qanastek/EMEA-V3 huggingface dataset:
The reconstituted solution should be administered immediately by intravenous injection.
Is- soluzzjoni rikostitwita għandha tingħata immedjatament b' injezzjoni fil- vini.
BAXTER AG Industriestrasse 67 A-1220 Vienna Austria
BAXTER AG Industriestrasse 67 A- 1220 Vienna Awstrija
16 July 2001 Date of last renewal:
16 ta 'Lulju 2001 Data ta' l- aħħar tiġdid:
16 July 2006
16 ta 'Lulju 2006
CEPROTIN 1000 IU powder and solvent for solution for injection
CEPROTIN 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni
CEPROTIN 1000 IU* is prepared as a powder containing nominally 1000 IU human protein C per container.
CEPROTIN 1000 IU * huwa ppreparat bħala trab li jkun fih b’ mod nominali 1000 IU ta 'proteina Ċ tal- bniedem f' kull kontenitur.
The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ ml human protein C.
Il- prodott li jiġi rikostitwit b’ 10 ml ilma għall- injezzjoni jkun fih madwar 100 IU/ ml ta ’ proteina Ċ.
88 mg/ vial Sodium citrate.
88 mg/ kunjett Sodium citrate:
44 mg/ vial
44 mg/ kunjett
CEPROTIN is indicated in purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein C deficiency.
CEPROTIN huwa indikat f’ purpura fulminans u f’ nekrożi tal- ġilda kkaġunata minn kumarina f’ pazjenti li għandhom defiċjenza konġenitali serja tal- Proteina Ċ.
A protein C activity of 100% should be achieved initially and the activity should be maintained above 25% for the duration of the treatment.
Fil- bidu għandha tinkiseb attività tal- proteina Ċ ta '100% u l- attività għandha tinżamm' il fuq minn 25% għat- tul tal- kura.
An initial dose of 60 to 80 IU/ kg for determination of recovery and half-life is advised.
9 Doża inizjali ta ’ 60 sa 80 IU/ kg hija rakkomandata sabiex jiġi stabbilit l- irkupru u t- tul ta ’ żmien li jieħu biex jinżel bin- nofs.
9 The measurement of protein C activity using chromogenic substrates is recommended for the determination of the patient’ s plasma level for protein C before and during treatment with CEPROTIN.
Il- kejl ta 'l- attività tal- proteina Ċ bl- użu ta' substratti kromoġeniċi huwa rakkomandat sabiex jiġi stabbilit il- livell tal- proteina Ċ fil- plażma tal- pazjent qabel u waqt il- kura b' CEPROTIN.
If the patient is switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (See 4.5).
Jekk il- pazjent jiġi maqlub għal profilassi permanenti b' sustanzi orali kontra l- koagulazzjoni tad - demm, is- sostituzzjoni tal- proteina Ċ għandha titwaqqaf biss meta tinkiseb antikoagulazzjoni stabbli (Ara sezzjoni 4. 5).
4.4 Special warnings and precautions for use
10 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
As the risk of an allergic type hypersensitivity reaction cannot be excluded, patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Billi r- riskju ta ’ reazzjoni ta ’ sensittività eċċessiva ta ’ tip allerġiku ma tistax tiġi eskluża, il- pazjenti għandhom jiġu infurmati bl- istadji bikrija ta ’ reazzjonijiet ta ’ sensittività eċċessiva inklużi ħorriqija, urtikarja ġeneralizzata, għafis tas- sider, tħarħir, pressjoni baxxa ħafna u anafilassi.
If these symptoms occur, they should inform the physician.
Jekk ikun hemm dawn is- sintomi, huma għandhom jinfurmaw lit- tabib.
10 No experience in the treatment of patients with renal and/ or hepatic impairment is available and therefore it is recommended that such patients be monitored more closely.
M' hemmx disponibbli esperjenza fil- kura ta 'pazjenti b' indeboliment renali u/ jew epatiku u għalhekk huwa rakkomandat li dawn il- pazjenti jiġu mmonitorjati aktar mill- qrib.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Il- miżuri meħuda jistgħu jkunu ta 'valur limitat kontra virus mhux miksija bħall - parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e. g. haemolytic anaemia).
Infezzjoni bil- parvovirus B19 tista 'tkun serja għal nisa tqal (infezzjoni tal- fetu) u għal persuni b' immunodefiċjenza jew eritrpoesi akbar (p. e. anemija emolitika).
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular / repeated receipt of human plasma-derived Protein C products.
Għandu tiġi kkunsidrata vaċċinazzjoni xierqa (epatite A u B) għal pazjenti li jirċievu b' mod regolari/ ripetut prodotti tal- Proteini C derivati minn plażma umana.
In patients with HIT, symptoms such as arterial and venous thrombosis, disseminated intravascular coagulation (DIC), purpura, petechiae and gastrointestinal bleeding (melena), may occur.
F’ pazjenti b’ HIT, jistgħu jseħħu sintomi bħalma huma trombożi ta ’ l - arterja u tal- vina, koagulazzjoni intravaskulari mifruxa (DIC), purpura, tbenġil, u emorraġija fl - imsaren (melena).
II, IX and X).
Dan l- effett temporanju jista 'jiġi spjegat bil- fatt li l- proteina Ċ, li hija nnifisha proteina tal- plażma dipendenti fuq
11 4.6 Pregnancy and lactation
11 il- vitamina K, għandha half- life iqsar mill- biċċa l- kbira tal- proteini dipendenti fuq il- vitamina K (jiġifieri II, IX u X).
Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomitingand wheezing.
