natgillin/translations-raw huggingface dataset:
What you need to know before you take Sildenafil Actavis Do not take Sildenafil Actavis - If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Nemojte uzimati Sildenafil Actavis - Ako ste alergični na sildenafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
If you take more Sildenafil Actavis than you should You may experience an increase in side effects and their severity.
Ako uzmete više Sildenafil Actavis tableta nego što ste trebali Mogli biste imati brojnije i jače nuspojave.
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered.
Budući da je klirens sildenafila smanjen u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina <30 ml/min), potrebno je razmotriti primjenu doze od 25 mg.
The tablets are provided in blister packs containing 1, 2, 4, 8, 12 or 24 tablets.
Tablete se isporučuju u blister pakiranjima koja sadrže 1, 2, 4, 8,12 ili 24 tablete.
- Chest pains - this occurs uncommonly If this occurs during or after intercourse Get in a semi-sitting position and try to relax.
Ako se to javi tijekom ili nakon spolnog odnosa: Zauzmite polusjedeći položaj i pokušajte se opustiti.
How to take Sildenafil Actavis
Kako uzimati Sildenafil Actavis
Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5).
Prilikom primjene sildenafila u bolesnika koji uzimaju alfa-blokator savjetuje se oprez jer istodobna primjena može dovesti do simptomatske hipotenzije u manjeg broja osjetljivih osoba (vidjeti dio 4.5).
You should not take Sildenafil Actavis if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure.
Ne smijete uzimati Sildenafil Actavis ako uzimate lijekove koji se nazivaju nitrati jer kombinacija ovih lijekova može dovesti do opasnog pada krvnog tlaka.
Aurobindo Pharma (Italia) s.r.l.
Aurobindo Pharma B.V.
In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment.
Kako bi se smanjila mogućnost razvoja posturalne hipotenzije kod bolesnika koji dobivaju terapiju alfa-blokatorima, bolesnici moraju biti stabilizirani uz terapiju alfa-blokatorima prije početka liječenja sildenafilom.
The Sildenafil Actavis tablet contains lactose monohydrate.
Tableta Sildenafil Actavis sadrži laktozu hidrat.
Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate).
Jedna tableta sadrži 25 mg, 50 mg ili 100 mg sildenafila (u obliku sildenafilcitrata).
Reykjavíkurvegi 78 IS-220 Hafnarfjörður Iceland
Reykjavíkurvegi 78 IS-220 Hafnarfjörður Island
In volunteers with severe renal impairment (creatinine clearance <30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
U dobrovoljaca s teškim poremećajem funkcije bubrega (klirens kreatinina <30 ml/min) klirens sildenafila bio je snižen što je rezultiralo srednjim porastom AUC i Cmax od 100%, odnosno 88% u usporedbi s dobrovoljcima odgovarajućim po dobi bez oštećenja bubrega.
Cerebrovascular accident, Transient ischaemic attack, Seizure,*
Cerebrovaskularni inzult, tranzitorna ishemijska ataka, napadaji,* ponavljanje napadaja,* sinkopa
Common (³ 1/100 and
Često (³ 1/100 do
You should not take Sildenafil Actavis if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
Ne smijete uzimati Sildenafil Actavis ako uzimate bilo koje od lijekova poznatih kao donori dušikovog oksida poput amil nitrita jer kombinacija također može dovesti do opasnog pada krvnog tlaka.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Rijetko (mogu se javiti kod do 1 na 1000 osoba): nesvjestica, moždani udar, srčani udar, nepravilni otkucaji srca, privremeno smanjenje protoka krvi u određene dijelove mozga, osjećaj stezanja u grlu, gubitak osjeta u ustima, krvarenje u očnoj pozadini, dvostruki vid, smanjena oštrina vida, neuobičajen osjet u oku, oticanje oka ili očnog kapka, sitne čestice ili mrlje u vidnom polju, aureole oko izvora svjetlosti, širenje zjenice oka, promjena boje bjeloočnice, krvarenje iz penisa, krv u sjemenoj tekućini, suhoća nosne sluznice, oticanje unutrašnjosti nosa, osjećaj razdražljivosti i iznenadno smanjenje ili gubitak sluha.
