natgillin/translations-raw huggingface dataset:
- Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome) - If you notice any suspicious skin changes because there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section 2).
- če vidite ali slišite stvari, ki jih ni (halucinacije); - če se vam pojavi kombinacija halucinacij, vročice, nemira, tresavice in potenja (serotoninski sindrom); - če opazite sumljive spremembe na koži, ker je pri bolnikih s Parkinsonovo boleznijo večje tveganje za kožnega raka (ne samo melanom) (glejte poglavje 2).
What AZILECT looks like and contents of the pack
Izgled zdravila AZILECT in vsebina pakiranja
Each tablet contains 1 mg of rasagiline (as mesilate).
Ena tableta vsebuje 1 mg razagilina (kot mesilat).
Patients should be cautioned about possible additive effects of sedating medicinal products, alcohol, or other central nervous system depressants (e.g. benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline, or when taking concomitant medications that increase plasma levels of rasagiline (e.g. ciprofloxacin) (see section 4.4).
Bolnike je treba opozoriti o morebitnih dodatnih učinkih pomirjeval, alkohola ali drugih depresorjev centralnega živčnega sistema (npr. benzodiazepini, antipsihotiki, antidepresivi) v kombinaciji z razagilinom ali med sočasnim jemanjem zdravil, ki zvišajo koncentracije razagilina v plazmi (npr.
If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.
Če začenjate zdravljenje z zdravilom AZILECT, morate po prenehanju zdravljenja s fluoksetinom počakati vsaj 5 tednov.
If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking AZILECT do not drive or operate machinery (see section 2).
Če ste v preteklosti ali med jemanjem zdravila AZILECT že doživeli zaspanost in/ali epizode nenadnega spanca, ne vozite ali upravljajte strojev (glejte poglavje 2).
In both studies, the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “OFF” state during the day (determined from “24-hour” home diaries completed for 3 days prior to each of the assessment visits).
»OFF« stanju (opredeljenih iz »24-urnih« domačih dnevnikov, ki so bili zaključeni 3 dni pred vsakim ocenjevalnim obiskom).
White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.
Bela plastenka iz polietilena visoke gostote, z ali brez za otroke varnim pokrovčkom, vsebuje
- The active substance is rasagiline.
- Učinkovina je razagilin.
Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate (CLcr 30-49 ml/min) renal impairment were similar to healthy subjects.
80 ml/min) in zmerno (CLcr 30-49 ml/min) podobne kot pri zdravih osebah.
21 February 2005
Datum prve odobritve: 21. februar 2005 Datum zadnjega podaljšanja: 21. september 2009
Contents of the pack and other information
Shranjevanje zdravila AZILECT Vsebina pakiranja in dodatne informacije
ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Motnje pri obvladovanju impulzov (Impulse control disorders - ICDs) Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali dopaminergičnimi zdravljenji, lahko pride do motenj pri obvladovanju impulzov.
The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
kompulzivno nakupovanje, dermatilomanija, sindrom motene regulacije dopamina, motnja obvladovanja impulzov, impulzivno vedenje, kleptomanija, kraja, obsesivne misli, obsesivnokompulzivna motnja, stereotipnost, hazardiranje, patološko hazardiranje, povečan libido, hiperseksualnost, psihoseksualna motnja in neprimerno spolno vedenje.
Less than 1% of rasagiline is excreted as unchanged product in urine.
razagilina se izloči nespremenjenega z urinom.
Renal impairment No special precautions are required in patients with renal impairment.
Ledvična okvara Pri bolnikih z ledvično okvaro niso potrebni posebni previdnostni ukrepi.
Rasagiline pharmacokinetics is linear with dose over the range of 0.5-2 mg in Parkinson's disease patients.
Linearnost/nelinearnost Farmakokinetika razagilina pri bolnikih s Parkinsonovo boleznijo je linearna pri odmerkih od 0,5 do
Urinary urgency
- siljenje na uriniranje
Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Prekomerna dnevna zaspanost in epizode nenadnega spanca Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, lahko pride do prekomerne dnevne zaspanosti (hipersomnija, letargija, sedacija, napadi spanja, somnolenca, nenaden spanec).
In patients taking AZILECT and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Pri bolnikih, ki jemljejo zdravilo AZILECT in/ali druga zdravila, ki se uporabljajo za zdravljenje Parkinsonove bolezni, so opazili vedenja, kot so kompulzije, obsesivne misli, odvisnost od iger na srečo, prekomerno zapravljanje denarja, impulzivno vedenje in nenormalna povečana spolna sla ali obsedenost s pretiranim predajanjem mislim ali občutkom v povezavi s spolnostjo.
