FrancophonIA/ELRC3.0 huggingface dataset:
English: The joint survey drug utilisation final study report submitted by the MAHs, together with the joint database drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0003), complies with their obligation to conduct a drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Maltese: Ir-rapport tal-istudju finali dwar l-utilizzazzjoni tal-mediċina fl-istħarriġ konġunt sottomess mill-MAHs, flimkien mar-rapport tal-istudju finali dwar l-utilizzazzjoni tal-mediċina fid-database konġunt sottomess mill-MAHs bħala proċedura separata (EMEA/H/N/PSR/J/0003), hu konformi mal-obbligu tagħhom biex iwettqu studju tal-utilizzazzjoni tal-mediċina biex jikkaratterizzaw il-prattiċi tal-għoti tar-riċetta għallprodott mediċinali matul l-użu tipiku u kliniku fi gruppi rappreżentattivi ta' dawk li jagħtu riċetta, u biex jevalwaw ir-raġuni ewlenija għar-riċetta kif imposti matul il-proċedura ta' Artikolu 107i EMA/H/A107i/1357 għal prodotti li fihom cyproterone/ethinylestradiol.
English: Therefore, in view of available data regarding the joint survey drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0003), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Maltese: Għalhekk, abbażi tad-dejta disponibbli dwar ir-rapport tal-istudju finali dwar l-istħarriġ konġunt talutilizzazzjoni tal-mediċina fid-database konġunta, flimkien mar-rapport tal-istudju finali dwar lutilizzazzjoni tal-mediċina fid-database konġunta sottomess bħala proċedura separata (EMEA/H/N/PSR/J/0003), il-PRAC ikkunsidra li l-bidliet fil-kundizzjonijiet tal-awtorizzazzjoni għattqegħid fis-suq kienu ġġustifikati.
English: OTHER Bayer-Logo
Maltese: Bayer-Logo
English: Apply a tourniquet.
Maltese: Applika t-turnikett.
English: Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.
Maltese: Aktar parametri farmakokinetiċi ta' KOGENATE Bayer għall- injezzjoni bolus huma: żmien medju residenzjali [MRT (0-48)] ta' madwar 22 siegħa, u tneħħija ta' madwar 160 ml/h.
English: KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Maltese: KOGENATE Bayer fih livelli baxxi ta' polysorbate-80 bħala sustanza mhux attiva li hu magħruf li jżid ir-rata ta' estrazzjoni ta' di-(2-ethylhexyl)phthalate (DEHP) minn materjali magħmula minn polyvinyl chloride (PVC).
English: Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Maltese: Tneħħija medja fillinja bażi għal 14-il pazjent adult li kellhom interventi kirurġiċi maġġuri b'infużjoni kontinwa hija ta' 188 ml/siegħa li tikkorrispondi għal 3.0 ml/h/kg (firxa 1.6-4.6 ml/h/kg).
English: 100 % (1 IU/ml) 60 % (0.6 IU/ml) 40 % (0.4 IU/ml)
Maltese: IU/ml) 1.8 40% (0.4
English: If you have any questions about KOGENATE Bayer and compatible separate filters contact Bayer Pharma AG.
Maltese: Jekk għandek xi mistoqsijiet dwar KOGENATE Bayer u l-filtri kompatibbli separati kkuntattja Bayer Pharma AG.
English: 2 plasters
Maltese: 2 iġbajjar
English: This indicates that the system is activated (D).
Maltese: Dan jindika li s-sistema ġiet attivata (D).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Bayer Pharma AG 13342 Berlin
English: These compatible filters are luer adaptor-type of Polyacrylic housing with integrated filter element of a Polyamide screen of 5 - 20 micrometer mesh size.
Maltese: Dawn il-filtri kompatibbli huma tat-tip luer adapter magħmula minn qafas ta' Polyacrylic b'element għall-iffiltrar integrat magħmul minn xibka ta' Polyamide b'daqs tal-malja ta' 5-20 mikrometru.
English: 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.
