FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose in complicated intra-abdominal infections, complicated urinary tract infections, and acute pyelonephritis subjects with end stage renal disease on haemodialysis is a single loading dose of 500 mg / 250 mg ceftolozane/tazobactam followed by a 100 mg / 50 mg maintenance dose of ceftolozane/tazobactam administered every 8 hours for the remainder of the treatment period.
Maltese: Id-doża rakkomandata f'persuni b'infezzjonijiet intraddominali kkumplikati, infezzjonijiet ikkumplikati tal-passaġġ urinarju, u pajelonefrite akuta li jkollhom mard tal-kliewi fl-aħħar stadju u jkunu fuq l-emodijalisi hi ta' doża għolja waħda tal-bidu ta' 500 mg / 250 mg ta' ceftolozane/tazobactam segwita minn doża ta' manteniment ta' 100 mg / 50 mg ta' ceftolozane/tazobactam mogħtija kull 8 sigħat għall-bqija talperjodu ta' trattament.
English: Applies across all indications: complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, and hospital-acquired pneumonia, including ventilator-associated pneumonia.
Maltese: Tapplika għall-indikazzjonijiet kollha: infezzjonijiet intraddominali kkumplikati, pajelonefrite akuta, infezzjonijiet ikkumplikati fl-apparat tal-awrina, pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur.
English: A single loading dose of 500 mg ceftolozane / 250 mg tazobactam followed after 8 hours by a 100 mg ceftolozane / 50 mg tazobactam maintenance dose administered every 8 hours for the remainder of the treatment period (on haemodialysis days, the dose should be administered at the earliest possible time following completion of haemodialysis)
Maltese: Doża għolja waħda tal-bidu ta' 500 mg ceftolozane / 250 mg tazobactam segwita wara 8 sigħat minn doża ta' manteniment ta' 100 mg ceftolozane / 50 mg tazobactam mogħtija kull 8 sigħat għallbqija tal-perjodu ta' trattament (fil-ġranet meta jkun hemm emodijalisi, id-doża għandha tingħata fl-iktar ħin bikri possibbli wara t-tlestija tal-emodijalisi)
English: 1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours
Maltese: 1 g ceftolozane / 0.5 g tazobactam ġolvini kull 8 sigħat
English: A single loading dose of 1.5 g ceftolozane / 0.75 g tazobactam followed after 8 hours by a 300 mg ceftolozane / 150 mg tazobactam maintenance dose administered every 8 hours for the remainder of the treatment period (on haemodialysis days, the dose should be administered at the earliest possible time following completion of haemodialysis)
Maltese: Doża għolja waħda tal-bidu ta' 1.5 g ceftolozane / 0.75 g tazobactam segwita wara 8 sigħat minn doża ta' manteniment ta' 300 mg ceftolozane / 150 mg tazobactam mogħtija kull 8 sigħat għallbqija tal-perjodu ta' trattament (fil-ġranet meta jkun hemm emodijalisi, id-doża għandha tingħata fl-iktar ħin bikri possibbli wara t-tlestija tal-emodijalisi)
English: 1, venous thrombosis
Maltese: 1, trombożi fil-vini
English: Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam.
Maltese: Kull kunjett fih ceftolozane sulfate ekwivalenti għal 1 g ta' ceftolozane u tazobactam sodium ekwivalenti għal 0.5 g ta' tazobactam.
English: The highest single dose of Zerbaxa used in clinical trials was 3 g / 1.5 g of ceftolozane/tazobactam administered to healthy volunteers.
Maltese: L-ogħla doża singola ta' Zerbaxa użata filprovi kliniċi kienet ta' 3 g/1.5 g ta' ceftolozane/tazobactam mogħtija lill-voluntiera f'saħħithom.
English: Susceptibility testing breakpoints
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: This is equivalent to 11.5% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 11.5% tat-teħid massimu ta' sodium rakkomandat li jittieħed middieta kuljum għal adult.
