qanastek/EMEA-V3 huggingface dataset:
125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
125 TAGĦRIF MINIMU LI JRID JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE WITH 5.0 ML WATER FOR INJECTIONS
SIRINGA MIMLIJA LESTA B '5, 0 ML ILMA GĦALL- INJEZZJONI
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
126 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
1 vial with powder for solution for injection.
Kunjett 1 bit- trab għal soluzzjoni għal injezzjoni.
1 vial adapter 1 venipuncture set 2 sterile alcohol swabs for single use 2 dry swabs 2 plasters
Siringa 1 mimlija minn qabel b ’ 2, 5 ml ilma għall- injezzjonijiet bil- planġer tas- siringa separat Adapter 1 għall- kunjett Sett biex ittaqab il- vina 2 msiħ sterili bl- alkoħol biex jintużaw darba 2 msiħ xotti 2 iġbajjar
The product when kept in its outer carton may be stored at ambient room temperature (< 25°C) for a single period of up to 3 months; note the new expiry date on the carton.
Il- prodott meta miżmum fil- pakkett ta ’ barra jista ’ jiġi maħżun fit- temperatura tal- kamra (< 25oC) għal perjodu wieħed li jdum sa 3 xhur; Innota d- data l- ġdida ta ’ l- iskadenza `fuq il- kartuna.
Use the reconstituted solution immediately.
Uża mill - ewwel wara li tirrikostitwixxi l- prodott.
129 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
129 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
130 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
130 TAGĦRIF MINIMU LI GĦANDUJIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
131 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
131 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
134 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
135 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
135 TAGĦRIF MINIMU LI GĦANDUJIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
136 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
136 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
139 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
139 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
140 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
140 TAGĦRIF MINIMU LI GĦANDUJIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
141 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
141 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
1 vial adapter 1 venipuncture set 2 sterile alcohol swabs for single use 2 dry swabs 2 plasters
Siringa 1 mimlija minn qabel b ’ 5, 0 ml ilma għall- injezzjonijiet bil- planġer tas- siringa separat Adapter 1 għall- kunjett Sett biex ittaqab il- vina 2 msiħ sterili bl- alkoħol biex jintużaw darba 2 msiħ xotti 2 iġbajjar
144 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
144 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
145 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
145 TAGĦRIF MINIMU LI GĦANDUJIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
147 PACKAGE LEAFLET:
147 FULJETT TA 'TAGĦRIF:
KOGENATE Bayer 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 250 IU trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
What KOGENATE Bayer 250 IU is and what it is used for 2.
X' inhu KOGENATE Bayer 250 IU u għalxiex jintuża 2.
Before you use KOGENATE Bayer 250 IU 3.
Qabel ma tieħu KOGENATE Bayer 250 IU 3.
How to use KOGENATE Bayer 250 IU 4.
Kif għandek tieħu KOGENATE Bayer 250 IU 4.
How to store KOGENATE Bayer 250 IU 6.
Kif taħżen KOGENATE Bayer 250 IU 6.
WHAT KOGENATE Bayer 250 IU IS AND WHAT IT IS USED FOR
X' INHU KOGENATE Bayer 250 IU U GĦALXIEX JINTUŻA
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 100 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall - injezzjoni) kull kunjettkunjett ikun fih 100 IU/ ml octocog alfa.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Għall- kura u l- profilassi tal- fsada f' pazjenti li għandhom emofilja A (nuqqas konġenitali tal- fattur VIII).
BEFORE YOU USE KOGENATE Bayer 250 IU
QABEL MA TIEĦU KOGENATE Bayer 250 IU
Do not use KOGENATE Bayer 250 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of KOGENATE Bayer 250 IU.
Tużax KOGENATE Bayer 250 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 250 IU.
Take special care with KOGENATE Bayer 250 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 250 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 250 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 250 IU.
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.
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.
If your bleeding is not being controlled with KOGENATE Bayer 250 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' KOGENATE Bayer 250 IU, ikkonsulta mat- tabib tiegħek minnufih.
You may have developed factor VIII inhibitors and your doctor may wish to carry out
Jista 'jkun li żviluppajt inibituri għall- fattur VIII u t- tabib tiegħek għandu mnejn
148 tests to confirm this.
