natgillin/translations-raw huggingface dataset:
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
V treh specifičnih študijah medsebojnega delovanja zdravil so bolnikom z benigno prostatično hiperplazijo (BPH), stabiliziranih na zdravljenju z doksazosinom, sočasno dali antagonist adrenergičnih receptorjev alfa doksazosin (4 mg in 8 mg) in sildenafil (25 mg, 50 mg ali 100 mg).
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 filmsko obložena tableta] EU/1/09/595/007 [2 filmsko obloženi tableti] EU/1/09/595/008 [4 obložene tablete] EU/1/09/595/009 [8 obloženih tablet] EU/1/09/595/010 [12 obloženih tablet] EU/1/09/595/017 [24 obloženih tablet]
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 79% and 200% respectively.
Poleg tega sta se pomembno zvečali tudi AUC (za 79%) in Cmaks (za 200%) N-dezmetilnega presnovka.
Sildenafil Actavis 100 mg tablets Each tablet contains 249.52 mg lactose (as monohydrate).
Ena tableta vsebuje 249.52 mg laktoze (v obliki monohidrata).
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.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) so slabost s siljenjem na bruhanje, zardevanje obraza, vročinski oblivi (nenaden občutek vročine v zgornjem delu telesa), prebavne težave, spremenjeno zaznavanje barv, zamegljen vid, motnje vida, zamašenost nosu in omotica.
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Pri zdravih prostovoljcih enkraten peroralni odmerek 100 mg sildenafila ni vplival na gibljivost ali morfologijo semenčic (glejte poglavje 4.6).
croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171),
- Pomožne snovi so laktoza monohidrat, mikrokristalna celuloza, povidon K29-32, premreženi natrijev karmelozat, magnezijev stearat, hipromeloza, titanov dioksid (E171), makrogol 6000,
Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate).
Ena tableta vsebuje 25 mg, 50 mg ali 100 mg sildenafila (kot citrata) - Zdravilna učinkovina je sildenafil.
Reproductive system and breast disorders
Infekcijske in parazitske bolezni rinitis
Sildenafil Actavis 50 mg tablets Each tablet contains 124.76 mg lactose (as monohydrate).
Ena tableta vsebuje 124.76 mg laktoze (v obliki monohidrata).
If you get any side effects, talk to you doctor, pharmacist or nurse.
Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
You may find that Sildenafil Actavis takes longer to work if you take it with a heavy meal.
Če zdravilo Sildenafil Actavis vzamete s težjim obrokom, lahko traja dlje, preden začne delovati.
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 filmsko obložene tablete Pretisni omoti iz PVC-PVDC/aluminija v škatlah z 1, 2, 4, 8, 12 ali 24 tabletami.
INFORMATION IN BRAILLE Sildenafil Actavis 100 mg
PODATKI V BRAILLOVI PISAVI Sildenafil Actavis 100 mg
INFORMATION IN BRAILLE Sildenafil Actavis 25 mg
PODATKI V BRAILLOVI PISAVI Sildenafil Actavis 25 mg
Sildenafil Actavis 25 mg tablets Each tablet contains 62.38 mg lactose (as monohydrate).
Ena tableta vsebuje 62,38 mg laktoze (v obliki monohidrata).
Sildenafil Actavis 50 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Sildenafil Actavis 50 mg filmsko obložene tablete Pretisni omoti iz PVC-PVDC/aluminija v škatlah z 1, 2, 4, 8, 12 ali 24 tabletami.
Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano in med opazovalno študijo poročali o primerih nearteritične anteriorne ishemične optične nevropatije, redke bolezni (glejte poglavje 4.8).
Each tablet contains 100 mg of sildenafil (as citrate).
Ena tableta vsebuje 100 mg sildenafila (kot citrata).
Contact your doctor if you take more tablets than you should.
Če vzamete več tablet, kot bi smeli, se posvetujte z zdravnikom.
Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked “SL50” on one side.
Filmsko obložene tablete Sildenafil Actavis 50 mg so modre, eliptične, bikonveksne tablete, velike 13,0 x 6,5 mm in z oznako "SL50" na eni strani.
Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked “SL25” on one side.
Filmsko obložene tablete Sildenafil Actavis 25 mg so modre, eliptične, bikonveksne tablete, velike 10,0 x 5,0 mm in z oznako "SL25" na eni strani.
Each tablet contains 25 mg of sildenafil (as citrate).
Ena tableta vsebuje 25 mg sildenafila (kot citrata).
INFORMATION IN BRAILLE Sildenafil Actavis 50 mg
PODATKI V BRAILLOVI PISAVI Sildenafil Actavis 50 mg
- An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Simptomi: nenadno piskajoče dihanje, težko dihanje, omotica ali oteklost vek, obraza, ustnic ali grla.
