qanastek/EMEA-V3 huggingface dataset:
- Doxorubicin, docetaxel and irinotecan, which are other cancer treatments
- Doxorubicin, docetaxel u irinotecan, li huma kura oħra kontra l- kanċer
- Digoxin, a treatment for mild to moderate heart failure
- Digoxin, kura għall- insuffiċjenza tal- qalb ħafifa għal moderata
Tell your doctor or pharmacist if you are taking these or any other medicines (or have taken anything recently) – even those not prescribed.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding Avoid becoming pregnant while being treated with Nexavar.
Tqala u treddigħ Evita li tinqabad tqila waqt li qed tiġi kkurata b’ Nexavar.
If you could become pregnant use adequate contraception during treatment.
Jekk tista ’ tinqabad tqila uża kontraċezzjoni xierqa waqt il- kura.
If you become pregnant while being treated with Nexavar, immediately tell your doctor who will decide if the treatment should be continued.
Jekk tinqabad tqila waqt li qed tiġi kkurata b’ Nexavar, għid lit - tabib tiegħek immedjatament li jiddeċidi jekk il- kura għandiex titkompla.
You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby.
M’ għandekx tredda ’ lit- tarbija tiegħek waqt kura b’ Nexavar, minħabba li din il- mediċina tista ’ tinterferixxi mat- tkabbir u l- iżvilupp tat- tarbija tiegħek.
Driving and using machines There is no evidence that Nexavar will affect the ability to drive or to operate machinery.
Sewqan u tħaddim ta ’ magni M’ hemmx evidenza li Nexavar jaffettwa l- ħila li ssuq jew li tħaddem il- magni.
HOW TO TAKE NEXAVAR
KIF GĦANDEK TIEĦU NEXAVAR
The usual dose of Nexavar in adults is 2 x 200 mg tablets, twice daily.
Id- doża tas- soltu ta ’ Nexavar fl- adulti hija ta ’ 2 x 200 mg pilloli, darbtejn kuljum.
This is equivalent to a daily dose of 800 mg or four tablets a day.
Din hija ekwivalenti għal doża kuljum ta ’ 800 mg jew erba ’ pilloli kuljum.
Swallow Nexavar tablets with a glass of water, either without food or with a low-fat or moderate fat meal.
Ibla ’ l- pilloli ta ’ Nexavar ma ’ tazza ilma, jew bla ikel jew ma ’ ikla li fiha ftit jew ammont moderat ta ’ xaħam.
Do not take this medicine with high fat meals, as this may make Nexavar less effective.
Tieħux din il- mediċina ma ’ ikliet b’ ħafna xaħam, għax dan jista ’ jagħmel lil Nexavar inqas effettiv.
If you intend to have a high fat meal take the tablets at least 1 hour before or 2 hours after the meal.
Jekk għandek ħsieb li tieħu ikla b’ ħafna xaħam hu l- pilloli ta ’ l- inqas siegħa qabel jew sagħtejn wara l- ikel.
Always take Nexavar exactly as your doctor has told you to.
Dejjem għandek tieħu Nexavar skond il- parir tat- tabib.
It is important to take Nexavar at about the same times each day, so that there is a steady amount in the bloodstream.
Huwa mportanti li tieħu Nexavar f’ madwar l- istess ħin kuljum, sabiex ikun hemm ammont stabbli fiċ - ċirkolazzjoni tad- demm.
You will usually carry on taking Nexavar as long as you are getting clinical benefits, and not suffering unacceptable side effects.
24 Normalment inti tkompli tieħu Nexavar sakemm tkun qed tieħu benefiċċji kliniċi, jew ma tkunx qed issofri minn effetti sekondarji mhux aċċettabli.
24 If you take more Nexavar than you should Tell your doctor straight away if you (or anyone else) have taken more than your prescribed dose.
Jekk tieħu Nexavar aktar milli suppost Għid lit- tabib tiegħek minnufih jekk int (jew xi ħadd ieħor) ħadt aktar mid- doża preskritta.
Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions.
Teħid żejjed ta ’ Nexavar jagħmel l- effetti sekondarji aktar probabbli jew aktar severi, speċjalment dijarrea u reazzjonijiet tal- ġilda.
Your doctor may tell you to stop taking Nexavar.
It- tabib tiegħek jista ’ jgħidlek biex tieqaf tieħu Nexavar.
If you forget to take Nexavar If you have missed a dose, take it as soon as you remember.
Jekk tinsa tieħu Nexavar Jekk qbist doża, ħudha malajr kemm jista ’ jkun kif tiftakar.
If it is nearly time for the next dose, forget about the missed one and carry on as normal.
Jekk ikun sar kważi l- ħin għad- doza li jmiss, insa dwar id- doża li qbist u kompli bħas- soltu.
Like all medicines, Nexavar can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Nexavar jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
This medicine may also affect the results of some blood tests.
Din il- mediċina jista ’ taffettwa wkoll ir- riżultati ta ’ xi testijiet tad- demm.