148 ikun irid iwettaq xi testijiet biex jikkonferma dan.
If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
Jekk qabel tkun żviluppajt inibitur ta ’ fattur VIII u taqleb il- prodotti ta ’ fattur VIII, tista ’ tkun f’ riskju li l- inibitur jerġa ’ jitfaċċa.
Using other medicines Interactions with other medicines are not known.
Meta tieħu mediċini oħra M’ hemmx prodotti mediċinali magħrufa li ma jaqblux ma ’ KOGENATE Bayer.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer 250 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 250 IU fit- tqala u t- treddigħ m' hiex disponibbli.
No effects on the ability to drive or use machines have been observed.
L- ebda effett fuq il- ħila ta ’ sewqan u t- tħaddim ta ’ magni ma ġie osservat.
Important information about some of the ingredients of KOGENATE Bayer 250 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 250 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 250 IU
KIF GĦANDEK TIEĦU KOGENATE Bayer 250 IU
KOGENATE Bayer 250 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 250 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices for reconstitution and administration provided with each package of KOGENATE Bayer 250 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett ta 'KOGENATE Bayer 250 IU.
KOGENATE Bayer 250 IU must not be mixed with other infusion solutions.
KOGENATE Bayer 250 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
Follow the directions given by your doctor closely and use the instructions below as a guide:
Segwi l- istruzzjonijiet mogħtija mit- tabib tiegħek b 'kawtela u uża l- istruzzjonijiet t' hawn isfel bħala gwida:
Remove protective caps from the vials.
Neħħi l- għotjien minn fuq il- kunjetti.
Then clean each of the rubber stoppers with a different sterile swab (A) (or use an antiseptic spray).
Imbagħad naddaf kull wieħed mill - għotjien tal- gomma b' msiħ sterili differenti (A) (jew uża sprej antisettiku).
Place the water vial upright on a firm, clean surface and attach the transfer device (B) with the corrugated edge facing the vial (C).
Qiegħed il- kunjett ta 'l- ilma f’ pożizzjoni dritta fuq wiċċ sod u nadif, ehmeż it- tagħmir li jitrasferixxi (B) max- xifer ippjegat faċċata tal- kunjett (C).
Make sure that the vial and transfer device are vertically aligned and centred (C) and press down.
Kun żgur li l- kunjett u t- tagħmir li jittrasferixxi huma allinjati vertikalment u ċċentrati (C) u agħfas l- isfel.
Do not screw the transfer device onto the water vial.
Tinvitax it- tagħmir li jittrasferixxi fuq il - kunjett ta ’ l- ilma.
Place the powder vial upright on a firm, clean surface.
Qiegħed il- kunjett tat- trab f’ pożizzjoni dritta fuq wiċċ sod u nadif.
Turn the water vial with the transfer device mounted upside down and attach them onto the powder vial.
Dawwar il- kunjett ta’ l- ilma u t- tagħmir li jitrasferixxi `l fuq `l- isfel u waħħalhom mal- kunjett tat- trab.
Make sure that the powder vial and transfer device are vertically aligned and centred and press down immediately.
Kun żgur li l- kunjett tat- trab u t- tagħmir ta ’ trasferriment huma allinjati vertikalment u ċċentrati u agħfas `l isfel minnufih.
Do not screw the transfer device onto the powder vial (D).
Tinvitax it- tagħmir li jittrasferixxi fuq il- kunjett tat- trab (D).
Hold all three elements together and wait until all the water has been drawn into the powder vial by the vacuum.
Żomm it- tlett elementi flimkien u stenna sakemm l- ilma kollu jkun ġie miġbud fil- kunjett li fiha t- trab permezz tal- vakwu.
Remove and discard the water vial and transfer device.
Neħħi u armi l- kunjett tal- ilma u t- tagħmir li jitrasferixxi.
Swirl vial gently until all material is dissolved (E).
Dawwar il- kunjett bil- mod sakemm il- materjal kollu jkun inħall (E).
Do not shake vial.
Tħawwadx il- kunjett bis- saħħa.
Be sure that the powder is completely dissolved.
Iżgura li t- trab huwa maħlul kollu.
Do not use solutions containing visible particles or that are cloudy.
Tużax soluzzjoni li fih jidher xi frak jew li jkun mdardar.
