natgillin/translations-raw huggingface dataset:
Mannitol (E 421) Microcrystalline cellulose Aspartame (E 951) Crospovidone Magnesium stearate
6.1 Popis pomoćnih tvari manitol (E421) celuloza, mikrokristalična aspartam (E951) krospovidon magnezijev stearat
How to take Olanzapine Glenmark
Kako uzimati Olanzapin Glenmark
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/hr).
U žena je prosječno poluvrijeme eliminacije nešto duže u odnosu na muškarce (36,7 naspram 32,3 sata), a klirens je smanjen (18,9 naspram 27,3 l/h).
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina ili povraćanje rijetko su prijavljivani (≥ 0,01% i < 0,1%) nakon naglog prekida uzimanja olanzapina.
anticholinergic effects including constipation and dry mouth distension9
Poremećaji probavnog sustava blagi, prolazni antikolinergički učinci uključujući konstipaciju i suha usta distenzija abdomena9 pankreatitis11
9 Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Nuspojava je identificirana iz kliničkih ispitivanja u integriranoj bazi podataka za olanzapin.
Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Prijavljeno je da se napadaji manje često pojavljuju u bolesnika liječenih olanzapinom.
13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 %of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
13 Nakon kratkotrajnog liječenja (medijan trajanja 22 dana), povećanje tjelesne težine ≥ 7% od početne tjelesne težine (kg) bilo je vrlo često (40,6%), porast ≥ 15% od početne tjelesne težine bio je čest (7,1%), a ≥ 25% bio je čest (2,5%).
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l - < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Promjene u vrijednosti triglicerida natašte od početnih graničnih vrijednosti (≥ 1,69 -< 2,26 mmol/l) do visokih vrijednosti (≥ 2,26 mmol/l) bile su vrlo česte.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Prosječno poluvrijeme eliminacije olanzapina u zdravih ispitanika nakon peroralne primjene varira ovisno o dobi i spolu.
Dysarthria Stuttering11
dizartrija mucanje11
6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56, 70, 98 tablets per carton.
6.5 Vrsta i sadržaj spremnika Aluminij/aluminij blisteri u kutijama s 28, 56, 70, 98 tableta.
What Olanzapine Glenmark contains - The active substance is olanzapine - Each Olanzapine Glenmark tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine
- Svaka Olanzapin Glenmark tableta sadrži 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg ili 20 mg olanzapina.
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1 %; a potential contributing factor could be high plasma valproate levels.
U jednom kliničkom ispitivanju u bolesnika s bipolarnom manijom, kombinacijska terapija valproatom i olanzapinom uzrokovala je incidenciju neutropenije od 4,1%.
How to store Olanzapine Glenmark
Kako čuvati Olanzapin Glenmark
Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Tijekom dugotrajne izloženosti lijeku (najmanje 48 tjedana) povećanje tjelesne težine ≥ 7%, ≥ 15% i ≥ 25% od početne bilo je vrlo često (64,4%, 31,7%, odnosno
Neuroleptic malignant syndrome (see section
sindrom nemirnih nogu neuroleptički maligni sindrom (vidjeti dio 4.4)12
11 Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database.
11 Nuspojava je identificirana iz spontanih prijava nakon stavljanja lijeka u promet, a učestalost je određena uz pomoć integrirane baze podataka za olanzapin.
Eosinophilia Leukopenia10 Neutropenia10
Poremećaji krvi i limfnog sustava eozinofilija leukopenija10 neutropenija10
Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Često su uočeni prolazni asimptomatski porasti vrijednosti jetrenih aminotransferaza, ALT i AST, osobito u ranoj fazi liječenja.
Olanzapine Glenmark contains the active substance olanzapine.
Olanzapine Glenmark sadrži djelatnu tvar olanzapin.
- High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Glenmark.
• U bolesnika koji uzimaju lijek Olanzapine Glenmark uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
Only take other medicines while you are on Olanzapine Glenmark if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Ako uzimate lijek Olanzapine Glenmark u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizeri), možete se osjećati omamljeno.
SmokingIn non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Prosječno poluvrijeme eliminacije u ispitanika nepušača (muškarci i žene) bilo je duže nego u ispitanika pušača (38,6 naspram 30,4 sata), a klirens je bio manji (18,6 naspram 27,7 l/h).
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Promjene ukupnog kolesterola natašte od početnih graničnih vrijednosti (≥ 5,17-< 6,2 mmol/l) do visokih vrijednosti (≥ 6,2 mmol/l) bile su vrlo česte.
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Glenmark and regularly during treatment.
Prije početka uzimanja lijeka Olanzapine Glenmark te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i određenih masnoća u krvi.
