natgillin/translations-raw huggingface dataset:
Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Ena trda kapsula vsebuje alektinibijev klorid, kolikor ga ustreza 150 mg alektiniba.
In the phase III clinical trial BO28984 15% of patients treated with Alecensa had post-dose heart rate values below 50 bpm versus 20% of patients treated with crizotinib.
BO28984 je imelo 15 % bolnikov, zdravljenih z zdravilom Alecensa, srčno frekvenco po odmerku manj kot 50 utripov na minuto v primerjavi z 20 % bolnikov, zdravljenih s krizotinibom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR BLISTER
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA ZA PRETISNE OMOTE
Bottles: Store in the original package and keep the bottle tightly closed in order to protect from moisture.
Plastenke: Shranjujte v originalni ovojnini, plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago.
Adverse reactions of bilirubin elevations were reported in 18% of the patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Neželen učinek zvišanega bilirubina so zabeležili pri 18 % bolnikov, zdravljenih z zdravilom Alecensa vkliničnih preskušanjih (NP28761, NP28673, BO28984).
Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE36.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz.
Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Glede na učinke na skupno izpostavljenost alektinibu in M4 med sočasno uporabo zdravila Alecensa in induktorjev CYP3A odmerka ni treba prilagoditi.
These include:
Med takšnimi neželenimi učinki so:
This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
Zdravilo Alecensa vsebuje natrij To zdravilo vsebuje 48 mg natrija (glavne sestavine kuhinjske soli) v priporočenem dnevnem odmerku
Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa.
Med zdravljenjem z zdravilom Alecensa bo zdravnik opravljal preiskave krvi vsaj na 2 tedna v prvem mesecu zdravljenja in pozneje po potrebi.
The primary endpoint was to evaluate the efficacy of Alecensa by Objective Response Rate (ORR) as per central Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the overall population (with and without prior exposure of cytotoxic chemotherapy treatments).
(IRC - Independent Review Committee) na podlagi meril RECIST (Response Evaluation Criteria in Solid Tumors, različica 1.1) v celotni populaciji (tako pri bolnikih, ki so bili, in tistih, ki niso bili predhodno izpostavljeni citotoksični kemoterapiji).
The PFS benefit was consistent for patients with CNS metastases at baseline (HR = 0.40, 95% CI: 0.25-0.64, median PFS for Alecensa = NE, 95% CI: 9.2-NE, median PFS for crizotinib = 7.4 months, 95%CI: 6.6-9.6) and without CNS metastases at baseline (HR = 0.51, 95% CI: 0.33-0.80, median PFS for Alecensa = NE, 95% CI: NE, NE, median PFS for crizotinib = 14.8 months, 95% CI:10.8-20.3), indicating benefit of Alecensa over crizotinib in both subgroups.
IZ: 9,2-NO, mediano PFS za krizotinib = 7,4 mececev, 95-% IZ: 6,6-9,6) in bolniki brez metastaz v osrednjem živčevju v izhodišču (HR = 0,51; 95-% IZ: 0,33-0,80; mediano PFS za zdravilo
Co-administration of multiple oral doses of 600 mg rifampicin once daily, a strong CYP3A inducer, with a single oral dose of 600 mg alectinib reduced alectinib Cmax, and AUCinf by 51% and 73% respectively and increased M4 Cmax and AUCinf 2.20 and 1.79-fold respectively.
enkrat na dan z enkratnim peroralnim odmerkom 600 mg alektiniba je zmanjšala Cmax alektiniba za 51 % in AUCinf alektiniba za 73 % ter zvečala Cmax M4 2,20-krat in AUCinf M4 1,79-krat.
ULN) with total bilirubin elevation > 2 times ULN in the absence of cholestasis or haemolysis
> 2-kratno ZMN, brez holestaze ali hemolize
Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Zdravilo Alecensa je v monoterapiji indicirano za zdravljenje odraslih bolnikov z ALK-pozitivnim,
Following administration of a single oral dose of 300 mg alectinib in subjects with severe (Child-Pugh C) hepatic impairment, alectinib Cmax was the same and AUCinf was 2.2-fold higher compared with the same parameters in matched healthy subjects.
Po uporabi enkratnega peroralnega odmerka 300 mg alektiniba je bila Cmax alektiniba pri preskušancih s hudo okvaro jeter (razreda C po Child-Pughovi lestvici) enaka kot pri zdravih preskušancih, AUCinf alektiniba pa 2,2-krat večja; Cmax M4 je bila manjša za 39 %, AUCinf M4 pa za 34 %.
