FrancophonIA/ELRC3.0 huggingface dataset:
English: The following table includes adverse reactions of carmustine listed by MedDRA system organ class and frequency convention presented in order of decreasing seriousness: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to < 1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
Maltese: It-tabella li ġejja tinkludi reazzjonijiet avversi ta' carmustine elenkati permezz tas-sistema talklassifika tal-organi u l-konvenzjoni tal-frekwenza ta' MedDRA u ppreżentati f'ordni dixxendenti ta' serjetà: 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); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Not known Extravasation hazard: vesicant
Maltese: Mhux magħrufa Periklu ta' extravasation: vesicant
English: Each ampoule of solvent contains 3 ml ethanol anhydrous (that is equivalent to 2.37 g).
Maltese: Kull ampolla ta' solvent fiha 3 ml ta' ethanol anhydrous (li huwa ekwivalenti għal 2.37 g).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ema/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/ema/.
English: Not known Muscular pain, status epilepticus, seizure, grand mal seizure.
Maltese: Mhux magħrufa Uġigħ fil-muskoli, status epilepticus, attakk ta' puplesija, puplesija grand mal.
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Aħżen u ġorr fi friġġ (2˚C - 8˚C)
English: Carmustine Obvius with alcohol
Maltese: Carmustine Obvius mal-alkoħol
English: Platelets/mm3
Maltese: Pjastrini/mm3
English: Compatibility/Incompatibility with containers
Maltese: Kumpatibbiltà/Inkumpatibbiltà mal-kontenituri.
English: Myelosuppression.
Maltese: Majelosuppressjoni.
English: Not known Infertility, teratogenesis.
Maltese: Mhux magħrufa Infertilità, teratoġenesi.
English: After reconstitution and dilution (se section 6.6), one mL of solution contains 3.3 mg carmustine.
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni (ara sezzjoni 6.6), mL wieħed ta' soluzzjoni fih 3.3 mg carmustine.
English: - Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
Maltese: - Tumuri fil-moħħ (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), metastasi tal-moħħ
English: A specialized antidote is not available.
Maltese: Antidotu speċjalizzat mhuwiex disponibbli.
English: Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
Maltese: Tumuri fil-moħħ (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), metastasi tal-moħħ
English: Pneumonitis is seen for doses >450 mg/m2 and interstitial lung disease is seen with prolonged therapy and cumulative dose > 1,400 mg/m2.
Maltese: >450 mg/m2 u l-marda interstizjali tal-pulmun ġiet osservata fil-każ ta' terapija għal tul ta' żmien u doża kumulattiva ta' > 1,400 mg/m2
English: - Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Maltese: - Terapija sekondarja fil-limfoma mhux ta' Hodgkin u fil-marda ta' Hodgkin
English: During treatment, lung function tests (FVC, DLCO) should be performed regularly.
Maltese: Waqt it-trattament, ittestijiet tal-funzjoni tal-pulmun (FVC, DLCO) għandhom isiru regolarment.
English: Veno-occlusive disease (high-dose therapy).
Maltese: Marda venookklużiva (terapija b'doża għolja).
English: Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Maltese: Terapija sekondarja fil-limfoma mhux ta' Hodgkin u fil-marda ta' Hodgkin
English: Other medicines and Carmustine Obvius
Maltese: Mediċini oħra u Carmustine Obvius
English: Paediatric population Carmustine is contraindicated in children and adolescents aged <18 years (see section 4.3)
Maltese: Popolazzjoni pedjatrika Carmustine huwa kontraindikat fit-tfal u fl-adoloxxenti taħt it-18-il sena (ara sezzjoni 4.3)
English: This corresponds to 11.2 ml of beer or 4.65 ml wine, per dose.
Maltese: Dan huwa ekwivalenti għal 11.2 ml ta' birra jew 4.65 ml ta' nbid, għal kull doża.
English: In addition, carmustine is known to carbamoylate lysine residues on proteins causing irreversible inactivation of enzymes including glutathione reductase.
Maltese: carbamoylation fuq ir-residwi ta-lysine fuq il-proteini li jikkawża inattivazzjoni irriversibbli tal-enzimi inkluża glutathione reductase.
English: The intravenous solution is unstable in polyvinyl chloride containers.
Maltese: Is-soluzzjoni li tingħata għal ġol-vina ma tkunx stabbli f'kontenituri tal-polyvinyl chloride.
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, nitrosoureas, ATC code: L01AD01
Maltese: Aġenti antineoplastiċi, aġenti alkylating, nitrosoureas, kodiċi
English: Carmustine Obvius is a medicine which contains carmustine.
Maltese: Carmustine Obvius huwa prodott mediċinali li fih carmustine.
