FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥
Maltese: Reazzjonijiet tat-tip ta' sensittività eċċessiva, li jinkludu raxx tal-ġilda, urtikarja, anġjoedema, dispnea, eritema, fwawar u pressjoni baxxa ġew osservati fil-bidu tat-trattament jew wara b'pegfilgrastim (mhux komuni [≥ 1/1,000 sa < 1/100]).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Juta Pharma GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Juta Pharma GmbH,
English: Magyarország Aramis Pharma Kft 1095 Mester u. 28 Budapest Hungary
Maltese: Kft 1095 Mester u. 28 Budapest Hungary Tel:+36-1-299-1051
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: It-tagħrif fit-tabella t'hawn isfel jiddeskrivi reazzjonijiet avversi rapportati minn provi kliniċi u rapportaġġ spontanju.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, iddaqs tal-milsa għandha tiġi monitorata b'attenzjoni (eż. eżami kliniku, ultrasawnd).
English: Germany
Maltese: Polska
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Maltese: L-aktar reazzjonijiet avversi komuni rapportati kienu uġigħ fl-għadam (komuni ħafna [≥ 1/10]) u uġigħ muskoloskeletriku (komuni).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali wrew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Maltese: Uġigħ muskoluskeletriku (uġigħ fl-għadam, Uġigħ filġogi, uġigħ fl-estremitajiet, uġigħ fid-dahar, uġigħ muskoluskeletriku, uġigħ fl-għonq)
English: Sickle cell crisis Splenomegaly2;
Maltese: M'għandekx tuża s-siringa mimlija għal-lest jekk:
English: Thrombocytopenia and anaemia
Maltese: Tromboċitopenija u anemija
English: Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (uncommon in sickle cell patients) (see section 4.4).
Maltese: Każijiet iżolati ta' kriżi tas-sickle cell ġew rapportati f'pazjenti b'karatteristiċi tas-sickle cell jew ilmarda tas-sickle cell (mhux komuni f'pazjenti bis-sickle cell) (ara sezzjoni 4.4).
English: • general aches and pains in the joints and muscles.
Maltese: • uġigħ ġenerali fil-ġogi u l-muskoli.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see section 4.8).
Maltese: Pazjenti bi storja medika riċenti ta' infiltrati pulmonari jew pnewmonja jistgħu jkunu f'riskju ogħla (arasezzjoni 4.8).
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Maltese: Ma kienx hemm effetti avversi osservati fi frieħ minn firien tqal meta pegfilgrastim ingħata taħt il-ġilda, iżda fil-fniek pegfilgrastim intwera li jikkaġuna tossiċità embrijonika/fetali (telf ta' embrijun) f'dożi kumulattivi ta' madwar 4 darbiet id-doża rakkomandata għall-bniedem, li ma deherux meta fniek tqal kienu esposti għad-doża rakkomandata għall-bniedem.
English: Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease (see section 4.8).
Maltese: Kriżi tas-sickle cell ġiet assoċjata bl-użu ta' pegfilgrastim f'pazjenti bil-karatteristika tas-sickle cell jew il-marda tas-sickle cell (ara sezzjoni 4.8).
English: Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Maltese: It-terapija b'pegfilgrastim għandha tinbeda u tiġi monitorata minn tobba b'esperjenza fl-onkoloġija u/jew ematoloġija.
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Maltese: • ħsara lil filtri ċkejknin ġewwa l-kliewi tiegħek (glomerulonefrite)
English: Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal (see section 4.4).
Maltese: Bi frekwenza mhux komuni każijiet rriżultaw f'falliment respiratorju jew ARDS, li jista' jkun fatali (ara sezzjoni 4.4).
English: EXP
Maltese: RAFARM
English: 2 This adverse reaction was identified through post-marketing surveillance of pegfilgrastim but not observed in randomised, controlled clinical trials in adults.
Maltese: Din ir-reazzjoni avversa ġiet identifikata permezz tas-sorvelljanza ta' wara t-tqegħid fis-suq ta' pegfilgrastim imma ma kinetx osservata fi provi kliniċi każwali b'kontrolli f'adulti.
English: • The expiry date printed on the label has passed the last day of the month shown.
Maltese: • Id-data ta' skadenza stampata fuq it-tikketta tkun għaddiet l-aħħar jum tax-xahar muri.
English: The injections should be given into the thigh, abdomen or upper arm. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Maltese: F'ċirkostanzi bħal dawn pegfilgrastim għandu jitwaqqaf fid-diskrezzjon tat-tabib u ttrattament xieraq mogħti (ara sezzjoni 4.8).
