qanastek/EMEA-V3 huggingface dataset:
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion (see section 4.2). – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 2 mg/ ml Għall- infużjoni kontinwa ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 2 mg/ ml: – Irrikostitwixxi żewġ kunjetti (kull wieħed fih 20 mg ta ’ lepirudin) b’ 0. 4 ml kull wieħed billi tuża ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċetrazzjoni finali ta ’ 2 mg/ ml tinkiseb billi jiġu trasferiti iż- żewġ soluzzjonijiet ġo siringa perfusor sterili waħda, li tintuża darba biss (kapaċità ta ’ 50 ml) u aktar dilwazzjoni sa volum totali ta ’ 20 ml permezz ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Il- veloċità ta ’ l- infużjoni tal- perfusor awtomat għandha tiġi ssettjata b’ mod dipendenti mil- piż tal- ġisem (ara sezzjoni 4. 2). – Is- siringa perfusor għandha tinbidel mill- inqas kull 12- il siegħa wara l- bidu ta ’ l- infużjoni.
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom
Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, Renju Unit
REFLUDAN - 20 mg - Powder for solution for injection or infusion - 1 vial REFLUDAN - 20 mg - Powder for solution for injection or infusion - 10 vials
REFLUDAN - 20 mg - Trab għal soluzzjoni għall- injezzoni jew infużjoni – 10 kunjetti
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL
13-03-1997 Date of last renewal:
13- 03- 1997 Data ta ’ l- aħħar tiġdid:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu
Refludan 50 mg powder for solution for injection or infusion
Refludan 50 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni
Each vial contains 50 mg lepirudin.
Kull fjala fiha 50 mg lepirudin.
11 – The aPTT should be monitored at least once daily.
11 – Firxa mmirata (tieqa terapewtika) għal aPTT:
12 Table 1:
12 Tabella 1:
13 4.3 Contraindications
13 4. 3 Kontra- indikazzjonijiet
No specific dosage adjustment is made for elderly patients.
14 indeboliment tal- kliewi f’ pazjenti anzjani trid tingħata konsiderazzjoni Ma hemm l- ebda aġġustament speċifiku tad- dożaġġ f’ pazjenti anzjani.
15 Very common (> 1/ 10); Common (> 1/ 100 ,< 1/10); Uncommon (> 1/1 ,000 < 1/100); Rare (> 1/10,000 < 1/ 1,000); Very Rare (< 1/10,000)
15 Komuni Ħafna (> 1/ 10); Komuni (> 1/ 100, < 1/ 10); Mhux Komuni (> 1/ 1, 000 < 1/ 100); Rari (> 1/ 10, 000 < 1/ 1, 000); Rari Ħafna (< 1/ 10, 000)
16 Results from studies in pigs showed that the application of von Willebrand Factor (vWF, 66 I. U. / kg body weight) markedly reduced the bleeding time.
Riżultati minn studji fil- ħnieżer urew li applikazzjoni tal- Fattur von Willebrand (vWF, 66 I. U. / kg piż tal - ġisem) naqqas ħafna il- ħin ta ’ fsada.
Antithrombotic agent – direct thrombin inhibitor, ATC Code:
Aġent antitrombotiku – inibitur dirett ta ’ thrombin, Kodiċi ATC:
Antibodies against hirudin which appeared in several of the treated monkeys resulted in prolongation of the terminal half-life and an increase in systemic exposure to lepirudin.
17 hirudin li dehru f’ ħafna mix- xadini kkurati wassal għal titwil tal- half- life terminali u żieda fl - espożizzjoni sistemika għal lepirudin.
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution, sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently.
Rakkomandazzjonijiet ġenerali – Rikostituzzjoni u aktar dilwazzjoni iridu jsiru taħt kondizzjonijiet sterili. – Għar- rikostituzzjoni għandhom jintużaw ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Għal aktar dilwazzjoni, soluzzjonijiet ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5% huma tajbin. – Għar- rikostituzzjoni ta ’ malajr u kompluta, injetta 1 ml tad- dilwent ġol- kunjett mingħajr arja u ħawwad bil- mod.
18 – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
18 – Għall- injezzjoni, jistgħu jintużaw biss siringi ta ’ polypropylene.
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion (see section 4.2).
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 5 mg/ ml Għall- injezzjoni bolus ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 5 mg/ ml: – Irrikostitwixxi kunjett wieħed (50 mg ta ’ lepirudin) b’ 1 ml ta ’ imla għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċentrazzjoni finali ta ’ 5 mg/ ml hija miksuba billi jiġi trasferit ġo siringa sterili, li tintuża darba (b’ kapaċità mill- inqas ta ’ 10 ml) u aktar dilwazzjoni sa volum totali ta ’ 10 ml bl- użu ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Is- soluzzjoni finali trid tiġi amministrata b’ mod dipendenti mill- piż tal- ġisem (ara sezzjoni 4. 2).
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion (see section 4.2). – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 2 mg/ ml Għall- infużjoni kontinwa ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 2 mg/ ml: – Irrikostitwixxi żewġ kunjetti (kull wieħed fih 50 mg ta ’ lepirudin) b’ 1 ml kull wieħed billi tuża ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċetrazzjoni finali ta ’ 2 mg/ ml tinkiseb billi jiġu trasferiti iż- żewġ soluzzjonijiet ġo siringa perfusor sterili waħda, li tintuża darba biss (kapaċità ta ’ mill- inqas 50 ml) u aktar dilwazzjoni sa volum totali ta ’ 50 ml permezz ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Il- veloċità ta ’ l- infużjoni tal- perfusor awtomat għandha tiġi ssettjata b’ mod dipendenti mil- piż tal- ġisem (ara sezzjoni 4. 2). – Is- siringa perfusor għandha tinbidel mill- inqas kull 12- il siegħa wara l- bidu ta ’ l- infużjoni.
