qanastek/EMEA-V3 huggingface dataset:
For the injection you will need the following: • 1 prepared syringe for your IL-2 injection (refer to the IL-2 package leaflet and your doctor’ s dose instructions). • 1 prepared syringe containing Ceplene. • Alcohol wipe(s). • A timer, clock or watch with a second hand. • A puncture-proof container so you can dispose of used syringes safely.
Għall- injezzjoni jkollok bżonn dan li ġej: • siringa preparata għall- injezzjoni ta 'IL- 2 (ara l- fuljett ta' tagħrif u l- istruzzjonijiet tad- doża li tak it- tabib). • siringa preparata b' Ceplene. • Biċċa mbilla fl- alkoħol biex timsaħ (alcohol wipe[ s]). • timer, arloġġ jew arloġġ tal- id bis- sekondiera. • Kontenitur li ma jittaqqabx biex tkun tista 'tarmi s- siringi użati mingħajr ma jweġġa' ħadd.
Method 1.
Metodu 1.
Find a comfortable, well-lit place to sit and where you can lie back.
Sib post komdu, imdawwal tajjeb fejn toqgħod bilqiegħda u fejn tista 'timtedd.
For
Qiegħed is- siringi mimlija għal- lest b' IL- 2, Ceplene u biċċa mbilla fl- alkoħol biex timsaħ miftuħa fejn tista 'tilħaqha b' idek.
28 your safety it is very important that you are sitting where you can lean back or lie flat when you perform the injections.
Għal raġunijiet ta 'sigurtà, huwa importanti li toqgħod bilqiegħda f' post fejn tista' tintelaq lura jew timtedd ċatt meta tinjetta.
Inject IL-2 as you have been instructed.
Injetta IL- 2 skont l- istruzzjonijiet li tawk.
Wait 1 to 3 minutes.
Stenna bejn minuta u 3 minuti.
Decide where you will inject Ceplene.
Iddeċiedi fejn se tinjetta Ceplene.
You may choose the inner or outer thighs, arms or stomach.
Tista 'tagħżel in- naħa ta' ġewwa jew ta 'barra tal- koxxa, id - dirgħajn jew l- istonku.
Ceplene and IL-2 must not be injected into the same region.
Ceplene u IL- 2 ma għandhomx jiġu injettati fl- istess post.
For example, if you inject IL-2 in the left arm, you could inject Ceplene into the left or right thigh, the stomach, or the right arm.
Pereżempju, jekk tinjetta IL- 2 fid- driegħ tax- xellug, tista 'tinjetta Ceplene fil- koxxa tax- xellug jew tal- lemin, fl - istonku, jew fi driegħek tal- lemin.
Always vary the site that you inject.
Dejjem varja s- sit li tinjetta fih.
For possible injection sites, see Figure 4.
Għal punti tal- injezzjoni possibbli, ara l- Figura 4.
Make sure that the area of the skin you selected is exposed.
Kun żgur li ż- żona tal- ġilda li għażilt tkun mikxufa sew.
Use an alcohol wipe to clean it.
Uża biċċa mbilla fl- alkoħol biex timsaħ biex tnaddafha.
Allow the area to dry for 10 seconds.
Ħalli ż- żona tinxef għal 10 sekondi.
Pinch up a section of the cleaned skin between your thumb and forefinger, without squeezing it.
Oqros biċċa mill- ġilda mnaddfa bejn is- saba 'l- kbir u l- werrej, mingħajr ma tagħfas iżżejjed.
See Figure 5.
Ara Figura 5.
7 Hold needle either vertically (90°) or at a 45° angle to the skin and insert it under the skin as far as it will go in one quick motion.
7 Żomm il- labra f' pożizzjoni vertikali (90°) jew f' angolu ta '45° mal- ġilda u daħħalha taħt il- ġilda sa fejn tidħol' il ġewwa f' moviment wieħed rapidu.
The needle must be inserted under the skin, but not into any blood vessels below the skin.
Il- labra trid tiddaħħal taħt il- ġilda, iżda mhux f' xi vina taħt il- ġilda.
See Figure 6.
Ara l- Figura 6.
Slightly pull back the plunger.
Iġbed il- plunger ftit lura.
If blood appears, do not inject Ceplene because the needle has entered a blood vessel.
Jekk jidher id- demm, tinjettax Ceplene għax il- labra tkun daħlet f' xi vina.
Withdraw and discard the syringe as instructed.
Oħroġ u armi s- siringa kif spjegawlek.
Obtain new supplies and start the procedure over again, even if 3 minutes have passed after injection of IL-2.
Iġbed il- mediċina mill- ġdid u erġa 'ibda l- proċedura mill- ġdid, anke jekk ikunu għaddew 3 minuti mill- ewwel injezzjoni ta' IL- 2.
Notice the numbered marks on each syringe.
Innota l- marki bin- numri.
Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 ml).
Kull marka (0. 1, 0. 2, 0. 3, eċċ.) tirrappreżenta wieħed minn kull għaxra ta 'millilitru (0. 1 ml).
Push down the syringe plunger and inject one-tenth of a millilitre (0.1 ml) every minute, or more slowly if instructed to do so by your doctor.
Imbotta l- plunger tas- siringa u injetta 0. 1 ml kull minuta, jew iktar bil- mod jekk l- istruzzjonijiet tat- tabib kienu hekk.
See Figure 7.
Ara l- Figura 7.