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: Fattur li jistimula l-kolonja ta' granuloċiti jista' jqanqal l-iżvilupp ta' ċelloli mijelojdi in vitro u effetti simili jistgħu jiġu osservati f'xi ċelloli mhux mijelojdi in vitro.
English: Renal and urinary disorders
Maltese: Glomerulonefrite urinarja
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Maltese: Pegfilgrastim hija proteina prodotta bit-teknoloġija minn batterja li tissejjaħ E.coli. Hija tappartjeni għall-grupp ta' proteini msejħa ċitokini, u hija simili ħafna għal proteina naturali (fattur li jistimula l-kolonji ta' granuloċiti) prodotta mill-ġisem tiegħek.
English: − The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections (see section 2).
Maltese: − Is-sustanzi l-oħra huma sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall-injezzjonijiet
English: • spleen rupture.
Maltese: Twissija/Prekawzjoni:
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Maltese: Reazzjonijiet allerġiċi serji, li jinkludu anafilassi jistgħu jseħħu f'pazjenti li kienu qed jirċievu pegfilgrastim (mhux komuni) (ara sezzjoni 4.4).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinjifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tarriskji).
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Maltese: Wara doża waħda ta' pegfilgrastim taħt il-ġilda, il-konċentrazzjoni massima ta' pegfilgrastim fis-serum seħħet wara 16 sa 120 siegħa wara t-teħid tagħha u l-konċentrazzjoni ta' pegfilgrastim fis-serum baqgħet tiġi sostnuta matul il-perijodu ta' newtropenija wara l-kimoterapija mijelosuppressiva.
English: For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Maltese: Għal injezzjoni aktar komda, ħalli s-siringa mimlija għal-lest fit-temperatura ambjentali tal-kamra għal madwar 30 minuta qabel tinjetta.
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch
Maltese: • jekk tesperjenza reazzjoni allerġika li tinkludi dgħufija, waqgħa fil-pressjoni tad-demm, diffikultà biex tieħu n-nifs, nefħa fil-wiċċ (anafilassi), ħmura u fwawar, raxx tal-ġilda u partijiet tal-ġilda li trid tħokk.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg pegfilgrastim f'0.6 ml ta' soluzzjoni.
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il-fattur uman li jistimula l-kolonja ta' granuloċiti (G-CSF) jikkonsisti minn glikoproteina li tirregola lproduzzjoni u l-ħruġ ta' newtrofili mill-mudullun.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Maltese: Is-sensittivita eċċessiva, li tinkludi reazzjonijiet anafilattiċi, li sseħħew fil-bidu tat-trattament jew fi trattament sussegwenti ġiet rapportata f'pazjenti trattati b'pegfilgrastim.
English: RAFARM A.E.B.E
Maltese: Is-siringa qabel l-għoti
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Maltese: Ġeneralment, każijiet asintomatiċi ta' splenomegalija u każijiet mhux komuni ta' tiċrit tal-milsa, li jinkludu xi każijiet fatali, ġew rapportati wara l-għoti ta' pegfilgrastim (ara sezzjoni 4.8).
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. c-reactive protein and white blood cell count).
Maltese: Is-sintomi esperjenzati jinkludu deni, uġigħ addominali, tħossok marid, uġigħ fid-dahar u żieda fil-markaturi tal-infjammazzjoni (eż. proteina reattiva għaċ-ċ, żieda fl-għadd ta' ċelluli bojod).
English: Wash your hands thoroughly with soap and water.
Maltese: Aħsel idejk sew b'ilma u sapun. .
English: see section 2.
Maltese: (ara sezzjoni 2).
English: Injecting Grasustek yourself
Maltese: Mediċini oħra u Grasustek
English: • if you have any of the following or combination of the following side effects: ­ swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: • jekk għandek kwalunkwe wieħed minn dawn li ġejjin jew kombinazzjoni tal-effetti sekondarji li ġejjin: ­ fewġa jew nefħa, li tista' tkun assoċjata ma' meta tgħaddi l-ilma b'anqas frekwenza, diffikultà biex tieħu n-nifs, nefħa fiż-żaqq u tħossok mimli, u sensazzjoni ġenerali ta' għeja.
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Maltese: L-aortite ġiet rapportata wara l-għoti ta' G-CSF f'individwi b'saħħithom u f'pazjenti bil-kanċer.
English: Uncommon
Maltese: Komuni ħafna
English: There is no evidence that such an interaction would be harmful.
