qanastek/EMEA-V3 huggingface dataset:
The Committee for Medicinal products for Human Use (CHMP) decided that TESLASCAN’ s benefits are greater than its risks as a contrast medium for diagnostic MRI, for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas, and as an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ TESLASCAN huma ikbar mir- riskji tiegħu meta jintuża għal MRI dijanjostika, għat- tiftix ta ’ leżjonijiet tal- fwied li jkun hemm suspett li seħħew minħabba metastasi jew kankrijiet fiċ- ċelloli tal - fwied, u bħala għajnuna għall- MRI biex jiġu investigati leżjonijiet fokali fil- frixa.
They recommended that TESLASCAN be given marketing authorisation.
Huma rrakkomandaw li TESLASCAN jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about TESLASCAN:
Informazzjoni oħra dwar TESLASCAN:
The European Commission granted a marketing authorisation valid throughout the European Union, for TESLASCAN to GE Healthcare AS on 22 May 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal TESLASCAN lil GE Healthcare AS fit- 22 ta ’ Mejju 1997.
The marketing authorisation was renewed on 22 May 2002 and 22 May 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 22 ta ’ Mejju 2002 u t- 22 ta ’ Mejju 2007.
The full EPAR for TESLASCAN is available here.
L- EPAR sħiħ dwar TESLASCAN jista ’ jinstab hawnhekk.
Package size
Kontenut( konċentrazzjoni) Daqs tal- pakkett
0.01 mmol/ ml
0. 01 mmol/ ml Soluzzjoni għall- infużjoni Użu għal ġol- vini
50 ml
Kunjett (tal- ħġieġ) 50 ml
TESLASCAN 0.01 mmol/ ml solution for infusion.
TESLASCAN 0. 01 mmol/ ml soluzzjoni għall- infużjoni.
Each ml contains 7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μ mol), equivalent to 6.91 mg of mangafodipir.
Kull ml fih 7. 57 mg ta 'anhydrous mangafodipir trisodium, 0. 01 mmol (10 μmol), ekwivalenti għal 6. 91 mg ta' mangafodipir.
50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol (500 μ mol), equivalent to 345.5 mg of mangafodipir.
50 ml fih 378. 5 mg ta 'anhydrous mangafodipir trisodium, 0. 50 mmol (500 μmol), ekwivalenti għal 345. 5 mg ta ’ mangafodipir.
Sodium 0.16 mmol (3.6 mg)/ ml equivalent to 126 mg per normal dose of 35 ml.
Sodium 0. 16 mmol (3. 6 mg) / ml ekwivalenti għal 126 mg kull doża normali ta ’ 35 ml.
TESLASCAN has the following physicochemical properties:
Soluzzjoni trasparenti li tkanġi bejn isfar jgħajjat u isfar skur TESLASCAN għandu l- karatteristiċi fiżikokimiċi:
7.0-8.0.
7. 0- 8. 0.
Osmolality (mosmol/ kg H2O) at 37 °C Viscosity (mPa. s) at 20 °C Viscosity (mPa. s) at 37 °C Density (g/ ml) at 20 °C
Ożmolalità (mosmol/ kg H2O) f’ 37 °C Viskosità (mPa. s) f’ 20 °C Viskosità (mPa. s) f’ 37 °C Densità (g/ ml) f’ 20 °C
290 1.0 0.7 1.01
290 1. 0 0. 7 1. 01
Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas.
Medjum għall- kuntrast għad- dijanjosi permezz tar- Ritratti bir- Reżonanza Manjetika (MRI) għall - osservazzjoni ta 'feriti fil- fwied li hemm suspett li huma kkawżati minn mard metastatiku jew karcinomi epatoċellulari.
As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Bħala żieda ma 'l- MRI biex jgħin fl- investigazzjoni ta' feriti fokali fil- frixa.
The medicinal product is for single intravenous use only as repeated dosing has not been studied.
Il- prodott mediċinali jingħata darba biss fil- vina billi ma ġewx studjati dożi ripetuti.
It should be administered as an intravenous infusion at the rate of 2-3 ml/ min for liver imaging and at a rate of 4-6 ml/ min for imaging of the pancreas.
Għandu jingħata bħala infużjoni fil- vina b' rata ta '2- 3 ml/ min għal ritratti tal- fwied u b' rata ta' 4- 6 ml/ min għal ritratti tal- frixa.
Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately 4 hours.
Il- parenkima normali ta 'l- fwied u tal- frixa tidher l- aħjar wara 15- 20 minuta minn meta jibda jingħata u l- effett jibqa ’ għal madwar 4 sigħat.
At the clinical dose the contrast agent has no T2-effect, and pre- and post- T2-weighted images are equivalent.
Fil- livell tad- doża klinika l- aġent tal- kuntrast m' għandux effett T2,, u l- istampi ta ’ qabel u ta ’ wara T2 huma ekwivalenti.
The clinical use of TESLASCAN has been investigated at field strengths from 0.5 to 2.0 Tesla.
L- użu kliniku ta 'TESLASCAN ġie investigat b' qawwiet manjetiċi minn 05 sa 2. 0 Tesla.
2 Dosage for adults The recommended dose is 0.5 ml/ kg bodyweight (5 µmol/ kg bodyweight).
- 2 - Id- doża rakkomandata hija ta '0. 5 ml/ kg tal- piż tal- ġisem (5 µmol/ kg tal- piż tal- ġisem).
This corresponds to a dose of 35 ml for a 70 kg person.
Dan jikkorrispondi għal doża ta '35 ml għal persona ta' 70 kg.
Above 100 kg body weight, 50 ml is usually sufficient to provide a diagnostically adequate contrast effect.
Għal piż ta ’ ‘ l fuq minn 100 kg, 50 ml is - soltu jkunu biżżejjed biex ikun hemm effett adegwat ta 'kuntrast għad- djanjosi.
Dosage for elderly Pharmacokinetics in the elderly has not been investigated.
Doża għall- anzjani Il- karatteristiċi farmakokinetiċi fl- anzjani għandhom ma ġewx investigati.
However, clinical studies to date do not suggest that a dose adjustment is required.
Madankollu, l- istudji kliniċi sa llum ma jissuġġerux li hemm bżonn bidla fid- doża.