English: The safety and efficacy of ceftolozane/tazobactam in children and adolescents below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' ceftolozane/tazobactam fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Citric acid, anhydrous
Maltese: Sodium chloride Arginine Citric acid, anidru
English: Patients treated for complicated infections within the abdomen, and kidney and urinary system Common side effects (may affect up to 1 in 10 people):
Maltese: Pazjenti ttrattati għal infezzjonijiet ikkumplikati fl-addome, u fil-kliewi u fis-sistema awrinarja Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10):
English: A decline in renal function has been seen in patients receiving ceftolozane/tazobactam.
Maltese: Tnaqqis fil-funzjoni tal-kliewi deher f'pazjenti li kienu qed jirċievu ceftolozane/tazobactam.
English: To maintain similar systemic exposures to those with normal renal function, dosage adjustment is required (see section 4.2).
Maltese: Biex jinżammu esponimenti sistemiċi simili għal dawk b'funzjoni normali tal-kliewi, hu meħtieġ aġġustament fid-doża (ara sezzjoni 4.2).
English: The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium in each vial.
Maltese: Il-kunjett rikostitwit b'10 mL ta' 0.9% sodium chloride (salina normali) għallinjezzjoni fih 265 mg sodium f'kull kunjett.
English: 1, infusion site reactions
Maltese: 1, reazzjonijiet fil-post tal-infużjoni
English: Ceftolozane/tazobactam should be used with caution in patients with a history of any other type of hypersensitivity reaction to penicillins or other beta-lactam antibacterial agents.
Maltese: Ceftolozane/tazobactam għandu jintuża b'kawtela f'pazjenti bi storja medika ta' kwalunkwe tip ieħor ta' reazzjoni ta' sensittività eċċessiva għal penicillins jew sustanzi antibatteriċi beta-lactam oħra.
English: Some medicines may interact with ceftolozane and tazobactam.
Maltese: Xi mediċini jistgħu jkollhom interazzjoni ma' ceftolozane u tazobactam.
English: In clinical trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis, the efficacy of ceftolozane/tazobactam was lower in patients with moderate renal impairment compared with those with normal or mildly impaired renal function at baseline.
Maltese: Fi provi kliniċi ta' infezzjonijiet intraddominali kkumplikati u infezzjonijiet ikkumplikati tal-passaġġ urinarju inkluża pajelonefrite, l-effikaċja ta' ceftolozane/tazobactam kienet inqas f'pazjenti b'indeboliment moderat tal-kliewi meta mqabbla ma' dawk b'funzjoni tal-kliewi normali jew kemxejn indebolita fil-linja bażi.
English: For preparation of the 1.5 g ceftolozane / 0.75 g tazobactam dose: Withdraw the entire contents from one reconstituted vial (approximately 11.4 mL per vial) and 5.7 mL from a second reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Maltese: Iġbed il-kontenut kollu minn kunjett wieħed rikostitwit (madwar 11.4 mL kull kunjett) u 5.7 mL mit-tieni kunjett rikostitwit permezz ta' siringa u żidu ma' borża tal-infużjoni li jkun fiha 100 mL ta' 0.9% sodium chloride għallinjezzjoni (salina normali) jew 5% glucose għall-injezzjoni.
English: Ceftolozane/tazobactam contains 230 mg sodium per vial, equivalent to 11.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Ceftolozane/tazobactam fih 230 mg ta' sodium f'kull kunjett, ekwivalenti għal 11.5% tal-ammont massimu ta' 2 g ta' sodium li għandu jittieħed minn adult kuljum irrakkomandat mill-WHO.
English: Thrombocytosis
Maltese: Suxxettibbl
English: Patients with kidney problems
Maltese: Pazjenti bi problemi tal-kliewi
English: Ischemic stroke
Maltese: Puplesija iskemika
English: Powder for concentrate for solution for infusion (powder for concentrate).
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni (trab għal konċentrat).
English: MM/YYYY
Maltese: U L-UŻU
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: Pathogen
Maltese: Treddigħ
English: For preparation of the 300 mg ceftolozane / 150 mg tazobactam dose: Withdraw 3.5 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Maltese: Iġbed 3.5 mL tal-kontenut tal-kunjett rikostitwit u żidu ma' borża tal-infużjoni li jkun fiha 100 mL ta' 0.9% sodium chloride għall-injezzjoni (salina normali) jew 5% glucose għall-injezzjoni.
