natgillin/translations-raw huggingface dataset:
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is placed on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 2. 0 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached, At the request of the EMEA.
Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti: če se pridobijo nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja. v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja). na zahtevo Evropske agencije za zdravila (EMEA).
47 ANNEX III
48 DODATEK III
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
OZNAČEVANJE
OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
BESEDILO NA ŠKATLI (PLASTENKE IN PRETISNI OMOTI) IN BESEDILO NA NALEPKI PLASTENKE
Baraclude 0.5 mg film-coated tablets entecavir
Baraclude 0, 5 mg filmsko obložene tablete entekavir
Each film-coated tablet contains 0.5 mg of entecavir.
Vsaka filmsko obložena tableta vsebuje 0, 5 mg entekavirja.
Blister pack:
Pakiranje v pretisnem omotu:
30 x 1 film-coated tablets 90 x 1 film-coated tablets
30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta
50 Bottle pack:
51 Pakiranje v plastenki:
EU/ 1/ 06/ 343/ 003 EU/ 1/ 06/ 343/ 006
EU/ 1/ 06/ 343/ 003 30 x 1 filmsko obložena tableta EU/ 1/ 06/ 343/ 006 90 x 1 filmsko obložena tableta
EU/ 1/ 06/ 343/ 001
EU/ 1/ 06/ 343/ 001 30 filmsko obloženih tablet
51 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Baraclude 0.5 mg tablets entecavir
Baraclude 0, 5 mg tablete entekavir
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
53 Bottle pack:
54 Pakiranje v plastenki:
EU/ 1/ 06/ 343/ 004 EU/ 1/ 06/ 343/ 007
EU/ 1/ 06/ 343/ 004 30 x 1 filmsko obložena tableta EU/ 1/ 06/ 343/ 007 90 x 1 filmsko obložena tableta
EU/ 1/ 06/ 343/ 002
EU/ 1/ 06/ 343/ 002 30 filmsko obloženih tablet
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
56 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Baraclude 0.05 mg/ ml oral solution entecavir
Baraclude 0, 05 mg/ ml peroralna raztopina entekavir
Each ml contains 0.05 mg entecavir.
Vsak ml vsebuje 0, 05 mg entekavirja.
58 PACKAGE LEAFLET:
58 B.
Baraclude 0.5 mg film-coated tablets Entecavir
Baraclude 0, 5 mg filmsko obložene tablete entekavir
What Baraclude is and what it is used for 2.
Kaj je zdravilo Baraclude in za kaj ga uporabljamo 2.
Before you take Baraclude 3.
Kaj morate vedeti, preden boste vzeli zdravilo Baraclude 3.
How to take Baraclude 4.
Kako jemati zdravilo Baraclude 4.
How to store Baraclude 6.
Shranjevanje zdravila Baraclude 6.
WHAT BARACLUDE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO BARACLUDE IN ZA KAJ GA UPORABLJAMO
Baraclude tablets are anti-viral medicines, used to treat chronic hepatitis B virus (HBV) infection in adults.
Baraclude tablete so protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) pri odraslih.
BEFORE YOU TAKE BARACLUDE
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO BARACLUDE
Do not take Baraclude if you are allergic (hypersensitive) to entecavir or any of the other ingredients of Baraclude.
Ne jemljite zdravila Baraclude, če ste alergični na (preobčutljivi za) entekavir ali katero koli sestavino zdravila Baraclude.
Take special care with Baraclude if you have ever had problems with your kidneys, tell your doctor.
Bodite posebno pozorni pri jemanju zdravila Baraclude Če ste kdaj imeli težave z ledvicami, to povejte svojemu zdravniku.
do not stop taking Baraclude without your doctor’ s advice since your hepatitis may worsen after stopping treatment.
Zdravila Baraclude ne smete nehati jemati brez nasveta zdravnika, saj se hepatitis po prekinitvi zdravljenja lahko poslabša.
When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.
Zdravnik bo še več mesecev opravljal krvne preiskave.
discuss with your doctor whether you have liver cirrhosis and what the possible effects on your Baraclude treatment may be.
Z zdravnikom se posvetujte tudi o možnih vplivih na zdravljenje z zdravilom Baraclude.
if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor.