Attach the filter needle to a syringe (F).
Waħħal il- labra bil- filtru ma 'siringa (F).
Pull back the syringe plunger to the 3 ml mark.
Iġbed lura l- planġer tas- siringa sal- marka ta '3 ml.
Insert the needle into the vial with the solution by puncturing through the stopper and push plunger fully forward to inject air into the vial.
Daħħal il- labra fil- kunjett bis- soluzzjoni billi ttaqqab t - tapp u imbotta il- planġer il- quddiem sabiex tinjetta l- arja fil- kunjett.
Hold the vial on end above the filter and syringe (G).
Żomm il- kunjett fit- tarf 'l fuq mill- filter u s- siringa (G).
Fill the syringe by drawing the plunger out slowly and smoothly.
Imla s- siringa billi tiġbed il- planġer lura bil- mod u bis- sod.
Ensure that the entire content of the vial is drawn into the syringe.
Iżgura li l- kontenut kollu tal - kunjett huwa miġbud fis- siringa.
Holding the plunger in place, remove the syringe from the filter needle (the latter should remain attached to the vial).
(ta 'l - aħħar għandha tibqa mwaħla mal- kunjett).
Attach the syringe to the venipuncture set and ensure that no blood enters the syringe.
Ehmeż is- siringa mas- sett li jtaqqab il- vina u żgura li l- ebda demm ma jidħol fis- siringa.
Inject the solution intravenously over several minutes, keeping an eye on the position of the needle.
Injetta s- soluzzjoni ġol- vina fuq medda ta ’ ħin, waqt li żżomm għajnejk fuq il- pożizzjoni tal - labra.
If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Jekk ikun hemm bżonn li doża oħra tiġi mogħtija, uża siringa ġdida bil- prodott jiġi 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 ġol- vina u s- siringa.
Hold a swab firmly over the injection site on the outstretched arm for approx.
Żomm l - msiħ 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- aħħar, qiegħed ġbajra tal- pressjoni għal fuq il- ferita.
The amount of KOGENATE Bayer 250 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 250 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 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.
In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in% of normal) in the corresponding period:
F’ każijiet ta ’ l- emorraġiji elenkati, il- livell ta ’ l- attività tal- fattur VIII, ma tridx ikun anqas mil- livell indikat (bħala% tan- normal) waqt dan il- perjodu:
Degree of haemorrhage/
Qawwa ta ’ l- emorraġija / Tip ta ’ proċedura kirurġika Emorraġija
Factor VIII level
Livell ta’ Fattur VIII meħtieġ (%) (IU/ dl)
Frequency of doses (hours)/
Frekwenza tad- dożi (sigħat) / Dewmien tat- terapija (ġranet) Irrepeti d- doża kull 12 sa 24 siegħa.
until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% b) By continuous infusion Raise factor VIII activity pre- surgery 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.
Għolli l- attività ta ’ fattur VIII qabel l- intervent kirurġiku permezz ta ’ bolus infużjonali fil- bidu u minnufih segwi b’ infużjoni kontinwa (f’ IU/ Kg/ h) u aġġusta skond ir- rata ta ’ eliminazzjoni ta ’ kuljum tal - pazjent u l- livelli ta ’ fattur VIII mixtieqa almenu għal 7ijiem.
Your doctor should always adapt the amount of KOGENATE Bayer 250 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 250 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
If you are using KOGENATE Bayer 250 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża KOGENATE Bayer 250 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d- doża għalik.
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 -
However, in some cases, especially younger patients, shorter dose intervals or higher doses may be necessary.
Madankollu, f 'ċerti każi, speċjalment f' pazjenti żgħar jaf ikun meħtieġ li d- dożi jingħataw aktar ta 'spiss jew id- dożi jkunu aktar għoljin.
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 you have the impression that the effect of KOGENATE Bayer 250 IU is too strong or too weak, talk to your doctor.
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.
Pazjent 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.
Do not increase the dose of KOGENATE Bayer you use to control your bleeding without consulting your doctor.
Iżżidtx id- doża ta 'KOGENATE Bayer li tuża biex tikkontrolla l- fsada mingħajr ma tikkonsulta mat- tabib tiegħek.
KOGENATE Bayer 250 IU should be injected intravenously over several minutes.
