natgillin/translations-raw huggingface dataset:
- Cardboard box with 1 and 10 glass vials of 5 doses.
- kartonska škatla z 1 in 10 steklenimi vialami po 5 odmerkov.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije Laboratorios Hipra, S.A.
Cardboard box with 20 glass vials of 1 dose.
- katonska škatla z 20 steklenimi vialami po 1 odmerek.
Cardboard box with 10 glass vials of 1 dose.
- kartonska škatla z 10 steklenimi vialami po 1 odmerek.
- Cardboard box with 1 and 10 glass vials of 25 doses.
- kartonska škatla z 1 in 10 stekla vialami po 25 odmerkov.
EXP Once opened, use within a 10-hour period, stored at 15-25 ºC.
Odprto zdravilo, shranjeno pri 15 ºC do 25ºC, uporabite v naslednjih 10 urah.
Cardboard box with 10 glass vials of 25 doses.
- kartonska škatla z 10 stekleimi vialami po 25 odmerkov.
- Cardboard box with 1 PET vial of 125 doses.
- kartonska škatla z 1 PET-plastenko po 125 odmerkov.
Cardboard box with 1 glass vial of 25 doses.
- kartonska škatla z 1 stekleno vialo po 25 odmerkov.
Cardboard box with 1 PET vial of 125 doses.
-kartonska škatla z 1 PET-plastenko po 125 odmerkov.
Batch{number}
serija {številka}
Special precautions for use in animals: Vaccinate healthy animals only.
Posebni previdnostni ukrepi za uporabo pri živalih:
Cardboard box with 10 glass vials of 5 doses.
- kartonska škatla z 10 steklenimi vialami po 5 odmerkov.
Cardboard box with 1 glass vial of 5 doses.
- kartonska škatla z 1 stekleno vialo po 5 odmerkov.
To be supplied only on veterinary prescription.
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le na veterinarski recept.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POT(I) UPORABE Intramuskularna uporaba.
Cardboard box with 1 glass vial of 1 dose.
velikost ovojnine: - kartonska škatla z 1 stekleno vialo po 1 odmerek.
- Cardboard box with 1 PET vial of 5 doses.
- kartonska škatla z 1 PET-plastenko po 5 odmerkov.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11/02/2009
- Cardboard box with 1 PET vial of 25 doses.
- kartonska škatla z 1 PET-plastenko po 25 odmerkov.
Cardboard box with 1 PET vial of 5 doses.
-kartonska škatla z 1 PET-plastenko po 5 odmerkov.
Cardboard box with 1 PET vial of 25 doses.
-kartonska škatla z 1 PET-plastenko po 25 odmerkov.
Withdrawal period: Zero days.
KARENCA Karenca: Nič dni.
WITHDRAWAL PERIODS
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
An additional 5 deaths were reported subsequently.
Pozneje so poročali o dodatnih 5 primerih smrti.
95% confidence interval
Ocenjena razlika 95 % interval zaupanja
It is not possible to determine whether these events are related directly to these factors or to other factors.
Ali so ti dogodki neposredno povezani s temi ali pa z drugimi dejavniki, ni mogoče ugotoviti.
The causes of deaths were related to PAH.
Vzroki smrti so bili povezani s PAH.
- have a severe heart problem.
- imate kakšno hudo težavo s srcem.
Sildenafil is rapidly absorbed.
Sildenafil se hitro absorbira.
- if you are taking riociguat.
- če jemljete riociguat.
1047 Budapest Hungary
1047 Budapest Madžarska
The subsequent effect on efficacy is unknown.
Posledični vpliv na učinkovitost ni znan.
Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Večina teh bolnikov (ne pa vsi) je imela že prej obstoječe kardiovaskularne dejavnike tveganja.
Tmax was estimated at approximately 1 hour and was almost independent from body weight.
Tmax je bila ocenjena na približno 1 uro in je bila skoraj neodvisna od telesne mase.