CNS responders n (%) [95% CI]
Odzivni bolniki n (%) [95-% IZ]
Constipation (35%), nausea (19%), diarrhoea (16%) and vomiting (11%) were the most commonly reported gastrointestinal (GI) reactions.
(19 %), driski (16 %) in bruhanju (11 %).
ALT or AST elevation of Grade ≥ 2 (> 3 times
Zvišanje ALT ali AST ≥ stopnje 2 (> 3-kratna ZMN) in zvišanje celokupnega bilirubina na
Severe myalgia has not been reported in the clinical trial BO28984.
BO28984 o hudi mialgiji niso poročali.
What you need to know before you take Alecensa
Kaj morate vedeti, preden boste vzeli zdravilo Alecensa Ne jemljite zdravila Alecensa:
upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
ko se stanje izboljša na stopnjo ≤ 1 (asimptomatska bradikardija) oz. ko je srčna frekvenca ≥ 60 utripov/minuto.
Duration of response (INV) Median (months) [95 % CI]
Trajanje odziva (raziskovalec) Mediana (meseci) [95-% IZ]
Alectinib absorbs UV light between 200 and 400 nm and demonstrated a phototoxic potential in an in vitro photosafety test in cultured murine fibroblasts after UVA irradiation.
Pokazal je fototoksičen potencial v preizkusu svetlobne varnosti in vitro na kulturi mišjih fibroblastov po obsevanju z UVA.
There are no or limited amount of data from the use of Alecensa in pregnant women.
O uporabi zdravila Alecensa pri nosečnicah je malo podatkov ali jih ni. Glede na mehanizem delovanja bi zdravilo Alecensa lahko škodovalo plodu, če je uporabljeno pri nosečnici.
● abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
● nenormalni izvidi preiskav krvi, ki odražajo delovanje jeter (velike koncentracije alanin aminotransferaze, aspartat-aminotransferaze in bilirubina); ● nenormalni izvidi preiskav krvi, ki odražajo poškodbo mišic (velika koncentracija kreatin fosfokinaze);
● Yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal (potential signs of liver problems)
srbenje kože, občutek manjše lakote kot običajno, slabost ali bruhanje, občutek utrujenosti, večja nagnjenost h krvavitvam ali modricam kot običajno (morebitni znaki težav z jetri);
Severe ILD/pneumonitis occurred in patients treated with Alecensa.
Pri bolnikih, zdravljenih z zdravilom Alecensa, so se pojavili hudi primeri IBP/pnevmonitisa.
Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater than or equal to two times the ULN, with normal alkaline phosphatase, occurred in one patient (0.2%) treated in Alecensa clinical trials.
V kliničnih preskušanjih z zdravilom Alecensa so pri enem bolniku (0,2 %) zabeležili sočasno zvišanje ALT ali AST na več ali enako kot 3-kratno ZMN ali celokupnega bilirubina na več ali enako kot 2-kratno ZMN, vrednosti alkalne fosfataze so bile normalne.
● methotrexate, a medicine used to treat certain types of cancer or to treat autoimmune diseases (e.g.
● metotreksat, zdravilo za zdravljenje nekaterih vrst raka ali za zdravljenje avtoimunskih bolezni
Abnormal erythrocyte morphology was observed at exposures equal or greater than 10-60% the human exposure by AUC at the recommended dose.
Pri izpostavljenosti, ki je bila (glede na AUC) enaka ali večja 10 do 60 % izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, so opažali nenormalno morfologijo eritrocitov.
Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inhibitors.
Glede na učinke na skupno izpostavljenost alektinibu in M4 med sočasno uporabo zdravila Alecensa in zaviralcev CYP3A odmerka ni treba prilagoditi.
Table 3 lists the ADRs occurring in patients who received Alecensa across two phase II clinical trials (NP28761, NP28673) and one phase III clinical trial (BO28984; ALEX), and during post-marketing.
Preglednica 3 navaja neželene učinke, ki so se v dveh kliničnih preskušanjih faze II (NP28761 in NP28673) in enem kliničnem preskušanju faze III (BO28984; ALEX) in med obdobjem trženja pojavili pri bolnikih, zdravljenih z zdravilom Alecensa.
