natgillin/translations-raw huggingface dataset:
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.
Da bo možnost za pojav posturalne hipotenzije čim manjša med bolniki, ki prejemajo terapijo z antagonisti adrenergičnih receptorjev alfa, morajo biti bolniki pred začetkom zdravljenja s sildenafilom stabilni na terapiji z antagonisti adrenergičnih receptorjev alfa.
Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Študije in vitro Metabolizem sildenafila v glavnem poteka z izooblikama 3A4 (glavna pot) in 2C9 (manj pomembna pot) citokroma P450 (CYP).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The European Medicines Agency has waived the obligation to submit the results of studies with Sildenafil Teva in all subsets of the paediatric population for the treatment of erectile dysfunction.
Sildenafil Teva za vse podskupine pediatrične populacije za zdravljenje erektilne disfunkcije.
Musculoskelet al and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija,
*Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased
**Motnje zaznavanja barv: kloropsija, kromatopsija, cianopsija, eritropsija in ksantopsija
Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Filmska obloga poli(vinilalkohol) titanov dioksid (E171)
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate.
mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat, magnezijev stearat.
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.
Sočasna uporaba zviralca proteaz HIV sakvinavirja, ki zavira CYP3A4, je v stanju dinamičnega ravnovesja (1.200 mg trikrat na dan) in sildenafila (enkratni odmerek 100 mg) povzročila 140 % zvečanje Cmax sildenafila in 210 %zvečanje AUC sildenafila.
Sildenafil Teva 25 mg film-coated tablets Sildenafil Teva 50 mg film-coated tablets Sildenafil Teva 100 mg film-coated tablets
Sildenafil Teva 25 mg filmsko obložene tablete Sildenafil Teva 50 mg filmsko obložene tablete Sildenafil Teva 100 mg filmsko obložene tablete
Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate
Jedro tablete mikrokristalna celuloza brezvodni kalcijev hidrogenfosfat premereženi natrijev karmelozat magnezijev stearat
Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.
V obdobju trženja so bili v časovni povezanosti z uporabo zdravila Sildenafil Teva opisani resni kardiovaskularni dogodki, med drugim miokardni infarkt, nestabilna angina pektoris, nenadna srčna smrt, ventrikularna aritmija, cerebrovaskularna krvavitev, tranzitorna ishemična ataka, hipertenzija in hipotenzija.
− 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.
• Če jemljete zdravila, ki so znana kot dajalci dušikovega oksida, kakršen je amilnitrit (“poppers”nelegalno spolno poživilo), ker lahko sočasno jemanje vodi v nevaren padec vašega krvnega tlaka.
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil Teva.
Da bi zmanjšali verjetnost za pojav teh simptomov, morate pred začetkom uporabe zdravila Sildenafil Teva redno jemati dnevni odmerek antagonista adrenergičnih receptorjev alfa.
Myopia,
hemofilijo).
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (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).
Pogostnosti so opredeljene na naslednji način: (zelo pogosti (≥ 1/10), pogosti (≥ 1/100 to < 1/10),
However, you may find that Sildenafil Teva takes longer to start working if you take it with a heavy meal.
Čeprav boste morda ugotovili, da v primeru zaužitja zdravila s težjim obrokom, lahko traja dlje, preden zdravilo Sildenafil Teva začne delovati.
Sildenafil Teva 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Sildenafil Teva 100 mg filmsko obložene tablete Pretisni omoti iz PVC/aluminija v škatlah po 2, 4, 8, 12 ali 24 tablet.
Sildenafil Teva 50 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Sildenafil Teva 50 mg filmsko obložene tablete Pretisni omoti iz PVC/aluminija v škatlah po 2, 4, 8, 12 ali 24 tablet.
Sildenafil Teva 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
Sildenafil Teva 25 mg filmsko obložene tablete Pretisni omoti iz PVC/aluminija v škatlah po 2, 4, 8 ali 12 tablet.
You may find that Sildenafil Teva takes longer to work if you take it with a heavy meal.