Very common side effects (may affect 1 in 10 people or more)
Effetti sekondarji komuni ħafna (jistgħu jaffettwaw 1 minn kull 10 persuni jew aktar)
- diarrhoea
- dijarrea
- feeling sick (nausea)
- tħossok ma tiflaħx (tqallih)
- feeling weak or tired
- tħossok dgħajjef jew għajjien
- pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain)
- uġigħ (inkluż uġigħ fil- ħalq, uġigħ fiż- żaqq, uġigħ ta ’ ras, uġigħ fl- għadam, uġigħ tat- tumur)
- hair loss
- telf ta ’ xagħar
- flushed or painful palms or soles (hand foot syndrome)
- pali ta ’ l- idejn u s- saqajn ħomor jew jgħuġu (sindromu ta ’ l- id u s- sieq)
- itching or rash
- ħakk u raxx
- throwing up (vomiting)
- ittella ’ (rimettar)
- bleeding (including bleeding in the brain, gut wall and respiratory tract; haemorrhage)
- fsada (inkluż fsada fil- moħħ, ħajt tal- musrana u fil- passaġġ respiratorju; (emorraġġija)
- high blood pressure, or increases in blood pressure
- pressjoni għolja tad- demm, jew żjieda fil- pressjoni tad- demm
Common side effects (may affect between 1 in 10 and 1 in every 100 people)
Effetti sekondarji komuni (jistgħu jaffettwaw bejn 1 minn kull 10 u 1 minn kull 100 persuna)
- flu-like illness
- marda bħal l- influwenza
- difficulty swallowing
- diffikultà biex tibla ’
- inflamed or dry mouth, tongue pain
- ħalq infjammat jew xott, uġigħ fl- ilsien
- weight loss
- telf fil- piż
- loss of appetite
- telf t’ aptit
- joint or muscle pain (arthralgia)
- uġigħ fil- ġogi jew muskoli (artralġja)
- disturbed sensations in fingers and toes, including tingling or numbness
- sensazzjonijiet imfixkla fis- swaba ta ’ l- idejn u tas- saqajn, inkluż tnemnim jew tirżiħ
- erection problems (impotence)
- problemi fl- erezzjoni (impotenża)
- hoarseness
- ħanqa
- inflamed, dry or scaly skin that sheds
- ġilda infjammata, xotta jew bil- qxur li jaqgħu
- tinnitus
- żanżin fil- widnejn
- kidney failure
- insuffiċjenza tal- kliewi
Uncommon side effects (may affect fewer than 1 in every 100 people)
Effetti sekondarji mhux komuni (jistgħu jaffettwaw inqas minn 1 kull 100 persuna)
- allergic like reactions (including skin reactions and hives)
- uġigħ ta ’ żaqq (addome) ikkawżata minn pankrejatite, infjammazzjoni tal- marrara u/ jew tal -
- infections of hair follicles (folliculitis)
- ġilda jew għajnejn sofor (suffejra) ikkawżata minn livelli għolja ta ’ pigmenti tal- bili
- general infections
- infezzjonijiet ġenerali
- dehydration
- diżidratazzjoni
- enlarged breasts
- sider imkabbar
- persistent runny nose
- mnieħer iqattar persistenti
- eczema
- ekżema
- heart attack (myocardial infarction), heart failure or chest pain
- attakk tal- qalb (infart mijokardiku), insuffiċjenza tal- qalb jew uġigħ fis- sider
- underactive thyroid
- tirojde inqas attiva
- multiple skin eruptions (erythema multiforme minor)
- eruzzjonijiet multipli fil- ġilda (erythema multiformi minuri)
- abnormally high blood pressure
- pressjoni tad- demm għolja b’ mod anormali
- holes in the gut wall (gastrointestinal perforation)
- ħofor fil- ħajt tal- musrana (perforazzjoni gastro- intestinali)
- reversible swelling in the rear part of the brain that can be associated with headache, altered
- nefħa riversibbli fil- parti ta ’ wara tal- moħħ li tista ’ tkun assoċjata ma ’ uġigħ ta ’ ras, bidla fis -
consciousness, fits and visual symptoms including visual loss (reversible posterior leukoencephalopathy)
sensi,, aċċessjonijiet u sintomi fil- vista inkluż telf fil- vista (lewkoenċelopatija posterjuri riversibbli)
- benign localised skin growth (keratoacanthoma)/ skin cancer
- massa beninja localizzata fil- ġilda/ kanċer tal- ġilda
If any of the side effects happens to you, ask your doctor for advice.
Jekk int tħoss xi wieħed minn dawn l- effetti sekondarji, saqsi lit- tabib tiegħek għall- parir.
HOW TO STORE NEXAVAR
KIF TAĦŻEN NEXAVAR
Do not use the tablets after the expiry date which is stated on the carton and on each blister after EXP.
Tużax il- pilloli wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq kull folja wara EXP.
What Nexavar contains
X’ fih Nexavar
The active substance is sorafenib.
Is- sustanza attiva hi sorafenib.
1 tablet contains 200 mg sorafenib (as tosylate).
Pillola waħda fiha 200 mg sorafenib (bħala tosylate).
Core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate.
Qalba: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate.
Coating: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide red (E 172).
Rita: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide aħmar (E 172).
What Nexavar looks like and contents of the pack
26 Id- Dehra ta ’ Nexavar u l- kontenut tal- pakkett
Nexavar 200 mg tablets are red, round and film-coated, with the Bayer cross on one side and “ 200 ” on the other side.
Pilloli ta ’ Nexavar 200 mg huma ħomor, tondi u miksija b’ rita, bis- salib ta ’ Bayer fuq naħa u “ 200 ” fuq in- naħa l- oħra.
They come in packs of 112: four transparent blister packs of 28 tablets each.
Jiġu f’ pakketti ta ’ 112: erba ’ folji trasparenti ta ’ 28 pillola kull wieħed.
Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
26 Manufacturer Bayer Schering Pharma AG 51368 Leverkusen Germany
Manifattur Bayer Schering Pharma AG 51368 Leverkusen Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
27 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This leaflet was last approved in {}
Dan il- fuljett kien approvat l- aħħar f ’ {}
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TAL- VALUTAZZJONI PUBBLIKU EWROPEW (EPAR)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubbliku Ewropew (EPAR).
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.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu tal- bniedem (CHMP) ivvaluta l- istudji mwettqin, sabiex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża din il- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk għandek bżonn ta ’ iktar informazzjoni dwar il- kundizzjoni medika jew il- kura tiegħek, aqra l - Fuljett ta ’ Tagħrif (li huwa wkoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid iżjed informazzjoni dwar il- bażi tar- rakkomandazzjonijiet tas- CHMP, aqra id- Diskussjoni Xjentifika (li hija wkoll parti mill- EPAR).
What is Nonafact?
X’ inhu Nonafact?
Nonafact is a powder and solvent that are mixed together to form a solution for infusion (drip into a vein).