REFLUDAN - 50 mg - Powder for solution for injection or infusion - 1 vial REFLUDAN - 50 mg - Powder for solution for injection or infusion - 10 vials
REFLUDAN - 50 mg - Trab għal soluzzjoni għall- injezzoni jew infużjoni – 10 kunjetti
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
CSL Behring GmbH Emil- von- Behring- Straße 76 35041 Marburg Ġermanja
• CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON:
PAKKETT TA ’ BARRA:
20 mg x 1 VIAL
20 mg x KUNJETT WIEĦED
1 vial contains 20 mg lepirudin.
Kunjett wieħed fih 20 mg lepirudin.
Also contains: mannitol, sodium hydroxide.
Fih ukoll: mannitol, sodium hydroxide.
1 vial of powder for solution for injection or infusion.
Kunjett wieħed ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni.
Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution.
Użu għal ġol- vini Irrikonstitwixxi kunjett wieħed (20 mg ta ’ lepirudin) b ’ 0. 4 ml jew ta ’ ilma għall- injezzjoni jew ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Further dilution is necessary prior to use.
Aktar diluzzjoni hija neċessarja qabel l- użu.
The reconstituted solution is to be used immediately.
Is- soluzzjoni rikonstitwita għandha tintuża mmedjatament.
Do not use solutions which are cloudy or contain particles.
Tużax soluzzjonijiet li huma mdardra jew li fihom xi frak.
EXP {MM/ YYYY}
JIS {MM/ YYYY}
Discard unused solution appropriately.
Armi kull fdal tas- soluzzjoni li ma tkunx intużat b’ mod xieraq.
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
20 mg x 10 vials
20 mg x 10 Kunjetti
10 x 1 vial of powder for solution for injection or infusion.
10 x 1 kunjetti ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni.
VIAL LABEL:
TIKKETTA TAL- KUNJETT:
Refludan 20 mg powder for solution for injection or infusion Lepirudin Intravenous use
Refludan 20 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni Lepirudin Użu għal ġol- vini
. Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
< EXP {MM/YYYY} >
JIS {MM/ YYYY}
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
50 mg x 1 VIAL
50 mg x KUNJETT WIEHED
Refludan 50 mg powder for solution for injection or infusion lepirudin
Refludan 20 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni lepirudin
1 vial contains 50 mg lepirudin.
Kunjett wieħed fih 50 mg lepirudin.
Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution.
Użu għal ġol- vini Irrikonstitwixxi kunjett wieħed (50 mg ta ’ lepirudin) b ’ 0. 4 ml jew ta ’ ilma għall- injezzjoni jew ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
50 mg x 10 vials
50 mg x 10 KUNJETTI
Refludan 50 mg powder for solution for injection or infusion lepirudin
Refludan 50 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni lepirudin
Refludan 50 mg powder for solution for injection or infusion Lepirudin Intravenous use.
Refludan 50 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni Lepirudin Użu għal ġol- vini
Refludan 20 mg powder for solution for injection or infusion Lepirudin
Refludan 20 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni Lepirudin
- If any of the side effects gets serious, or if you notice side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Refludan is and what it is used for 2.
X’ inhu Refludan u għalxiex jintuża 2.
Before you use Refludan 3.
Qabel ma tuża Refludan 3.
How to use Refludan 4.
Kif għandek tuża Refludan 4.
Possible side effects 5 How to store Refludan 6.
Effetti sekondarji li jista ’ jkollu 5.
WHAT REFLUDAN IS AND WHAT IT IS USED FOR
X’ INHU REFLUDAN U GĦALXIEX JINTUŻA
Refludan is an antithrombotic medicine.
Refludan huwa mediċina antitrombolitika.
Antithrombotics are medicines to prevent formation of blood clots (thrombosis).
Antitrombolitiċi huma mediċini biex jipprevjenu l- formazzjoni ta ’ emboli (trombożi).
Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines.
Refludan huwa wżat għal antikoagulazzjoni f’ pazjenti adulti bi tromboċitopenija indotta mill- eparina (HIT) tat- tip II u mard tromboembolitiku li jeħtieġ mediċini antitrombolitiċi mogħtija bħala injezzjoni.
HIT type II is an illness which can occur after you have received heparin containing medicines.
HIT tat- tip II hija marda li tista ’ sseħħ wara li tkun irċevejt mediċini li fihom l- eparina.
It constitutes a certain kind of allergy towards heparin.
Din tikkostitwixxi ċertu forma ta ’ allerġija għall- eparina.
It may result in a too low number of blood platelets and/ or clots in your blood vessels (thrombosis).
Din tista ’ tirriżulta fl- għadd ta ’ plajtlets fid- demm baxx iżżejjed u/ jew emboli fil - kanali tad- demm tiegħek (trombożi).
This may additionally lead to deposition of clots in organs.
Din tista ’ twassal ukoll għal depożizzjoni ta ’ emboli fl- organi.
BEFORE YOU USE REFLUDAN
QABEL MA TUŻA REFLUDAN
Do not use Refludan
Tużax Refludan
- if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal lepirudin, għal hirudins jew sustanzi oħra
Refludan.
ta ’ Refludan
- if you are pregnant or breast-feeding.
