FrancophonIA/ELRC3.0 huggingface dataset:
English: Intrarosa has not been studied in women with a current hormonal treatment: hormone replacement therapy (oestrogens alone or combined with progestogens) or androgens treatment.
Croatian: Intrarosa nije ispitivana u žena koje trenutačno primaju hormonsku terapiju: hormonsko nadomjesno liječenje (samo estrogenima ili kombinacije estrogena s progestagenima) ili androgensko liječenje.
English: Table 1: Primary Efficacy Analysis - Change from Baseline to Week 12 in the Most Bothersome Symptom Dyspareunia (ITT Population; LOCF)
Croatian: Tablica 1.: Primarna analiza djelotvornosti - promjena od početka ispitivanja do 12. tjedna za najgori simptom, dispareuniju (populacija predviđena za liječenje (engl. intent to treat, ITT); zadnje opažanje preneseno dalje (engl. last observation carried forward, LOCF)
English: In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk.
Croatian: U svim slučajevima potrebno je provesti pažljivu procjenu rizika i koristi svakih 6 mjeseci.
English: Abnormal Pap smear
Croatian: Abnormalni nalazi Papa testa
English: INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: 16. PODACI NA BRAILLEOVOM PISMU JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: Since Intrarosa acts locally in the vagina, no dosage adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease.
Croatian: Bolesnice s oštećenjem bubrega i/ili jetre Budući da lijek Intrarosa djeluje lokalno u rodnici, prilagodba doze nije potrebna u žena u postmenopauzi s oštećenjem bubrega ili jetre ili nekom drugom sistemskom anomalijom ili bolesti.
English: • Select the position for insertion of the pessary that is most comfortable for you.
Croatian: • Odaberite najudobniji položaj za umetanje vagitorija.
English: Trial 1
Croatian: Ispitivanje 1.
English: Trial 2
Croatian: Ispitivanje 2.
English: How to store Intrarosa
Croatian: Kako primjenjivati lijek Intrarosa
English: It is not required to stop Intrarosa if vaginal discharge occurs (see section 4.4).
Croatian: Ako dođe do pojave vaginalnog iscjetka, ne treba prekidati primjenu lijeka Intrarosa (vidjeti dio 4.4).
English: What Intrarosa is used for
Croatian: Za što se Intrarosa koristi
English: Table 2: Percentage of Patients with Improvement, Relief or Substantial Improvement of MBS Dyspareunia after 12 Weeks on Intrarosa vs.
Croatian: Tablica 2.: Postotak bolesnica s poboljšanjem, olakšanjem ili značajnim poboljšanjem najgoreg simptoma (MBS) dispareunije nakon 12. tjedana primanja lijeka Intrarosa u odnosu na placebo (ITT, LOCF)
English: None of these conditions has been observed with Intrarosa during the clinical trials.
Croatian: Nijedno od tih stanja nije primijećeno tijekom primjene lijeka Intrarosa u kliničkim ispitivanjima.
English: Endometrial safety
Croatian: Sigurnost s obzirom na endometrij
English: This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment.
Croatian: Uzrokovan je topljenjem tvrdih masti koje se koriste kao podloga za vagitorij, uz očekivano povećanje vaginalne sekrecije zbog liječenja.
English: For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
Croatian: Očekuje se da će u žena u 50-tim godinama koje uzimaju hormonsko nadomjesno liječenje tijekom 5 godina biti 11 takvih slučajeva na 1000 žena (tj. dodatna 3 slučaja).
English: Weight fluctuation
Croatian: Oscilacije tjelesne težine
English: How to use Insert the pessary into the vagina with your finger or with an applicator provided in the pack.
Croatian: Umetnite vagitorij u rodnicu prstom ili pomoću aplikatora koji se isporučuje u pakiranju.
English: Intrarosa has not been studied in women with abnormal Pap smears (Atypical Squamous Cells of Undetermined Significance (ASCUS)) or worse.
Croatian: Atypical Squamous Cells of Undetermined Significance, ASCUS)) ili još gorim nalazima.