Nonafact huwa magħmul minn trab u solvent li jitħalltu flimkien sabiex jifformaw soluzzjoni għall - infużjoni (għall- użu minn ġol- vini permezz ta ’ drip).
Nonafact contains the active ingredient human coagulation factor IX, which helps blood to clot.
Nonafact fih is- sustanza attiva fattur IX ta ’ koagulazzjoni uman, li tgħin sabiex id- demm jagħqad.
What is Nonafact used for?
Għalxiex jintuża Nonafact?
Nonafact is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Nonafact jintuża għall- kura u l- prevenzjoni ta ’ fsada f’ pazjenti b’ emofilja B (marda ereditarja ta ’ fsada kkawżata minn nuqqas ta ’ fattur IX).
Nonafact can be used in adults and children over the age of 6.
Nonafact jista ’ jintuża fl- adulti u fit- tfal ’ il fuq minn 6 snin.
Nonafact is intended for either short-term or long-term use.
Nonafact huwa intiż għall- użu kemm għal żmien twil kif ukoll għal żmien qasir.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss permezz ta ’ riċetta.
How is Nonafact used?
Kif jintuża Nonafact?
Nonafact is given by intravenous infusion (into a vein) at no more than 2 ml per minute.
Nonafact jingħata permezz ta ’ infużjoni intravenuża (minn ġol- vini) b’ rata ta ’ mhux iżjed minn 2 ml kull minuta.
The dose depends on whether Nonafact is used to treat haemorrhage (bleeding) or to prevent it during surgery.
Id- doża tiddependi fuq jekk Nonafact ikunx qiegħed jintuża għall- kura ta ’ emorraġija (fsada) jew biex din tiġi evitata waqt operazzjoni.
The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Id- doża tiġi aġġustata wkoll skont is- severità ta ’ l - emorraġija jew it- tip ta ’ operazzjoni.
It is generally administered once a day, except in life-threatening situations.
Normalment jingħata darba kuljum, ħlief f’ sitwazzjonijiet ta ’ periklu ta ’ mewt.
The full detail on how to calculate the doses is included in the Package Leaflet.
Id- dettallji kollha dwar kif tikkalkula d- dozi huma inklużi fil- Fuljett ta ’ Tagħrif.
How does Nonafact work?
Kif jaħdem Nonafact?
Nonafact contains human coagulation factor IX, extracted and purified from human plasma (the liquid part of the blood).
Nonafact fih il- fattur IX uman tal- koagulazzjoni tad- demm, estratt u ppurifikat mill- plażma umana (il - parti likwida tad- demm).
In the body, factor IX is one of the substances (factors) involved in blood coagulation (clotting).
Fil- ġisem, il- fattur IX huwa wieħed mis- sustanzi (fatturi) involuti fil - koagulazzjoni tad- demm (meta jgħaqad id- demm).
Patients with haemophilia B lack factor IX, and this causes blood coagulation problems, such as bleeding in the joints, muscle or internal organs.
Pazjenti bl- emofilja B għandhom nuqqas ta ’ fattur IX, u dan jikkawża problemi fil- koagulazzjoni tad- demm, bħal fsada fil- ġogi, fil- muskoli u fl- organi interni.
Nonafact is used to replace the missing factor IX, it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Nonafact jintuża biex jissostitwixxi il- fattur IX nieqes, jikkoreġi n- nuqqas ta ’ fattur IX u jagħti kontroll temporanju fil- problema ta ’ fsada.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Nonafact shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Nonafact?
Nonafact was rated as “ good” or “ excellent” in its ability to prevent bleeding in patients with haemophilia B.
Nonafact ġie meqjus bħala “ tajjeb ” jew “ eċċellenti ” fil- kapaċità tiegħu li jippreveni l- fsada f’ pazjenti b’ emofilja B.
What is the risk associated with Nonafact?
X’ inhuwa r- riskju assoċjat ma ’ Nonafact?
Haemophilia B patients may develop antibodies (inhibitors) to factor IX.
Pazjenti bl- emofilja B jistgħu jiżviluppaw antikorpi għall- fattur IX.
If this happens Nonafact may not work effectively.
Jekk jiġri hekk, jista ’ jagħti l- każ li Nonafact ma jaħdimx b’ mod effettiv.
Hypersensitivity (allergic reactions) has been sometimes seen in patients treated with factor IX-containing products.
Xi kultant, f’ pazjenti kkurati bi prodotti li fihom il- fattur IX, dehru reazzjonijiet allerġiċi (sensittività eċċessiva).
If this happens, Nonafact will not work effectively.
Jekk jiġri hekk, Nonafact ma jaħdimx b’ mod effettiv.
For the full list of all the side effects reported with Nonafact, please see the Package Leaflet.
Għal lista kompluta tal- effetti sekondarji kollha rrapportati b’ Nonafact, jekk jogħġbok ara l - Fuljett ta ’ Tagħrif.
Nonafact should not be used in people who may be hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.
Nonafact m’ għandux jintuża f’ nies li jistgħu jkunu allerġiċi (ibatu minn sensittività eċċessiva) għall - fattur IX tal- koagulazzjoni umana jew għal xi wieħed mis- sustanzi l- oħra, jew għal proteini tal- ġrieden.
Why has Nonafact been approved?
Għaliex ġie approvat Nonafact?
The Committee for Medicinal Products for Human Use (CHMP) decided that Nonafact’ s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B.
Il- Kumitat għal Prodotti Mediċinali għall- Użu tal- Bniedem (CHMP) iddeċieda li għall- kura u l - prevenzjoni ta ’ fsada f’ pazjenti bl- emofilja B, Nonafact għandu iżjed benefiċċji milli riskji.
They recommended that Nonafact be given marketing authorisation.
Irrakkomandaw li Nonafact jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Nonafact:
Tagħrif ieħor dwar Nonafact:
The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact to Sanquin, CLB, Products Division on 3 July 2001.