- jekk inti tqila jew qed tredda ’.
Take special care with Refludan If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit.
Oqgħod attent ħafna b’ Refludan Jekk għandek tendenza għal fsada, it- tabib tiegħek se jiżen ir- riskju ta ’ għotja ta ’ Refludan kontra l - benefiċċju tiegħu.
Thus, please tell your doctor if you have or have had: – Recent puncture of large vessels or organs – Anomaly of vessels or organs – Recent stroke, accident or surgery involving the brain – High blood pressure – Inflammation of the inner membrane of the heart – Advanced kidney disease – Advanced bleeding tendency
Għalhekk, jekk jogħġbok għid lit- tabib tiegħek jekk għandek jew qatt kellek: – Titqib riċenti tal- kanali l- kbar tad- demm jew tal- organi – Anomalija tal- kanali l- kbar tad- demm jew tal- organi – Attakk reċenti ta ’ puplesija, aċċident jew kirurġija li jinvolvu l- moħħ – Pressjoni tad- demm għolja – Infjammazzjoni tal- membrana ta ’ ġewwa tal- qalb – Mard avvanzat tal- kliewi – Tendenza avvanzata għall- fsada – Kirurġija maġġuri reċenti Fsad reċenti (e. ż. fil- moħħ, stonku/ intestini, għajnejn, pulmun) –
35 – Recent major surgery – Recent bleeding (e. g. in brain, stomach/ intestine, eye, lung) – Obvious signs of bleeding – Recent active peptic ulcer – Age > 65 years
35 – Sinjali viżibbli ta ’ fsada – Ulċera peptika attiva reċenti – Eta ’ > 65 sena.
Please inform your doctor if you suffer from reduced kidney function or liver cirrhosis (advanced disease of the liver) for he will then reduce the dosage.
Jekk jogħġbok għid lit- tabib tiegħek jekk issofri minn funzjoni tal- kliewi mnaqqsa jew ċirrożi tal- fwied (mard avvanzat tal- fwied) għax f’ dan il- każ inaqqas id- dożaġġ.
You should also inform your doctor if you have ever received Refludan, hirudin or a hirudin analogue.
Għandek ukoll tgħid lit- tabib tiegħek jekk xi darba ħadt Refludan, hirudin jew analogu ta ’ hirudin.
Medicines given to break up clots or tablets to prevent clot formation (coumarins) may increase the risk of bleeding when given at the same time.
Mediċini li jingħataw biex ikissru emboli jew pilloli biex jipprevjenu l- formazzjoni ta ’ emboli (coumarins), jistgħu jżidu r- riskju ta ’ fsada meta jingħataw fl- istess waqt.
Refludan should not be administered to pregnant women or nursing mothers.
Refludan m’ għandux jingħata lil nisa tqal jew ommijiet li qed ireddgħu.
HOW TO USE REFLUDAN
KIF GĦANDEK TUŻA REFLUDAN
Your doctor will determine and control the dosage and duration of your treatment with Refludan according to your clinical condition, your body weight, and certain laboratory values.
It- tabib tiegħek se jiddetermina u jikkontrolla id- dożaġġ u kemm iddum ik- kura tiegħek b’ Refludan skond il- kundizzjoni klinika tiegħek, il- piż tiegħek, u ċertu riżultati tal- laboratorju.
If you have the impression that the effect of Refludan is too strong or too weak, talk to your doctor or pharmacist.
Jekk għandek l- impressjoni li l- effett ta ’ Refludan huwa qawwi jew baxx iżżejjed, kellem lit- tabib jew lill - ispiżjar tiegħek.
Refludan, once reconstituted with an appropriate solvent, will be administered into a vein, by injection and then by infusion.
Refludan, la darba jiġi rikostitwit b’ solvent xieraq, jingħata ġo vina permezz ta ’ injezzjoni u wara permezz ta ’ infużjoni.
Like all medicines, Refludan can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Refludan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common (at least 1 in 10 people) – Bleeding
Komuni ħafna (mill- anqas 1 kull 10 persuni) – Fsada
Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain.
Episodji ta ’ fsada rrappurtati jinkludu: anemija jew tnaqqis fil- valur tal- emoglobina mingħajr post ovvju ta ’ fsada, tbenġil, fsada minn postijiet ta ’ titqib, fsada mill- imnieħer, demm fl- awrina, fsada gastro- intestinali, fsada mill- vaġina, fsada mir- rektum, emorraġijja pulmonari, fsada fl- ispazju ta ’ ġewwa tas- sider u madwar il- qalb wara kirurġija, fsada fil- moħħ.
Severe bleeding and, in particular, intracranial bleeding may be fatal.
Fsada severa, speċjalment fsada intrakranjali tista ’ tkun fatali.
In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1% and intracranial bleeding in 0.2% of patients.
F’ sorveljanza intensifikata ta ’ wara t- tqegħid fis- suq f’ HIT ta ’ tip II, fsada fatali kienet irrappurtata f’ 1% u fsada intrakranjali f’ 0. 2% tal- pazjenti.
Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae.
Fsada severa tista ’ twassal għall- volum imnaqqas ta ’ demm fiċ- ċirkolazzjoni, pressjoni tad- demm baxx, xokk, u l - konsegwenzi kliniċi tagħhom.