Children and adolescents Safety and efficacy in patients below the age of 18 have not been documented i. e. children (2-11 years) and adolescents (12-18 years).
Tfal u adoloxxenti Is- sigurta` u l- effikaċja fil- pazjenti taħt l- eta` ta ’ 18 – il sena ma ġietx dokumentata i. e. tfal (2- 11 snin) u adoloxxenti (12- 18).
Pregnancy and lactation.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi Tqala u treddiegħ.
Phaeochromocytoma.
Faokromosajtoma.
Severely reduced liver function (Child - Pugh class C), especially severe obstructive hepatobiliary disease.
Il- funzjoni tal- fwied mnaqqsa b’ mod serju (Child - Pugh klassi C), speċjalment imblokk qawwi epatobiljari.
Severely reduced renal function.
Il- funzjoni tal- kliewi mnaqqsa b’ mod serju.
Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) or anaphylactoid reactions may occur.
B' mod rari, jistgħu iseħħu reazzjonijiet ta 'sensittivita` eċċessiva (urtikarja u possibiliment forom oħra ta' allerġiji) jew reazzjonijiet anafilattojdi.
Familiarity with the practice and technique of resuscitation and treatment of anaphylaxis is essential.
Huwa essenzjali li wieħed ikun familjari mal- prattika u t - teknika ta 'qawmien f’ każ li l- pazjent jintilef minn sensih u tal- kura ta' l- anafilassi.
Appropriate medicinal products and instruments should be readily available.
Il- prodotti mediċinali u l- istrumenti xierqa għandhom ikunu aċċessibbli.
Care should be exercised in patients with severe cardiac disease and in patients with injuries of the blood brain barrier and severe cerebral disease.
Wieħed għandu joqgħod attent f’ kaz li l- pazjenti jkollhom mard serju tal- qalb u f’ pazjenti li għandhom feriti fil- membrana tad- demm tal- moħħ u mard serju ċelebrali.
The fact that long term parenteral nutrition with manganese supplementation can cause manganese accumulation in the basal ganglia should be considered when administering TESLASCAN to patients on such treatment.
Il- fatt li nutriment injettat fit- tul b' supplement tal- manganese jista 'jwassal biex il- manganese jakkumula fil- ganglija ta' taħt għandu jiġi kkonsidrat meta TESLASCAN ikun qed jingħata lil pazjenti li jkunu qed jieħdu din il- kura.
This medicinal product contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml.
Dan il- prodott mediċinali fih 5. 5 mmol (126 mg) ta ’ sodium f’ kull doża normali ta ’ 35 ml.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jitqies f' pazjenti li jikkontrollaw l- ammont ta 'sodium li jieħdu fid- dieta.
No interaction studies have been performed.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effettt farmaċewtiku tal- prodott..
Pregnancy The safety of TESLASCAN in human pregnancy has not been established.
Tqala Ma ġietx stabbilita s- sigurta` ta 'TESLASCAN fit- tqala, fil- bniedem.
TESLASCAN must not be used during pregnancy (see section 4.3).
TESLASCAN m' għandux jintuża waqt it- tqala (ara sezzjoni 4. 3).
Prior to administration of TESLASCAN to women of child bearing potential, pregnancy should be excluded.
Qabel ma TESLASCAN jingħata lil nisa li jista 'jkollhom it- tfal, għandha tiġi eskluża t- tqala.
Pre-clinical studies in rats have established teratogenic effects when TESLASCAN was given repeatedly during major organogenesis.
Studji pre- kliniċi fuq il- firien stabbilew li kien hemm effetti teratoġeniċi meta TESLASCAN ngħata repetutament waqt organoġenesi maġġuri.
TESLASCAN causes foetotoxicity and embryotoxicity in rabbits.
TESLASCAN jikkawża tossiċita` fil- fetu u l- embriju fil - fniek.
TESLASCAN is not teratogenic in rabbits.
TESLASCAN mhux teratoġeniku fil- fniek.
TESLASCAN has no effect on male or female fertility in rats.
TESLASCAN m' għandux effett fuq il- fertilita` ta 'firien nisa jew irġiel.
3 Lactation The degree of excretion into human breast milk is not known.
- 3 - Mhux magħruf kemm il- prodott farmaċewtiku joħrog fil- ħalib ta 'l- omm.
Breast-feeding should be discontinued from the time of administration and should not be recommenced until 14 days after administration of TESLASCAN.
L- omm għandha tieqaf tredda 'minn meta tingħata l- prodott u m' għandhiex terġa' tibda qabel 14- il ġurnata wara li tingħata TESLASCAN.
Most of the adverse reactions reported were transient and of mild intensity.
Il- biċċa l- kbira ta 'l- effetti mhux mixtieqa li ġew rappurati għaddew u kienu ħfief.
Those most commonly reported were: feeling of warmth/ flushing, headache and nausea.
L- iktar komuni kienu: sensazzjoni ta 'sħana/ fawra, uġigħ ta' ras u nawżja.
In clinical trials with Teslascan, adverse reactions have been reported with the following frequencies given in the table below (very common ≥ 1/ 10; common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare < 1/ 10,000, not known (cannot be estimated from the available data).
Fi studji kliniċi ma ’ Teslascan, kienu rrapportati reazzjonijiet avversi bil- frekwenzi li ġejjin li huma mogħtija fit- tabella ta ’ hawn taħt (komuni ħafna ≥1/ 10; komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000); rari ħafna < 1/ 10, 000, mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Frequency
Frekwenzi
Hypersensitivity reactions (such as skin Uncommon reactions, rhinitis, pharyngitis)
Reazzjonijiet ta 'sensittivita` eċċessiva (bħal ma' huma reazzjonijiet tal- ġilda, rinite, farinġite)
Anaphylactic/ anaphylactoid reactions Not known
Mhux komuni mhux
Headache Common
Uġigħ ta ’ ras
Dizziness,
Komuni
paraesthesia,
Sturdament, paresteżja, sensazzjoni tat - togħma li hi perverta li tgħaddi
transient Uncommon
Mhux komuni
perverted sensation of taste Eye disorders Cardiac disorders Vascular disorders Gastrointestinal disorders
Disturbi fl- għajnejn Disturbi fil- qalb Disturbi vaskulari Disturbi gastro- intestinali
Visual disturbance Palpitation Hypertension Nausea
Disturbi tal- vista Palpitazzjoni Pressjoni għolja Nawżja
Very rare Uncommon Rare Common
Rari ħafna Mhux komuni Rari Komuni
Abdominal pain, diarrhoea, vomiting
Uġigħ addominali, dijarrea, remettar
Flatulence
Mhux komuni
Very rare
Gass
General
Rari ħafna
disorders
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn
and Flushing, feeling hot
Fawra, tħoss is- sħana
administration site conditions
jingħata
Fever, injection site pain
Deni, uġigħ fejn tingħata t- tilqima
Mangafodipir can cause transient increases of bilirubin and liver transaminases and transient decreases in plasma zinc.