Il- pazjenti għandhom jiġu infurmati dwar is- sinjali bikrija tar- reazzjonijiet ta 'sensittività eċċessiva, li jistgħu jinkludu anġjoedema, ħruq u tingiż fil- post ta' l- injezzjoni, kesħa, fwawar, raxx, urtikarja ġeneralizzata, uġigħ ta 'ras, ħorriqija, pressjoni baxxa, ħedla, nawsja, nuqqas ta' kwiet, takikardija, uġigħ tas- sider, tnemnim, rimettar, u tħarħir.
During clinical studies with CEPROTIN, a total of 6 non-serious adverse drug reactions (ADRs) were reported in 3 of 225 patients enrolled.
Waqt studji kliniċi b' CEPROTIN, kienu rrapportati b' kollox 6 reazzjonijiet avversi mhux serji għall- mediċina (ADRs) fi 3 mill- 225 pazjent irreġistrat.
APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S.
APC hija protease tas- serine b’ effetti qawwija ta ’ kontra l- koagulazzjoni, speċjalment fil- preżenza tal- kofattur proteina S.
APC exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation.
APC jeżerċita l- effett tiegħu bl- inattivazzjoni tal - għamliet attivati tal- fatturi V u VIII li jwasslu għat- tnaqqis fil- formazzjoni ta ’ trombin.
12 Twelve courses of short-term prophylaxis prior to surgery or invasive therapy and 7 courses of long- term prophylaxis were included in the efficacy analyses.
Tnax- il- kors ta ’ profilassi fuq perjodu qasir qabel il- kirurġija jew terapija invażiva u 7 korsijiet ta ’ profilassi fuq tul ta ’ żmien ġew inklużi f’ analiżi ta ’ l- effikaċja.
21asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data.
Ġew evalwati 21suġġett asimtomtomatiku b’ defiċjenza tal- proteina omożigota jew eterożigota doppja għal informazzjoni farmakokinetika.
The individual half-lives varied from 4.4 to 15.8 hours using a compartmental model and from 4:9 to 14.7 using the non-compartmental method.
Iż- żminijiet individwali li jieħdu biex jinżlu bin- nofs varjaw minn 4. 4 sa 15. 8 sigħat bl- użu tal- mudell kumpartimentali u minn 4. 9 sa 14. 7 sigħat bl- użu tal- mudell mhux kumpartimentali.
Repeated toxicity studies were not conducted because prior experience with coagulation preparations had shown them to be of limited value.
13 Ma sarux studji ripetuti tat- tossiċità minħabba li l- esperjenza preċedenti bi preparazzjonijiet tal- koagulazzjoni wriet li dawn kienu ta ’ valur ristrett.
13 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Special precautions for storage
Prekawzjonijiet speċjali għall- ħażna
Any unused product or waste material should be disposed of in accordance with local requirements.
14 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
MARKETING AUTHORISATION NUMBER
NUMRU TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance(s)
Isem u indirizz tal- manifattur( i) tas- sustanza( i) bijoloġika( ċi) attiva( i)
Baxter AG Industriestrasse 67 A-1220 Vienna Austria
Baxter AG Industriestrasse 67 A- 1220 Vienna L- Awstrija
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni 4. 2).
The Marketing Authorisation Holder is requested to submit yearly PSURs unless otherwise specified by the CHMP.
Id- detentur ta ’ l awtorizzazzjoni għat- tqegħid fis- suq huwa mitlub jissottometti PSURs kull sena sakemm ma jiġix speċifikat mod ieħor mill- CHMP.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
LABELING
TIKKETTA
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON
KARTUNA TA 'BARRA
CEPROTIN 500 IU Powder and solvent for solution for injection Human Protein C
Proteina Ċ tal- bniedem
One vial provides 100 IU per ml of human protein C when reconstituted as recommended.
Kunjett wieħed jagħti 100 IU għal kull ml ta 'proteina Ċ tal- bniedem meta rikostitwita kif rakkomandata.
Human albumin, sodium chloride and sodium citrate.2H2O
Albumina tal- bniedem, sodium chloride u sodium citrate. 2H2O
Contents:
Kontenut:
Powder and solvent for solution for injection One transfer needle and one filter needle
Labra waħda ta ’ trasferiment u labra tal- filtru waħda
Intravenous use
Użu fil- vini
OTHER SPECIAL WARNINGS, IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXP {month/ year}
JIS {xahar/ sena}
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
Baxter AG A-1220 Vienna, Austria
Baxter AG A- 1220 Vienna, L- Awstrija
Lot {number}
Lott {numru}
Medicinal product subject to medical prescription.
Prodott mediċinali li jingħata bir- riċetta tat- tabib.
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CEPROTIN 500 IU Powder for solution for injection Human Protein C IV
CEPROTIN 500 IU Trab għal soluzzjoni għall- injezzjoni Proteina Ċ tal- Bniedem IV
METHOD OF ADMINISTRATION
METODU TA ’ KIF JINGĦATA
22 WATER FOR INJECTIONS
22 ILMA GĦALL- INJEZZJONIJIET
5 ml Sterilised Water for Injections
5 ml Ilma Sterilizzat għall- Injezzjonijiet
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CEPROTIN 1000 IU Powder and solvent for solution for injection Human Protein C
Proteina Ċ tal- bniedem
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( i) ATTIVA( I)
Human albumin, sodium chloride and sodium citrate.2H2O
Albumina umana, sodium chloride u sodium citrate. 2H2O
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CEPROTIN 1000 IU Powder for solution for injection Human Protein C IV
CEPROTIN 1000 IU Trab għal soluzzjoni għall- injezzjoni Proteina Ċ tal- bniedem IV
26 WATER FOR INJECTIONS
26 ILMA GĦALL- INJEZZJONIJIET
10 ml Sterilised Water for Injections
10 ml Ilma Sterilizzat għall- injezzjonijiet
PACKAGE LEAFLET
FULJETT TA 'TAGĦRIF
28 PACKAGE LEAFLET:
28 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER CEPROTIN 500 IU powder and solvent for solution for injection Human Protein C
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA CEPROTIN 500 IU trab u solvent għal soluzzjoni għall- injezzjoni Proteina Ċ tal- bniedem
You may need to read it again.
