FrancophonIA/ELRC3.0 huggingface dataset:
English: - You must have regular thyroid function tests as this medicine can affect the amount of thyroid
Maltese: - Inti jrid ikollok testijiet regolari tal-funzjoni tat-tirojde għax din il-mediċina tista' taffettwa
English: - Somatropin Biopartners 4 mg: 4 mg (12 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Maltese: - Somatropin Biopartners 4 mg: 4 mg (12 IU) ta' somatropin bħala trab f'kunjett tal-ħġieġ magħluq b'tapp tal-lastku (butyl) u għatu roża tat-tip flip-off (aluminju u plastik) u 1.5 mL ta' solvent (medium chain triglycerides) f'kunjett tal-ħġieġ b'tapp tal-lastku (butyl).
English: For monitoring, the attainment of a normal peak bone mass defined as a T score > - 1 (i.e. standardised to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account gender and ethnicity) is one of the therapeutic objectives during the transition period.
Maltese: Għal monitoraġġ, il-kisba ta' massa massima normali tal-għadam definita bħala punteġġ T ta' > -1 (i.e. standardizzat għall-medja tal-massa massima tal-għadam fl-adulti kif imkejla minn dual energy X-ray absorptiometry meta jiġu kkunsidrati s-sess u l-etniċità tal-persuna) hu wieħed mill-għanijiet terapewtiċi matul il-perjodu ta' transizzjoni.
English: The biological effects of somatropin are equivalent to those of hGH of pituitary origin.
Maltese: L-effetti bijoloġiċi ta' somatropin huma ekwivalenti għal dawk ta' hGH ta' oriġini pitwitarja.
English: After reconstitution, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.2 mL ta' suspensjoni jkun fih 2 mg ta' somatropin (10 mg/mL).
English: In paediatric patients there is no evidence that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
Maltese: F'pazjenti pedjatriċi m'hemm l-ebda evidenza li sostituzzjoni bl-ormoni tat-tkabbir tinfluwenza r-rata ta' rikorrenza jew it-tkabbir mill-ġdid ta' neoplażmi intrakranjali, iżda l-prattika klinika standard teħtieġ immaġni pitwitarji regolari f'pazjenti bi storja medika ta' patoloġija pitwitarja.
English: figure 3b
Maltese: NUMRU(I)
English: Pregnancy and breast-feeding
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Maltese: Minħabba dan, mhuwiex probabbli li t-tkomplija tat-terapija ta' sostituzzjoni b'somatropin se tkun meħtieġa f'nisa b'defiċjenza tal-ormon tat-tkabbir nisa fit-tielet trimestru tat-tqala.
English: INFORMATION IN BRAILLE Somatropin Biopartners 20 mg
Maltese: Somatropin Biopartners 20 mg
English: For other doses vials with 2 or 4 mg somatropin are available.
Maltese: Għal dożi oħrajn, kunjetti bi 2 jew 4 mg ta' somatropin huma disponibbli.
English: After reconstitution, 0.2 mL of suspension contains 2 mg (10 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.2 mL tas-suspensjoni jkun fih 2 mg (10 mg/mL).
English: - Somatropin Biopartners 10 mg: 10 mg (30 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Maltese: - Somatropin Biopartners 10 mg: 10 mg (30 IU) ta' somatropin bħala trab f'kunjett tal-ħġieġ magħluq b'tapp tal-lastku (butyl) u għatu aħdar ċar tat-tip flip-off (aluminju u plastik) u 1.5 mL ta' solvent (medium chain triglycerides) f'kunjett tal-ħġieġ b'tapp tal-lastku (butyl).
English: - Somatropin Biopartners 2 mg: 2 mg (6 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in a glass vial with a rubber stopper (butyl).
Maltese: - Somatropin Biopartners 2 mg: 2 mg (6 IU) ta' somatropin bħala trab f'kunjett tal-ħġieġ magħluq b'tapp tal-lastku (butyl) u għatu isfar tat-tip flip-off (aluminju u plastik) u 1.5 mL ta' solvent (medium chain triglycerides) f'kunjett tal-ħġieġ b'tapp tal-lastku (butyl).
English: For other doses vials with 2 or 7 mg somatropin are available.
Maltese: Għal dożi oħrajn, kunjetti bi 2 jew 7 mg ta' somatropin huma disponibbli.
