FrancophonIA/ELRC3.0 huggingface dataset:
English: • Allergic (hypersensitivity) reactions are possible.
Maltese: • Reazzjonijiet allerġiċi (ta' sensittività eċċessiva) huma possibbli.
English: Formation of inhibitor to factor IX has been reported during factor replacement therapy with IDELVION in the treatment of haemophilia B. After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Maltese: Wara trattament ripetut bi prodotti tal-fattur IX ta' koagulazzjoni umana, il-pazjenti għandhom jiġu mmonitorjati għall-iżvilupp ta' antikorpi li jinnewtralizzaw (inibituri) li għandhom jiġu kkwantifikati f'Unitajiet Bethesda (UB) bl-użu ta' ittestjar bijoloġiku xieraq.
English: Haemophilia B is a sex linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: L-emofilja B hija disturb marbut mas-sess tal-persuna, ereditarju ta' koagulazzjoni tad-demm minħabba tnaqqis fil-livelli ta' fattur IX u jwassal għal ħafna ħruġ ta' demm fil-ġogi, fil-muskoli, jew fl-organi interni jew b'mod spontanju jew inkella minħabba inċident jew trawma kirurġika.
English: A dose of 1000 IUs of IDELVION, administered to a 25 kg patient, should be expected to result in a peak post-injection factor IX increase of 1000 IUs/25 kg x 1.0 (IU/dl per IU/kg) = 40 IU/dl (40 % of normal).
Maltese: UI/25 kg x 1.0 (UI/dl għal kull UI/kg) = 40 UI/dl (40 % tan-normal).
English: One previously untreated patient (PUP) from the ongoing clinical trial developed high titre inhibitor against factor IX.
Maltese: Pazjenti wieħed li ma kienx ittrattat qabel (PUP - previously untreated patient) mill-prova klinika li għadha għaddejja żviluppa inibitur b'titre għoli kontra fattur IX.
English: Prophylaxis and control of bleeding in PTPs below 12 years The efficacy of IDELVION has been evaluated in a phase 3 study, in which a total of 27 male PTPs between 1 and 10 years (median age 6.0 years) with 12 patients < 6 years, received IDELVION for prophylaxis and control of bleeding episodes.
Maltese: Profilassi u kontroll ta' ħruġ ta' demm f'PTPs ta' taħt it-12-il sena L-effikaċja ta' IDELVION ġiet ivvalutata fi studju ta' fażi 3, li fih total ta' 27 PTPs subien bejn sena u 10 snin (medjan tal-età ta' 6.0 snin) bi 12-il pazjent ta' < 6 snin, irċivew IDELVION għall-profilassi u l-kontroll ta' episodji ta' ħruġ ta' demm.
English: PK simulations suggest the time to reach 5% plasma FIX activity following a single injection of 50 IU/kg IDELVION to be 7 days for 1-<6years, 9 days for 6-<12 years and 11 days for 12-<18 years of age).
Maltese: IU/kg IDELVION ikun 7 ijiem għal dawk li għandhom sena sa <6 snin, 9 ijiem għal dawk li għandhom 6 snin-<12-il sena u 11-il jum għal dawk li għandhom 12-<18-il sena).
English: A phase 1/2 study evaluated the treatment efficacy and prevention of bleeding episodes of rIX-FP in 17 subjects (ages 13-46 years), 13 subjects in the prophylaxis arm received weekly prophylaxis with IDELVION for approximately 11 months, and 4 subjects in the on-demand arm received IDELVION upon occurrence of bleeding events.
Maltese: Studju ta' fażi 1/2 ivvaluta l-effikaċja tat-trattament u l-prevenzjoni ta' episodji ta' ħruġ ta' demm ta' rIX-FP fi 17-il individwu (etajiet 13-il sena-46 sena), 13-il individwu fil-fergħa ta' profilassi rċivew profilassi darba fil-ġimgħa b'IDELVION għal madwar 11-il xahar, u 4 individwi fil-fergħa skont ilħtieġa rċivew IDELVION meta seħħew il-każijiet ta' ħruġ ta' demm.
English: Pharmacokinetic Parameters for subjects with severe haemophilia (Median (min, max)) following a single injection of 50 IU/kg IDELVION
Maltese: Parametri Farmakokinetiċi għal individwi b'emofilja severa (Medjan (min, max)) wara injezzjoni waħda ta' 50
English: MediSanus d.o.o.
Maltese: Tħawdux.