Jista 'jkollok bżonn terġa' taqrah.
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek
It may harm them, even
Tista 'tagħmlilhom il- ħsara,
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex
please tell your doctor or pharmacist.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What CEPROTIN is and what it is used for 2.
X' inhu CEPROTIN u għalxiex jintuża 2.
Before you use CEPROTIN 3.
Qabel ma tuża CEPROTIN 3.
How to use CEPROTIN 4.
Kif għandek tuża CEPROTIN 4.
How to store CEPROTIN 6.
Kif taħżen CEPROTIN 6.
WHAT CEPROTIN IS AND WHAT IT IS USED FOR
X' INHU CEPROTIN U GĦALXIEX JINTUŻA
CEPROTIN belongs to a class of medicines called antithrombotics.
CEPROTIN jagħmel parti minn klassi ta 'mediċini msejħa antitrombotiċi.
This medicine contains Protein C, a natural protein that is made in the liver and is present in your blood.
Din il- mediċina fiha l- proteina Ċ, proteina naturali li ssir fil- fwied u hija preżenti fid- demm tiegħek.
Protein C plays a major role in prevention of excessive clot formation thus, prevent and/ or treat intravascular thrombosis.
Il- proteina Ċ għandha rwol importanti fil- prevenzjoni tal- ħolqien eċċessiv ta 'emboli u b' hekk, timpedixxi u/ jew tikkura trombożi intravaskulari.
CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency.
CEPROTIN jintuża fil- kura u l- prevenzjoni ta 'feriti trombotiċi u emorraġiċi tal- ġilda (imsejħa purpura fulminans) f' pazjenti b' defiċjenza konġenita severa ta' proteina Ċ.
Additionally, CEPROTIN may be used to treat a rare complication of a blood thinner medication (anticoagulant medication named coumarin) which may result in severe skin lesion (necrosis).
Barra minn hekk, CEPROTIN jista 'jintuża biex tiġi kkurata komplikazzjoni rari ta' medikazzjoni li traqqaq id- demm (medikazzjoni kontra l- koagulazzjoni tad- demm imsejħa coumarin) li tista 'tirriżulta f' leżjonijiet severi tal- ġilda (nekrożi).
Furthermore CEPROTIN is used to prevent thrombosis in patients with severe congenital protein C deficiency if one or more of the following conditions are met: • surgery or invasive therapy is imminent • while initiating coumarin (anticoagulant medication, blood thinner) therapy • when coumarin therapy alone is not sufficient • when coumarin therapy is not feasible.
Barra minn hekk, CEPROTIN jintuża sabiex tkun evitata trombożi f' pazjenti b' defiċjenza konġenita severa ta 'proteina Ċ jekk tiġi sodisfatta waħda jew aktar mill- kondizzjonijiet li ġejjin: • kirurġija jew terapija intensiva tkun imminenti • waqt li tinbeda terapija b' kumarin (medikazzjoni kontra l- koagulazzjoni tad- demm, traqqiq tad- demm) • meta terapija bil- kumarina weħedha biss m’ hijiex biżżejjed • meta t- terapija bil- kumarina ma tkunx vijabbli.
BEFORE YOU USE CEPROTIN
QABEL MA TUŻA CEPROTIN
Do not use CEPROTIN,
Tużax CEPROTIN,
- if you are allergic (hypersensitive) to Human Protein C or any of the other ingredients of
- jekk int allerġiku (tbati minn sensittività eċċessiva) għall- Proteina Ċ tal- bniedem jew għal xi
CEPROTIN including mouse protein or heparin.
sustanza oħra ta 'CEPROTIN inkluż il- proteina tal- ġrieden jew l- eparina.
However, in the case of life-threatening thrombotic complications your doctor may still decide to continue treatment with CEPROTIN.
Madankollu, f’ każijiet fejn jista ’ jkun hemm komplikazzjonijiet mit- trombozi li jkunu ta ’ theddida għall- ħajja, it- tabib tiegħek jista ’ jiddeċiedi li jissokta bit- trattament ta’ ĊEPROTIN.
Take special care with CEPROTIN,
29 Oqgħod attent ħafna b' CEPROTIN,
if symptoms of allergy occur.
jekk jidhru sintomi ta 'allerġija.
Symptoms of allergy include rash, hives, breathing difficulties, low blood pressure, tightness of chest, and shock.
Is- sintomi ta 'allerġija jinkludu raxx, ħorriqija, diffikultajiet fit- teħid tan- nifs, pressjoni baxxa tad- demm, uġigħ tas- sider, u xokk.
If such symptoms occur during the administration of CEPROTIN, injection should be stopped.
Jekk sintomi bħal dawn iseħħu waqt l- għoti ta 'CEPROTIN, l- injezzjoni għandha titwaqqaf.
Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin.
Tali sintomi jistgħu jirrappreżentaw reazzjoni allerġika għal xi wieħed mill- komponenti, għall- proteina tal- ġrieden jew l- eparina.
The preparation may contain traces of heparin and/ or
Il- preparazzjoni jista 'jkun fiha traċċi ta' eparina u/ jew proteina tal- ġrieden bħala riżultat tal- proċess ta 'produzzjoni.
If such a reaction occurs, your doctor will decide on the most appropriate treatment.