36 – Anaphylactic/ oid reactions including urticaria, difficulty in breathing (e. g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
Rari (anqas minn 1 kull 1, 000 persuna affettwati) – Reazzjonijiet allerġiċi tal- ġilda (inkluż raxx), ħakk, fwawar, deni, tertir. – Reazzjonijiet anafilattiċi/ ojdi, inkluż urtikarja, diffikultà biex tieħu n- nifs (e. ż. li tikkonsisti fi spażmi), sogħla, ħoss qawwi man- nifs, akkumulazzjoni ta ’ ilma fil- ġisem u fil- ħajt ta ’ ġewwa ta ’ kanal (inkluż: edema fil- wiċċ, edema fl- ilsien, edema fil- griżmejn).
In severe cases these may lead to shock and death. – Injection site reactions, including pain.
F’ każijiet rari dawn jistgħu jwasslu għal xokk u mewt. – Reazzjonijiet fil- lok ta ’ l- injezzjoni, inkluż uġigħ.
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.
36 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 REFLUDAN
KIF TAĦŻEN REFLUDAN
Do not use Refludan after the expiry date which is stated on the carton and the vial after EXP.
Tużax Refludan wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- kunjett wara JIS.
Keep the -vial in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra.
Do not use Refludan if the reconstituted solution is cloudy or contains particles.
Tużax Refludan jekk is- soluzzjoni rikostitwita hija mdardra jew fiha xi frak.
Once reconstituted Refludan is to be used immediately.
La darba rikostitwit, Rifludan għandu jintuża mmedjatament.
Any unused solution must be discarded appropriately.
Kull fdal tas- soluzzjoni li ma tkunx intużat għandha tintrema b’ mod xieraq.
What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells.
Is- sustanza attiva hi lepirudin, prodott ta ’ DNA rikombinat li ġej minn ċellolli tal- ħmira.
The other ingredients are mannitol (E421) and sodium hydroxide for PH adjustment.
Is- sustanzi l- oħra huma mannitol (E421) u sodium hydroxide għall- aġġustament tal- PH.
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 20 mg lepirudin.
Refludan huwa trab abjad għal soluzzjoni għall- injezzjoni jew infużjoni pprovdut f’ kunjett li fih 20 mg lepirudin.
Refludan is available in packs of 1 or 10 vials.
Refludan huwa disponibbli f’ pakketti ta ’ kunjett wieħed jew 10 kunjetti.
Marketing Authorisation Holder Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Celgene Europe Ltd., Riverside House, Riverside Walk, Windsor, SL4 1NA, Renju Unit.
Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany.
Manifattur CSL Behring GmbH, Emil- von- Behring- Straße 76, 35041 Marburg, Ġermanja.
The following information is intended for medical or healthcare professionals only:
L- informazzjoni li ġejja hija maħsuba biss għall- professjonisti mediċi jew professjonisti fil- kura tas- saħħa:
Instructions for use and handling:
Istruzzjonijiet dwar l- użu u l- immaniġġjar:
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 0.4 ml of diluent into the vacuum vial and shake it gently.
Rakkomandazzjonijiet ġenerali – Rikostituzzjoni u aktar dilwazzjoni iridu jsiru taħt kondizzjonijiet sterili. – Għar- rikostituzzjoni għandhom jintużaw ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Għal aktar dilwazzjoni, soluzzjonijiet ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5% huma tajbin. – Għar- rikostituzzjoni ta ’ malajr u kompluta, injetta 0. 4 ml tad- dilwent ġol- kunjett mingħajr arja u ħawwad bil- mod.
On reconstitution a clear, colourless solution is usually obtained within less than 3 minutes. – Do not use solutions which are cloudy or contain particles. – The reconstituted solution is to be used immediately. – The preparation should be warmed to room temperature before administration. – Any unused solution must be discarded appropriately. – For injection only polypropylene syringes may be used.
Wara r- rikostituzzjoni, soluzzjoni ċara u bla kulur ġeneralment tinkiseb f’ inqas minn 3 minuti. – Tużax soluzzjonijiet li huma mdardra jew fihom xi frak. – Is- soluzzjoni rikostitwita għandha tintuża immedjatament. – Il- preparazzjoni għandha tissaħħan sat- temperatura tal- kamra qabel l- amministrazzjoni. – Kull soluzzjoni li ma tintużax għandha tintrema kif xieraq. – Għall- injezzjoni, jistgħu jintużaw biss siringi ta ’ polypropylene.
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous. bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion.
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 5 mg/ ml Għall- injezzjoni bolus ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 5 mg/ ml: – Irrikostitwixxi kunjett wieħed (20 mg ta ’ lepirudin) b’ 0. 4 ml ta ’ imla għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċentrazzjoni finali ta ’ 5 mg/ ml hija miksuba billi jiġi trasferit ġo siringa sterili, li tintuża darba (b’ kapaċità mill- inqas ta ’ 5 ml) u aktar dilwazzjoni sa volum totali ta ’ 4 ml bl- użu ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Is- soluzzjoni finali trid tiġi amministrata b’ mod dipendenti mill- piż tal- ġisem.
