natgillin/translations-raw huggingface dataset:
In this case, he/she may decide to give you a lower dose.
Molimo o tome obavijestite svog liječnika koji Vam u tom slučaju može propisati manju dozu lijeka.
Penile haemorrhage, Priapism*, Haematospermia, Erection increased
Penilna hemoragija, prijapizam, * hematospermija, produžena erekcija
Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper,
Gastroezofagealna refluksna bolest, povraćanje, bol u gornjem dijelu abdomena, suha usta
Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
Poremećaj suzenja očiju***, bol u oku, fotofobija, fotopsija, hiperemija oka, osjećaj svjetline pri gledanju, konjuktivitis
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.
Istodobna primjena inhibitora HIV proteaze, ritonavira, koji je jaki P450 inhibitor, u stanju dinamičke ravnoteže (500 mg dva puta dnevno) sa sildenafilom (100 mg u jednoj dozi) rezultirala je 300%-tnim (4 puta) porastom Cmax sildenafila i 1000%-tnim (11 puta) porastom AUC sildenafila u plazmi.
What Sildenafil ratiopharm looks like and contents of the pack Sildenafil ratiopharm are white to off-white, oblong film-coated tablets with edge.
Kako Sildenafil ratiopharm izgleda i sadržaj pakiranja Sildenafil ratiopharm su bijele do skoro bijele, duguljaste filmom obložene tablete s rubom.
Sildenafil ratiopharm 25 mg film-coated tablets EU/1/09/603/001
Sildenafil ratiopharm 25 mg filmom obložene tablete EU/1/09/603/001
(≥ 1/1,000 and
(≥1/1000 i
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 najviše 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, dvoslike, smanjena oštrina vida, neuobičajena osjetljivost oka, oticanje oka ili vjeđe, 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 slabljenje ili gubitak sluha.
The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Nakon peroralne ili intravenske primjene, sildenafil se izlučuje u obliku metabolita, uglavnom stolicom (približno 80% primijenjene oralne doze) i u manjoj mjeri mokraćom (približno 13% primijenjene oralne doze).
EU/1/09/603/005 1 film-coated tablet EU/1/09/603/006 4 film-coated tablets EU/1/09/603/007 8 film-coated tablets EU/1/09/603/008 12 film-coated tablets EU/1/09/603/014 2 film-coated tablets EU/1/09/603/017 24 film-coated tablets
EU/1/09/603/005 1 filmom obložena tableta EU/1/09/603/006 4 filmom obložene tablete EU/1/09/603/007 8 filmom obloženih tableta EU/1/09/603/008 12 filmom obloženih tableta EU/1/09/603/014 2 filmom obložene tablete EU/1/09/603/017 24 filmom obložene tablete
Sildenafil ratiopharm 100 mg film-coated tablets EU/1/09/603/009
Sildenafil ratiopharm 100 mg filmom obložene tablete EU/1/09/603/009
What Sildenafil ratiopharm looks like and contents of the pack Sildenafil ratiopharm are white to off-white, oblong film-coated tablets with edge and score line on one side.
Kako Sildenafil ratiopharm izgleda i sadržaj pakiranja Sildenafil ratiopharm su bijele do skoro bijele, duguljaste filmom obložene tablete s rubom i razdjelnom crtom s jedne strane.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Manje često (mogu se javiti kod najviše 1 na 100 osoba): povraćanje, kožni osip, iritacija oka, krvave oči/crvene oči, bol u očima, bljeskovi pred očima, osjećaj svjetline pri gledanju, osjetljivost na svjetlo, suzenje očiju, lupanje srca, ubrzani otkucaji srca, visoki krvni tlak, niski krvni tlak, bol u mišićima, osjećaj pospanosti, smanjeni osjet dodira, vrtoglavica, zvonjenje u ušima, suha usta, puni ili začepljeni sinusi, upala nosne sluznice (simptomi uključuju curenje iz nosa, kihanje i začepljen nos), bol u gornjem dijelu abdomena, gastroezofagealna refluksna bolest (simptomi uključuju žgaravicu), krv u mokraći, bol u rukama ili nogama, krvarenje iz nosa, osjećaj vrućine i osjećaj umora.
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 sildenafila.
(≥ 1/10,000 and
(≥1/10 000 i
You may find that this medicine takes longer to work if you take it with a heavy meal.
Kad se ovaj lijek uzima s jelom, potrebno je malo dulje da počne djelovati.