Pancreatitis11
trombocitopenija11
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2
3 Uočeno za početne normalne razine natašte (< 5,17 mmol/l) koje su porasle na visoke razine
The pharmacokinetics of olanzapine are similar between adolescents and adults.
Adolescenti (u dobi od 13 do 17 godina): farmakokinetika olanzapina je slična između adolescenata i odraslih.
Olanzapine Glenmark 7.5 mg: yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Olanzapin Glenmark 7,5 mg: žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘C' na jednoj strani.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26
Uočeno za početne normalne razine natašte (< 1,69 mmol/l) koje su porasle na visoke razine
Olanzapine Glenmark tablets are for oral use.
Olanzapine Glenmark obložene tablete uzimaju se kroz usta.
Olanzapine Glenmark 7.5 mg tablets
Olanzapin Glenmark 7,5 mg tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg olanzapine.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 7,5 mg olanzapina.
Olanzapine Glenmark contains a source of phenylalanine.
Olanzapin Glenmark sadrži aspartam Olanzapin Glenmark sadrži izvor fenilalanina.
Olanzapine Glenmark 5 mg: yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Olanzapin Glenmark 5 mg: žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘B' na jednoj strani.
Olanzapine Glenmark 10 mg tablets
Olanzapin Glenmark 10 mg tablete
• Weight gain
• tegobe s prostatom
Tablet Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Tableta Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘C' na jednoj strani.
There is a risk of feeling drowsy when you are given Olanzapine Glenmark.
Kad uzimate lijek Olanzapine Glenmark postoji rizik da se osjećate omamljeno.
Olanzapine Glenmark 15 mg tablets
Olanzapin Glenmark 15 mg tablete
Olanzapine Glenmark 20 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
Olanzapin Glenmark 20 mg: žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘OL' na jednoj i ‘F' na drugoj strani.
Tablet Yellow coloured circular flat bevelled edge tablets with ‘A' debossed on one side.
Tableta Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘A' na jednoj strani.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg olanzapine.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 10 mg olanzapina.
NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH
Nositelj odobrenja za stavljanje lijeka u promet Glenmark Arzneimittel GmbH
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg olanzapine.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 2,5 mg olanzapina.
Olanzapine Glenmark 2.5 mg tablets
Olanzapin Glenmark 2,5 mg tablete
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 7.5 mg tablets
NAZIV LIJEKA Olanzapin Glenmark 7,5 mg tablete
Excipient with known effect: Each tablet contains 0.46 mg of aspartame For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,46 mg aspartama.
Dystonia (including oculogyration) 11
distonija (uključujući okulogiraciju)11 tardivna diskinezija11 amnezija9
Olanzapine Glenmark 15 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Olanzapin Glenmark 15 mg: žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘OL' na jednoj i ‘E' na drugoj strani.
Excipient with known effect: Each tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,23 mg aspartama.
Olanzapine Glenmark 10 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Olanzapin Glenmark 10 mg: žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘OL' na jednoj i ‘D' na drugoj strani.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg olanzapine.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 15 mg olanzapina.
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets
NAZIV LIJEKA Olanzapin Glenmark 20 mg tablete
Excipient with known effect: Each tablet contains 0.35 mg of aspartame For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,35 mg aspartama.
Excipient with known effect: Each tablet contains 0.69 mg of aspartame For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: Svaka tableta sadrži 0,69 mg aspartama.
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 2.5 mg tablets
NAZIV LIJEKA Olanzapin Glenmark 2,5 mg tablete
Yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘B' na jednoj strani.
4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
4 Uočeno za početne normalne razine natašte (< 5,56 mmol/l) koje su porasle na visoke razine
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 10 mg tablets
NAZIV LIJEKA Olanzapin Glenmark 10 mg tablete
MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/016
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/016
Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘OL' na jednoj i ‘E' na drugoj strani.
Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Žute, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom ‘OL' na jednoj i ‘D' na drugoj strani.
Glenmark Arzneimittel GmbH Industriestr.
Glenmark Pharmaceuticals B.V.
• Bleeding from the nose.
Za primjenu kroz usta.
Marketing Authorisation Holder Glenmark Arzneimittel GmbH Industriestr.
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Glenmark Arzneimittel GmbH
Aluminium/aluminium blisters in cartons of 28, 35, 56, 70 and 98 tablets per carton.
6.5 Vrsta i sadržaj spremnika Aluminij/aluminij blisteri u kutijama s 28, 35, 56, 70 i 98 tableta.
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets Olanzapine
NAZIV LIJEKA Olanzapin Glenmark 20 mg tablete olanzapin
Microcrystalline cellulose Aspartame E 951
6.1 Popis pomoćnih tvari manitol (E421) celuloza, mikrokristalična aspartam (E951)
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets
NAZIV LIJEKA Olanzapin Glenmark 15 mg tablete
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 5 mg tablets
NAZIV LIJEKA Olanzapin Glenmark 5 mg tablete
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 10 mg tablets Olanzapine
NAZIV LIJEKA Olanzapin Glenmark 10 mg tablete olanzapin
MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/010
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/010
The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Prosječni porast AUC-a olanzapina iznosio je 52% u žena nepušača, odnosno 108% u muškaraca pušača.