Če imate sočasno okužbo z virusom HIV (virusom humane imunske pomanjkljivosti) morate o tem obvestiti svojega zdravnika.
taking Baraclude will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination).
Za preprečevanje
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV.
60 prenosa okužbe s HBV na druge je pomembno, da še naprej izvajate ustrezne varnostne ukrepe.
59 Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Zdravilo Baraclude spada v skupino zdravil, ki lahko povzročijo laktacidozo (čezmerno kopičenje mlečne kisline v krvi) in povečanje jeter.
Pregnancy and breastfeeding Tell your doctor if you are pregnant or planning to become pregnant.
Nosečnost in dojenje Če ste noseči ali nameravate zanositi, to povejte svojemu zdravniku.
It has not been demonstrated that Baraclude is safe to use during human pregnancy.
Varnost uporabe zdravila Baraclude med nosečnostjo ni dokazana.
Tell your doctor if you are breastfeeding.
Če dojite, to povejte svojemu zdravniku.
Driving and using machines Baraclude is unlikely to affect your ability to drive or operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Verjetnost, da bi zdravilo Baraclude vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
Dizziness, fatigue and somnolence are common side effects which may impair your ability to drive and use machines.
Sposobnost vožnje in upravljanja s stroji lahko zmanjšajo omotica, utrujenost in somnolenca (zaspanost), ki so pogosti neželeni učinki.
Important information about some of the ingredients of Baraclude tablets This medicinal product contains lactose.
Pomembne informacije o nekaterih sestavinah tablet Baraclude Zdravilo vsebuje laktozo.
HOW TO TAKE BARACLUDE
KAKO JEMATI ZDRAVILO BARACLUDE
Always take Baraclude exactly as your doctor has told you.
Pri jemanju zdravila Baraclude natančno upoštevajte zdravnikova navodila.
The usual dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Običajen odmerek je bodisi 0, 5 mg bodisi 1 mg enkrat na dan peroralno (skozi usta).
Taking Baraclude with food and drink In most cases you may take Baraclude with or without food.
Jemanje zdravila Baraclude skupaj s hrano in pijačo V večini primerov lahko zdravilo Baraclude jemljete skupaj s hrano ali brez nje.
If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily.
V primeru zamenjave zdravljenja, če vam je zdravnik zdravilo Baraclude predpisal zato, ker je bilo predhodno zdravljenje z zdravilom z zdravilno učinkovino lamivudin neuspešno, pa morate zdravilo Baraclude jemati enkrat na dan na prazen želodec.
Empty stomach means at least 2 hours after a meal or at least 2 hours before your next meal.
Jemanje na prazen želodec pomeni vsaj 2 uri po obroku ali vsaj 2 uri pred naslednjim obrokom.
If you take more Baraclude than you should Contact your doctor at once.
61 Če ste vzeli večji odmerek zdravila Baraclude, kot bi smeli Nemudoma se posvetujte s svojim zdravnikom.
60 If you forget to take Baraclude It is important that you do not miss any doses.
Če ste pozabili vzeti zdravilo Baraclude Pomembno je, da ne pozabite vzeti nobenega odmerka.
Do not stop Baraclude without your doctor’ s advice Some people get very serious hepatitis symptoms when they stop taking Baraclude.
Zdravila Baraclude ne smete nehati jemati brez nasveta zdravnika Pri nekaterih bolnikih se po prekinitvi zdravljenja z zdravilom Baraclude lahko pojavijo zelo resni bolezenski znaki hepatitisa.
Like all medicines, Baraclude can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Baraclude neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Patients treated with Baraclude in clinical studies have reported the following side effects: very common (at least 1 in 10 patients): headache common (at least 1 in 100 patients): insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea and dyspepsia (indigestion).
Pri bolnikih, ki so se v kliničnih študijah zdravili z zdravilom Baraclude, so poročali o naslednjih neželenih učinkih: zelo pogosti (pri več kot 1 od 10 bolnikov): glavobol; pogosti (pri več kot 1 od 100 bolnikov): insomnija (nespečnost), utrujenost (močna oslabelost), omotica, somnolenca (zaspanost), bruhanje, driska, siljenje na bruhanje in dispepsija (prebavne motnje).
Some patients may also experience rash.
Pri nekaterih bolnikih se lahko pojavi izpuščaj.