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion. – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 2 mg/ ml Għall- infużjoni kontinwa ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 2 mg/ ml: – Irrikostitwixxi żewġ kunjetti (kull wieħed fih 20 mg ta ’ lepirudin) b’ 0. 4 ml kull wieħed billi tuża ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċetrazzjoni finali ta ’ 2 mg/ ml tinkiseb billi jiġu trasferiti iż- żewġ soluzzjonijiet ġo siringa perfusor sterili waħda, li tintuża darba biss (kapaċità ta ’ 50 ml) u aktar dilwazzjoni sa volum totali ta ’ 20 ml permezz ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Il- veloċità ta ’ l- infużjoni tal- perfusor awtomat għandha tiġi ssettjata b’ mod dipendenti mil- piż tal- ġisem. – Is- siringa perfusor għandha tinbidel mill- inqas kull 12- il siegħa wara l- bidu ta ’ l- infużjoni.
Refludan 50 mg powder for solution for injection or infusion Lepirudin
Refludan 50 mg trab għal soluzzjoni għall- injezzjoni jew infużjoni Lepirudin
If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit.
Oqgħod attent ħafna b’ Refludan Jekk għandek tendenza għal fsada, it- tabib tiegħek se jiżen ir- riskju ta ’ għotja ta ’ Refludan kontra l - benefiċċju tiegħu.
Thus, please tell your doctor if you have or have had: – Recent puncture of large vessels or organs – Anomaly of vessels or organs – Recent stroke, accident or surgery involving the brain – High blood pressure – Inflammation of the inner membrane of the heart – Advanced kidney disease – Advanced bleeding tendency
Għalhekk, jekk jogħġbok għid lit- tabib tiegħek jekk għandek jew qatt kellek: – Titqib riċenti tal- kanali l- kbar tad- demm jew tal- organi – Anomalija tal- kanali l- kbar tad- demm jew tal- organi – Attakk reċenti ta ’ puplesija, aċċident jew kirurġija li jinvolvu l- moħħ – Pressjoni tad- demm għolja – Infjammazzjoni tal- membrana ta ’ ġewwa tal- qalb – Mard avvanzat tal- kliewi – Tendenza avvanzata għall- fsada – Kirurġija maġġuri reċenti – Fsad reċenti (e. ż. fil- moħħ, stonku/ intestini, għajnejn, pulmun)
39 – Recent major surgery – Recent bleeding (e. g. in brain, stomach/ intestine, eye, lung) – Obvious signs of bleeding – Recent active peptic ulcer – Age > 65 years
39 – Sinjali viżibbli ta ’ fsada – Ulċera peptika attiva reċenti – Eta ’ > 65 sena.
Like all medicines, Refludan can have side effects although not everybody gets them.
Bħal kull mediċina oħra, Refludan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
40 – Anaphylactic/ oid reactions including urticaria, difficulty in breathing (e. g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
Rari (anqas minn 1 kull 1, 000 persuna affettwati) – Reazzjonijiet allerġiċi tal- ġilda (inkluż raxx), ħakk, fwawar, deni, tertir. – Reazzjonijiet anafilattiċi/ ojdi, inkluż urtikarja, diffikultà biex tieħu n- nifs (e. ż. li tikkonsisti fi spażmi), sogħla, ħoss qawwi man- nifs, akkumulazzjoni ta ’ ilma fil- ġisem u fil- ħajt ta ’ ġewwa ta ’ kanal (inkluż: edema fil- wiċċ, edema fl- ilsien, edema fil- griżmejn).
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.
40 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.
The other ingredients are mannitol (E421) and sodium hydroxide for pH adjustment.
Is- sustanzi l- oħra huma mannitol (E421) u sodium hydroxide għall- aġġustament tal- PH.
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 50 mg lepirudin.
Refludan huwa trab abjad għal soluzzjoni għall- injezzjoni jew infużjoni pprovdut f’ kunjett li fih 50 mg lepirudin.
41 < ------------------------------------------------------------------------------------------------------------------------------
41 < -------------------------------------------------------------------------------------------------------------------------- ----
General recommendations – Reconstitution and further dilution must be carried out under sterile conditions. – For reconstitution water for injections or sodium chloride 9 mg/ ml (0.9%) solution are to be used. – For further dilution sodium chloride 9 mg/ ml (0.9%) or glucose 5% solutions are suitable. – For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently.
Rakkomandazzjonijiet ġenerali – Rikostituzzjoni u aktar dilwazzjoni iridu jsiru taħt kondizzjonijiet sterili. – Għar- rikostituzzjoni għandhom jintużaw ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Għal aktar dilwazzjoni, soluzzjonijiet ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5% huma tajbin. – Għar- rikostituzzjoni ta ’ malajr u kompluta, injetta 1 ml tad- dilwent ġol- kunjett mingħajr arja u ħawwad bil- mod.
Preparation of a Refludan solution with a concentration of 5 mg/ ml For intravenous. bolus injection a solution with a concentration of 5 mg/ ml is needed: – Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 5 mg/ ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The final solution is to be administered in a body weight-dependent fashion.
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 5 mg/ ml Għall- injezzjoni bolus ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 5 mg/ ml: – Irrikostitwixxi kunjett wieħed (50 mg ta ’ lepirudin) b’ 1 ml ta ’ imla għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċentrazzjoni finali ta ’ 5 mg/ ml hija miksuba billi jiġi trasferit ġo siringa sterili, li tintuża darba (b’ kapaċità mill- inqas ta ’ 10 ml) u aktar dilwazzjoni sa volum totali ta ’ 4 ml bl- użu ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Is- soluzzjoni finali trid tiġi amministrata b’ mod dipendenti mill- piż tal- ġisem.