Fit- 3 ta ’ Lulju 2001, il- Kummissjoni Ewropea tat lil Sanquin, CLB, Products Division l- awtorizzazzjoni għat- tqegħid fis- suq li hija valida fl- Unjoni Ewropea kollha.
The full EPAR for Nonafact can be found here.
L- EPAR komplut ta ’ Nonafact jinsab hawn.
This summary was last updated in 03-2006
Dan is- sommarju ġie rivedut l- aħħar f’ 03- 2006
EU Number
Numru tal- UE
Trade name
Marka
Content (concentration) Package size
Kontenut (konċentrazzjoni)
100IU/ ml
100UI/ ml
Powder and solvent for solution for injection
Trab u solvent għal
Intravenous use
Għall- użu minn ġol -
Powder: vial (glass) Powder:
Trab: kunjett (ħġieġ)
500 IU Solvent: vial (glass) Solvent:
500 UI
1 vial + 1 vial
kunjett 1
100 IU/ ml
100UI/ ml
1000 IU Solvent: vial (glass) Solvent:
1000 UI
Nonafact 100 IU/ ml powder and solvent for solution for injection.
Nonafact 100 IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni.
Nonafact contains 100 IU/ ml (500 IU/ 5ml or 1000 IU/ 10ml) human coagulation factor IX when reconstituted with 5 ml or 10 ml, respectively, of water for injections.
Nonafact fih 100IU/ ml (500 IU/ 5ml jew 1000 IU/ 10ml) ta ’ fattur IX ta ’ koagulazzjoni umana meta jkun rikostitwit b’ 5 ml jew 10 ml, rispettivament, ta ’ ilma għall- injezzjonijiet.
Each vial contains 500 IU of human coagulation factor IX/ Each vial contains 1000 IU of human coagulation factor IX.
Kull fjala fiha 500 IU ta ’ fattur IX ta ’ koagulazzjoni umana / Kull fjala fiha 1000 IU ta ’ fattur IX ta ’ koagulazzjoni umana.
The potency (IU) is determined using a method equivalent to the test method described in the European Pharmacopoeia.
Il- qawwa tal- prodott (IU) hija determinata bl- użu ta ’ metodu ekwivalenti għall- metodu tat- test deskritt fil- Famakopeja Ewropea.
The specific activity of Nonafact is at least 200 IU/ mg protein.
L- attività speċifika ta ’ Nonafact hija mill- inqas 200 IU/ mg proteina.
This medicinal product contains 75mmol/ l sodium chloride per dose.
Dan il- prodott mediċinali fih 75mmol/ l klorur tas- sodju f’ kull doża.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jitqies u jiġi kkunsidrat minn pazjenti li qegħdin fuq dieta ta 'sodju kkontrollat.
White lyophilized powder and solvent for solution for injection.
Trab abjad lajofilizzat u solvent għal soluzzjoni għall- injezzjoni.
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Kura u profilassi ta ’ fsada (ħruġ ta ’ demm) f’ pazjenti li jbatu mill- emofilja B (defiċjenza konġenitali tal- fattur IX)
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Il- kura għandha tinbeda taħt is- sorveljanza ta ’ tabib esperjenzat fil- kura ta ’ l- emofilja.
The dose and the duration of substitution therapy depend on the severity of the factor IX deficiency.
Id- doża u t- tul tat- terapija ta ’ sostituzzjoni jiddependu mis- severità tad- defiċjenza tal- fattur IX.
Other determining factors are the site and extent of the haemorrhage and the patient’ s clinical condition.
Fatturi oħra determinanti huma l- post u l- gravità ta ’ l- emorraġija u l- kondizzjoni klinika tal- pazjent.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current International Standard for factor IX concentrate as approved by the WHO.
In- numru ta ’ unitajiet ta ’ fattur IX mogħtija huwa espress f’ Unitajiet Internazzjonali (IU), li huma relatati ma ’ l- Istandard Internazzjonali kurrenti għal konċentrat ta ’ fattur IX kif approvat mill- WHO.
Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma).
L- attivita ’ tal- fattur IX fil- plażma hija espressa jew bħala peċentwali (relattiva għall- plażma umana normali) jew f’ Unitajiet Internazzjonali (relattiva għal l- istandard internazzjonali għal fattur IX fil - plażma).
One International Unit (IU) of factor IX activity is related to the quantity of factor IX in the International Standard for factor II, VII, IX and X in human plasma (approved by the WHO) which approximates to the quantity of factor IX in one ml of normal human plasma.
Unità Internazzjonali waħda( IU) ta ’ l- attività ta ’ fattur IX hija relatata mal- kwantità ta ’ fattur IX fl - Istandard Internazzjonali għal fattur II, VII, IX u X fil- plażma umana (approvati mill- WHO) li, bejn wieħed u ieħor, hija daqs il- kwantità ta ’ fattur IX f’ ml wieħed ta ’ plażma umana normali.
The calculation of the required dosage of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1.1% of normal activity.
Il- kalkolu tad- doża ta ’ fattur IX, meħtieġa huwa bbażat fuq is- sejba empiriku li Unità Internazzjonali (IU) waħda ta ’ fattur IX għal kull kilo ta ’ piż tal- ġisem tgħolli l- attività ta ’ fattur IX fil- plażma b’ 1. 1% ta ’ l - attività normali.
The required dosage is determined using the following formula:
Id- doża meħtieġa hija determinata bl- użu tal- formola li ġejja:
Required units = body weight (kg) x desired factor IX rise (%) (IU/ dl) x 0.9
Unitajiet meħtieġa = Piż tal- ġisem (kg) x żieda mixtieqa tal- fattur IX (%) (IU/ dl) x 0. 9
2 The amount to be administered and the frequency of treatment should always be determined on the basis of clinical effectiveness in the individual patient.
2 L- ammont li għandu jiġi mgħoti u l- frekwenza tal- kura għandhom dejjem jiġu determinati fuq il- bażi ta ’ l- effett kliniku fil- pazjent individwali.
