qanastek/EMEA-V3 huggingface dataset:
- low white blood cell count (a reduced white blood cell count can make you more prone to
- għadd baxx ta ’ ċelloli bojod tad- demm (għadd imnaqqas ta ’ ċelloli bojod tad- demm jista ’
infection)
jagħmlek suxxettibbli għall- infezzjoni)
- increased fatty acids (triglycerides), bilirubin or sugar levels in the blood
- aċidi grassi (trigliċeridi), bilirubina jew livelli ta ’ zokkor fid- demm miżjuda
- liver and pancreas problems
- problemi bil- fwied u l- frixa.
Uncommon side effects (These can affect 1 to 10 users in 1,000)
50 Effetti sekondarji mhux komuni (Dawn jistgħu jaffettwaw 1 sa 10 utenti f’ kull 1, 000)
- angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, seeing or
- imġiba rrabjata, ideat suwiċidali, ħsibijiet strambi, paranojja, ma tistax taħseb sewwa, tara jew
hearing things that are not really there (hallucinations), suicide attempts, personality change, feeling abnormal
tisma ’ affarijiet li ma jkunux veru hemm (alluċinazzjonijiet), attentati ta ’ suwiċidju, tibdil fil - personalità, tħossok anormali.
- forgetfulness, confusion, problems with co-ordination, fitting (seizures), disorientation,
- tinsa, konfużjoni, problemi bil- ko- ordinazzjoni, aċċessjonijiet, diżorjentament, diskors li ma
incoherent speech, feeling jittery
jiftiehemx, tħossok nervuż/ a
- blurred vision, visual disturbance
- vista mċajpra, disturb fil- vista
- a feeling of spinning or tilting (vertigo)
- sensazzjoni ta ’ tidwir jew tmejjil (vertiġni)
- tingling or numbness of the mouth, dry mouth
- tnemnim jew tirżiħ fil- ħalq, ħalq xott
- allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson
- reazzjoni allerġika (sensittività eċċessiva) li tista ’ tikkawża reazzjonijiet serji tal- ġilda
syndrome, erythema multiforme, see section 2)
(sindrome ta ’ Stevens- Johnson, eritema multiformi, ara sezzjoni 2)
- yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the
- ġilda jew għajnejn sofor, ħakk, jew uġigħ fl- addome (stonku) ikkaġunat minn infjammazzjoni
liver
tal- fwied
- pain in the abdomen (stomach), caused by inflammation of the pancreas
- uġigħ fl- addome (stonku), ikkaġunat minn infjammazzjoni tal- frixa
- fat redistribution, weight decreased, increased appetite
- distribuzzjoni mill- ġdid tax- xaħam, tnaqqis fil- piż, żieda fl- aptit
- anaemia (low red blood cell count)
- anemija (għadd taċ- ċelloli ħomor tad- demm baxx)
- decreased sexual drive
- tnaqqis fl- aptit sesswali
- chills
- tertir ta ’ bard.
49 Other possible effects (frequency cannot be estimated from the available data) Lactic acidosis (excess lactic acid in the blood) is a serious side effect that can be life-threatening.
Effetti oħra possibbli (il- frekwenza ma tistax tiġi kkalkulata mill- informazzjoni disponibbli) Aċidożi lattika (eċċess ta ’ aċidu lattiku fid- demm) huwa effett sekondarju serju li jista ’ jkun ta ’ theddida għall- ħajja.
The following side effects may be signs of lactic acidosis:
L- effetti sekondarji li ġejjin jistgħu jkunu sinjali ta ’ aċidożi lattika:
- deep rapid breathing
- teħid tan- nifs fil- fond u mgħaġġel
- feeling sick (nausea), vomiting and stomach pain.
- dardir (nawsja), rimettar u uġigħ fl- istonku.
If you think you may have lactic acidosis, contact your doctor immediately.
Jekk taħseb li jista ’ jkollok aċidożi lattika, ikkuntattja lit- tabib tiegħek minnufih.
Unwanted effects to the kidney have been reported.
Ġew irrapportati effetti mhux mixtieqa fuq il- kilwa.
These include changes to your urine, increased level of creatinine in your blood, and back pain caused by kidney problems, including kidney failure and damage to kidney tubule cells.
Dawn jinkludu tibdil fl- awrina tiegħek, livell miżjud ta ’ krejatinina f’ demmek, u uġigħ fid- dahar ikkaġunat minn problemi tal- kliewi, inklużi insuffiċjenza tal- kliewi u ħsara liċ- ċelloli tubuli tal- kliewi.
Your doctor may do blood tests to see if your kidneys are working properly.
It- tabib tiegħek jista ’ jagħmel testijiet tad - demm biex jara jekk il- kliewi tiegħek humiex qed jaħdmu sewwa.
You may also experience inflammation of the kidney, passing a lot of urine and feeling thirsty.
Tista ’ tesperjenza wkoll infjammazzjoni tal- kilwa, tgħaddi ħafna awrina u tħossok bil- għatx.
Breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may also occur in patients who develop damage to the kidney tubule cells.
Il- kollass tal- muskoli, l- irtubija ta ’ l- għadam (b’ uġigħ fl- għadam u li xi kultant jirriżulta fi ksur), uġigħ fil- muskoli, dgħjufija fil- muskoli u tnaqqis fil- potassju jew fosfat fid- demm jistgħu jseħħu wkoll f’ pazjenti li jiżviluppaw ħsara liċ- ċelloli tubuli tal- kliewi.
Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis, psychosis (personality changes).
Effetti sekondarji psikjatriċi flimkien ma ’ dawk elenkati hawn fuq jinkludu delużjonijiet (twemmin falz), newrożi, psikożi (tibdil fil- personalità).
Some patients have committed suicide.
Xi pazjenti kkommettew suwiċidju.
These problems tend to occur more often in those who have a history of mental illness.
Dawn il- problemi għandhom tendenza li jseħħu aktar spiss f’ dawk li għandhom storja ta ’ mard mentali.
Always notify your doctor immediately if you have these symptoms.
Dejjem informa lit- tabib tiegħek minnufih jekk ikollok dawn is- sintomi.
Other unwanted effects include: itchy rash to the skin caused by a reaction to sunlight, shortness of breath, fatty liver, disturbances of coordination and balance.