11 Never inject Ceplene any faster or all at once.
11 Qatt tinjetta Ceplene b' rata iktar mgħaġġla jew kollu f' daqqa.
12 When the syringe is empty, remove the needle from your skin.
12 Meta s- siringa tkun vojta, neħħi l- labra minn ġol- ġilda.
13 Apply gentle pressure with the alcohol wipe over the injection site without rubbing it.
13 Agħfas bil- mod bil- biċċa mbilla fl- alkoħol fuq is- sit tal- injezzjoni mingħajr ma togħrokha.
14 Remain seated or lying down for 20 minutes after injecting Ceplene.
14 Ibqa 'bilqiegħda jew mimdud( a) għal 20 minuta wara l- injezzjoni ta' Ceplene.
15 Dispose of the syringe in the puncture-proof container as instructed.
15 Armi s- siringa fil- kontenitur li ma jittaqqabx kif urewk.
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
L - għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP), abbażi ta 'l- istudji mwettqa, wasslet għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abba\ i tar- rakkommandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR)
What is CEPROTIN?
X’ inhu CEPROTIN?
CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection.
CEPROTIN huwa trab u solvent, li jitħalltu flimkien biex jifformaw soluzzjoni għal injezzjoni.
It contains the active substance human protein C.
Huwa fih is- sustanza attiva proteina Ċ tal- bniedem.
What is CEPROTIN used for?
Għal xiex jintuża CEPROTIN?
Protein C is a natural substance in the blood that controls clotting.
Proteina Ċ hija soluzzjoni naturali fid- demm li tikkontrolla t- tgħaqqid tad- demm.
CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death).
CEPROTIN jintuża f’ pazjenti b’ defiċjenza konġenitali (ereditarja) ta ’ proteina Ċ severa biex jikkura purpura fulminans (tgħaqqid tad- demm estensiv fil- vini u l- arterji tad- demm, li tikkaġuna l- mewt tat- tessuti eżatt taħt il - ġilda, li ta ’ spiss iwassal għal falliment ta ’ l- organi u amputazzjonijiet) u nekrożi tal- ġilda mqanqla mill- coumarin (kumplikazzjoni ta ’ kura b’ mediċini bħal ma ’ huma warfarin, li tikkaġuna mewt tal - ġilda).
CEPROTIN is also used for the short-term prevention of clotting in patients with severe congenital protein C deficiency in certain situations when there is an increased risk of clotting, such as surgery or when treatment with a coumarin is not sufficient or possible.
CEPROTIN jintuża ukoll għal impediment ta ’ tgħaqqid tad- demm fuq qasir żmien f’ pazjenti b’ defiċjenza konġenitali ta ’ proteina Ċ severa f’ ċerti sitwazzjonijiet fejn hemm riskju miżjud ta ’ tgħaqqid tad- demm, bħal fil- kirurġija jew meta kura b’ coumarin mhix biżżejjed jew possibbli.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss permezz ta ’ riċetta ta ’ tabib.
How is CEPROTIN used?
Kif jintuża CEPROTIN?
CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity.
Kura b’ CEPROTIN għandha tinbeda minn tabib li għandu esperjenza f’ din it- tip ta ’ terapija u fejn huwa possibbli li tkejjel l- attività ta ’ proteina Ċ.
CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
CEPROTIN jingħata permezz ta ’ injezzjoni intravenuża (injezzjoni ġol- vina) f’ rata massima ta ’ injezzjoni ta ’ 2 ml kull minuta ħlief fi tfal b’ piż korporali ta ’ anqas minn 10 kg, fejn ir- rata ta ’ injezzjoni m’ għandhiex taqbeż 0. 2 ml għal kull kilogramma tal- piż korporali kull minuta.
How does CEPROTIN work?
Kif jaħdem CEPROTIN?
CEPROTIN contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
CEPROTIN fih proteina Ċ tal- bniedem, estratta u ippurifikata minn plażma tal- bniedem (il- parti likwida tad- demm).
In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting.
Fil- ġisem, il- proteina Ċ tikkontrolla l- ġenerazzjoni ta ’ trombin, wieħed mis - sustanzi (fatturi) involuti fit- tgħaqqid tad- demm.
Protein C slows down the production of thrombin, and therefore slows down further clotting.
Il- proteina Ċ tittardja l- produzzjoni ta ’ trombin, u għaldaqstant tittardja aktar it- tgħaqqid tad- demm.
An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C.
Injezzjoni ta ’ CEPROTIN tagħti żieda immedjata iżda temporanja fil- livelli ta ’ proteina Ċ.
Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.
Sostituzzjoni ta ’ proteina Ċ f’ pazjenti defiċjenti f’ proteina Ċ għandha tikkontrolla jew timpedixxi problemi trombotiċi (tgħaqqid tad- demm) f’ dawn il- pazjenti.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 protein C levels and other indicators of coagulation (clotting) activation.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 Kif ġie studjat CEPROTIN?
Additionally, any improvement in skin lesions was monitored.
CEPROTIN ġie studjat f’ total ta ’ 79 pazjent, li 22 minnhom kellhom dijanjożi ta ’ forom aktar severi ta ’ defiċjenza konġenitali tal- proteina Ċ.
What benefit has CEPROTIN shown during the studies?
X’ benefiċċju wera CEPROTIN waqt l- istudji?
In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.
F’ pazjenti b’ defiċjenza konġenitali ta ’ proteina Ċ severa, CEPROTIN tejjeb is- 16- il każ kollha ta ’ purpura fulminans u s- sitt episodji kollha ta ’ nekrożi tal- ġilda imqanqla mill- coumarin.
