qanastek/EMEA-V3 huggingface dataset:
Place the vial on a rigid, non-slip surface and hold it firmly with one hand.
Qiegħed il- kunjett fuq wiċċ riġidu u li ma jiżloqx u żommha soda b’ id waħda.
Then, strongly press down the fingerplate near the syringe tip using your thumb and index finger (C) until the finger plate meets the top edge of the Bio-Set.
Imbagħad agħfas bis- saħħa `l isfel il- pjanċa tas- saba ’ ħdejn it- tarf tas- siringa billi tuża l- behem u s- saba ’ iż- żgħir (C) sakemm il- pjanċa tas- saba tmiss it- tarf ta ’ fuq tal- Bio- Set.
This indicates that the system is activated (D).
Dan jindika li s- sistema ġiet attivata (D).
Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).
Ehmeż il- planġer mas- siringa billi tilwiha mat- tapp tal- gomma (E).
Inject the solvent by slowly pushing the syringe’ s plunger down (F).
Injetta s- solvent billi bil- mod tniżżel il- planġer tas- siringa l- isfel (F).
Dissolve the powder by gently swirling the vial.
Ħoll it- trab billi ddawwar bil- mod il- kunjett.
Do not shake the vial!
Theżżizhiex il- kunjett!
Ensure that the powder is completely dissolved before use.
Iżgura li t- trab huwa maħlul kollu.
Do not use solutions that contain visible particles or that are cloudy (G).
Tużax soluzzjoni li fih jidher il- frak jew li jkun mdardar( G).
Invert vial/ syringe and transfer the solution into syringe by drawing the plunger out slowly and smoothly (H).
Dawwar il- kunjett/ siringa u ttrasferixxi soluzzjoni għal ġos- siringa billi imbotta il- planġer bil - mod u bis- sod (H).
Ensure that the entire contents of the vial are drawn into the syringe.
Iżgura li l- kontenut kollu tal- kunjett huwa miġbud fis- siringa.
If you need more than one dose, reconstitute the desired amount of product repeating steps 2. - 9.
Jekk għandek bżonn ta 'aktar minn doża waħda, irrikostitwixxi l- ammont mixtieq tal- prodott billi tirrepeti l- istadji 2 - 9.
Use separate syringes!
Uża siringi separati!
11.
11 Applika t- turnikett.
Determine the point of injection, clean the skin with an alcohol swab, and prepare site of injection antiseptically as advised by your doctor.
Istabilixxi s- sit tat- tilqima u naddaf il- ġilda bl- msiħ tal- alkoħol u pprepara l - lok tat- tilqima b' mod antisettiku kif irrakomandalek it- tabib tiegħek.
Puncture the vein and secure the venipuncture set with a plaster.
Taqqab il- vina, u qiegħed is- sett li jtaqqab il- vina sew bi ġbajra.
Unscrew the syringe to disconnect the vial (I).
Ħoll is- siringa biex tiskonnettja l- kunjett (I).
Attach the syringe to the venipuncture set by screwing it clockwise and ensure that no blood enters the syringe (J).
Ehmeż is- siringa mas- sett li jtaqqab il- vina billi tilwiha favur l- arloġġ u żżgura li ma jkunx hemm demm li jidħol fis- siringa (J).
Remove tourniquet!
Neħħi t- turnikett!
Inject the solution intravenously over several minutes, keeping an eye on the position of the needle.
Injetta s- taħlita soluzzjoni ġol- vina fuq medda ta ’ ħin, waqt li żżomm għajnejk fuq il- pożizzjoni tal- labra.
The rate of administration should be determined by the patient’ s comfort (maximum rate of injection:
Ir- rata ta ’ l- għotja għandu jiġi stabbilit skond il- qagħda tal- pazjent (rata massima ta 'infużjoni:
If a further dose is required, remove the empty syringe by turning it anti-clockwise.
Jekk ikun hemm bżonn li doża oħra tiġi mogħtija, neħħi s- siringa l- vojta billi ddawarha kontra d- direzzjoni ta ’ l- arloġġ.
Connect the newly prepared syringe.
Ikkonnettja s- siringa ppreparata l- gdida.
Hold a swab firmly over the injection site on the outstretched arm for approx.
Jekk l- ebda doża oħra ma hija meħtieġa, neħħi s- sett tat- titqib minn ġol- vina u s- siringa, Żomm l- msiħ sew fuq il- post ta ’ l- injezzjoni fuq d- driegħ stirat għal madwar 2 minuti.