Sildenafil ratiopharm 50 mg film-coated tablets EU/1/09/603/005
Sildenafil ratiopharm 50 mg filmom obložene tablete EU/1/09/603/005
EU/1/09/603/001 1 film-coated tablet EU/1/09/603/002 4 film-coated tablets EU/1/09/603/003 8 film-coated tablets EU/1/09/603/004 12 film-coated tablets EU/1/09/603/013 2 film-coated tablets
EU/1/09/603/001 1 filmom obložena tableta EU/1/09/603/002 4 filmom obložene tablete EU/1/09/603/003 8 filmom obloženih tableta EU/1/09/603/004 12 filmom obloženih tableta EU/1/09/603/013 2 filmom obložene tablete
Throat tightness, Nasal oedema, Nasal dryness
Stezanje u grlu, nazalni edem, suhoća nosne sluznice
The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively,
Srednja AUC i Cmax N-dezmetil metabolita porasla je do 126% odnosno do 73%, u usporedbi s dobrovoljcima odgovarajućim po dobi, bez oštećenja bubrega.
1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets 48 film-coated tablets
1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 24 filmom obloženih tableta 48 filmom obloženih tableta
What Sildenafil ratiopharm is
Što je Sildenafil ratiopharm
Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Nositelj odobrenja za stavljanje lijeka u promet ratiopharm GmbH
Sildenafil ratiopharm 25 mg film-coated tablets White to off-white, oblong film-coated tablet with edge.
Sildenafil ratiopharm 25 mg filmom obložene tablete Bijela do skoro bijela, duguljasta filmom obložena tableta s rubom.
NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil ratiopharm 100 mg film-coated tablets
Sildenafil ratiopharm 25 mg filmom obložene tablete Sildenafil ratiopharm 50 mg filmom obložene tablete Sildenafil ratiopharm 100 mg filmom obložene tablete
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC code: G04BE03
Farmakoterapijska skupina: urološki preparati; lijekovi koji se primjenjuju kod erektilne disfunkcije.
- if you suffer from any of the following disorders, please tell your doctor who will check carefully whether this medicine is suitable for you: if you currently have a stomach ulcer; if you have a blood-clotting disorder (e.g. haemophilia).
- ako patite od nekog od sljedećih poremećaja, o tome obavijestite svojeg liječnika koji će pažljivo provjeriti odgovara li Vam ovaj lijek:
No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Nakon peroralne primjene sildenafila u ispitivanjima reprodukcije u štakora i kunića nisu opažene značajne nuspojave.
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 dnevno) rezultirao sa 49,8%-tnim povećanjem AUC bosentana i 42%-tnim povećanjem Cmax bosentana (125 mg dva puta dnevno).
1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 24 filmom obložen tablete
1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta
NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ratiopharm
INFORMATION IN BRAILLE Sildenafil ratiopharm 100 mg
PODACI NA BRAILLEOVOM PISMU Sildenafil ratiopharm 100 mg
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Nakon jednokratnih oralnih doza sildenafila od 100 mg u zdravih dobrovoljaca nije bilo učinka na motilitet ili morfologiju spermija (vidjeti dio 4.6).
INFORMATION IN BRAILLE Sildenafil ratiopharm 25 mg
PODACI NA BRAILLEOVOM PISMU Sildenafil ratiopharm 25 mg
How to take Sildenafil ratiopharm
Kako uzimati Sildenafil ratiopharm
How to store Sildenafil ratiopharm
Kako čuvati Sildenafil ratiopharm
What Sildenafil ratiopharm is used for
Za što se Sildenafil ratiopharm koristi
Sildenafil ratiopharm 25 mg film-coated tablets Pack sizes of 1, 2, 4, 8, or 12 film-coated tablets.
Sildenafil ratiopharm 25 mg filmom obložene tablete Veličine pakiranja od 1, 2, 4, 8, ili 12 filmom obloženih tableta.
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 najviše 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.
INFORMATION IN BRAILLE Sildenafil ratiopharm 50 mg
PODACI NA BRAILLEOVOM PISMU Sildenafil ratiopharm 50 mg
Sildenafil ratiopharm 50 mg film-coated tablets Pack sizes of 1, 2, 4, 8, 12 or 24 film-coated tablets.
