natgillin/translations-raw huggingface dataset:
Nevertheless, physicians are advised to refer to prescribing information for recommendations regarding management of concomitant therapy, especially for agents with a narrow therapeutic index metabolised by these enzymes (e. g. cyclosporin).
Zdravnikom pa kljub temu svetujemo, da upoštevajo informacije o predpisovanju, in sicer priporočila o izvajanju sočasnega zdravljenja, še posebej za učinkovine z ozko terapevtsko širino, ki jih presnavljajo ti encimi (npr. ciklosporin).
Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered due to induction of lamotrigine glucuronidation.
Zato se ob sočasni uporabi s kombiniranimi hormonskimi kontraceptivi plazemske koncentracije lamotrigina pomembno zmanjšajo, kar lahko vodi v zmanjšanje nadzora nad epileptičnimi napadi.
This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Morda bo potrebno prilagoditi odmerke lamotrigina.
Certain endocrine and liver function tests and blood components may be affected by hormonal contraceptives:
Hormonski kontraceptivi lahko vplivajo na rezultate določenih endokrinih testov, teste jetrnih funkcij ter na rezultate testov sestavin krvi:
− Increased prothrombin and factors VII, VIII, IX and X; decreased anti-thrombin III; decreased protein S; increased norepinephrine (noradrenaline)-induced platelet aggregability.
− Povišane koncentracije protrombina in faktorjev VII, VIII, IX in X; znižane koncentracije antitrombina III in proteina S; povečana agregacija trombocitov, ki jo povzroča noradrenalin.
− Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay.
− Povečane količine tiroglobulina, ki veže ščitnične hormone v krvi (TBG- thyroid binding globulins), kar vodi do povečane celotne količine ščitničnih hormonov v krvi, ki ga merijo prek joda, vezanega na proteine (PBI- protein- bound iodine), T4 s kolonsko kromatografijo ali z radioimunskimi testi.
Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
Privzem prostega T3 s smolami je zmanjšan, kar odraža povečano količino TBG, koncentracija prostega T4 pa ni spremenjena.
Other binding proteins may be elevated in serum.
V serumu se vrednosti drugih vezavnih proteinov lahko povišajo.
Sex hormone-binding globulins (SHBG) are increased and result in elevated levels of total circulating endogenous sex steroids.
Količina globulinov (SHBG- sex hormone- binding globulins), na katere se vežejo spolni hormoni, je povečana, kar povzroči zvišanje skupne koncentracije steroidnih spolnih hormonov v krvi.
However, the free or biologically active levels of sex steroids either decrease or remain the same.
Koncentracije prostih ali biološko aktivnih hormonov v krvi pa se bodisi znižajo ali ostanejo nespremenjene.
High-density lipoprotein (HDL-C), total cholesterol (Total-C), low-density lipoprotein (LDL-C) and triglycerides may all increase slightly with EVRA, while LDL-C/ HDL-C ratio may remain unchanged.
Med uporabo obližev EVRA se lahko koncentracije lipoproteinov visoke gostote (HDL- high- density lipoproteins), skupnega holesterola, lipoproteinov nizke gostote (LDL- low density lipoproteins) in trigliceridov rahlo zvišajo, pri čemer pa lahko razmerje med LDL in HDL ostane nespremenjeno.
Glucose tolerance may be decreased.
Toleranca za glukozo je lahko zmanjšana.
Serum folate levels may be depressed by hormonal contraceptive therapy.
Zaradi hormonske kontracepcije se lahko serumska koncentracija folata zniža.
This has potential to be of clinical significance if a woman becomes pregnant shortly after discontinuing hormonal contraceptives.
Če ženska zanosi kmalu po prenehanju uporabe hormonskih kontraceptivov, je to lahko klinično pomembno.
All women are now advised to take supplemental folic acid peri-conceptionally.
Vsem ženskam svetujemo, da pred zanositvijo dodatno uživajo folno kislino.
EVRA is not indicated during pregnancy.
Med nosečnostjo obliži EVRA niso indicirani.
Epidemiological studies indicate no increased risk of birth defects in children born to women who used hormonal contraceptives prior to pregnancy.
Epidemiološke raziskave niso pokazale povečanega tveganja za prirojene anomalije pri otrocih žensk, ki so pred nosečnostjo jemale hormonske kontraceptive.