English: Powder and solvent for prolonged-release suspension for injection 1 vial of 10 mg powder
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod 1 kunjett b'10 mg ta' trab
English: Talk to your doctor before using Somatropin Biopartners if you: - are an adult who has been treated with growth hormone during childhood: Your doctor will re-examine you for lack of growth hormone before restarting/continuing treatment; - have a hereditary disease called Prader-Willi syndrome: You should not be treated with this medicine unless you also have a lack of growth hormone; - have had a tumour: Your doctor will examine you frequently to ensure that the tumour has not come back; - have symptoms like severe and recurrent headache, visual changes, nausea and/or vomiting which may be due to increased pressure in the skull during growth hormone treatment; - suffer from an organic growth hormone deficiency (lack of growth hormone due to damage to the pituitary gland or the part of the brain called the hypothalamus) or decreased secretion of
Maltese: It-tabib tiegħek se jeżaminak ta' spiss biex jiżgura li l-tumur ma jkunx irritorna; - għandek sintomi bħal uġigħ ta' ras sever u rikorrenti, tibdil fil-vista, dardir u/jew rimettar li jistgħu jkunu minħabba żieda fil-pressjoni fuq il-qorriegħa waqt il-kura tal-ormon tat-tkabbir; - tbati minn defiċjenza organika tal-ormon tat-tkabbir (nuqqas ta' ormon tat-tkabbir minħabba ħsara lill-glandola pitwitarja jew il-parti tal-moħħ imsejħa l-ipotalamu) jew tnaqqis fis-sekrezzjoni ta' ormoni tal-glandola pitwitarja:
English: Male
Maltese: Tqala
English: Only stop swirling the vial once the suspension appears uniform, white and all the powder on the bottom is dispersed.
Maltese: Id-dawrien għandu jitwaqqaf biss ġaladarba s-suspensjoni tkun tidher uniformi, bajda, u t-trab kollu tal-qiegħ ikun tferrex.
English: Other medicines and Somatropin Biopartners
Maltese: Mediċini oħra u Somatropin Biopartners
English: One powder vial delivers 20 mg of somatropin (60 IU).
Maltese: Kunjett wieħed bit-trab iforni 20 mg ta' somatropin (60
English: Somatropin Biopartners 2 mg should be reconstituted with 0.4 mL solvent.
Maltese: Somatropin Biopartners 2 mg għandu jiġi rikostitwit f'suspensjoni b'0.4 mL ta' solvent.
English: A similar improvement was observed for the secondary efficacy endpoints namely increase in lean body mass, serum IGF-I and IGF-I SDS.
Maltese: Titjib simili ġie osservat għall-punti aħħarin sekondarji tal-effikaċja, jiġifieri żieda fil-lean body mass, serum
English: Pack size of 4 vials of powder and 4 vials of solvent.
Maltese: Daqs tal-pakkett ta' 4 kunjetti bit-trab u 4 kunjetti bis-solvent.
English: Somatropin Biopartners 7 mg powder for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 7 mg trab għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: Inject the entire contents of the syringe into the vial of powder, holding the syringe against the vial wall.
Maltese: Armi b'mod sigur il-labar tal-injezzjoni u s-siringi użati kollha wara użu wieħed.
English: Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective.
Maltese: L-ormon tat-tkabbir inaqqas il-konverżjoni ta' cortisone għal cortisol u jista' jikxef ipoadrenaliżmu ċentrali li qabel kien moħbi, jew jirrendi ineffettivi dożi baxxi ta' sostituzzjoni ta' glukokortikojdi.
English: The solvent is a clear, oily liquid.
Maltese: Is-solvent hu likwidu ċar u żejtni.
English: Common: Hyperbilirubinaemia, cholecystitis, liver test abnormal Skin and subcutaneous tissue disorders
Maltese: Iperbilirubinimja, koleċistite, testijiet tal-fwied b'riżultat anormali
English: Inadequate treatment of hypothyroidism may prevent optimal response to somatropin.
Maltese: Kura inadegwata ta' ipotirojdiżmu tista' tnaqqas l-aħjar rispons possibbli għal somatropin.
English: Once a normal peak bone mass is attained patients should be switched to Somatropin Biopartners for adults, if clinically indicated, and the dosing recommendation for adults should be followed.
Maltese: Ġaladarba tintlaħaq massa massima tal-għadam, il-pazjenti għandhom jinqalbu għal Somatropin Biopartners għall-adulti, jekk ikun klinikament indikat, u r-rakkomandazzjoni għad-dożaġġ fl-adulti għandha tiġi segwita.
English: Starting dose
Maltese: Twissijiet u prekawzjonijiet
English: Initially, patients should have their IGF-I levels assessed at 3- to 4-weekly intervals until IGF-I SDS is in the target range of -0.5 to +1.5.