Mangafodipir jista 'jikkawża żidiet li jgħaddu malajr fil- bilirubin u fit- transaminases tal- fwied u tnaqqis, li jgħaddi malajr, ta' żinc fil- plażma.
The frequency of mild and moderate, non-serious adverse reactions, mainly transient warmth and flushing, is likely to increase when TESLASCAN is administered at the faster rate advised (4– 6 ml/ min).
Il- frekwenza ta 'reazzjonijiet avversi mhux serji minn ħfief sa moderati, l- iktar sħana u fwawar li jgħaddu, aktarx li tiżdied meta TESLASCAN jingħata bir- rata rakkomandata l- iktar mgħaġġla (4– 6 ml/ min).
Serious adverse events have not been reported in healthy subjects with dosages up to 5 times the normal clinical dose (maximum dose investigated).
- 4 - L- ebda effett avvers ma ġie rrapurtat f' persuni f' saħħithom b' dożi sa 5 darbiet id- doża klinika normali (doża massima investigata).
High doses of manganese can have negative inotropic and vasodilatory effects as well as effects on heart rhythm and conduction because of calcium antagonism.
Dożi għolja ta 'manganese jistgħu jkollhom effetti inotropiċi u vażodilatorji negattivi kif ukoll effetti fuq ir- ritmu u l- konduzzjoni tal- qalb minħabba l- antagoniżmu tal- calcium.
Treatment of an overdose should be symptomatic and directed towards the support of vital functions.
Il- kura ta 'doża eċċessiva għandha tkun sintomatika u tkun intenzjonata biex issostni l- funzjonijiet vitali.
There is no antidote to this contrast medium.
M' hemmx antidotu għal dan il- medjum għall- kuntrast.
Mangafodipir and its metabolites are dialysable whereas manganese is not dialysable because of protein binding (see also section 5.2).
Mangafodipir u l- metaboli tiegħu huma dijaliżabbli waqt li manganese mhux dijaliżabbli minħabba l - proteini li jorbtu (ara sezzjoni 5. 2).
Paramagnetic MRI contrast medium, ATC Code:
Kategorija farmakoterapewtika: medjum għall- kontrast paramanjetiku għall- MRI, Kodiċi ATC:
Mangafodipir is a chelate containing the metal manganese - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand fodipir (dipyridoxyl diphosphate).
Mangafodpir huwa chelate li fih il- metall manganese li għandu karatteristiċi paramanjetiċi u li jżid l - effett tal- kuntrast fl- MRI - u fih il- ligand fodipir (dipyridoxyl diphosphate).
Manganese is preferentially taken up by normal liver parenchyma and also in the pancreas so that contrast enhancement between abnormal and normal tissue can be expected.
Idealment, Il- manganese jittieħed mill- parenkima normali tal- fwied u saħansitra mill- frixa, sabiex wieħed jistenna li jkun hemm żieda fil- kuntrast bejn tessut anormali u dak normali.
The effect of mangafodipir is to shorten the longitudinal relaxation time (T1) of targeted tissues during MRI, leading to an increase in signal intensity (brightness) of, for example, pancreas and liver parenchyma.
L- effett ta 'mangafodipir huwa li jqassar iż- żmien ta' rilassament lonġitudinali (T1) fit- tessuti magħżula waqt l- MRI, li jwassal għal żieda fl- intensita` tas- sinjal (jixgħel iktar) ta ', ngħidu aħna, il - parenkima tal- frixa u tal- fwied.
4 hours after the end of administration.
Iż- żewġ organi jistgħu jiġu osservati bl- aħjar mod sa, bejn wieħed u ieħor, 4 sigħat wara t- tmiem ta 'l- għoti tal- mediċina.
Lesion-related enhancement of certain types of lesions, such as liver metastases and hepatocellular carcinomas, may be detectable for up to 24 hours.
It- tkattir fil- viżibilita` ta 'ċerti tipi ta' feriti, bħal ma 'huma metastases tal- fwied u karċinomi epatoċellulari, jistgħu jiġu osservati sa 24 siegħa wara.
Clinical studies have demonstrated that mangafodipir facilitates the detection of liver lesions in patients with such lesions.
Studju kliniċi wrew li mangafodipir jiffaċilita l- osservazzjoni ta 'feriti tal- fwied f' pazjenti b' feriti bħal dawn.
TESLASCAN is isotonic with blood and normal body fluids.
TESLASCAN huwa isotoniku mad- demm u mal- fluwidi normali tal- ġisem.
Mangafodipir trisodium is metabolised (dephosphorylated) and manganese ions are released from the mangafodipir by exchange with plasma zinc (mainly) after intravenous administration.
Mangafodipir trisodium huwa metabolizzat (defosforilatat) u ioni tal- manganese jinħallu minn mangafodipir billi jinbidlu maż- zinc tal- plażma, wara li l- prodott jingħata fil- vina.
Manganese and the ligand (fodipir), which have different pharmacokinetics, are eliminated by different routes.
Il- manganese u l - ligand (fodipir), li għandhom karatteristiċi farmakodinamiċi differenti, jitneħħew mill- ġisem minn rotot differenti.
The mean initial plasma half-life of manganese is 20 minutes or less, with significant uptake into the liver, pancreas, kidneys and spleen.
Il- half- life medja inizzjali ta ’ manganese fil- plażma hija ta ’ 20 minuta jew anqas, u jinġabar b' mod sinifikanti fil- fwied, fil- frixa, fil- kliewi u fil- marrara.
The initial plasma half-life of ligand is about 50 minutes.
Il- half- life inizzjali tal- ligand fil- plażma hija ta ’ madwar 50 minuta.