Jekk isseħħ reazzjoni simili, it- tabib tiegħek għandu jiddeċiedi dwar l- aktar kura adattata.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Meta l- mediċini jkunu magħmulin mid- demm jew plażma umana, jiddaħħlu ċerti miżuri biex jiġi evitat li jiġu mgħoddija infezzjonijiet lill- pazjenti.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/ infections.
Dawn jinkludu l- għażla attenta tad- donaturi tad- demm u plażma sabiex jiġi żgurat li dawk f' riskju li jġorru xi infezzjonijiet huma esklużi, u l- ittestjar ta 'kull donazzjoni u puls ta' plażma għal sinjali ta 'virus/ infezzjonijiet.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Il- manifatturi ta 'dawn il- prodotti jinkludu wkoll passi fl- ipproċessar tad- demm jew plażma li jistgħu jwaqqfu jew ineħħu l- virus.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Minkejja dawn il- miżuri, meta jingħataw mediċini ppreparati mid- demm jew plażma umana, il- possibbilta 'li tiġi mgħoddija infezzjoni ma tistax tiġi eliminata għalkollox.
This also applies to any unknown or emerging viruses or other types of infections.
Dan japplika wkoll għal kull virus mhux magħruf jew emerġenti jew tipi oħra ta 'infezzjonijiet.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Il- miżuri meħuda huma meqjusa effettivi għal virus miksija bħal ngħidu aħna l- virus ta 'l- immunodefiċjenza umana (HIV), il- virus ta' l- epatite B u l- virus ta 'l- epatite C, u għall- virus mhux miksi ta' l- epatite A.
Parvovirus B 19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e. g. sickle cell disease or haemolytic anaemia).
Infezzjoni bil- parvovirus B19 tista 'tkun serja għal nisa tqal (infezzjoni tal- fetu) u għal persuni li s- sistema immunitarja tagħhom hija depressa jew li għandhom xi tipi ta' anemija (p. e. sickle cell disease jew anemija emolitika).
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/ repeatedly receive human plasma-derived Protein C products.
It- tabib tiegħek jista 'jissuġġerilek li tikkunsidra li tieħu tilqima kontra l- epatite A u B jekk inti tirċievi b' mod regolari/ ripetut prodotti tal- proteina Ċ derivati minn plażma umana.
Taking other medicines
Meta tieħu CEPROTIN ma ’ l- ikel u max- xorb
Nevertheless, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Madankollu, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you change to treatment with oral anticoagulants, treatment with CEPROTIN must continue until the blood level of the oral anticoagulation is adequate and stable.
Jekk taqleb għal kura b' sustanzi orali kontra l- koagulazzjoni tad- demm, il- kura b' CEPROTIN trid tissokta sakemm il- livell fid- demm tas- sustanza orali kontra l- koagulazzjoni jkun adegwat u stabbli.
Using CEPROTIN with food and drink
Meta tieħu CEPROTIN ma 'l- ikel u xorb
Pregnancy and breast-feeding
Tqala u Treddigħ
Inform your doctor if you are pregnant or breast-feeding.
Informa lit- tabib tiegħek jekk inti tqila jew qiegħda tredda '.
Your doctor will decide if CEPROTIN may be used during pregnancy and lactation.
It- tabib tiegħek jiddeċiedi jekk CEPROTIN jistax jintuża waqt it- tqala u treddigħ.
CEPROTIN has no influence on your ability to drive or to operate machines.
Sewqan u tħaddim ta 'magni CEPROTIN m' għandux effett fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Important information about some of the ingredients of CEPROTIN
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'CEPROTIN
As the quantity of sodium in the maximum daily dose may exceed 200 mg, this should be taken into consideration by patients on a controlled sodium diet.
Billi l- kwantità ta 'sodju fid- doża massima ta' kuljum tista 'taqbeż 200 mg, dawk il- pazjenti li qegħdin fuq dieta ta' sodju kkontrollat għandhom jikkunsidraw dan.
HOW TO USE CEPROTIN
KIF TUŻA CEPROTIN
CEPROTIN is intended for intravenous administration (infusion into a vein).
CEPROTIN huwa maħsub sabiex jingħata ġol- vini (infużjoni ġo vina).
It is given to you under close supervision of your doctor who is experienced in substitution therapy of coagulation factors/ inhibitors and where monitoring of protein C activity is possible.
Huwa jingħatalek taħt is- superviżjoni mill- qrib tat- tabib tiegħek li għandu esperjenza f' terapija ta 'sostituzzjoni ta' fatturi/ inibituri tal- koagulazzjoni tad- demm u fejn ikun possibbli monitoraġġ ta 'l- attività tal- proteina Ċ.
Dosage will vary depending on your condition and your body weight.
Id- dożaġġ ivarja skond il- kondizzjoni tiegħek u l- piż korporju tiegħek.
30 Dosage
Dożaġġ
The dose, administration frequency and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and on your plasma level of protein C.
Id- doża, il- frekwenza ta 'kemm jingħata u t- tul tal- kura jiddependu fuq is- severità tad- defiċjenza ta' proteina C kif ukoll fuq il- kondizzjoni klinika tiegħek u fuq il- livell ta 'proteina Ċ fil- plażma tiegħek.
They should be adjusted accordingly on the basis of clinical effectiveness and laboratory assessment.
Dawn għandhom jiġu aġġustati kif meħtieġ fuq il- bażi ta 'l- effikaċja klinika u valutazzjoni fil- laboratorju.
An initial dose of 60 to 80 IU/ kg should be administered.
Fil- bidu għandha tingħata doża ta '60 sa 80 IU/ kg.
Your physician will take several blood drawings over time to determine how long protein C is remaining in your body.