HOW TO STORE BARACLUDE
SHRANJEVANJE ZDRAVILA BARACLUDE
Do not use Baraclude after the expiry date which is stated on the bottle, blister or carton after EXP.
Zdravila Baraclude ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki, pretisnem omotu ali škatli poleg oznake "Uporabno do".
Blister packs: do not store above 30°C.
Pakiranje v pretisnem omotu: shranjujte pri temperaturi do 30°C.
Bottle packs: do not store above 25°C.
Pakiranje v plastenki: shranjujte pri temperaturi do 25°C.
What Baraclude contains The active substance is entecavir.
Kaj vsebuje zdravilo Baraclude Zdravilna učinkovina je entekavir.
Each film-coated tablet contains 0.5 mg entecavir.
Ena filmsko obložena tableta vsebuje 0, 5 mg entekavirja.
The other ingredients are:
62 Pomožne snovi so:
What Baraclude looks like and contents of the pack The film-coated tablets (tablets) are white to off-white and triangular-shaped.
Izgled zdravila Baraclude in vsebina pakiranja Filmsko obložene tablete (tablete) so bele do sivobele barve in trikotne oblike.
They are marked with “ BMS ” on one side and “ 1611” on the other.
Na eni strani imajo oznako “ BMS ”, na drugi strani pa “ 1611 ”.
Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablets (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Baraclude 0, 5 mg filmsko obložene tablete so na voljo v škatlah s 30 x 1 ali 90 x 1 filmsko obloženo tableto (v pretisnih omotih za enkratni odmerek) in v plastenkah s 30 filmsko obloženimi tabletami.
61 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Bristol-Myers Squibb Rue du Docteur André Gilles 28230 Epernon France
Bristol- Myers Squibb Rue du Docteur André Gilles 28230 Epernon Francija
Bristol-Myers Squibb La Goualle B. P.6 19250 Meymac France
Bristol- Myers Squibb La Goualle B. P. 6 19250 Meymac Francija
Deutschland BRISTOL-MYERS SQUIBB GMBH & CO.
63 Deutschland BRISTOL- MYERS SQUIBB GMBH & CO.
Baraclude 1 mg film-coated tablets Entecavir
Baraclude 1 mg filmsko obložene tablete entekavir
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV.
65 prenosa okužbe s HBV na druge je pomembno, da še naprej izvajate ustrezne varnostne ukrepe.
64 Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Zdravilo Baraclude spada v skupino zdravil, ki lahko povzročijo laktacidozo (čezmerno kopičenje mlečne kisline v krvi) in povečanje jeter.
If you take more Baraclude than you should Contact your doctor at once.
66 Če ste vzeli večji odmerek zdravila Baraclude, kot bi smeli Nemudoma se posvetujte s svojim zdravnikom.
65 If you forget to take Baraclude It is important that you do not miss any doses.
Če ste pozabili vzeti zdravilo Baraclude Pomembno je, da ne pozabite vzeti nobenega odmerka.
The other ingredients are:
67 Pomožne snovi so:
What Baraclude looks like and contents of the pack The film-coated tablets (tablets) are pink and triangular-shaped.
Izgled zdravila Baraclude in vsebina pakiranja Filmsko obložene tablete (tablete) so rožnate barve in trikotne oblike.
They are marked with “ BMS” on one side and “ 1612” on the other.
Na eni strani imajo oznako “ BMS ”, na drugi strani pa “ 1612 ”.
Baraclude 1 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablets (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Baraclude 1 mg filmsko obložene tablete so na voljo v škatlah s 30 x 1 ali 90 x 1 filmsko obloženo tableto (v pretisnih omotih za enkratni odmerek) in v plastenkah s 30 filmsko obloženimi tabletami.
66 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Deutschland BRISTOL-MYERS SQUIBB GMBH & CO.
68 Deutschland BRISTOL- MYERS SQUIBB GMBH & CO.
Baraclude 0.05 mg/ ml oral solution Entecavir
Baraclude 0, 05 mg/ ml peroralna raztopina entekavir
Baraclude oral solution is an anti-viral medicine, used to treat chronic hepatitis B virus (HBV) infection in adults.
Baraclude peroralna raztopina je protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) pri odraslih.
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV.
70 prenosa okužbe s HBV na druge je pomembno, da še naprej izvajate ustrezne varnostne ukrepe.