Sildenafil Actvis 25 mg, 50 mg and 100 mg film-coated tablets Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets sildenafil
Sildenafil Actvis 25 mg, 50 mg i 100 mg filmom obložene tablete Sildenafil Actavis 25 mg filmom obložene tablete Sildenafil Actavis 50 mg filmom obložene tablete Sildenafil Actavis 100 mg filmom obložene tablete sildenafil
When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Kod primjene jednokratne doze od 100 mg sildenafila s eritromicinom, umjerenim inhibitorom CYP3A4, u stanju dinamičke ravnoteže (500 mg dva puta dnevno tijekom 5 dana) uočen je 182%-tni porast sustavne izloženosti sildenafilu (AUC).
Sildenafil Actavis 100 mg film-coated tablets EU/1/09/595/011
Sildenafil Actavis 100 mg filmom obložene tablete EU/1/09/595/011
Lactose monohydrate Microcrystalline cellulose Povidone K29-32
Jezgra tablete: laktoza hidrat celuloza, mikrokristalična povidon K29-32 karmelozanatrij, umrežena magnezijev stearat
You should not use Sildenafil Actavis with any other oral or local treatments for erectile dysfunction.
Ne smijete uzimati Sildenafil Actavis s drugim oralnim (primijenjenim kroz usta) ili lokalnim lijekovima za erektilnu disfunkciju (poremećaj erekcije).
Islândia
Island
How to store Sildenafil Actavis
Kako čuvati Sildenafil Actavis
Sildenafil Actavis 25 mg film-coated tablets EU/1/09/595/001
Sildenafil Actavis 25 mg filmom obložene tablete EU/1/09/595/001
EU/1/09/595/011 [1 film-coated tablet] EU/1/09/595/012 [2 film-coated tablets] EU/1/09/595/013 [4 film-coated tablets] EU/1/09/595/014 [8 film-coated tablets] EU/1/09/595/015 [12 film-coated tablets] EU/1/09/595/018 [24 film-coated tablets]
EU/1/09/595/011 [1 filmom obložena tableta] EU/1/09/595/012 [2 filmom obložene tablete] EU/1/09/595/013 [4 filmom obložene tablete] EU/1/09/595/014 [8 filmom obloženih tableta] EU/1/09/595/015 [12 filmom obloženih tableta] EU/1/09/595/018 [24 filmom obložene tablete]
Sildenafil Actavis 50 mg film-coated tablets EU/1/09/595/006
Sildenafil Actavis 50 mg filmom obložene tablete EU/1/09/595/006
Sildenafil Actavis should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Muškarci s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom laktaze ili glukoza-galaktoza malapsorpcijom ne bi trebali uzimati Sildenafil Actavis.
Penile haemorrhage, Priapism, Haematospermia, Erection increased
Penilna hemoragija, Prijapizam, * hematospermija, produžena erekcija
Retinal vascular occlusion,*
Poremećaj suzenja očiju***,
EU/1/09/595/001 [1 film-coated tablet] EU/1/09/595/002 [2 film-coated tablets] EU/1/09/595/003 [4 film-coated tablets] EU/1/09/595/004 [8 film-coated tablets] EU/1/09/595/005 [12 film-coated tablets] EU/1/09/595/016 [24 film-coated tablets]
EU/1/09/595/001 [1 filmom obložena tableta] EU/1/09/595/002 [2 filmom obložene tablete] EU/1/09/595/003 [4 filmom obložene tablete] EU/1/09/595/004 [8 filmom obloženih tableta] EU/1/09/595/005 [12 filmom obloženih tableta] EU/1/09/595/016 [24 filmom obložene tablete]
EU/1/09/595/006 [1 film-coated tablet] EU/1/09/595/007 [2 film-coated tablets] EU/1/09/595/008 [4 film-coated tablets] EU/1/09/595/009 [8 film-coated tablets] EU/1/09/595/010 [12 film-coated tablets] EU/1/09/595/017 [24 film-coated tablets]
EU/1/09/595/006 [1 filmom obložena tableta] EU/1/09/595/007 [2 filmom obložene tablete] EU/1/09/595/008 [4 filmom obložene tablete] EU/1/09/595/009 [8 filmom obloženih tableta] EU/1/09/595/010 [12 filmom obloženih tableta] EU/1/09/595/017 [24 filmom obložene tablete]
macrogol 6000, indigo carmine aluminium lake (E132).
Film ovojnica: hipromeloza titanijev dioksid (E171) makrogol 6000 indigo carmine aluminium lake (E132)
Myocardial infarction, Ventricular arrhythmia, Atrial fibrillation, Unstable angina
Iznenadna srčana smrt,* infarkt miokarda, ventrikularna aritmija,* fibrilacija atrija,
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Istodobna primjena inhibitora HIV proteaze, sakvinavira, inhibitora CYP3A4, u stanju dinamičke ravnoteže (1200 mg tri puta dnevno) sa sildenafilom (100 mg u jednoj dozi) rezultirala je 140%-tnim porastom Cmax sildenafila i 210%-tnim porastom AUC-a sildenafila.