Če zdravilo Sildenafil Teva vzamete s težkim obrokom, bo morda minilo dalj časa, preden bo delovalo.
Nasal congestion
konvulzije,*
Sildenafil Teva 100 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Sildenafil Teva 100 mg filmsko obložene tablete Ena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
Sildenafil Teva should not be given to individuals under the age of 18.
Posamezniki do 18. leta starosti ne smejo dobiti zdravila Sildenafil Teva.
Each tablet contains 100 mg of sildenafil (as the citrate salt).
Ena tableta vsebuje 100 mg sildenafila (v obliki soli sildenafilijevega citrata).
Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
100 mg odmerku ugotovili blage in prehodne spremembe razločevanja barv (modra/zelena); 2 uri po odmerku ta učinek ni bil več opazen.
Sildenafil Teva 25 mg are white, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side.
Sildenafil Teva 25 mg so bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 25' na eni strani in brez oznak na drugi strani.
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.
Pri prostovoljcih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) se je očistek sildenafila zmanjšal, to pa je povzročilo povprečno zvečanje AUC za 100 %
Visual colour distortions**, Visual disturbance, Vision blurred
Očesne bolezni motnje zaznavanja barv**, motnje vida, zamegljen vid motnje solzenja***,
Each tablet contains 25 mg of sildenafil (as the citrate salt).
Ena tableta vsebuje 25 mg sildenafila (v obliki soli sildenafilijevega citrata).
Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Sildenafil Teva 25 mg filmsko obložene tablete Ena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
Chest pain, Fatigue, Feeling hot
bruhanje, bolečine v zgornjem delu trebuha, suha usta hipestezija ust
Uncommon (≥ 1/1,000 and
(≥ 1/1.000 in
Hepatic impairment
občutek vročine razdražljivost
Each tablet contains 50 mg of sildenafil (as the citrate salt).
Ena tableta vsebuje 50 mg sildenafila (v obliki soli sildenafilijevega citrata).
Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil
Ena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
Eye disorders
draženje oči,
Sildenafil Teva 100 mg are white, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side.
Sildenafil Teva 100 mg filmsko obložene tablete so bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 100' na eni strani in brez oznak na drugi strani.
Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Sildenafil Teva 50 mg filmsko obložene tablete Ena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
Ena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper,
Bolezni prebavil navzea, dispepsija gastroezofagealna refluksna bolezen,
Sildenafil Teva 50 mg are white, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side.
Sildenafil Teva 50 mg filmsko obložene tablete so bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 50' na eni strani in brez oznak na drugi strani.
Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
Ena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Pri prostovoljcih z blago do zmerno okvaro ledvic (očistek kreatinina = 30 do 80 ml/min)
White, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side.
Bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 25' na eni strani in brez oznak na drugi strani.
Film-coat
- Filmska obloga:
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).
je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182 %zvečanja sistemske izpostavljenosti (AUC) sildenafilu.
Sildenafil Teva 25 mg film-coated tablets sildenafil
Sildenafil Teva 25 mg filmsko obložene tablete sildenafil
Sildenafil Teva 25 mg film-coated tablets
Sildenafil Teva 25 mg filmsko obložene tablete
White, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side.
Bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 100' na eni strani in brez oznak na drugi strani.
White, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side.
Bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 50' na eni strani in brez oznak na drugi strani.
Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral discoloration
arteriosklerotična retinopatija, motnj e mrežnice, glavkom, izpad vidnega polja, diplopija, zmanjšanje ostrine vida, miopija, astenopija, motnjave v steklovini,
Sildenafil Teva 100 mg film-coated tablets sildenafil
Sildenafil Teva 100 mg filmsko obložene tablete sildenafil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 25 mg Film-coated tablets
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Sildenafil Teva 25 mg filmsko obložene tablete
Penile haemorrhage, Priapism,* Haematospermia , Erection increased
Motnje reprodukcije in dojk krvavitev iz penisa, priapizem,* hematospermija, dolgotrajna erekcija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 100 mg Film-coated tablets
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Sildenafil Teva 100 mg filmsko obložene tablete
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered.