Maltese: M'hemmx evidenza li interazzjoni bħal din tista' tkun ta' ħsara.
English: Glomerulonephritis2
Maltese: F'dan il-fuljett
English: • swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: • fewġa jew nefħa, li tista' tkun assoċjata ma' meta tgħaddi l-ilma b'anqas frekwenza, diffikultà biex tieħu n-nifs, nefħa fiż-żaqq u tħossok mimli, u sensazzjoni ġenerali ta' għeja.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section
Maltese: Dawn ġeneralment seħħew f'pazjenti b'mard malinn avvanzat, sepsis, it-teħid ta' prodotti mediċinali kimpterapewtiċi multipli jew waqt li jkunu f'aferesi (ara sezzjoni
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Maltese: Minħabba s-sensittività potenzjali ta' ċelluli mijelojdi jiddividu malajr għal kimoterapija ċitotossika, pegfilgrastim għandu jingħata tal-anqas 24 siegħa wara l-għoti ta' kimoterapija ċitotossika.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE
Maltese: BIJOLOĠIKA(ĊI) ATTIVA/I
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg pegfilgrastim* f'0.6 ml soluzzjoni għall-injezzjoni.
English: Median time to recovery from severe neutropenia was estimated as 22 days in both treatment groups.
Maltese: Iż-żmien medjan għall-irkupru minn newtropenija severa kien stmat għal 22 jum fiż-żewġ gruppi ta' trattament.
English: This medicine contains 30 mg sorbitol in each 6 mg dose, which is equivalent to 50 mg/ml This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free'.
Maltese: Grasustek fih sorbitol (E420) u sodju Din il-mediċina fiha 30 mg sorbitol f'kull doża ta' 6 mg, li hu ekwivalenti għal 50 mg/ml.
English: Capillary leak syndrome1
Maltese: .8 Effetti mhux mixtieqa
English: Splenic rupture including some fatal cases is uncommonly reported following administration of pegfilgrastim (see section 4.4).
Maltese: Ġew rapportati każijiet fatali ta' tiċrit tal-milsa b'mod mhux komuni wara l-għoti ta' pegfilgrastim (ara sezzjoni 4.4).
English: Grasustek 6 mg solution for injection in pre-filled syringe pegfilgrastim
Maltese: Grasustek 6 mg Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest pegfilgrastim
English: The safety and efficacy of Grasustek have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Maltese: Is-sigurtà u l-effikaċja ta' Grassustek ma ġewx evalwati f'pazjenti li kienu qed jirċievu kimoterapija assoċjata ma' mijelosuppressjoni ttardjata eż. nitrosoureas.
English: How to store Grasustek
Maltese: Kif taħżen Grasustek
English: POSSIBLE SIDE EFFECTS
Maltese: Effetti sekondarji possibbli
English: • gastroenterology
Maltese: • gastroenteroloġija
English: Aminocaproic acid has multiple pharmacological effects.
Maltese: Aminocaproic acid għandu effetti farmakoloġiċi multipli.
English: - Hormonal medication such as oestrogens
Maltese: - Mediċina ormonali bħal oestrogens
English: Pulmonary embolism
Maltese: Emboliżmu pulmonari
English: Other medicines and X
Maltese: Mediċi oħra u X
English: Leukopenia, thrombocytopenia
Maltese: Lewkopenija, tromboċitopenija
English: Confusion, seizures, delirium, hallucinations, intracranial hypertension, stroke, syncope
Maltese: Konfużjoni, aċċessjonijiet, delirju, alluċinazzjonijiet, pressjoni għolja intrakranjali, puplesija sinkope
English: Acute myopathy, rhabdomyolysis
Maltese: Mijopatija akuta, rabdomijolosi
English: The intravenous and oral lethal dose 50 of aminocaproic acid was 3 and 12 g/kg, respectively, in mice and 3.2 and 16.4 g/kg, respectively, in rats.
Maltese: Id-doża letali 50 ta' aminocaproic acid mgħoti minn ġol-vini u b'mod orali kienet 3 u 12 g/kg, rispettivament, fil-ġrieden u 3.2 u 16.4 g/kg, rispettivament, fil-firien.
English: Undesirable effects a.
Maltese: .8. Effetti mhux mixtieqa a.
English: Children (0-17 years):
Maltese: Tfal (0-17-il sena)
English: The following adverse reactions have been reported from clinical trials, post-authorisation safety studies and from spontaneously-reported cases with the following frequencies: 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).