The volume of distribution for manganese is between 0.5 and 1.5 l/ kg, and for fodipir 0.17 to 0.45 l/ kg.
Il- volum tad- distribuzzjoni għall- manganese huwa bejn 0. 5 u 1. 5 l/ kg, u għal fodipir huwa minn 0. 17 sa 0. 45 l/ kg.
Following its metabolism, nearly all of the ligand (fodipir) is excreted in urine within 24 hours, with negligible amounts being eliminated via the faeces.
Wara li jimmetabolizza, l- ligand (fodipir) jitneħħa kważi kollu fl - urina fi żmien 24 siegħa, u parti negliġibbli titneħħa ma 'l- ippurgar.
About 15-20% of the manganese is eliminated in the urine within the first 24 hours, most of the remainder is excreted in the faeces over the following 4 days.
Madwar 15- 20% tal- maganese jitneħħa ma 'l- urina fi żmien 24 siegħa, u ħafna mill- bqija jinteħħa ma' l- ippurgat matul l- 4 ijiem ta 'wara.
In whole human blood in vitro, the protein binding of manganese is approximately 27% but binding of fodipir to protein is negligible.
Fid- demm kollu tal- bniedem in vitro, ir- rata ta 'rbit tal- manganese mal- proteini hija ta' 27% imma l - irbit ta 'fodipir mal- proteini huwa negliġibbli.
Relevant adverse effects
- 5 - Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ effett tossiku fuq il- ġeni, sigurtà farmakoloġika, aspetti kinetiċi validati u metaboliżmu ma ’ turi l- ebda periklu speċjali għall - bnedmin.
5 from repeated dose toxicity studies were liver toxicity (cholangiohepatitis) observed at relatively low dosages in dogs, while sufficient margins of safety were determined in rats and monkeys.
L- effetti mhux mixtieqa relevanti, li ħarġu minn studji dwar it- tossiċita` ta 'dożi repetuti huwa tossiċita` fil- fwied (kolanġjoëpatite) li kien osservat b' dożi relattivament żgħar fil- klieb, filwaqt li fil- firien u fix- xadini ġew determinati marġini ta' sigurta` suffiċjenti.
Mangafodipir is teratogenic in rats; it causes increased foetal skeletal abnormalities when given daily by intravenous injection to female rats at dosages slightly greater than clinical dosages.
Jikkawża anormalitajiet fl- iskeletru tal- fetu meta jingħata kuljum b' injezzjoni fil- vina fil- firien nisa b' dożi li huma ftit ogħla mid- dożi kliniċi.
Embryo- and foetotoxicity has been observed in rabbits.
Fil- fniek ġiet osservata tossiċita` fl- embriju u fil- fetu.
Ascorbic acid Sodium chloride Sodium hydroxide and/ or hydrochloric acid (pH adjustment) Water for injections.
Ascorbic acid Sodium chloride Sodium hydroxide u/ jew hydrochloric acid (bidla fil- pH) Ilma għall- injezzjonijiet.
A separate cannula should be used.
Għandha tintuża kannula seperata.
Unopened:
Mhux miftuħ:
Once opened the product should be used immediately.
Hekk kif jinfetaħ il- prodott għandu jintuża minnufih
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil - kartuna ta 'barra sabiex tilqa ’ mid- dawl.
The product should be used immediately after first opening (see section 6.3).
Il- prodott għandu jintuża minnufih wara li jinfetaħ għall- ewwel darba (ara sezzjoni 6. 3)
50 ml clear, colourless vials (type 1 glass).
Kunjetti tal- 50ml (tat- tip I, tal- ħġieġ) trasparenti, bla kulur.
The containers are closed with rubber stoppers and sealed with aluminium caps with polypropylene lids.
Il- kontenituri jingħalqu b' tappijiet tal - gomma u jkunu ssigillati b' kappa ta 'l- aluminjum u b' għotjien tal- polypropylene.
TESLASCAN is supplied in packs of 1 x 50 ml and 10 x 50 ml vials.
TESLASCAN jiġi f' pakketti ta 'kunjett 1 x 50 ml u 10 kunjetti x 50 ml.
TESLASCAN vials should be visually inspected for particulate matter and for the integrity of the container prior to use.
Il- kunjetti ta 'TESLASCAN għandhom jiġu spezzjonati viżwalment għal xi frak u għall- integrita` tal - kontenitur qabel jintuża.
Vials are intended for single use only; any unused portions must be discarded.
Il- kunjetti għandhom jintużaw darba biss; il- porzjonijiet mhux użati għandhom jintremew.
The required volume to be given to the patient should be determined and any excess volume should be withdrawn from the vial before infusion.
Għandu jiġi determinat il- volum li hemm bżonn jingħata lill- pazjent u l- volum żejjed għandu jinġibed mill- kunjett qabel l- infużjoni.
Connective tubing may be flushed with physiological saline (sodium chloride 9 mg/ ml (0.9%)), to ensure complete administration of the contrast medium.
L- intubar jista 'jitlaħlaħ b' salina fiżjoloġika (sodium chloride 9 mg/ ml (0. 9%), biex tkun aċċertat li jingħata l- medju għall- kuntrast kollu.
6 7.
- 6 - 7.
Box 4220 Nydalen NO-0401 OSLO, Norway
GE Healthcare AS Nycoveien 1- 2 P. O. Box 4220 Nydalen NO- 0401 OSLO, Norveġja
22.05.1997 Date of latest renewal:
22. 05. 1997 Data ta ’ l- aħħar tiġdid:
7 ANNEX II
- 7 - ANNESS II
CONDITIONS OF THE MARKETING AUTHORISATION
KONDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
8 A.
- 8 - A.
CONDITIONS OF THE MARKETING AUTHORISATION
KONDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KONDIZZJONJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
9 ANNEX III
- 9 - ANNESS III
10 A.
- 10 -
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
- 11 -
TESLASCAN 0.01 mmol/ ml solution for infusion mangafodipir trisodium
TESLASCAN 0. 01mmol/ ml soluzzjoni għall- infużjoni mangafodipir trisodium
7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μ mol), equivalent to 6.91 mg of mangafodipir
Mangafodipir trisodium anhydr. 7. 57 mg (ekwiv. għal 0. 01 mmol) 7. 57 mg ta ’ anhydrous mangafodipir trisodium, 0. 01 mmol (10 μmol), ekwivalenti għal 6. 91 mg ta ’ mangafodipir
Ascorbic acid Sodium chloride Sodium hydroxide or hydrochloric acid Water for injections Also contains Sodium:
Aċidu assorbiku Kloro tas- sodju Idrossidu tas- sodju jew aċidu idrokloriku Ilma għall- injezzjonijiet Fih ukoll Sodium:
0.16 mmol (3.6 mg) per ml.