Your doctor will calculate the dose of KOGENATE Bayer 250 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta '- KOGENATE Bayer 250 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
frequency of administration according to the clinical effectiveness in your individual case.
It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'KOGENATE Bayer 250 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
Although dosage can be estimated by the calculations presented above, it is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Għalkemm id- doża tista 'tiġi stmata fuq il- kalkulazzjonijiet mogħtija hawn fuq, huwa rakkomandat bil - qawwa li jsiru testijiet xierqa fil- laboratorju tal- plażma f' intervalli xierqa sabiex jiġi żgurat li livelli tal- fattur VIII ikunu ġew milħuqa u miżmuma.
175 If you have the impression that the effect of KOGENATE Bayer 250 IU is too strong or too weak, talk to your doctor.
175 Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 250 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Patients with inhibitors If you have been informed by your doctor that you have developed factor VIII inhibitors you will possibly be required to use a larger amount of KOGENATE Bayer than previously to control a bleeding.
Pazjenti bl- inibituri Jekk ġejt infurmat mit- tabib tieghek li żviluppajt l- inibituri tal- fatturi VIII għandek mnejn ikollok bżonn ta 'ammont akbar ta' KOGENATE Bayer minn qabel biex tikkontrolla l- fsada.
The rate of administration should be determined by the patient’ s comfort level (maximal rate of injection:
Ir- rata ta ’ l- għotja għandha tiġi stabbilita skond kif iħossu l- pazjent (l- ogħla rata ta ’ l- injezzjoni:
176 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
176 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
If allergic or anaphylactic reactions occur, the injection/ infusion should be stopped immediately.
Jekk iseħħu reazzjonijiet allerġiċi u anafilattiċi, waqqaf l- injezzjoni / infużjoni minnufih.
Do not refrigerate the solution after reconstitution.
Tista 'żżomm il- prodott fil- pakkett fit- temperatura tal- kamra (sa 25°C) għal perjodu wieħed sa 3 xhur; F’ dan il- każ, il- prodott jiskadi fl- aħħar ta ’ perjodu tat- 3 xhur; għandek tinnota d- data ta ’ meta jiskadi ġdida fil- kaxxa ta ’ barra. Tagħmilx is- soluzzjoni rikostitwita fil- friġġ.
This product is for single use only.
Dan il- prodott qiegħed biex jintuża darba biss.
Do not use KOGENATE Bayer 250 IU after the expiry date which is stated on labels and cartons.
177 M' għandekx tuża KOGENATE Bayer 250 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
177 Do not use KOGENATE Bayer 250 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 250 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
178 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
178 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
179 PACKAGE LEAFLET:
179 FULJETT TA 'TAGĦRIF:
KOGENATE Bayer 500 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 500 IU Trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
The vial with powder for solution for injection nominally contains 500 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 500 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 200 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall- injezzjoni), kull kunjett ikun fih 200 IU/ ml.
KOGENATE Bayer 500 IU is used for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
KOGENATE Bayer 500 IU huwa intiż għal kura u l- profilassi tal- fsada f 'pazjenti li għandhom l - emofilja A (nuqqas konġenitali tal- fattur 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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 500 IU fih kunjett bit- tagħmir li jitrasferixxi Bio- Set, u siringa mimlija lesta bi planġer separat, kif ukoll sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
180 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 500 IU is sufficient to reach and maintain adequate factor VIII levels.
180 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 500 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
Use only the medical devices (powder vial with Bio-Set device, pre- filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 500 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett (kunjett tat- trab mat- tagħmir tal- Bio- Set, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 500 IU.
Your doctor will calculate the dose of KOGENATE Bayer 500 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta '- KOGENATE Bayer 500 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
frequency of administration according to the clinical effectiveness in your individual case.
It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'KOGENATE Bayer 500 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
183 If you have the impression that the effect of KOGENATE Bayer 500 IU is too strong or too weak, talk to your doctor.
183 Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 500 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
184 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
184 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
Do not use KOGENATE Bayer 500 IU after the expiry date which is stated on labels and cartons.