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 2.5 mg tablets Olanzapine
NAZIV LIJEKA Olanzapin Glenmark 2,5 mg tablete olanzapin
Dose escalation, when indicated, should be conservative in such patients (See sections 4.5 and 5.2.
Povećanje doze, kada je indicirano, treba biti konzervativno u takvih bolesnika.
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 5 mg tablets Olanzapine
NAZIV LIJEKA Olanzapin Glenmark 5 mg tablete olanzapin
MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/001
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets Olanzapine
NAZIV LIJEKA Olanzapin Glenmark 15 mg tablete olanzapin
See package leaflet for further information
Vidjeti Uputu o lijeku za dodatne informacije.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,92 mg aspartama.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/007
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/007
MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/004
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) 11
povišene razine kolesterola2,3 povišene razine glukoze4 povišene razine triglicerida2,5 glikozurija pojačan apetit razvoj ili egzacerbacija dijabetesa, ponekad povezana s ketoacidozom ili komom, uključujući i neke slučajeve sa smrtnim ishodom (vidjeti dio 4.4)11
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg olanzapine.
Svaka tableta sadrži 7,5 mg olanzapina.
If you stop taking Olanzapine Glenmark
Nemojte uzimati lijek Olanzapine Glenmark
SE-11276 Stockholm Sweden
SE-11276 Stockholm Švedska
If you have not used it within 3 hours, throw it away.
Ako je ne primijenite u roku od 3 sata, bacite je.
Repeat every 12-24 hours.
Ponoviti svakih 12-24 sata.
Additional Instructions:
Dodatne upute:
The required dose is determined using the following formula:
Potrebna doza određuje se pomoću sljedeće formule:
This is of importance particularly when changing the laboratory and/or reagents used.
To je posebice važno prilikom promjene laboratorija i/ili korištenog reagensa.
It is important that the recommendations in section 6.3 be followed closely.
Važno je pažljivo slijediti preporuke u dijelu 6.3.
No long-term outcome is available.
Nisu dostupni podaci o dugoročnom ishodu.
Date removed from the refrigerator:
Datum uklanjanja iz hladnjaka:
(pre- and post-operative)
(prije i poslije operacije)
PK parameter
PK parametar
Always wash your hands before performing the following procedures.
Uvijek operite ruke prije provođenja sljedećih postupaka.
SD Median
SD Medijan
Do not attempt self-infusion unless properly trained.
Nemojte pokušavati sami sebi dati infuziju ako niste primili ispravnu obuku.
Every 24 hours, at least 1 day, until healing is achieved.
Svaka 24 sata, najmanje 1 dan, do izlječenja.
Clinical studies did not include subjects aged 65 and over.
Klinička ispitivanja nisu uključila ispitanike starije od 65 godina i više.
In case of shock, standard medical treatment for shock should be implemented.
U slučaju šoka, potrebno je primijeniti standardno medicinsko liječenje šoka.
Do not stop using ReFacto AF without consulting your doctor.
Nemojte prestati primjenjivati ReFacto AF bez savjetovanja s Vašim liječnikom.
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C.
Dokazana je kemijska i fizikalna stabilnost tijekom 3 sata na temperaturi do 25
• dizziness and loss of consciousness
• omaglica i gubitak svijesti
Consumption and efficacy results in paediatric population
Rezultati upotrebe i djelotvornosti u pedijatrijskoj populaciji
Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Stoga se faktor VIII smije primjenjivati tijekom trudnoće i dojenja samo ako je to jasno indicirano.
- if you are allergic to moroctocog alfa or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na moroktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Thrombin then converts fibrinogen into fibrin, and a clot is formed.
Trombin potom pretvara fibrinogen u fibrin i nastaje ugrušak.
Pack size of 1.
Veličina pakiranja od 1.
Other in-use storage times and conditions are the responsibility of the user.
Drugačije vrijeme i uvjeti čuvanja odgovornost su korisnika.
Repeat infusion every 8-24 hours until threat is resolved.
Ponoviti infuziju svakih 8-24 sata do prestanka prijetnje.
The amount of drug product left in the infusion set will not affect your treatment.
Količina lijeka koja preostane u priboru za infuziju neće utjecati na Vaše liječenje.