Sildenafil ratiopharm 50 mg filmom obložene tablete Veličine pakiranja od 1, 2, 4, 8, 12 ili 24 filmom obložene tablete.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Kod maksimalnih preporučenih doza, prisutna je 80 puta veća selektivnost u usporedbi s PDE1 te preko 700 puta u usporedbi s PDE2, 3, 4, 7, 8, 9, 10 i 11. Posebno, sildenafil ima preko 4000 puta veću selektivnost za PDE5 u usporedbi s PDE3, cAMP-specifičnoj izoformi fosfodiesteraze uključenoj u kontrolu kontraktilnosti srca.
Effects of sildenafil on other medicinal products In vitro studies
Učinci sildenafila na druge lijekove
Sildenafil ratiopharm 100 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Sildenafil ratiopharm 100 mg filmom obložene tablete Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
Sildenafil ratiopharm 25 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Sildenafil ratiopharm 25 mg filmom obložene tablete Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
Flushing, Hot flush
Naleti crvenila, navala vrućine
Sildenafil ratiopharm 100 mg film-coated tablets
Sildenafil ratiopharm 100 mg filmom obložene tablete sildenafil
Sildenafil ratiopharm 25 mg film-coated tablets
Sildenafil ratiopharm 25 mg filmom obložene tablete sildenafil
Sildenafil ratiopharm 50 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Sildenafil ratiopharm 50 mg filmom obložene tablete Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
(≥ 1/10,000 and eye,
(≥1/10 000 i mokraćnog sustava
Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets in blisters.
Sildenafil ratiopharm je dostupan u pakiranjima od 1, 2, 4, 8, 12, 24 ili 48 filmom obloženih tableta u blisterima
Haematuria
Doziranje
Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8 or 12 film-coated tablets in blisters.
Sildenafil ratiopharm je dostupan u pakiranjima od 1, 2, 4, 8 ili 12 filmom obloženih tableta u blisterima.
Deafness
Hematurija
Sildenafil ratiopharm 50 mg film-coated tablets
Sildenafil ratiopharm 50 mg filmom obložene tablete sildenafil
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
dispepsija, nazalna kongestija, omaglica, mučnina, navale vrućine, poremećaji vida, cijanopsija i zamagljen vid.
Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
- Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
- Chest pains - this occurs uncommonly.
- Bolovi u prsnom košu - javljaju se manje često.
Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12 or 24 film-coated tablets in blisters.
Sildenafil ratiopharm je dostupan u pakiranjima od 1, 2, 4, 8, 12 ili 24 filmom obložene tablete u blisterima.
Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
- Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
- Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in
(≥1/10 000 i midrijaza, svjetlosne aureole, edem oka, oticanje oka, poremećaj oka, konjuktivalna hiperemija, iritacija oka, neuobičajena osjetljivost oka, edem vjeđe, diskoloracija bjeloočnice
Heart rate increased
Ubrzan rad srca
Tabulated list of adverse reactions
Opći poremećaji i reakcije na mjestu primjene
Transient ischaemic attack,
Cerebrovaskularni inzult, tranzitorna ishemijska ataka, napadaji,* ponavljanje napadaja,* sinkopa
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
DODATAK II A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
TVARI Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
TVARI Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
Sildenafil ratiopharm with food, drink and alcohol When this medicine is taken with food, it may take a little longer for Sildenafil ratiopharm to work.
Sildenafil ratiopharm s hranom, pićem i alkoholom
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
TVARI Svaka filmom obložena tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
There are also links to other websites about rare diseases and treatments.
Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i liječenjima istih.
D-82319 Starnberg Germany
D-82319 Starnberg
FEV1 should be measured before and after nebulisation.
FEV1 je potrebno mjeriti prije i nakon raspršivanja.
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija.
The medicine is not intended for use in children under 6 years of age.
Lijek nije namijenjen za primjenu u djece mlađe od 6 godina.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može izazvati nuspojave iako se one neće javiti kod svakoga.
• blood in your sputum (the substance you cough up);
• krv u sputumu (sadržaj koji iskašljavate);
If you use more Vantobra than you should
Ako primijenite više Vantobre nego što ste trebali
• Keep the rest of the medicine refrigerated in the original carton.
• Ostatak lijeka čuvajte u hladnjaku u originalnoj kutiji.
Stability after opening of the pouch: 4 weeks when stored below 25 °C 6.4 Special precautions for storage
Stabilnost nakon otvaranja vrećice: 4 tjedna ako se čuva na temperaturi ispod 25°C 6.4 Posebne mjere pri čuvanju lijeka
If the product has been stored at room temperature for longer than 4 weeks, it has to be disposed according to local requirements.