English: IDELVION 2000 IU powder and solvent for solution for injection Albutrepenonacog alfa
Maltese: UI trab u solvent għal soluzzjoni għall-injezzjoni Albutrepenonacog alfa
English: Haemorrhage
Maltese: Preżentazzjoni
English: Albutrepenonacog alfa is a purified protein produced by recombinant DNA technology, generated by the genetic fusion of recombinant albumin to recombinant coagulation factor IX.
Maltese: Albutrepenonacog alfa huwa proteina ppurifikata magħmula bit-teknoloġija rikombinanti tad-DNA, iffurmata bil-fużjoni ġenetika ta' albumina rikombinanti mal-fattur IX rikombinanti ta' koagulazzjoni.
English: 1 disposable 5 ml syringe 1 venipuncture set 2 alcohol swabs 1 non-sterile plaster
Maltese: 2 imselħiet bl-alkoħol stikka 1 mhux sterili
English: Factor IX is involved in blood clotting.
Maltese: Il-fattur IX huwa involut fit-tagħqid tad-demm.
English: 21 PTPs remained on the extended 14 day prophylaxis interval for additional treatment duration of 98 to 575 (median 386) days.
Maltese: Sottogrupp ta' pazjenti qalbu għal intervalli itwal ta' trattament (kull 10 ijiem jew 14-il jum) b' 'doża rakkomandata ta' 75 IU/kg u aġġustamenti individwali. 21 PTPs baqgħu fuq l-intervall estiż ta' profilassi ta' 14-il jum għal tul ta' żmien ta' trattament addizzjonali ta '98 sa 575 (medjan 386) jum.
English: PK simulations suggest the time to reach 5% plasma FIX activity following a single injection of 50 IU/kg IDELVION to be 12.5 days for adults.
Maltese: UI/kg IDELVION ikun 12.5 jum għall-adulti.
English: IDELVION is used to prevent or to halt bleeding caused by the lack of factor IX in patients of all age groups with haemophilia B (also called congenital factor IX deficiency or Christmas disease).
Maltese: IDELVION jintuża biex jiġi evitat jew jitwaqqaf ħruġ ta' demm ikkawżat minn nuqqas ta' fattur IX fil-pazjenti ta' kull età bl-emofilja B (imsejħa wkoll defiċjenza konġenitali ta' fattur IX jew marda ta' Christmas).
English: A peak level of 50 % of normal is required in a 20 kg patient with severe haemophilia B. The appropriate dose would be 20 kg x 50 IU/dl x 1 dl/kg = 1000 IUs.
Maltese: L-ogħla livell ta' 50 % tan-normal huwa meħtieġ f'pazjenti ta' 20 kg b'emofilja B severa.
English: Other medicines and IDELVION
Maltese: Mediċini oħra u IDELVION
English: Nervous system disorders
Maltese: Disturbi fis-sitema nervuża
English: IDELVION 250 IU powder and solvent for solution for injection IDELVION 500 IU powder and solvent for solution for injection IDELVION 1000 IU powder and solvent for solution for injection IDELVION 2000 IU powder and solvent for solution for injection Albutrepenonacog alfa
Maltese: L-analiżi ta' effikaċja skont il-protokoll tinkludi 15-il operazzjoni li saru fi 12-il pazjent bejn l-etajiet ta' 8 u 51 sena li sarulhom proċeduri kirurġiċi kbar jew żgħar, proċeduri fis-snien jew proċeduri kirurġiċi invażivi oħra.
English: powder and solvent for solution for injection 1 vial with powder: 250 IU albutrepenonacog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Maltese: trab u solvent għal soluzzjoni għall-injezzjoni kunjett 1 bit-trab:250 UI albutrepenonacog alfa (100 UI/ml wara r-rikostituzzjoni) kunjett 1 b'2.5 ml ilma għall-injezzjonijiet apparat 1 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha: siringa 1 ta' 5 ml li tintrema wara li tintuża sett 1 għat-titqib tal-vina
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi kardjovaskulari diġà eżistenti, is-sostituzzjoni ta' terapija b'FIX tista' żżid ir-riskju kardjovaskulari.
English: The product contains traces of hamster proteins (see also “Do not use IDELVION”).
Maltese: Il-prodott fih traċċi ta' proteini tal-ħamster (ara wkoll “Tużax IDELVION”).
English: A peak level of 50 % of normal is required in a 80 kg patient with severe haemophilia B. The appropriate dose would be 80 kg x 50 IU/dl x 0.77 dl/kg = 3080 IUs.