0. 16 mmol (3. 6 mg) kull ml.
See the package leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar dettalji.
1 x 50 ml 10 x 50 ml
TESLASCAN 0. 01mmol/ ml soluzzjoni għall- infużjoni 1 x 50 ml 10 x 50ml
MRI contrast medium Intravenous infusion Read the package leaflet before use.
Medjum għall- kuntrast fl- MRI Infużjoni fil- vina Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Each vial for one patient only.
Kull kunjett għal pazjent wieħed.
Discard unused portion.
Armi l- parti li ma tintużax.
12 9.
- 12 -
SPECIAL STORAGE CONDITIONS
DATA TA ’ META JISKADI
GE Healthcare AS Nycoveien 1-2 NO-0401 Oslo, Norway
GE Healthcare AS Nycoveien 1- 2 NO- 0401 Oslo, Norveġja
13 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
- 13 -
7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μ mol), equivalent to 6.91 mg of mangafodipir
7. 57 mg ta ’ anhydrous mangafodipir trisodium, 0. 01 mmol (10 μmol), ekwivalenti għal 6. 91 mg ta ’ mangafodipir
0.16 mmol (3.6 mg) per ml.
0. 16 mmol (3. 6 mg) per ml.
Infusion 50 ml
Soluzzjoni għall- infużjoni 50 ml
14 8.
- 14 -
EXP
ΕΧP
--------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------
The labels will be designed as triple-labels in the same way as for our other contrast media.
It- tikketta jinħadmu bħala tikketti trippli bħal fil- każ tal- midja l- oħra tagħna.
The tear-off labels are intended to be stuck to the patient records and to the syringe if this is used.
It- tikketti li jinqatgħu huma maħsuba biex jitwaħħlu mal- fajl tal- pazjent u s- siringa li se tintuża.
Text on the two tear-off labels:
Kitba fuq iż- żewġ tikketti li jinqatgħu:
TESLASCAN 50 ml Batch
TESLASCAN 50 ml Lott
15 B.
- 15 -
16 PACKAGE LEAFLET:
- 16 -
Mangafodipir trisodium
TESLASCAN 0. 01 mmo1/ ml soluzzjoni għall- infużjoni Mangafodipir trisodium
please tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
2.
X’ inhu TESLASCAN u għalxiex jintuża 2.
Before you use TESLASCAN.
Qabel ma tuża TESLASCAN 3.
How to use TESLASCAN.
Kif għandek tuża TESLASCAN 4.
6.
Kif taħżen TESLASCAN 6.
WHAT TESLASCAN IS AND WHAT IT IS USED FOR
X’ INHU TESLASCAN U GĦALXIEX JINTUŻA
TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information.
TESLASCAN huwa medjum għall- kuntrast paramanjetiku li jintuża għat- teħid ta 'Ritratti ta' Reżonanza Manjetika (MRI), biex itejjeb l- informazzjoni dijanjostika.
TESLASCAN is used in magnetic resonance imaging (MRI) to detect certain lesions in the liver and pancreas.
TESLASCAN jintuża għat- teħid ta 'Ritratti ta' Reżonanza Manjetika (MRI) biex jiġu osservati certi tipi ta 'feriti fil- fwied u fil- frixa.
BEFORE YOU USE TESLASCAN
QABEL MA TUŻA TESLASCAN
Do not use TESLASCAN if one of the following conditions exists:
Tużax TESLASCAN jekk hemm xi waħda minn dawn il- kondizzjonijiet:
- Pregnancy
- tqala
- Allergy (hypersensitivity) to the active substance or any of the other ingredients of TESLASCAN
- Allerġija (sensittivita` eċċessiva) għas- sustanza attiva jew sustanzi oħra ta ’ TESLASCAN
- Pheochromocytoma
- Fekromosajtoma
- Breast-feeding
- Treddiegħ
- Severe kidney disease
- Mard serju tal- kliewi
- Severe liver disease
- Mard serju tal- fwied
Take special care with TESLASCAN if one of the following conditions exists:
Oqgħod attent ħafna b' TESLASCAN jekk hemm xi waħda minn dawn il- kondizzjonijiet:
- Severe heart disease - in particular heart failure or when there is a risk of disorders of heart rhythm
- Mard serju tal- qalb - speċjalment insiffiċjenza tal- qalb jew meta jkun hemm ir- riskju ta 'disturbi
- in patients with injuries of the blood brain barrier and severe cerebral disease
- f’ pazjenti li għandhom feriti fil- membrana tad- demm tal- moħħ u mard serju ċelebrali
Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) may occur.
F’ każijiet rari jista 'jkun hemm reazzjonijiet ta' sensittivita` eċċessiva (urtikarja u tipi oħra ta 'allerġiji).
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok ghid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
17 Pregnancy and breast-feeding
- 17 -
TESLASCAN must not be used if you are pregnant.
TESLASCAN m' għandux jintuża jekk int tqila.
The amount of TESLASCAN in breast milk is not known.
L- ammont ta 'TESLASCAN fil- ħalib tas- sider mhux magħruf.
As a precaution, to prevent exposing infants to the medicine, breast-feeding should be stopped from the time of dosing and all milk should be discarded for the first 14 days afterwards.
Bħala prekawzjoni, biex it- trabi ma jkunux esposti għall- mediċina, it- treddiegħ għandu jitwaqqaf minn meta tibda tingħata d- doża u l - ħalib kollu għandu jintrema fl- 14- il ġurnata ta 'wara.
No effects are known.
Mhux magħruf li hemm effetti.
There is no reason why you cannot drive after the investigation, unless you feel dizzy or are unsure of yourself.
M' hemm l- ebda raġuni għaliex m' għandekx issuq wara l - investigazzjoni, sakemm ma tħossokx strodut jew m' intix cert kif qed tħossok.
Important information about some of the ingredients of Teslascan
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Teslascan
This medicine contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml.