English: Intravenously administered carmustine is rapidly degraded, with no substance intact detectable after 15 minutes.
Maltese: Carmustine li jingħata b'mod għal ġol-vina jiddegrada malajr, bl-ebda sustanza intatta identifikata wara 15-il minuta.
English: This medicine contains 0.57 vol% ethanol (alcohol), which means 7.62 g per dose.
Maltese: Din il-mediċina fiha 0.57 vol% ethanol (alkoħol), li jfisser 7.62 g għal kull doża.
English: Approximately 60-70% of a total dose is excreted in the urine in 96 hours and about 10% as respiratory CO2.
Maltese: Madwar 60 % sa 70 % tad-doża totali tiġi eliminata fl-awrina fi żmien 96 siegħa u madwar 10 % bħala CO2 respiratorju.
English: Renal toxicity Renal toxicity is rare, but occurs for cumulative doses < 1,000 mg/m2.
Maltese: Tossiċità fil-kliewi It-tossiċità fil-kliewi hija rari, iżda sseħħ fil-każ ta' dożi kumulattivi ta' < 1,000 mg/m2.
English: Patients with a baseline below 70% of the predicted forced vital capacity (FVC) or carbon monoxide diffusing capacity (DLCO) are particularly at risk.
Maltese: Pazjenti b'linja bażi ta' inqas minn 70 % tal-kapaċità vitali forzata (forced vital capacity - FVC) imbassra jew tal-kapaċità ta' diffużjoni tal-monossidu tal-karbonju (carbon monoxide diffusing capacity - DLCO) huma f'riskju partikolari.
English: This medicinal product contains 0.57 vol% ethanol (alcohol), i.e. up to 7.62 g per dose, equivalent to 11.2 ml beer or 4.65 ml wine per dose.
Maltese: Dan il-prodott mediċinali fih 0.57 vol% ethanol (alkoħol), jiġifieri sa 7.62 g kull doża, ekwivalenti għal 11.2 ml ta' birra jew 4.65 ml ta' nbid għal kull doża.
English: Pulmonary toxicity, interstitial fibrosis (with prolonged therapy and cumulative dose)
Maltese: Komuni ħafna Tossiċità pulmonari, fibrożi interstizjali (b'terapija mtawla u doża kumulattiva)
English: SOLVENT AMPOULE
Maltese: AMPOLLA TAS-SOLVENT
English: Myelosuppression
Maltese: Majelosuppressjoni
English: Common Anaemia.
Maltese: Anemija.
English: Digoxin
Maltese: Treddigħ
English: How to store Carmustine Obvius
Maltese: X'fih Carmustine Obvius
English: It is able to form interstrand crosslinks in DNA, which prevents DNA replication and transcription.
Maltese: Hija kapaċi tifforma retikolazzjonijiet bejn il-ħjut tad-DNA (interstrand crosslinks), li jipprevjenu r-replikazzjoni u ttraskrizzjoni tad-DNA.
English: In combination with chemotherapeutic medicinal products reduced activity of antiepileptic medicinal products must be anticipated.
Maltese: Flimkien ma' prodotti mediċinali kimoterapewtiċi, għandha tiġi antiċipata attività mnaqqsa ta' prodotti mediċinali antiepilettiċi.
English: Baseline pulmonary function studies and chest X-ray should be conducted along with frequent pulmonary function tests during treatment.
Maltese: Studji dwar il-funzjoni pulmonari tal-linja bażi u X-ray tas-sider għandhom isiru flimkien ma' testijiet frekwenti tal-funzjoni pulmonari waqt it-trattament.
English: Common Encephalopathy (high-dose therapy and dose-limiting).
Maltese: Enċefalopatija (terapija b'doża għolja u li tillimita d-doża).
English: After reconstitution and dilution, one mL of solution contains 3.3 mg carmustine.
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni, mL wieħed ta' soluzzjoni fih 3.3 mg carmustine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI 10.
English: In patients having received carmustine in childhood or adolescence, cases of extremely delayedonset pulmonary fibrosis (up to 17 years after treatment) have been described.
Maltese: F'pazjenti li jkunu ngħataw carmustine fi tfulithom jew fl-adolexxenza, ġew osservati każijiet ta' fibrożi pulmonari ttardjata ħafna (sa 17-il sena wara t-trattament).
English: Interstitial fibrosis (with lower doses).
Maltese: Fibrożi interstizjali (b'dożi aktar baxxi).