The majority of recent studies also do not indicate a teratogenic effect when hormonal contraceptives are used inadvertently during early pregnancy.
Večina sodobnih raziskav tudi ni dokazala teratogenega učinka hormonskih kontraceptivov, ki jih ženska nenamerno uporablja na začetku nosečnosti.
For EVRA there are no clinical data on exposed pregnancies, which allow conclusions about its safety during pregnancy.
Kliničnih podatkov od nosečnic, ki so bile izpostavljene obližem EVRA, na podlagi katerih bi lahko sklepali, da se med nosečnostjo le- ti lahko varno uporabljajo, ni.
10 Studies in animals have shown reproductive toxicity (see section 5.3).
Raziskave na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
On the basis of available data, a potential risk of masculinisation as a consequence of an exaggerated hormonal action cannot be excluded.
Na podlagi razpoložljivih podatkov ne moremo izključiti možnega tveganja za maskulinizacijo kot posledico povečanega delovanja hormonov.
Lactation may be influenced by combination hormonal contraceptives as they may reduce the quantity and change the composition of breast milk.
Kombinirani hormonski kontraceptivi lahko vplivajo na dojenje, saj lahko zmanjšajo količino mleka in spremenijo njegovo sestavo.
EVRA has no or negligible influence on the ability to drive and use machines.
Obliži EVRA ne vplivajo na sposobnost vožnje in upravljanja s stroji oz. je njihov vpliv zanemarljiv.
4.8.1 Clinical Trial Data
4. 8. 1 Podatki iz kliničnih preskušanj
The most commonly reported adverse drug reactions (ADRs) in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, respectively.
V kliničnih preskušanjih so bili najpogosteje poročani neželeni učinki (NU) glavobol, slabost in občutljivost dojk, ki so se pojavljali pri 21, 0%, 16, 6%, oziroma 15, 9% žensk.
Frequency estimate: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Ocena pogostnosti: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Adverse Drug Reactions in Clinical Trials Frequency
Neželeni učinki v kliničnih preskušanjih Pogostnost
Very
zelo
Uncommon
pogosti občasni redki
Rare
zelo redki
Very rare
glivične Infekcijske okužbe (samo in parazitske vaginalne), bolezni vaginalna kandidiaza, vulvovaginaln a glivična okužba zastajanje Presnovne in tekočine prehranske hiperholesterole motnje mija Psihiatrične
common Infections and infestations
depresija,
Fungal infection (vaginal only), Vaginal candidiasis, Vulvovaginal mycotic infection
čustvena
Metabolism and nutrition disorders
jokanje,
Fluid retention, Hypercholesterolemia
nasilnost
Psychiatric disorders
spremembe
Depression, Mood altered, Mood swings
labilnost,
Affect lability, Anxiety, Insomnia, Libido decreased
razpoloženja, nihanje razpoloženja
Crying, Libido increased, Tearfulness
tesnoba, nespečnost, zmanjšan libido
Aggression
libido, jokavost
Nervous system disorders
11 Bolezni živčevja Bolezni dihal, prsnega koša in mediastinaln ega prostora
Dizziness, Migraine
vrtoglavica, migrena
Gastrointestinal disorders
Bolezni prebavil Bolezni jeter, žolčnika in žolčevodov
Nausea
slabost
Abdominal distension, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Vomiting, Diarrhoea
napihnjen trebuh, bolečina v trebuhu, bolečina v spodnjem delu trebuha, bolečina v zgornjem delu trebuha, bruhanje, driska
Skin and subcutaneous tissue disorders
Bolezni kože
Acne, Pruritus, Skin irritation
akne, pruritus,
Dermatitis contact, Erythema
kontaktni
Chloasma
kloazma
Musculoskeletal and connective
in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Muscle spasms
razdražena koža mišični krči
tissue disorders
dermatitis, eritem
11
Motnje
Reproductive system and breast disorders
občutljivost
Breast tenderness
nelagoden
Breast discomfort, Breast enlargement, Breast pain, Dysmen- orrhoea, Menorrhagia, Metrorrhagia, Uterine spasm, Vaginal discharge
spremembe v
Breast disorder, Breast engorgement, Breast swelling, Fibrocystic breast disease, Galactorrhoea, Premenstrual syndrome, Vaginal haemorrhage, Vulvovaginal dryness
izloček iz
Genital discharge, Menstrual disorder, Menstruation irregular
polimenoreja
Polymen- orrhoea
reprodukcije
General disorders and administration site conditions
dojk