However, you may find that Sildenafil Actavis takes longer to start working if you take it with a heavy meal.
Međutim, ako uzmete Sildenafil Actavis uz obilniji obrok, možda će proći više vremena do početka njegovog djelovanja.
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04BE03.
Farmakoterapijska skupina: urološki preparati; lijekovi koji se primjenjuju kod erektilne disfunkcije.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Često (mogu se javiti kod do 1 na 10 osoba): mučnina, naleti crvenila u licu, navala vrućine (simptomi uključuju iznenadan osjećaj vrućine u gornjem dijelu tijela), probavne tegobe, obojeni vid, zamagljen vid, poremećaj vida, začepljenost nosa i omaglica.
- Seizures or fits - this occurs rarely
Napadaji - javljaju se rijetko
If Sildenafil Actavis does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.
Trebate obavijestiti svog liječnika ako Vam Sildenafil Actavis ne pomaže u postizanju erekcije ili ako erekcija ne traje dovoljno dugo za dovršetak spolnog odnosa.
Visual colour distortions**, Visual disturbance, Vision blurred
Vizualni poremećaj percepcije boja**,
Sildenafil Actavis 50 mg tablets Each tablet contains 124.76 mg lactose (as monohydrate).
Jedna tableta sadrži 124,76 mg laktoze (u obliku hidrata).
Sildenafil Actavis 100 mg tablets Each tablet contains 249.52 mg lactose (as monohydrate).
Jedna tableta sadrži 249,52 mg laktoze (u obliku hidrata).
Aurobindo Pharma B.V. Tel: +31 355429933
Aurobindo Pharma (Italia) s.r.l. Tel: +39 0296392601
Rare (³ 1/10000 and discoloration
Rijetko (³ 1/10000 do nestabilna angina
resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.
U zdravih muških dobrovoljaca, sildenafil je u stanju dinamičke ravnoteže (80 mg tri puta na dan) rezultirao sa 49,8%-tnim povećanjem AUC bosentana i 42%-tnim povećanjem Cmax bosentana (125 mg dva puta na dan).
Sildenafil Actavis 100 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Sildenafil Actavis 100 mg filmom obložene tablete Blisteri od PVC-PVDC/aluminija u kutijama s 1, 2, 4, 8,12 ili 24 tablete.
croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171),
- Pomoćne tvari su: laktoza hidrat, mikrokristalična celuloza, povidon K29-32, umrežena karmelozanatrij, magnezijev stearat, hipromeloza, titanijev dioksid (E171), makrogol 6000,
Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral
glaukom, ispadi vidnog polja, diplopija, smanjena jasnoća vida, miopija, astenopija, flotirajuće mutnine staklastog tijela, poremećaj šarenice, midrijaza, svjetlosne aureole, edem oka, oticanje oka, poremećaj oka, konjuktivalna hiperemija, iritacija oka, neuobičajena osjetljivost oka, edem kapka, diskoloracija bjeloočnice
INFORMATION IN BRAILLE Sildenafil Actavis 100 mg
16. PODACI NA BRAILLEOVOM PISMU Sildenafil Actavis 100 mg
Τηλ: +357 22583333
Potamitis Medicare Ltd Τηλ: +357 22583333
Headache Dizziness
zamagljeni vid
Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 25, 50 ili 100 mg sildenafila u obliku sildenafilcitrata.
Uncommon (³ 1/1000 and
Manje često (³ 1/1000 do
Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked “SL50” on one side.
Sildenafil Actavis 50 mg filmom obložene tablete su plave, eliptičnog oblika, bikonveksne, dimenzija 13,0 x 6,5 mm, s oznakom „SL50“ na jednoj strani.
Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked “SL25” on one side.
Sildenafil Actavis 25 mg filmom obložene tablete su plave, eliptičnog oblika, bikonveksne, dimenzija 10,0 x 5,0 mm, s oznakom „SL25“ na jednoj strani.
Sildenafil Actavis 50 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Sildenafil Actavis 25 mg filmom obložene tablete Blisteri od PVC-PVDC/aluminija u kutijama s 1, 2, 4, 8, 12 ili 24 tablete.