It- tabib tiegħek se jeħodlok id- demm diversi drabi fuq perjodu ta 'ħin sabiex jistabbilixxi kemm qiegħda ddum il- proteina Ċ fil- ġisem tiegħek.
The measurement of protein C activity using chromogenic substrates is recommended for the determination of your plasma level for protein C before and during treatment with CEPROTIN.
Il- kejl ta 'l- attività tal- proteina Ċ bl- użu ta' substratti kromoġeniċi huwa rakkomandat sabiex jiġi stabbilit il- livell tal- proteina Ċ fil- plażma tal- pazjent qabel u waqt il- kura b' CEPROTIN.
In the case of an acute thrombotic event these should be performed every 6 hours until your condition is stabilised, thereafter twice a day and always immediately before the next injection.
Fil- każ ta 'episodju trombotiku akut dawn għandhom isiru kull 6 sigħat sakemm il- kondizzjoni tiegħek tistabbilizza ruħha, imbagħad darbtejn kuljum u dejjem immedjatament qabel l- injezzjoni li tmiss.
If you have kidney and/ or liver disease, please inform your doctor, because he may have to adjust your treatment accordingly.
Jekk għandek mard tal- kliewi u/ jew tal- fwied, jekk jogħġbok informa lit- tabib tieħek, billi huwa jista 'jkollu bżonn jaġġusta l- kura tiegħek f' dak ir- rigward.
If you are switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see “ Important information about some of the ingredients of CEPROTIN”).
Jekk tiġi mdawwar għal profilassi permanenti b' sustanzi orali kontra l- koagulazzjoni tad- demm, is- sostituzzjoni tal- proteina C għandha titwaqqaf biss meta tinkiseb antikoagulazzjoni stabbli (ara “ Tagħrif importanti dwar xi wħud mis- sustanzi ta 'CEPROTIN ”).
If you receive prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Jekk inti tirċievi amministrazzjoni profilattika ta 'proteina C, jistgħu jkunu meħtieġa livelli minimi aktar għoljin f' sitwazzjonijiet ta' riskju akbar ta 'trombożi (bħal infezzjoni, trawma, jew intervent kirurġiku).
If you have APC resistance which is a thromboembolic risk factor present in up to 5% of the population in Europe your doctor may need to adjust your treatment accordingly.
Jekk inti għandek reżistenza għall- APC li hija fattur ta 'riskju trombo- emboliku preżenti f' sa 5% tal- popolazzjoni fl- Ewropa, it- tabib tiegħek jista' jkollu bżonn jaġġusta l- kura tiegħek kif dovut.
Administration
Kif jingħata
CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
CEPROTIN jingħatalek b' injezzjoni fil- vina wara rikostituzzjoni tat- trab għal soluzzjoni għall- injezzjoni b' Ilma Sterilizzat għall- Injezzjonijiet.
It is strongly recommended that every time you receive a dose of CEPROTIN the name and batch number of the product are recorded in order to maintain a record of the batches used.
Huwa rakkomandat ħafna li kull darba li tirċievi doża ta 'CEPROTIN l- isem u n- numru tal- lott tal- prodott jiġu rrekordjati sabiex jinżamm rekord tal- lottijiet użati.
After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe.
Wara li tiġi rikostitwita, is- soluzzjoni tinġibed minn ġol- labra tal- filtru sterilizzata għal ġo siringa sterilizzata li wara tista 'tintrema.
The solution should be discarded if particulate matter is visible.
Is- soluzzjoni għandha tiġi skartata jekk tara materjal f' sura ta 'partikoli separati.
CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
31 CEPROTIN għandu jingħata b' rata massima ta 'injezzjoni ta' 2 ml fil- minuta.
In children with a body weight of less than 10 kg, the injection rate should not exceed a rate of 0.2 ml/ kg/ min.
Fi tfal li għandhom piż korporju ta 'anqas minn 10 kg, ir- rata ta' l- injezzjoni m' għandhiex taqbeż rata ta '0. 2ml/ kg/ min.
All unused solution, empty vials and used needles and syringes must be discarded appropriately.
Kull soluzzjoni mhux użata, kunjetti vojta u labar u siringi użati għandhom jintremew b' mod xieraq.
Frequency and duration of treatment depend on the severity of your protein C deficiency, on the results of determination of protein C levels in your plasma as well as on the location and extent of thrombosis.
Il- frekwenza u t- tul tal- kura jiddependu fuq is- severità tad- defiċjenza ta 'proteina C tiegħek, fuq ir- riżultati ta' l- istabbiliment tal- livelli ta 'proteina C fil- plażma tiegħek kif ukoll fuq il- post u l- miżura tat- trombożi.
31 In case of acute thrombosis CEPROTIN may be administered to you every 6 hours.
F' każ ta 'trombożi akuta CEPROTIN jista' jingħatalek kull 6 sigħat.
As the tendency for thrombus formation decreases, the frequency may be reduced.
Hekk kif tonqos it- tendenza għall- ħolqien ta 'emboli tad- demm, il- frekwenza tista' tiġi mnaqqsa.
If you use more CEPROTIN than you should
Jekk tuża CEPROTIN aktar milli suppost
It is recommended that you adhere to the dose level and frequency of administration as recommended by your doctor.
Huwa rakkomandat li inti żżomm mal- livell ta 'doża u l- frekwenza ta' amministrazzjoni kif rakkomandat mit- tabib tiegħek.
In case you administered more CEPROTIN than recommended, please inform your doctor as soon as possible.
F' każ li tieħu aktar CEPROTIN milli rakkomandat, jekk jogħġbok informa lit- tabib tiegħek mill- aktar fis.
If you forgot to take CEPROTIN
Jekk tinsa tieħu CEPROTIN
If you stop using CEPROTIN
Jekk tieqaf tuża CEPROTIN
Do not stop using CEPROTIN without consulting your doctor.