Maltese: L-ogħla livell ta' 50 % tan-normal huwa meħtieġ f'pazjent ta' 80 kg b'emofilja B severa.
English: Individual patients may vary in their responses to factor IX, demonstrating different half-lives and recoveries.
Maltese: Ir-rispons ta' pazjenti individwali għall-fattur IX jista' jvarja b'half-lives u rkupru differenti.
English: IDELVION is a haemophilia medicine that replaces a natural blood clotting (coagulation) factor IX.
Maltese: IDELVION huwa mediċina tal-emofilja li tissostitwixxi l-fattur IX naturali ta' tagħqid tad-demm (koagulazzjoni).
English: Paediatric Population Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Maltese: Il-frekwenza, it-tip u s-severità tar-reazzjonijiet avversi fit-tfal hija mistennija li tkun simili għal dik fladulti.
English: The potency (International Units [IU]) is determined using an in-vitro activated partial thromboplastin time (aPTT)-based one-stage clotting assay calibrated against the World Health Organization (WHO) International Standard for factor IX concentrate.
Maltese: [UI]) hija determinata bl-użu ta' assaġġ ta' tagħqid tad-demm in vitro bi stadju wieħed ibbażat fuq il-ħin parzjali attivat għal tromboplastin (aPTT - activated partial thromboplastin time) ikkalibrat skont l-Istandard Internazzjonali tal-Għaqda Dinjija tas-Saħħa (WHOWorld Health Organization) għall-konċentrat tal-fattur IX.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati bis-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja mifruxa, tagħfis fis-sider, tħarħir, pressjoni baxxa u anafilassi.
English: The following side effects have been observed with factor IX medicines:
Maltese: L-effetti sekondarji li ġejjin kienu osservati b'mediċini ta' fattur IX:
English: For an incremental recovery of 1 IU/dl per 1 IU/kg, the dose is calculated as follows: Dose (IU) = body weight (kg) x desired factor IX increase (IU/dl) x 1 dl/kg
Maltese: Għal irkupru b'żieda regolari ta' 1 UI/dl għal kull 1 UI/kg, id-doża tiġi kkalkulata kif ġej: Doża (UI) = piż tal-ġisem (kg) x żieda mixtieqa fil-fattur IX (UI/dl) x 1 dl/kg
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 2.5 ml
Maltese: Ż-ŻGĦAR EWLENIN Tikketta tal-kunjett tas-solvent ta' 2.5 ml
English: 2.5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: 2.5 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku) ċirku (tal-plastik) u għatu (talaluminju).
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Maltese: fattur IX, b'riskju akbar bi preparazzjonijiet li jkollhom purità baxxa.
English: Major haemorrhage Life threatening haemorrhages, deep muscle bleeding including iliopsoas
Maltese: Emorraġiji ta' periklu għall-ħajja, ħruġ ta' demm minn muskolu filfond inkluż iliopsoas
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fir-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tar-RMP.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Maltese: Armi l-kunjett tas-solvent bl-adapter Mix2Vial il-blu imwaħħal miegħu.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta 'min jinnota illi RMAF ma jkunx komparabbli bejn konċentrati differenti tal-fattur u bejn istudji kliniċi differenti.
English: The safety and efficacy of using IDELVION for immune tolerance induction has not been established.
Maltese: Is-sigurtà u l-effikaċja tal-użu ta' IDELVION għal induzzjoni ta' tolleranza immuni ma ġewx determinati s'issa.
English: The rate of administration should be determined by the patient's comfort level, up to a maximum of 5 ml/min.
Maltese: Ir-rata tal-għoti għandha tiġi determinata mill-livell ta' kumdità tal-pazjent, sa massimu ta' 5 ml/min.
English: Some patients who are well-controlled on a once-weekly regimen might be treated with up to 75 IU/kg on an interval of 10 or 14 days (see section 5.1).
Maltese: Xi pazjenti li jkunu kkontrollati tajjeb fuq kors ta' darba fil-ġimgħa jistaw jiġu trattati sa 75 UI/kg fuq intervall ta' 10 jew 14-il jum (ara sezzjoni 5.1).
English: 5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: 5 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku) ċirku (tal-plastik) u għatu (tal-aluminju).
English: While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise.
Maltese: Kun ċert li tiġbed 'il barra il-pakkett biss u mhux issett Mix2Vial ukoll.
English: 1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Maltese: UI f'kull kunjett; wara rikostituzzjoni b'2.5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 400 UI/ml ta' albutrepenonacog alfa.