No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
V študijah vpliva na sposobnost razmnoževanja na podganah in kuncih po peroralni uporabi sildenafila niso ugotovili pomembnih neželenih učinkov.
Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked “SL100” on one side.
Filmsko obložene tablete Sildenafil Actavis 100 mg so modre, eliptične, bikonveksne tablete, velike 17,0 x 8,5 mm in z oznako "SL100" na eni strani.
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 filmsko obložene tablete Sildenafil Actavis 50 mg filmsko obložene tablete Sildenafil Actavis 100 mg filmsko obložene tablete
Each tablet contains 50 mg of sildenafil (as citrate).
Ena tableta vsebuje 50 mg sildenafila (kot citrata).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered.
Pri prostovoljcih s hudo okvaro ledvic (očistek kreatinina <30 mL/min) je bil očistek sildenafila manjši.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Sočasna uporaba zaviralca proteaz HIV ritonavirja (ki zelo močno zavira P450) v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 300%,
Marketing Authorisation Holder Actavis Group PTC ehf.
Imetnik dovoljenja za promet Actavis Group PTC ehf.
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).
- če imate trenutno razjedo na želodcu ali če imate motnje strjevanja krvi (npr. hemofilijo).
Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Zato je njegova sočasna uporaba z donorji dušikovega oksida (npr. amilnitritom) ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje 4.3).
Penile haemorrhage, Priapism, Haematospermia, Erection increased
Motnje reprodukcije in dojk krvavitev iz penisa, priapizem,* hematospermija, dolgotrajna erekcija
Sildenafil Actavis 25 mg film-coated tablets sildenafil
Sildenafil Actavis 25 mg filmsko obložene tablete sildenafil
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba
Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Znano je, da sildenafil učinkuje na pot dušikovega oksida/cikličnega gvanozinmonofosfata (cGMP) (glejte poglavje 5.1); s tem se sklada ugotovitev, da stopnjuje hipotenzivno delovanje nitratov.
6.5 Nature and contents of container Sildenafil Actavis 25 mg film-coated tablets PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets.
Sildenafil Actavis 25 mg filmsko obložene tablete Pretisni omoti iz PVC-PVDC/aluminija v škatlah z 1, 2, 4, 8, 12 ali 24 tabletami.
Sildenafil Actavis 100 mg film-coated tablets sildenafil
Sildenafil Actavis 100 mg filmsko obložene tablete sildenafil
Sildenafil has a peripheral site of action on erections.
Na erekcijo vpliva periferno.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil Actavis, before driving or operating machinery.
Zdravilo Sildenafil Actavis lahko povzroči omotico in lahko neugodno vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na zdravilo Sildenafil Actavis.
How to store Sildenafil Actavis
Shranjevanje zdravila sildenafil actavis
Sildenafil Actavis 50 mg film-coated tablets sildenafil
Sildenafil Actavis 50 mg filmsko obložene tablete sildenafil
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04BE03.
Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije.
Sildenafil Actavis 25 mg film-coated tablets
Sildenafil Actavis 25 mg tablete
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
Bolezni dihal, prsnega koša in mediastinalnega prostora zamašenost nosu epistaksa, zamašenost sinusov stiskanje v grlu, edem nosu, suha nosna sluznica
Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect,
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica, tinitus oglušelost
Epistaxis, Sinus congestion
Bolezni sečil hematurija
Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Pri bolnikih z okvaro jeter (npr. s cirozo) je očistek sildenafila zmanjšan, zato je priporočljivi začetni odmerek 25 mg. Glede na učinkovitost in prenašanje je odmerek mogočepostopno povečati na 50 mg in vse do 100 mg, če je potrebno.
Sildenafil Actavis 50 mg film-coated tablets
Sildenafil Actavis 50 mg tablete
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.
Zaradi tega se je v primerjavi s starostno primerljivimi prostovoljci brez okvare ledvic AUC povečala za 100% in Cmaks za 88 %.
Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
You should not take Sildenafil Actavis if you are a woman.
Če ste ženska, zdravila Sildenafil Actavis ne smete jemati.
Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
Date of first authorisation: 28 October 2005 Date of latest renewal: 23 September 2010
Datum prve odobritve: 28. oktober 2005 Datum zadnjega podaljšanja: 23. september 2010
• At the request of the European Medicine Agency;
• na zahtevo Evropske agencije za zdravila;
The Information for healthcare professionals should contain the following key elements:
Informacije za zdravstvene delavce morajo vsebovati naslednje ključne elemente:
Chemical and physical compatibility has been demonstrated with the following diluents:
Kemična in fizikalna kompatibilnost je bila prikazana s sledečimi raztopinami:
Dry the two parts.
Posušite oba dela.
Do not squirt the medicine out quickly.
Zdravila ne iztisnite hitro.
Estimated difference 95% confidence interval
Ocenjena razlika 95 % interval zaupanja
These results are relevant to other populations and routes of administration.