The results in the treatment of other types of clotting disorders, and of patients with other protein C deficiencies, were not sufficient to assess completely the use of CEPROTIN in these groups.
Ir- riżultati fil - kura ta ’ tipi oħra ta ’ disturbi ta ’ tgħaqqid tad- demm, u ta ’ pazjenti b’ defiċjenzi ta ’ proteina Ċ oħra, ma kinux suffiċjenti biex jistmaw kompletament l- użu ta ’ CEPROTIN f’ dawn il- gruppi.
What is the risk associated with CEPROTIN?
X’ inhu r- riskju assoċjat ma ’ CEPROTIN?
Hypersensitivity (allergic reactions) has sometimes been seen.
Sensittività eċċessiva (reazzjonijiet avversi) dehret xi kultant.
If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Jekk CEPROTIN jintuża f’ pazjenti b’ defiċjenza konġenitali ta ’ proteina Ċ severa, jistgħu jiżviluppaw antikorpi li jimpedixxu l- proteina Ċ.
For the full list of all side effects reported with CEPROTIN, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti kollha irrapportati b’ CEPROTIN, ara l- Fuljett tal- Pakkett.
CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.
CEPROTIN m’ għandux jintuża f’ nies li jistgħu jkunu eċċessivament sensittivi (allerġiċi) għall - proteina Ċ tal- bniedem, proteina tal- ġurdien jew għal heparin, ħlief f’ kumplikazzjonijiet li jgħeddu l - ħajja.
When patients start receiving other anticoagulant medicines, such as warfarin, special care is needed and CEPROTIN treatment must be continued until the warfarin treatment is adjusted.
Meta pazjenti jibdew jirċievu mediċini antikoagulanti oħra, bħal ma hija warfarin, hija meħtieġa attenzjoni speċjali u kura b’ CEPROTIN għandha titkompla sakemm il- kura b’ warfarin hija aġġustata.
Why has CEPROTIN been approved?
Għaliex ġie approvat CEPROTIN?
The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN’ s benefits are greater than its risks for patients with severe congenital protein C deficiency.
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ CEPROTIN huma akbar mir- riskji tiegħu għal pazjenti b’ defiċjenza konġenitali ta ’ proteina Ċ severa.
The Committee recommended that CEPROTIN be given marketing authorisation.
Il- Kumitat irrakkomanda li CEPROTIN jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
CEPROTIN was originally authorised under ’ Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease.
CEPROTIN kien oriġinarjament awtorizzat taħt ‘ Ċirkostanzi Eċċezzjonali ’, minħabba li ma kienx possibbli f’ dak iż- żmien li jinkiseb tagħrif sħiħ fuq il- mediċina minħabba n- numru baxx ta ’ pazjenti dijanjożati b’ din il- marda.
As the company had supplied the additional information requested, the ’ Exceptional Circumstances ’ ended on 28 July 2006.
Peress li l- kumpanija pprovdiet it- tagħrif addizjonali mitlub, iċ - ‘ Ċirkostanzi Eċċezzjonali ’ spiċċaw fit- 28 ta ’ Lulju 2006.
CEPROTINCEPROTINOther information about CEPROTIN:
Tagħrif ieħor dwar CEPROTIN:
The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal CEPROTIN lil Baxter AG fis- 16 ta ’ Lulju 2001.
The marketing authorisation was renewed on 16 July 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 16 ta ’ Lulju 2006.
The full EPAR for CEPROTIN is available here.
L- EPAR sħiħ għal CEPROTIN jinsab hawnhekk.
Invented name Strength Pharmaceutical form
Għamla Farmaċewtika
Content (concentration) Package size
Daqs tal- pakkett
Powder and solvent for Intravenous use solution for injection
Trab u solvent għal soluzzjoni għall- injezzjoni.
Powder: vial (glass) Solvent: vial (glass)
trab: kunjett (ħġieġ); solvent: kunjett (ħġieġ)
Powder:
trab:
500 IU Solvent:
500 IU; solvent:
1 vial + 1 vial
1 kunjett + 1 kunjett
Powder and solvent for Intravenous use
Trab u solvent għal soluzzjoni għall- injezzjoni.
Powder: vial (glass)
trab: kunjett (ħġieġ); solvent: kunjett (ħġieġ)
1000 IU
1000 IU; solvent:
CEPROTIN 500 IU powder and solvent for solution for injection
CEPROTIN 500 IU trab u solvent għal soluzzjoni għall- injezzjoni
Protein C from human plasma purified by mouse monoclonal antibodies.
Proteina Ċ mill- plażma tal- bniedem ppurifikata b’ antikorpi monoklonali tal- ġurdien.
CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container.
CEPROTIN 500 IU * huwa ppreparat bħala trab li jkun fih b’ mod nominali 500 IU ta 'proteina Ċ tal- bniedem f' kull kontenitur.
The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ ml human protein C.
Il- prodott li jiġi rikostitwit b’ 5 ml ilma għall- injezzjoni jkun fih madwar 100 IU/ ml ta ’ proteina Ċ.
The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard.
Il- qawwa (IU) tiġi stabbilita billi jintuża metodu tas- sostratt kromoġeniku li jitqabbel ma ’ l- istandard Internazzjonali ta 'l- Organizzazzjoni Dinjija tas- Saħħa (WHO).
Sodium chloride:
Sodium chloride:
44 mg/ vial Sodium citrate.
44 mg/ kunjett Sodium citrate:
22 mg/ vial
22 mg/ kunjett
For a full list of excipients see 6.1
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
* One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
* Unità Internazzjonali Waħda (IU) ta ’ proteina Ċ tikkorispondi għall- attività imkejla b’ mod amidolitikali ta ’ proteina Ċ f’ 1 ml ta ’ plażma normali.