Application site erythema, Application site irritation, Application site pruritus, Application site rash, Application site reaction, Fatigue, Malaise
občutek v
Application site dermatitis, Application site discolouration, Application site hypersensitivity, Application site pain, Application site papules, Application site vesicles, Generalized oedema
dojkah, naval
Application site urticaria, Swelling
spolovil,
Applica- tion site oedema
in dojk
Investigations
dojkah,
Weight increased
mleka, otekanje
Blood pressure increased, Blood triglycerides increased
povečanje dojk, boleče dojke, dismenoreja, menoragija, metroragija, krči maternice, izcedek iz nožnice
Blood cholesterol increased
dojk, fibrocistična bolezen dojke, galaktoreja, predmenstrualni sindrom, vaginalna krvavitev, vulvovaginalna suhost
4.8.2 Postmarketing Data Additional adverse drug reactions first identified during postmarketing experience with EVRA are listed below:
menstruacij e, neredne menstruacij e
12 Infections and infestations
12 Splošne
Application site pustules, Rash pustular
težave in
Neoplasms benign, malignant and unspecified (Incl cysts and polyps)
mestu
Breast cancer, Breast cancer stage IV, Cervix carcinoma, Fibroadenoma of breast, Hepatic adenoma, Hepatic neoplasm, Uterine leiomyoma
mestu
Immune system disorders
spremembe
Hypersensitivity
aplikacije,
Metabolism and nutrition disorders
aplikacije,
Hyperglycaemia, Insulin resistance
aplikacije,
Psychiatric disorders Nervous system disorders
aplikacije
Anger, Emotional disorder, Frustration Basilar artery thrombosis, Brain stem infarction, Carotid artery occlusion, Cerebral artery embolism, Cerebral artery occlusion, Cerebral artery thrombosis, Cerebral haemorrhage, Cerebral infarction, Cerebral thrombosis, Cerebral venous thrombosis, Cerebrovascular accident, Embolic stroke, Haemorrhage intracranial, Haemorrhagic stroke, Intracranial venous sinus thrombosis, Ischaemic cerebral infarction, Ischaemic stroke, Lacunar infarction, Migraine with aura, Subarachnoid haemorrhage, Superior sagittal sinus thrombosis, Thromboembolic stroke, Thrombotic stroke, Transient ischaemic attack, Transverse sinus thrombosis
na mestu
Eye disorders
draženje na
Contact lens intolerance
razbarvanje
Cardiac disorders
aplikacije
Acute myocardial infarction, Myocardial infarction
aplikacije, srbenje mesta aplikacije, izpuščaj na mestu aplikacije, reakcija na mestu aplikacije, utrujenost, slabo počutje
Vascular disorders
zvišan krvni
Arterial thrombosis, Arterial thrombosis limb, Axillary vein thrombosis, Budd-Chiari syndrome, Coronary artery thrombosis, Deep vein thrombosis, Embolism, Hepatic vein thrombosis, Hypertension, Hypertensive crisis,, Iliac artery thrombosis, Intracardiac thrombus, Jugular vein thrombosis, Mesenteric vein thrombosis, Pelvic venous thrombosis, Peripheral embolism, Portal vein thrombosis, Renal embolism, Renal vein thrombosis, Retinal artery occlusion, Retinal vascular thrombosis, Retinal vein occlusion, Splenic vein thrombosis, Superficial thrombophlebitis, Thrombophlebitis, Thrombosis, Vena cava thrombosis, Venous thrombosis, Venous thrombosis limb
telesne mase
Respiratory, thoracic and mediastinal disorders
tlak, zvišana koncentracija trigliceridov v krvi
Pulmonary artery thrombosis, Pulmonary thrombosis
koncentracija holesterola v krvi
Gastrointestinal disorders
4. 8. 2 Podatki po prihodu zdravila na trg
Colitis
rak dojke, IV stadij raka dojke, cervikalni karcinom, fibroadenom Benigne, maligne in dojke, adenom jeter, neoplazma jeter, leiomiom v maternici neopredeljene novotvorbe (vključno s cistami in polipi)
Hepatobiliary disorders
preobčutljivost Bolezni imunskega sistema
Cholelithiasis, Cholestasis, Hepatic lesion, Jaundice cholestatic
hiperglikemija, rezistenca za insulin Presnovne in prehranske motnje
Skin and subcutaneous tissues
jeza, motnje čustvovanja, frustracija Psihiatrične motnje
Alopecia, Angioedema, Dermatitis allergic, Eczema, Erythema multiforme, Erythema nodosum, Exfoliative rash,