Preparation of a Refludan solution with a concentration of 2 mg/ ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ ml is needed: – Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ ml (0.9%) solution. – The final concentration of 2 mg/ ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ ml (0.9%) or glucose 5% solution. – The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion. – The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Preparazzjoni ta ’ soluzzjoni ta ’ Refludan b’ konċetrazzjoni ta ’ 2 mg/ ml Għall- infużjoni kontinwa ġol- vina, hija meħtieġa soluzzjoni b’ konċetrazzjoni ta ’ 2 mg/ ml: – Irrikostitwixxi żewġ kunjetti (kull wieħed fih 50 mg ta ’ lepirudin) b’ 1 ml kull wieħed billi tuża ilma għall- injezzjoni jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%). – Il- konċetrazzjoni finali ta ’ 2 mg/ ml tinkiseb billi jiġu trasferiti iż- żewġ soluzzjonijiet ġo siringa perfusor sterili waħda, li tintuża darba biss (kapaċità ta ’ 50 ml) u aktar dilwazzjoni sa volum totali ta ’ 50 ml permezz ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew glucose 5%. – Il- veloċità ta ’ l- infużjoni tal- perfusor awtomat għandha tiġi ssettjata b’ mod dipendenti mil- piż tal- ġisem. – Is- siringa perfusor għandha tinbidel mill- inqas kull 12- il siegħa wara l- bidu ta ’ l- infużjoni.
EU Number
ANNESS A Numru ta ’ l- UE
Route of Administration
Mnjen jingħata
Packaging
Ippakketjar
Gel
Ġell
Cutaneous use
Għal fuq il- ġilda
Tube (polythylene)
Tubu b' ħafna dożi
1/ 1
Tubu wieħed
REGRANEX 0.01% gel
REGRANEX 0. 01% gel
REGRANEX contains100 µg of becaplermin per gram of gel.
REGRANEX fih 100 μg ta ’ becaplermin għal kull gramma ta ’ ġell.
Becaplermin is a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
Becaplermin huwa Fattur tat - Tkabbir Derivat mill- Platelet uman rikombinanti – BB (rhPDGF- BB).
It is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae. rhPDGF-BB is a dimeric protein with a molecular weight of approximately 24,500 daltons.
Huwa prodott bl- inserzjoni tal - ġene għall- katina B fattur tat- tkabbir derivat mill- platelet uman fil- ħmira, Saccharomyces cerevisiae. rhPDGF- BB huwa proteina dimerika b’ piż molekolari ta ’ madwar 24, 500 daltons.
For excipients, see 6.1.
Għal sustanzi mhux attivi, ara 6. 1.
REGRANEX is a clear colourless to straw-coloured preserved gel.
REGRANEX huwa ġell priżervat ċar ta ’ kważi l- ebda kulur għal kulur it- tiben.
REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
REGRANEX huwa indikat flimkien ma ’ miżuri tajbin għall- kura tal- feriti, sabiex jippromwovu l - granulazzjoni u l- konsegwenti fejqan ta ’ ulċeri dijabetiċi ta’ ħxuna sħiħa newropatiċi, kroniċi ta ’ inqas minn jew daqs 5cm2.
Treatment with REGRANEX should be initiated and monitored by physicians (specialists or non- specialists) who are experienced in the management of diabetic wounds.
Trattament b’ REGRANEX għandu jinbeda u jiġi segwit mit- tobba (speċjalisti jew mhux speċjalisti) li għandhom esperjenza fil- maneġġjar ta ’ feriti dijabetiċi.
REGRANEX should always be used in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/ or infected tissue), additional debridement as necessary and a non-weight-bearing regimen to alleviate pressure on the ulcer.
REGRANEX għandu dejjem jintuża flimkien ma ’ kura tajba ta ’ feriti konsistenti f’ debridement inizjali (sabiex jitneħħa t- tessut nekrotiku u/ jew infettat kollu), debridement addizzjonali kif ikun neċessarju u reġimen li fih ma jkunx hemm piż sabiex tiġi allevjata l- pressjoni minn fuq l- ulċera.
Wound-related infection should be identified and treated with appropriate antimicrobial therapy prior to the use of REGRANEX.
Infezzjoni relatata mal- ferita għandha tiġi identifikata u trattata b’ terapija approprijata antimikrobika qabel l- użu ta ’ REGRANEX.
Prior to the use of REGRANEX, related underlying conditions such as osteomyelitis and peripheral arteriopathy should be excluded or treated if present.
Qabel ma jintuża REGRANEX, kundizzjonijiet sottostanti relatati bħal ostjomelite u arterjoterapija periferali għandhom jiġu esklużi jew trattati jekk preżenti.
Osteomyelitis should be assessed by X-ray examination.
Ostejomelite għandu jiġi assessjat b’ eżaminazzjoni permezz ta ’ X- ray.
Peripheral arteriopathy should be excluded by assessment of the pedal pulses or other techniques.
Arterjoterapija periferali għandu jiġi eskluż permezz ta ’ assessjar tal- pedal pulses jew tekniċi oħrajn.
Ulcers with a suspicious appearance should be biopsied to exclude malignancy.
Ulċeri b’ apparenza suspettuża għanda ssirilhom bijopsija sabiex tiġi eskluża l- malinjita`.
REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using a clean application aid.
REGRANEX għandu jiġi applikat bħala saff irqiq kontinwu fuq iż- żoni intieri li fihom l- ulċeri darba kuljum bl- użu ta ’ strument għall- applikazzjoni nadif.
The site(s) of application should then be covered by a moist saline gauze dressing that maintains a moist wound-healing environment.