Paediatric population (1 year to 17 years)
Pediatrična populacija (od 1 leta do 17 let)
Date of first authorisation: 14th November 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 14. november 2016
n=29 for placebo group
n = 29 za skupino, ki je prejemala placebo
The improvement in 6MWD was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and 12.
Izboljšanje 6MWD je bilo opazno po 4 tednih zdravljenja in ta učinek se je ohranil 8. in 12. teden.
Elderly (≥65 years)
Starejši bolniki (≥ 65 let)
90 tablets 300 tablets 15x1 tablet 90x1 tablet 300x1 tablet
90 tablet 300 tablet 15x1 tablet 90x1 tablet 300x1 tablet
Tablets should be taken approximately 6 to 8 hours apart with or without food.
Tablete naj se vzame približno 6 do 8 ur narazen, z ali brez hrane.
- take medicines for erectile dysfunction.
- jemljete zdravila za zdravljenje erektilne disfunkcije.
During the conduct of the study, there were a total of 42 deaths reported, whether on treatment or reported as part of the survival follow-up.
Med študijo so poročali o skupno 42 smrtih, bodisi med zdravljenjem ali pa v okviru spremljanja preživetja.
Cardiovascular risk factors
Srčnožilni dejavniki tveganja
6.6 Special precautions for disposal and other handling No special requirements for disposal.
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev za odstranjevanje.
Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
Klinična učinkovitost, merjena s prehojeno razdaljo v 6 minutah, je pri starejših bolnikih lahko manjša.
Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual subjects ranged from 3 to 3129 days.
Pri kratko- in dolgoročnih študijah je celotno trajanje zdravljenja od začetka dvojno slepe faze za posamezne preiskovance znašalo od 3 do 3.129 dni.
Visual events
Vizualni dogodki
Tell your doctor if you are taking any of these medicines.
Zdravniku morate povedati, če jemljete katero od teh zdravil.
Higher doses should not be used in children.
Večjih odmerkov se pri otrocih ne sme uporabljati.
The duration of treatment was 12 weeks.
Zdravljenje je trajalo 12 tednov.
Use of sildenafil with bosentan
Uporaba sildenafila z bosentanom
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Zdravniku morate povedati, če imate težave z ledvicami ali jetri, kajti morda vam bo moral prilagoditi odmerek.
In cases of overdose, standard supportive measures should be adopted as required.
V primeru prevelikega odmerjanja je treba uporabiti standardne podporne ukrepe.
Granpidam passes into your breast milk at very low levels and would not be expected to harm your baby.
Zdravilo Granpidam prehaja v vaše mleko v zelo majhnih količinah in ni pričakovati, da bi škodovalo vašemu otroku.
Efficacy in adult patients with PAH (when used in combination with epoprostenol)
Učinkovitost pri odraslih bolnikih s PAH(uporabljen v kombinaciji z epoprostenolom)
The safety and efficacy of sildenafil in children below 1 year of age has not been established.
Varnost in učinkovitost zdravila sildenafil pri otrocih, mlajših od 1 leta, nista bili dokazani.
In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Če pride do erekcije, ki traja dlje kot 4 ure, naj bolnik takoj poišče zdravniško pomoč.
The use of sildenafil in other forms of PAH is not recommended.
Uporaba sildenafila pri drugih oblikah PAH ni priporočljiva.
The duration of treatment was 16 weeks.
Zdravljenje je trajalo 16 tednov.
Pharmacokinetics in special patient groups
Farmakokinetika v posebnih skupinah bolnikov
These reports included dizziness and lightheadedness, but not syncope.
Ta poročila so obsegala omotico in vrtoglavico, ne pa sinkope.
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, nekaj dogodkov pa kmalu po uporabi sildenafila, brez spolne dejavnosti.
