almindeligt under behandling med fulvestrant.
Table 1 Adverse Drug Reactions reported in patients treated with fulvestrant monotherapy
6.3 Opbevaringstid 2 år
2 years
Antal OS-hændelser* OS-hazard ratio (95% CI) og pværdi
PFS Median [months (95% CI)] Number of OS Events* OS Hazard Ratio (95% CI) and p-value
Rygsmertera
Posology
Klinisk benefit rate Klinisk benefit rate-odds ratio (95% CI) og p-værdi
CBR Odds Ratio (95% CI) and p-value
Lægemidlet er receptpligtigt.
PHARMACEUTICAL FORM Solution for injection.
{navn} kan tages med eller uden føde.
{Invented name}may be taken with or without food.
Denne information vil blive opdateret, så snart de endelige data foreligger.
This information will be updated as final data become available.
Den øgede risiko blev synlig efter ca. 1 års behandling.
The increased risk became apparent after approximately 1 year of treatment.
Der er en genetisk polymorfisme af dette enzym.
There is a genetic polymorphism of this enzyme.
1515 Lefkosia Cypern
1515 Lefkosia Cyprus
Indtagelse sammen med føde (fedtrigt måltid) forsinker absorptionen omkring 1 time.
Dosing with food (high fat meal) delays absorption by about 1 hour.
Ingen klinisk erfaring med overdosering.
There is no clinical experience of overdose.
LT-01112 Vilnius Litauen
LT-01112 Vilnius Lithuania
Via Robert Koch, 1-2 20152 Milano Italien
Via Robert Koch, 1-2 20152 Milano Italy