English: Coombs test positive
Maltese: Riżultat pożittiv għat-test ta' Coombs
English: See section 6.6 for instructions on reconstitution and dilution of the medicinal product before administration.
Maltese: Ara sezzjoni 6.6 għal struzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel lamministrazzjoni.
English: Preparation of doses
Maltese: Preparazzjoni tad-dożi
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204 201 msd_slovenia@merck.com
English: 3, increased serum gamma-glutamyl transpeptidase (GGT)
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: What Zerbaxa contains - The active substances are ceftolozane and tazobactam.
Maltese: X'fih Zerbaxa - Is-sustanzi attivi huma ceftolozane u tazobactam.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zerbaxa in one or more subsets of the paediatric population in complicated intra-abdominal infection, complicated urinary tract infection, and hospital-acquired pneumonia, including ventilator-associated pneumonia (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Zerbaxa f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika b'infezzjoni intraddominali kkumplikata, infezzjoni kkumplikata tal-passaġġ urinarju, u pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: For preparation of the 500 mg ceftolozane / 250 mg tazobactam dose: Withdraw 5.7 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Maltese: Iġbed 5.7 mL tal-kontenut tal-kunjett rikostitwit u żidu ma' borża tal-infużjoni li jkun fiha 100 mL ta' 0.9% sodium chloride għall-injezzjoni (salina normali) jew 5% glucose għall-injezzjoni.
English: For preparation of the 100 mg ceftolozane / 50 mg tazobactam dose: Withdraw 1.2 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Maltese: Iġbed 1.2 mL tal-kontenut tal-kunjett rikostitwit u żidu ma' borża tal-infużjoni li jkun fiha 100 mL ta' 0.9% sodium chloride għall-injezzjoni (salina normali) jew 5% glucose għall-injezzjoni.
English: Tel: + 386 1 5204 201 msd_slovenia@merck.com
Maltese: +370 5 278 02 47 msd_lietuva@merck.com
English: Ceftolozane exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs), resulting in inhibition of bacterial cell-wall synthesis and subsequent cell death.
Maltese: Ceftolozane jeżerċita attività batteriċida billi jeħel ma' proteini importanti li jeħlu mal-penicillin (PBPs, penicillin-binding proteins), u dan jirriżulta fl-inibizzjoni tas-sintesi tal-ħajt taċ-ċellula tal-batterja u l-mewt sussegwenti taċ-ċellula.
English: For preparation of the 1 g ceftolozane / 0.5 g tazobactam dose: Withdraw the entire contents (approximately 11.4 mL) of the reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Maltese: Iġbed il-kontenut kollu (madwar 11.4 mL) tal-kunjett rikostitwit billi tuża siringa u żidu ma' borża tal-infużjoni li jkun fiha 100 mL ta' 0.9% sodium chloride għall-injezzjoni (salina normali) jew 5% glucose għall-injezzjoni.
English: Skin and subcutaneous tissue disorders
Maltese: Mikroorganiżmi mhux suxxettibbli
English: Clinical efficacy data in patients with complicated lower urinary tract infection are limited.
Maltese: Dejta dwar l-effikaċja klinika f'pazjenti b'infezzjoni kkumplikata fil-parti t'isfel tal-apparat tal-awrina hija limitata.
English: This is equivalent to 13.3% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 13.3% tat-teħid massimu ta' sodium rakkomandat li jittieħed mid-dieta kuljum għal adult.
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to Zerbaxa in the absence of acquired mechanisms of resistance:
Maltese: L-effikaċja klinika ma ġietx stabbilita kontra l-patoġeni li ġejjin, għalkemm studji in vitro jissuġġerixxu li huma jkunu suxxettibbli għal Zerbaxa fin-nuqqas ta' mekkaniżmi miksuba ta' reżistenza:
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia** *Based on 1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours.
Maltese: Pulmonite li tittieħed fi sptar, inkluża pulmonite assoċjata mal-ventilatur** *Ibbażat fuq 1 g ceftolozane / 0.5 g tazobactam ġol-vini kull 8 sigħat. **Ibbażat fuq 2 g ceftolozane / 1 g tazobactam ġol-vini kull 8 sigħat.