English: − with a common frequency (may affect up to 1 in 10 people): abnormal Pap smear (mostly
Croatian: - često (može se javiti u do 1 na 10 osoba): abnormalni nalazi Papa testa (većinom ASCUS ili LGSIL),
English: ASCUS or LGSIL), weight fluctuations (either increase or decrease);
Croatian: oscilacije u tjelesnoj težini (povećanje ili smanjenje),
English: • Known or suspected oestrogen-dependent malignant tumours (e.g endometrial cancer);
Croatian: • Ustanovljeni zloćudni tumori ovisni o estrogenu (npr. rak endometrija) ili sumnja na njih; • Neliječena hiperplazija endometrija;
English: Additional cases per 1000 never-users of HRT over a 5 year period*1
Croatian: 1000 žena koje nikada nisu primale HNL tijekom 5 godina*1
English: In a study conducted in postmenopausal women, administration of the Intrarosa pessary once daily for 7 days resulted in a mean prasterone Cmax and area under the curve from 0 to 24 hours (AUC0-24) at day 7 of 4.4 ng/mL and 56.2 ng h/mL, respectively, which were significantly higher than those in the group treated with placebo (Table 3; Figure 1).
Croatian: U ispitivanju u kojem su sudjelovale žene u postmenopauzi, primjena Intrarosa vagitorija jednom dnevno tijekom 7 dana dovela je 7. dana do prosječne vrijednosti Cmax prasterona od 4,4 ng/mL i prosječne vrijednosti površine ispod krivulje (AUC0-24) od 56,2 ng h/mL.
English: Cases of ovarian and breast cancer have rarely been reported in women treated with 6.5 mg of prasterone for 52 weeks.
Croatian: Zabilježeni su rijetki slučajevi raka dojke i jajnika u žena koje su primale 6,5 mg prasterona tijekom
English: Intrarosa has not been studied in women with history of thromboembolic diseases, uncontrolled hypertension or heart disease.
Croatian: Učinak hormonskog nadomjesnog liječenja na srce i cirkulaciju Lijek Intrarosa nije ispitivan u žena s poviješću tromboembolijskih bolesti, nekontrolirane hipertenzije ili srčanih bolesti.
English: Intrarosa has not been studied in women with current or previous arterial thromboembolic disease.
Croatian: Lijek Intrarosa nije ispitivan u žena s postojećom ili prethodnom arterijskom tromboembolijskom bolešću.
English: In clinical trials, no deep vein thrombosis has been observed with intravaginal prasterone while one case of pulmonary embolism which corresponds to an incidence lower with Intrarosa than in the placebo group.
Croatian: Zabilježen je jedan slučaj plućne embolije, što je odgovaralo manjoj pojavnosti pri primjeni lijeka Intrarosa, nego u skupini koja je primala placebo.
English: Non-interventional PASS - Drug Utilisation Study (DUS) to describe the baseline characteristics, utilisation patterns of EU postmenopausal women initiating treatment with Intrarosa and to assess whether EU prescribers abide by the contraindications stated in the EU SmPC.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS) - ispitivanje potrošnje lijeka (DUS) radi opisa početnih karakteristika i uzorka potrošnje u žena u postmenopauzi koje započinju liječenje lijekom
English: In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Croatian: Kod žena u dobi od 50 do 54 godine koje nisu primale HNL, u otprilike 2 od 2000 žena dijagnosticirat će se rak jajnika tijekom razdoblja od 5 godina.
English: Intrarosa 6,5 mg pessary prasterone
Croatian: Intrarosa 6,5 mg vagitoriji prasterone
English: • For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen.
Croatian: • Ne preporučuje se dodavanje progestagena estrogenskim lijekovima za vaginalnu primjenu kod kojih sustavna izloženost estrogenu ostaje u normalnom rasponu za postmenopauzu.
English: The plunger of the applicator should be pressed to release the pessary.
Croatian: Treba pritisnuti klip aplikatora da bi se vagitorij otpustio.
English: For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Croatian: Na primjer, u skupini žena u dobi od 50 do 54 godine koje nisu primale hormonsko nadomjesno liječenje, u otprilike 2 od 2000 žena doći će do raka jajnika tijekom razdoblja od 5 godina.
English: Instructions on how to use Intrarosa How should I use Intrarosa
Croatian: Upute o primjeni lijeka Intrarosa Kako primjenjivati lijek Intrarosa
English: • Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk.
Croatian: • Bolesnice s ustanovljenim trombofilnim stanjima imaju povećani rizik od venske tromboembolije,
English: No cases of endometrial hyperplasia have been reported in women treated for 52 weeks during the clinical studies.
Croatian: U žena koje su primale terapiju 52 tjedna tijekom kliničkih ispitivanja nisu zabilježeni slučajevi hiperplazije endometrija.
English: If vaginal discharge occurs, it is not required to stop Intrarosa.
Croatian: U slučaju vaginalnog iscjetka ne treba prekidati primjenu lijeka Intrarosa.
English: The extra risk depends on how long you take HRT.
Croatian: Dodatni rizik ovisi o trajanju primjene hormonskog nadomjesnog liječenja.