Maltese: 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':
English: • discomfort
Maltese: • skonfort
English: Oedema
Maltese: Edema
English: • oedema (swelling),
Maltese: • edema (nefħa)
English: Peripheral ischaemia
Maltese: Bradikardija Iskemija periferali
English: The safety and efficacy of EACA in children aged 0 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' EACA fit-tfal minn età ta' 0 sa 17-il sena ma ġewx determinati s'issa.
English: Therapeutic subgroup: Antihemorrhagics Pharmacotherapeutic group: Antifibrinolytics ATC code: B02AA01.
Maltese: Antiemorraġiċi Kategorija farmakoterapewtika: Antifibrinolitiċi Kodiċi ATC:
English: • urology (surgery of the bladder and prostate)
Maltese: • uroloġija (operazzjoni tal-bużżieqa tal-awrina u tal-prostata)
English: Aminocaproic acid is an amino acid that is structurally similar to other physiological amino acids, especially two fundamental amino acids, lysine and arginine.
Maltese: Aminocaproic acid hu amino acid li hu strutturalment simili għal amino acids fiżjoloġiċi oħrajn, speċjalment żewġ amino acids fundamentali, lysine u arginine.
English: It has been shown that there are evident relationships between the proteolytic activity of plasmin and the system that forms quinines, polypeptides with different biological effects basically related to inflammation and allergy.
Maltese: Intwera li hemm relazzjonijiet evidenti bejn l-attività proteolitika ta' plasmin u s-sistema li tifforma quinines, polypeptides b'effetti bijoloġiċi differenti bażikament relatati ma' infjammazzjoni u allerġija.
English: • postsurgical haemorrhages in urology (bladder and prostate surgery), gynaecology (surgery of the cervix), obstetrics (post-partum and post-abortion haemorrhage), cardiac surgery, gastroenterology, and odontostomatology (dental extractions in haemophiliacs and patients who are receiving anticoagulant therapy);
Maltese: • emorraġiji wara operazzjoni tal-uroloġija (operazzjoni tal-bużżieqa tal-awrina u tal-prostata), ġinekoloġija (operazzjoni tal-għonq tal-utru), ostetrija (emorraġija wara l-ħlas u wara korriment), operazzjoni kardijaka, gastroenteroloġija, u odontostomatoloġija (qlugħ ta' snien f'persuni emofilijaċi u pazjenti li jkunu qed jirċievu mediċini kontra l-koagulazzjoni);
English: Fertility There are no clinical data on the effects of [invented name] on fertility.
Maltese: Fertilità M'hemm l-ebda dejta klinika dwar l-effetti ta' [isem ivvintat] fuq il-fertilità.
English: Contraindications
Maltese: .3. Kontra-indikazzjonijiet
English: - Coagulation factors (Factor IX)
Maltese: - Fatturi tal-koagulazzjoni (Fattur IX)
English: - Euglobulin clot test: abnormal in primary fibrinolysis and normal in DIC.
Maltese: - Test ta' tagħqid ta' euglobulin: riżultat anormali f'persuni b'fibrinolisi primarja u riżultat normali f'persuni b'DIC.
English: Uncommon (affects between 1 and 100 in 1,000 patients):
Maltese: Mhux komuni (jaffettwaw bejn 1 u 100 minn kull 1,000 pazjent):
English: Dizziness
Maltese: Dispneja
English: The patient received 2 g of aminocaproic acid every 6 hours to make a total dose of 26 g. The patient died from prolonged cerebrovascular haemorrhage.
Maltese: 2 g ta' aminocaproic acid kull 6 sigħat biex irċieva doża totali ta' 26 g.
English: Common (affects between 1 and 10 in 100 patients):
Maltese: Komuni (jaffettwaw bejn 1 u 10 minn kull 100 pazjent):
English: 6.1 List of excipients [To be completed nationally]
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti [Biex jimtela mill-pajjiż partikolari]
English: • abdominal pain
Maltese: • uġigħ addominali
English: • rash,
Maltese: • raxx
English: b. Tabulated list of adverse reactions
Maltese: Lista tabulata ta' reazzjonijiet avversi
English: One patient with a history of brain tumour and seizures presented seizures after receiving a bolus injection of 8 g of aminocaproic acid.
Maltese: Pazjent wieħed bi storja medika ta' tumur tal-moħħ u aċċessjonijiet kellu aċċessjonijiet wara li rċieva injezzjoni bolus ta' 8 g ta' aminocaproic acid.
English: Total dosage should not exceed 18 g/m2 (600 mg/kg) in 24 hours.