Dan il- prodott mediċinali fih 5. 5 mmol (126 mg) ta ’ sodium f’ kull doża normali ta ’ 35 ml.
HOW TO USE TESLASCAN
KIF GĦANDEK TUŻA TESLASCAN
TESLASCAN is for use in patients over the age of 18 years.
TESLASCAN jintuża f’ pazjenti ikbar minn 18- il sena.
The amount given will depend on the weight of the patient:
L- ammont li jingħata jiddependi mill- piż tal- pazjent:
0.5 ml/ kg body weight is the recommended dosage for adults and elderly.
0. 5 ml/ kg tal- piż tal- ġisem hija d- doża rakkomandata għall- adulti jew għall- anzjani.
TESLASCAN is for intravenous use and will be infused before the MRI examination.
TESLASCAN jintuża fil- vina u jkun infuż qabel l- eżami bl- MRI.
TESLASCAN may be infused into a vein, normally an arm vein, via a thin plastic tube.
TESLASCAN jista 'jkun infuż fil - vina, normalment vina fid- driegħ, permezz ta' tubu rqieq tal- plastik.
The administration may last for up to 15-20 minutes.
Jista ’ jdum jingħata sa 15- 20 minuta.
TESLASCAN should be visually inspected for particulate matter and for the integrity of the container prior to use.
TESLASCAN għandu jiġi spezzjonat viżwalment għall- frak u għall- integrita` tal- kontenitur qabel ma jintuża.
Vials are intended for single use only.
Il- kunjetti għandhom jintużaw darba biss.
The medicinal product should not be mixed with other medicinal products.
Il- prodott mediċinali m' għandux jitħallat ma prodotti mediċinali oħra.
Any unused portions must be discarded.
Kull parti mhux użata trid tintrema.
There is no known antidote to this contrast medium.
M' hemmx antidotu għal dan il- medjum għall- kuntrast.
Treatment of any overdose will be performed at the hospital.
Il- kura ta 'doża eċċessiva tingħata fl- isptar.
Treatment will be supportive to relieve the symptoms.
Tingħatalek kura biex jitnaqqsu s- sintomi.
High doses of manganese can make the heart pump less efficiently, dilate the blood vessels, as well as induce disturbances of heart rhythm.
Dożi għolja ta 'manganese jistgħu jġiegħlu l- qalb tħabbat b' inqas effiċenza, l- vini u l- arterji tad- demm jitwessgħu, kif ukoll iwasslu għal disturbi fir- ritmu tat- taħbit tal- qalb.
Like all medicines, TESLASCAN can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TESLASCAN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The reported side effects are usually mild and of short duration:
L- effetti sekondarji, fil- biċċa l- kbira tagħhom, jgħaddu u huma ħfief.
Common (1 in 100 to 1 in 10 patients experiences the side effect): • Headache • Nausea • Feeling of warmth/ flushing
Komuni (1 f’ 100 sa 1 f’ 10 pazjenti jħossu dawn l- effetti sekondarji): • Uġigħ ta ’ ras • Nawżja • Sensazzjoni ta ’ sħana/ fawra
18 Uncommon (1 in 1,000 to 1 in 100 patients experiences the side effect): • Hypersensitivity reactions (e. g., skin reactions, rhinitis (nasal catarrh) pharyngitis (throat inflammation)) • Fever • Diarrhoea • Vomiting • Dizziness • Palpitation • Paraesthesia (sensation of tingling) • Abdominal pain • Injection site pain • Taste sensations
Mhux komuni (1 f’ 1, 000 sa 1 f’ 100 pazjent iħossu dawn l- effetti sekondarji) • Reazzjonijiet ta ’ sensittivita` eċċessiva (p. e. bħal reazzjonijiet fil- ġilda, rinite (katarru fl - imnieħer), farinġite (infjammazzjoni tal- gerżuma) • Deni • Dijarrea • Remettar • Sturdament • Taħbit mgħaġġel tal- qalb • Paresteżija (sensazzjoni ta ’ tnemnin) • Uġigħ addominali • Uġigħ fil- post fejn saret l- injezzjoni • Sensazzjonijiet tat- togħma
Rare (1 in 10,000 to 1 in 1,000 patients experiences the side effect): • Hypertension
Rari (1 f’ 10, 000 pazjent sa 1 f’ 1, 000 pazjent iħoss dan l- effett sekondarju): • Pressjoni għolja
Very rare (less than 1 in 10,000 patients experiences the side effect): • Visual disturbances • Chest pain • Flatulence
Rari ħafna (inqas minn 1 f’ 10, 000 pazjent iħoss l- effett sekondarju) • Disturbi fil- vista • Uġigħ fis- sider • Gass
Anaphylactoid reactions (wheeziness, difficulty in breathing or tightness or pain in the chest) may occur.
Jista 'jkun hemm reazzjonijiet anafilattojdi (tħarħir, diffikulta` biex tieħu n- nifs jew tagħfis jew uġigħ fis- sider).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the radiologist/ radiographer or 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 lir- radjologu/ radjografu jew lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TESLASCAN
KIF TAĦŻEN TESLASCAN
Expiry date
Data ta 'meta jiskadi
Do not use TESLASCAN after the expiry date which is stated on the label after EXP.
Tużax TESLASCAN wara d- data ta ’ skadenza li tidher fuq it- tikketta wara EXP.
The expiry date refers to the last day of that month.
Id- Data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar..
Storage precautions
Prekawzjoni tal- ħażna
Once opened the product should be used immediately.
Hekk kif jinfetaħ il- prodott għandu jintuża minnufih.
Do not use Teslascan if the colour changes from dark yellow to brown.
Kwalunkwe parti li ma tintużax għandha tintrema Tużax Teslascan jekk jinbidel il- kulur minn isfar skur għall- kannella.
Ask your pharmacist how to dispose of medicines no longer required.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent.
These measures will help to protect the environment.
- Is- sustanza attiva hi mangafodipir trisodium.
19 6.