Factor IX products rarely require to be administered more than once daily.
Prodotti tal- fattur IX rari jeħtieġu li jingħataw aktar minn darba kuljum.
In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in% of normal or IU/ dl) in the corresponding period.
Fil- każ tas- sitwazzjonijiet emorraġiċi li ġejjin, l- attività ta ’ fattur IX m’ għandhiex taqa ’ taħt il- livell ta ’ attività ta ’ plażma mogħti (f ’% tan- normal jew IU/ dl) fil- perjodu korrispondenti.
The following table can be used to guide dosing in bleeding episodes and surgery:
It- tabella li ġejja tista ’ tintuża bħala gwida għal dożi f’ episodji ta ’ fsada u kirurġija:
Degree of haemorrhage / Type of surgical procedure Haemorrhage
Il- Grad ta ’ emorraġija / Tip ta ’ proċedura kirurġika
Factor IX level Frequency of doses (hours)/ Duration required (%) of therapy (days) (IU/ dl)
Livell ta ’ Fattur IX meħtieġ (%) (IU/ dl)
Early haemarthrosis, muscle bleeding or oral bleeding
Emorraġija Emartrożi bikrija, fsada mill - muskolu jew orali
20-40 Repeat every 24 hours.
Irrepeti kull 24 siegħa.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Mill- inqas ġurnata waħda sakemm l- episodju ta ’ fsada kif indikat mill- uġigħ itaffi jew ikun hemm fejqan.
More extensive haemarthrosis, muscle bleeding or haematoma
Emartrożi aktar estensiva, fsada mill- muskolu jew ematoma
30-60 Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Irrepeti l- infużjoni kull 24 siegħa għal 3- 4 ijiem jew aktar sakemm l - uġigħ u d- disabilità akuta jgħaddu
Life threatening haemorrhages Surgery
Emorraġiji li jipperikolaw il- ħajja Kirurġija
60-100 Repeat infusion every 8 to 24 hours until threat is resolved.
Irrepeti l- infużjoni kull 8 sa 24 siegħa sakemm ir- riskju jiġi kontrollat.
Minor including tooth extraction Major
Minuri Inkluża l- qlugħ tas- snien
30-60 Every 24 hours, at least 1 day, until healing is achieved.
Kull 24 siegħa, mill- inqas ġurnata waħda, sakemm ikun hemm fejqan.
80-100 Repeat infusion every 8-24 hours until adequate wound healing, then (pre- and therapy for at least another 7 days to postoperative) maintain a factor IX activity of 30% to 60% (IU/ dl).
inqas 7 ijiem oħra biex iżżomm l - attività ta ’ Fattur IX minn 30% sa 60% (IU/ dl).
During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated injections.
Matul il- kura, huwa rrakkomandat li l- livelli ta ’ fattur XI jiġu stabbiliti sabiex ikun hemm gwida għad - doża li għandha tingħata u l- frekwenza ta ’ injezzjonijiet ripetuti.
In the case of major surgical interventions in particular, precise monitoring of substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Fil- każ ta ’ interventi kirurġiċi maġġuri b’ mod partikolari, il- monitoraġġ preċiż ta ’ terapija ta ’ sostituzzjoni permezz ta ’ analiżi ta ’ koagulazzjoni (attività ta ’ fattur IX tal- plażma) huwa indispensabbli.
Individual patients may vary in their response to factor IX, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pazjenti individwali għandu mnejn jkollhom rispons differenti għall- fattur IX, hekk juru livelli differenti ta ’ fejqan in vivo u juru differenzi fil- half- lives.
For long-term prophylaxis of haemorrhages in patients with severe haemophilia B, doses of 20 to 40 IU of factor IX per kilogram of body weight could be given at intervals of 3 to 4 days.
Għal profilassi ta ’ emorraġiji għal żmien twil f’ pazjenti b’ emofilja B serja, dożi ta ’ 20 sa 40 IU ta ’ fattur IX għal kull kilogramma ta ’ piz tal- ġisem jistgħu jingħataw f’ intervalli ta ’ 3 sa 4 ijiem.
In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
F’ xi każijiet, speċjalment f’ pazjenti iżgħar, jista ’ jkun hemm bżonn ta ’ intervalli iqsar ta ’ dożi jew dożi ogħla.
There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Hemm tagħrif insuffiċjenti biex l- użu ta ’ Nonafact ikun rakkomandat għal tfal ta ’ età ta ’ inqas minn 6 snin.
Patients should be monitored for the development of factor IX inhibitors.
Il- pazjenti għandhom jiġu monitorjati għall- iżvilupp ta ’ inibituri għal fattur IX.
If the expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor IX inhibitor is present.
Jekk il- livelli mixtieqa ta ’ l- attività ta ’ fattur IX fil- plażma ma jintlaħqux, jew jekk il- fsada ma tiġix ikkontrollat b’ doża adattata, għandha titwettaq analiżi sabiex jiġi stabbilit jekk hemmx inibitur ta ’ fattur IX.
In patients with high levels of inhibitor, factor IX therapy may not be effective and other therapeutic options should be considered.
F’ pazjenti b’ livelli għolja ta ’ inibitur, it- terapija bil- fattur IX tista ’ ma tkunx effettiva u għandhom jiġu kkunsidrati għażliet terapewtiċi oħra.
Management of such patients should be directed by physicians with experience in the care of patients with haemophilia, see also 4.4.
3 Il- kura ta ’ dawn il- pazjenti għandha tkun immexxija minn tobba b’ esperjenza fil- kura ta ’ pazjenti bl - emofilja, ara wkoll 4. 4.
Dissolve the product as described at 6.6.
Dewweb il- prodott kif spjegat f’ 6. 6.
The product should be administered via the intravenous route.
Il- prodott għandu jingħata minn ġol- vina.
It is recommended that the rate of administration should not exceed 2 ml/ min.
Huwa rrakkmandat li r - rata tat- teħid ma tkunx aktar minn 2ml kull minuta.