If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila AZILECT, kot bi smeli Če menite, da ste vzeli preveč tablet zdravila AZILECT, se morate nemudoma posvetovati z zdravnikom ali farmacevtom.
Influenza
- gripa (influenca)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Navodilo za uporabo AZILECT 1 mg tablete razagilin Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Pred vožnjo in upravljanjem strojev prosite za nasvet zdravnika, saj Parkinsonova bolezen sama in zdravljenje z zdravilom AZILECT lahko vplivata na vašo sposobnost upravljanja vozil in strojev.
The data collected suggests that Parkinson's disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
povezana z visokim tveganjem karcinoma kože (ne izključno melanoma).
In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Levodopa in druga zdravila za Parkinsonovo bolezen Pri bolnikih s Parkinsonovo boleznijo, ki prejemajo razagilin kot dodatno terapijo poleg kronične terapije z levodopo, zdravljenje z levodopo ni klinično pomembno učinkovalo na očistek razagilina.
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
(231 bolnikov) ali katehol-o-metil-transferazni inhibitor (COMT) entakapone 200 mg, skupaj s predvidenimi odmerki levodope (LD)/dekarboksilazni inhibitor (227 bolnikov); zdravljeni so bili 18 tednov.
In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
glavobol, depresija, vrtoglavica in gripa (influenca in rinitis) pri monoterapiji; diskinezija, ortostatska hipotenzija, padec, bolečine v trebuhu, siljenje na bruhanje in bruhanje ter suha usta pri dodatni terapiji k levodopi; mišično-skeletna bolečina, bolečina v hrbtu in vratu in artralgija pri obeh režimih.
Carpal tunnel syndrome, Balance disorder accident syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Bolezni živčevja diskinezija distonija, sindrom karpalnega kanala, motnje ravnotežja možgansko-žilni dogodek serotoninski sindrom*, prekomerna dnevna zaspanost in epizode nenadnega spanca*
Non-clinical data reveal no special hazard for humans based on the standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development.
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
1 mg razagilina na dan (134 bolnikov) ali 2 mg razagilina na dan (132 bolnikov); zdravljeni so bili 26 tednov; aktivne primerjave ni bilo.
Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Razagilin lahko povzroči dnevno zaspanost, somnolenco, in občasno, zlasti če se uporablja z drugimi dopaminergičnimi zdravili - nastop spanca med dejavnostmi vsakdanjega življenja.
Do not take the following medicines while taking AZILECT: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease,
Medtem ko jemljete zdravilo AZILECT, ne jemljite naslednjih zdravil: - zaviralcev monoaminooksidaze (MAO) (npr. za zdravljenje depresije ali Parkinsonove bolezni ali pa za katero koli drugo indikacijo), vključno z zdravili in naravnimi pripravki brez recepta kot je npr. šentjanževka.
Orthostatic hypotension*
Žilne bolezni ortostatska hipertenzija*
Pregelatinised maize starch Colloidal anhydrous silica Stearic acid
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol koruzni škrob predgelirani koruzni škrob brezvodni koloidni silicijev dioksid stearinska kislina smukec
You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Po prenehanju zdravljenja z zdravilom AZILECT morate počakati vsaj 14 dni, preden začnete z zdravljenjem z zaviralci MAO ali petidinom.
Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Neznana prekomerna dnevna zaspanost in epizode nenadnega spanca*
AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Zdravilo AZILECT tablete so bele do belkaste, okrogle, ploščate, prirezane tablete z vtisnjenim "GIL"
Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Zaradi inhibitorne monoaminooksidazne aktivnosti razagilina sočasna uporaba razagilina in simpatikomimetikov, kot so tisti, ki so prisotni v nazalnih in peroralnih dekongestivih, ali zdravilih proti prehladu, ki vključujejo efedrin ali psevdoefedrin, ni priporočljiva
Dermatitis
artritis
≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
V kliničnih preskušanjih z razagilinom niso smeli sočasno uporabljati fluoksetina ali fluvoksamina z razagilinom, lahko pa so bili uporabljeni naslednji antidepresivi in odmerki: amitriptilin ≤ 50 mg dnevno, trazodon ≤ 100 mg dnevno, citalopram ≤ 20 mg dnevno, sertralin ≤ 100 mg dnevno in paroksetin ≤ 30 mg dnevno (glejte poglavje 4.5).
In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
95 % IZ [-1,36; -0,51]; p < 0,0001.