Ti izsledki so pomembni za druge populacije in načine uporabe.
This will force the medicine back into the bottle.
To bo potisnilo zdravilo nazaj v steklenico.
This medicinal product must not be mixed with other medicinal products or intravenous diluents except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili ali intravenskimi raztopinami, razen s tistimi, ki so omenjena v poglavju 6.6.
- Information for healthcare professionals
• informacije za zdravstvene delavce
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.
Zdravnik bo določil, koliko časa bo trajalo vaše zdravljenje in koliko zdravila Revatio za intravensko injiciranje boste dobili na dan; prav tako bo spremljal vaš odziv in vaše stanje.
The syringe should be washed after each dose.
Brizgo je treba očistiti po vsakem odmerku.
Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse.
Zdravilo Revatio se uporablja v intravenski injekciji in vam ga bo vedno dal zdravnik ali medicinska sestra.
-195 dyne.sec/cm
-195 din.s/cm
Press the bottle adaptor into the neck of the bottle (as shown on figure 5 below).
Potisnite nastavek v vrat steklenice (kot je prikazano na sliki 5 spodaj).
Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.
Zdravilo Revatio prehaja v vaše mleko v zelo majhnih količinah in ni pričakovati, da bi škodovalo vašemu otroku.
- Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems
• obrazec za zajem podatkov (DCF - Data Capture Form), ki bo oblikovan za lažje poročanje o pojavu hipotenzije in povezanih težav
Keep it in a clean safe place with the medicine.
Shranite jo skupaj z zdravilom na varnem in čistem mestu.
n=29 for placebo group
(p = 0,056) n = 29 za skupino, ki je prejemala placebo
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Številni dogodki so se zgodili med ali kmalu po spolnem odnosu, nekateri pa kmalu po uporabi sildenafila, brez spolne dejavnosti.
It was judged to be unrelated to the study medicinal product.
Učinek je bil ocenjen kot nepovezan s študijskim zdravilom.
Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 30 days from the date of constitution).
Na nalepko na steklenici napišite datum izteka roka uporabnosti rekonstituirane peroralne suspenzije (datum izteka roka uporabnosti rekonstituirane peroralne suspenzije je 30 dni od dneva rekonstitucije).
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Ker boste zdravilo dobivali pod natančnim zdravniškim nadzorom, ni verjetno, da bi bil kakšen odmerek izpuščen.
What Revatio is and what it is used for
Kaj je zdravilo Revatio in za kaj ga uporabljamo
Pull the plunger out of the syringe and wash both parts in water.
Izvlecite bat iz brizge in očistite oba dela z vodo.
Other medicines and Revatio
Druga zdravila in zdravilo Revatio
- Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.
• Informacije o programu farmakovigilančnega nadzora glede možnega tveganja klinično pomembne hipotenzije in povezanih težav, ki bo vzpostavljen z uporabo obrazca DCF.
If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Če pozabite vzeti zdravilo Revatio, vzemite odmerek, čim se spomnite, potem pa nadaljujte z jemanjem zdravila ob običajnem času.
Similarly 191 of 229 subjects (83 %) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Podobno se je pri 191 od 229 preiskovancev (83 %), ki so prejemali sildenafil, po enem letu ocenjevanja funkcijski razred po SZO ohranil ali izboljšal.
After dosing, sitting and standing blood pressure and heart rate were recorded at 30, 60, 120, 180 and 360 minute post dose.
Krvni tlak v sedečem in stoječem položaju ter srčno frekvenco so zabeležili 30, 60, 120, 180 in 360 minut po odmerku.
- if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
- če ste alergični na sildenafil ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Revatio has moderate influence on the ability to drive and use machines.
Zdravilo Revatio ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine (figure 9).
Če zdravilo dajete otroku, se prepričajte, da otrok sedi ali ga držite v pokončnem položaju, preden mu date zdravilo (slika 9).
Reconstituted oral suspension
Rekonstituirana peroralna suspenzija
Please see instructions below before using the oral suspension.
Prosimo, da pred uporabo peroralne suspenzije preberete spodnja navodila.
Mean pulmonary systolic blood pressure decreased by 9 %.
Povprečni pljučni sistolični krvni tlak se je znižal za 9 %.
Taking more Revatio than you should may increase the risk of known side effects.
Večji odmerek zdravila Revatio, kot je dovoljen, lahko poveča tveganje znanih neželenih učinkov.
Remove the cap (figure 6).
Odstranite zaporko (slika 6).
Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child.
Predpisovalci zdravila morajo skrbno oceniti klinično potrebo matere po sildenafilu in morebitne neželene učinke na dojenčka.
Cleaning and storing the syringe:
Čiščenje in shranjevanje brizge:
This is based on Pharmacokinetic data only (see section 5.2.