- Hypersensitivity to the active substance or to any of the excipients;
- Ipersensittività għas- sustanza attiva jew xi wieħed mis- sustanzi mhux attivi;
- Hypersensitivity to mouse proteins.
- Ipersensittività għall- proteini tal- ġrieden.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Bħal ma jista ’ jiġri bi kwalunkwe prodott ta ’ proteina li jingħata minn gol- vini, jista ’ jkun hemm reazzjonijiet ipersensittivi tat- tip allerġiċi.
The product contains traces of mouse proteins.
Il- prodott fih traċċi ta ’ proteini tal- ġrieden.
Patients should be informed of the early signs of hypersensitivity reactions including urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Il- pazjenti għandhom jiġu nfurmati bis- sintomi bikrija ta ’ reazzjonijiet ta ’ ipersensittività li jinkludu urtikarja, għafsa fis- sider, tħarħir, pressjoni baxxa, u anafilassi.
If these symptoms occur, patients should be advised to discontinue use of the product immediately and contact their physician.
Jekk dawn is- sintomi jinħassu, il- pazjenti għandhom jingħataw il- parir li jwaqqfu l- prodott immedjatament u jikkuntattjaw lit- tabib tagħhom.
In case of shock, the current medical standards for shock-treatment should be observed.
Fil- każ ta ’ xokk, l- istandards mediċi kurrenti għal kura ta ’ xokk għandhom jiġu osservati.
Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the risk being higher in low purity preparations, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).
Billi l- użu ta ’ konċentrati tal- komplessi tal- fattur IX kien assoċjat storikament ma ’ komplikazzjonijiet tromboemboliċi, b’ riskju ogħla meta jittieħdu sustanzi ta ’ purità baxxa, l- użu ta ’ prodotti li fihom fattur IX jista ’ jkun potenzjalment riskjuż f’ pazjenti li għandhom sinjali ta ’ fibrinoliżi u f’ pazjenti b’ koagulazzjoni intravaskulari mifruxa (DIC).
Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Minħabba dan ir- riskju potenzjali ta ’ komplikazzjonijiet trombotiċi, għandu jkun hemm sorveljanza klinika għal sinjali bikrija ta ’ koagulopatija trombotika u li tikkonsma, permezz ta ’ testijiet bioloġiċi adattati, meta jingħata lill- pazjenti b’ mard tal- fwied, lil pazjenti wara l- operazzjonijiet, lit- trabi tat- twelid, jew lil pazjenti b’ riskju ta ’ mard trombotiku jew DIC.
In each of these situations, the benefit of treatment with Nonafact should be weighed against the risk of these complications.
F’ kull waħda minn dawn is- sitwazzjonijiet, il- benefiċċju ta ’ kura b’ Nonafact għandu jiġi meqjus kontra r- riskju ta ’ dawn il- komplikazzjonijiet.
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 virus.
Miżuri standard mittieħda biex jevitaw infezzjonijiet kkaġunati mill- użu ta ’ prodotti mediċinali magħmula mid- demm uman jew mill- plażma umana, jinkludu l- għażla tad- donaturi, l- ittestjar tad - donazzjonijiet individwali u tal- ġabra tal- plażma għal sinjali speċifiċi li jindikaw li hemm infezzjoni, kif ukoll it- teħid ta ’ miżuri effettivi għat- twaqqif / tneħħija tal- virus waqt il- manifattura tal- prodott.
Despite this, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jingħataw mediċini magħmula mid- demm uman jew mill- plażma umana, il - possibbiltà ta ’ tixrid ta ’ aġenti li jinfettaw ma tistax tiġi totalment eskluża.
This also applies to unknown or emerging viruses or other pathogens.
Dan japplika ukoll għal virusis li m’ humiex magħrufa jew li għadhom qegħdin jitfaċċaw, jew patoġeni oħra.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Il- miżuri mittieħda huma kkunsidrati bħala effettivi għall- virusis imgeżwra bħall- HIV, HBV u HCV, u għall- virusis HAV u parovirus B19, li m’ humiex imgeżwra.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of plasma-derived factor IX concentrates.
F’ każ ta ’ pazjenti li jirċievu konċentrati ta ’ fattur IX derivati mill- plażma b’ mod regolari/ ripetutament, għandu jiġi kkunsidrat it- tilqim adattat (epatite A u B).
It is strongly recommended that every time that Nonafact 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 rrakkomandat ħafna li kull darba li Nonafact jingħata lil xi pazjent, jitniżżel u jinżamm l- isem u n- numru tal- lott tal- prodott, u dan biex tinżamm konnessjoni bejn il- pazjent u n- numru tal- lott tal - prodott.
After repeated treatment with Nonafact, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Wara kura repetut b’ Nonafact, il- pazjenti għandhom jiġu monitorjati biex ikun stabbilit jekk hemmx anti- korpi newtralizzanti (inibituri), li għandhom jiġu kkwantifikati f’ Unitajiet Bethesda (BU) bl- użu ta ’ testijiet bioloġiċi adattati.
There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Saru rapporti fil- litteratura li juru korrelazzjoni bejn l- inċidenza ta ’ inibitur tal- fattur IX u reazzjonijiet allerġiċi.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Għalhekk, pazjenti li jkollhom reazzjonijiet allergiċi għandhom jiġu eżaminati għall - preżenza ta ’ inibitur.
It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Wieħed għandu jżomm f’ moħħu li pazjenti b’ inibituri għall- fattur IX jistgħu ikunu qiegħdin f’ riskju akbar ta ’ anafilassi meta jerġa ’ jingħata fattur IX.
Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician’ s judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
4 Minħabba r- riskju ta ’ reazzjonijiet allerġiċi b’ konċentrati tal- fattur IX, skond l- opinjoni tat- tabib li jkun qiegħed jagħti t- kura, id- dożi inizzjali tal- fattur IX, għandhom jingħataw taħt osservazzjoni medika meta tkun tista ’ tiġi pprovduta kura medika adattata għal reazzjonijiet allerġiċi.