Minor surgery including tooth extraction
Manji kirurški postupak uključujući vađenje zuba
This dose and duration will depend upon your individual needs for replacement factor VIII therapy.
Ta doza i trajanje ovisit će o Vašim individualnim potrebama za nadomjesnom terapijom faktorom VIII.
• swelling of lips and tongue
• oticanje usana i jezika
Grasp the plunger rod as shown in the following diagram.
Uhvatite klip kako je prikazano na sljedećoj slici.
• severe allergic reaction
• teška alergijska reakcija
What ReFacto AF is and what it is used for
Što je ReFacto AF i za što se koristi
Talk to your doctor or pharmacist before using ReFacto AF - if you experience allergic reactions.
Obratite se svom liječniku ili ljekarniku prije nego primijenite ReFacto AF - ako dobijete alergijsku reakciju.
• increased liver enzymes, increased bilirubin
• povišeni jetreni enzimi, povišen bilirubin
Doses administered should be titrated to the patient's clinical response.
Primijenjene doze treba titrirati prema kliničkom odgovoru bolesnika.
Do not use this medicine if you notice that it is cloudy or contains visible particles.
Nemojte primijeniti ovaj lijek ako primijetite da je zamućen ili sadrži vidljive čestice.
After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
Nakon čišćenja, nemojte dodirivati gumeni čep rukama i pazite da ne dodirne neku drugu površinu.
Check with your doctor or pharmacist.
Provjerite s Vašim liječnikom ili ljekarnikom.
Immune Tolerance Induction
Izazivanje imunološke tolerancije
Animal reproduction studies have not been conducted with factor VIII, therefore no data are available on fertility.
Nisu provedena ispitivanja reprodukcije na životinjama s faktorom VIII, stoga nema dostupnih podataka o utjecaju na plodnost.
In the presence of an inhibitor, higher doses or appropriate specific treatment may be required.
Ako je prisutan inhibitor, mogu biti potrebne više doze ili odgovarajuće specifično liječenje.
The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
Specifična aktivnost lijeka ReFacto AF je 7600-13 800 IU/mg proteina.
Date of first authorisation: 13 April 1999 Date of latest renewal: 15 April 2014
Datum posljednje obnove odobrenja: 15. travnja 2014.
The following table can be used to guide dosing in bleeding episodes and surgery:
Sljedeća tablica može poslužiti kao smjernica za doziranje kod epizoda krvarenja i kirurških zahvata:
Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Učestalosti su procijenjene u skladu sa sljedećom konvencijom: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i < 1/100).
In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
U nekim slučajevima, osobito kod mlađih bolesnika, mogu biti potrebni kraći vremenski razmaci između doza ili više doze.
• slight increase in heart enzymes
• blagi porast srčanih enzima
Inform your doctor if you are on a controlled sodium diet.
Obavijestite svog liječnika ako ste na dijeti s ograničenim unosom natrija.
Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Teški simptomi, uključujući otežano disanje i (skoru) nesvjesticu zahtijevaju hitno liječenje.
In general, dose selection for an elderly patient should be individualised.
Općenito, odabir doze za starijeg bolesnika treba se temeljiti na individualnom pristupu.
What ReFacto AF looks like and contents of the pack
Kako ReFacto AF izgleda i sadržaj pakiranja
** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
** Ljudski faktor koagulacije VIII proizveden tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka (CHO).
ReFacto AF is appropriate for use in adults and children of all ages, including newborns.
ReFacto AF je pogodan za primjenu u odraslih i djece svih dobi, uključujući novorođenčad.
Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Ponoviti infuziju svakih 8-24 sata do odgovarajućeg cijeljenja rane, a potom terapija još najmanje 7 dana da bi se aktivnost faktora VIII održala na 30% do 60% (IU/dl).
Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved.
Ponoviti infuziju svakih 12-24 sata tijekom 3-4 dana ili više do prestanka bola i akutne onesposobljenosti.
No investigations on carcinogenic potential or toxicity to reproduction have been conducted.
Nisu provedena ispitivanja kancerogenosti i reproduktivne toksičnosti.
At least 1 day until the bleeding episode as indicated by pain is resolved or healing is achieved.
Najmanje 1 dan do prestanka epizode krvarenja praćenog bolom ili do izlječenja.
Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Bolesnici ili njihovi skrbnici mogu davati injekcije s lijekom ReFacto AF, uz uvjet da su dobili odgovarajuću obuku.
It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
To je glikoprotein približne molekularne mase od 170 000 Da koji se sastoji od 1438 aminokiselina.
White to off-white cake/powder
Bijeli do gotovo bijeli kolačić/prašak
Aged <6 years Aged 6 to <12 years Cmax, IU/mLb
U dobi < 6 godina U dobi od 6 do < 12 godina Cmax, IU/ml