English: The adverse reaction observed with prasterone 6.5 mg pessaries obtained from clinical studies is tabulated below.
Croatian: Tablični popis nuspojava Nuspojave primijećene pri primjeni vagitorija od 6,5 mg prasterona u kliničkim ispitivanjima navedene su u tablici u nastavku.
English: No case of stroke has been observed with Intrarosa during clinical trials.
Croatian: Nijedan slučaj moždanog udara nije zabilježen tijekom primjene lijeka Intrarosa u kliničkim ispitivanjima.
English: Once you have started on Intrarosa you should see your doctor for regular check-ups (at least every 6 months).
Croatian: Nakon što počnete primjenjivati lijek Intrarosa, trebate posjećivati liječnika radi redovitih pregleda
English: This is likely due to melting of the hard fat added to an expected increase in vaginal secretions due to treatment.
Croatian: Uzrokovana je topljenjem tvrdih masti vagitorija, uz očekivano povećanje vaginalnog iscjetka zbog liječenja.
English: Intrarosa is not meant for women with child-bearing potential.
Croatian: Intrarosa nije namijenjena ženama u reproduktivnoj dobi.
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and special warnings and precautions for use according to the decision of their doctor.
Croatian: kontraindikacije te posebna upozorenja i mjere opreza za upotrebu u skladu s odlukom liječnika.
English: Each pessary contains 6.5 mg of prasterone.
Croatian: Jedan vagitorij sadržava 6,5 mg prasterona.
English: Table 2 shows the percentage of subjects who reported a change from baseline in their MBS dyspareunia at week 12.
Croatian: U tablici 2. prikazuje se postotak ispitanica koje su prijavile promjenu u pogledu najgoreg simptoma dispareunije od početka ispitivanja do 12. tjedna.
English: The use of Intraorsa in combination with hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens is not recommended.
Croatian: Ne preporučuje se primjena lijeka Intrarosa s hormonskim nadomjesnim liječenjem (samo estrogenom ili kombinacijom estrogena i progestagena ili androgenskom terapijom) ili vaginalnim estrogenima.
English: One case of pulmonary embolism has been reported in the 6.5 mg group and one in the placebo group during clinical trials.
Croatian: Tijekom kliničkih ispitivanja zabilježen je jedan slučaj plućne embolije u skupini koja je primala dozu od 6,5 mg i jedan slučaj plućne embolije u skupini koja je primala placebo.
English: • You may have vaginal discharge due to melting of the ‘hard fat base' which adds to increased vaginal secretions due to treatment.
Croatian: • Može se pojaviti vaginalni iscjedak zbog topljenja tvrdih masti u podlozi vagitorija uz pojačanu vaginalnu sekreciju uzrokovanu terapijom.
English: If any of the above conditions appears for the first time while taking Intrarosa, stop taking it at once and consult your doctor immediately.
Croatian: Ako se bilo koje od prethodno navedenih stanja prvi put pojavi tijekom primjene lijeka Intrarosa,
English: Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period.
Croatian: Za žene u 50-tim godinama koje ne uzimaju hormonsko nadomjesno liječenje, očekuje se da bi tijekom 5 godina, u prosjeku 8 na 1000 žena moglo dobiti moždani udar.
English: Cases of abnormal Pap smears corresponding to ASCUS or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported in women treated with the 6.5 mg dose (common frequency).
Croatian: U žena koje su primale dozu od 6,5 mg (često) su primijećeni slučajevi abnormalnih nalaza Papa testa koji odgovaraju nalazu ASCUS ili LSIL (skvamozna intraepitelna lezija niskog stupnja).
English: • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness);
Croatian: • ako se krvni tlak znatno povisi (simptomi mogu uključivati glavobolju, umor, omaglicu), • glavobolje nalik na migrene koje se događaju prvi put,
English: • Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
Croatian: Stoga treba pomno nadzirati bolesnice sa srčanim ili bubrežnim poremećajima.
English: • gall bladder disease
Croatian: • bolest žučnog mjehura
English: Intrarosa 6.5 mg pessary.
Croatian: Intrarosa 6,5 mg vagitoriji.
English: Absorption
Croatian: Dispareunija
English: • Known, past or suspected breast cancer;
Croatian: • Genitalno krvarenje nepoznatog uzroka; • Ustanovljeni rak dojke, rak dojke u prošlosti, sumnja na rak dojke;
English: How to use Intrarosa
Croatian: Kako primjenjivati
English: The pessary should be inserted in the vagina as far as it can comfortably go without force.
Croatian: Vagitorij treba umetnuti u rodnicu što dublje bez primjene sile.