4 4.5 Interactions with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No interactions of Nonafact with other medicinal products are known.
Mhux magħruf li hemm interazjoni ta ’ Nonafact ma ’ prodotti prodotti mediċinali oħra.
Animal reproduction studies have not been conducted with factor IX.
Għadhom ma sarux studji dwar l- effett ta ’ fattur IX fuq ir- riproduzzjoni ta ’ l- annimali.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast- feeding is not available.
Abbażi tal- fatt li l- inċidenza ta’ emofilja B fin- nisa hija rari, ma hemmx disponibbli esperjenza dwar l- użu ta ’ fattur IX waqt it- tqala u l- irdigħ.
Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Għalhekk, il- fattur IX għandu jintuża waqt it- tqala u l- irdigħ biss jekk indikat b’ mod ċar.
Nonafact has no influence on the ability to drive or use machines.
Nonafact m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently in patients treated with factor IX containing products.
Ipersensittività jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis- sit ta ’ l - infużjoni, tkexkix ta ’ bard, fwawar, urtikarja ġenerali, uġigħ ta ’ ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta ’ sabar, takikardija, għafsa fis- sider, tnemnim, remettar, tħarħir) ġew osservati b’ mod infrekwenti f’ pazjenti trattati bi prodotti li fihom il- fattur IX.
In some case, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
F’ xi każijiet, dawn ir - reazzjonijiet avvanzaw għal anafilassi serja, u dan kien f’ assoċjazzjoni temporanja ma ’ l- iżvilupp ta ’ inibituri ta ’ fattur IX (ara wkoll 4. 4).
Nephrotic syndrome has been reported following attempted immune tolerance induction on haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Sindromu nefrotiku ġie rappurtat wara attentat ta ’ induzzjoni ta ’ tolleranza immuni f’ pazjenti li jbatu minn emofilja B b’ inibituri ta ’ fattur IX u li kellhom reazzjoni allerġika fil- passat.
On rare occasions, fever has been observed.
F’ okkażjonijiet rari, ġie osservat id- deni.
Haemophilia B patients may develop antibodies (inhibitors) to factor IX.
Pazjenti b’ emofilja B jistgħu jiżviluppaw anti- korpi (inibituri) għall- fattur IX.
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Jekk jirriżultaw dawn l - inibituri, il- kondizzjoni tkun meqjusa bħalha rispons kliniku insuffiċjenti.
In such cases, it is recommended that a specialised haemophilia centre be contracted.
F’ dawn il- każijiet, huwa rrakkomandat li wieħed jikkuntattjat ċentru speċċjalizzat ta ’ l- emofilja.
During clinical trials with Nonafact conducted in previously treated patients development of inhibitors was not reported.
Waqt provi kliniċi b’ Nonafact li saru fuq pazjenti li qabel kienu diġa` ġew ittrattati b’ Nonafact, ma ġiex rapportat l- iżvilupp ta ’ inibituri.
There is no experience of the treatment of previously untreated patients with Nonafact.
Ma hemm ebda esperjenza dwar Il- kura ta ’ pazjenti li ma kienux qabel trattati b’ Nonafact.
There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Hemm riskju potenzjali ta ’ episodji tromboemboliċi meta jingħataw prodotti ta ’ fattur IX, b’ riskju ogħla meta dawn ikunu ta ’ purità baxxa.
The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
L- użu ta ’ prodotti b ’ fattur IX ta ’ purità baxxa kien assoċjat ma ’ każijiet ta ’ infart mijokardijaku, koagulazzjoni intravaskulari mifruxa, trombożi fil- vina u emboliżmu pulmonari.
The use of high purity factor IX is rarely associated with such side effects.
L- użu ta ’ fattur IX ta ’ purità għolja huwa rarament assoċjat ma ’ dawn l- effetti.
Nonafact contains trace amounts (< 0.1 ng mouse IgG/ IU of factor IX) of the murine monoclonal antibody used in its purification.
Nonafact fih traċċi (≤ 0. 1ng IgG/ IU tal- ġurdien ta ’ fattur IX) ta ’ l- anti- korp monoklonali tal- ġurdien użat fil- purifikazzjoni tiegħu.
In theory, therefore, the use of Nonafact could generate antibodies to mouse protein.
Fit- teorija, għalhekk, l- użu ta ’ Nonafact jista ’ jiġġenera anti- korpi għall - proteina tal- ġurdien.
The clinical relevance of antibodies to mouse protein, if these do indeed arise, is not known.
Ir- rilevanza klinika ta ’ l- anti- korpi għall- proteina tal- ġurdien, jekk dawn tassew jiffurmaw, mhijiex magħrufa.
For safety with respect to transmissible agents, see 4.4.
Għas- sigurta f’ dak li għandu x’ jaqsam ma ’ aġenti trasmissibbli, ara 4. 4
No symptoms of overdose with human coagulation factor IX have been reported.
5 Ma kienu rrapurtati l- ebda sintomi ta ’ doża eċċessiva bil- fattur IX ta ’ koagulazzjoni umana.
Antihaemorrhagics, blood coagulation factor IX.
Antiemorraġiċi, fattur IX ta ’ koagulazzjoni tad- demm.
Factor IX is a single chain glycoprotein with a molecular weight of about 68,000 Dalton.
Il- fattur IX huwa glikoproteina ta ’ katina waħda b’ piż molekulari ta ’ madwar 68, 000 Dalton.
It is a vitamin K-dependent coagulation factor and is synthesised in the liver.
Huwa fattur ta ’ koagulazzjoni li jiddependi fuq il- vitamina K u jiġi sintesizzat fil- fwied.
Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/ tissue factor complex in the extrinsic pathway.
Il- fattur IX huwa attivat permezz tal- fattur XIa fil- passaġġ intrinsiku ta ’ koagulazzjoni u permezz tal - fattur VII / kumpless tal- fattur tat- tessut fil- passaġġ estrinsiku.