Effetti oħra mhux mixtieqa jinkludu: raxx u ħakk fil- ġilda kkaġunat minn reazzjoni għad- dawl tax - xemx, qtugħ ta ’ nifs, fwied li jkun fih ix- xaħam, disturbi tal- koordinazzjoni u tal- bilanċ.
Combination antiretroviral therapy (such as Atripla) may change your body shape, by changing the way body fat is distributed.
Terapija antiretrovirali kkombinata (bħal Atripla) tista ’ tbiddel il- forma ta ’ ġismek, billi tbiddel il - mod kif inhu distribwit ix- xaħam.
You may lose fat from your legs, arms and face; gain fat around the abdomen (tummy) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘ buffalo hump’).
Tista ’ titlef xaħam minn riġlejk, dirgħajk u wiċċek; tiggwadanja xaħam madwar l- addome (żaqq) u organi interni; tikseb sider akbar jew għoqod tax- xaħam fuq in - naħa ta ’ wara ta ’ l- għonq (‘ ħotba tal- buflu ’).
The cause and the long-term effects of these changes are not yet known.
Il- kaġun u l- effetti fuq tul ta ’ żmien ta ’ dawn il - mutazzjonijiet għadhom mhumiex magħrufa.
Combination antiretroviral therapy may also cause increased fat levels in the blood (hyperlipaemia) and resistance to insulin.
51 Terapija antiretrovirali kkombinata tista ’ ukoll tikkaġuna żidiet fil- livelli tax- xaħam fid- demm (iperlipidimja) u reżistenza għall- insulina.
Your doctor will test for these changes.
It- tabib tiegħek se jittestja għal dawn il- mutazzjonijiet.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ATRIPLA
KIF TAĦŻEN ATRIPLA
Do not use Atripla after the expiry date which is stated on the bottle label and carton after {EXP}.
Tużax Atripla wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kartuna u tal- flixkun wara {JIS}.
What Atripla contains
X’ fiha Atripla
- The active substances are efavirenz, emtricitabine and tenofovir disoproxil.
- Is- sustanzi attivi huma efavirenz, emtricitabine u tenofovir disoproxil.
Each Atripla
Kull pillola Atripla
film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).
miksija b’ rita fiha 600 mg ta ’ efavirenz, 200 mg ta ’ emtricitabine u 245 mg ta ’ tenofovir disoproxil (bħala fumarate).
- The other ingredients in the tablet are croscarmellose sodium, hydroxypropylcellulose,
- Is- sustanzi l- oħra fil- pillola huma croscarmellose sodium, hydroxypropylcellulose, magnesium
magnesium stearate, microcrystalline cellulose, sodium laurilsulfate.
stearate, microcrystalline cellulose, sodium laurilsulfate.
- The other ingredients in the tablet film coating are iron oxide black, iron oxide red,
- Is- sustanzi l- oħra fil- kisja- rita tal- pillola huma iron oxide black, iron oxide red, macrogol 3350,
macrogol 3350, poly(vinyl alcohol), talc, titanium dioxide.
poly( vinyl alcohol), talc, titanium dioxide.
What Atripla looks like and contents of the pack
Id- dehra ta ’ Atripla u l- kontenuti tal- pakkett
Atripla film-coated tablets are pink, capsule shaped tablets, engraved on one side with the number “ 123” and plain on the other side.
Il- pilloli Atripla miksijin b’ rita huma pilloli roża, f’ għamla ta ’ kapsula, migrufa fuq naħa waħda bin - numru “ 123 ” u sempliċi fuq in- naħa l- oħra.
Atripla comes in bottles of 30 tablets (with a silica gel sachet that must be kept in the bottle to help protect your tablets).
Atripla tiġi fi fliexken ta ’ 30 pillola (b’ qartas tas- silika ġel li għandu jitħalla fil- flixkun biex jipproteġi aħjar il- pilloli tiegħek).
The silica gel desiccant is contained in a separate sachet and should not be swallowed.
Id- dessikant silika ġel jinstab f’ qartas separat u m’ għandux jinbela ’.
Manufacturer:
52 Il- Manifattur:
France Gilead Sciences Tél: + 33 (0) 1 42 73 70 70
53 France Gilead Sciences Tél: + 33 (0) 1 42 73 70 70
What is ATryn?
X' inhu ATryn?
ATryn is a white powder to be made up into a solution for infusion (drip into a vein), containing the active substance antithrombin alfa.
ATryn hu trab abjad li jinħall biex jifforma soluzzjoni ta 'l- infużjoni (drip fil- vina), li jkun fih is - sustanza attiva antithrombin alfa.
What is ATryn used for?
Għal x' hiex jintuża ATryn?
ATryn is used in patients who have an inherited reduction of the protein antithrombin (congenital antithrombin deficiency), when they undergo surgery, to prevent problems due to the formation of clots in the vessels (thromboembolism).
ATryn jintuża f' pazjenti li jkollhom tnaqqis ereditarju fil- proteina antithrombin (defiċjenza konġenitali ta 'l- antithrombin), meta jiġu operati, biex jipprevjenu problemi minħabba l- formazzjoni ta' għoqod tad- demm fl- arterji u l- vini (tromboemboliżmu).
ATryn is normally given with heparin (another anti-clotting medicine).
ATryn normalment jingħata ma 'l- eparina (mediċina oħra għat- traqqiq tad- demm).
How is ATryn used?
Kif jintuża ATryn?
Treatment with ATryn should only be started by doctors who are experienced in treating patients with congenital antithrombin deficiency.
It- trattament b' ATryn għandu jinbeda minn tobba li jkollhom esperjenza fit- trattament ta 'pazjenti b' defiċjenza konġenitali ta' antithrombin.
The aim is to restore, for the time when the patient is at risk, a level of antithrombin activity that is normal.
L- għan hu li, għaż- żmien li fih ikunu f' riskju, il- livell ta 'attività ta' l- antithrombin jitreġġa 'lura għan- normal.
The doctor needs to calculate the doses to use, based both on the patient’ s weight and the patient’ s level of antithrombin activity.