Musculoskeletal pain,
Ušesne bolezni,
*See section description of selected adverse reactions Adjunct Therapy
*Glejte poglavje opis izbranih neželenih učinkov Opis izbranih neželenih učinkov
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
SSRI/SNRI/triciklični in tetraciklični antidepresivi Sočasni uporabi razagilina in fluoksetina ali fluvoksamina se je treba izogibati (glejte poglavje 4.4).
Uncommon (may affect up to 1 in 100 people) - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - kap (možgansko-žilni dogodek)
Not known disorders
Neznana hipotenzija*
In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was -0.78h, 95% CI [-1.18, -0.39], p=0.0001.
0,78 ur, 95 % IZ [-1,18; -0,39 ur], p = 0,0001.
In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS, parts I-III).
Združeni ocenjevalni lestvici Parkinsonove bolezni (Unified Parkinson's Disease Rating Scale
MAO Inhibitors
Inhibitorji monoaminooksidaze (MAO)
Common (may affect up to 1 in 10 people) - Abdominal pain - Fall - Allergy - Fever - Flu (influenza) - General feeling of being unwell (malaise) - Neck pain - Chest pain (angina pectoris) - Low blood pressure when rising to a standing position with symptoms like dizziness/light headedness (orthostatic hypotension) - Decreased appetite - Constipation - Dry mouth - Nausea and vomiting
(ortostatska hipotenzija) - zmanjšan apetit - zaprtje - suha usta - siljenje na bruhanje in bruhanje - napenjanje - neustrezni izvidi krvnih preiskav (levkopenija)
- Flatulence - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
- zmanjšanje telesne mase - nenavadne sanje - težave z usklajevanjem delovanja mišic (motnje ravnotežja) - depresija - omotica (vrtoglavica)
How to store AZILECT
Shranjevanje zdravila AZILECT
Neck pain, Arthritis
- vnetje sklepa (artritis)
EU/1/05/322/002 Yttriga vial (glass) 1 vial (flat bottom)
1 viala (ravnim dnom)
(Invented) name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/05/322/001 Yttriga vial (glass) 1 vial (V-shaped bottom)
1 viala (dnom v obliki črke V)
(Invented) name
(izmišljeno) ime
4 (4 x 1) prefilled syringes (multipack)
4 (4 x 1) napolnjene injekcijske brizge (paket)
Repeat every 24 hours.
Ponovite vsakih 24 ur.
Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
Datum prve odobritve: 27. avgust 1997 Datum zadnjega podaljšanja: 20. julij 2012
(pre- and postoperative)
(pre- in postoperativno)
1, 28700 San Sebastian de los Reyes, Madrid Spain
1, 28700 San Sebastian de los Reyes, Madrid Španija
Blood should not enter the syringe.
Kri ne sme vstopiti v brizgo.
The required dose is determined using the following formula:
Potreben odmerek se določi po naslednji formuli:
It is important that the recommendations in section 4.2 be followed closely.
Pomembno je, da dosledno upoštevate navodila v poglavju 4.2.
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25C.
Kemijsko in fizikalno stabilnost med uporabo so dokazali za 3 ure pri temperaturi do 25 °C.
These reactions are potentially life-threatening.
Te reakcije so lahko življenjsko ogrožajoče.
The parameters estimated using the final 2-compartment model are shown in Table 2.
Parametri, ki so jih ocenili s pomočjo končnega 2-prostornega modela, so prikazani v preglednici 2.
• Dizziness, altered taste
• omotica, spremenjen okus
Safety analysis of 25 evaluable patients reflected a safety profile as expected.
Analiza varnosti 25 ovrednotenih bolnikov je dala varnostni profil, ki ustreza pričakovanjem.
Frequency of doses (hours)/Duration of Therapy (days)
Pogostost odmerkov (ure)/Trajanje zdravljenja (dnevi)
In most of the cases, an infusion rate of up to 4 mL per minute has been used.
V večini primerov so uporabljali hitrost infuzije do 4 ml na minuto.
• Fast heart rate, low blood pressure
• hiter srčni utrip, nizek krvni tlak
A summary of pharmacokinetic data is presented in Table 1.
Povzetek farmakokinetičnih podatkov je predstavljen v preglednici 1.
Paediatric population Allergic reactions might be experienced more frequently in children than in adults.
Pediatrična populacija Pri otrocih se lahko alergijske reakcije pojavijo pogosteje kot pri odraslih.
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Če se taki inhibitorji pojavijo, se lahko stanje pokaže kot nezadosten klinični odziv.
Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Pogostnost je ocenjena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
BeneFIX can be used for all age groups.
Zdravilo BeneFIX se lahko uporablja pri vseh starostnih skupinah.