To temelji samo na farmakokinetičnih podatkih (glejte poglavje 5.2 Farmakokinetične lastnosti).
Pack size: 1 bottle
Pakiranje: 1 steklenica
Efficacy of oral sildenafil in adult patients with PAH (when used in combination with epoprostenol)
Učinkovitost peroralnega sildenafila pri odraslih bolnikih s PAH (uporabljen v kombinaciji z epoprostenolom)
No symptoms of hypotension were associated with these changes.
Teh sprememb niso spremljali simptomi hipotenzije.
After reconstitution, the oral suspension is stable for 30 days.
Po rekonstituciji je peroralna suspenzija stabilna 30 dni.
Remove the cap.
Odstranite zaporko.
Its use is accordingly not recommended in these patients.
Zato uporaba tega zdravila pri takšnih bolnikih ni priporočljiva.
If the powder is not reconstituted, you should reconstitute the oral suspension by following the instructions below.
Če prašek ni rekonstituiran, morate peroralno suspenzijo rekonstituirati s sledenjem spodnjim navodilom.
Shake bottle well before use.
Pred uporabo steklenico dobro pretresite.
Contains glucose and water for injections.
Vsebuje glukozo in vodo za injekcije.
Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose.
Zdravniki naj bolnikom svetujejo, da v primeru, da pozabijo vzeti zdravilo Revatio, vzamejo odmerek takoj, ko je možno in nato nadaljujejo z normalnim odmerkom.
Once reconstituted the bottle contains 112 ml of oral suspension, of which 90 ml is intended for dosing and administration.
Po rekonstituciji steklenica vsebuje 112 ml peroralne suspenzije, od katere je 90 ml namenjeno odmerjanju in uporabi.
90 film-coated tablets 90 x 1 film-coated tablets 300 film-coated tablets
90 filmsko obloženih tablet 90 x 1 filmsko obložena tableta 300 filmsko obloženih tablet
Sildenafil and its major circulating N-desmethyl metabolite are approximately 96 % bound to plasma proteins.
Sildenafil in njegov glavni krožeči N-dezmetilni presnovek sta približno 96 % vezana na beljakovine v plazmi.
Due to agedifferences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40 %.
Zaradi starostnih razlik v vezavi na beljakovine v plazmi so se ustrezne plazemske koncentracije prostega sildenafila povečale za približno 40 %.
The safety and efficacy of Revatio in children below 1 year of age has not been established.
Varnost in učinkovitost zdravila Revatio pri otrocih, mlajših od 1 leta, nista bili dokazani.
However tell your doctor or pharmacist if you think that a dose has been forgotten.
Vendar pa zdravniku ali farmacevtu povejte, če mislite, da je bil odmerek izpuščen.
Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Posebna navodila za bolnike, ki imajo težave z ledvicami ali jetri Zdravniku morate povedati, če imate težave z ledvicami ali jetri, kajti morda vam bo moral prilagoditi odmerek.
In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section 4.3).
V primeru kakršnekoli nenadne okvare vida je treba zdravljenje nemudoma prekiniti ter razmisliti o alternativnem zdravljenju (glejte poglavje 4.3).
Revatio can cause a serious increase in the effects of these medicines.
Zdravilo Revatio lahko močno poveča njihov učinek.
The constituted oral suspension (a white, grape flavoured oral suspension) should be taken approximately 6 to 8 hours apart with or without food.
Pripravljena peroralna suspenzija (bela, peroralna suspenzija z okusom grozdja) naj se vzame približno 6 do 8 ur narazen, z ali brez hrane.
- Copy of the Summary of Product Characteristics (SPC)
• izvod povzetka glavnih značilnosti zdravila (SmPC)
Eight subjects were taking bosentan and one subject was taking treprostinil in addition to bosentan and Revatio.
Osem preiskovancev je jemalo bosentan, en preiskovanec pa je poleg bosentana in zdravila Revatio jemal še treprostinil.
Solution for injection 1 vial 10 mg/12.5 ml
raztopina za injiciranje 1 viala 10 mg/12,5 ml
Do not take Revatio:
Ne uporabljajte zdravila Revatio:
Your pharmacist should advise you how to measure the medicine using the oral dosing syringe provided in the pack.
Vaš farmacevt vam bo svetoval, kako odmeriti zdravilo s pomočjo peroralne odmerne brizge, ki je priložena v pakiranju.
The mean changes in heart rate were clinically insignificant.
Srednje vrednosti srčne frekvence so bile klinično nepomembne.
- if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (< 90/50 mmHg).
- če ste nedavno doživeli možgansko kap ali srčni infarkt ali če imate hudo bolezen jeter ali zelo nizek krvni tlak (< 90/50 mmHg).
Do not stop taking Revatio unless your doctor tells you to.
Zdravila ne nehajte jemati, če vam tega ne naroči zdravnik.