Maltese: Fi studji kliniċi, KOGENATE Bayer intuża fil-kura ta' episodji ta' fsada f'37 pazjent li ma kinux ikkurati qabel (PUPs - previously untreated patients) u fi 23 pazjent pedjatriku kkurati b'mod minimu (MTPs - minimally treated patients, imfissra bħala li kellhom esponiment ta' ≤4 ijiem) b'FVIII:C < 2 IU/dl residwu.
English: • syringe plunger rod
Maltese: SIRINGA MIMLIJA LESTA
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with KOGENATE Bayer developed inhibitors within 20 exposure days.
Maltese: Ħamsa minn 37 (14%) pazjent PUP u 4 minn 23 (17%) pazjent MTP ikkurati
English: Repeat infusion every 8 to 24 hours until threat is resolved
Maltese: Irrepeti l-infużjoni kull 8 sa 24
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with KOGENATE Bayer (followed up to 75 exposure days).
Maltese: Fi studju wieħed ta' osservazzjoni, l-inċidenza ta' żvilupp ta' inibitur f'pazjenti li ma kinux ikkurati qabel li għandhom emofilija A severa kienet ta' 64/183 (37.7%) b'KOGENATE Bayer (segwiti sa 75 jum ta' esponiment).
English: KOGENATE Bayer can be infused by continuous infusion.
Maltese: Infużjoni kontinwa KOGENATE Bayer jista' jingħata permezz ta' infużjoni kontinwa.
English: KOGENATE Bayer is used for treatment and prophylaxis of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Maltese: KOGENATE Bayer huwa intiż għal kura u l-profilassi ta' fsada f'adulti, adolexxenti u tfal ta' kull età li għandhom l-emofilja A (nuqqas konġenitali tal-fattur VIII).
English: Remove protective cap from the vial (A) then clean the rubber stopper with a sterile swab (or use an antiseptic spray).
Maltese: Neħħi l-għatu protettiv mill-kunjett (A) imbagħad naddaf l-għant tal-lastku b'imsieħ sterili (jew uża sprej antisettiku).
English: Determine the point of injection and prepare antiseptically 14.
Maltese: Stabilixxi l-lok tal-injezzjoni u pprepara b'mod antisettiku.
English: One ml of KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Maltese: IU fih madwar 400 IU (1000 IU / 2,5 ml) ta' fattur VIII talkoagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni.
English: Use the venipuncture set provided as it contains an in-line filter.
Maltese: Uża l-apparat għat-titqib tal-vini pprovdut mal-prodott peress li fih filtru in-line.
English: PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below
Maltese: PUPs = pazjenti li ma ġewx ikkurati fil-passat PTPs = pazjenti li ġew ikkurati fil-passat
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 3000 IU.
Maltese: Tagħmir mediku għar-rikostituzzjoni u l-għoti huwa pprovdut ma' kull pakkett ta' KOGENATE Bayer 3000 IU.
English: INFORMATION IN BRAILLE KOGENATE Bayer 3000
Maltese: KOGENATE Bayer 3000
English: INFORMATION IN BRAILLE KOGENATE Bayer 1000
Maltese: Tużax KOGENATE Bayer 1000
English: One ml of KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Maltese: IU (250 IU / 2,5 ml) ta' fattur VIII talkoagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni.
English: • one vial plus Bio-Set device, containing powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper plus transfer device with protective cap [Bio-Set])
Maltese: Kull pakkett ta' KOGENATE Bayer fih: - kunjett wieħed flimkien mat-tagħmir Bio-Set li fih it-trab (10 ml, ħġieġ trasparenti tip1 kunjett magħluqa b'għatu griż tal-gomma tal-bromobutajl li ma fihx latex, flimkien ma' tagħmir li jitrasferixxi bl-għatu protettiv [Bio-Set]).
English: INFORMATION IN BRAILLE KOGENATE Bayer 500
Maltese: Tużax KOGENATE Bayer 500
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the integrated transfer device (Bio-Set).
Maltese: Trab ta' KOGENATE Bayer għandu jiġi rrikostitwit biss bis-solvent ipprovdut (2,5 ml ilma għallinjezzjonijiet) fis-siringa mimlija lesta u t-tagħmir li jitrasferixxi integrat (Bio-Set).
English: However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see sections 4.3 and 4.4).