185 M' għandekx tuża KOGENATE Bayer 500 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
185 Do not use KOGENATE Bayer 500 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 500 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
186 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
186 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
187 PACKAGE LEAFLET:
187 FULJETT TA 'TAGĦRIF:
KOGENATE Bayer 1000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 1000 IU Trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
The vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 1000 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 400 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall- injezzjoni), kull kunjett ikun fih 400 IU/ ml.
KOGENATE Bayer 1000 IU is used for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
KOGENATE Bayer 1000 IU huwa intiż għal kura u l- profilassi tal- fsada f 'pazjenti li għandhom l - emofilja A (nuqqas konġenitali tal- fattur VIII).
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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 1000 IU fih kunjett bit- tagħmir li jitrasferixxi Bio- Set, u siringa mimlija lesta bi planġer separat, kif ukoll sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
188 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 1000 IU is sufficient to reach and maintain adequate factor VIII levels.
188 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 1000 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
Use only the medical devices (powder vial with Bio-Set device, pre- filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 1000 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett (kunjett tat- trab mat- tagħmir tal- Bio- Set, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 1000 IU.
Your doctor will calculate the dose of KOGENATE Bayer 1000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta '- KOGENATE Bayer 1000 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
This will usually be in the range of 20 to 60 IU of octocog alfa per kg of body weight, administered at intervals of 2 to 3 days.
Din ġenerlament tkun fuq firxa ta 'bejn 20 sa 60 IU ta' octocog alfa kull kg ta 'piż tal- ġisem, mogħti f' intervalli ta 'jumejn sa 3 ijiem.
191 If you have the impression that the effect of KOGENATE Bayer 1000 IU is too strong or too weak, talk to your doctor.
191 Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 1000 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
192 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
192 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
Do not use KOGENATE Bayer 1000 IU after the expiry date which is stated on labels and cartons.
193 M' għandekx tuża KOGENATE Bayer 1000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
193 Do not use KOGENATE Bayer 1000 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 1000 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
194 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
194 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
195 PACKAGE LEAFLET:
195 FULJETT TA 'TAGĦRIF:
KOGENATE Bayer 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 2000 IU Trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
What KOGENATE Bayer 2000 IU is and what it is used for 2.
X' inhu KOGENATE Bayer 2000 IU u għalxiex jintuża 2.
Before you use KOGENATE Bayer 2000 IU 3.
Qabel ma tieħu KOGENATE Bayer 2000 IU 3.
How to use KOGENATE Bayer 2000 IU 4.
Kif għandek tieħu KOGENATE Bayer 2000 IU 4.
How to store KOGENATE Bayer 2000 IU 6.
Kif taħżen KOGENATE Bayer 2000 IU 6.
WHAT KOGENATE Bayer 2000 IU IS AND WHAT IT IS USED FOR
X' INHU KOGENATE Bayer 2000 IU U GĦALXIEX JINTUŻA
The vial with powder for solution for injection nominally contains 2000 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 2000 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).
KOGENATE Bayer 2000 IU is used for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
KOGENATE Bayer 2000 IU huwa intiż għal kura u l- profilassi tal- fsada f 'pazjenti li għandhom l - emofilja A (nuqqas konġenitali tal- fattur VIII).
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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 2000 IU fih kunjett bit- tagħmir li jitrasferixxi Bio- Set, u siringa mimlija lesta bi planġer separat, kif ukoll sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
BEFORE YOU USE KOGENATE Bayer 2000 IU
QABEL MA TIEĦU KOGENATE Bayer 2000 IU
Do not use KOGENATE Bayer 2000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of KOGENATE Bayer 2000 IU.
Tużax KOGENATE Bayer 2000 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal- ġurdien jew għal proteini tal- ħemster jew għal xi wieħed mis- sustanzi l- oħra ta 'KOGENATE Bayer 2000 IU.
Take special care with KOGENATE Bayer 2000 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction).
Oqgħod attent ħafna b' KOGENATE Bayer 2000 IU billi hemm ċans rari li jista jkollok reazzjoni anafilattika (reazzjoni allerġika f' daqqa u serja).
If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to KOGENATE Bayer 2000 IU.
Jekk int tħoss għafsa fis- sider, sturdamenti, tħossok dgħajjef jew ma tiflaħx, tħossok stordut waqt li int bil- wieqfa, jista 'jkun li qed tbati minn reazzjoni allerġika għal KOGENATE Bayer 2000 IU.
196 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 2000 IU is sufficient to reach and maintain adequate factor VIII levels.