In vivo studies
Študije in vivo
Patients using other medicinal products
Bolniki, ki uporabljajo druga zdravila
Concomitant use with other PDE5 inhibitors
Sočasna uporaba z drugimi zaviralci PDE5
37 deaths occurred prior to a decision taken by the Data Monitoring Committee to down titrate subjects to a lower dosage, based on an observed mortality imbalance with increasing sildenafil doses.
37 smrti se je pojavilo pred odločitvijo Odbora za preverjanje podatkov (DMC - data monitoring committee), da se pri preiskovancih opravi titracija na manjši odmerek, kar je temeljilo na opaženem neravnovesju umrljivosti pri večjih odmerkih sildenafila.
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Not all pack sizes may be marketed.
Na trgu morda niso vse velikosti pakiranj.
Sildenafil has moderate influence on the ability to drive and use machines.
Sildenafil ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Galactose intolerance
Intoleranca za galaktozo
Peak VO2 was assessed 1 year after the start of the placebo-controlled study.
Največjo vrednost VO2 so ocenili 1 leto po začetku s placebom nadzorovane študije.
Veno-occlusive disease
Venookluzivna bolezen
- 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).
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.
There was a doubling of the Cmin compared to healthy volunteers.
Cmin je bila dvakrat tolikšna kot pri zdravih prostovoljcih.
Serious adverse events were reported in 94 (41%) of the 229 subjects receiving sildenafil.
O resnih neželenih učinkih so poročali pri 94 (41 %) od 229 preiskovancev, ki so prejemali sildenafil.
The adverse reactions profile seen in this paediatric study was generally consistent with that in adults (see table above).
Profil neželenih učinkov, ki so ga opažali v tej pediatrični študiji, je bil na splošno skladen s tistim, ki so ga opažali pri odraslih (glejte preglednico zgoraj).
There are no adequate and well controlled studies in lactating women.
Zadostnih in dobro nadzorovanih študij pri doječih materah niso izvajali.
Your doctor may tell you to reduce the dose over a few days before stopping completely.
Zdravnik vam bo morda svetoval, da pred popolno opustitvijo zdravila odmerek nekaj dni postopoma zmanjšujete.
- have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia),
- imate nepravilnost rdečih krvnih celic (srpastocelično anemijo), raka krvnih celic (levkemijo),
If you forget to take Granpidam, take a dose as soon as you remember, then continue to take your medicine at the usual times.
Če pozabite vzeti zdravilo Granpidam, vzemite odmerek, čim se spomnite, potem pa nadaljujte z jemanjem zdravila ob običajnem času.
Mean pulmonary systolic blood pressure decreased by 9%.
Povprečni pljučni sistolični krvni tlak se je znižal za 9 %.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Španija
There is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11.
Selektivnost je 80-kratna v primerjavi s PDE1 in prek 700-kratna v primerjavi s PDE2, 3, 4, 7, 8, 9, 10 in 11.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo:
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.
No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended.
Prilagajanje odmerka ni potrebno, vendar pa hkratna uporaba soka grenivke in sildenafila ni priporočljiva.
- have a rare inherited eye disease (retinitis pigmentosa).
- imate redko dedno očesno bolezen (pigmentozni retinitis).
This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila ni posebnih pogojev.
In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Na splošno je treba vsako prilagoditev odmerka izvesti šele po natančni oceni koristi in tveganja.
Do not stop taking Granpidam unless your doctor tells you to.
Zdravila Granpidam ne nehajte jemati, če vam tega ne naroči zdravnik.
The effect of sildenafil on mortality is unknown.
Vpliv sildenafila na smrtnost ni znan.
Sildenafil plasma concentration half-life values were estimated to range from 4.2 to 4.4 hours for a range of 10 to 70 kg of body weight and did not show any differences that would appear as clinically relevant.
Ocenjeno je bilo, da se vrednosti razpolovnega časa koncentracij sildenafila v plazmi gibljejo v območju od 4,2 do 4,4 ure za območje telesnih mas od 10 do 70 kg, pri teh vrednostih pa niso ugotovili nobenih razlik, ki bi jih lahko imeli za klinično pomembne.