Is- sit( i) tal- applikazzjoni għandhom jiġu mgħottija b’ garża niedja bl- ilma bil- melħ (saline) li żżomm ambjent niedi għall- fejqan tal- feriti.
REGRANEX should not be used in conjunction with occlusive dressings.
REGRANEX m’ għandux jintuża b’ garża okklużiva.
REGRANEX should not be used for more than 20 weeks in any individual patient.
REGRANEX m’ għandux jintuża għal iktar minn 20 ġimgħa fuq pazjent individwali.
If during treatment with REGRANEX no meaningful healing progress is evident after the first ten weeks of continuous therapy, treatment should be re-evaluated, and factors known to compromise healing (such as osteomyelitis, ischaemia, infection) should be re-assessed.
Jekk waqt it- trattament b’ REGRANEX ma jidhrux sinjali sinjifikanti ta ’ progress ta ’ fejqan wara 10 ġimgħat ta ’ terapija kontinwa, it- trattament għandu jiġi rivalwat, u fatturi magħrufa li jikkompromettu l- fejqan (bħal ostjomelite, iskemija, infezzjoni) għandhom jiġu assesjati mill- ġdid.
Therapy should be continued to the maximum of 20 weeks as long as healing progress is seen on periodic evaluations.
It- terapija għandha titkompla għal massimu ta ’ 20 ġimgħa sakemm jirriżulta progress ta ’ fejqan waqt valutazzjonijiet perjodiċi.
2 REGRANEX is not intended for repeated use.
2 REGRANEX mhux intiż għal użu ripetut.
REGRANEX has not been studied in children.
REGRANEX ma ġiex studjat fuq tfal.
- Known hypersensitivity to the active substance or to any of the excipients of this product.
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi ta ’ dan il- prodott.
- Known neoplasm(s) at or near the site(s) of application.
- Neoplażma/ i maġhruf/ a fuq jew ħdejn is- sit( i) tal- applikazzjoni.
(See section 4.4).
- F’ pazjenti b’ ulċeri klinikament infettati (ara sezzjoni 4. 4)
Safety and effectiveness in children and adolescents below the age of 18 years have not been established.
Ma ġietx stabbilita is- sikurezza u l- effikaċja fi tfal u addoloxxenti ta ’ taħt l- eta` ta ’ 18 il- sena.
In view of the lack of data, REGRANEX should be used with caution in patients with known malignancies.
Minħabba nuqqas ta ’ informazzjoni, REGRANEX għandu jintuża b’ attenzjoni f’ pazjenti bi stat malin magħruf.
REGRANEX should not be used in patients with ulcers that are not of primarily neuropathic origin, such as those due to arteriopathy or other factors.
REGRANEX m’ għandux jintuża f’ pazjenti b’ ulċeri li m’ humiex ta ’ oriġini primarjament newropatiċi, bħal dawk ikkaġunati minn arterjopatija jew fatturi oħrajn.
Infection should be treated prior to the use of REGRANEX.
Infezzjonijiet għandhom jiġu trattati qabel ma jinbeda l- użu ta ’ REGRANEX.
If a wound becomes infected during REGRANEX therapy, the product should be discontinued until the infection has cleared.
Jekk ferita ssir infettata waqt terapija b' REGRANEX, l- prodott m’ għandux jibqa jintuża sakemm tfieq l- infezzjoni.
REGRANEX should not be used in ulcers of baseline surface area > 5 cm2, or for more than 20 weeks in any individual.
REGRANEX m’ għandux jintuża f’ ulċeri ta ’ linja bażi ta ’ erja superfiċjali > 5ċm2, jew fuq individwu għal iktar minn 20 ġimgħa.
There are insufficient data to support safe use of the product for more than 20 weeks (see 5.1 Pharmacodynamic properties).
M’ hemmx biżżejjed informazzjoni sabiex jassikura l- użu tal- prodott għal iktar minn 20 ġimgħa (ara 5. 1 Tagħrif farmakodinamiku).
Efficacy has not been demonstrated for ulcers of baseline surface area > 5 cm2.
Ma ġietx dimostrata l- effikaċja fuq ulċeri ta ’ linja bażi ta ’ erja superfiċjali > 5ċm2.
It is not known whether REGRANEX interacts with other topical medications applied to the ulcer site.
Mhux magħruf jekk REGRANEX jinteraġixxix ma ’ medikazzjonijiet topiċi oħrajn applikati fuq is- sit tal- ulċera.
Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.
Konsegwentement, huwa rrakomandat illi REGRANEX m’ għandux jiġi applikat fuq is- sit tal- ulċera b’ mod konġunt ma ’ medikazzjonijiet topiċi oħrajn.
No studies in pregnant women have been conducted.
Ma ġewx magħmula studji fuq nisa tqal.
Therefore, REGRANEX should not be used in pregnant women.
Għalhekk REGRANEX m’ għandux jintuża waqt it- tqala.
Nursing mothers
Ommijiet li qed ireddgħu
It is not known whether becaplermin is excreted in human milk.
Mhux magħruf jekk becaplermin huwiex eskretat fil- ħalib uman.
Therefore, REGRANEX should not be used in nursing mothers.
Għalhekk REGRANEX m’ għandux jintuża f’ ommijiet li qed ireddgħu.
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.
Il- lista segwenti ta ’ reazzjonijiet avversi hija bbażata fuq esperjenza minn provi kliniċi u fuq esperjenza wara li tpoġġa fuq is- suq.
