natgillin/translations-raw huggingface dataset:
How much KOGENATE Bayer 250 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Koliko zdravila KOGENATE Bayer 250 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KOGENATE Bayer 2000 IU powder for solution for injection Recombinant coagulation factor VIII (octocog alfa) Intravenous use.
IME ZDRAVILA IN POT(I) UPORABE KOGENATE Bayer 2000 i.e. prašek za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
Inspect visually for particulate matter and discoloration prior to administration.
Pred uporabo zdravila raztopino vizualno preglejte,
KOGENATE Bayer 2000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Zdravilo KOGENATE Bayer 2000 i.e. vsebuje zdravilno učinkovino humani rekombinantni koagulacijski faktor VIII (oktokog alfa)..
KOGENATE Bayer 3000 IU contains sodium This medicinal product contains less than 23 mg sodium per vial, i.e. essentially “sodium-free”.
Zdravilo KOGENATE Bayer 3000 i.e. vsebuje natrij To zdravilo vsebuje manj kot 23 mg natrija na vialo, kar v bistvu pomeni "brez natrija".
KOGENATE Bayer 2000 IU contains sodium This medicinal product contains less than 23 mg sodium per vial, i.e. essentially “sodium-free”.
Zdravilo KOGENATE Bayer 2000 i.e. vsebuje natrij To zdravilo vsebuje manj kot 23 mg natrija na vialo, kar v bistvu pomeni "brez natrija".
In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
minimally treated patient, kar pomeni, da so bili izpostavljeni 4 dni ali manj) z rezidualnim faktorjem VIII: c < 2 i.e./dl.
How much KOGENATE Bayer 500 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Koliko zdravila KOGENATE Bayer 500 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
How much KOGENATE Bayer 3000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Koliko zdravila KOGENATE Bayer 3000 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
Each pack of KOGENATE Bayer 500 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 500 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
KOGENATE Bayer 1000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Zdravilo KOGENATE Bayer 1000 i.e. vsebuje zdravilno učinkovino humani rekombinantni koagulacijski faktor VIII (oktokog alfa).
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 500 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Each pack of KOGENATE Bayer 250 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 250 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 250 IU.
Pred začetkom uporabe zdravila KOGENATE Bayer 250 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 500 IU.
Pred začetkom uporabe zdravila KOGENATE Bayer 500 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/007
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/007
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/009
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/009
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KOGENATE Bayer 1000 IU powder for solution for injection Recombinant coagulation factor VIII (octocog alfa) Intravenous use.
IME ZDRAVILA IN POT(I) UPORABE KOGENATE Bayer 1000 i.e. prašek za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
How much KOGENATE Bayer 2000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Koliko zdravila KOGENATE Bayer 2000 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/011
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/011
Package Leaflet: Information for the user KOGENATE Bayer 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Navodilo za uporabo KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/013
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/013
If you want to stop using KOGENATE Bayer 2000 IU Do not stop using KOGENATE Bayer without consulting your doctor.
Ne prenehajte uporabljati zdravila KOGENATE Bayer, ne da bi se prej posvetovali z vašim zdravnikom.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/010
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/010
MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/004
PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below
predhodno nezdravljenih bolnikih in 23 minimalno zdravljenih pediatričnih bolnikih (MTP
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Navodilo za uporabo KOGENATE Bayer 2000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
How much KOGENATE Bayer 1000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Koliko zdravila KOGENATE Bayer 1000 i.e. morate uporabiti in kako pogosto je odvisno od več dejavnikov, npr. vaše telesne mase, stopnje motnje strjevanja krvi, mesta krvavitve in kako obsežna je krvavitev, prisotnosti inhibitorjev faktorja VIII, titra inhibitorjev ter od želene aktivnosti faktorja VIII.
KOGENATE Bayer 1000 IU contains sodium This medicinal product contains less than 23 mg sodium per vial, i.e. essentially “sodium-free”.
Zdravilo KOGENATE Bayer 1000 i.e. vsebuje natrij To zdravilo vsebuje manj kot 23 mg natrija na vialo, kar v bistvu pomeni "brez natrija".