Maltese: Il-mira tal-kura għandha tkun konċentrazzjonijiet ta' IGF-I fil-medda ta' -0.5 u+1.5
English: Somatropin Biopartners 4 mg powder for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 4 mg trab għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: Pack size of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Maltese: Daqs tal-pakkett ta' 1 kunjett bit-trab u 1 kunjett bis-solvent u 4 kunjetti bit-trab u 4 kunjetti
English: Somatropin Biopartners 20 mg powder for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 20 mg trab għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: Leukaemia
Maltese: Pożoloġija
English: Your doctor may need to adjust the dose of Somatropin Biopartners or of the other medicines: - corticosteroids, such as cortisone or prednisolone: medicines to reduce inflammation or immune system activity, to prevent organ transplant rejection or to treat asthma - thyroxine: a medicine to treat reduced thyroid gland function - insulin: a medicine to lower blood sugar levels
Maltese: It-tabib tiegħek jista' jkollu bżonn li jaġġusta d-doża ta' Somatropin Biopartners jew tal-mediċini l-oħrajn: - kortikosterojdi, bħal cortisone jew prednisolone: mediċini biex inaqqsu l-infjammazzjoni jew l-attività tas-sistema immuni, biex jipprevjenu rifjut ta' trapjant ta' organu jew għall-kura tal-ażżma - thyroxine: mediċina għall-kura ta' tnaqqis fil-funzjoni tal-glandola tat-tirojde
English: In the pivotal paediatric study, antibody responses to somatropin at two or more consecutive visits were observed in 33% of the patients.
Maltese: Fl-istudju pedjatriku importanti ħafna, ir-risponsi tal-antikorpi għal somatropin f'żewġ żjarat konsekuttivi jew aktar kienu osservati fi 33% tal-pazjenti.
English: Somatropin Biopartners 2 mg powder for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 2 mg trab għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: Young adult patients with closed epiphyses who have previously been treated as children for GHD should be re-evaluated for GHD using the criteria for adult patients (see section 4.1) before replacement therapy is commenced at the doses recommended for adults.
Maltese: Pazjenti adulti żgħażagħ b'epiphyses magħluqin li fil-passat ikun ġew ikkurati bħala tfal għal GHD, għandhom jiġu evalwati mill-ġdid għal GHD bl-użu tal-kriterji għal pazjenti adulti (ara sezzjoni 4.1) qabel ma tinbeda terapija ta' sostituzzjoni fid-dożi rakkomandati għall-adulti.
English: Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 20 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: INFORMATION IN BRAILLE Somatropin Biopartners 10 mg
Maltese: Somatropin Biopartners 10 mg
English: Powder and solvent for prolonged-release suspension for injection.
Maltese: Dan jgħin biex jipprevjeni l-infezzjoni.
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a light-blue flip-off cap (aluminium and plastic).
Maltese: Kunjett (ħġieġ ta' Tip I) magħluq b'tapp tal-lastku (butyl) u għatu blu ċar tat-tip flip-off (aluminju u plastik).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial delivers 2 mg of somatropin* (corresponding to 6 IU).
Maltese: Kunjett wieħed iforni 4 mg ta' somatropin* (li jikkorrispondu għal 12 IU).
English: Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin.
Maltese: Pazjenti b'GHD fiż-żmien meta jkunu saru adulti huma definiti bħala pazjenti li għandhom patoloġija pitwitarja ipotalamika magħrufa u mill-inqas defiċjenza waħda addizzjonali magħrufa ta' ormon pitwitarju li ma jkunx prolactin.
English: Treatment with growth hormone may facilitate the development of adrenal insufficiency and potentially fatal adrenal crises in patients with organic GHD or idiopathic panhypopituitarism.
Maltese: Il-kura bl-ormon tat-tkabbir tista' jiffaċilita l-iżvilupp ta' insuffiċjenza adrenali u kriżijiet adrenali potenzjalment fatali f'pazjenti b'GHD organika jew panipopitwitariżmu idjopatiku.
English: Somatropin Biopartners 4 mg powder and solvent prolonged-release for suspension for injection somatropin
Maltese: Somatropin Biopartners 4 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: For children up to 20 kg Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection is available.
Maltese: Għal tfal li jiżnu sa 20 kg, Somatropin Biopartners 10 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod hu disponibbli.
English: Somatropin Biopartners 2 mg powder and solvent for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 2 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT SOMATROPIN BIOPARTNERS 20 MG
Maltese: KITBA GĦALL-KARTUNA TA' BARRA SOMATROPIN BIOPARTNERS 20
English: For children heavier than 20 kg, Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection is available.