196 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 2000 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
If your bleeding is not being controlled with KOGENATE Bayer 2000 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' KOGENATE Bayer 2000 IU, ikkonsulta mat- tabib tiegħek minnufih.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer 2000 IU during pregnancy and breast-feeding is not available.
Tqala u Treddigħ Minħabba każijiet rari ta ’ emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ KOGENATE Bayer 2000 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Important information about some of the ingredients of KOGENATE Bayer 2000 IU This medicinal product contain less than 1 mmol sodium (23 mg) per vial, i. e. essentially “ sodium- free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ KOGENATE Bayer 2000 IU Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull kunjett, i. e essenzjalment huwa “ ħieles mis- sodju ”.
HOW TO USE KOGENATE Bayer 2000 IU
KIF GĦANDEK TIEĦU KOGENATE Bayer 2000 IU
KOGENATE Bayer 2000 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 2000 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices (powder vial with Bio-Set device, pre- filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 2000 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett (kunjett tat- trab mat- tagħmir tal- Bio- Set, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 2000 IU.
KOGENATE Bayer 2000 IU must not be mixed with other infusion solutions.
KOGENATE Bayer 2000 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
The amount of KOGENATE Bayer 2000 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the amount of factor VIII inhibitors that you may have and the factor VIII level required.
L- ammont ta ’ KOGENATE Bayer 2000 IU li għandek tuża jiddependi fuq ħafna fatturi bħal piż tal - ġisem, kemm hija severa l- emofilja, kemm hi kbira u minn fejn hi l- fsada, l- għadd ta ’ sustanzi inibituri tal- fattur VIII li jista ’ jkollok, u l- livell tal- fattur VIII meħtieġ.
Your doctor will calculate the dose of KOGENATE Bayer 2000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta '- KOGENATE Bayer 2000 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
Your doctor should always adapt the amount of KOGENATE Bayer 2000 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case.
It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'KOGENATE Bayer 2000 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
If you are using KOGENATE Bayer 2000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża KOGENATE Bayer 2000 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d- doża għalik.
199 If you have the impression that the effect of KOGENATE Bayer 2000 IU is too strong or too weak, talk to your doctor.
199 Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 2000 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
KOGENATE Bayer 2000 IU should be injected intravenously over several minutes.
KOGENATE Bayer għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
Your doctor will tell you, how often and at what intervals KOGENATE Bayer 2000 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm KOGENATE Bayer 2000 IU għandu jiġi meħud.
Usually, the substitution therapy with KOGENATE Bayer 2000 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' KOGENATE Bayer 2000 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more KOGENATE Bayer 2000 IU than you should:
Jekk tieħu aktar KOGENATE Bayer 2000 IU milli suppost għandek:
If you have used more KOGENATE Bayer 2000 IU than you should, please inform your doctor.
Jekk tuża aktar KOGENATE Bayer 2000 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use KOGENATE Bayer 2000 IU: • Proceed with the next administration immediately and continue at regular intervals as advised by your doctor. • Do not take a double dose to make up for a forgotten doses.
Jekk tinsa tieħu KOGENATE Bayer 2000 IU: • Kompli bl- għotja li jmiss minnufih u ssokta f' intervalli regolari kif rakkomandat mit- tabib tiegħek • M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using KOGENATE Bayer 2000 IU Do not stop using KOGENATE Bayer 2000 IU without consulting your doctor.
Jekk tieqaf tieħu KOGENATE Bayer 2000 IU Tieqafx tieħu KOGENATE Bayer 2000 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, KOGENATE Bayer 2000 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, KOGENATE Bayer 2000 IU jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In rare cases, you may notice any of the following side effects after administration of KOGENATE Bayer 2000 IU: • rash/ itchy rash, local reactions at the injection site (e. g. burning sensation, temporary redness) • hypersensitivity reactions (e. g. tightness of the chest/ general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) • unusual taste in the mouth • fever.
F' każijiet rari, tista tinnota xi wieħed mill- effetti oħra li jista jkollu li ġejjin wara l- għotja ta 'KOGENATE Bayer 2000 IU: • raxx/ ħakk tal- ġilda, reazzjonijiet fil post ta ’ l- injezzjoni (eż. ħruq, eritema temporanja) • reazzjonijiet ta' sensittività eċċessiva (eż. għafsa tas- sider/ tħossok ma tiflaħx, sturdament u dardir u pressjoni tad- demm kemmxejn baxxa, li tista 'tagħmlek dgħajjef waqt li tkun bil - wieqfa) • togħma mhux tas- soltu fil- ħalq • deni.