Maltese: ammonti żgħar ħafna ta' proteina mill-ġrieden u mill-ħamster preżenti fil-preparazzjoni (ara sezzjoni 4.3 u 4.4).
English: • one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)
Maltese: - siringa waħda mimlija minn qabel b' 2,5 ml solvent (ċilindru trasparenti ta' tip 1 b'għotjien griżi tal-gomma tal-bromobutajl li ma fihomx latex)
English: INFORMATION IN BRAILLE KOGENATE Bayer 250
Maltese: Tużax KOGENATE Bayer 250
English: KOGENATE Bayer 3000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Maltese: KOGENATE Bayer 3000 IU fih il-Fattur VIII tal-koagulazzjoni humana (octagon alpha).
English: INFORMATION IN BRAILLE KOGENATE Bayer 2000
Maltese: Tużax KOGENATE Bayer 2000
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/007
Maltese: EU/1/00/143/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/009
Maltese: EU/1/00/143/009
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Maltese: KOGENATE Bayer 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/012
Maltese: EU/1/00/143/012
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) in the prefilled syringe and the integrated transfer device (Bio-Set).
Maltese: Trab ta' KOGENATE Bayer għandu jiġi rrikostitwit biss bis-solvent ipprovdut (5,0 ml ilma għallinjezzjonijiet) fis-siringa mimlija lesta u t-tagħmir li jitrasferixxi integrat (Bio-Set).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/008
Maltese: EU/1/00/143/008
English: 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.
Maltese: Kull pakkett ta' KOGENATE Bayer 3000 IU fih kunjett, u Siringa mimlija għal-lest bi planġer separat, kif ukoll adapter għall-kunjett, sett biex ittaqqab il-vina (għal injezzjoni ġo vina), żewġ imsielaħ sterili bl-alkoħol, żewġ imsielaħ xotti u żewġt iġbajjar.
English: • one pre-filled syringe with 5.0 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)
Maltese: - siringa waħda mimlija minn qabel b' 5,0 ml solvent (ċilindru trasparenti ta' tip 1 b'għotjien griżi tal-gomma tal-bromobutajl li ma fihomx latex)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/013
Maltese: EU/1/00/143/013
English: How to store KOGENATE Bayer 3000 IU
Maltese: Tużax KOGENATE Bayer 3000 IU
English: - Keep this leaflet.
Maltese: Formazzjoni ta'
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/004
Maltese: EU/1/00/143/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/006
Maltese: EU/1/00/143/006
English: After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Maltese: Distribuzzjoni u eliminazzjoni Wara l-għoti ta' KOGENATE Bayer, l-ogħla attività tal-fattur VIII naqset permezz ta' degradazzjoni esponenzjali f'żewġ fażijiet b'half-life terminali medja ta' madwar 15-il siegħa.
English: In extensive post-registration observational studies with KOGENATE Bayer, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors.
Maltese: Fi studji estensivi ta' osservazzjoni ta' wara r-reġistrazzjoni b'KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
English: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Maltese: Kull pakkett ta' KOGENATE Bayer fih: - kunjett wieħed bit-trab (10 ml tat-tip 1 tal-ħġieġ ċar b'għant griż tal-gomma tal-halogenobutyl li ma fihx latex, u siġill tal-aluminju). - siringa waħda mimlija lesta b' 5,0 ml solvent (ċilindru trasparenti ta' tip 1 b'għotjien griżi tal gomma tal-bromobutyl li ma fihomx latex)
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative).
Maltese: Fi studju kliniku li twettaq fuq pazjenti adulti b'emofilja A li kellhom operazzjoni maġġuri, intwera li KOGENATE Bayer jista' jintuża għall-infużjoni kontinwa fl-operazzjonijiet (qabel, matul u wara l operazzjoni).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/011
Maltese: EU/1/00/143/011
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Maltese: aktar fattur VIII rikombinanti tal-koagulazzjoni għandu mnejn jinnewtralizza l-inibitur u jippermetti li titkompla terapija effettiva klinika b'KOGENATE Bayer.
English: No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
Maltese: Ma sarux studji dwar il-possibbiltà ta' effetti mutaġeniċi minn KOGENATE Bayer peress li ma kien hemm ebda effett mutaġeniku potenzjali kemm in vitro kif ukoll in vivo minn prodott predeċessur ta'
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/005
Maltese: EU/1/00/143/005
English: Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37 °C).