Maltese: Iddożaġġ totali m'għandux jaqbeż 18 g/m2 (600 mg/kg) f'24 siegħa.
English: [If applicable:] <For oral administration: 100 mg/kg or 3 g/m2 during the first hour, then 33.3 mg/kg per hour or 1 g/m2 per hour (maximum 18 g/m2 (600 mg/kg) in 24 hours)>
Maltese: [Jekk applikabbli:] <Għall-għoti mill-ħalq: 100 mg/kg jew 3 g/m2 matul l-ewwel siegħa, imbagħad 33.3 mg/kg kull siegħa jew 1 g/m2 kull siegħa (massimu 18 g/m2 (600 mg/kg) f'24 siegħa)>
English: - Protamine paracoagulation test: positive in DIC; a precipitate forms when a drop of protamine sulphate is added to “citrate” plasma.
Maltese: - Test ta' parakoagulazzjoni ta' protamine: riżultat pożittiv f'persuni b'DIC; jifforma preċipitat meta qatra ta' protamine sulphate tiżdied ma' plażma b'“citrate”.
English: [If applicable] <[Oral route: Aminocaproic acid may be given by mouth in an initial dose of 4 to 5 g, followed by 1 to 1.25 g every hour.
Maltese: (Jekk applikabbli) <[Għoti orali: Aminocaproic acid jista' jingħata mill-ħalq f'doża inizjali ta' 4 sa 5 g, segwita minn 1 sa 1.25 g kull siegħa.
English: An intravenous dose of 2.3 g/kg was fatal in dogs.
Maltese: Doża ġol-vini ta' 2.3 g/kg kienet fatali fil-klieb.
English: Some patients have tolerated doses of up to 100 g, while cases of acute kidney failure have been described after a dose of 12 g.
Maltese: Xi pazjenti ttolleraw dożi sa 100 g, filwaqt li każijiet ta' insuffiċjenza akuta tal-kliewi ġew osservati wara doża ta' 12 g.
English: • or a collapse.
Maltese: • jew kollass.
English: However, the following doses have been used in patients aged less than 18 years: Intravenous route: 100 mg/kg or 3 g/m2 by slow intravenous infusion during the first hour, followed by continuous infusion at the rate of 33.3 mg/kg per hour or 1 g/m2 per hour.
Maltese: Madankollu, id-dożi li ġejjin intużaw f'pazjenti li kellhom inqas minn 18-il sena: Għoti ġol-vini: 100 mg/kg jew 3 g/m2 permezz ta' infużjoni bil-mod ġol-vini matul l-ewwel siegħa, segwita minn infużjoni kontinwa b'rata ta' 33.3 mg/kg kull siegħa jew 1 g/m2 kull siegħa.
English: [If applicable:] <For oral administration: an initial dose of 4 to 5 g will be administered, followed by 1 to 1.25 g per hour.
Maltese: [Jekk applikabbli:] <Għall-għoti mill-ħalq: se tingħata doża inizjali ta' 4 sa 5g, segwita minn 1 sa 1.25 g kull siegħa.
English: Haemorrhage of the upper urinary tract
Maltese: Disturbi filkliewi u fissistema urinarja
English: • dark-coloured urine, decreased amount or frequency of urine
Maltese: • awrina ta' kulur skur, tnaqqis fl-ammont jew fil-frekwenza tal-awrina
English: This test is negative in primary fibrinolysis.
Maltese: Dan it-test jagħti riżultat negattiv f'persuni b'fibrinolisi primarja.
English: Inhibition of plasmin activity
Maltese: Inibizzjoni tal-attività ta' plasmin
English: Laboratory tests: the administration of aminocaproic acid can alter the results of platelet function tests.
Maltese: Testijiet tal-laboratorju: l-għoti ta' aminocaproic acid jista' jibdel ir-riżultati tat-testijiet tal-funzjoni tal-plejtlits.
English: NAME OF THE MEDICINAL PRODUCT <Aminocaproic acid containing medicinal products> [See Annex I - To be completed nationally]
Maltese: <Prodotti mediċinali li fihom aminocaproic acid> [Ara Anness I - Biex jimtela mill-pajjiż partikolari]
English: • significant bleeding induced by thrombolytic drugs;
Maltese: • ħruġ sinifikanti ta' demm ikkaġunat minn mediċini trombolitiċi;
English: The maximum daily dose should not exceed 24 g.
Maltese: Id-doża massima ta' kuljum m'għandhiex taqbeż 24g .