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina <30 ml/min) je očistek sildenafila zmanjšan, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
Sildenafil Teva 50 mg film-coated tablets sildenafil
Sildenafil Teva 50 mg filmsko obložene tablete sildenafil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 50 mg Film-coated tablets
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Sildenafil Teva 50 mg filmsko obložene tablete
Sildenafil Teva 100 mg film-coated tablets
Sildenafil Teva 100 mg filmsko obložene tablete
Sildenafil Teva 50 mg film-coated tablets
Sildenafil Teva 50 mg filmsko obložene tablete
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): slabost s siljenjem na bruhanje, zardevanje obraza, vročinski oblivi (simptomi vključujejo nenaden občutek vročine v zgornjem delu telesa),
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).
Sildenafil se po peroralni in intravenski uporabi izloča v obliki presnovkov, pretežno z blatom (približno 80 %
You should not take Sildenafil Teva if you are a woman.
Če ste ženska, zdravila Sildenafil Teva ne smete jemati.
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. ciroza) je očistek sildenafila zmanjšan, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je potrebno.
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,
Plasma concentrations of this metabolite are approximately 40 % of those seen for sildenafil.
Koncentracija tega presnovka v plazmi je približno
What Sildenafil Teva is and what it is used for What you need to know before you take Sildenafil Teva How to take Sildenafil Teva Possible side effects
Zdravilo Sildenafil Teva lahko povzroči omotico in lahko neugodno vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na zdravilo Sildenafil Teva.
The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
PDE6, ki sodeluje pri fototransdukcijski kaskadi v mrežnici.
vision blurred.
obarvanje beločnice
• Chest pains - this occurs uncommonly If this occurs during or after intercourse
• Bolečine v prsnem košu - to se zgodi občasno
Dizziness
Občasni
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 hkratna uporaba z donorji dušikovega oksida ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje 4.3).
Asthenopia, Vitreous floaters, Iris disorder, Mydriasis,
motnje šarenice, midriaza, videnje svetlobnih krogov, očesni edem,
Talk to your doctor, pharmacist or nurse before taking Sildenafil Teva
V primeru zdravstvene obravnave morate povedati zdravniku, farmacevtu ali medicinki sestri, da ste vzeli zdravilo Sildenafil Teva in kdaj ste ga vzeli.
Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion,* Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect,
občutek svetlosti pri gledanju, konjunktivitis nearteritična anteriorna ishemična optična nevropatija (NAION), *
The Member States shall ensure that the Marketing Authorisation Holder provides all physicians who are expected to prescribe YERVOY with the following:
Države članice morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom vsem zdravnikom, ki bodo predpisovali zdravilo YERVOY, priskrbi:
The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse.
Kartica bolnike opozarja na ključne simptome, o katerih morajo nemudoma obvestiti zdravnika/medicinsko sestro.
Key elements for the Patient Information Brochure and Alert Card:
Ključni elementi brošure z informacijami za bolnike in opozorilne kartice:
• Patient Information Brochures including Alert Cards
• brošure z informacijami za bolnike, vključno z opozorilnimi karticami.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo zagotoviti, da se izvajajo vsi v nadaljevanju navedeni pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila:
• Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.
• Opis glavnih simptomov imunsko pogojenih neželenih učinkov in pomembnost, da bolnik o njih nemudoma obvesti svojega zdravnika, če se simptomi pojavijo, vztrajajo ali poslabšajo.
• Follow-up of patients due to late onset (months after treatment) of irARs
• Spremljanje bolnikov zaradi možnosti zakasnelega pojava imunsko pogojenih neželenih učinkov (več mesecev po zdravljenju).
The National Competent Authority shall agree the format and content of the above material with the Marketing Authorisation Holder prior to launch of the product in its territory.