Twaqqafx CEPROTIN mingħajr ma tikkonsulta mat- tabib tiegħek.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA 'JKOLLU
Like all medicines, CEPROTIN can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CEPROTIN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You may notice any of the following side effects after administration of CEPROTIN: • As with any product administered by infusion into a vein allergic reactions including severe and potentially life-threatening reactions (anaphylaxis) are possible but have not been seen with CEPROTIN.
Inti tista 'tinnota kull wieħed mill- effetti sekondarji li ġejjin wara li tieħu CEPROTIN: • Bħal fil- każ ta' kull prodott ieħor mogħti b' infużjoni ġo vina jista 'jkun hemm reazzjonijiet allerġiċi fosthom reazzjonijiet severi u potenzjalment ta' periklu għall- ħajja iżda dawn ma dehrux b' CEPROTIN.
Nevertheless you should be aware of the early signs of allergic reactions such as burning and stinging at the injection site, chills, flushing, rash, hives, breathing difficulty, nausea, headache, lethargy, low blood pressure, and tightness of the chest. • The following side effects were very rarely observed during clinical studies (less than 1 case in 10 000 administrations given to patients): fever (pyrexia), increased C-reactive protein, wheals (urticaria), itching (pruritus), rash and dizziness. • In the postmarketing experience there have been reports of restlessness, bleeding into the chest, excessive sweating, increased body temperature, and increased need for catecholamines (medicine to elevate blood pressure) in the course of the treatment.
Madankollu inti għandek tkun konxju tas- sinjali bikrija ta 'reazzjonijiet allerġiċi bħal ngħidu aħna ħruq u tingiż fil- post ta' l- injezzjoni, kesħa, fwawar, raxx, ħorriqija, diffikultà fit- teħid tan- nifs, nawsja, uġigħ ta 'ras, ħedla, pressjoni baxxa tad- demm, u wġigħ tas- sider. • L- effetti sekondarji li ġejjin kienu osservati rari ħafna waqt studji kliniċi (anqas minn każ wieħed f' 10 000 amministrazzjoni mogħtija lil pazjenti): deni (pyrexia), proteina Ċ- reattiva aktar, urtikarja, ħakk (pruritus), raxx u sturdament. • Fl- esperjenza wara t- tqegħid fis- suq kien hemm rapporti ta' nuqqas ta 'mistrieħ, fsada fis- sider, tagħriq eċċessiv, temperatura tal- ġisem aktar għolja, u ħtieġa akbar ta' catecholamines (mediċina biex tgħolli l- pressjoni tad- demm) waqt il- kura.
If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop that can inhibit protein C and therefore diminish the effect of the preparation.
Jekk il- preparazzjoni tintuża f' pazjenti b' defiċjenza konġenita severa ta 'proteina Ċ, jistgħu jiżviluppaw antikorpi li jwaqqfu l- proteina C u b' hekk inaqqsu l- effett tal- preparazzjoni.
However, this has not been observed in the clinical studies to date.
Madankollu, dan ma ġiex osservat fl- istudji kliniċi li saru sa issa.
If any of these side effects gets worse or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CEPROTIN
KIF TAĦŻEN CEPROTIN
Do not use CEPROTIN after the expiry date which is stated on the label after EXP.
Tużax CEPROTIN wara d- data ta ’ skadenza li tidher fuq it- tikketta wara JIS.
The expiry date refers to the last day of that month.
Id- data ta 'skadenza tirreferi għall- aħħar ġurnata ta' dak ix- xahar.
The reconstituted solution should be used immediately.
Is- soluzzjoni rikonstitwita għandha tintuża minnufih.
32 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m' għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta 'l- ambjent.
What CEPROTIN contains
X' fih CEPROTIN
Powder:
Trab:
- The active substance is human protein C
- Is- sustanza attiva hija l- proteina umana C
As solvent
- Is- sustanzi l- oħra huma l- albumina umana, sodium chloride u sodium citrate. 2H2O.
Sterilised Water for Injections is used.
Bħala solvent jintuża Ilma Sterilizzat għall- Injezzjonijiet.
What CEPROTIN looks like and contents of the pack
Id- dehra ta 'CEPROTIN u d- daqs tal- pakkett
CEPROTIN is presented as powder and solvent for solution for injection and is a white or cream coloured powder or friable solid.
CEPROTIN huwa ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni u huwa trab abjad jew lewn il- krema jew solidu li jista 'jitfarrak.
After reconstitution the solution is colourless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles.
Wara li tiġi rikostitwita s- soluzzjoni tkun bla kulur għal ftit fl- isfar u ċara għal daqsxejn opalexxenti u effettivament ħielsa minn partikoli viżibbli.
Each pack also contains one transfer needle and one filter needle.
Kull pakkett fih ukoll labra tat- trasferiment u labra tal- filtru.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
33 For any information about this medicine, please contact the local representative of BAXTER AG given below.
33 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali ta 'BAXTER AG mogħti taħt.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f '
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il- mediċini (EMEA): http: // www. emea. europa. eu /
35 PACKAGE LEAFLET:
35 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER CEPROTIN 1000 IU powder and solvent for solution for injection Human Protein C
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA CEPROTIN 1000 IU trab u solvent għal soluzzjoni għall- injezzjoni Proteina Ċ tal- bniedem
36 Take special care with CEPROTIN,
Oqgħod attent ħafna b' CEPROTIN,
Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin.
36 allerġika għal xi wieħed mill- komponenti, għall- proteina tal- ġrieden jew l- eparina.
The preparation may contain traces of heparin and/ or mouse protein as a result of the manufacturing process.