It- tabib irid jikkalkula d- dożi li għadhom jintużaw, kemm skond il- piż tal- pazjent kif ukoll skond il- livell ta 'attività ta' antithrombin tiegħu.
The medicine is given as an infusion.
Il- mediċina tingħata b' infużjoni.
The first infusion lasts 15 minutes (loading dose), and it is then followed by a continuous infusion.
L- ewwel infużjoni ddum 15- il minuta (loading dose), u tkun segwita b' infużjoni kontinwa.
The patients should be continually monitored to adjust the infusion rate so that their antithrombin activity is at least 80% of the normal level for the duration of the treatment.
Il- pazjenti għandhom jiġu sorveljati kontinwament biex ir- rata ta 'l- infużjoni tiġi aġġustata b' mod li l- attività ta' l- antithrombin tkun ta 'l- inqas 80% tal- livell normali għat- tul kollu tat - trattament.
See the Package Leaflet for the full instructions on calculating and adjusting the doses.
Ara l- Fuljett ta 'Tagħrif għall- istruzzjonijiet kollha fuq il- kalkolu u l- aġġustament tad- dożi.
How does ATryn work?
Kif jaħdem ATryn?
ATryn is an anti-clotting agent.
ATryn hu aġent għat- traqqqiq tad- demm.
The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein that is produced by recombinant DNA technology.
Is- sustanza attiva f' ATryn, antithrombin alfa, hi kopja tal - proteina naturali fid- demm li tiġi prodotta permezz tat- teknoloġija rekombinanti tad- DNA.
It is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Tiġi estratta mill- ħalib tal- mogħoż li fihom tkun ġiet inserita ġene (DNA), li tagħmilhom kapaċi jipproduċu l- proteina umana fil- ħalib tagħhom.
In the body, antithrombin blocks thrombin, one of the substances involved in blood coagulation (clotting).
Fil- ġisem, antithrombin jimblokka t- thrombin, wieħed mis- sustanzi li jieħdu sehem fil- għaqid tad - demm (clotting).
Thrombin plays a central role in the process of blood clotting.
Thrombin għandu parti ċentrali fil- proċess tal- għaqid tad- demm.
Patients who have a congenital antithrombin deficiency have blood levels of antithrombin that are lower than normal, which may result in a reduced anti-clotting capacity of the blood.
Il- pazjenti li jkollhom defiċjenza konġenitali ta 'antithrombin ikollhom livelli ta' antithrombin fid- demm iktar baxxi min- normal, li jista 'jwassal fi tnaqqis fil- kapaċità ta' kontra l- għaqid tad- demm.
This increases the risk of the formation of clots during high-risk situations.
Dan iżid ir- riskju tal - formazzjoni ta 'għoqod tad- demm f' sitwazzjonijiet riskjużi ħafna.
ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
ATryn jikkoreġi d- defiċjenza ta 'l - antithrombin, u jagħti kontroll temporanju għad- disturb ta ’ l- għaqid tad- demm.
(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 How has ATryn been studied?
(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 ATryn?
The effects of ATryn were first tested in experimental models before being studied in humans.
L- effetti ta 'ATryn għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
One study was carried out in 14 patients aged from 21 to 74 years of age, with congenital antithrombin deficiency and at risk of a thromboembolic event (surgery [5 patients] or childbirth [9 patients]).
Fi studju minnhom ħadu sehem 14- il pazjent ta 'bejn 21 u 74 sena b' defiċjenza konġenitali ta' antithrombin b' riskju ta 'avveniment tromboemboliku (kirurġija [5 pazjenti] jew ħlas [9 pazjenti]).
The studies measured how many patients developed DVT (deep vein thrombosis: formation of a clot in the vessels of the leg) up to 30 days after treatment.
L- istudji kejlu kemm pazjenti żviluppaw DVT (deep vein thrombosis: il- formazzjoni ta 'għoqda tad - demm fl- arterji jew vini tas- sieq) sa 30 jum wara t- trattament.
The condition is rare (it is estimated that about one person in 3,000 to 5,000 has a congenital antithrombin deficiency), and this explains why few patients have been treated during the study.
Il- kundizzjoni hi rari (hu stmat li madwar persuna waħda minn bejn 3, 000 u 5, 000 ruħ kellhom defiċjenza konġenitali ta 'l- anthrombin), u dan jispjega għaliex ftit pazjenti kienu ttrattati waqt l- istudju.
What benefit has ATryn shown during the studies?
X' benefiċċji ta 'ATryn intwerew f' dawn l- istudji?
In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, 2 had an episode of DVT, of which only one needed treatment.
Fl- istudju, minn fost it- 13- il pazjent li fihom setgħet tiġi valutata l- effettività tat- trattament, tnejn kellhom episodju ta 'DVT, li waħda minnhom kellha bżonn trattament.
In addition, when ATryn was used in 5 patients who received the medicine during surgery in a ‘ compassionate use programme’ (when a Company makes available to doctors a medicine before it is fully licensed to treat a specific patient who needs it), no thromboembolism was seen.
Barra minn hekk, meta ATryn intuża f' 5 pazjenti li kienu ngħataw il- mediċina waqt il- kirurġija fi 'programm ta' użu kompassjonat '(meta Kumpanija tforni lit- tobba b' mediċina qabel ma tkun ingħatatilha liċenzja kompleta biex tittratta pazjent speċifiku li jkollu bżonnha), ma deher l- ebda tromboemboliżmu.
The results taken together support the effectiveness of ATryn in preventing thromboembolism in such patients.
Ir- riżultati meħudin flimkien jappoġġjaw l- effettività ta 'ATryn fil- prevenzjoni tat- tromboemboliżmu f' pazjenti bħal dawn.
What is the risk associated with ATryn?
X' inhu r- riskju assoċjat ma 'ATryn?
During the studies of ATryn, the most common side effects (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection, or bleeding after surgery), nausea (feeling sick), and wound secretion (discharge at the site of the surgical cut).
Waqt l- istudju ta 'ATryn, l- iktar effetti sekondarji komuni (li dehru f' bejn pazjent wieħed u għaxra minn kull mija) kienu l- isturdament, l- uġigħ ta' ras, l- emorroġija (fsada, inkluż fsada mis- sit ta 'l - injezzjoni jew fsada wara l- operazzjoni), dardir, u tnixxija mill- ġerħa (mill- qatgħa li tkun saret fl - operazzjoni).