The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056) (see Table 2).
Rezultati glavne analize (vsi odmerki v primerjavi s placebom) niso bili statistično pomembni (p = 0,056) (glejte Preglednico 2).
Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd
Ime in naslov izdelovalca, odgovornega za sproščanje serij Accord Healthcare Ltd
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.
Do not take Granpidam - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Ne uporabljajte zdravila Granpidam: - če ste alergični na sildenafil ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Special considerations for patients with kidney or liver problems
Posebna navodila za bolnike, ki imajo težave z ledvicami ali jetri
Treatment with sildenafil significantly delayed the time to clinical worsening of PAH compared to placebo (p = 0.0074).
Zdravljenje s sildenafilom je znatno podaljšalo čas do kliničnega poslabšanja PAH v primerjavi s placebom (p = 0,0074).
Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11%), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Sildenafil ni pomembno vplival na izpostavljenost atorvastatinu (AUC se je povečala za 11 %), kar kaže, da nima klinično pomembnega vpliva na CYP3A4.
Each tablet also contains 0.2 mg of lactose (as monohydrate).
Ena tableta vsebuje tudi 0,2 mg laktoze (v obliki monohidrata).
Protein binding is independent of total drug concentrations.
Vezava na beljakovine ni odvisna od celotne koncentracije zdravila.
Its effect is more potent on PDE5 than on other known phosphodiesterases.
Njegov učinek na PDE5 je močnejši od učinka na druge znane fosfodiesteraze.
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Zdravljenje sme uvesti in nadzorovati le zdravnik, ki ima izkušnje z zdravljenjem pljučne arterijske hipertenzije.
Physicians should advise patients who forget to take Granpidam 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 Granpidam, vzamejo odmerek takoj, ko je možno in nato nadaljujejo z normalnim odmerkom.
If you take more medicine than you have been told to take contact your doctor immediately.
Če ste vzeli več zdravila, kot vam je bilo naročeno, nemudoma obvestite zdravnika.
From the analysis of the pharmacokinetic profile of sildenafil in patients involved in the paediatric clinical trials, body weight was shown to be a good predictor of drug exposure in children.
V analizi farmakokinetičnega profila sildenafila pri bolnikih, ki so bili vključeni v pediatrična klinična preskušanja, se je pokazalo, da je telesna masa dober napovedni dejavnik izpostavljenosti zdravilu pri otrocih.
For dose recommendations, see sections 4.2 and 4.3.
Za priporočila o odmerjanju glejte poglavji 4.2 in 4.3.
- if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
- če jemljete zdravila za zdravljenje glivičnih okužb, kot sta ketokonazol ali itrakonazol ali zdravila, ki vsebujejo ritonavir (za HIV).
Reports from post-marketing experience are included in italics.
Poročila iz izkušenj v obdobju trženja zdravila so navedena v ležeči pisavi.
In the two placebo-controlled studies adverse events were generally mild to moderate in severity.
V teh dveh s placebom nadzorovanih študijah so bili neželeni učinki na splošno blagi do zmerni.
- have low blood pressure at rest. - lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids.
- izgubite veliko količino telesnih tekočin (dehidracija), kar se lahko pojavi, ko se čezmerno potite ali ne pijete dovolj tekočin.
This can happen if you are sick with a fever, vomiting, or diarrhoea.
To se lahko zgodi, če vam je slabo in imate vročino, bruhate ali imate drisko.
By sildenafil treatment group, median duration of sildenafil treatment was 1696 days (excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study).
V skupini s sildenafilom je bila mediana trajanja zdravljenja s sildenafilom 1.696 dni (pri čemer je bilo izključenih 5 preiskovancev, ki so v dvojno slepi fazi prejemali placebo in jih niso zdravili v dolgoročni podaljšani študiji).
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "Uporabno do:" ali "EXP".
Granpidam can cause a serious increase in the effects of these medicines.