Il- preparazzjoni jista 'jkun fiha traċċi ta' eparina u/ jew proteina tal- ġrieden bħala riżultat tal- proċess ta 'produzzjoni.
Driving and using machines
Sewqan u tħaddim ta 'magni
CEPROTIN has no influence on your ability to drive or to operate machines.
CEPROTIN m' għandux effett fuq il- ħila tiegħek biex issuq jew tħaddem magni.
It is given to you under close supervision of your doctor who is experienced in substitution therapy of coagulation factors/ inhibitors and where monitoring of protein C activity is possible.
Huwa jingħatalek taħt is- superviżjoni mill- qrib tat- tabib tiegħek li għandu esperjenza f' terapija ta 'sostituzzjoni ta' fatturi/ inibituri tal- koagulazzjoni tad- demm u fejn ikun possibbli monitoraġġ ta 'l- attività tal- proteina C.
Dosage
37 Dożaġġ
If you have APC resistance which is a thromboembolic risk factor present in up to 5% of the population in Europe your doctor may need to adjust your treatment accordingly.
Jekk inti għandek reżistenza għall- APC li hija fattur ta 'riskju trombo- emboliku preżenti f' sa 5% tal - popolazzjoni fl- Ewropa, it- tabib tiegħek jista' jkollu bżonn jaġġusta l- kura tiegħek kif dovut.
It is strongly recommended that every time you receive a dose of CEPROTIN the name and batch number of the product are recorded in order to maintain a record of the batches used.
Huwa rakkomandat ħafna li kull darba li tirċievi doża ta 'CEPROTIN l- isem u n- numru tal- lott tal- prodott jiġu rrekordjati sabiex jinżamm rekord tal - lottijiet użati.
38 CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
CEPROTIN għandu jingħata b' rata massima ta 'injezzjoni ta' 2 ml fil- minuta.
Frequency and duration of treatment depend on the severity of your protein C deficiency, on the results of determination of protein C levels in your plasma as well as on the location and extent of thrombosis.
38 Il- frekwenza u t- tul tal- kura jiddependu fuq is- severità tad- defiċjenza ta 'proteina Ċ tiegħek, fuq ir- riżultati ta' l- istabbiliment tal- livelli ta 'proteina C fil- plażma tiegħek kif ukoll fuq il- post u l- miżura tat- trombożi.
In case of acute thrombosis CEPROTIN may be administered to you every 6 hours.
F' każ ta 'trombożi akuta CEPROTIN jista' jingħatalek kull 6 sigħat.
Store in a refrigerator (2°C – 8°C).
39 Aħżen fi friġġ (2°C - 8°C).
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
- The other ingredients are human albumin, sodium chloride and sodium citrate.2H2O.
- Is- sustanzi l- oħra huma l- albumina umana, sodium chloride u sodium citrate. 2H2O.
As solvent
Bħala
Sterilised Water for Injections is used.
solvent jintuża Ilma Sterilizzat għall- Injezzjonijiet.
40 For any information about this medicine, please contact the local representative of BAXTER AG given below.
40 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali ta 'BAXTER AG mogħti taħt.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu /
London, 19 July 2007 Doc.
Londra, id- 19 ta 'Lulju 2007 Dok.
EMEA/ 318692/ 2007
EMEA/ 382238/ 2007
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for CEREPRO
MISTOQSIJIET U TWEĠIBIET DWAR L- IRTIRAR TA 'L- APPLIKAZZJONI GĦAT - TQEGĦID FIS- SUQ għal CEREPRO
Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene
Sustanza attiva: adenovirus- mediated Herpes simplex virus- thymidine kinase gene
On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.
Fit- 13 ta 'Lulju 2007, Ark Therapeutics uffiċjalment għarrfu lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li jixtiequ jirtiraw l- applikazzjoni tagħhom għall- awtorizzazzjoni tat- tqegħid fis- suq għal Cerepro, użata għat- trattament ta' pazjenti li l- glijoma ta 'grad għoli tagħhom tista ’ tiġi operata.
Cerepro was designated an orphan medicinal product on 6 February 2002.
Cerepro ġie kklassifikat bħala prodott mediċinali orfni fis- 6 ta 'Frar 2002.
What is Cerepro?
X' inhu Cerepo?
Cerepro is a medicine containing a gene (a Herpes simplex virus thymidine kinase gene) carried by an adenovirus.
Cerepro hu mediċina li jkun fiha ġene (ġene tat- tip Herpes simplex virus thymidine kinase) li jinġarr minn adenovirus.
It is made up into a solution that is injected directly into the brain during surgery.
Huwa magħmul minn soluzzjoni li tiġi injettata direttament fil- moħħ waqt kirurġija.
What was Cerepro expected to be used for?
Għal x' hiex kien mistenni li jintuża Cerepro?
Cerepro was to be used in combination with ganciclovir sodium to treat high-grade glioma in patients who are eligible for surgery.
Cerepro kellu jintuża flimkien ma 'ganciclovir sodium fit- trattament ta' pazjenti bi glijoma ta 'grad għoli li kienu eliġibbli għal operazzjoni.
Glioma is a type of brain tumour that begins in ‘ glial’ cells (the cells that surround and support nerve cells).
Il- glijoma hi tip ta 'tumur fil- moħħ li tibda fiċ- ċelloli' glijali '(iċ- ċelloli li jiċċirkundaw u li jappoġġjaw iċ- ċelloli tan- nervituri).
Cerepro was intended for use during an operation.
Cerepro kien maħsub għal użu waqt operazzjoni.
After removing as much of the brain tumour as possible, the surgeon would have made up to 70 small injections of Cerepro into the area from where the tumour was removed.