200 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
200 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
HOW TO STORE KOGENATE Bayer 2000 IU
KIF TAĦŻEN KOGENATE Bayer 2000 IU
Do not use KOGENATE Bayer 2000 IU after the expiry date which is stated on labels and cartons.
201 M' għandekx tuża KOGENATE Bayer 2000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
201 Do not use KOGENATE Bayer 2000 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 2000 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
What KOGENATE Bayer 2000 IU contains
X’ fih KOGENATE Bayer 2000 IU
What KOGENATE Bayer 2000 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
KOGENATE Bayer 2000 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
KOGENATE Bayer 2000 IU jiġi bħala trab u solvent għall- soluzzjoni għal injezzjoni u huwa trab xott jew kejk ta ’ lewn bajdani li jkanġi ftit fl- isfar.
Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 2000 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ KOGENATE Bayer 2000 IU.
202 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
202 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
203 PACKAGE LEAFLET:
203 FULJETT TA 'TAGĦRIF:
The vial with powder for solution for injection nominally contains 250 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 250 IU octocog alfa (IU tfisser International Units - Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 100 IU/ ml.
Wara li jiġi rikostitwiti bil- volum xieraq ta 'solvent (ilma għall- injezzjonijiet), kull kunjettkunjett ikun fih 100 IU/ ml octocog alfa.
Pharmacotherapeutic group: blood coagulation factor VIII (ATC-Code B02B D02).
Il- Fattur VIII tal- koagulazzjoni tad- demm (Kodiċi ATC B02B D02).
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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 250 IU fih kunjett, u siringa mimlija lesta bi planġer separat, kif ukoll adapter għall- kunjett, sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
The vial contains a dry white to slightly yellow powder or cake.
Il- kunjett fiha trab niexef abjad li jkanġi daqsxejn fl- isfar, jew kejk.
The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial.
Is- siringa mimlija lesta fiha l- ilma għall- injezzjoni li għandu jintuża biex jirrikostitwixxi l- kontenut tal- kunjett.
204 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 250 IU is sufficient to reach and maintain adequate factor VIII levels.
204 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 250 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
KOGENATE Bayer 250 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 250 IU huwa intiż għall- użut ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices (vial adapter, pre-filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 250 IU.
Uża biss it- tagħmir mediku għar- rikostituzzjoni u l- għoti pprovduti f’ kull pakkett (adapter għall- kunjett, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 250 IU.
If a package is opened or damaged, do not use this medical device.
Jekk il- pakkett ikun miftuħ jew bil- ħsara dan it- tagħmir m’ għandux jintuża.
Follow the directions given by your doctor closely and use the instructions below as a guide:
Segwi l- istruzzjonijiet mogħtija mit- tabib tiegħek b 'attenzjoni u uża l- istruzzjonijiet t' hawn isfel bħala gwida:
Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37 °C).
Saħħan kemm il- kunjett magħluqa u s- siringa b 'idejk sakemm din tiġi għal temperatura konvenjenti (taqbizx 37 °C).
Remove protective cap from the vial (A) then clean the rubber stopper with a sterile swab (or use an antiseptic spray).
Neħħi l- għatu protettiv mill- kunjett (A) imbagħad naddaf l- għant tal- lastku b’ imsieħ sterili (jew uża sprej antisettiku).
Place product vial on a firm, non-skid surface.
Qiegħed il- prodott fuq wiċċ nadif u li ma jiżloqx.
Peel off the paper cover on the vial adapter plastic housing.
Qaxxar il- qoxra tal- karta minn fuq l- għatu tal - plastik ta ’ l- adapter għall- kunjett.
Do not remove the adapter from the plastic housing.
Tneħħiex l- adapter minn fuq l- għata tal- plastik.
Holding the adapter housing, place over the product vial and firmly press down (B).
Waqt li żżomm l- għant ta ’ l- adapter, qegħdu fuq il- kunjett tal- prodott u agħfsu sew 'l- isfel (B).
The adapter will snap over the vial cap.
L - adapter għandu jikklikkja fuq l- għatu tal- kunjett.
Do not remove the adapter housing at this step.