Powder and solvent for solution for injection.
Trab u solvent għal soluzzjoni għall- injezzjoni.
White or cream coloured powder or friable solid.
Trab abjad jew kulur il- krema jew solidu li jista 'jitfarrak.
After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/ kg.
Wara rikostituzzjoni s- soluzzjoni jkollha pH ta 'bejn 6. 7 u 7. 3 u osmolalità ta' mhux anqas minn 240 mosmol/ kg.
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’ nekrosi tal- ġilda kkaġunata minn kumarina f’ pazjenti li għandhom defiċjenza konġenitali serja tal- Proteina Ċ.
Furthermore CEPROTIN is indicated for short-term prophylaxis 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 therapy • when coumarin therapy alone is not sufficient • when coumarin therapy is not feasible.
Barra minn hekk, CEPROTIN huwa indikat għal profilassi għal terminu qasir, f’ pazjenti b’ nuqqas serju ta ’ proteina Ċ f’ xi waħda jew aktar mill- kondizzjonijiet li wieħed jiltaqa ’ magħhom fis- sitwazzjonijiet li ġejjin: • kirurġija jew terapija intensiva tkun imminenti • waqt li tinbeda t- terapija bil- kumarina • meta terapija bil- kumarina weħedha biss m’ hijiex biżżejjed • meta t- terapija bil- kumarina ma tkunx vijabbli.
Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in substitution therapy with coagulation factors/ inhibitors where monitoring of protein C activity is feasible.
It- trattament b’ CEPROTIN għandu jinbeda taħt superviżjoni ta ’ tabib b’ esperjenza f’ terapija ta ’ sostituzzjoni b’ fatturi/ inibitturi ta ’ koagulazzjoni fejn sorveljanza ta ’ l- attività tal- proteina Ċ hija possibbli.
The dose should be adjusted on the basis of laboratory assessment for each individual case.
Id- doża għandha tiġi aġġustata fuq il- bażi ta 'valutazzjoni fil- laboratorju għal kull każ individwali.
A protein C activity of 100% should be achieved initially and the activity should be maintained above 25% for the duration of the treatment.
Attività tal- proteina Ċ ta ’ 100% għandha tintlaħaq fil- bidu u l- attività għandha tibqa 'tinżamm ogħla minn 25% għal kemm idum it- trattament.
The measurement of protein C activity using chromogenic substrates is recommended for the
Doża inizzjali ta ’ 60 sa 80 IU/ kg hija rakkomandata sabiex jiġi stabbilit l- irkupru u t- tul ta ’ żmien li jieħu biex jinżel bin- nofs.
2 determination of the patient’ s plasma level for protein C before and during treatment with CEPROTIN.
2 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.
The dosage should be determined on the basis of laboratory measurements of the protein C activity.
Id- dożaġġ għandu jiġi stabbilit fuq il- bażi tal- kejl ta ’ l- attività tal- proteina Ċ tal- laboratorju.
In the case of an acute thrombotic event these should be performed every 6 hours until the patient is stabilised, thereafter twice a day and always immediately before the next injection.
Meta jseħħ xi każ ta ’ trombożi akuta dan għandu jitwettaq kull 6 sigħat sakemm il- pazjent ikun stabbli, u minn hemm darbtejn kuljum u dejjem qabel l- injezzjoni li jmiss.
It should be kept in mind that the half-life of protein C may be severely shortened in certain clinical conditions such as acute thrombosis with purpura fulminans and skin necrosis.
Wieħed għandu jiftakar li t- tul ta ’ żmien li l- proteina Ċ tieħu biex tinżel bin- nofs jista ’ jitqassar sew f’ ċertu kondizzjonijiet kliniċi bħalma huma l- purpura fulminans u n- nekrożi tal- ġilda.
Patients treated during the acute phase of their disease may display much lower increases in protein C activity.
Pazjenti ttrattati waqt il- fażi akuta tal- marda tagħhom jistgħu juru żjidiet ħafna anqas f’ attività tal- proteina Ċ.
The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly.
Il- varjazzjoni wiesgħa f’ reazzjonijiet individwali timplika li l- effetti ta ’ CEPROTIN fuq il- parametri ta ’ koagulazzjoni għandhom jiġu kkontrollati b’ mod regolari.
(see section 4.4)
Il- pazjenti b' indeboliment renali u/ jew epatiku għandhom jiġu mmonitorjati aktar mill- qrib (ara sezzjoni 4. 4).
Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).
Abbażi ta ’ l- esperjenza klinika ristretta miksuba fi tfal minn rapporti u studji li jkopru 83 pazjent, il - linji gwida dwar dożaġġi f’ suġġetti adulti huma kkonsidrati validi għal popolazzjonijiet ta ’ trabi li għadhom jitwieldu u pazjenti pedjatriċi (ara sezzjoni 5. 1).
In rare and exceptional cases, subcutaneous infusion of 250-350 IU/ kg was able to produce therapeutic protein C plasma levels in patients with no intravenous access.
F’ każijiet rari u eċċezzjonali, infużjoni taħt il- ġilda ta ’ 250- 350 IU/ kg kienet kapaċi tipproduċi livelli terapewtiċi ta ’ proteina Ċ fil- plażma f’ pazjenti li ma kellhom ebda aċċess ġol- vini.
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).