KOGENATE Bayer għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
The rate of administration should be determined by the patient’ s comfort level (maximal rate of infusion:
Ir- rata ta ’ l- għotja għandha tiġi stabbilita skond kif iħossu l- pazjent (l- ogħla rata ta ’ l- injezzjoni:
Your doctor will tell you, how often and at what intervals KOGENATE Bayer 250 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm KOGENATE Bayer 250 IU għandu jiġi meħud.
Usually, the substitution therapy with KOGENATE Bayer 250 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' KOGENATE Bayer 250 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more KOGENATE Bayer 250 IU than you should:
Jekk tieħu aktar KOGENATE Bayer 250 IU milli suppost għandek:
If you have used more KOGENATE Bayer 250 IU than you should, please inform your doctor.
Jekk tuża aktar KOGENATE Bayer 250 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use KOGENATE Bayer 250 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 250 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 250 IU Do not stop using KOGENATE Bayer 250 IU without consulting your doctor.
Jekk tieqaf tieħu KOGENATE Bayer 250 IU Tieqafx tieħu KOGENATE Bayer 250 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, KOGENATE Bayer 250 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, KOGENATE Bayer 250 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 250 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 250 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.
152 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days).
Fi studji kliniċi, KOGENATE Bayer intuża fit- trattamenti ta ’ episodji emorraġiċi f’ 37 pazjent li ma kienux trattati qabel (PUPs) u 23 pazjent pedjatriku minimamemt ittrattati (MTPs, imfisser bħala li kellhom espożizzjoni ugwali għal jew inqas minn 4 ijiem).
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed:
Fi studji estensivi ta ’ wara r- reġistrazzjoni b’ KOGENATE Bayer, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
153 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KOGENATE Bayer 250 IU
KIF TAĦŻEN KOGENATE Bayer 250 IU
Do not use KOGENATE Bayer 250 IU after the expiry date, which is stated on labels and cartons.
M' għandekx tuża KOGENATE Bayer 250 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
153 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.
What KOGENATE Bayer 250 IU contains
X’ fih KOGENATE Bayer 250 IU
What KOGENATE Bayer 250 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
KOGENATE Bayer 250 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 250 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 250 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ KOGENATE Bayer 250 IU.
154 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
154 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
155 PACKAGE LEAFLET:
155 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)
What KOGENATE Bayer 500 IU is and what it is used for 2.
X' inhu KOGENATE Bayer 500 IU u għalxiex jintuża 2.
Before you use KOGENATE Bayer 500 IU 3.
Qabel ma tieħu KOGENATE Bayer 500 IU 3.
How to use KOGENATE Bayer 500 IU 4.
Kif għandek tieħu KOGENATE Bayer 500 IU 4.
How to store KOGENATE Bayer 500 IU 6.
Kif taħżen KOGENATE Bayer 500 IU 6.
WHAT KOGENATE Bayer 500 IU IS AND WHAT IT IS USED FOR
X' INHU KOGENATE Bayer 500 IU U GĦALXIEX JINTUŻA
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 kunjettkunjett ikun fih 200 IU/ ml octocog alfa.
BEFORE YOU USE KOGENATE Bayer 500 IU
QABEL MA TIEĦU KOGENATE Bayer 500 IU
Do not use KOGENATE Bayer 500 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of KOGENATE Bayer 500 IU.
Tużax KOGENATE Bayer 500 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 500 IU.
Take special care with KOGENATE Bayer 500 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 500 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 500 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 500 IU.
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.
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.
If your bleeding is not being controlled with KOGENATE Bayer 500 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' KOGENATE Bayer 500 IU, ikkonsulta mat- tabib tiegħek minnufih.
156 tests to confirm this.
156 ikun irid iwettaq xi testijiet biex jikkonferma dan.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer 500 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 500 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Important information about some of the ingredients of KOGENATE Bayer 500 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 500 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 500 IU
KIF GĦANDEK TIEĦU KOGENATE Bayer 500 IU
KOGENATE Bayer 500 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 500 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices 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 ta 'KOGENATE Bayer 500 IU.
KOGENATE Bayer 500 IU must not be mixed with other infusion solutions.
KOGENATE Bayer 500 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
The amount of KOGENATE Bayer 500 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 500 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 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.