INFORMATION IN BRAILLE Sildenafil Actavis 25 mg
16. PODACI NA BRAILLEOVOM PISMU Sildenafil Actavis 25 mg
Sildenafil Actavis 25 mg tablets Each tablet contains 62.38 mg lactose (as monohydrate).
Jedna tableta sadrži 62,38 mg laktoze (u obliku hidrata).
Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
fotofobija, fotopsija, kromatopsija, hiperemija oka, osjećaj svjetline pri gledanju, konjuktivitis
Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked “SL100” on one side.
Sildenafil Actavis 100 mg filmom obložene tablete su plave, eliptičnog oblika, bikonveksne, dimenzija 17,0 x 8,5 mm, s oznakom „SL100“ na jednoj strani.
INFORMATION IN BRAILLE Sildenafil Actavis 50 mg
16. PODACI NA BRAILLEOVOM PISMU Sildenafil Actavis 50 mg
Your doctor should carefully check whether your heart can take the additional strain of having sex. - If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
- Ako trenutno imate čir na želucu ili probleme s krvarenjem (kao što je hemofilija).
Non-arteritic anterior ischaemic optic neuropathy (NAION), *
Nearteritična anteriorna ishemijska optička neuropatija (NAION), * retinalna vaskularna okluzija,* retinalno krvarenje, arteriosklerotska retinopatija, porem ećaj mrežnice,
NAME OF THE MEDICINAL PRODUCT Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets
Sildenafil Actavis 25 mg filmom obložene tablete Sildenafil Actavis 50 mg filmom obložene tablete Sildenafil Actavis 100 mg filmom obložene tablete
Each tablet contains 100 mg of sildenafil (as citrate).
Jedna tableta sadrži 100 mg sildenafila (u obliku sildenafilcitrata).
Each tablet contains 25 mg of sildenafil (as citrate).
Jedna tableta sadrži 25 mg sildenafila (u obliku sildenafilcitrata).
If you get any side effects, talk to you doctor, pharmacist or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
You may find that Sildenafil Actavis takes longer to work if you take it with a heavy meal.
Ako uzmete Sildenafil Actavis uz obilniji obrok, možda će proći više vremena do početka njegovog djelovanja.
Each tablet contains 50 mg of sildenafil (as citrate).
Jedna tableta sadrži 50 mg sildenafila (u obliku sildenafilcitrata).
Sildenafil Actavis 25 mg film-coated tablets sildenafil
Sildenafil Actavis 25 mg filmom obložene tablete sildenafil
Sildenafil Actavis 100 mg film-coated tablets sildenafil
Sildenafil Actavis 100 mg filmom obložene tablete sildenafil
Sildenafil Actavis 25 mg film-coated tablets
Sildenafil Actavis 25 mg filmom obložene tablete
Marketing Authorisation Holder Actavis Group PTC ehf.
Nositelj odobrenja Actavis Group PTC ehf.
Sildenafil Actavis 50 mg film-coated tablets sildenafil
Sildenafil Actavis 50 mg filmom obložene tablete sildenafil
Sildenafil Actavis 50 mg film-coated tablets
Sildenafil Actavis 50 mg filmom obložene tablete
Sildenafil Actavis 100 mg film-coated tablets
Sildenafil Actavis 100 mg tablete
You should be aware of how you react to Sildenafil Actavis before you drive or use machinery.
Prije upravljanja vozilima ili strojevima trebate biti svjesni kako Sildenafil Actavis djeluje na Vas.
Repeat step 3 again.
Ponovite korak 3.
Elderly (≥ 65 years)
Stariji (≥ 65 godina)
The Information for healthcare professionals should contain the following key elements:
Informacija za zdravstvene radnike mora sadržavati sljedeće ključne elemente:
Do not squirt the medicine out quickly.
Nemojte brzo uštrcati lijek.
Keep it in a clean safe place with the medicine.
Čuvajte je na čistom i sigurnom mjestu, zajedno s lijekom.
There are also links to other website about rare diseases and treatments.
Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i njihovom liječenju.
Chemical and physical compatibility has been demonstrated with the following diluents:
Dokazana je kemijska i fizikalna kompatibilnost sa sljedećim otapalima:
MedDRA system organ class (V.14.0)
MedDRA klasa organskog sustava (v14.0)
Estimated difference 95% confidence interval
Procijenjena razlika Interval pouzdanosti 95%
Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse.
Revatio se primjenjuje u obliku intravenske injekcije i uvijek će Vam ga dati liječnik ili medicinska sestra.