Maltese: Saħħan kemm il-kunjett magħluqa u s-siringa b' idejk sakemm din tiġi għal temperatura konvenjenti (taqbizx 37 °C).
English: However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion.
Maltese: Madankollu, waqt studji in vitro, l-istabbilità kimika u fiżika waqt l-użu ntweriet għal 3 sigħat wara rrikostituzzjoni u wara d-dilwizzjoni għal 24 siegħa f'temperatura ta' 30°C f'boroż tal-PVC għall infużjoni kontinwa.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Maltese: sseħħ tiswija temporanjament tad-defiċjenza tal-fattur u tnaqqas it-tendenza ta' fsada.
English: Do not shake vial.
Maltese: Formazzjoni ta' Inibitur għal FVIII
English: Patients should be monitored for the development of factor VIII inhibitors.
Maltese: 3 sigħat fi studji in vitro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/010
Maltese: EU/1/00/143/010
English: Attach the syringe to the venipuncture set by screwing it clockwise and ensure that no blood enters the syringe (J).
Maltese: Jekk iseħħu reazzjonijiet allerġiċi u anafilattiċi, waqqaf l-injezzjoni / infużjoni minnufih.
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.
Maltese: Għall-profilassi kontra fsada li ddum għal żmien twil, f'pazjenti li għandhom emofilija A severa, id dożi tas-soltu huma ta' 20 sa 40 IU ta' KOGENATE Bayer għal kull kg ta' piż tal-ġisem f' intervalli ta' jumejn sa 3 ijiem.
English: Common: may affect up to 1 in 10 users
Maltese: Jekk inibitur huwa preżenti f'livelli li ma jaqbżux 10
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 3000 IU powder and solvent for solution for injection.
Maltese: Informazzjoni għall-utent KOGENATE Bayer 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni
English: How to store KOGENATE Bayer 3000 IU Contents of the pack and other information
Maltese: Kif jidher KOGENATE Bayer 3000 IU u l- kontenut tal-pakkett
English: What KOGENATE Bayer 3000 IU is and what it is used for What you need to know before you use KOGENATE Bayer 3000 IU How to use KOGENATE Bayer 3000 IU Possible side effects
Maltese: Kif għandek tuża KOGENATE Bayer 3000 IU Effetti sekondarji possibbli Kif taħżen KOGENATE Bayer 3000 IU
English: Infusion related febrile reaction (pyrexia)
Maltese: Dewmien tat-terapija (ġranet)
English: Read the package leaflet before use.
Maltese: IU waqt it-tqala u t-treddigħ mhux disponibbli.
English: This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Maltese: Din il-preparazzjoni ma fihiex il-fattur von Willebrand u għalhekk mhux indikata għal-kura tal-marda von Willebrand.
English: 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.
Maltese: Kull pakkett ta' KOGENATE Bayer 3000 IU fih kunjett bit-tagħmir li jitrasferixxi Bio-Set, u Siringa mimlija għal-lest bi planġer separat, kif ukoll sett biex ittaqqab il-vina (għal injezzjoni ġo vina), żewġ imsielaħ sterili bl-alkoħol, żewġ imsielaħ xotti u żewġt iġbajjar.
English: Take special care with KOGENATE Bayer 250 IU
Maltese: IU Tieqafx tuża KOGENATE Bayer 250
English: Take special care with KOGENATE Bayer 3000 IU
Maltese: Mediċini oħra u KOGENATE Bayer 3000 IU
English: How to use KOGENATE Bayer 1000 IU
Maltese: KOGENATE Bayer 1000
English: After reconstitution with the water for injection, each vial contains octocog alfa 400 IU/ml.
Maltese: Wara r-rikostituzzjoni blilma għall-injezzjoni, kull kunjett ikun fih 400 IU/ml ta' octocog alfa.
English: Take special care with KOGENATE Bayer 1000 IU
Maltese: Mediċini oħra u KOGENATE Bayer 1000
English: In situations where the venipuncture set provided cannot be used (e.g. when infusing into a peripheral or central line), a separate filter compatible with KOGENATE Bayer should be used.