CI = confidence interval; DOR = duration of response; IRC = independent review committee; NE = not estimable; ORR = objective response rate; PFS= progression free survival; RE = response evaluable a
Committee); NO = ni ocenljivo; ORR = delež objektivnega odziva (objective response rate); PFS = preživetje brez napredovanja bolezni (progression free survival).
Severe myalgia and creatine phosphokinase (CPK) elevation Myalgia or musculoskeletal pain was reported in patients in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Pri bolnikih v ključnih preskušanjih z zdravilom Alecensa so poročali o mialgiji ali mišično-skeletnih bolečinah, vključno z dogodki stopnje 3 (glejte poglavje 4.8).
Crizotinib pre-treated patients
Bolniki, predhodno zdravljeni s krizotinibom
● St. John's Wort, a herbal medicine used to treat depression
● šentjanževka, zdravilo rastlinskega izvora za zdravljenje depresije,
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Še zlasti morate zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil: ● digoksin, zdravilo za zdravljenje težav s srcem,
The hepatic impairment study also included a group with moderate (Child-Pugh B) hepatic impairment, and a modestly higher alectinib exposure was observed in this group compared with matched healthy subjects.
V tej skupini so v primerjavi z zdravimi preskušanci opazili zmerno povečanje izpostavljenosti alektinibu.
Primary efficacy parameters ORR (IRC) in RE population Responders N (%) [95% CI]
Primarni parametri učinkovitosti ORR (IRC) v populaciji z ocenljivim odzivom
Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
Magnezijev stearat Kalcijev karmelozat
Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Titanov dioksid (E171) Koruzni škrob Karnauba vosek
Permanently discontinue Alecensa.
Takoj prekinite zdravljenje z zdravilom Alecensa.
Talk to your doctor, pharmacist or nurse before taking Alecensa:
Pred začetkom jemanja zdravila Alecensa se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
This is to check you do not have any liver problems while taking Alecensa.
da med jemanjem zdravila Alecensa nimate težav z jetri.
Your doctor will take blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often.
nato na 2 tedna v prvih 3 mesecih zdravljenja, pozneje pa manj pogosto.
Table 6 Summary of the pooled analysis of CNS endpoints from studies NP28673 and NP28761 CNS Parameters (NP28673 and NP28761)
Povzetek kumulativne analize opazovanih dogodkov v osrednjem živčevju v študijah NP28673 in NP28761
When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Če zdravilo Alecensa uporabljamo sočasno s substrati BCRP (takšni so npr. metotreksat, mitoksantron,
● mitoxantrone, a medicine used to treat certain types of cancer or autoimmune diseases (e.g.
● mitoksantron, zdravilo za zdravljenje nekaterih vrst raka ali za zdravljenje avtoimunskih bolezni
Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
pozitivnim (ALK - anaplastična limfomska kinaza), napredovalim nedrobnoceličnim rakom pljuč.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje alektinibijev klorid, kolikor ga ustreza 150 mg alektiniba.
1) includes cases of anaemia and haemoglobin decreased includes cases of dysgeusia and hypogeusia 3) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia 4) includes cases of bradycardia and sinus bradycardia includes cases of stomatitis and mouth ulceration 6) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic, rash macular and exfoliative rash includes cases of myalgia and musculoskeletal pain includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema
Vključuje primere izpuščaja, makulopapuloznega izpuščaja, akneiformnega dermatitisa, eritema, generaliziranega izpuščaja, papuloznega izpuščaja, pruritičnega izpuščaja, makuloznega izpuščaja in eksfoliativnega izpuščaja.
ALT or AST elevation of Grade ≥ 3 (> 5 times
Zvišanje ALT ali AST ≥ stopnje 3 (> 5-kratna ZMN) in celokupni bilirubin ≤ 2-kratna ZMN
ILD/pneumonitis of any severity grade
Intersticijska bolezen pljuč (IBP)/pnevmonitis katere koli stopnje
Name and address of the manufacturer(s) responsible for batch release Roche Pharma AG
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
Number of patients with events N (%) Median (months) [95% CI]
Število bolnikov z dogodkom n (%) Mediana (meseci) [95-% IZ]
NE [17.3, NE]
[17,3; NO]
The majority of these events were of Grade 1 and 2 intensity, and events of Grade ≥ 3 were reported in 3.7% and 3.7% of the patients, respectively.
2, zvišanje stopnje ≥ 3 so zabeležili pri 3,7 % (AST) oziroma 3,7 % (ALT) bolnikov.