Maltese: Għal tfal li jiżnu iktar minn 20 kg, Somatropin Biopartners 20 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod hu disponibbli.
English: Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection somatropin
Maltese: Somatropin Biopartners 10 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod somatropin
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic).
Maltese: Kunjett (ħġieġ ta' Tip I) magħluq b'tapp tal-lastku (butyl) u għatu isfar tat-tip flip-off (aluminju u plastik).
English: Powder and solvent for prolonged-release suspension for injection 4 vials of 7 mg powder
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod 4 kunjetti b'7 mg ta' trab
English: The cut-off point of the dynamic test should be strict.
Maltese: Il-punt cut-off tat-test dinamiku għandu jkun strett.
English: Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection Somatropin
Maltese: Somatropin Biopartners 7 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: Common: Haematuria, increased blood uric acid, increased blood creatinine Reproductive system and breast disorders
Maltese: Komuni: Ematurja, żieda tal-uric acid fid-emm, żieda tal-kreatinina fid-demm
English: INFORMATION IN BRAILLE Somatropin Biopartners 2 mg
Maltese: Somatropin Biopartners 2 mg
English: Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations.
Maltese: L-ormon tat-tkabbir iżid il-konverżjoni extratirojdjali ta' T4 għal T3, li tista' tirriżulta fi tnaqqis tal-konċentrazzjonijiet ta' T4 fis-serum u f'żieda tal-konċentrazzjonijiet ta' T3 fis-serum.
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic).
Maltese: Kunjett (ħġieġ ta' Tip I) magħluq b'tapp tal-lastku (butyl) u għatu roża tat-tip flip-off (aluminju u plastik).
English: Somatropin Biopartners is indicated in children and adolescents aged 2 to 18 years for long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Maltese: Somatropin Biopartners hu indikat fi tfal u adolexxenti li għandhom minn sentejn sa 18-il sena għal kura tat-tkabbir fit-tul li ma rnexxietx minħabba tnixxija insuffiċjenti tal-ormon tat-tkabbir endoġenu.
English: For the treatment of children and adolescents aged 2 to 18 years vials with 10 mg and 20 mg somatropin should be used.
Maltese: Għall-kura ta' tfal u adolexxenti li għandhom bejn sentejn u 18-il sena, kunjetti b'10 mg u 20 mg ta' somatropin għandhom jintużaw.
English: Common: Nipple pain
Maltese: Komuni: Uġigħ fil-beżżula
English: Powder and solvent for prolonged-release suspension for injection 4 vials of 4 mg powder
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod 4 kunjetti b'4 mg ta' trab
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Malignancies
Maltese: Reutlingen
English: Hepatobiliary disorders Common: Hyperbilirubinaemia, cholecystitis, liver test abnormal
Maltese: Kwalunkwe tifel/tifla li jibda jzappap matul it-terapija bl-ormon tat-tkabbir għandu jiġi evalwat.
English: Common: Impaired fasting glucose, hyperlipidaemia, increased blood insulin, increased blood cholesterol, decreased blood sodium, increased blood triglycerides, increased blood glucose, increased or decreased HDL, increased LDL
Maltese: Indeboliment ta' glucose fl-istat sajjem, iperlipidemija, żieda tal-insulina fid-demm, żieda tal-kolesterol fid-demm, tnaqqis tas-sodium fid-demm, żieda fit-trigliċeridi fid-demm, żieda tal-glucose fid-demm, żieda jew tnaqqis ta' HDL, żieda ta' LDL Mhux magħrufa:
English: Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like growth factor-I (IGF-I) concentrations (< -2 standard deviation score (SDS)), who may be considered for one test.
Maltese: F'pazjenti li fit-tfulija tagħhom kellhom il-bidu ta' GHD iżolata (l-ebda evidenza ta' mard ipotalamiku-pitwitarju jew irradjazzjoni kranjali), żewġ testijiet dinamiċi għandhom jitwettqu wara li t-tkabbir ikun spiċċa, ħlief għal dawk il-pazjenti li jkollhom konċentrazzjonijiet baxxi ta' fattur-I tat-tkabbir qisu insulina (IGF-I - insulin-like growth factor-I) (punteġġ ta' devjazzjoni standard SDS (standard deviation score) ta' < -2) li jistgħu jiġu kkunsidrati għal test wieħed.
English: Powder and solvent for prolonged-release suspension for injection 4 vials of 2 mg powder
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod 4 kunjetti b'2 mg ta' trab
English: The metabolic fate of hGH involves classical protein catabolism in both the liver and kidney.