Activated factor IX, in combination with activated factor VIII, activates factor X.
Il- Fattur IX attivat, flimkien mal- fattur VIII attivat, jattivaw il- fattur X.
This ultimately results in the conversion of prothrombin to thrombin.
Dan, fl- aħħar mill- aħħar jirriżulta fil- bidla ta ’ protrombin għal trombin.
Thrombin then converts fibrinogen into fibrin and a clot is formed.
Trombin imbagħad jibdel fibrinoġen għal fibrin u hekk jifforma embolu.
Haemophilia B is a gender-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Hija dovuta għal livelli mnaqqsa tal- fattur IX u tirriżulta fi fsada qawwija fil - ġogi, fil- muskoli jew fl- organi interni, b’ effett spontanju jew bħala riżultat ta ’ trawma aċċidentali jew kirurġika.
By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor IX deficiency and correction of the bleeding tendencies.
Permezz ta ’ terapija ta ’ sostituzzjoni il- livelli ta ’ fattur IX fil- plażma jiżdiedu, u b’ hekk ikun hemm korrezzjoni temporanja tan- nuqqas ta ’ fattur IX u tat- tendenza ta ’ fsada.
The in vivo increase in factor IX levels obtained with Nonafact is 1.1 IU/ dl per IU administered per kg body weight, which corresponds to an in vivo recovery of 49%.
Iż- żieda fil- livelli ta ’ fattur IX in vivo miksuba b’ Nonafact hija ta ’ 1. 1 IU/ dl għal kull IU li tingħata għal kull kg ta ’ piż tal- ġisem, li jikkorrispondi għal fejqan ta ’ 49% in vivo.
Nonafact has a half-life of approximately 19 (17 – 21) hours.
Nonafact għandu half- life ta ’ bejn wieħed u ieħor 19 (17 – 21) - il siegħa.
5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurta ’ tal- medicina
Plasma coagulation factor IX is a normal constituent of human plasma.
Il- fattur IX ta ’ koagulazzjoni huwa kostitwent normali tal- plażma umana.
Factor IX in this product therefore behaves like endogenous factor IX.
Għalhekk il- fattur IX f’ dan il- prodott iġib ruħu bħal fattur IX endoġeniku.
Conventional animal toxicity studies and mutagenicity studies with plasma coagulation factor IX were not carried out.
Ma twettqux studji konvenzjonali dwar it- tossiċità fuq l- annimali u studji ta ’ mutaġeniċità bil- fattur IX ta ’ koagulazzjoni tal- plasma.
In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
Minn studji farmakodinamiċi fuq fniek u fuq il- fniek ta ’ l- Indi, irriżulta li t- tromboġeniċità ta ’ Nonafact hija minima.
Sodium chloride Sucrose Histidine.
Sodium chloride Sucrose Histidine
Water for injections.
Solvent Ilma għall- injezzjonijiet
From a microbiological point of view, the product should be used immediately.
Mill- aspett mikrobioloġiku, il- prodott għandu jintuża immedjatament.
Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21 °C.
L- istabbilità kimika u fiżika waqt l- użu ġiet ippruvat li ddum 3 sigħat f’ temperatura ta ’ 21°C.
6 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali dwar kif għandu jinħażen
Store in a refrigerator (at 2°C – 8°C).
Aħżen fi friġġ (2°C – 8°C).
Keep the vials in the outer carton, in order to protect from light.
Żomm il- fjali fil- kartuna ta ’ barra, sabiex tipproteġi kontra d- dawl.
500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl).
500 IU: fjala (tip ta ’ ħġieġ I) ta ’ trab + fjala (tip ta ’ ħġieġ I) ta ’ 5 ml solvent bit- tappijiet (bromobutyl).
1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl).
1000 IU: fjala (tip ta ’ ħġieġ I) ta ’ trab + fjala (tip ta ’ ħġieġ I) ta ’ 10 ml solvent bit- tappijiet (bromobutyl).
6.6 Instructions for use/ and handling, and disposal
6. 6 Tagħrif għall- użu/ u maniġġar, u għar- rimi
Bring the two vials to a temperature between 15°C and 25°C.
Ġib it- temperatura taż- żewġ fjali bejn 15°C u 25°C.
Remove the plastic cap from the vials.
Neħħi l- għatu tal- plastik tal- fjali.
Disinfect the surface of the stoppers of both vials with a gauze soaked in 70% alcohol.
Iddiżinfetta il- wiċċ tat- tappijiet taż- żewġ fjali b’ garża mxarrba b’ alkoħol 70%.
Remove the protective sheath from one end of a transfer needle and pierce the stopper of the vial containing water for injections.
Neħħi l- kopertura prottettiva min- naħa waħda tal- labra tat- trasferiment u taqqab it- tapp tal- fjala li fiha l- ilma għall- injezzjonijiet.
Remove the protective sheath from the other end of the transfer needle.
Neħħi l- kisja prottettiva minn- naħa l- oħra tal- labra tat - trasferiment.
Invert the solvent vial and pierce the stopper of the vial containing the powder.
Aqleb il- fjala tas- solvent ta ’ taħt fuq u taqqab it- tapp tal- fjala li fiha t- trab.
Tilt the product vial when transferring the solvent to allow the solvent to flow down the side of the vial.
Mejjel il- fjala tal- prodott waqt li tkun qed titrasferixxi s- solvent sabiex tħalli s- solvent jinżel mal- ġenb tal- fjala.
Remove the empty vial and the transfer needle.
Warrab il- fjala l- vojta u l- labra tat- trasferiment.
Swirl the vial gently to completely dissolve the powder within 5 minutes.
Dawwar il- fjala bil- mod biex it- trab jinħall kompletament f’ ħames minuti.
The resulting solution is clear, colourless to light yellow and has a neutral pH.
It- soluzzjoni li tirriżulta hija ċara, bejn bla kulur u isfar ċar, u ta ’ pH newtrali.