Administration (Intravenous Injection):
Aplikacija (intravensko injiciranje):
Common to < 1/10
Pogosti do < 1/10
Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Trombin nato pretvori fibrinogen v fibrin in nastane strdek.
Repeat infusion every 8 to 24 hours until threat is resolved.
Ponovite infuzijo vsakih 8 do 24 ur, dokler nevarnost ne mine.
The terminal phase has not been covered unambiguously due to lack of data beyond 24 hours in paediatric subjects < 6 years of age.
Končna faza ni nedvoumno raziskana zaradi pomanjkanja podatkov po 24 urah pri pediatričnih osebah, starih < 6 let.
- If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6).
če ste alergični na nonakog alfa ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
X 1.3 IU/kg
X 1,3 i.e./kg
This is of importance particularly when changing the laboratory and/or reagents used in the assay.
To je še posebej pomembno ob zamenjavi laboratorija in/ali reagentov za testiranje.
• two alcohol swabs
•dva alkoholna zloženca,
• Development of neutralising antibodies (inhibitors)
• razvoj nevtralizirajočih protiteles (inhibitorjev)
• Lack of response to treatment (failure to stop or prevent bleeding episodes)
• nezadosten odziv na zdravljenje (neuspešno zaustavljanje ali preprečevanje krvavitev)
In the case of shock, the current medical standards for treatment of shock should be observed.
V primeru šoka se ravnajte po trenutno veljavnih medicinskih standardih za zdravljenje šoka.
The contents of the pack are:
Pakiranje vsebuje:
Mean  SD Pharmacokinetic Parameters Based on Individual Bayes Estimates from Population Pharmacokinetic Analysis
Povprečni  SD farmakokinetični parametri na osnovi posameznih Bayesovih ocen iz populacijske farmakokinetične analize
Do not use this medicine after the expiry date which is stated on the outer box and vial label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Zdravljenje je treba izvajati pod nadzorom zdravnika, ki je izkušen v zdravljenju hemofilije.
Do not stop taking BeneFIX without consulting your doctor.
Ne prenehajte jemati zdravila BeneFIX, ne da bi se posvetovali z zdravnikom.
Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor.
Če boste doživeli alergijske reakcije, kot so opisane zgoraj, vas bo zato treba testirati na prisotnost inhibitorja.
Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Zato naj se faktor IX uporablja med nosečnostjo in dojenjem le, če je to nujno potrebno.
METHOD OF ADMINISTRATION Use the entire contents.
Porabite vso vsebino.
- If you suffer from liver or heart disease or if you have recently had surgery, there is an increased risk for blood clotting (coagulation) complications.
Če imate bolezen jeter ali srca ali če ste bili pred nedavnim operirani, je tveganje za zaplete s strjevanjem krvi (koagulacijo) zvečano.
Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX; ATC code: B02BD04
Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktor IX; oznaka ATC: B02BD04
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Vsaj 1 dan, dokler sodeč po bolečini krvavitev ne izzveni ali je dosežena ozdravitev.
This dose and duration will depend upon your individual needs for replacement factor IX therapy and how quickly your body uses up factor IX, which will be checked regularly.
Odmerek in trajanje bosta odvisna od vaših individualnih potreb po nadomestnem zdravljenju s faktorjem IX in od tega, kako hitro vaše telo porabi faktor IX, kar bo treba redno nadzirati.
In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications.
Pri teh stanjih je treba pretehtati korist zdravljenja z zdravilom BeneFIX v primerjavi s tveganjem za omenjene zaplete.
In some cases, these reactions have progressed to severe anaphylaxis.
V nekaterih primerih so te reakcije napredovale do hude anafilaksije.
This should be considered during the preparation and administration of BeneFIX.
To je treba upoštevati pri pripravi in dajanju zdravila BeneFIX.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should only take BeneFIX upon specific instructions from your doctor.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, smete uporabiti zdravilo BeneFIX le po posebnem navodilu zdravnika.
White/almost white powder and clear and colourless solvent.
Bel/skoraj bel prašek in bister in brezbarven vehikel.
Administration by continuous infusion has not been approved and is not recommended (see also sections 4.4 and 6.6).
Kontinuirana infuzija Dajanje s kontinuirano infuzijo ni odobreno in ni priporočljivo (glejte tudi poglavji 4.4 in 6.6).
Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
V kliničnih študijah z zdravilom BeneFIX ni sodelovalo dovolj oseb, starih 65 let ali več, da bi določili, ali se odzivajo drugače kot mlajše osebe.
The safety and efficacy of using BeneFIX for immune tolerance induction has not been established.
Varnost in učinkovitost uporabe zdravila BeneFIX za indukcijo imunske tolerance nista bili dokazani.