For the full list of all side effects reported with ATryn, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' ATryn, ara l- Fuljett ta' Tagħrif.
Because ATryn is a protein given by injection, patients can develop antibodies (when the body makes special proteins against the medicine), with a risk of an allergic reaction at the time of injection.
Billi ATryn hu proteina mogħtija b' injezzjoni, il- pazjenti jistgħu jiżviluppaw antikorpi (meta l- ġisem jagħmel proteini speċjali kontra l- mediċina), b' riskju ta 'reazzjoni allerġika waqt l- injezzjoni.
However, until now this has not been seen in patients treated with ATryn.
Madankollu, sa issa dan ma deherx f' pazjenti ttrattati b' ATryn.
ATryn should not be used in people who may be hypersensitive (allergic) to any of the ingredients, or to goat or goat milk.
ATryn m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal xi sustanza oħra tiegħu jew għall- mogħoż jew għall- ħalib tal- mogħoż.
Why has ATryn been approved?
Għaliex ġie approvat ATryn?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the data provided by the Company have shown that, used at a dose that is calculated as recommended, ATryn, can bring the antithrombin activity levels to an acceptable level in non-pregnant patients with congenital antithrombin deficiency undergoing surgery.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li d- dejta pprovvduta mill- Kumpanija wriet li, meta użat f' doża kkalkulata kif rakkomandat, ATryn jista 'jwassal għal livelli aċċettabbli ta' attività ta 'antithrombin f' pazjenti (nisa) mhux tqal b' defiċjenza konġenitali ta' antithrombin li tkun se ssirilhom operazzjoni.
They decided that ATryn’ s benefits are greater than its risks, and recommended that ATryn be given marketing authorisation.
Iddeċieda li l- benefiċċji ta 'ATryn huma ikbar mir - riskji tiegħu, u rrakkomanda li ATryn jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
ATryn has been authorised under “ Exceptional Circumstances”.
ATryn kien awtorizzat taħt "Ċirkustanzi ta 'Eċċezzjoni".
This means that because the disease is rare, it has not been possible to obtain complete information about ATryn.
Dan ifisser li, għal raġunijiet xjentifiċi, ma kienx possibbli li jinġabar it- tagħrif kollu dwar ATryn.
Every year, the EMEA will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea dwar il - Mediċini (l- EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista 'jinkiseb u dan is- sommarju se jiġi aġġornat kif meħtieġ.
What information is still awaited for ATryn?
X' tagħrif dwar ATryn għadu mistenni?
The company that makes ATryn will complete a study currently ongoing to look in particular at the use of ATryn at the time of childbirth in pregnant women with congenital antithrombin deficiency.
Il- kumpanija li tagħmel ATryn se tlesti studju li għaddej bħalissa b' mod partikolari biex tistudja l- użu ta 'ATryn waqt il- ħlas f' nisa tqal b' defiċjenza konġenitali ta' l- antithrombin.
They will also put in place, before launch, programmes to ensure that doctors can report on the patients they treat, especially to monitor the development of antibodies against ATryn.
Qabel it- tnedija se torganizza wkoll programmi biex tiżgurw li t- tobba jistgħu jirrapportaw dwar il- pazjenti li jittrattaw, speċjalment biex jissorveljaw l- iżvilupp ta 'antikorpi għal kontra ATryn
Which measures are being taken to ensure the safe use of ATryn?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ ATryn?
Once the medicine is on the market, the company that makes ATryn will closely monitor its safety, looking in particular at the development of antibodies.
Ladarba l- mediċina titqiegħed fis- suq, il- kumpanija li tagħmel ATryn se tissorvelja s- sigurtà tiegħu, partikolarment l- iżvilupp ta 'l- antikorpi.
Other information about ATryn:
Tagħrif ieħor dwar ATryn:
The European Commission granted a marketing authorisation valid throughout the European Union for ATryn on 28 July 2006.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal ATryn valida fl- Unjoni Ewropea kollha fit- 28 ta 'Lulju ta' l- 2006.
The marketing authorisation holder is LEO Pharma A/ S.
LEO Pharma A/ S hija d- detentur ta 'l- awtorizzazzjoni għat - tqegħid fis- suq.
The full EPAR for ATryn can be found here.
L- EPAR sħiħ għal ATryn jinsab hawn.
SUMMARY OF PRODUCT CHARACTERISTICS
KARATTERISTICI TAL- PRODOTT FIL- QOSOR
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDICINALI
ATryn 1750 IU powder for solution for infusion
ATryn 1750 IU trab ghas- soluzzjoni ghall- infuzjoni
QUALITATIVE AND QUANTITATIVE COMPOSITION
GHAMLA KWALITATTIVA U KWANTITATTIVA
ATryn is presented as a powder for solution for infusion containing nominally 1750 IU antithrombin alfa per vial.
ATryn hu pprezentat bhala trab ghas- soluzzjoni ghall- infuzjo ni li nominalment ikun fih 1750 IU ta 'antithrombin alfa f' kull kunjett.
The product contains approximately 175 IU/ ml antithrombin alfa when reconstituted with 10 ml of Sterile Water for Injection (WFI).
Il- prodott fih madwar 175 IU/ ml ta 'antithrombin alfa meta jkun rikostitwit ma' 10 ml ta 'Ilma Sterili ghall- Injezzjoni (Water for Injection - WFI).
Antithrombin alfa is a recombinant form of human antithrombin and is produced by recombinant DNA technology in the milk of transgenic goats.
Antithrombin alfa hu forma rikombinanti ta 'antithrombin uman u hu prodott b ’ teknologija DNA? rikombinanti fil- halib ta' moghoz transgenici.
The potency (IU) is determined using the European Pharmacopoeial chromogenic assay.
Il- qawwa (IU) hi stabbilita bl- uzu ta 'l- analizi kromogeniku tal- European Pharmacopoeial.
The specific activity of ATryn is approximately 7 IU/ mg protein.
L - attività specifika ta 'ATryn hi ta' madwar 7 IU/ mg ta 'proteina.
For a full list of excipients, see section 6.1.