Maltese: Il-destin metaboliku tal-hGH jinvolvi kataboliżmu klassiku tal-proteini kemm fil-fwied kif ukoll fil-kliewi.
English: Rare, may affect up to 1 in 1,000 people - symptoms of increased pressure in the skull such as severe and recurrent headache, visual changes, nausea and/or vomiting
Maltese: Rari, jistgħu jaffettwaw sa 1 minn kull 1,000 persuna - sintomi ta' żieda fil-pressjoni fil-kranju bħal uġigħ sever u rikorrenti, tibdil fil-vista, dardir u/jew rimettar
English: Because hGH may induce a state of insulin resistance, an adjustment of the insulin dose may be required.
Maltese: Minħabba li hGH jista' jinduċi stat ta' reżistenza għall-insulina, jista' jkun meħtieġ aġġustament fid-doża tal-insulina.
English: In general, Cmax and AUC increased approximately proportionally with dose over a dose range of 0.2 to 0.7 mg/kg in prepubertal children with GHD.
Maltese: B'mod ġenerali, is-Cmax u l-AUC żdiedu bejn wieħed u ieħor b'mod proporzjonali mad-doża fuq medda ta' doża ta' 0.2-0.7 mg/kg fit-tfal qabel l-età tal-pubertà b'GHD.
English: The apparent terminal half-life was about 7.4 h in children, presumably reflecting slow absorption from the site of injection.
Maltese: Il-half-life terminali apparenti kienet ta' madwar 7.4 fit-tfal, preżumibilment, tirrifletti l-assorbiment bil-mod mis-sit tal-injezzjoni.
English: It is available as 20-mg tablets.
Maltese: Jiġi bħala pilloli ta' 20-mg.
English: Further information on Doptelet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/doptelet.
Maltese: ema.europa.eu/medicines/human/EPAR/doptelet.
English: Other information about Doptelet
Maltese: Informazzjoni oħra dwar Doptelet
English: Doptelet contains the active substance avatrombopag.
Maltese: Doptelet fih is-sustanza attiva avatrombopag.
English: Among patients with more severe thrombocytopenia, 67% of those given Doptelet 60 mg daily did not require a transfusion or rescue procedure compared with 29% of those who received placebo.
Maltese: Fost pazjenti bi tromboċitopenija aktar severa, 67% ta' dawk li ngħataw 60 mg ta' Doptelet kuljum ma kinux jirrikjedu trasfużjoni jew proċedura ta' salvataġġ meta mqabbla ma' 29% ta' dawk li rċevew ilplaċebo.
English: Doptelet (avatrombopag) EMA/243810/2019
Maltese: EMA/243810/2019
English: What are the risks associated with Doptelet?
Maltese: X'inhuma r-riskji assoċjati ma' Doptelet?
English: In these studies, 88% of patients who received Doptelet 40 mg daily did not require a transfusion or rescue procedure compared with 36% of patients who were given placebo (a dummy treatment).
Maltese: F'dawn l-istudji, 88% tal-pazjenti li ngħataw 40 mg ta' Doptelet kuljum ma kinux jirrikjedu trasfużjoni jew proċedura ta' salvataġġ meta mqabbla ma' 36% tal-pazjenti li ngħataw il-plaċebo (kura finta).
English: Two main studies in 435 patients with low levels of platelets due to long-standing liver disease found Doptelet effective at increasing platelet levels before an invasive procedure.
Maltese: Żewġ studji ewlenin f'435 pazjent b'livelli baxxi ta' pjastrini minħabba l-mard tal-fwied li ilu jeżisti sabu li Doptelet kien effettiv biex iżid il-livelli ta' pjastrini qabel proċedura invażiva.
English: As for all medicines, data on the use of Doptelet are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Doptelet hija ssorveljata kontinwament.
English: The active substance in Doptelet, avatrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.
Maltese: Is-sustanza attiva f'Doptelet, l-avatrombopag, teħel mal-istess riċetturi bħattrombopojetin, u b'hekk tgħinhom iżidu l-għadd tal-pjastrini.
English: The dose is 2 or 3 tablets (depending on the platelet count at the start of treatment), daily for 5 days.
Maltese: Id-doża hija ta' 2 jew 3 pilloli (skont l-għadd ta' pjastrini fil-bidu tal-kura), kuljum għal 5 ijiem.
English: Doptelet is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease.
Maltese: Doptelet huwa mediċina li tintuża biex tipprevjeni fsada eċċessiva fl-adulti bi tromboċitopenija minħabba mard tal-fwied fit-tul.