Tneħħiex l- għant ta ’ l- adapter f’ dan l- istadju.
Hold the pre-filled sterile water for injection (SWFI) syringe upright, grasp the plunger rod per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C).
Żomm is- siringa mimlija minn qabel bl- ilma għall- injezzjonijiet ‘ il fuq, żomm sod il- planġer kif jidher fl- istampa u waħħal il- virga billi ddawwarha sew skond id- direzzjoni ta ’ l- arloġġ fuq it - tapp bil- kamini (C).
Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Waqt li żżomm is- siringa mill- bettija, qaċċat l- għatu tas- siringa minn mat- tarf (D).
Do not touch the syringe tip with your hand or any surface.
Tmissx it - tarf tas- siringa jew xi tarf ieħor b’ idejk.
Set the syringe aside for further use.
Poġġi s- siringa ġenb biex tintuża aktar 'il quddiem.
Now remove and discard the adapter housing (E).
Issa neħħi u armi l- għant ta ’ l- adapter (E).
Attach the pre-filled syringe to the threaded vial adapter by turning clockwise (F).
Ehmeż is- siringa mimlija minn qabel ma ’ l- adapter inkaminat tal- kunjett billi ddawwar skond id- direzzjoni ta ’ l- arloġġ (F).
Inject the diluent by slowly pushing down on the plunger rod (G).
Injetta d- dilwent billi bil- mod tniżżel il- virga tal- planġer tas- siringa 'l- isfel (G).
Swirl vial gently until all material is dissolved (H).
Ħoll it- trab billi ddawwar bil- mod il- kunjett (H).
Do not shake vial.
Theżżizx il- kunjett!
Do not use solutions containing visible particles or that are cloudy.
Tużax soluzzjoni li fih jidher il- frak jew li jkun mdardar.
Fill the syringe by drawing the plunger out slowly and smoothly.
11 Dawwar il- kunjett/ siringa u ttrasferixxi soluzzjoni għal ġos- siringa billi imbotta il- planġer bil - mod u bis- sod (I).
Ensure that the entire content of the vial is drawn into the syringe.
Iżgura li l- kontenut kollu tal- kunjett huwa miġbud fis- siringa.
Puncture the vein and secure the venipuncture set with a plaster.
Taqqab il- vina u żgura li s- sett tat- titqieb joqgħod f’ postu permezz ta ’ ġbara.
Holding the plunger in place, remove the syringe from the vial adapter (the latter should remain attached to the vial).
Filwaqt li żżomm il- planġer f’ postu, neħħi s- siringa minn fuq l- adapter tal- kunjett (ta ’ l- aħħar għandu jibqa ’ mwaħħal mal- kunjett).
Attach the syringe to the venipuncture set and ensure that no blood enters the syringe (J).
Waħħal is- siringa mas- sett tat- titqib u żżgura li l- ebda demm ma jidħol fis- siringa (J).
Remove tourniquet.
Neħħi t- turnikett!
Inject the solution intravenously over several minutes, keeping an eye on the position of the needle.
Injetta s- soluzzjoni ġol- vina fuq medda ta ’ diversi minuti, waqt li żżomm għajnejk fuq il - pożizzjoni tal- labra.
The rate of administration should be determined by the patient’ s comfort (maximum rate of infusion:
Ir- rata ta ’ l- għoti għandu jiġi stabbilit skond il- qagħda tal- pazjent (rata massima ta 'infużjoni:
If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Jekk ikun hemm bżonn li tingħata doża oħra, uża siringa ġdida bil- prodott rikostitwit kif deskritt hawn fuq.
If no further dose is required, remove the venipuncture set and syringe.
Jekk l- ebda doża oħra ma hija meħtieġa, neħħi s- sett tat- titqib minn ġol- vina u s- siringa.
Hold a swab firmly over the injection site on the outstretched arm for approx.
Żomm l- imsiħ sew fuq il- post ta ’ l- injezzjoni fuq d- driegħ stirat għal madwar 2 minuti.
Finally, apply a small pressure dressing to the wound.
Fl- aħħarnett, qiegħed ġbajra tal- pressjoni għal fuq il- ferita.
Factor VIII level
206
Although dosage can be estimated by the calculations presented above, it is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that
Għalkemm id- doża tista 'tiġi stmata fuq il- kalkulazzjonijiet mogħtija hawn fuq, huwa rakkomandat bil- qawwa li jsiru testijiet xierqa fil- laboratorju tal- plażma f' intervalli xierqa sabiex jiġi żgurat li livelli tal- fattur VIII ikunu ġew milħuqa u miżmuma.