69 Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Zdravilo Baraclude spada v skupino zdravil, ki lahko povzročijo laktacidozo (čezmerno kopičenje mlečne kisline v krvi) in povečanje jeter.
Important information about some of the ingredients of Baraclude oral solution This medicinal product contains maltitol which may have a mild laxative effect (13 g maltitol liquid per 20 ml dose).
Pomembne informacije o nekaterih sestavinah peroralne raztopine Baraclude Zdravilo vsebuje maltitol (20- mililitrski odmerek vsebuje 13 g tekočega maltitola), ki ima lahko blag odvajalni učinek.
The usual dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).
Običajen odmerek je bodisi 0, 5 mg (10 ml) bodisi 1 mg (20 ml) enkrat na dan peroralno (skozi usta).
Entecavir oral solution is designed as a ready-to-use product.
Peroralna raztopina entekavirja je že pripravljena za uporabo.
Baraclude oral solution comes with a measuring spoon with milliliter marks from 1 up to 10 milliliters.
Merilna žlička ima mililitrske oznake od 1 do 10 mililitrov.
If you take more Baraclude than you should Contact your doctor at once.
Če ste vzeli večji odmerek zdravila Baraclude, kot bi smeli Nemudoma se posvetujte s svojim zdravnikom.
If you forget to take Baraclude It is important that you do not miss any doses.
Če ste pozabili vzeti zdravilo Baraclude Pomembno je, da ne pozabite vzeti nobenega odmerka.
Some patients may also experience rash.
72 Pri nekaterih bolnikih se lahko pojavi izpuščaj.
71 Do not use Baraclude after the expiry date which is stated on bottle or carton after EXP.
Zdravila Baraclude ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki ali škatli poleg oznake "Uporabno do".
Each ml of oral solution contains 0.05 mg entecavir.
En mililiter peroralne raztopine vsebuje 0, 05 mg entekavirja.
The other ingredients are: citric acid anhydrous, maltitol liquid (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.
Pomožne snovi so: brezvodna citronska kislina, tekoči maltitol (E965), metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), aroma pomaranče (akacija in naravne arome), natrijev citrat, natrijev hidroksid, klorovodikova kislina in prečiščena voda.
What Baraclude looks like and contents of the pack The oral solution is a clear, colorless to pale yellow solution.
Izgled zdravila Baraclude in vsebina pakiranja Peroralna raztopina je bistra, brezbarvna do bledorumena raztopina.
Baraclude 0.05 mg/ ml oral solution is supplied in a bottle containing 210 ml oral solution.
Baraclude 0, 05 mg/ ml peroralna raztopina je na voljo v plastenki, ki vsebuje 210 ml peroralne raztopine.
Bristol-Myers Squibb S. r. l.
73 Bristol- Myers Squibb S. r. l.
Italia BRISTOL-MYERS SQUIBB S. R. L.
74 Italia BRISTOL- MYERS SQUIBB S. R. L.
The measuring spoon is manufactured by:
Izdelovalec merilne žličke:
Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
Comar Plastics Division, One Comar Place, Buena, NJ 08310, ZDA.
Authorised Representative in the EEA for Comar Plastics:
Pooblaščeni zastopnik za Comar Plastics v Evropskem gospodarskem prostoru:
MDSS, Burckhardstrasse 1, 30163 Hannover, Germany
MDSS, Burckhardstrasse 1, 30163 Hannover, Nemčija.
What is BeneFIX?
Kaj je zdravilo Benefix?
BeneFIX is a powder and solvent that are mixed together for injection.
Zdravilo BeneFIX je prašek in vehikel, ki ju zmešamo za injiciranje.
BeneFIX contains the active ingredient nonacog alfa (recombinant coagulation factor IX, which helps blood to clot).
BeneFIX vsebuje zdravilno učinkovino nonakog alfa (rekombinantni koagulacijski faktor IX, ki pomaga pri strjevanju krvi).
BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Zdravilo BeneFIX se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B (prirojeno motnjo strjevanja krvi zaradi pomanjkanja faktorja IX).
BenFIX can be used in adults and children over the age of 6.
BeneFIX se lahko uporablja pri odraslih in otrocih, starih več kot 6 let.
BeneFIX is intended for either short-term or long-term use.