Furthermore, during the initiation of oral anticoagulant therapy it is advisable to start with a low dose and adjust this incrementally, rather than use a standard loading dose.
Barra minn hekk, fil- bidu ta 'terapija orali kontra l- koagulazzjoni tad- demm huwa rakkomandabbli li wieħed jibda b' doża baxxa u jaġġustaha gradwalment, pjuttost milli juża doża aktar għolja.
In patients receiving 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).
F’ pazjenti li jirċievu amministrazzjoni profilattika ta ’ proteina Ċ, livelli ogħla ta ’ tnaqqis għandhom mnejn ikunu meħtieġa f’ sitwazzjonijiet ta ’ riskju ogħla ta ’ trombożi (bħal infezzjoni, trawma, jew intervent kirurġiku).
In patients with combined severe congenital protein C deficiency and with APC resistance, there are limited clinical data to support the safety and efficacy of CEPROTIN.
Fil- każ ta 'pazjenti b' defiċjenza konġenita severa magħquda ta' proteina Ċ u b' reżistenza għall- APC, ftit hemm tagħrif kliniku biex isostni s- sigurtà u l- effikaċja ta 'CEPROTIN.
CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
CEPROTIN jingħata b' injezzjoni ġol- vini wara rikostituzzjoni tat- trab għal soluzzjoni għall- injezzjoni b' Ilma Sterilizzat għall- Injezzjonijiet.
CEPROTIN should be administered at a maximum injection rate of 2 ml per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 ml/ kg/ min.
CEPROTIN għandu jiġi amministrat b’ rata massima ta ’ injettar ta ’ 2 ml kull minuta ħlief fit- tfal li għandhom piż korporali ta ’ < 10 kg, fejn ir- rata ta ’ injezzjoni m’ għandhiex taqbeż 0. 2 ml/ kg/ min.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Bħal fil- każ ta 'kull prodott ieħor tal- proteini li jingħata fil- vini, jista' jkun hemm reazzjonijiet ta 'sensittività eċċessiva ta ’ tip allerġiku.
For the events that allergic symptoms arise which are of an acute and life-threatening nature, administration should be made within reach of life-supporting facilities.
Fil- każ li jkun hemm sintomi allerġiċi li huma ta ’ natura akuta u ta ’ theddida għall- ħajja, l- għoti għandu jsir f’ post fejn hemm faċilitajiet ta ’ appoġġ tal- ħajja.
Hypersensitivity to the active substance or to any of the excipients or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Sensittività eċċessiva għas- sustanza attiva, jew għal xi sustanzi mhux attivi jew għal proteina tal- ġrieden, jew għal eparina, għajr għal kontroll ta ’ komplikazzjonijiet mit- trombożi li jkunu ta ’ theddida għall- ħajja.
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.
Jekk ikun
If these symptoms occur, they should inform the physician.
3 hemm dawn is- sintomi, huma għandhom jinfurmaw lit- tabib.
Immediate discontinuation of product use is advised.
Huwa rakkomandabbli waqfien immedjat ta ’ l- użu tal- prodott.
In case of shock, the current medical standards for shock treatment are to be observed.
F’ każ ta ’ xokk, għandhom jiġu osservati l- istandards mediċi attwali għat- trattament ta ’ xokkijiet.
3 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.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Il- miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill- użu ta 'prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l- għażla tad- donaturi, eżami tad- donazzjonijiet individwali u ta' puls ta 'plażma għal indikaturi speċifiċi ta' infezzjoni, u l- inklużjoni ta 'passi effettivi tal- manifattura għat- twaqqif/ tneħħija ta' virus.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jiġu amministrati prodotti mediċinali ppreparati mid- demm jew plażma umana, il- possibbiltà li jiġu trasmessi aġenti infettivi ma tistax tiġi eskluża għal kollox.
This also applies to unknown or emerging viruses and other pathogens.
Dan japplika wkoll għal patoġeni li sa issa għadhom mhux magħrufa.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Il- miżuri meħuda huma meqjusa effettivi għal virus miksija bħall- HIV, HBV u HCV u għall- virus mhux miksi HAV.
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 eritropoesi 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 vaċinazzjoni xierqa (epatite A u B) għal pazjenti li jirċievu b' mod regolari/ ripetut prodotti tal- Proteini C derivati minn plażma umana.
It is strongly recommended that every time that CEPROTIN is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Huwa rakkomandat ħafna li kull darba li jiġi amministrat CEPROTIN lil pazjent, l- isem u n- numru tal- lott tal- prodott jiġu rrekordjati sabiex tinżamm rabta bejn il- pazjent u l- lott tal- prodott.
CEPROTIN may contain trace amounts of heparin.
CEPROTIN jista 'jkun fih traċċi ta' eparina.
Heparin induced allergic reactions, which can be associated with a rapid decrease of the number of thrombocytes, may be observed (heparin induced thrombocytopenia [HIT]).
Reazzjonijiet allerġiċi kkaġunati mill- eparina jistgħu jkunu assoċjati ma ’ tnaqqis rapidu fl- għadd ta ’ tromboċiti li jistgħu jiġu osservati (tromboċitopenja kkaġunata mill- eparina, [HIT]).
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).
If HIT is suspected, the number of thrombocytes should be determined immediately and if necessary therapy with CEPROTIN should be stopped.
Jekk ikun hemm suspett ta ’ HIT, l- għadd ta ’ tromboċiti għandu jiġi stabbilit minnufih u jekk ikun hemm bżonn, it- terapija biċ- CEPROTIN għandha titwaqqaf.