tromboza bazilarne arterije, infarkt možganskega debla, okluzija Bolezni živčevja karotidne arterije, embolija cerebralne arterije, okluzija cerebralne arterije, tromboza cerebralne arterije, možganska krvavitev, možganska kap, cerebralna tromboza, cerebralna venska tromboza, cerebrovaskularni dogodek, embolična kap, intrakranialna krvavitev, hemoragična kap, tromboza intrakranialnega venskega sinusa, ishemični cerebralni infarkt, ishemična kap, lakunarni infarkt, migrena z auro, subarahnoidna krvavitev, tromboza zgornjega sagitalnega sinusa, trombembolična kap, trombotična kap, tranzitorna ishemična ataka, tromboza transverzalnega sinusa
13
13 neprenašanje kontaktnih leč Očesne bolezni
disorders
arterijska tromboza, tromboza arterij v okončinah, tromboza Žilne bolezni aksilarne vene, Budd- Chiarijev sindrom, tromboza koronarne arterije, globoka venska tromboza, embolija, tromboza jetrne vene, hipertenzija, hipertenzivna kriza, tromboza iliakalne arterije, strdek v srcu, tromboza jugularne vene, tromboza mezenterične vene, tromboza medenične vene, periferna embolija, tromboza portalne vene, embolija ledvice, tromboza ledvične vene, okluzija retinalne arterije, tromboza žil v mrežnici, okluzija retinalne vene, tromboza vranične vene, tromboflebitis površinskih ven, tromboflebitis, tromboza, tromboflebitis votle vene, tromboza ven, tromboza ven v okončinah
Photosensitivity reaction, Pruritus generalised, Rash, Rash erythematous, Rash pruritic, Seborrhoeic dermatitis, Skin reaction, Urticaria
tromboza pljučne arterije, tromboza pljuč Bolezni dihal, prsnega koša in mediastinalnega prostora
Reproductive system and breast disorders
kolitis Bolezni prebavil
Amenorrhoea, Breast mass, Cervical dysplasia, Hypomenorrhoea, Menometrorrhagia, Oligomenorrhoea, Suppressed lactation
holelitiaza, holestaza, jetrna lezija, holestatska zlatenica Bolezni jeter, žolčnika in žolčevodov alopecija, angioedem, alergijski dermatitis, ekcem, multiformni Bolezni kože in eritem, nodozni eritem, eksfoliativni dermatitis, fotosenzitivna podkožja reakcija, generalizirani pruritus, izpuščaj, eritematozni izpuščaj, srbeč izpuščaj, seboroični dermatitis, kožna reakcija, urtikarija
General disorders and administration site conditions
amenoreja, zatrdlina v dojki, cervikalna displazija, hipomenoreja, Motnje reprodukcije in neredne menstruacije, oligomenoreja, zavrta laktacija dojk
Application site abscess, Application site anaesthesia, Application site atrophy, Application site bleeding, Application site bruising, Application site burn, Application site discharge, Application site discomfort, Application site dryness, Application site eczema, Application site erosion, Application site excoriation, Application site exfoliation, Application site induration, Application site infection, Application site inflammation, Application site mass, Application site nodule, Application site odour, Application site paraesthesia, Application site photosensitivity reaction, Application site scab, Application site scar, Application site swelling, Application site ulcer, Application site warmth, Face oedema, Irritability, Localised oedema, Oedema peripheral, Pitting oedema
absces na mestu aplikacije, neobčutljivost mesta aplikacije, atrofija Splošne težave in mesta aplikacije, krvavitev na mestu aplikacije, modrica na mestu spremembe na mestu aplikacije, opeklina na mestu aplikacije, izcedek na mestu aplikacije, aplikacije nelagodje na mestu aplikacije, suho mesto aplikacije, ekcem na mestu aplikacije, erozija mesta aplikacije, opraskanina na mestu aplikacije, luščenje kože na mestu aplikacije, induracija na mestu aplikacije, okužba mesta aplikacije, vnetje mesta aplikacije, zatrdlina na mestu aplikacije, vozliči na mestu aplikacije, vonj mesta aplikacije, parestezija mesta aplikacije, fotosenzitivna reakcija mesta aplikacije, krasta na mestu aplikacije, brazgotina na mestu aplikacije, oteklina mesta aplikacije, razjeda na mestu aplikacije, toplo mesto aplikacije, edem obraza, razdražljivost, lokaliziran edem, periferni edem, vtisni edem
Blood cholesterol abnormal, Blood glucose abnormal, Blood glucose decreased, Low density lipoprotein increased
nenormalne koncentracije holesterola v krvi, nenormalne Preiskave koncentracije glukoze v krvi, znižana koncentracija glukoze v krvi, zvišana koncentracija lipoproteinov majhne gostote
Injury, poisoning and procedural complications
zapleti pri uporabi kontaktnih leč Poškodbe in zastrupitve in zapleti pri posegih
Contact lens complication
14 4. 9 Preveliko odmerjanje
Overdosage may cause nausea or vomiting.