● weight gain.
● povečanje telesne mase.
In pregnant rabbits, alectinib caused embryo-foetal loss, small fetuses and increased incidence of skeletal variations at exposures 2.9-fold of the human AUC exposure at the recommended dose.
2,9-krat večja od izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, povzročil embriofetalno izgubo, majhne plodove in povečano incidenco skeletnih sprememb.
Investigations Weight increased
Preiskave povečanje telesne mase zelo pogosti
Although PK simulations for Alecensa do not indicate a low exposure in patients with extreme body weight (i.e. >130 kg), alectinib is widely distributed and clinical studies for alectinib enrolled patients within a range of body weights of 36.9−123 kg.
Alektinib se dobro porazdeljuje in v klinične študije so vključili bolnike z razponom telesne mase od 36,9 do 123 kg. Za bolnike s telesno maso nad 130 kg podatkov ni na voljo.
Cases of bradycardia (8.9%) of Grade 1 or 2 have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Pri bolnikih, zdravljenih z zdravilom Alecensa med kliničnimi preskušanji (NP28761, NP28673, BO28984), so bili opisani primeri bradikardije (8,9 %) stopnje 1 ali 2.
Vomiting
Mutagenost
In vitro, alectinib and its major active metabolite M4 are inhibitors of the efflux transporter P-glycoprotein (P-gp).
Substrati P-gp Alektinib in njegov glavni aktivni presnovek M4 in vitro zavirata izločevalni prenašalec P
Across clinical trials (NP28761, NP28673, BO28984), 1 out of 405 patients treated with Alecensa (0.2%) had a Grade 3 ILD.
V kliničnih preskušanjih (NP28761, NP28673, BO28984) se je IBP stopnje 3 pojavila pri 1 od 405
Diarrhoea
Kancerogenost
Concurrent elevations in ALT or AST greater than or equal 3 times the ULN and total bilirubin greater than or equal 2 times the ULN, with normal alkaline phosphatase, occurred in one patient treated in Alecensa clinical trials.
V kliničnih preskušanjih z zdravilom Alecensa so pri enem bolniku zabeležili sočasno zvišanje ALT ali AST na več ali enako kot 3-kratno ZMN in celokupnega bilirubina na več ali enako kot 2-kratno ZMN,
CNS responders n (%)
Število bolnikov z dogodki n (%)
Renal and urinary disorders Blood creatinine increased
Bolezni sečil zvišan kreatinin v krvi pogosti akutna poškodba jeter pogosti
Hrvatska
alecensa
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč/pnevmonitis občasni
Patients with measurable CNS lesions at baseline CNS ORR (IRC)
ORR v osrednjem živčevju (IRC)
CNS-DOR, median (months) [95% CI]
Mediana (meseci) [95-% IZ]
Responders (%) [95% CI]
Odzivni bolniki (%) [95-% IZ] Popolni odziv Delni odziv
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
Eye disorders Vision disorders3)
Glicerilmonooleat 6.2 Inkompatibilnosti
Do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Med jemanjem zdravila Alecensa in še 7 dni po prenehanju jemanja se izogibajte dolgotrajnejšemu izpostavljanju soncu.
ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy.
Za izbiro bolnikov, ki imajo ALK-pozitivnega nedrobnoceličnega raka pljuč, je treba opraviti validiran preizkus za ALK. Ali je bolnikov nedrobnocelični rak pljuč ALK-pozitiven, je treba ugotoviti pred začetkom zdravljenja z zdravilom Alecensa.
Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Roche Registration GmbH
Median time to onset for constipation, nausea, diarrhea, and/or vomiting events across clinical trials (NP28761, NP28673, BO28984) was 21 days.
V kliničnih preskušanjih (NP28761, NP28673, BO28984) je bil mediani čas do pojava zaprtosti, navzee, driske in/ali bruhanja 21 dni.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA STIČNI OVOJNINI NALEPKA NA PLASTENKI
Cases of myalgia (28%) including myalgia events (22%) and musculoskeletal pain (7.4%) have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Pri bolnikih, zdravljenih z zdravilom Alecensa vkliničnih preskušanjih (NP28761, NP28673, BO28984) so zabeležili primere mialgije (28 %), ki so obsegali mialgične dogodke (22 %) in mišičnoskeletne bolečine (7,4 %).
Alecensa has not been studied in patients with severe renal impairment.