Identifying HIT is complicated by the fact that these symptoms may already be present in acute phase patients with severe congenital protein C deficiency.
M’ huwiex faċli li tiġi identifikata l- HIT minnħabba l- fatt li dawn is- sintomi jistgħu jkunu diġà preżenti f’ pazjenti fil- fażi akuta b’ defiċjenza konġenitali tal- proteina Ċ.
Patients with HIT should avoid the use of heparin containing drugs in the future.
Pazjenti b' HIT għandhom jevitaw l- użu ta 'mediċini li fihom l- eparina fil- ġejjieni.
In the context of clinical experience several bleeding episodes have been observed.
Fil- kuntest ta 'l- esperjenza klinika kienu osservati diversi episodji ta' emorraġija.
Concurrent anticoagulant medication (such as heparin) may have been responsible for these bleeding episodes.
Medikazzjoni simultanja kontra l- koagulazzjoni tad- demm setgħet kienet responsabbli għal dawn l- episodji ta 'emorraġija.
However, it cannot be completely ruled out that the administration of CEPROTIN further contributed to these bleeding events.
Madankollu, ma jistax jiġi eskluż għalkollox li l- għoti ta 'CEPROTIN kompla jikkontribwixxi għal dawn l- episodji ta' emorraġija.
The quantity of sodium in the maximum daily dose may exceed 200 mg.
L- ammont ta 'sodju fid- doża massima ta' kuljum jista 'jaqbeż 200 mg.
This should be taken into consideration by patients on a controlled sodium diet.
Dawk il- pazjenti li qegħdin fuq dieta ta 'kontroll tas- sodju għandhom jikkunsidraw dan.
No interactions with other medicinal products are currently known.
Attwalment mhumiex magħrufa interazzjonijiet ma 'prodotti mediċinali oħra.
In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists (e. g. warfarin), a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent.
F' pazjenti li jibdew kura b' sustanzi orali kontra l- koagulazzjoni tad- demm li jappartjenu għall- klassi ta 'antagonisti għall- vitamina K (p. e. warfarina), jista' jkun hemm stat temporanju ta 'koagulazzjoni eċċessiva qabel ma l- effett mixtieq ta' kontra l- koagulazzjoni tad- demm isir evidenti.
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 il- vitamina K, għandha half- life iqsar mill- biċċa l- kbira tal- proteini dipendenti fuq il- vitamina K (jiġifieri II, IX u X).
Subsequently, in the initial phase of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors.
Għalhekk, fil- fażi inizjali tal- kura, l- attività tal- proteina Ċ tiġi mrażżna aktar malajr minn dik tal- fatturi proagulanti.
For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained.
Għalkemm nekrożi tal- ġilda
(See 4.2.).
4 ssensitizzata minn Walfarina tista 'sseħħ f' kull pazjent fil- bidu ta' terapija orali kontra l- koagulazzjoni tad- demm, persuni b' defiċjenza konġenita ta 'proteina Ċ huma partikolarment f' riskju (Ara 4. 2.).
4 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Although CEPROTIN has been used safely in the treatment of pregnant protein C-deficient women, its safety for use in human pregnancy has not been established in controlled clinical trials.
Għalkemm CEPROTIN ġie użat mingħajr periklu fit- trattament ta ’ nisa tqal li huma defiċjenti mill- proteina Ċ, is- sigurtà fl- użu fit- tqala tal- bniedem għadha ma ġietx stabbilita fi provi kliniċi kkontrollati.
Furthermore no information on excretion of protein C in the milk is available.
Barra minn hekk l- ebda informazzjoni fl- eliminazzjoni tal- proteina Ċ fil- ħalib ma hija disponibbli.
Therefore, the benefit of using CEPROTIN during pregnancy or lactation must be judged against the risk for the mother and baby, and should be used only if clearly needed.
Għalhekk, il- benefiċċju li CEPROTIN jintuża waqt it- tqala jew tirdigħ għandu jiġi ġġudikat kontra r- riskju ta ’ l- omm u t- tarbija, u għandu jintuża biss jekk jintwera b’ mod ċar il- bżonn tiegħu.
CEPROTIN has no influence on the ability to drive and to operate machines.
CEPROTIN m' għandu l- ebda effett fuq il- ħila ta 'sewqan u l- użu ta' magni.
As with any intravenous product allergic type hypersensitivity reactions are possible.
Bħal fil- każ ta 'kull prodott ieħor tal- proteini li jingħata fil- vini, jista' jkun hemm reazzjonijiet ta 'sensittività eċċessiva ta ’ tip allerġiku.
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, vomiting, and 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.
Patients should be advised to immediately contact their physician if these symptoms occur (see section 4.4).
Il- pazjenti għandhom jingħataw parir biex jikkuntattjaw immedjatament lit- tabib tagħhom jekk jitfaċċaw dan is- sintomi (ara sezzjoni 4. 4).
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 (ADRss) fi 3 mill- 225 pazjent irreġistrat.
In total 21,988 administrations of CEPROTIN have been given.
B' kollox kien hemm 21, 988 amministrazzjoni ta 'CEPROTIN.
The distribution of the related ADRs is as follows: one report of pyrexia and one report of increased C-reactive protein in one subject, one case of urticaria in one subject, one report of pruritus, one report of rash and one report of dizziness in one subject.
It- tqassim ta 'l- ADRs relatati huwa kif ġej: rapport wieħed ta' deni u rapport wieħed ta 'proteina Ċ- reattiva akbar f' suġġett wieħed, każ wieħed ta' urtikarja f' suġġett wieħed, rapport wieħed ta 'ħakk rapport wieħed ta' raxx u rapport wieħed ta 'sturdament f' suġġett wieħed.