Wara t- tneħħija ta 'kemm jista' jkun mit- tumur tal - moħħ, il- kirurgu kien jinjetta sa 70 injezzjoni żgħira ta 'Cerepro fiż- żona minn fejn ikun tneħħa t - tumur.
Cerepro injection was to be followed by a two-week course of treatment with ganciclovir sodium, starting five days after the operation.
L- injezzjon ta 'Cerepro kellha tkun segwita b' kors ta' ġimagħtejn ta 'trattament b' ganciclovir sodium, li jibda minn ħamest ijiem wara l- operazzjoni.
Cerepro would only have worked in combination with ganciclovir.
Cerepro kien jaħdem biss flimkien ma 'ganciclovir.
How is Cerepro expected to work?
Kif kien mistenni li jaħdem Cerepro?
Cerepro contains the gene for the enzyme ‘ thymidine kinase’ from the herpes virus.
Cerepro fih ġene għall- enzim ‘ thymidine kinase ’ mill- virus tal- ħerpes.
The gene is carried within a ‘ vector’, a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body.
Il- ġene jinġarr f '‘ vector ’, tip ta' virus li jkun ġie mibdul ġenetikament biex ikun jista 'jġorr ġene (DNA) fiċ- ċelloli tal- ġisem.
The virus in Cerepro is an ‘ adenovirus’ that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Il- virus f' Cerepro hu ‘ adenovirus ’ li jkun ġie manipulat biex ma jkunx jista 'jagħmel kopji tiegħu nnifsu u għalhekk ma jikkawżax infezzjonijiet fil- bniedem.
When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites.
Meta Cerepro jiġi injettat fil- moħħ, il- virus modifikat jidħol fiċ- ċelloli qrib is- siti ta 'l- injezzjoni.
The cells then start to produce the thymidine kinase enzyme.
Iċ - ċelloli mbagħad jibdew jipproduċu l- enzim thymidine kinase.
This enzyme helps to convert ganciclovir into a form which can kill cells that are dividing, including any cancerous cells that were not removed during the operation.
L- enzim jgħin biex jikkonverti ganciclovir f' forma li tista 'toqtol ċelloli li jkunu qed jinqasmu, inkluż ċelloli tal- kanċer li ma jkunux tneħħew waqt l- operazzjoni.
What documentation did the company present to support its application to the CHMP?
X' dokumentazzjoni ppreżentat il- kumpanija biex tappoġġja l- applikazzjoni tagħha lill- CHMP?
The effects of Cerepro were first tested in experimental models before being studied in humans.
L- effetti ta 'Cerepo għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
Cerepro has also been studied in 36 patients with high-grade glioma.
Cerepro ġie studjat f' 36 pazjent bi glijoma ta 'grad għoli.
The study compared the effects of adding Cerepro and ganciclovir sodium to standard treatment with the effects of standard treatment alone.
L- istudju qabbel l- effetti taż- żieda ta 'Cerepro u ganciclovir sodium mat- trattament standard ma' l- effetti tat- trattament standard waħdu.
The main measure of effectiveness was how long the patients survived after the first operation.
Il- mezz ewlieni ta 'l- effettività kien kemm idumu ħajjin il- pazjenti wara l- ewwel operazzjoni.
How far into the evaluation was the application when it was withdrawn?
Sa fejn kienet waslet l- evalwazzjoni ta 'l- applikazzjoni qabel ma ġiet irtirata?
The evaluation had finished and the CHMP had given a negative opinion.
L- evalwazzjoni kienet intemmet u l- CHMP kien ta opinjoni negattiva.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Il- kumpanija kienet talbet li jsir eżami mill- ġdid ta 'l- opinjoni negattiva, iżda din ma kinitx għadha ntemmet meta l- kumpanija rtirat.
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What was the recommendation of the CHMP at that time?
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X' kienet ir- rakkomandazzjoni tas- CHMP f' dak iż- żmien?
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.
Abbażi ta 'l- analiżi tad- dejta u r- rispons tal- kumpanija għal- lista ta' mistoqsijiet, fi żmien l- irtar, il - CHMP kien ta opinjoni negattiva u ma rrakomandax li tingħata l- awtorizzazzjoni għat- tqegħid fis- suq għal Cerepro għat- trattament ta 'pazjenti bi glijoma ta' grad għoli li setgħu jiġu operati.
What were the main concerns of the CHMP?
X' kien it- tħassib ewlieni tal- CHMP?
The CHMP had concerns that a benefit of Cerepro had not yet been shown.
Il- CHMP kien imħasseb għax ma kien għadu ntwera l- ebda benefiċċju ta 'Cerepro.
It was concerned over the low number of patients included in the main study of Cerepro, which prevented a benefit of the medicine being demonstrated.
Kien imħasseb dwar in- numru żgħir ta 'pazjenti li ħadu sehem fl- istudju ewlieni ta' Cerepro, u minħabba f' hekk ma setax jintwera benefiċċju tal- mediċina.
The Committee also had concerns over the ways in which the study had been carried out, which made it difficult to interpret the results.
Il- Kumitat kien imħasseb wkoll dwar il- mod kif kien sar l - istudju, li għamilha diffiċli biex jiġu interpretati r- riżultati.
In addition, the CHMP considered there to be insufficient information on the safety of Cerepro, and, since the benefits of the medicine had not been demonstrated, that its risks, when used in combination with ganciclovir, could be of concern.
Barra minn hekk, il- CHMP ikkunsidra li ma kienx hemm biżżejjed tagħrif dwar is- sigurtà ta 'Cerepro, u, billi ma kinux intwerew benefiċċji tal - mediċina, ir- riskji tiegħu, meta użat flimkien ma' ganciclovir, seta 'jwassal għal tħassib.