English: Tazobactam crosses the placenta.
Maltese: Tazobactam jgħaddi mill-plaċenta.
English: For preparation of the 250 mg ceftolozane / 125 mg tazobactam dose: Withdraw 2.9 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection.
Maltese: Iġbed 2.9 mL tal-kontenut tal-kunjett rikostitwit u żidu ma' borża tal-infużjoni li jkun fiha 100 mL ta' 0.9% sodium chloride għall-injezzjoni (salina normali) jew 5% glucose għall-injezzjoni.
English: Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion
Maltese: Zerbaxa 1 g/0.5 g trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Estimated
Maltese: INDIVIDWALI
English: Impaired renal function
Maltese: Effett fuq il-funzjoni tal-kliewi
English: METHOD OF ADMINISTRATION
Maltese: Mekkaniżmi ta' reżistenza
English: In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in ceftolozane/tazobactam AUC were observed in Caucasians compared to other ethnicities.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' ceftolozane/tazobactam, ma ġew osservati l-ebda differenzi klinikament rilevanti fl-AUC ta' ceftolozane/tazobactam fil-Kawkasi meta mqabbla maletniċitajiet l-oħrajn.
English: EMA/434816/2014 EMEA/H/C/000825
Maltese: EMEA/H/C/000825
English: The full EPAR for Ratiograstim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance filgrastim.
Maltese: Fih is-sustanza attiva filgrastim.
English: The active substance in Ratiograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Maltese: Is-sustanza attiva f'Ratiograstim, il-filgrastim, hija simili ħafna għal proteina umana msejħa fattur stimolanti tal-kolonja granuloċiti (G CSF).
English: Ratiograstim is a ‘biosimilar' medicine.
Maltese: Ratiograstim huwa mediċina ‘bijosimili'.
English: This is a summary of the European public assessment report (EPAR) for Ratiograstim.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ratiograstim.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ratiograstim on 15 September 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Ratiograstim fil-15 ta' Settembru 2008.
English: This summary was last updated in 07-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2014.
English: Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim.
Maltese: Il-filgrastim huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': jiġi magħmul minn batterji li fihom ikun ġie introdott ġene (DNA) li jagħmilhom kapaċi jipproduċu l-filgrastim.
English: The CHMP decided that, in accordance with EU requirements, Ratiograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Maltese: Is-CHMP iddeċieda li, b'mod konformi mar-rekwiżiti tal-UE, Ratiograstim wera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli ma' dak ta' Neupogen.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Maltese: • biex inaqqas iż-żmien ta' newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm) u l-okkorrenza ta' newtropenija febbrili (newtropenija bid-deni) f'pazjenti li jirċievu l-kimoterapija (kura kontra l-kanċer) li hija ċitotossika (toqtol iċ-ċelloli);
English: During the first 21-day chemotherapy cycle, patients treated with either Ratiograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Maltese: Matul lewwel 21 jum ta' ċiklu kimoterapewtiku, il-pazjenti kkurati jew b'Ratiograstim jew b'Neupogen kellhom newtropenija severa għal medja ta' 1.1 jum, meta mqabbla ma' 3.8 jiem f'dawk li rċevew plaċebo.
English: Other information about Ratiograstim
Maltese: Informazzjoni oħra dwar Ratiograstim
English: The reference medicine for Ratiograstim is Neupogen.
Maltese: Il-mediċina ta' referenza għal Ratiograstim hija Neupogen.
English: Ratiograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Maltese: Ratiograstim ġie studjat biex jintwera li huwa komparabbli mal-mediċina ta' referenza, Neupogen.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument mistoqsija u tweġiba hawnhekk.
English: What is Ratiograstim?
Maltese: X'inhu Ratiograstim?
English: What is the risk associated with Ratiograstim?
Maltese: X'inhu r-riskju assoċjat ma' Ratiograstim?
English: This means that Ratiograstim 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').
Maltese: Dan ifisser li Ratiograstim huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi l-istess sustanza attiva (magħrufa bħala l‘mediċina ta' referenza').