- 19 -
1 ml of solution contains 7.57 mg mangafodipir trisodium anhydrous (corresponding to 0.01 mmol per ml)
1 ml ta ’ soluzzjoni fiha 7. 57 mg mangafodipir trisodium anhydrous (li jikkorrispondi ma ’ 0. 01 mmol kull ml)
- The other ingredients are ascorbic acid, sodium chloride, sodium hydroxide and/ or hydrochloric
- Is- sustanzi l- oħra huma ascorbic acid, sodium chloride, sodium hydroxide, u/ jew hydrochloric
acid (for pH adjustment) and water for injections.
acid (għal aġġustament pH) u ilma għall- injezzjonijiet.
What TESLASCAN looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Solution for infusion. The solution is clear and bright to dark yellow in colour.
Is- soluzzjoni hi ċara u jew ta ’ kulur isfar jgħajjat jew skur
The medicine is supplied in pack of:
Il- mediċina tingħata f’ pakkett ta ’:
1 vial of 50 ml 10 vials of 50 ml
Kunjett ta ’ 50 ml 10 kunjetti ta ’ 50 ml
Marketing Authorization Holder and Manufacturer:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- manifattur:
Box 4220 Nydalen NO-0401 OSLO, Norway
GE Healthcare AS Nycoveien 1- 2 P. O. Box 4220 Nydalen NO- 0401 OSLO, In - Norveġja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- mediċina, jekk jogħġbok agħmel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ:
22
- 22 -
What is Tevagrastim?
X’ inhu Tevagrastim?
Tevagrastim is a solution for injection or for infusion (drip into a vein).
Tevagrastim hu konċentrat li jiġi mdewweb biex jingħata b’ infużjoni (drip fil- vina).
Tevagrastim is a ‘ biosimilar’ medicine.
Tevagrastim hija mediċina ‘ bijosimili ’.
This means that Tevagrastim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Tevagrastim huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl- Unjoni Ewropea (UE) u li tinkludi fiha l- istess sustanza attiva (magħrufa bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Tevagrastim is Neupogen.
Il- mediċina ta ’ referenza għal Tevagrastim hija Neupogen.
What is Tevagrastim used for?
Għal xiex jintuża Tevagrastim?
Tevagrastim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Tevagrastim huwa wżat sabiex jistimula l- produzzjoni ta ’ ċelloli bojod fid- demm fis- sitwazzjonijiet li ġejjin: • Inaqqas iż- żmien ta ’ newtropenija (livelli baxxi ta ’ newtrofili, tip ta ’ ċellola bajda tad- demm) u l - każ li jkun hemm newtropenija febbrili (newtropenija fil- fwied) f’ pazjenti li jirċievu l - kemoterapija (trattament tal- kanċer) li huwa ċitotossiku (joqtol iċ- ċelloli); • Inaqqas iż- żmien ta ’ newtropenija f’ pazjenti li għaddejjin bi trattament li jkisser iċ- ċelloli tal - mudullum qabel ma ’ l- mudullum jiġi trapjantat (bħal f’ xi pazjenti bil- lewkimja) jekk ikunu f’ riskju ta ’ newtropenija severa fuq żmien twil; • Iżid il- livelli ta ’ newtrofili u jnaqqas ir- riskju ta ’ infezzjonijiet f’ pazjenti bin- newtropenija li għandhom storja ta ’ infezzjonijiet severi u repetuti; • Jittratta newtropenija persistenti f’ pazjenti bil- vajrus uman ta ’ l- immunodefiċjenza fi stat avvanzat [HIV]). Tevagrastim jista ’ jintuża wkoll f’ pazjenti li ser jagħtu ċ- ċelloli staminali tad- demm għal trapjant, sabiex dan jgħin fir- rilaxx taċ- ċelloli mill- mudullum.
How is Tevagrastim used?
Kif jintuża Tevagrastim?
Tevagrastim is given by injection under the skin or infusion into a vein.
Tevagrastim jingħata b’ injezzjoni taħt il- ġilda jew infużjoni fil- vina.
Tevagrastim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Tevagrastim normalment jingħata f’ ċentru ta ’ trattament speċjalizzat, minkejja li pazjenti li jirċievuh b’ injezzjoni taħt il- ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
How does Tevagrastim work?
Kif jaħdem Tevagrastim?
The active substance in Tevagrastim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Is- sustanza attiva f’ Tevagrastim, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal- kolownja granuloċijto (G- CSF).
How has Tevagrastim been studied?
Kif ġie studjat Tevagrastim?
Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen.
Tevagrastim ġie studjat biex jiġi muri li huwa komparabbli mal- mediċina ta ’ referenza, Neupogen.
Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Tevagrastim ġie kumparat ma ’ Neupogen u ma ’ placebo (trattament fint) fi studju prinċipali li kien jinvolvi 348 pazjent bil- kanċer tas- sider.
To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’ s lymphoma.
Sabiex tiġi studjata s- sigurtà ta ’ Tevagrastim, saru żewġ studju oħrajn fuq pazjenti bil- kanċer tal - pulmun u limfoma non- Hodgkin.
What benefit has Tevagrastim shown during the studies?
X' benefiċċju wera Tevagrastim matul l- istudji mwettqa?
Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe neutropenia.
Trattament bir- Tevagrastim u n- Neupogen ġab tnaqqis simili fiż- żmien ta ’ newtropenija severa.
During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Matul l- ewwel 21 jum ta ’ ċiklu kemoterapewtiku, pazjenti trattati b’ kemm Tevagrastim jew Neupogen kellhom newtropenija severa għal medja ta ’ 1. 1 jum, kumparat ma ’ 3. 8 jum f’ dak li jirċievu placebo.
Therefore, the effectiveness of Tevagrastim was shown to be equivalent to that of Neupogen.
Għalhekk, l- effikaċja ta ’ Tevagrastim ġiet murija bħala ekwivalenti għal dik ta ’ Neupogen.
What is the risk associated with Tevagrastim?
X’ inhu r- riskju assoċjat ma ’ Tevagrastim?
The most common side effect with Tevagrastim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
X' inhu r- riskju assoċjat ma 'Tevagrastim (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu uġiegħ muskoloskeletali (uġigħ fil- muskoli u fl- għadam).
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Tevagrastim is being used for.
Effetti sekondarji oħrajn jistgħu jidhru f’ aktar minn pazjent minn għaxra skond il- kondizzjoni li Tevagrastim jkun użat għaliha.
For the full list of all side effects reported with Tevagrastim, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Tevagrastim, ara l- Fuljett ta ’ Tagħrif.