Namenjen je bodisi za kratkotrajno ali dolgotrajno uporabo.
BeneFIX is given by a slow infusion into a vein (usually up to 4 ml per minute).
BeneFIX se daje s počasno infuzijo v veno (navadno do 4 ml na minuto).
BeneFix should not be mixed with other infusions solutions or be given using another giving set that the set supplied with the medicine.
Zdravila BeneFIX se ne sme mešati z drugimi raztopinami za infundiranje, pri dajanju pa se sme uporabljati samo komplet za dajanje, ki je priložen zdravilu.
The dose depends on whether BeneFIX is used to treat haemorrhage (bleeding) or to prevent it during surgery.
Odmerek zdravila je odvisen od tega, ali se BeneFIX uporablja za zdravljenje hemoragičnih dogodkov (krvavitev) ali za preprečevanje le- teh med operacijo.
The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Odmerek je potrebno prilagoditi tudi glede na stopnjo resnosti krvavitve ali vrsto operacije.
It is generally administered once a day, except in life threatening situations.
Načeloma se daje enkrat dnevno, razen v življenjsko nevarnih situacijah.
The full detail on how to calculate the doses is included in the Package Leaflet.
Podrobni podatki o tem, kako izračunati ustrezni odmerek, so na voljo v Navodilih za uporabo.
BeneFIX contains nonacog alfa.
BeneFIX vsebuje nonakog alfa.
Nonacog alfa is a blood coagulation factor protein.
Nonakog alfa je beljakovinski krvni koagulacijski faktor.
In the body, Factor IX is one of the substances (factors) involved in blood coagulation (clotting).
Faktor IX je ena izmed snovi (faktorjev) v telesu, ki sodelujejo pri koagulaciji (strjevanju) krvi.
Patients with haemophilia B lack Factor IX, and this causes blood coagulation problems, such as bleeding in the joints, muscle or internal organs.
Bolnikom s hemofilijo B primanjkuje faktorja IX, kar povzroča zaplete s strjevanjem krvi, kot je krvavenje v sklepe, mišice ali notranje organe.
BeneFIX is used to replace the missing factor IX, it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Z zdravilom BeneFIX se nadomesti manjkajoči faktor IX in posledično popravi pomanjkanje faktorja IX ter vzpostavi začasni nadzor nad krvavitvami.
Nonacog alfa is not extracted from human plasma but produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor IX.
Nonakog alfa se ne pridobiva iz človeške plazme, temveč se proizvaja z metodo, znano pod imenom “ rekombinantna DNA tehnologija ”: proizvede ga celica, ki je prejela gen (DNA), s pomočjo katerega postane sposobna tvoriti človeški koagulacijski faktor IX.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged bleeding episodes that occurred and rated BeneFIX’ s effectiveness using a four-point scale (“ excellent ”, “ good”, “ moderate”, and “ no response”).
Preučevali so ga tudi pri bolnikih, ki še niso prejemali nobenega predhodnega zdravljenja za hemofilijo.
What benefit has BeneFIX shown during the studies?
Kakšne koristi je zdravilo BeneFIX izkazalo med raziskavami?
In previously treated patients, of the 693 haemorrhages treated, 566 (82%) resolved after a single infusion of BeneFIX.
Pri predhodno zdravljenih bolnikih je od 693 zdravljenih epizod krvavitev 566 (82%) izzvenelo po prvem dajanju zdravila BeneFIX.
Out of 972 infusions, 815 (84%) infusions were rated to have “ good” or “ excellent” responses.
Od 972 danih infuzij je bil odziv pri 815 (84%) infuzijah ocenjen kot “ dober ” ali “ odličen ”.
If this happens, BeneFIX will not work effectively. Hypersensitivity or allergic reactions have been seen sometimes in patients treated with factor IX containing products..
Občasno so pri bolnikih, zdravljenih z zdravili, ki vsebujejo faktor IX, opazili preobčutljivostne ali alergične reakcije.
For the full list of all the side effects reported with BeneFIX, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila BeneFIX najdete v Navodilih za uporabo.
BeneFIX should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor IX or to any of the other ingredients or to hamster proteins.
Zdravila BeneFIX ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rekombinantni koagulacijski faktor IX ali katerokoli drugo sestavino zdravila ali na beljakovine hrčka.