Pri bolnikih s hudo okvaro ledvic zdravilo Alecensa ni raziskano.
Common
pogosti
Special attention should be paid to the interaction with lamotrigine.
Posebej je treba biti pozoren na interakcijo z lamotriginom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Datum prve odobritve: 16. november 2011
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije
Before you can begin taking IOA, your doctor will ask you some questions about your personal health history and that of your close relatives.
Preden lahko začnete jemati zdravilo IOA, vam bo zdravnik postavil nekaj vprašanj o vašem zdravju v preteklosti in o zdravju vaših bližnjih sorodnikov.
Keep taking IOA as usual.
Nadaljujte z jemanjem zdravila IOA kot običajno.
• as you get older (particularly above about 35 years); • if you gave birth less than a few weeks ago
• z višjo starostjo (zlasti nad 35 let); • če ste rodili pred manj kot nekaj tedni.
If you have missed one or more periods Clinical trials with IOA have shown that you may occasionally miss your regular monthly period after Day 24.
Če niste dobili ene ali več menstruacij Klinična preskušanja z zdravilom IOA so pokazala, da vam lahko občasno izostane redna mesečna menstruacija po 24. dnevu.
• changes to menstrual periods (e.g. absence or irregularity)
• akne • spremembe menstruacije (npr. odsotnost ali nerednost)
Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Kombiniranih hormonskih kontraceptivov (KHK) se ne sme uporabljati pri naslednjih stanjih.
If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;
Če kajenja ne morete opustiti in ste starejši od 35 let, vam bo zdravnik morda svetoval drugačno vrsto kontracepcije,
For more detailed information on the different risks from taking combined hormonal contraceptives, please see section 2, “What you need to know before you use IOA”.
Za podrobnejše informacije o različnih tveganjih jemanja kombiniranih hormonskih kontraceptivov glejte poglavje 2, "Kaj morate vedeti, preden boste uporabili zdravilo IOA".
Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
1 Srednja točka razpona 5-7 na 10.000 žensk-let glede na relativno tveganje za CHC, ki vsebujejo levonorgestrel v primerjavi s približno 2,3 do 3,6 za neuporabo
There are no antidotes and further treatment should be
Antidotov ni in nadaljnje zdravljenje mora biti simptomatsko.
The duration of the withdrawal bleeding in women using IOA is on average 3-4 days.
Trajanje odtegnitvene krvavitve pri ženskah, ki jemljejo zdravilo IOA, je v povprečju 3 do 4 dni.
If you forgot to take one of these tablets the reliability of IOA is maintained.
Tudi če ste pozabili vzeti eno od teh tablet, je zanesljivost zdravila IOA ohranjena.
So contact your doctor immediately.
zato se morate nemudoma posvetovati z zdravnikom.
Average serum concentrations are 50 pg/ml and these estradiol levels correspond with the early and late phase of a woman's menstrual cycle.
Povprečna serumska koncentracija je 50 pg/ml in ta koncentracija estradiola ustreza zgodnji in pozni fazi menstruacijskega ciklusa pri ženski.
It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”).
Posebej pomembno je, da preberete simptome krvnega strdka - glejte poglavje 2 "Krvni strdki").
A relationship between COC use and clinical hypertension has not been established.
Povezava med uporabo KPK in klinično hipertenzijo še ni bila ugotovljena.
Prior to the initiation or reinstitution of IOA use a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Pred začetkom ali ponovno uvedbo zdravila IOA se je treba seznaniti s celotno anamnezo (vključno z družinsko) in izključiti nosečnost.
• Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
• Čeprav so pri mnogih ženskah, ki jemljejo KPK, poročali o majhnem povečanju krvnega tlaka, pa je klinično pomembno povečanje redko.
If you are having any blood or urinary test, tell your doctor that you are using IOA as it may affect the results of some tests.
Če imate kakršnokoli preiskavo krvi ali urina, povejte zdravniku, da uporabljate zdravilo IOA, saj bi lahko le-to vplivalo na izvide nekaterih preiskav.
Before you start using IOA you should read the information on blood clots (thrombosis) in section 2.
Pred začetkom uporabe zdravila IOA morate prebrati informacije o krvnih strdkih (trombozi) v poglavju 2.
When you stop IOA your risk of a blood clot returns to normal within a few weeks.
Ko prenehate jemati zdravilo IOA, se tveganje za nastanek krvnega strdka v nekaj tednih vrne na normalno raven.