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Maltese: • biex iżid il-livelli ta' newtrofili u jnaqqas ir-riskju ta' infezzjonijiet f'pazjenti bin-newtropenija li għandhom storja ta' infezzjonijiet severi u repetuti;
English: Treatment with Ratiograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Maltese: Il-kura b'Ratiograstim u b'Neupogen ġabet tnaqqis simili fiż-żmien ta' newtropenija severa.
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal Neupogen, il-benefiċċji huma akbar mir-riskji identifikati.
English: Ratiograstim 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.
Maltese: Ratiograstim normalment jingħata f'ċentru ta' kura speċjalizzata, minkejja li pazjenti li jirċievuh b'injezzjoni taħt il-ġilda jistgħu jinjettaw rwieħhom ladarba jitħarrġu sabiex jagħmlu dan.
English: • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV)
Maltese: • biex jikkura newtropenija persistenti f'pazjenti b'infezzjoni tal-immunodefiċjenza umana fi stat avvanzat (HIV), biex jitnaqqas ir-riskju ta' infezzjonijiet batterjali meta kuri oħra ma jkunux adatti.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
Maltese: • biex inaqqas iż-żmien ta' newtropenija f'pazjenti li jkunu għaddejjin b'kura li tkisser iċ-ċelloli talmudullun qabel trapjant tal-mudullun (bħal f'xi pazjenti bil-lewkimja) jekk ikunu f'riskju ta' newtropenija severa fuq żmien twil;
English: Why has Ratiograstim been approved?
Maltese: Għaliex ġie approvat Ratiograstim?
English: Ratiograstim is a solution for injection or for infusion (drip into a vein).
Maltese: Ratiograstim hu soluzzjoni għal injezzjoni jew għal infużjoni (dripp fil-vina).
English: How does Ratiograstim work?
Maltese: Għal xiex jintuża Ratiograstim?
English: The most common side effect with Ratiograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Maltese: L-effett sekondarju l-aktar komuni b'Ratiograstim (li deher f'iktar minn pazjent wieħed minn kull għaxra) hu wġiegħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam).
English: The full EPAR for NutropinAq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Each cartridge contains 10 mg of the active substance somatropin.
Maltese: Kull kunjett fih 10 mg tas-sustanza attiva somatropina.
English: Other side effects seen at this lower frequency are reactions at the injection site, headache, hypertonia (muscle tension), hypothyroidism (under-activity of the thyroid gland), impaired glucose tolerance, asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq).
Maltese: Effetti sekondarji oħra li dehru fi frekwenzi daqshekk żgħar kienu reazzjonijiet fis-sit tal-injezzjoni, uġigħ ta' ras, ipertonja (tensjoni fil-muskoli), ipotirojdiżmu (attività baxxa tal-glandola tirojde), tolleranza limitata għall-glukożju, astenja (għeja) u żvilupp ta' antikorpi (proteini prodotti bħala rispons għal NutropinAq).
English: EPAR summary for the public somatropin
Maltese: Sommarju tal-EPAR għall-pubbliku somatropina
English: This summary was last updated in 05-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'05-2013.
English: NutropinAq has also been studied in 171 adults with growth hormone deficiency.
Maltese: NutropinAq ġie studjat ukoll f'171 adult b'defiċjenza fl-ormon tal-iżvilupp.
English: NutropinAq has been studied in children with growth failure caused by a lack of growth hormone (230 patients), Turner syndrome (117 patients) or kidney disease (195 patients).
Maltese: NutropinAq ġie studjat fi tfal bi problemi fl-iżvilupp ikkawżati minn problemi fl-ormon tal-iżvilupp (230 pazjent), is-sindromu ta' Turner (117-il pazjent) jew mard fil-kliewi (195 pazjent).
English: This is a summary of the European public assessment report (EPAR) for NutropinAq.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal NutropinAq.
English: In adults, the most common side effects with NutropinAq (seen in more than 1 patient in 10) are myalgia (muscle pain), arthralgia (joint pain) and oedema (swelling).
Maltese: Fl-adulti, l-effetti sekondarji l-aktar komuni b'NutropinAq (li dehru f'pazjent 1 minn kull 10) huma mijalġija (uġigħ fil-muskoli), artalġija (uġigħ fil-ġogi) u oedema (nefħa).