natgillin/translations-raw huggingface dataset:
Both the powder vial and the vial containing 2 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Viala s praškom in viala s 2 ml vehikla sta iz stekla tipa I in zaprti z zamaškoma iz klorobutilne gume.
Both the powder vial and the vial containing 5 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Viala s praškom in viala s 5 ml vehikla sta iz stekla tipa I in zaprti z zamaškoma iz klorobutilne gume.
Use the product immediately once the powder is completely dissolved.
Ko se prašek popolnoma raztopi, zdravilo nemudoma uporabite.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000
IME ZDRAVILA IN POT(I) UPORABE ADVATE 2000
NAME OF THE MEDICINAL PRODUCT ADVATE 250
IME ZDRAVILA ADVATE 250
Powder vial and 2 ml solvent preassembled in BAXJECT III system.
Viala s praškom in 2 ml vehikla, sestavljeni v sistemu BAXJECT III.
c) ADR explained in the section below.
Neželeni učinek je razložen v spodnjem razdelku.
Powder vial and 5 ml solvent preassembled in BAXJECT III system.
Viala s praškom in 5 ml vehikla, sestavljeni v sistemu BAXJECT III.
INFORMATION IN BRAILLE ADVATE 250
PODATKI V BRAILLOVI PISAVI ADVATE 250
Of the 229 treated patients who were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend, 2 displayed a sustained peak or transient spike and one patient had both.
Pri 10 so opazili trend zviševanja titra, ki je bil statistično značilen, pri 2 dalj časa trajajoč ali prehoden vrh titra, pri enem bolniku pa oboje.
NAME OF THE MEDICINAL PRODUCT ADVATE 3000
IME ZDRAVILA ADVATE 3000
INFORMATION IN BRAILLE ADVATE 3000
PODATKI V BRAILLOVI PISAVI ADVATE 3000
INFORMATION IN BRAILLE ADVATE 1500
PODATKI V BRAILLOVI PISAVI ADVATE 1500
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and with resuscitation support immediately available in case of anaphylaxis.
Zdravljenje mora biti vpeljano pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije primeru anafilakse.
The product may not be returned to refrigerated storage after storage at room temperature.
Po shranjevanju pri sobni temperaturi zdravila več ne smete vrniti v hladilnik.
Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a
Skupni AUC (i.e. *·h/dl) Korigirana vrednost prirastnega zvečanja aktivnosti pri Cmax (i.e./dl na i.e./kg)a
After reconstitution, the solution is clear, colourless and free from foreign particles.
Po pripravi je raztopina bistra in brezbarvna in ne vsebuje vidnih tujih delcev.
NAME OF THE MEDICINAL PRODUCT ADVATE 1500
IME ZDRAVILA ADVATE 1500
Keep the blister with the product in the outer carton in order to protect from light.
Pretisni omot z zdravilom shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
NAME OF THE MEDICINAL PRODUCT ADVATE 1000
IME ZDRAVILA ADVATE 1000
With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Vialo z vehiklom, na katero je pritrjen pripomoček BAXJECT II, obrnite tako, da bo viala na zgornji strani pripomočka.
Calcium chloride Trometamol Polysorbate 80
Prašek manitol natrijev klorid histidin trehaloza kalcijev klorid trometamol polisorbat 80 glutation (reduciran)
Attach a butterfly needle to the syringe.
Priključite iglo v obliki metuljčka na brizgo.
ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection ADVATE 2000 IU powder and solvent for solution for injection ADVATE 3000 IU powder and solvent for solution for injection
ADVATE 250 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 2000 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 3000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
- For administration the use of a luer-lock syringe is required.
- Pri dajanju je treba uporabiti brizgo s sistemom luer-lock.
Urticaria
Zaviralci
Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration.
Po intraarterijski uporabi in po paravenski uporabi so opazili blago, prehodno pordelost.
Talk to your doctor before using ADVATE.
Pred začetkom uporabe zdravila ADVATE se posvetujte z zdravnikom.
Remove the blue cap from BAXJECT II / BAXJECT III.
Snemite modri pokrovček s pripomočka BAXJECT II / sistema BAXJECT III.
Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports MedDRA Standard System Organ Class
Pogostnost neželenih učinkov zdravila v kliničnih preskušanjih in v spontanih poročilih
- If you get any side effects talk to your doctor.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
INFORMATION IN BRAILLE ADVATE 1000
PODATKI V BRAILLOVI PISAVI ADVATE 1000
INFORMATION IN BRAILLE ADVATE 500
PODATKI V BRAILLOVI PISAVI ADVATE 500
NAME OF THE MEDICINAL PRODUCT ADVATE 500
IME ZDRAVILA ADVATE 500
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000
IME ZDRAVILA IN POT(I) UPORABE ADVATE 1000
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250
IME ZDRAVILA IN POT(I) UPORABE ADVATE 250
- ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 5 ml solvent are preassembled with the system for reconstitution).
- Zdravilo ADVATE s sistemom BAXJECT III: Vsako pakiranje vsebuje pripravljen sistem BAXJECT III v zapečatenem pretisnem omotu (viala s praškom in viala s 5 ml vehikla, sestavljeni v sistemu za rekonstitucijo raztopine).
Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Zdravilo lahko shranjujete pri sobni temperaturi (do 25 °C), največ enkrat za obdobje do šestih mesecev.
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADVATE.
Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom ADVATE, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 people); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 people).
Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno (pri manj kot 1 od 100 bolnikov).
The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.
Tako začasno odpravimo pomanjkanje faktorja VIII in zmanjšamo nagnjenost h krvavitvam.
Hyperhidrosis
Pogostnosta pruritus izpuščaj hiperhidroza
Inject intravenously.
Rekonstituirano raztopino injicirajte v veno.
Malaise
Preobčutljivost
ADVATE 250 IU powder and solvent for solution for injection ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection
ADVATE 250 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
ADRs specific to residues from the manufacturing process Of the 229 treated patients who were assessed for antibodies to Chinese hamster ovary (CHO) cell protein, 3 showed a statistically significant upward trend in titres, 4 displayed sustained peaks or transient spikes and one patient had both but no clinical symptoms.
Pri 3 bolnikih so opazili trend zviševanja titra, ki je bil statistično značilen, pri 4 dalj časa trajajoče ali prehodne vrhove titrov, pri enem bolniku pa oboje, vendar brez kliničnih simptomov.
- ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 2 ml solvent are preassembled with the system for reconstitution).
- Zdravilo ADVATE s sistemom BAXJECT III: Vsako pakiranje vsebuje pripravljen sistem BAXJECT III v zapečatenem pretisnem omotu (viala s praškom in viala s 2 ml vehikla, sestavljeni v sistemu za rekonstitucijo raztopine).
IV use
uporabo
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500
IME ZDRAVILA IN POT(I) UPORABE ADVATE 1500
- ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II).
- Zdravilo ADVATE s pripomočkom BAXJECT II: Vsako pakiranje vsebuje vialo s praškom, vialo s 5 ml vehikla in pripomoček za rekonstitucijo raztopine (BAXJECT II).
- ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II).
- Zdravilo ADVATE s pripomočkom BAXJECT II: Vsako pakiranje vsebuje vialo s praškom, vialo s 2 ml vehikla in pripomoček za rekonstitucijo raztopine (BAXJECT II).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000
IME ZDRAVILA IN POT(I) UPORABE ADVATE 3000
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2000 i.e. oktokoga alfa
Remove the blue cap from BAXJECT III.
Snemite modri pokrovček s sistema BAXJECT III.
How to store ADVATE
Shranjevanje zdravila ADVATE
Infections and infestations
V zvezi s kirurškimi posegi
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 i.e. oktokoga alfa
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500
IME ZDRAVILA IN POT(I) UPORABE ADVATE 500
The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.
Izberite hitrost injiciranja, ki jo bolnik dobro prenaša, ne sme pa biti večja od 10 ml/min.
Remove the blue cap from BAXJECT II.
Snemite modri pokrovček s pripomočka BAXJECT II.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve reakcija na mestu posega a)
Respiratory, thoracic and mediastinal disorders Dyspnoea
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja driska bolečine v zgornjem delu trebuha navzea
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3000 i.e. oktokoga alfa
Verify that the solvent transfer is complete.