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 2000 IU.
Pred začetkom uporabe zdravila KOGENATE Bayer 2000 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Each pack of KOGENATE Bayer 3000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 3000 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Package Leaflet: Information for the user KOGENATE Bayer 500 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Navodilo za uporabo KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 1000 IU.
Pred začetkom uporabe zdravila KOGENATE Bayer 1000 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
Each pack of KOGENATE Bayer 1000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 1000 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
Each pack of KOGENATE Bayer 2000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 2000 i.e. vsebuje vialo s priborom Bio-Set za prenos vehikla, napolnjeno injekcijsko brizgo z ločenim batom brizge ter pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila KOGENATE Bayer 2000 i.e.. Imetnik dovoljenja za promet Bayer Pharma AG 13342 Berlin
Package Leaflet: Information for the user KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Navodilo za uporabo KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
Only the provided components (powder vial with Bio-Set device, pre-filled syringe containing solvent and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Če se uporabi drug pribor, je lahko zdravljenje zaradi adsorpcije humanega rekombinantnega faktorja strjevanja krvi VIII na notranje stene nekaterih priborov za injiciranje neuspešno.
Do not pass it on to others.
Ne uporabljajte po tem datumu.
1 vial with Bio-Set device with powder for solution for injection.
Bio-Set, z vehiklom napolnjeno injekcijsko brizgo in pribor za vensko punkcijo).
NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 1000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Navodilo za uporabo KOGENATE Bayer 1000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
How to store KOGENATE Bayer 3000 IU
Shranjevanje zdravila KOGENATE Bayer 3000 i.e.
How to store KOGENATE Bayer 500 IU
Shranjevanje zdravila KOGENATE Bayer 500 i.e.
Do not use KOGENATE Bayer 2000 IU
Če želite prenehati uporabljati zdravilo KOGENATE Bayer 2000 i.e.
How to store KOGENATE Bayer 1000 IU
Shranjevanje zdravila KOGENATE Bayer 1000 i.e.
The speed of administration should be based on the patient's comfort, but should not be faster than 2 ml/min maximum rate of injection.
Hitrost vbrizgavanja naj bo prilagojena bolnikovemu počutju, vendar naj injiciranje ne bo hitrejše kot
How to store KOGENATE Bayer 250 IU
Shranjevanje zdravila KOGENATE Bayer 250 i.e.
Each pack of KOGENATE Bayer 3000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 3000 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Each pack of KOGENATE Bayer 500 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 500 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Other medicines and KOGENATE Bayer 3000 IU Interactions with other medicines are not known.
Druga zdravila in zdravilo KOGENATE Bayer 3000 i.e.
Each pack of KOGENATE Bayer 2000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 2000 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Each pack of KOGENATE Bayer 250 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 250 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Warnings and precautions Talk to your doctor or pharmacist before using KOGENATE Bayer 3000 IU.
Pred začetkom uporabe zdravila KOGENATE Bayer 3000 i.e. se posvetujte s svojim zdravnikom ali farmacevtom.
Each pack of KOGENATE Bayer 1000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Eno pakiranje zdravila KOGENATE Bayer 1000 i.e. vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo, dva alkoholna tampona, dva suha tampona in dva obliža.
Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Za rekonstitucijo in dajanje zdravila se sme uporabiti samo priloženi pribor (vialo s praškom, z vehiklom napolnjeno injekcijsko brizgo, adapter za vialo in pribor za vensko punkcijo).
This summary was last updated in 02-2019.
Povzetek je bil nazadnje posodobljen 02-2019.
This means that Silapo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Silapo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silapo?
Silapo received a marketing authorisation valid throughout the EU on 18 December 2007.
Za zdravilo Silapo je bilo 18. decembra 2007 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
The iron levels of all patients should be checked and iron supplements given if necessary.
Pri vseh bolnikih je treba preveriti raven železa in jim po potrebi predpisati dodatke železa.
After that, the two groups switched to receiving the other medicine for a further 12 weeks.
Zatem sta obe skupini bolnikov za nadaljnjih 12 tednov prešli na zdravljenje z drugim zdravilom.