Ghal- lista shiha ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
PHARMACEUTICAL FORM
GHAMLA FARMACEWTIKA
Powder for solution for infusion.
Trab ghas- soluzzjoni ghall- infuzjoni.
White to off-white powder.
Trab ta ’ lewn abjad jew abjad jaghti fil- griz.
CLINICAL PARTICULARS
TAGHRIF KLINIKU
4.1 Therapeutic indications
4. 1 Indikazzjonijiet terapewtici
ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency.
ATryn hu indikat ghall- profilassi ta 'tromboembolizmu fil- vini fl- operazzjonijiet ta' pazjenti b' deficjenza kongenitali ta 'l- antithrombin.
ATryn is normally given in association with heparin or low molecular weight heparin.
ATryn normalment jinghata flimkien ma 'l- eparina jew eparina b' piz molekulari baxx.
4.2 Posology and method of administration
4. 2 Pozologija u metodu ta ’ kif ghandu jinghata
Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with congenital antithrombin deficiency.
It- trattament ghandu jinbeda taht is- supervizjoni ta ’ tabib b’ esperjenza fit- trattament ta 'pazjenti b' deficjenza kongenitali ta' l- antithrombin.
Posology
Pozologija
Due to differences in pharmacokinetics of antithrombin alfa and plasma-derived antithrombin, treatment with ATryn should follow the specific dosing recommendations described below.
Minhabba d- differenzi fil- farmakokinetika ta 'antithrombin alfa u ta' l- antithrombin li jinkiseb mill- plazma, il- kura b' ATryn ghandha ssegwi r- rakkomandazzjonijiet specifici tad- dozagg deskritti hawn taht.
In the treatment of congenital antithrombin deficiency, the dosage and duration of treatment should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment.
Fil- kura tad- deficjenza kongenitali ta 'l- antithrombin, id- dozagg u t- tul ta' zmien tal- kura ghandhom jitfasslu ghal kull pazjent, u l- istorja medika tal- familja tigi kkunsidrata fir- rigward ta 'avvenimenti tromboembolici, il- fatturi tar- riskji attwali klinici, u l - evalwazzjoni tal laboratorju.
The number of units of antithrombin alfa administered is expressed in International Units (IU), which is related to the current WHO standard for antithrombin concentrate.
L -
Antithrombin (AT) activity in plasma is expressed either as a percentage (relative to human plasma) or in International Units (relative to the International Standard for antithrombin in plasma).
attività ta 'l- antithrombin (AT) fil- plazma hi espressa jew bhala percentwali (meta mqabbla mal- plazma umana) jew f' International Units (meta mqabbla ma' l Istandard Internazzjonali
One International Unit (IU) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal human plasma.
Il- kalkulazzjoni
The calculation of the required dosage of antithrombin alfa is based on pre-treatment plasma antithrombin activity and body weight.
2 tad- dozagg mehtieg ta 'antithrombin alfa hija bbazata fuq l- attività ta' l- antithrombin ta 'qabel il- kura u fuq il- piz tal- gisem.
2 The therapeutic goal of treatment with ATryn is to increase to, and maintain antithrombin activity between 80 – 120% (0.8 – 1.2 IU/ ml) for the duration of treatment.
Il- ghan terapewtiku tal- kura b' ATryn huwa biex tizdied, u tinzamm l- attività ta 'l - antithrombin bejn 80 – 120% (0. 8 – 1. 2 IU/ ml) ghal kemm iddum il- kura.
Initial treatment starts with a loading dose of ATryn targeting an antithrombin activity level of 100%.
Il- kura inizjali tib da b' doza qawwija tal- bidu ta 'ATryn biex jintlahaq livell ta' attività ta 'l - antithrombin ta' 100%.
This initial loading dose is based on body weight and on the pretreatment antithrombin activity level.
Din id- doza inizjali qawwija hi bbazata fuq il- piz tal- gisem u fuq il - livell ta 'attività ta' l- antithrombin ta 'qabel il- kura.
The required loading dose is determined using the following formula:
Id- doza tal- bidu mehtiega tigi stabbilita billi tintuza l- formula li gejja:
Loading Dose (IU) = [(100 – patient’ s pre -treatment AT activity level in%) / 2.28] x Body Weight in kg
Doza qawwija tal- bidu (IU) = [(100 – il- livell ta 'l- attività AT ta' qabel il- kura tal - pazjent f '%) / 2. 28] x il- piz tal- gisem f' kg
The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/ kg bodyweight.
Id- doza qawwija tal- bidu normali f' pazjenti kirurgici (50% attività AT fil- linja bazi, piz tal - gisem 75 kg) b’ deficjenza kongenitali ta 'l- antithrombin f' sitwazzjonijiet ta' riskju kliniku hija ta '20- 25 IU/ kg tal- piz tal- gisem.
The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Id- doza tal- bidu ghandha tinghata bhala infuzjoni ta '15- il minuta u minnufih ghandha tinbeda l- infuzjoni tal- mauntenzjoni.
The required maintenance dose for surgical patients is given as a continuous infusion and is determined using the following formula:
Id- doza tal- manutenzjoni mehtiega ghal pazjenti kirurgici tinghata bhala infuzjoni kontinwa u tigi stabbilita billi tuza l- formula li gejja:
Maintenance Dose (IU/ hour) = [(100 – patient’ s pre -treatment AT activity level in%) / 10.22] x Body Weight in kg
Doza tal- manutenzjoni (IU/ siegha) = [(100 – il- livell ta 'l- attività AT ta' qabel il- kura f '%) / 10. 22] x il- piz tal- gisem f' kg
The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/ kg/ h.
Normalment id- doza tal- manuntenzoni f' pazjenti kirurgici b' deficjenza kongenitali ta 'l - antithrombin f' sitwazzjonijiet ta' riskju kliniku hija ta '4- 5 IU/ kg/ h.
During consumptive states (e. g. major surgery, concomitant use of heparin) the actual dose may be higher.
Matul l- istati tal- konsum (ez. operazzjoni magguri, uzu fl- istess hin ta 'l- eparina), id- doza attwali tista' tkun oghla.
See therapeutic monitoring and dose adjustment recommendations below.