If the factor VIII level of your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dosage, the presence of factor VIII inhibitors should be suspected.
Permezz ta '
By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.
207 proċeduri xierqa tal- laboratorju, il- preżenza ta 'inibituri għal fattur VIII għandu jiġi ċċekjat u kwantifikat minn tabib bl- esperjenza.
208 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
208 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
Do not refrigerate the solution after reconstitution.
Tista 'żżomm il- prodott fil- pakkett fit- temperatura tal- kamra (sa 25°C) għal perjodu wieħed sa 3 xhur; F’ dan il- każ, il- prodott jiskadi fl- aħħar ta ’ perjodu tat- 3 xhur; għandek tinnota d- data l- ġdida ta ’ meta jiskadi ġdida fil- kaxxa ta ’ barra. Tagħmilx is- soluzzjoni rikostitwita fil - friġġ.
Do not use KOGENATE Bayer 250 IU after the expiry date which is stated on labels and cartons.
209 M' għandekx tuża KOGENATE Bayer 250 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
209 Do not use KOGENATE Bayer 250 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 250 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
210 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
210 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
211 PACKAGE LEAFLET:
211 FULJETT TA 'TAGĦRIF:
The vial with powder for solution for injection nominally contains 500 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 500 IU octocog alfa (IU tfisser International Units - Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 200 IU/ ml.
Wara li jiġi rikostitwiti bil- volum xieraq ta 'solvent (ilma għall- injezzjonijiet), kull kunjettkunjett ikun fih 200 IU/ ml octocog alfa.
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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 500 IU fih kunjett, u siringa mimlija lesta bi planġer separat, kif ukoll adapter għall- kunjett, sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
212 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 500 IU is sufficient to reach and maintain adequate factor VIII levels.
212 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 500 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
KOGENATE Bayer 500 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 500 IU huwa intiż għall- użut ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices (vial adapter, pre-filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 500 IU.
Uża biss it- tagħmir mediku għar- rikostituzzjoni u l- għoti pprovduti f’ kull pakkett (adapter għall- kunjett, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 500 IU.
Factor VIII level
214
By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.
215 proċeduri xierqa tal- laboratorju, il- preżenza ta 'inibituri għal fattur VIII għandu jiġi ċċekjat u kwantifikat minn tabib bl- esperjenza.
216 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
216 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
Do not use KOGENATE Bayer 500 IU after the expiry date which is stated on labels and cartons.
217 M' għandekx tuża KOGENATE Bayer 500 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
217 Do not use KOGENATE Bayer 500 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 500 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
218 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
218 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
219 PACKAGE LEAFLET:
219 FULJETT TA 'TAGĦRIF:
The vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 1000 IU octocog alfa (IU tfisser International Units - Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 400 IU/ ml.
Wara li jiġi rikostitwiti bil- volum xieraq ta 'solvent (ilma għall- injezzjonijiet), kull kunjettkunjett ikun fih 400 IU/ ml octocog alfa.
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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 1000 IU fih kunjett, u siringa mimlija lesta bi planġer separat, kif ukoll adapter għall- kunjett, sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
220 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 1000 IU is sufficient to reach and maintain adequate factor VIII levels.
220 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 1000 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
KOGENATE Bayer 1000 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 1000 IU huwa intiż għall- użut ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices (vial adapter, pre-filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 1000 IU.
Uża biss it- tagħmir mediku għar- rikostituzzjoni u l- għoti pprovduti f’ kull pakkett (adapter għall- kunjett, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 1000 IU.
Factor VIII level
222
By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.
223 proċeduri xierqa tal- laboratorju, il- preżenza ta 'inibituri għal fattur VIII għandu jiġi ċċekjat u kwantifikat minn tabib bl- esperjenza.
224 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
224 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
Do not use KOGENATE Bayer 1000 IU after the expiry date which is stated on labels and cartons.
225 M' għandekx tuża KOGENATE Bayer 1000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
225 Do not use KOGENATE Bayer 1000 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 1000 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
226 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
226 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
227 PACKAGE LEAFLET:
227 FULJETT TA 'TAGĦRIF:
KOGENATE Bayer 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
The vial with powder for solution for injection nominally contains 2000 IU octocog alfa (IU equals International Units).