English: • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining
Croatian: • ako imate rak osjetljiv na estrogene, na primjer rak sluznice maternice (endometrija) ili ako postoji sumnja da ga imate;
English: No case of coronary artery disease has been reported during clinical trials.
Croatian: U kliničkim ispitivanjima nije zabilježen nijedan slučaj bolesti koronarnih arterija.
English: No cases of arterial thromboembolic disease have been reported during clinical trials.
Croatian: U kliničkim ispitivanjima nije zabilježen nijedan slučaj arterijske tromboembolijske bolesti.
English: Oestrogen only HRT
Croatian: HNL koji sadrži samo estrogen
English: Breast-feeding Intrarosa is not indicated during breast-feeding.
Croatian: Dojenje Lijek Intrarosa nije indiciran tijekom dojenja.
English: • If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism);
Croatian: • ako imate ili ste imali krvni ugrušak u veni (tromboza), na primjer u nogama (duboka venska tromboza) ili u plućima (plućna embolija); • ako imate poremećaj zgrušavanja krvi (na primjer nedostatak proteina C, proteina S ili antitrombina);
English: HRT and cancer
Croatian: Hormonsko nadomjesno liječenje i rak
English: For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).
Croatian: U žena koje su primale hormonsko nadomjesno liječenje tijekom 5 godina, u približno 3 od 2000 žena doći će do nastanka raka jajnika (tj. otprilike 1 dodatni slučaj).
English: • ovarian cancer;
Croatian: • rak jajnika,
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Croatian: Epidemiološki dokazi iz opsežne metaanalize ukazuju na blago povećani rizik u žena koje primaju sistemsko hormonsko nadomjesno liječenje koje sadrži samo estrogen.
English: It should be taken into account that these conditions may recur or be aggravated during treatment with Intrarosa, in particular: - Leiomyoma (uterine fibroids) or endometriosis - Risk factors for thromboembolic disorders (see below) - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer - Hypertension - Liver disorders (e.g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus.
Croatian: U obzir treba uzeti da se ta stanja mogu vratiti ili pogoršati tijekom liječenja lijekom Intrarosa, a posebno: - leiomiomi (fibroidi maternice) ili endometrioza
English: Final study report by Q4 2021
Croatian: tromjesečja 2021.
English: Package leaflet: Information for the user Intrarosa 6.5 mg pessary prasterone This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Intrarosa 6,5 mg vagitoriji prasteron (prasterone)
English: Oral oestrogen-only*3
Croatian: Lijekovi za oralnu primjenu koji sadrže samo estrogen*3
English: Efficacy data were obtained from two US and Canadian randomised, double-blind, placebo-controlled, multicentre, pivotal phase III trials (ERC-231/Trial 1 and ERC-238/Trial 2) performed in postmenopausal women aged 40 to 80 years (mean age = 58.6 years in Trial 1 and 59.5 years in Trial 2) with vulvar and vaginal atrophy (VVA ).
Croatian: dob = 58,6 godina u 1. ispitivanju i 59,5 godina u 2. ispitivanju) s vulvarnom i vaginalnom atrofijom (VVA).
English: Intrarosa has not been studied in women with current or previous venous thromboembolic disease.
Croatian: Venska tromboembolija Lijek Intrarosa nije ispitivan u žena s postojećom ili prethodnom venskom tromboembolijom.
English: • Press the applicator plunger with your index (pointer) finger to release the pessary.
Croatian: • Pritisnite klip aplikatora kažiprstom kako biste ispustili vagitorij.
English: The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Croatian: Uporaba lijekova za hormonsko nadomjesno liječenje (HNL) koji sadrže samo estrogene povezuje se s blago povećanim rizikom od nastanka raka jajnika.
English: - A history of endometrial hyperplasia (see below) - Epilepsy - Asthma - Otosclerosis
Croatian: - dijabetes melitus s vaskularnim komplikacijama ili bez njih - kolelitijaza - migrena ili (jaka) glavobolja - sistemski eritemski lupus - hiperplazija endometrija u anamnezi (vidjeti u nastavku) - epilepsija - astma - otoskleroza
English: Intrarosa has not been studied in women with active or past breast cancer.
Croatian: Lijek Intrarosa nije ispitivan u žena s aktivnim ili prethodnim rakom dojke.
English: HRT is associated with a 1.3-3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Croatian: HNL je povezan s 1,3 do 3 puta većim relativnim rizikom od razvoja venske tromboembolije (VTE),
English: Intrarosa has not been studied in women with active or past ovarian cancer.