Ara l- monitoragg terapewtiku u r- rakkomandazzjonijiet ghall- bdil tad- doza hawn taht.
Therapeutic Monitoring and Dose Adjustment
Monitoragg Terapewtiku u Bdil tad- Doza
The dosage should be adjusted on the basis of laboratory measurements of antithrombin activity.
Id- dozagg ghandu jinbidel fuq il- bazi tal- kejl ta 'l- attività ta' l- antithrombin fil- laboratorju.
Response to ATryn may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Ir - rispons ghal ATryn jista 'jvarja f' pazjenti individwali, u jilhaq livelli differenti ta' rkuprar in vivo u half- lives differenti.
Frequent antithrombin activity assessments and dosing adjustments may be necessary when starting treatment and just after surgery.
Evalwazzjonijiet frekwenti ta 'l attività ta' l- antithrombin u bdil
After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Wara l- bidu ta 'l- infuzjoni tad- doza tal- manutenzjoni, biex jitkejlu l- livelli ta' attività ta 'l- AT ghandu jittiehed id- demm wara 45 minuta wara l bidu ta' l - infuzjoni tad- doza qawwija tal -
In case the AT activity level is between 80% and 120% (0.8 - 1.2 IU/ ml), no dose adjustment is needed.
F' kaz li l- livell ta 'attività ta' l- AT ikun bejn 80% u 120% (0. 8 - 1. 2 IU/ ml), l- ebda tibdil fid- doza ma huwa mehtieg.
In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
F' kaz li l- livell ta 'attività ta' l- AT ikun inqas minn 80%, zid ir- rata ta 'l- infuzjoni tal- manutenzjoni b' 50%.
In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
120%, naqqas ir- rata ta 'l- infuzjoni tal- manutenzjoni bi 30%.
Check AT activity level 30 minutes after any change in infusion rate, or four hours after a value within the target range.
Iccekkja l- livell ta 'attività ta' l - AT 30 minuta wara kwalunkwe bidla fir- rata ta 'l- infuzjoni, jew erba' sighat wara valur li jk un fil- medda tal- valur i mixtieqa.
Subsequently, antithrombin activity should be checked 1-2 times a day and dose adjustments made accordingly.
Sussegwentement, - attività ta '- antithrombin ghandha tigi
The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
attività ta 'l- antithrombin ghandu jinzamm fuq it- 80% ghal kemm iddum il- kura, hlief jekk l - indikazzjonijiet klinici jkunu jindikaw livell effettiv differenti.
It is possible that the surgical procedure will influence AT activity levels.
G
Therefore, an additional check of the AT activity level should be done after the surgery.
iccekkjar addizzjonali tal- livell ta 'attività ta' l- AT ghandu jsir wara l- operazzjoni.
In case the activity level is below 80% a 15 minutes bolus infusion of AT can be given to quickly restore the AT activity level.
Fil- kaz li l - livell ta 'attività ikun taht 80%, infuzjoni bolus ta' 15- il minuta ta 'AT tista' tinghata biex tregga ’ lura malajr ghan- normal il- livell ta 'attività ta' l- AT.
The dose can be calculated utilizing the post-surgical AT activity in the loading dose formula above.
Id- doza tista 'tigi kkalkulata billi
3 Method of administration:
3 tintuza l- attività ta 'l- AT ta' wara l- operazzjoni fid- doza qawwija tal- bidu li ssemmiet hawn fuq.
Dissolve the preparation as described under 6.6.
Holl il- preparazzjoni kif deskritt f' sezzjoni 6. 6.
The product should be administered via the intravenous route.
Il- prodott ghandu jinghata minn gol- vina.
Paediatric Patients
Pazjenti Pedjatrici
There is no experience in children.
M' hemm l- ebda esperjenza fit- tfal.
Hypersensitivity to any of the constituents.
Sensittività eccessiva ghal xi wahda mis- sustanzi li jiffurmawh.
Hypersensitivity to goat proteins or goat milk components.
Sensittività eccessiva ghall- proteini tal- moghoz jew ghall- komponenti tal- halib tal- moghoz.
4.4 Special warnings and precautions for use
4. 4 Twissijiet spe cjali u prekawzjonijiet ghall- uzu
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Bhal fi kwalunkwe prodott tal- proteini li jinghata gol- vina, reazzjonijiet ta 'sensittività eccessiva bhal dawk ta' l allergija huma huma possibbli.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
mill- qrib u jridu jigu osservati bl- attenzjoni ghal kwalunkwe sintomi matul il- perjodu kollu ta 'l- infuzjoni.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Il- pazjenti ghandhom ikunu infurmati bis- sinjali bikrija ta 'reazzjonijiet ta' sensittività eccessiva li jinkludu urtikarja, urtikarja generalizzata, sensazzjoni ta 'dwejjaq fis - sider, tharhir, pressjoni tad- demm baxxa hafna, u anafilassi.
If these symptoms occur after administration, they should contact their physician.
Jekk dawn is- sintomi jsehhu wara l- ghoti, il- pazjenti ghandhom jikkuntattjaw it- tabib taghhom.
In case of shock, standard medical treatment should be administered.
F' kaz ta 'xokk, ghandha tinghata kura medika standard.
Patients treated with ATryn should be monitored for possible clinical immunological reactions.
Pazjenti kkurati b' ATryn ghandhom ikunu immonitorjati ghal reazzjonijiet immunologici possibbli.
Antibody status should be monitored and reported.
L- istatus ta 'l- anti- korpi ghandu jkun immonitorjat u rrappurtat.
The experience from repeated treatment with ATryn is very limited.
L- esperjenza mill- kura ripetuta b' ATryn hi limitata hafna.
Close surveillance with regard to immunological reactions is especially important in such situations.
Sorveljanza mill- qrib fir- rigward ta 'reazzjonijiet immunologici hija importanti b' mod specjali f' sitwazzjonijiet bhal dawn.
Due to differences in pharmacokinetic characteristics of ATryn in pregnant versus non- pregnant patients, recommendations for dosing in pregnancy or in the peripartum period cannot be given.
Minhabba d- differenzi fil- karatteristici farmakokinetici ta 'ATryn f' pazjenti tqal meta mqabbla ma' dawk ta 'pazjenti mhux tqal, l- ebda rakkomandazzjonijiet ghad- dozagg matul it- tqala jew matul il- perjodu tal- peripartum ma jistghu jinghataw.