What Revatio is and what it is used for
Što je Revatio i za što se koristi
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
S obzirom da ćete ovaj lijek primati pod strogim medicinskim nadzorom, nije vjerojatno da ćete propustiti dozu.
These results are relevant to other populations and routes of administration.
Rezultati tih ispitivanja relevantni su za ostale populacije i ostale putove primjene.
Do not take Revatio:
Nemojte uzimati Revatio:
Revatio can cause a serious increase in the effects of these medicines.
Revatio može uzrokovati ozbiljno pojačanje učinaka tih lijekova.
This will force the medicine back into the bottle.
Tako ćete lijek vratiti u bocu.
Revatio solution for injection is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Revatio otopina za injekciju ne preporučuje se za primjenu u djece mlađe od 18 godina zbog nedostatnih podataka o sigurnosti i djelotvornosti.
This medicinal product must not be mixed with other medicinal products or intravenous diluents except those mentioned in section 6.6.
Lijek se ne smije miješati s drugim lijekovima ni otapalima za intravensku primjenu osim onih navedenih u dijelu 6.6.
Pull the plunger out of the syringe and wash both parts in water.
Izvucite klip iz štrcaljke i oba dijela operite vodom.
- if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
- ako ste alergični na sildenafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
80 mg TID, respectively.
80 mg TID.
- Information for healthcare professionals
• Informacije za zdravstvene radnike
- Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems
Data Capture Form, DCF), oblikovan na način da se olakša prijavljivanje događaja hipotenzije i pridruženih joj tegoba
Its use is accordingly not recommended in these patients.
Stoga se ne preporučuje njegova primjena u takvih bolesnika.
Other medicines and Revatio
Drugi lijekovi i Revatio
If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Ako ste zaboravili uzeti Revatio, uzmite dozu čim se sjetite, a zatim nastavite uzimati lijek u uobičajeno vrijeme.
Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.
Revatio se izlučuje u majčino mlijeko u vrlo malim količinama i ne očekuje se da bi mogao naškoditi Vašem dojenčetu.
n=29 for placebo group
(p = 0,056) n = 29 za skupinu koja je primala placebo
Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose.
Liječnici trebaju savjetovati bolesnicima koji zaborave uzeti Revatio da uzmu dozu što prije, a zatim nastave s uobičajenom dozom.
After reconstitution, the oral suspension is stable for 30 days.
Nakon rekonstitucije, oralna suspenzija je stabilna 30 dana.
Date of first authorisation: 28 October 2005 Date of latest renewal: 23 September 2010
Datum posljednje obnove odobrenja: 23. rujna 2010.
In cases of overdose, standard supportive measures should be adopted as required.
U slučaju predoziranja, po potrebi se moraju primijeniti standardne suportivne mjere.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/foetal development.
Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću i razvoj embrija i fetusa.
Do not stop taking Revatio unless your doctor tells you to.
Nemojte prestati uzimati Revatio ako Vam tako ne kaže liječnik.
Your doctor will determine the duration of your treatment and how much Revatio intravenous injection you will receive each day and will monitor your response and condition.
Vaš će liječnik odrediti koliko dugo će liječenje trajati i koliko intravenskih injekcija lijeka Revatio ćete primiti svakoga dana.
The syringe should be washed after each dose.
Štrcaljku morate oprati nakon svake uporabe.
Revatio can cause dizziness and can affect vision.
Revatio može izazvati omaglicu i može utjecati na vid.
If large bubbles can be seen, slowly push the plunger back into the syringe.
Ako se vide veliki mjehurići, polagano gurnite klip nazad u štrcaljku.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and development.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
After dosing, sitting and standing blood pressure and heart rate were recorded at 30, 60, 120, 180 and 360 minute post dose.
Nakon davanja lijeka mjereni su krvni tlak u sjedećem i stojećem položaju i srčana frekvencija nakon 30, 60, 120, 180 i 360 minuta od primjene doze.
Concomitant use with other PDE5 inhibitors
Istodobna primjena s drugim PDE5 inhibitorima
Taking more Revatio than you should may increase the risk of known side effects.
Uzimanje više lijeka Revatio nego što je potrebno može povećati rizik od poznatih nuspojava.
Cleaning and storing the syringe:
Čišćenje i čuvanje štrcaljke:
IMMEDIATE PACKAGING/BLISTER
UNUTARNJE PAKIRANJE/BLISTER
Push the plunger back in to the syringe.
Gurnite klip natrag u štrcaljku.