Pred začetkom trženja zdravila mora pristojni nacionalni organ potrditi obliko in vsebino zgoraj navedenega materiala, ki ga pripravi imetnik dovoljenja za promet z zdravilom.
o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain, o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful
o prebavila: driska, krvavo blato, bolečine v trebuhu, slabost ali bruhanje; o jetra: rumeno obarvanje kože ali očesnih beločnic; o koža: izpuščaj, mehurji in/ali luščenje, vnetje ustne sluznice; o oči: zamegljen vid, spremembe vida, bolečine v očesu;
• The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
• Pomembnost, da imajo bolniki ves čas pri sebi opozorilno kartico, ki jo morajo pokazati pri vsakem obisku zdravnika (npr. nujna zdravniška pomoč), razen ob obisku zdravnika, ki je zdravilo predpisal.
It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab.
Kartica drugim zdravnikom služi kot opozorilo, da se bolnik zdravi z ipilimumabom.
• Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.
• Opomnik, da je treba bolnikom posredovati brošuro z informacijami za bolnike, ter da je bolnike in/ali njihove skrbnike, treba seznaniti s simptomi imunsko pogojenih neželenih učinkov in jim pojasniti pomembnost tega, da o njihovem pojavu nemudoma obvestijo zdravnika.
• Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.
• Pomen vrednotenja testov delovanja jeter, ščitnice in znakov/simptomov imunsko pogojenih neželenih učinkov pred aplikacijo vsakega posameznega odmerka.
• The importance of not attempting to self-treat any symptoms without consulting their Healthcare professional first.
• Pomembnost, da bolnik ne začne zdraviti simptomov brez predhodnega posveta z zdravnikom.
• Request to inform the physician of all medical conditions before treatment.
• Zahteva, da mora bolnik pred začetkom zdravljenja zdravnika natančno obvestiti o svojem zdravstvenem stanju.
• Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immunerelated adverse reactions in section 4.4 of the SmPC.
povzročijo smrt in zahtevajo hitro ukrepanje, kot je opisano v smernicah za ukrepanje v primeru imunsko pogojenih neželenih učinkov v poglavju 4.4 Povzetka glavnih značilnosti zdravila.
• List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system.
o vnetje jeter, kot je hepatitis, ki lahko povzroči odpoved jeter, o vnetje kože, ki lahko povzroči hudo kožno reakcijo (toksična epidermalna nekroliza), o vnetje živcev, ki lahko povzroči nevropatijo, o vnetje endokrinega sistema, vključno z nadledvično žlezo, hipofizo ali ščitnico, o vnetje oči, o drugi imunsko pogojeni neželeni učinki (npr. pljučnica, glomerulonefritis, odpoved več organov...), o huda infuzijska reakcija.
• Placeholder including the weblink of the Package Leaflet on the EMA website
• Spletno povezavo do navodila za uporabo na spletni strani Evropske agencije za zdravila.
Key elements of the Healthcare Professional FAQ Brochure (Q&A format):
Ključni elementi brošure s pogostimi vprašanji za zdravstvene delavce (v obliki vprašanj in odgovorov):
• Healthcare Professional FAQ Brochure
• brošuro s pogostimi vprašanji za zdravstvene delavce,
(See sections 4.2 and 5.2).
(Glejte poglavji 4.2 in 5.2.)
Date of first authorisation: 05 December 2014 Date of latest renewal:
Datum prve odobritve: 05. december 2014 Datum zadnjega podaljšanja:
Consequently, newborns should be monitored carefully.
Posledično je treba novorojenčke skrbno spremljati.
The difference is not likely to be of clinical relevance.
Razlika verjetno ni klinično pomembna.
Place on a clean surface.
Odložite na čisto površino.
Time(days) since Randomization
Čas (dnevi) od randomizacije
This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
To je treba upoštevati v primerih, v katerih je potrebna popolna budnost in pozornost, npr. med vožnjo avtomobila ali pri upravljanju strojev.
1 month after day 8
1 mesec po 8. dnevu
The primary efficacy variable was time to first relapse.
Primarna spremenljivka za oceno učinkovitosti je bil čas do prvega relapsa.
Check suspension
Preverite izgled suspenzije
Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive at the time of your next scheduled injection.
Glede na vaše simptome lahko zdravnik poveča ali zmanjša količino zdravila, ki jo boste prejeli ob naslednjem načrtovanem injiciranju.