Preveliki odmerki lahko povzročijo slabost ali bruhanje.
Norelgestromin and estrogen; ATC-code:
Farmakoterapevtska skupina: norelgestromin in estrogen, oznaka ATC:
CONT-002 EVRA
CONT - CONT - CONT - CONT - CONT -
CONT-003 EVRA
skupina
CONT-003 COC*
preiskovanke,
CONT-004 EVRA
EVRA EVRA
CONT-004 COC**
COC * EVRA
All EVRA Subjects
ki uporabljajo obliž EVRA
# of cycles 10,743 Overall 0.73 Pearl Index (0.15,1.31) (95% CI)
Št. ciklusov Celokupni
4005 2.27 (0.59,3.96)
Pearlov indeks (95% CI)
21,669 0.90 (0.44,1.35)
(0, 15; 1, 31 (0, 02; 1, 76))
14
(0; 1, 35)
Method
(0, 16; 2, 39 (0, 59; 3, 96))
0.61
(0, 44; 1, 35)
0.67
Indeks
0.28
0, 61 0, 67
1.02
0, 28
Failure Pearl Index (95% CI)
neučinkovitosti (0, 0; 1, 14) metode po Pearlu (95% CI) * DSG 150 µg + 20 µg EE
(0.0,1.14)
(0; 1, 42)
(0,1.42)
(0; 0, 84)
(0,0.84)
(0, 02; 2, 02 (0, 03; 2, 57))
(0.02,2.02) (0.03,2.57) (0.31,1.13)
(0, 31; 1, 13)
50 µg LNG + 30 µg for days 1 – 6, 75 µg LNG + 40 µg EE for days 7 – 11, 125 µg LNG + 30 µg EE for 12 – 21 days
** 50 µg LNG + 30 µg EE med 1. in 6. dnevom, 75 µg LNG + 40 µg EE med 7. in 11. dnevom, 125 µg LNG + 30 µg EE med 12. in 21. dnevom
Exploratory analyses were performed to determine whether in the Phase III studies (n=3319) the population characteristics of age, race and weight were associated with pregnancy.
Z analizami raziskav so ugotavljali, ali je pri ženskah, ki so sodelovale v raziskavah Faze III (n=3319), nosečnost povezana z njihovo starostjo, raso in telesno maso.
With respect to weight, 5 of the 15 pregnancies reported with EVRA were among women with baseline body weight equal or greater than 90 kg, which constituted < 3% of the study population.
Kar zadeva telesno maso pa je pri 5 od 15 žensk, ki so zanosile med uporabo obliža EVRA, izhodiščna telesna masa znašala 90 kg ali več, kar predstavlja < 3% proučevane populacije.
Although only 10-20% of the variability in pharmacokinetic data can be explained by weight (see Pharmacokinetic Properties, Special Populations), the greater proportions of pregnancies among women at or above 90 kg was statistically significant and indicates the EVRA is less effective in these women.
Čeprav lahko le 10 do 20% variabilnosti farmakokinetičnih podatkov utemeljimo s telesno maso (glejte Farmakokinetične lastnosti, Posebne skupine), je bil večji delež nosečnosti med ženskami, ki so tehtale 90 kg ali več, statistično pomemben in nakazuje, da so obliži EVRA pri teh ženskah manj učinkoviti.