Your doctor should always adapt the amount of KOGENATE Bayer 500 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 500 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
If you are using KOGENATE Bayer 500 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża KOGENATE Bayer 500 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d- doża għalik.
If you have the impression that the effect of KOGENATE Bayer 500 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 500 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
KOGENATE Bayer 500 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 500 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm KOGENATE Bayer 500 IU għandu jiġi meħud.
Usually, the substitution therapy with KOGENATE Bayer 500 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' KOGENATE Bayer 500 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more KOGENATE Bayer 500 IU than you should:
Jekk tieħu aktar KOGENATE Bayer 500 IU milli suppost għandek:
If you have used more KOGENATE Bayer 500 IU than you should, please inform your doctor.
Jekk tuża aktar KOGENATE Bayer 500 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use KOGENATE Bayer 500 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 500 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 500 IU Do not stop using KOGENATE Bayer 500 IU without consulting your doctor.
Jekk tieqaf tieħu KOGENATE Bayer 500 IU Tieqafx tieħu KOGENATE Bayer 500 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, KOGENATE Bayer 500 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, KOGENATE Bayer 500 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 500 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 500 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.
160 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
161 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KOGENATE Bayer 500 IU
KIF TAĦŻEN KOGENATE Bayer 500 IU
Do not use KOGENATE Bayer 500 IU after the expiry date, which is stated on labels and cartons.
M' għandekx tuża KOGENATE Bayer 500 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
161 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.
What KOGENATE Bayer 500 IU contains
X’ fih KOGENATE Bayer 500 IU
What KOGENATE Bayer 500 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
KOGENATE Bayer 500 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 500 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 500 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ KOGENATE Bayer 500 IU.
162 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
162 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
163 PACKAGE LEAFLET:
163 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)
What KOGENATE Bayer 1000 IU is and what it is used for 2.
X' inhu KOGENATE Bayer 1000 IU u għalxiex jintuża 2.
Before you use KOGENATE Bayer 1000 IU 3.
Qabel ma tieħu KOGENATE Bayer 1000 IU 3.
How to use KOGENATE Bayer 1000 IU 4.
Kif għandek tieħu KOGENATE Bayer 1000 IU 4.
How to store KOGENATE Bayer 1000 IU 6.
Kif taħżen KOGENATE Bayer 1000 IU 6.
WHAT KOGENATE Bayer 1000 IU IS AND WHAT IT IS USED FOR
X' INHU KOGENATE Bayer 1000 IU U GĦALXIEX JINTUŻA
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 kunjettkunjett ikun fih 400 IU/ ml octocog alfa.
BEFORE YOU USE KOGENATE Bayer 1000 IU
QABEL MA TIEĦU KOGENATE Bayer 1000 IU
Do not use KOGENATE Bayer 1000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of KOGENATE Bayer 1000 IU.
Tużax KOGENATE Bayer 1000 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 1000 IU.
Take special care with KOGENATE Bayer 1000 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 1000 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 1000 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 1000 IU.
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.
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.
If your bleeding is not being controlled with KOGENATE Bayer 1000 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' KOGENATE Bayer 1000 IU, ikkonsulta mat- tabib tiegħek minnufih.
164 tests to confirm this.
164 ikun irid iwettaq xi testijiet biex jikkonferma dan.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer 1000 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 1000 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Therefore, if you are pregnant or breast-feeding consult your doctor before using this product.
Għaldaqstant, jekk inti tqila jew qed tredda, ikonsulta mat- tabib tiegħek qabel ma tuża l- prodott.
Important information about some of the ingredients of KOGENATE Bayer 1000 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 1000 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 1000 IU
KIF GĦANDEK TIEĦU KOGENATE Bayer 1000 IU
KOGENATE Bayer 1000 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
KOGENATE Bayer 1000 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices 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 ta 'KOGENATE Bayer 1000 IU.
KOGENATE Bayer 1000 IU must not be mixed with other infusion solutions.
KOGENATE Bayer 1000 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
The amount of KOGENATE Bayer 1000 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 1000 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 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.
He will do this according to your particular needs using the formulae below.