Kunjett bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 2000 IU octocog alfa (IU tfisser International Units - Unitajiet Internazzjonali).
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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 2000 IU fih kunjett, u siringa mimlija lesta bi planġer separat, kif ukoll adapter għall- kunjett, sett biex ittaqqab il- vina, żewġ msiħ sterili bl- alkoħol, żewġ msiħ xotti u żewġt iġbajjar.
228 Your doctor may wish to carry out tests to ensure that your current dose of KOGENATE Bayer 2000 IU is sufficient to reach and maintain adequate factor VIII levels.
228 It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'KOGENATE Bayer 2000 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
KOGENATE Bayer 2000 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 2000 IU huwa intiż għall- użut ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices (vial adapter, pre-filled syringe containing solvent and venipuncture set) for reconstitution and administration provided with each package of KOGENATE Bayer 2000 IU.
Uża biss it- tagħmir mediku għar- rikostituzzjoni u l- għoti pprovduti f’ kull pakkett (adapter għall- kunjett, siringa mimlija lesta u sett ta ’ titqib) ta 'KOGENATE Bayer 2000 IU.
Factor VIII level
230
By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.
231 proċeduri xierqa tal- laboratorju, il- preżenza ta 'inibituri għal fattur VIII għandu jiġi ċċekjat u kwantifikat minn tabib bl- esperjenza.
If you have the impression that the effect of KOGENATE Bayer 2000 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 2000 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
232 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
232 Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
Do not use KOGENATE Bayer 2000 IU after the expiry date which is stated on labels and cartons.
233 M' għandekx tuża KOGENATE Bayer 2000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
233 Do not use KOGENATE Bayer 2000 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża KOGENATE Bayer 2000 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
234 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
234 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is Kuvan?
X’ inhu Kuvan?
Kuvan is a medicine that contains the active substance sapropterin dihydrochloride.
Kuvan huwa mediċina li fiha s- sustanza attiva sapropterin hydrochloride.
It is available as light yellow soluble tablets (100 mg).
Jiġi bħala pilloli sofor ċari li jinħallu fl- ilma (100 mg).
What is Kuvan used for?
Għal xiex jintuża Kuvan?
Kuvan is used to treat hyperphenylalaninaemia (HPA, high levels of phenylalanine in the blood) in patients with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.
Kuvan jintuża fit- trattament tal- iperfenilalaninemija (hyperphenylalaninaemia) (HPA, livelli għoljin ta ’ fenilalanina (phenylalanine) fid- demm) f’ pazjenti bid- disturbi ġenetiċi fenilketonurija (phenylketonuria) (PKU) jew b’ defiċjenza ta ’ tetraidrobjopterina (tetrahydrobiopterin) (BH4).
Patients with these disorders cannot convert the amino acid phenylalanine (found in protein in the diet) into tyrosine (another amino acid).
Il - pazjenti b’ dawn id- disturbi ma jkunux jistgħu jikkonvertu l- aċidu amminiku fenilalanina (li jinstab fil - proteini fid- dieta) f’ tirosina (tyrosine) (aċidu amminiku ieħor).
This causes a build-up of phenylalanine in the blood, which can lead to problems with the brain and nervous system.
Dan jikkawża l- bini ta ’ fenilalanina fid- demm, li jista ’ jwassal għal problemi fil- moħħ u fis- sistema nervuża.
Kuvan can be used in adults and children.
Kuvan jista ’ jintuża fl- adulti u fit- tfal.
Kuvan is intended for use in children with HPA due to PKU who are at least four years old.
Kuvan huwa maħsub għall- użu fit- tfal bl- HPA minħabba l- PKU li jkollhom tal- anqas erba ’ snin.
It has not been studied in children with HPA due to PKU who are younger than four years.
Ma ġiex studjat fi tfal li għandhom inqas minn erba ’ snin bl- HPA minħabba l- PKU.
Kuvan may be used in children of all ages with HPA due to BH4 deficiency.
Kuvan jista ’ jintuża fi tfal ta ’ kull età bl- HPA minħabba d- defiċjenza tal- BH4.
Kuvan treatment should only be continued in patients who respond adequately to the medicine.
It- trattament b’ Kuvan għandu jitkompla biss f’ pazjenti li jirrispondu b’ mod adegwat għall- mediċina.