5.2 Pharmacokinetic properties
15 5. 2 Farmakokinetične lastnosti
Steady state concentrations of norelgestromin and EE during one week of patch wear are approximately 0.8 ng/ ml and 50 pg/ ml, respectively.
50 pg/ ml.
In multiple-dose studies, serum concentrations and AUC for norelgestromin and EE were found to increase only slightly over time when compared to week 1 cycle 1.
V raziskavah, v katerih so ženske prejemale več odmerkov, so ugotovili, da serumske koncentracije norelgestromina in etinilestradiola ter površina pod krivuljo (AUC) sčasoma le rahlo narastejo v primerjavi s 1. tednom 1. ciklusa.
Results from an EVRA study of extended wear of single contraceptive patch for 7 days and 10 days indicated that target Css of norelgestromin and ethinyl estradiol were maintained during a 3-day period of extended wear of EVRA (10 days).
Rezultati raziskav, v katerih so ženske posamezen kontracepcijski obliž EVRA nosile dlje (7 in 10 dni) so pokazali, da so se med tridnevno podaljšano uporabo obliža EVRA (10 dni) ciljne Css norelgestromina in etinilestradiola ohranile.
Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins.
Norelgestromin in norgestrel (serumski metabolit norelgestromina) se v veliki meri vežeta (> 97%) na serumske proteine.
15 Elimination
Izločanje
Following removal of a patch, the mean elimination half-lives of norelgestromin and ethinyl estradiol were approximately 28 hours and 17 hours, respectively.
17 ur.
The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways.
Metaboliti norelgestromina in etinilestradiola se izločajo preko ledvic in z blatom.
Transdermal versus Oral Contraceptives
Transdermalni kontraceptivi v primerjavi s peroralnimi
In a study comparing EVRA to an oral contraceptive containing norgestimate (parent drug of norelgestromin) 250 µg/ ethinyl estradiol 35 µg, Cmax values were 2-fold higher for NGMN and EE in subjects administered the oral contraceptive compared to EVRA, while overall exposure (AUC and Css) was comparable in subjects treated with EVRA.
V raziskavi, ki je primerjala obliž EVRA s peroralnim kontraceptivom, ki je vseboval norgestimat (norelgestrominu sorodna učinkovina) 250 µg/ etinil estradiol 35 µg, so bile Cmax vrednosti 2- krat višje pri NGMN in EE, pri bolnicah, ki so prejemale peroralni kontraceptiv v primerjavi z obližem EVRA, medtem, ko je bila celokupna izpostavljenost (AUC in Css) pri bolnicah, ki so prejemale obliže EVRA primerljiva.
Effects of age, body weight, and body surface area
16 Vpliv starosti, telesne mase in telesne površine
The effects of age, body weight, and body surface area on the pharmacokinetics of norelgestromin and ethinyl estradiol were evaluated in 230 healthy women from nine pharmacokinetic studies of single 7- day applications of EVRA.
Pri 230 zdravih ženskah, ki so sodelovale v 9 farmakokinetičnih raziskavah in so obliž EVRA uporabljale samo 7 dni, so proučevali vpliv starosti, telesne mase in telesne površine na farmakokinetiko norelgestromina in etinilestradiola.
However, only a small fraction (10 – 20%) of the overall variability in the pharmacokinetics of the norelgestromin and EE following application of EVRA may be associated with any or all of the above demographic parameters.
Vendar pa lahko le majhen del (10- 20%) celotne variabilnosti v farmakokinetiki norelgestromina in etinilestradiola po namestitvi obliža EVRA povežemo s katerimkoli oz. vsemi zgoraj omenjenimi demografskimi parametri.
Middle layer: polyisobutylene/ polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate.
Srednja plast: poliizobutilen/ polibuten kot lepilo, krospovidon, netkan poliesterski material, lavrillaktat.
16 Third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
Tretja plast: film iz polietilen tereftalata (PET), obloga iz polidimetilsiloksana.
Do not refrigerate or freeze.
17 Ne shranjujte v hladilniku ali zamrzujte.
Secondary packaging material
Zunanja ovojnina
Apply immediately upon removal from the protective sachet.
Obliž moramo namestiti takoj, ko ga vzamemo iz zaščitne blazinice.
After use the patch still contains substantial quantities of active ingredients.
Po uporabi obliž še vedno vsebuje precejšnje količine učinkovin.