Maltese: F'sitwazzjonijiet fejn ma' jistax jintuża l-apparat għat-titqib tal-vini (eż. meta l-infużjoni tingħata f'linja periferali jew ċentrali), għandu jintuża filtru separat kompatibbli ma' KOGENATE Bayer.
English: How to use KOGENATE Bayer 500 IU
Maltese: KOGENATE Bayer 500
English: Inhibitor Formation to FVIII (reported in PTPs in clinical trials and Post
Maltese: UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KOGENATE Bayer 3000 IU powder for solution for injection Recombinant coagulation factor VIII (octocog alfa) Intravenous use.
Maltese: KOGENATE Bayer 3000 IU trab għal soluzzjoni għall-injezzjoni Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: b) By continuous infusion Raise factor VIII activity presurgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/kg/h) adjusting according to patient's daily clearance and desired factor VIII levels for at least 7 days.
Maltese: Għolli l-attività ta' fattur VIII qabel l-intervent kirurġiku permezz ta' infużjoni bolus fil-bidu u segwi minnufih b'infużjoni kontinwa (f'IU/kg/h) u aġġusta skont ir-rata ta' tneħħija ta' kuljum tal-pazjent u l-livelli ta' fattur VIII mixtieqa almenu għal 7 ijiem
English: Take special care with KOGENATE Bayer 500 IU
Maltese: Mediċini oħra u KOGENATE Bayer 500
English: This summary was last updated in 02-2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2019.
English: Further information on Silapo can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/Silapo
Maltese: ema.europa.eu/en/medicines/human/EPAR/Silapo
English: Other information about Silapo:
Maltese: Informazzjoni oħra dwar Silapo:
English: Haemoglobin levels were maintained at around 11.4 g/dl in both groups.
Maltese: Il-livelli tal-emoglobina nżammu madwar 11.4 g/dl fiż-żewġ gruppi.
English: Silapo received a marketing authorisation valid throughout the EU on 18 December 2007.
Maltese: Silapo ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Diċembru 2007.
English: Silapo contains the active substance epoetin zeta and is a ‘biosimilar' medicine.
Maltese: Silapo fih is-sustanza attiva epoetina żeta u huwa “mediċina bijosimili”.
English: The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.
Maltese: Il-mediċina ta' referenza għal Silapo hija Eprex/Erypo, li fiha l-epoetina alfa.
English: Silapo, injected into a vein, was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a procedure for removing waste products from the blood).
Maltese: Silapo, injettat f'vina, kien effettiv daqs Eprex/Erypo biex jikkoreġi u jżomm l-għadd ta' ċelloli ħomor tad-demm f'żewġ studji ewlenin li involvew 922 pazjent li kellhom anemija assoċjata ma' insuffiċjenza kronika renali li kienu jeħtieġu emodijaliżi (proċedura għat-tneħħija ta' prodotti ta' skart mid-demm).
English: 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.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' żewġ studji li juru li Silapo injettat taħt il-ġilda huwa effettiva daqs mediċini epoetini oħra: studju wieħed involva 261 pazjent bil-kanċer li kienu qed jieħdu l-kimoterapija, u l-ieħor qabbel lil Silapo ma' Eprex/Erypo f' 462 pazjent b'anemija kkawżata minn problemi fil-kliewi.
English: Erythropoietin is produced by the kidneys.
Maltese: L-eritropojetina hija prodotta mill-kliewi.
English: Laboratory studies comparing Silapo with Eprex/Erypo have shown that the active substance in Silapo is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Silapo ma' Eprex/Erypo wrew li s-sustanza attiva f'Silapo hija simili ħafna għal dik f'Eprex/Erypo f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Silapo?
Maltese: X'inhuma r-riskji assoċjati ma' Silapo?
English: Silapo (epoetin zeta)
Maltese: Kif jintuża Silapo?
English: This means that Silapo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Silapo huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: • 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.
Maltese: pazjenti li se jsirilhom intervent kirurġiku, inkluż intervent kirurġiku ortopediku maġġuri li għandhom problemi kardjovaskulari serji (fil-qalb u fil-vażu) inkluż attakk tal-qalb reċenti jew puplesija.