Clinical and biological surveillance when antithrombin is used together with heparin, low molecular weight heparin or other anticoagulants which potentiate the anticoagulant activity of antithrombin:
Sorveljanza klinika u bijologika meta l- antithrombin jintuza flimkien ma 'l- eparina, ma' eparina b' piz molekulari baxx jew ma 'medicini ohrajn li jraqqu d- demm li jzidu l- attività tal - medicini li jraqqu d- demm ta' l- antithrombin:
- In order to adjust dosage of the anticoagulant and to avoid excessive hypocoagulability,
- Sabiex tibdel d- dozagg tal- medicini li jraqqu d- demm u biex tevita ipokoagulabilità
controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/ hours following the start of antithr ombin use.
eccessiva, il- kontrolli tal- kwantità ta 'l- antikoagula zzjoni (APTT, u fejn ikun xieraq, l - attività ta' l- anti- fattur Xa) ghandhom jitwettqu regolarment, f' intervalli li jkunu qrib xulxin, u b' mod partikulari fl- ewwel minuti/ sighat wara l- bidu ta 'l- uzu ta' l - antithrombin.
- Measure antithrombin levels daily, in order to adjust the individual dose.
- Kejjel il- livelli ta 'l- antithrombin kuljum, biex tibdel id- doza individwali.
The risk of
Ir- riskju li l
diminution of antithrombin levels by prolonged treatment with a non-fractionated heparin should be taken into account.
livelli ta 'l- antithrombin jonqsu minhabba kura fit- tul b' eparina mhux frazzjonata, ghandu jigu kkunsidrat.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Interazzjoni ma 'prodotti me dicinali ohra u forom ohra ta' interazzjoni
The half-life of recombinant antithrombin may be altered with concomitant treatment with these anticoagulants due to an altered antithrombin turnover.
Is- sostituzzjoni ta 'l- antithrombin waqt l- ghoti ta' medicini li jraqqu d- demm li jzidu l- attività ta 'antithrombin biex iraqqaq id- demm (ez. eparina, eparina b' piz molekulari baxx), jistghu
4 No interaction studies have been performed.
4 izidu r- riskju ta 'hrug ta' demm.
4.6 Pregnancy and lactation
mibdul ta 'antithrombin.
Limited clinical data are available on the use of ATryn in pregnant women.
Informazzjoni
Available data do not suggest harmful effects to the mother or infant.
disponibbli ma tissuggerixxix effetti li jaghmlu hsara ghall- omm jew ghat- tarbija.
However due to the difference in pharmacokinetic characteristics of ATryn in pregnant vs. non-pregnant patients no recommendation for dosing in pregnancy can be given at this time (see section 4.4).
Studji fuq l annimali li twettqu fuq il -
Animal studies performed in rats did not indicate harmful effects on parturition, embryonal/ foetal and post-natal development.
firien ma indikaw l- ebda effetti ta 'hsara fuq il- hlas u fuq l- izvilupp ta' l- embriju/ fetu qabel it - twelid.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- hila biex issuq u thaddem magni
In clinical trials involving congenital antithrombin deficient patients (n=35) one mild undesirable effect of “ Application site pruritis” was reported as related to treatment with ATryn.
Fi provi klinici li kienu jinvolvu pazjenti b' deficjenza kongenitali ta 'l- antithrombin (n=35) effett hafif mhux mixtieq, ta' “ Hakk tal- gilda fil- parti minn fejn jinghata ” kien irrappurtat bhala li kien marbut mal- kura b' ATryn.
In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Fi provi klinici ohrajn fuq pazjenti li kellhom operazzjoni fil- qalb u li kellhom ukoll deficjenza miksuba ta 'l- antithrombin (n=118) u fuq voluntiera f' sahhithom (n=102), l- effetti mhux mixtieqa li kienu rrappurtati li kienu marbuta mal- kura b' ATryn li kienu osservati iktar minn darba, huma elenkati skond il- Klassi tas - Sistema tal- Organi fit- tabella hawn taht.
Common (1-10% of subje cts) Nervous system disorders dizziness headache Vascular disorders haemorrhage Gastrointestinal disorders nausea General disorders and administration site conditions venipuncture site haemorrhage Injury and poisoning post procedural haemorrhage wound secretion
Komuni (1- 10% tal- pazjenti) Mard tas- sistema nervuza: sturdament ugigh ta ’ ras Mard vaskulari emorragija Mard gastro- intestinali dardir Mard generali u kundizzjonijiet ta 'mnejn jinghata Emorragija fis- sit minn fejn il- vina tittaqqab bis - siringa Feriti u avvelenament emorragija wara l- procedura tnixxija mill- ferita
Uncommon (0.1-1% of subjects) General disorders and administration site conditions Feeling hot Infusion site erythema Infusion site pain Infusion site rash Venipuncture site bruise
Mhux komuni (0. 1- 1% tal- pazjenti) Mard generali u kundizzjonijiet ta 'mnejn jinghata Thoss is- shana Eritema fil- parti ta' l- infuzjoni
5 4.9 Overdose
5 Ugigh fil- parti ta 'l- infuzjoni Raxx fil- parti ta' l- infuzjoni Tbengil fis- sit minn fejn il- vina tittaqqab bis- siringa
No case of overdose has been reported.
L- ebda kaz ta ’ doza eccessiva ma gie rrappurtat.
PHARMACOLOGICAL PROPERTIES
KWALITAJIET FARMAKOLOGICI
5.1 Pharmacodynamic properties
5. 1 Kwalitajiet farmakodinamici
Pharmacotherapeutic Group:
Grupp Farmakoterawpewtiku:
ATC code:
Sustanzi antitrombotici: grupp ta '- eparina.
B01AB02.
Kodici ATC: l B01AB02.
Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Antithrombin, 58 kD, 432 amino- acid glycoprotein, jaghmel parti mis- super- familja ta 'serpin (inibitur ta' serine protease).
It is one of the most important natural inhibitors of blood coagulation.