English: For routine prophylaxis the recommended dose regimen for paediatric subjects is 35 to 50 IU/kg once weekly (see sections 5.1 and 5.2).
Maltese: UI/kg darba fil-ġimgħa (ara sezzjonijiet 5.1 u 5.2).
English: FIX inhibition/Inhibitor development
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: EXP
Maltese: CL
English: • If you need a central venous access device (CVAD for injection of IDELVION), the risk of complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Maltese: • Jekk teħtieġ apparat ta' aċċess għal vina ċentrali (CVAD - central venous access device għallinjezzjoni ta' IDELVION), ir-riskju ta' kumplikazzjonijiet inkluż infezzjonijiet lokali, batterja fid-demm (batterimja) u l-formazzjoni ta' tagħqid tad-demm f'kanal tad-demm (trombożi) fejn ikun imdaħħal il-kateter, għandhom jitqiesu mit-tabib tiegħek.
English: Do not shake.
Maltese: Dan huwa ta'
English: All subjects had severe (FIX level <1%) or moderately severe (FIX level ≤ 2%) haemophilia B. Forty PTPs received IDELVION for prophylaxis.
Maltese: UI/dl (1.0 % tannormal) f'pazjenti li għandhom < 12 il-sena.
English: 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Maltese: Kunjett 1 b'2.5 ml ilma għall-injezzjonijiet Apparat 1 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha:
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Maltese: B'mod partikolari fil-każ ta' interventi kirurġiċi kbar, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi ta' koagulazzjoni (attività tal-fattur IX fil-plażma) hija indispensabbli.
English: • Do not use this medicine after the expiry date, which is stated on the label and carton.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna.
English: All 27 subjects received weekly prophylaxis treatment with IDELVION for a mean time on study of 13.1 months (9, 18 months).
Maltese: Is-27 individwu kollha rċivew trattament ta' profilassi darba fil-ġimgħa b'IDELVION għal medja ta' żmien matul l-istudju ta' 13.1 xhur (9, 18-il xahar).
English: Because of the risk of allergic reactions with factor IX products, the initial administration of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Maltese: Minħabba r-riskju ta' reazzjonijiet allerġiċi bi prodotti tal-fattur IX, l-għoti inizjali tal-fattur IX għandu, skont il-fehma tat-tabib li qed jittratta, isir taħt sorveljanza medika fejn tista' tiġi pprovduta kura medika xierqa għal reazzjonijiet allerġiċi.
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.
Maltese: Istruzzjonijiet ġenerali - Is-soluzzjoni rrikostitwita għandha tkun trasparenti jew ftit tkanġi, minn safra sa bla kulur.
English: One pack with 2000 IU containing: 1 vial with powder 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni: kunjett 1 li fih it-trab kunjett 1 b'2.5 ml ilma għall-injezzjonijiet apparat 1 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha:
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of albutrepenonacog alfa.
Maltese: UI f'kull kunjett; wara rikostituzzjoni b'2.5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 100 UI/ml ta' albutrepenonacog alfa.
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of albutrepenonacog alfa.
Maltese: UI f'kull kunjett; wara rikostituzzjoni b'2.5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 200 UI/ml ta' albutrepenonacog alfa.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Maltese: Unità Internazzjonali waħda (UI) ta' attività ta' fattur IX hija ekwivalenti għal dik il-kwantità ta' fattur IX f'ml wieħed ta' plażma normali tal-bniedem.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata bir-riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Known allergic reaction to hamster protein.
Maltese: • Jekk inti allerġiku għal proteini tal-ħamsters.
English: Minor surgery
Maltese: Kirurġija ħafifa
English: Elderly
Maltese: Emorraġija
English: IDELVION 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Maltese: IU ta' proteina rikombinanti ta' fużjoni li tgħaqqad il-fattur IX ta' koagulazzjoni mal-albumina (rIX-FP), (INN = albutrepenonacog alfa.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Maltese: Kien hemm rapporti fil-publikazzjonijiet li juru korrelazzjoni bejn l-okkorrenza ta' inibitur ta' fattur IX u reazzjonijiet allerġiċi.
English: 1 disposable 5 ml syringe 1 venipuncture set
Maltese: siringa 1 ta' 5 ml li tintrema wara li tintuża sett 1 għat-titqib tal-vina 2 imselħiet bl-alkoħol stikka 1 mhux sterili
English: Prolongation of the half-life of IDELVION and the enhanced systemic exposure are achieved by fusion with recombinant albumin.