3 Adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000).
3 Reazzjonjiet avversi huma imnizzla taħt titli ta ’ frekwenza (numru ta ’ pazjenti mistennija li jesperjenzaw ir- reazzjoni), skond is- segwenti kategoriji: komuni ħafna (> 1/ 10); komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1000, < 1/ 100); rari (> 1/ 10, 000, < 1/ 1000); rari ħafna (< 1/ 10, 000).
Serious adverse reactions reported in clinical trials.
Reazzjonijiet avversi serji rrapurtati fil- provi kliniċi.
The following adverse reactions were reported in the randomised clinical trials of REGRANEX therapy:
Ir - reazzjonijiet avversi li ġejjin ġew irrapurtati fi provi kliniċi randomizzati ta ’ terapija b’ REGRANEX:
Infection (very common), osteomyelitis (common), cellulitis (very common), skin ulceration (very common), skin disorder (including erythema) (common), and pain (common).
Infezzjoni (komuni ħafna), ostjomelite (komuni), ċellulite (komuni ħafna), ulċerazzjoni tal- ġilda (komuni ħafna), mard fil- ġilda (inkluż eritema) (komuni), u uġigħ (komuni).
Bullous eruption and oedema were reported rarely.
Eruzzjoni bulloża u edima ġew irrapurtati rarament.
Serious adverse reactions based on postmarketing experience.
Reazzjonijiet avversi serji bbażati fuq esperjenza wara li tpoġġa fuq is- suq.
Rare cases of hypertrophic granulation have been reported.
Ġew irrapurtati każijiet rari ta ’ granulazzjoni ipertrofika.
Since absorption is insignificant from the site of topical application, no untoward systemic events are expected.
Minħabba li l- assorbiment huwa insinifikanti mis- sit tal- applikazzjoni topika, mhux mistennijja eventi sistemiċi inkonvenjenti.
Preparation for treatment of wounds and ulcers, ATC code:
Preparazzjoni għal trattament ta ’ feriti u ulċeri, Kodiċi ATC:
REGRANEX contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
REGRANEX fih becaplermin, Fattur tat- Tkabbir Derivat mill- Platelet uman rikombinanti – BB (rhPDGF- BB).
Becaplermin is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae.
Becaplermin huwa prodott permezz tal- inseriment tal - ġene għall- katina B fattur tat - tkabbir derivat mill- platelet uman fil- ħmira, Saccharomyces cerevisiae.
The biological activity of becaplermin includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair.
L- attivita` bijoloġika ta ’ becaplermin tinkludi li tgħin fir- reklutaġġ kemjotattiku u l- profilerazzjoni ta ’ ċelluli involuti fir - riparazzjoni ta ’ feriti.
Thus it helps the growth of normal tissue for healing.
Għalhekk, jgħin l- iżvilupp ta ’ tessut normali għall- fejqan.
In animal wound models, the predominant effect of becaplermin is to enhance the formation of granulation tissue.
F’ mudelli ta ’ feriti ta ’ annimali, l- effett predominanti ta ’ becaplermin huwa li jtejjeb il- formazzjoni ta ’ tessuti ta ’ granulazzjoni.
From data combined from 4 clinical trials conducted over a 20 week treatment phase for ulcers of baseline surface area less than or equal to 5 cm2, 47% of ulcers treated with becaplermin 100 µg/ g gel completely healed, compared to 35% which were treated with placebo gel alone.
Minn informazzjoni kkombinata minn 4 provi kliniċi magħmula fuq fażi ta ’ trattament ta ’ 20 ġimgħa għal ulċeri ta ’ linja bażi ta ’ erja superfiċjali ta ’ inqas minn jew daqs 5ċm2, 47% tal - ulċeri trattati b ’ becaplermin 100μg/ g ġell fiequ kompletament, ipparagunati ma ’ 35% li ġew trattati b’ ġell plaċebo waħdu.
Subjects recruited into these studies were diabetic adults aged 19 years or over who were suffering from at least one stage III or IV diabetic ulcer of at least 8 weeks duration.
Soġġetti reklutati f’ dawn l- istudji kienu dijabetiċi adulti ta ’ 19- il sena jew iktar li kienu qed ibatu minn ta ’ l- inqas stadju III jew IV ta ’ ulċeri dijabetiċi għal mill- inqas 8 ġimgħat.
Since becaplermin is a growth factor, which stimulates the proliferation of cells, it must be cautiously used in patients with malignancies.
Minħabba li becaplermin huwa fattur ta ’ tkabbir, li jistimula l- proliferazzjoni taċ- ċelluli, huwa għandu jintuża b’ mod kawt f’ pazjenti b’ malinjitajiet.
Clinical absorption studies were conducted in patients with a mean diabetic ulcer area of 10.5 cm² (range 2.3 - 43.5 cm²).
Studji kliniċi ta ’ assorbiment ġew magħmula f’ pazjenti ta ’ erja ta ’ ulċeri dijabetiċi medji ta ’ 10. 5ċm2 (firxa ta ’ 2. 3 – 43. 5 ċm2).
Following 14 consecutive daily topical applications of REGRANEX, only insignificant systemic absorption of becaplermin occurred.
Wara 14- il jum konsekutiv ta ’ applikazzjoni topikali ta ’ kuljum ta ’ REGRANEX, kien hemm biss assorbiment sistemiku insinifikanti ta ’ becaplermin.
4 5.3 Preclinical safety data
4 Becaplermin ma ’ kienx mutaġeniku f’ għadd ta ’ testjiet in vitro u in vivo.