Il- fatturi li huma l iktar inibiti huma thrombin u fattur Xa, izda
The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/ tissue factor complex.
wkoll il- fatturi ta 'l attivazzjoni tal- kuntatt, sistema intrinsika u l Fattur VIIa/ kumpless tal -
Antithrombin activity is greatly enhanced by heparin and the anticoagulant effects of heparin depend on the presence of antithrombin.
L- attività ta 'l- antithrombin tittejjeb hafna permezz ta' l- eparina u l- effetti tal - medicini li jraqqu d- demm jiddependu fuq il- prezenza ta 'l- antithrombin.
Antithrombin contains two functionally important domains.
L- antithrombin fih zewg dominji li huma funzjonalment importanti.
The first contains the reactive centre and provides a cleavage site for proteinases such as thrombin, a prerequisite for forming a stable proteinase-inhibitor complex.
It- tieni hu dominju ta l- irbit tal -
The second is a glycosaminoglycan binding domain responsible for the interaction with heparin and related substances, which accelerates the inhibition of thrombin.
glycosaminoglycan li hu responsabbli ghall- interazzjoni ma 'l eparina u sustanzi relatati, li
The inhibitor-coagulation enzyme complexes are removed by the reticulo-endothelial system.
Il- kumplessi ta 'l- enzima inibitur- koagulazzjoni jitnehhew mis- sistema retikulo- endoteljali.
Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ ml) and levels in neonates are about 40 - 60% (0.4-0.6 IU/ ml).
L- attività normali ta 'l antithrombin fl- adulti hi ta' 80 - 120% (0. 8- 1. 2 IU/ ml) u l - livelli fit -
In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
Fi prova klinika formali li fiha intuzaw ezamijiet ultrasonici Duplex serjali, intwera li l - antithrombin alfa kien effettiv fil- prevenzjoni ta 'avvenimenti tromboembolici f' erbatax- il pazjent b' deficjenza kongenitali ta' l- antithrombin f' sitwazzjonijiet ta 'riskju kliniku gholi.
Some additional data have been obtained from a number of patients in a compassionate use programme.
Xi informazzjoni addizzjonali inkisbet min- numru ta 'pazjenti fi programm compassionate use.
This medicinal product has been authorized under “ Exceptional Circumstances”.
Dan il- prodott medicinali kien awtorizzat taht “ Cirkustanzi Eccezzjonali ”.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li minhabba r- rarità tal- marda ma kienx possibbli li jinkiseb taghrif shih dwar dan il- prodott medicinali.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
L- Agenzija Ewropeja Dwar il- Medicini (EMEA) ser tevalwa kwalunkwe taghrif gdid li jista 'jsir disponibbli kull sena u dan l- SPC ser ikun aggornat kif mehtieg.
5.2 Pharmacokinetic properties
5. 2 Taghrif farmakokinetiku
After intravenous administration of ATryn (IV bolus dose of 50 IU/ kg or 100 IU/ kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/ IU/ kg body weight (mean ± SD).
Wara l- ghoti gol- vina ta 'ATryn (doza bolus IV ta' 50 IU/ kg jew 100 IU/ kg ta 'piz tal- gisem) lil pazjenti b' deficjenza kongenitali ta' l- antithrombin minghajr sintomi klinici ta 'trombozi, u minghajr l- uzu ta' l- eparina, l - irkuprar inkrementali kien ta '2. 07 ± 1. 54% / IU/ kg ta' piz tal - gisem (medja ± SD).
Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD): • Area under the curve:
Il- parametri farmakokinetici tal- popolazzjoni ghal ATryn miskuba mill - istess studju urew (medja ± SD): • Erja taht il- kurva:
587.88 ± 1.63 (% x h) • Distribution half-life:
587. 88 ± 1. 63 (% x h) • half - life tad- distribuzzjoni:
1.74 ± 1.28 h, elimination half-life:
1. 74 ± 1. 28 h, half- life ta 'l- eliminazzjoni:
10.16 ± 1.28 h. • Mean residence time (MRT):
6 • Hin medju tar- residenza (Mean residence time - MRT):
8.57 ± 1.24 h • Clearance:
8. 57 ± 1. 24 h • Tnehhija:
0.665 ± 0.0493 l/ h (Mean ± SE)
0. 665 ± 0. 0493 l/ h (Medja ± SE)
6 5.3 Preclinical safety data
5. 3 Taghrif ta ’ qabel l- uzu kliniku dwar is- sigurtà tal- medicina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
L- informazzjoni ta ’ l- uzu mhux kliniku ma wriet l- ebda perikli specjali ghall- bnedmin, ibbazata fuq studji konvenzjonali dwar is- sigurtà farmakolo gika, it- tossicità tad- doza ripetuta, genotossicità u tossicità ghar- riproduzzjoni.
PHARMACEUTICAL PARTICULARS
TAGHRIF FARMACEWTIKU
Glycine Sodium citrate Sodium chloride
Glycine Sodium citrate Sodium Chloride
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fl- assenza ta ’ studji dwar il- kompatibilità, dan il- prodott medicinali m’ ghandux jithallat ma ’ prodotti medicinali ohrajn.
6.3 Shelf life
6. 3 Zmien kemm idum tajjeb il- prodott medicinali
Unopened vials:
Kunjetti mhux miftuha:
It is recommended to reconstitute the product immediately prior to use.
Hu rakkomandat li tirrikostitwixxi l- prodott immedjatament qabel l- uzu.
Reconstituted product should be used immediately after preparation.
Il- prodott rikostitwit ghandu jintuza immedjatament wara l- preparazzjoni.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet spe cjali ghall- hazna
Store in a refrigerator (2°C – 8°C).
Ahzen f’ temperatura ta ’ 2°C – 8°C fil- frigg.
Powder containing 1750 IU antithrombin alfa in a clear vial (type I glass) with a stopper (siliconised bromobutyl rubber) and capped with a band (aluminium) and flip-off cap (plastic).
Trab li fih 1750 IU antithrombin alfa f' kunjett ta 'lewn car (hgieg ta' tip I glass) b' tapp (siliconised bromobutyl rubber) u maghluq bi strixxa (aluminju) u ghatu flip- off (plastik).
1, 10 or 25 vials.
1, 10 jew 25 kunjett.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu ghall- skop kummercjali.