Huwa jagħmel dan skond il- ħtiġijiet tiegħek billi juża l- formuli ta 'hawn taħt:
Your doctor should always adapt the amount of KOGENATE Bayer 1000 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 1000 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
If you are using KOGENATE Bayer 1000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża KOGENATE Bayer 1000 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d- doża għalik.
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.
167 ta 'piż tal- ġisem, mogħti f' intervalli ta 'jumejn sa 3 ijiem.
If you have the impression that the effect of KOGENATE Bayer 1000 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'KOGENATE Bayer 1000 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
KOGENATE Bayer 1000 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 1000 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm KOGENATE Bayer 1000 IU għandu jiġi meħud.
Usually, the substitution therapy with KOGENATE Bayer 1000 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' KOGENATE Bayer 1000 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more KOGENATE Bayer 1000 IU than you should:
Jekk tieħu aktar KOGENATE Bayer 1000 IU milli suppost għandek:
If you have used more KOGENATE Bayer 1000 IU than you should, please inform your doctor.
Jekk tuża aktar KOGENATE Bayer 1000 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use KOGENATE Bayer 1000 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 1000 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 1000 IU Do not stop using KOGENATE Bayer 1000 IU without consulting your doctor.
Jekk tieqaf tieħu KOGENATE Bayer 1000 IU Tieqafx tieħu KOGENATE Bayer 1000 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, KOGENATE Bayer 1000 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, KOGENATE Bayer 1000 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 1000 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 1000 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.
168 Furthermore, the possibility of an anaphylactic shock cannot be completely excluded.
Barra dan, il- possibiltà ta 'xokk anafilattiku ma tistax tiġi kompletament eskluża.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
169 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KOGENATE Bayer 1000 IU
KIF TAĦŻEN KOGENATE Bayer 1000 IU
Do not use KOGENATE Bayer 1000 IU after the expiry date, which is stated on labels and cartons.
M' għandekx tuża KOGENATE Bayer 1000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l - kartun.
169 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.
What KOGENATE Bayer 1000 IU contains
X’ fih KOGENATE Bayer 1000 IU
What KOGENATE Bayer 1000 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
KOGENATE Bayer 1000 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 1000 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 1000 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ KOGENATE Bayer 1000 IU.
170 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
170 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
171 PACKAGE LEAFLET:
171 FULJETT TA 'TAGĦRIF:
KOGENATE Bayer 250 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
KOGENATE Bayer 250 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 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 Unitajiet Internazzjonali).
After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 100 IU/ ml.
Wara li jiġi rikostitwit bil- volum xieraq ta 'solvent (ilma għall- injezzjoni), kull kunjett ikun fih 100 IU/ ml.
KOGENATE Bayer 250 IU is used for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
KOGENATE Bayer 250 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 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, two alcohol swabs, two dry swabs and two plasters.
Kull pakkett ta 'KOGENATE Bayer 250 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.
The vial contains a dry white to slightly yellow powder or cake.
Il- kunjett fih trab, jew kejk xott abjad li jkanġi daqsxejn fl- isfar.
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 għandha tintuża biex jirrikostitwixxi l- kontenut tal- kunjett.
172 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.
172 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.
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 250 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 250 IU.
Ensure you prepare the solution on a clean and dry surface.
Agħmel żgur li tipprepara s- soluzzjoni fuq wiċċ nadif u xott.
Warm the unopened powder vial and the solvent syringe in your hands to approximately body temperature (do not exceed 37 °C).
Saħħan il- kunjett tat- trab magħluqa u l- kunjett tas- solvent b 'idejk sakemm din tkun madwar it - temperatura tal- ġisem (taqbizx 37 °C).
Wipe any observable moisture from the vial.
Ixxotta kull ndewwa osservata minn fuq il- kunjett.
Remove the cap from the powder vial by gently moving it from side to side several times, whilst at the same time pulling upwards.
Neħħi l- għatu mill- kunjett li fiha t- trab billi ċċaqlaqha minn naħa għal oħra diversi drabi bil - mod, waqt li fl- istess ħin tiġbed 'il fuq.
Remove the stopper attached to the white cap from the syringe (A).
Neħħi l- għatu mehmuż mat- tapp l- abjad mis- siringa (A).
Gently screw the syringe on to the powder vial (B).
Bil- mod ilwi s- siringa fuq il- kunjett li fiha t- trab (B).