U slučaju da je lijek čuvan na sobnoj temperaturi duže od 4 tjedna potrebno ga je zbrinuti u skladu s lokalnim propisima.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja
• Lay out all the pieces of your Tolero nebuliser handset on a clean, dry paper or cloth towel.
• Položite sve dijelove svog ručnog atomizatora Tolero na čisti, suhi papir ili ručnik.
Make sure the nebuliser handset is on a flat, stable surface.
Osigurajte da je ručni atomizator na ravnoj, stabilnoj površini.
The contents of a single-dose ampoule should be used immediately after opening (see section 6.6).
Sadržaj jednodozne ampule mora se upotrijebiti odmah nakon otvaranja (vidjeti dio 6.6)
If you inhale too much Vantobra you may get a very hoarse voice.
Ako inhalirate previše Vantobre glas Vam može postati jako hrapav.
Hold the nebuliser handset horizontally and breath normally through your mouth.
Držite ručni atomizator u vodoravnom položaju i normalno dišite kroz usta.
Distribution Less than 10% of tobramycin is bound to plasma proteins.
Manje od 10 % tobramicina veže se na proteine plazme.
Outer carton contains:
Vanjsko pakiranje sadrži:
The marketing authorisation holder shall submit the first periodic safety update report for this product within 12 months following authorisation.
Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 12 mjeseci nakon dobivanja odobrenja.
If you don't have a refrigerator available (such as when you are transporting your medicine) you can store the carton with the medicine (pouches opened or unopened) below 25°C for up to 4 weeks.
Ako nemate dostupan hladnjak (u slučaju da prenosite Vaš lijek) kutiju s lijekom (vrećice, otvorene ili zatvorene) možete čuvati na temperaturi ispod 25°C najduže 4 tjedna.
Sputum concentrations were higher and more variable with Cmax of 1,951 + 2,187 µg/g.
Koncentracije u sputumu su bile još veće i promjenjivije s Cmax 1,951 + 2,187 µg/g.
See also information on clinical benefit and tolerability in sections 4.4, 4.8 and
Pogledajte informacije o kliničkoj koristi i podnošljivosti u dijelovima 4.4., 4.8. i 5.1.
However, aminoglycosides can cause foetal harm (e.g., congenital deafness and nephrotoxicity) when high systemic concentrations are achieved in a pregnant woman.
Međutim, aminoglikozidi mogu uzrokovati oštećenje ploda (npr. kongenitalnu gluhoću i nefrotoksičnost) kad se u trudnice postigne visoka sustavna koncentracija lijeka.
• Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using
• Inhalirajte na usta ukupni sadržaj jedne ampule ujutro i jedne ampule navečer koristeći ručni
When you inhale Vantobra, the antibiotic can enter directly into your lungs to fight the bacteria causing the infection.
Kada inhalirate Vantobru, antibiotik može ući izravno u Vaša pluća kako bi se borio protiv bakterija koje uzrokuju infekciju.
Any unused medicinal product or waste material should be disposed off in accordance with local
Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
Non-clinical data reveal that the main hazard for humans, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development, consists of renal toxicity and ototoxicity.
Neklinički podaci ukazuju da glavnu opasnost za ljude, na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti, predstavljaju bubrežna toksičnost i ototoksičnost.
As a result of study 12012.101, lung function improvement FEV1% predicted relative to baseline increased by 8.2 ± 9.4% under Vantobra and by 4.8 ± 9.6% under the reference therapy in the first treatment cycle showing non-inferior (p=0.0005) efficacy.
Kao rezultat ispitivanja 12012.101, predviđeno poboljšanje plućne funkcije FEV1 % u odnosu na osnovnu vrijednost povećano je za 8,2 ± 9,4 % uslijed uzimanja lijeka Vantobra i za 4,8 ± 9,6 % uslijed referentne terapije u prvom ciklusu liječenja pokazujući neinferiornost djelotvornosti (p = 0,0005).
In addition, the corresponding frequency category is provided using the following convention: 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
Uz to, za svaku je nuspojavu navedena i odgovarajuća kategorija učestalosti prema sljedećem načelu: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥
Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Ograničeni podaci prikupljeni u jednom kontroliranom kliničkom ispitivanju tijekom jednog ciklusa liječenja ukazuju da je poboljšanje plućne funkcije održano iznad početne tijekom 28-dnevnog razdoblja neuzimanja lijeka.