Preverite, ali je iztekla vsa vsebina viale z vehiklom.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1500 i.e. oktokoga alfa
Factor VIII inhibition
Infekcijske in parazitske bolezni laringitis zaviranje faktorja VIII
Adverse reaction
Preventiva
Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII activity and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Posledice so lahko obsežne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano ali zaradi poškodbe ali kirurškega posega.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 i.e. oktokoga alfa
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e. oktokoga alfa
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 1500 i.e. oktokoga alfa, približno 750 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PRIPOMOČEK BAXJECT II)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250 IU powder for solution for injection Octocog alfa
IME ZDRAVILA IN POT(I) UPORABE ADVATE 250 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 people); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100
Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 3000 i.e. oktokoga alfa, približno 600 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 IU powder for solution for injection Octocog alfa
IME ZDRAVILA IN POT(I) UPORABE ADVATE 2000 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
Diarrhoea
Krvavitev
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
NALEPKA NA VIALI S PRAŠKOM (SISTEM BAXJECT III)
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije neugodje v prsih
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 2000 i.e. oktokoga alfa, približno 400 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
During the shelf life the powder vial may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
V času roka uporabnosti lahko vialo s praškom shranjujete pri sobni temperaturi (do 25 °C), in sicer enkrat za največ šest mesecev.
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 2000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 250 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Vsaka viala vsebuje nominalno 250 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Zdravilo ADVATE po rekonstituciji vsebuje približno 750 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Vsaka viala vsebuje nominalno 3000 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa
ADVATE 2000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa.
Vsaka viala vsebuje nominalno 1500 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa
ADVATE 250 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa.
Vsaka viala vsebuje nominalno 1000 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
EU/1/03/271/016
EU/1/03/271/006 EU/1/03/271/016
Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Vsaka viala vsebuje nominalno 2000 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 250 i.e. oktokoga alfa, približno 125 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
NALEPKA NA PRETISNEM OMOTU (SISTEM BAXJECT III)
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/016
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 1000 i.e. oktokoga alfa, približno 200 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 3000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Zdravilo ADVATE po rekonstituciji vsebuje približno 125 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection.
IME ZDRAVILA ADVATE 2000 i.e. prašek in vehikel za raztopino za injiciranje
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/008
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa
ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
EU/1/03/271/012
EU/1/03/271/002 EU/1/03/271/012
Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Vsaka viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000 IU powder for solution for injection Octocog alfa
IME ZDRAVILA IN POT(I) UPORABE ADVATE 3000 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection.
IME ZDRAVILA ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500 IU powder for solution for injection Octocog alfa
IME ZDRAVILA IN POT(I) UPORABE ADVATE 500 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/018
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection.
IME ZDRAVILA ADVATE 250 i.e. prašek in vehikel za raztopino za injiciranje
EU/1/03/271/020
EU/1/03/271/010 EU/1/03/271/020
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/012
ADVATE should be administered via the intravenous route.
Zdravilo ADVATE dajemo intravensko.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 1500 i.e. oktokoga alfa, približno 300 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/006
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection.
IME ZDRAVILA ADVATE 3000 i.e. prašek in vehikel za raztopino za injiciranje
EU/1/03/271/011
EU/1/03/271/001 EU/1/03/271/011
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000 IU powder for solution for injection Octocog alfa
IME ZDRAVILA IN POT(I) UPORABE ADVATE 1000 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
EU/1/03/271/017
EU/1/03/271/007 EU/1/03/271/017
During the shelf life the blister with the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
V času roka uporabnosti lahko pretisni omot z zdravilom shranjujete pri sobni temperaturi (do 25 °C), in sicer enkrat za največ šest mesecev.
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection.
IME ZDRAVILA ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje
You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
V redkih primerih lahko pride do anafilaktične reakcije (hude, nenadne alergijske reakcije) na zdravilo ADVATE, zato morate poznati zgodnje znake alergijske reakcije, kot so izpuščaj, koprivnica, urtike (majhne srbeče rdeče pike po koži), srbenje po vsem telesu, otekanje ustnic in jezika, težave z dihanjem, piskanje v pljučih, občutek tiščanja v prsih, splošno slabo počutje in omotica.
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa
ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/015
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection.
IME ZDRAVILA ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500 IU powder for solution for injection Octocog alfa
IME ZDRAVILA IN POT(I) UPORABE ADVATE 1500 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/017
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
EU/1/03/271/013
EU/1/03/271/003 EU/1/03/271/013
EU/1/03/271/015
EU/1/03/271/005 EU/1/03/271/015
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 250 i.e. oktokoga alfa, približno 50 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/005
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
ADVATE 3000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
Sodium chloride Histidine
Bolezni prebavil bruhanje pruritus izpuščaj hiperhidroza urtikarija
ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Zdravilo ADVATE po rekonstituciji vsebuje približno 400 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/014