Tevagrastim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Tevagrastim m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal filgrastim jew għal xi ingredjenti oħra tiegħu.
Why has Tevagrastim been approved?
Għaliex ġie approvat Tevagrastim?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mal- ħtiġijiet ta ’ l- Unjoni Ewropea, Tevagrastim wera li għandu kwalità, sigurtà u effikaċja komparabbli ma ’ dawk ta ’ Neupogen.
The Committee recommended that Tevagrastim be given marketing authorisation.
Il- Kumitat irrakkomanda li Tevagrastim jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tevagrastim:
Tagħrif ieħor dwar Tevagrastim:
The European Commission granted a marketing authorisation valid throughout the EU for Tevagrastim to Teva Generics GmbH on 15 September 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Tevagrastim lil Teva Generics GmbH fil- 15 ta 'Settembru 2008.
The full EPAR for Tevagrastim can be found here.
L- EPAR sħiħ għal Tevagrastim jista ’ jinstab hawnhekk.
EU/ 1/ 08/ 445/ 001
Numru ta ’ l- EU EU/ 1/ 08/ 445/ 001
Tevagrastim
Isem inventat Tevagrastim
30 MIU (300 µg/
Qawwa 30 MIU (300 µg/ 0. 5 ml)
0.5 ml)
Għamla farmaċewtika Soluzzjoni għall- injezzjoni jew infużjoni
Solution for injection or infusion
Mnejn jingħata Użu għal taħt il- ġilda u għal ġol- vini
Subcutaneous or intravenous use
Il- pakkett siringa mimlija għal- lest (ħġieġ)
0.5 ml
Kontenut 0. 5 ml
1 pre-filled syringe
Daqs tal- pakkett 1 siringa mimlija għal- lest
0.5 ml)
Soluzzjoni għall- injezzjoni jew infużjoni
Solution for injection or infusion
Użu għal taħt il- ġilda u għal ġol- vini
Subcutaneous or intravenous use
siringa mimlija għal- lest (ħġieġ)
pre-filled syringe 0.5 ml (glass)
0. 5 ml
2 x 5 pre-filled syringes
2 x 5 siringi mimlijin għal- lest
0.8 ml)
Soluzzjoni għall- injezzjoni jew infużjoni
pre-filled syringe 0.8 ml (glass)
0. 8 ml
Tevagrastim 30 MIU/ 0.5 ml solution for injection or infusion
Tevagrastim 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni
Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Tevagrastim huwa indikat għat- tnaqqis fid- dewmien ta ’ newtropenja u fl- inċidenza ta ’ newtropenja bid- deni f’ pazjenti kkurati b’ kimoterapija ċitotossika stabbilita kontra malinni (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat- tnaqqis fid- dewmien ta ’ newtropenja f’ pazjenti, taħt kura majeloablativa u segwita bit- trapjant tal- mudullun, li huma meqjusa li għandhom riskju għola ta ’ newtropenja qawwija u mdewma.
Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Tevagrastim huwa indikat għall- mobilizzazzjoni taċ- ċelluli proġenitriċi tad- demm periferali( PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
F’ pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl- Għadd Assolut ta ’ Newtrofili (ANC) ta ’ 0. 5 x 109/ l, u storja ta ’ infezzjonijiet qawwija jew li jirkadu, it- terapija fit- tul b’ Tevagrastim huwa indikat biex jiżdied l- għadd ta ’ newtrofili u sabiex l- inċidenza u t- tul ta ’ ġrajjiet avversi relatati ma ’ infezzjonijiet jonqsu.
Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/ l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Tevagrastim huwa indikat għal kura ta ’ newtropenja persistenti (ANC ta ’ 1. 0 x 109/ l jew inqas) f’ pazjenti b’ infezzjoni avvanzata ta ’ l- HIV, sabiex jitnaqqas ir- riskju ta ’ infezzjonijiet batteriċi, dan meta għażliet oħra għall- immaniġġjar ta ’ newtropenja ma jkunux addattati.
Tevagrastim contains sorbitol.
Tevagrastim fih sorbitol.
During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Tevagrastim.
Fi studji kliniċi, 541 pazjenti b’ kanċer u 188 volontiera f’ saħħithom ġew esposti għal Tevagrastim.
The safety profile of Tevagrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Il- profil ta ’ sigurta ’ ta ’ Tevagrastim li ġie osservat f’ dawn l- istudji kliniċi kien konsistenti ma dak tal- prodott ta ’ referenza li ntuża f’ dawn l- istudji.
Tevagrastim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Tevagrastim, li fih r- metHuG- CSF (filgrastim), jikkawża żjieda sinifikanti fl- għadd ta ’ newtrofili fid- demm periferali fi żmien 24 siegħa, b’ żjidiet minuri fil- monoċiti.
The efficacy and safety of Tevagrastim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
L- effikaċja u s- sigurta ’ ta ’ Tevagrastim ġew stmati fi studji ta ’ fażi III, randomised u kontrollati bi placebo, f’ pazjenti b’ kanċer tas- sider, kanċer tal- pulmun u Non- Hodgkin- Limfoma.
There were no relevant differences between Tevagrastim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Ma kienx hemm differenzi rilevanti bejn Tevagrastim u l- prodott ta ’ referenza fir- rigward ta ’ dewmien ta ’ newtropenja qawwija u l- inċidenza ta ’ newtropenja bid- deni.
Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Tevagrastim was comparable to that of the reference product after subcutaneous and intravenous administration.
Studji randomised, single- blind, b’ doża waħda u crossover li saru fuq 196 voluntiera b’ saħħithom urew li l- profil farmakokinetiku ta’ Tevagrastim kien komparabbli ma ’ dak tal- prodott ta ’ referenza kemm wara amministrazzjoni taħt il- ġilda kif ukoll ġol- vina.
In cancer patients, the pharmacokinetic profile of Tevagrastim and the reference product was comparable after single and repeated subcutaneous administration.
F’ pazjenti b’ kanċer, il- profil farmacokinetiku ta ’ Tevagrastim u dak tal- prodott ta ’ referenza kienu komparabbli wara amministrazzjoni taħt il- ġilda ta ’ doża waħda jew dożi ripetuti.
15 Tevagrastim should not be diluted with sodium chloride solution.
Tevagrastim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
If required, Tevagrastim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm il- ħtieġa, Tevagrastim jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).