Maltese: Il-half-life imtawla ta' IDELVION u t-titjib fl-esponiment sistemiku jinkisbu permezz ta' fużjoni mal-albumina rikombinanti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeat dose toxicity, genotoxicity, thrombogenicity and local tolerability.
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' trombożi u tollerabbiltà lokali ma juri l-ebda periklu speċjali għall-bnedmin.
English: Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
Maltese: L-attività tal-fattur IX hija nieqsa għalkollox jew imnaqqsa ħafna f'pazjenti b'emofilja B u tista' tkun meħtieġa terapija ta' sostituzzjoni.
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Maltese: UI f'kull kunjett; wara rikostituzzjoni b'5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 400 UI/ml ta' albutrepenonacog alfa.
English: Inhibitor development has been observed in previously treated patients in the post-marketing experience with IDELVION.
Maltese: Ma ġew irrappurtati l-ebda sintomi ta' doża eċċessiva b'IDELVION.
English: Measurement with a one-stage clotting assay using a kaolin based aPTT reagent or Actin FS aPTT reagent will likely result in an underestimation of activity level.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendix V.
English: The following side effects have been observed with IDELVION commonly (may affect up to 1 in 10 people):
Maltese: L-effetti sekondarji li ġejjin ġew osservati b'IDELVION b'mod komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10):
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Maltese: Kunjett 1 b'5 ml ilma għall-injezzjonijiet Apparat 1 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha:
English: Draw air into an empty, sterile syringe.
Maltese: Iġbed l-arja f'siringa vojta u sterili.
English: Pharmaceutical Form Route of administrationPackaging
Maltese: Qawwa Għamla farmaċewtika
English: 4 - Possible side effects
Maltese: 4 - Effetti sekondarji possibbli
English: Frequency: common
Maltese: Frekwenza: komuni
English: Adopted at the 28 November-1 December 2016 PRAC
Maltese: Adottat mill-PRAC bejn it-28 ta' Novembru u l-1 ta' Diċembru 2016
English: Methylphenidate - Priapism (EPITT no 18719)
Maltese: 2. Methylphenidate - Priapism (EPITT nru 18719)
English: Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole ; pantoprazole; rabeprazole - Gastric polyps (EPITT no 18725)
Maltese: Inibituri tal-pompa tal-protoni (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole ; pantoprazole; rabeprazole - Polipi gastriċi (EPITT nru 18725)
English: Summary of product characteristics (acenocoumarol, phenprocoumon)
Maltese: Sommarju tal-karatteristiċi tal-prodott (acenocoumarol, phenprocoumon)
English: Vildagliptin; Vildagliptin, metformin - Pemphigoid (EPITT no 18692)
Maltese: Vildagliptina, metformina - Pemphigoid (EPITT nru 18692)
English: Gastrointestinal disorders: Fundic gland polyps (benign) Frequency: common
Maltese: Polipi tal-glandoli fundiċi (beninni) Frekwenza: komuni
English: Acenocoumarol; phenprocoumon; fluindione; phenindione - Calciphylaxis (EPITT no 18710)
Maltese: Acenocoumarol; phenprocoumon; fluindione; phenindione - Kalċifilassi (EPITT nru 18710)
English: Package leaflet (acenocoumarol, phenprocoumon) 4 - Possible side effects
Maltese: Fuljett ta' tagħrif (acenocoumarol, phenprocoumon) 4 - Effetti sekondarji possibbli
English: Priapism.
Maltese: Vildagliptina;
English: Summary of product characteristics (fluindione, phenindione)
Maltese: Sommarju tal-karatteristiċi tal-prodott (fluindione, phenindione)
English: Package leaflet
Maltese: Kalċifilassi
English: Bullous or exfoliative Exfoliative and bullous skin lesions, including bullous pemphigoid Frequency: not known
Maltese: Leżjonijiet fil-ġilda bl-infafet jew esfoljattivi Esfoljattivi u bl-infafet, inkluż pemphigoid bl-infafet Frekwenza: mhux magħrufa
English: Benign polyps in the stomach
Maltese: Polipi beninni fl-istonku
English: Rare cases of calciphylaxis have been reported in patients taking vitamin K antagonists including <product name>, also in the absence of renal disease.
Maltese: Ġew irrapportati każijiet rari ta' kalċifilassi f'pazjenti li jieħdu antagonisiti talvitamina K inkluż <isem tal-prodott>, anki fin-nuqqas ta' mard renali.