With a calculated adverse experience rate (per number of administrations) of 0,005% the frequency of these ADRs can be classified as very rare.
B' rata maħduma ta 'esperjenzi avversi (għal kull numru ta' amministrazzjonijiet) ta '0, 005%, il- frekwenza ta' dawn l- ADRs tista 'tiġi kklassifikata bħala rari ħafna.
In the spontaneous, postmarketing database, there have been reports of restlessness, haemothorax, hyperhydrosis, increased body temperature and increased need of catecholamines to support blood pressure (verbatim term: increased need for catecholamines) in the course of the treatment.
Fid- database spontanja ta 'wara l- kummerċjalizzazzjoni, kien hemm rapporti ta' nuqqas ta 'mistrieħ, emorraġija fil- kavità tal- plewra (haemothorax), iperidrolisi, temperatura tal- ġisem aktar għolja u ħtieġa akbar ta' catecholamines biex isostnu l- pressjoni tad- demm (terminu verbatim: ħtieġa akbar ta 'catecholamines) waqt il- kura.
If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Jekk il- preparazzjoni tintuża f' pazjenti b' defiċjenza konġenita severa ta 'proteina Ċ, jistgħu jiżviluppaw antikorpi li jimpedixxu l- proteina Ċ.
No symptoms of overdose with CEPROTIN have been reported.
L- ebda każ ta ’ doża eċċessiva b' CEPROTIN ma ġie rrappurtat.
Pharmacotherapeutic group: group antithrombotic; ATC Code:
Kategorija farmakoterapewtika: kategorija kontra t- trombożi; Kodiċi ATC:
Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver.
Il- proteina Ċ hija glikoproteina li taġixxi kontra l- koagulazzjoni tad- demm dipendenti fuq il- vitamina K li tiġi sintetizzata fil- fwied.
It is converted by thrombin/ thrombomodulin-complex on the endothelial surface to activated protein C (APC).
Hija tiġi mibdula bil- kumpless trombin/ trombomodulin fil- wiċċ endoteljali għal proteina Ċ attivata (APC).
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
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.
APC has also been shown to have profibrinolytic effects.
Ġie ppruvat ukoll li APC għandha effetti profibrinolitiċi.
The intravenous administration of CEPROTIN provides for an immediate but temporary increase in plasma levels of protein C.
L- għoti ta 'CEPROTIN ġol- vini jipprovdi għal żjieda immedjata imma temporanja fil- livelli ta ’ proteina Ċ fil- plażma.
Replacement of protein C in protein C deficient patients is expected to control or - if given prophylactically - prevent thrombotic complications.
Is- sostituzzjoni tal- proteina C f' pazjenti b' defiċjenza ta 'proteina Ċ huwa mistenni li jikkontrolla jew - jekk jingħata b' mod profilattiku - jevita kumplikazzjonijiet trombotiċi.
5 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.
No formal clinical study in either paediatric or neonatal population with severe congenital protein C deficiency was ever conducted.
Qatt ma kien sar studju kliniku u formali fil- popolazzjoni kemm pedjatrika jew fuq trabi għadhom jitwieldu u li għandhom defiċjenza konġenitali ta ’ proteina Ċ severa.
However, several small retrospective and prospective studies investigating other clinical application areas have been published in this population.
Madankollu, diversi studji żgħar retrospettivi u prospettivi li stħarrġu oqsma ta ’ applikazzjoni klinika ġew ippubblikati f’ din il - popolazzjoni.
Indication was prevention and treatment of purpura fulminans and thrombotic disease, enrolling overall 14 subjects of 2 days old throughout adolescence.
L- indikazzjoni kienet prevenzjoni u trattament ta ’ purpura fulminans u mard trombotiku, li globalment irreġistraw 14- il suġġett ta ’ età ta ’ jumejn waqt l- adoloxxenza.
Other experience with CEPROTIN covers case reports and a clinical study in overall 69 paediatric patients with acquired protein C deficiency.
Esperjenza oħra b’ CEPROTIN tkopri rapporti dwar każijiet u studju kliniku f’ 69 pazjent pedjatriku globalment li kellhom defiċjenza akkwiżita ta ’ proteina Ċ.
The study is a randomized, double-blind, placebo- controlled dose-finding study, in the indication of acquired protein C deficiency due to meningococcal sepsis (IMAG 112).
L- istudju hu randomised, double- blind, bi plaċebo bħala kontrolli għat- tfitxija ta ’ l- aħjar doża, fl- indikazzjoni ta ’ defiċjenza ta ’ proteina Ċ akkwiżita minħabba sepsis meningokokkali (IMAG 112).
The reports suggest that CEPROTIN is well tolerated in children and small infants.
Ir- rapporti jissuġerixxu li CEPROTIN hu ttollerat sew fi tfal u trabi żgħar.
Dosages of the above studies, covering 83 patients, indicate that dosing guidelines for adult subjects are also valid for neonatal and paediatric patient population.
Dożaġġi ta ’ l- istudji t’ hawn fuq, li jkopru 83 pazjent jindikaw li l- linji gwida għad- dożaġġ għal suġġetti adulti huma validi wkoll għal popolazzjoni ta ’ trabi li għadhom jitwieldu u pazjenti pedjatriċi.
In rare and exceptional cases, subcutaneous infusion of 250-350 IU/ kg was able to produce therapeutic protein C plasma levels in patients with no intravenous access.