Croatian: Lijek Intrarosa nije ispitivan u žena s aktivnim ili prethodnim rakom jajnika.
English: Cases of abnormal Pap smears either Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported with a common frequency in women treated with Intrarosa for 52 weeks (see section 4.4).
Croatian: U žena koje su primale lijek Intrarosa tijekom 52 tjedna (vidjeti dio 4.4) zabilježeni su česti slučajevi abnormalnih nalaza Papa testa koji se odnose na atipične pločaste stanice neodređenog značenja
English: • breast cancer;
Croatian: • rak dojke,
English: How to store Intrarosa 6.
Croatian: Moguće nuspojave 5. Kako čuvati lijek Intrarosa
English: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Croatian: Za žene u 50-tim godinama koje ne uzimaju HNL, očekuje se da bi tijekom 5 godina, u prosjeku 4 do 7
English: In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk following discussions with their doctor.
Croatian: Primjenu lijeka Intrarosa treba nastaviti nakon savjetovanja s liječnikom samo ako koristi nadmašuju rizike.
English: • Gently slide the pessary end of the applicator into your vagina as far as it will comfortably go.
Croatian: • Stranu aplikatora u kojoj se nalazi vagitorij nježno gurnite što dublje u rodnicu.
English: WHI Studies - Additional risk of VTE over 5 years' use
Croatian: WHI ispitivanja - dodatni rizik od venske tromboembolije tijekom 5 godina liječenja
English: Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer.
Croatian: Dokazi ukazuju na to da primjena kombinacije estrogena i progestagena, a moguće i lijekova za HNL
English: Speak to your doctor if you think this dose is too strong or not strong enough.
Croatian: Ako smatrate da je doza prejaka ili preslaba, razgovarajte sa svojim liječnikom.
English: Placebo p-value
Croatian: placebo Intrarosa
English: • gallstones;
Croatian: • žučni kamenci,
English: Intrarosa has not been studied in women with current or history of cancers.
Croatian: Lijek Intrarosa nije ispitivan u žena koje imaju rak ili su u prošlosti imale rak.
English: Cervical/ uterine polyps Breast mass (benign)
Croatian: Polipi na cerviksu/maternici Kvržica na dojci
English: Many may feel quite normal.
Croatian: Mnogi se osjećaju prilično normalno.
English: Date of first authorisation: 14 April 2011
Croatian: Datum prvog odobrenja: 14. travnja 2011.
English: These combinations were well tolerated.
Croatian: Te su se kombinacije dobro podnosile.
English: No carcinogenic potential was detected.
Croatian: Karcinogeni potencijal nije otkriven.
English: The volume of distribution is approximately 21 l/kg.
Croatian: Volumen distribucije je približno 21 l/kg.
English: Rasilamlo with food and drink
Croatian: Rasilamlo s hranom i pićem
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Croatian: CHMP je suglasan sa znanstvenim zaključima koje je donio PRAC.
English: • sudden, temporary loss of consciousness
Croatian: • iznenadan, privremeni gubitak svijesti
English: The AUC is 50% higher in elderly (>65 years) than in young subjects.
Croatian: AUC je 50% viši u starijih (>65 godina) nego u mladih ispitanika.
English: Data reported in children below 6 years are limited.
Croatian: Podaci prijavljeni u djece mlađe od 6 godina su ograničeni.
English: See also information under the heading “Do not take Rasilamlo”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Rasilamlo“.
English: Large variability in exposure between individuals was observed.
Croatian: Uočena je velika varijabilnost u izloženosti između pojedinaca.
English: • ringing noise in ears
Croatian: • zvonjava u ušima
English: Absolute bioavailability has been estimated as between 64% and 80%.
Croatian: Apsolutna bioraspoloživost je procijenjena na između 64% i 80%.
English: Always take this medicine exactly as your doctor has told you and do not exceed the recommended dose.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik i nemojte prekoračiti preporučenu dozu.
English: Do not take this medicine if you are pregnant (see section Do not take Rasilamlo).
Croatian: Nemojte uzimati ovaj lijek ako ste trudni (pogledajte dio Nemojte uzimati Rasilamlo).
English: , headache (especially at the beginning of treatment)
Croatian: , glavobolja (osobito na početku liječenja)
English: Both of these substances help to control high blood pressure (hypertension).
Croatian: Obje te tvari pomažu u kontroli povišenog krvnog tlaka (hipertenziji).
English: 85 to 90% of the maximal blood-pressure-lowering effect was observed after 2 weeks.
Croatian: 85 do 90% maksimalnog učinka sniženja krvnoga tlaka opaženo je nakon 2 tjedna.