Zdravilo Granpidam lahko močno poveča njihov učinek.
No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects.
Klinični podatki o neželenih učinkih pri dojenčkih niso na voljo, vendar ni pričakovati, da bi zaužite količine povzročile neželene učinke.
This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
To se sklada z izrazitimi učinki ritonavirja na številne substrate P450.
Sildenafil (or placebo) was added to patients' background therapy which could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen.
Sildenafil (ali placebo) so dodali osnovnemu zdravljenju bolnikov, ki je lahko vključevalo kombinacijo antikoagulantov, digoksina, zaviralcev kalcijevih kanalčkov, diuretikov in kisika.
Studies in vitro have shown that sildenafil is selective for PDE5.
Študije in vitro so pokazale, da je sildenafil selektiven za PDE5.
The most common adverse reactions reported across the duration of the short-term and long-term studies were generally similar to those observed in the short-term study.
Najpogostejši neželeni učinki, o katerih so poročali med kratko- in dolgoročno študijo, so bili na splošno podobni neželenim učinkom, opaženim v kratkoročni študiji.
In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose.
V dolgoročni razširjeni pediatrični študiji so pri bolnikih, ki so prejemali odmerke, višje od priporočenih, opazili povečano število smrtnih primerov.
- have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
- imate bolezen zaradi zamašene ali zožene vene v pljučih, ne pa zaradi zamašene ali zožene arterije.
The mean absolute oral bioavailability is 41% (range 25-63%).
Povprečna absolutna peroralna biološka uporabnost je 41 % (razpon: od 25 do 63 %).
MedDRA system organ class (V.14.0)
MedDRA podatkovna baza glede na organske sisteme (V. 14.0)
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinki drugih zdravil na sildenafil
However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered.
Da pa bi preprečili nenadno klinično poslabšanje med prekinitvijo, je odmerek treba zmanjševati postopoma.
Suddenly stopping your treatment with Granpidam may lead to your symptoms getting worse.
Če zdravilo Granpidam nehate jemati nenadoma, se vam simptomi lahko poslabšajo.
What you need to know before you take Granpidam
Kaj morate vedeti, preden boste vzeli zdravilo Granpidam
Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Poročali so tudi o kožnem izpuščaju, nenadnem poslabšanju sluha ali izgubi sluha ter znižanem krvnem tlaku z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Intensified monitoring is recommended during the discontinuation period.
Med obdobjem ukinjanja zdravila je priporočljiv intenzivnejši nadzor.
Other medicines and Granpidam
Druga zdravila in zdravilo Granpidam
Efficacy in adult patients with pulmonary arterial hypertension (PAH)
Učinkovitost pri odraslih bolnikih s pljučno arterijsko hipertenzijo (PAH)
What Granpidam is and what it is used for
Kaj je zdravilo Granpidam in za kaj ga uporabljamo
The primary objective of the study was to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in paediatric subjects to improve exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in subjects who were developmentally able to perform the test, n = 115).
Glavni namen raziskave je bil oceniti učinkovitost 16 tednov trajajočega zdravljenja s peroralno uporabljanim sildenafilom pri pediatričnih preiskovancih za izboljšanje zmožnosti prenašanja napora, kot se jo meri s preskusom srčnopljučne obremenitve (CPET - cardiopulmonary exercise test) pri bolnikih, ki so bili glede na razvoj sposobni opravljati ta preskus (n = 115).
When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group.
Analiza funkcijskega razreda po razvrstitvi SZO je pokazala statistično pomembno povečanje 6MWD v skupini z 20 mg odmerkom.
Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Zdravniki morajo bolnikom svetovati, kako naj ravnajo, če doživijo simptome posturalne hipotenzije.
Granpidam is for oral use only.
Zdravilo Granpidam je le za peroralno uporabo.
Sildenafil had no effect on saquinavir pharmacokinetics.
Sildenafil ni vplival na farmakokinetiko sakvinavirja.