Further information on Silapo can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/Silapo
Nadaljnje informacije o zdravilu Silapo so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/Silapo
• patients who cannot receive medicines to prevent blood clots;
bolnikih, ki ne morejo prejemati zdravil za preprečevanje krvnih strdkov;
An overview of Silapo and why it is authorised in the EU
Pregled zdravila Silapo in zakaj je odobreno v EU
What is Silapo and what is it used for?
Kaj je zdravilo Silapo in za kaj se uporablja?
Haemoglobin levels were maintained at around 11.4 g/dl in both groups.
Ravni hemoglobina so bile v obeh skupinah bolnikov ohranjene na približno 11,4 g/dl.
For these patients, the lowest dose that controls the symptoms well enough should be used.
Pri teh bolnikih je treba uporabiti najnižji odmerek, ki še zagotavlja dovolj dober nadzor nad simptomi.
During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment.
V zadnjih štirih tednih študije so bile ravni hemoglobina okoli 11,6 g/dl, kar pomeni, da so narasle z ravni okoli 8,0 g/dl pred zdravljenjem.
The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure.
Najpogostejša neželena učinka zdravila Silapo (ki se lahko pojavita pri več kot 1 bolniku od 100) sta glavobol in povišan krvni tlak.
Why is Silapo authorised in the EU?
Zakaj je zdravilo Silapo odobreno v EU?
What benefits of Silapo have been shown in studies?
Kakšne koristi je zdravilo Silapo izkazalo v študijah?
Silapo must not be used in the following groups:
Zdravilo Silapo se ne sme uporabljati pri naslednjih skupinah bolnikov:
As for all medicines, data on the use of Silapo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Silapo stalno spremljajo.
Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Silapo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Silapo?
Kakšna tveganja so povezana z zdravilom Silapo?
For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Silapo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• patients with hypertension (high blood pressure) that is not controlled;
bolnikih z nenadzorovano hipertenzijo (visokim krvnim tlakom);
Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Epoetin zeta se uporablja tudi pred kirurškimi posegi za povečanje števila rdečih krvnih celic in kot pomoč pri zmanjšanju posledic izgube krvi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Silapo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
• patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
bolnikih, ki so tik pred kirurškim posegom, vključno pred zahtevnejšim ortopedskim kirurškim posegom, in imajo resne kardiovaskularne (srčnožilne) težave, vključno z nedavnim srčnim napadom ali možgansko kapjo.
In these cases, epoetin zeta is used to increase red blood cell counts.
V teh primerih se za povečanje števila rdečih krvnih celic uporablja epoetin zeta.
The dose, how often it is given and how long it is used for also depend on why Silapo is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Odmerek, pogostost injiciranja in trajanje uporabe zdravila Silapo so odvisni od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range.
Pri bolnikih z odpovedjo ledvic ali mielodisplastičnimi sindromi ali pri tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati znotraj priporočenega območja.
All of the patients in the second study had received treatment with Eprex/Erypo for at least 3 months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks.
Vsi bolniki v drugi študiji so bili vsaj tri mesece zdravljeni z zdravilom Eprex/Erypo, preden so za 12 tednov bodisi prešli na zdravilo Silapo bodisi ostali pri zdravljenju z zdravilom Eprex/Erypo.
The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.
Referenčno zdravilo za zdravilo Silapo je zdravilo Eprex/Erypo, ki vsebuje epoetin alfa.
The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Podjetje je predstavilo tudi rezultate dveh študij, ki sta pokazali, da je zdravilo Silapo, injicirano v podkožje, enako učinkovito kot druga zdravila, ki vsebujejo epoetin: v eni študiji je sodelovalo 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi študiji pa so zdravilo Silapo primerjali z zdravilom Eprex/Erypo pri 462 bolnikih s slabokrvnostjo kot posledico težav z ledvicami.
• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
bolnikih, pri katerih se je po zdravljenju z epoetinom razvila aplazija rdečih krvnih celic (zmanjšano ali zaustavljeno tvorjenje rdečih krvnih celic);