F’ każijiet rari u eċċezzjonali, infużjoni taħt il- ġilda ta ’ 250- 350 IU/ kg kienet kapaċi tipproduċi livelli terapewtiċi ta ’ proteina Ċ fil- plażma f’ pazjenti li m’ għandhomx aċċess ġol- vina.
21 asymptomatic 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 protein C plasma activity was measured by chromogenic assay.
L- attività tal- proteina Ċ fil- plażma ġiet imkejla b’ assaġġ kromoġeniku.
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.
Il- half- lives individwali 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.
The individual incremental recovery ranged from 0.50 to 1.76 [(IU/ dL)/ (IU/ kg)].
L- irkupru inkrimentali individwali varja minn 0. 50 sa 1. 76 [(IU/ dL) / (IU/ kg)].
The patients differed significantly in age, body weight and plasma volume.
Il- pazjenti varjaw b' mod sinifikanti fl- età, fil- piż korporju u fil- volum ta 'plażma.
In patients with acute thrombotic disease, both the incremental increase in protein C plasma levels as well as half-life may be considerably reduced.
F' pazjenti b' mard trombotiku akut, kemm iż- żjieda fil- livelli ta ’ proteina Ċ fil- plażma kif ukoll iż- żmien li jieħu biex jinżel bin- nofs jistgħu jitnaqqsu b’ mod konsiderevoli
Protein C contained in CEPROTIN is a normal constituent of human plasma and acts like endogenous protein C.
Il- proteina Ċ li tinsab f’ CEPROTIN hija kostitwent normali fil- plażma tal- bniedem u taġixxi bħala proteina Ċ endoġenika.
Therefore experimental studies on tumorigenic or mutagenic effects - particularly in heterologous species - are not considered necessary.
Għalhekk studji esperimentali fuq effetti tumoriġeniċi jew mutaġeniċi – b’ mod partikolari fi speċi eteroloġiċi – m’ humiex meqjusin meħtieġa.
Single dose toxicity testing showed that even doses of several times the recommended human dosage per kilogram body weight (10-fold) did not result in toxic effects on rodents.
L- ittestjar tat- tossiċità b’ doża waħda wera li anke dożi li huma diversi drabi aktar mid- doża rakkomandata għal bniedem, għal kull kilogramm ta ’ piż korporali (10 darbiet), ma rriżultax f’ effetti tossiċi f’ annimali li jgerrmu.
CEPROTIN proved to have no mutagenic potential in the Ames test performed.
CEPROTIN ġie ppruvat li m' għandu ebda potenzjal mutaġeniku fit- test ta 'Ames li twettaq.
Repeated toxicity studies were not conducted because prior experience with coagulation preparations had shown them to be of limited value.
Ma sarux studji ripetuti tat- tossiċità minħabba li l- esperjenza preċedenti bi preparazzjonijiet tal - koagulazzjoni wriet li dawn kienu ta ’ valur ristrett.
Difference between the recipient species and human Protein C will inevitably result in an immune response with antibody formation.
Differenza bejn l- ispeċi riċevitura u proteina Ċ tal- bniedem għandha tirriżulta f’ rispons immuni bil- formazzjoni ta’ antikorp.
Powder Human albumin Sodium chloride Sodium citrate.
Trab Albumina tal- bniedem Sodium chloride Sodium citrate:
Solvent Sterilised Water for Injections
Solvent Ilma Sterilizzat għall- injezzjonijiet
6 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
3 years The reconstituted solution should be used immediately.
3 snin Is- soluzzjoni rikonstitwita għandha tintuża minnufih.
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°C - 8°C).
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kaxxa tal- kartun biex tilqa 'mid- dawl.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u x' hemm fih
500 IU and 1000 IU:
500 IU u 1000 IU:
CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU).
It- trab ta 'CEPROTIN jiġi f' kunjetti magħmulin minn ħġieġ newtrali tat- tip idrolitiku I (500 IU) jew tat- tip idrolitiku II (1000 IU).
The solvent comes in vials of neutral glass of hydrolytic type I.
Is- solvent jiġi f' kunjetti magħmulin minn ħġieġ newtrali tat- tip idrolitiku I.
The product and the solvent vials are closed with butyl rubber stoppers.
Il- kunjetti tal- prodott u tas- solvent huma magħluqin b' għatu magħmulin minn lastku tal- butyl.
Each pack also contains:
Kull pakkett fih ukoll:
• one transfer needle • one filter needle
• labra tat- trasferiment • labra tal- filtru
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle.
Ikkostitwixxi mill- ġdid it- trab xott ta 'CEPROTIN għal soluzzjoni għall- injezzjonijiet, bis- solvent fornut (Ilma Sterilizzat għall- Injezzjonijiet) billi tuża l- labra sterilizzata tat- trasferiment.
Gently rotate the vial until all powder is dissolved.
Dawwar b' mod ġentili l- kunjett sakemm it- trab kollu jinħall.
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 frak viżibbli.
The solution is drawn through the sterile filter needle into a sterile disposable syringe.
Is- soluzzjoni tinġibed minn ġol- labra tal- filtru sterilizzata għal ġo siringa sterilizzata li wara tista 'tintrema.
A separate unused filter needle must be used to withdraw each vial of reconstituted CEPROTIN.
Trid tintuża labra tal- filtru mhux użata separata biex jinġibed kull kunjett ta 'CEPROTIN rikostitwit.
The solution should be discarded if particulate matter is visible.
Is- soluzzjoni għandha tiġi skartata jekk tara materjal f' sura ta 'frak separati.