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml glucose 50 mg/ml (5%) solution for injection or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Maltese: Is-soluzzjoni ewlenija ta' 30 ml għandha tiġi dilwita immedjatament biż-żieda tas-soluzzjoni ewlenija ta' 30 ml jew ma' 500 ml ta' soluzzjoni għall-injezzjoni ta' 5 % ta' glucose jew ma' 500 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) ta' sodium chloride f'kontenituri tal ħġieġ.
English: Biotransformation It is presumed that the metabolites of carmustine cause its antineoplastic and toxic activity.
Maltese: Huwa preżunt li l-metaboliti ta' carmustine jikkawżaw l-attività antineoplastika u tossika tagħha.
English: Carmustine Obvius must not be used in children and adolescents aged <18 years.
Maltese: Carmustine Obvius ma għandux jingħata lil tfal u adolexxenti taħt it-18-il sena.
English: This may occur within 3 years of therapy and appears to be dose related with cumulative doses of 1,200-1,500 mg/m2 being associated with increased likelihood of lung fibrosis.
Maltese: Din tista' tiġri fi żmien tliet snin minn meta tittieħed it terapija u jidher li hija relatata mad-doża, b'dożi kumulattivi ta' 1,200-1,500 mg/m2 jiġu assoċjati ma' probabbiltà miżjuda ta' fibrożi fil-pulmun.
English: Liver, kidney and lung function should be checked and monitored regularly during therapy (see section 4.8).
Maltese: Il-funzjoni tal-fwied, tal-kliewi u tal-pulmun għandha tiġi ċċekkjata u mmonitorjata b'mod regolari waqt it-terapija (ara s-sezzjoni 4.8).
English: Carmustine, at clinically relevant dose levels, was carcinogenic in rats and mice.
Maltese: Carmustine, f'livelli ta' doża klinikament rilevanti, kien karċinoġeniku fil-firien u l-ġrieden.
English: Rare (may affect up to 1 in 1,000 people) - Veno-occlusive disease (progressive blockage of the veins) where very small (microscopic) veins in the liver are blocked.
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) - Marda venookklużiva (ibblukkjar progressiv tal-vini) fejn vini żgħar ħafna (mikroskopiċi) filfwied jiġu bblukkati.
English: Dexamethasone, used as an anti-inflammatory and immunosuppressive agent Cimetidine, used for stomach problems like indigestion Digoxin, used if you have abnormal heart rhythm Melphalan, an anticancer medicine
Maltese: Dexamethasone, użat bħala aġent antiinfjammatorju u immunosuppressiv Cimetidine, użat għal problemi fl-istonku bħall-indiġestjoni.
English: Carmustine is a cell-cycle phase nonspecific antineoplastic agent of the nitrosourea type, which exerts tumor cytotoxicity via multiple mechanisms.
Maltese: Carmustine huwa aġent antineoplastiku nonspeċifiku tal-fażi caċ-ċiklu taċ-ċellola (cell-cycle phase) tat-tip nitrosourea, li jeżerċita ċitotossiċità lejn it-tumur permezz ta' diversi mekkaniżmi.
English: Brown type I hydrolytic glass vial (50 ml) with light grey 20 mm bromobutyl rubber stopper and sealed with a dark red aluminium flip-off cap.
Maltese: Trab Kunjett (50 ml) tal-ħġieġ idrolitiku kannella tat-tip I b'tapp tal-lastku bromobutyl ta' 20 mm griż ċar u ssiġillat b'għatu tal-aluminju aħmar skur flip-off.
English: One pack of Carmustine Obvius contains one vial with 100 mg of powder and one ampoule with 3 ml of solvent.
Maltese: Pakkett wieħed ta' Carmustine Obvious fih kunjett wieħed b'100 mg ta' trab u ampolla waħda bi 3 ml ta' solvent.
English: Common (may affect up to 1 in 10 people) - Acute leukaemias and bone marrow dysplasias (abnormal development of the bone marrow).Symptoms may include bleeding from the gums, bone pain, fever, frequent infections, frequent or severe nosebleed, lumps caused by swollen lymph nodes in and around the neck, underarm, abdomen or groin, pale skin, shortness of breath, weakness, fatigue or a general decrease in energy; - Anaemia (decrease in the amount of red blood cells in the blood); - Encephalopathy (disorder of brain).
Maltese: Is-sintomi jistgħu jinkludu fsada mill-ħanek, uġigħ fl-għadam, deni, infezzjonijiet frekwenti, tinfaraġ b'mod frekwenti jew b'mod sever, għoqod ikkawżati minn noduli limfatiċi minfuħin fl-għonq jew madwaru, taħt id-driegħ, fl-addome jew fil-groin, ġilda pallida, nuqqas ta' nifs, għeja, eżawriment jew tnaqqis ġenerali fl-enerġija;
English: Reconstitution and dilution of the powder for concentrate for solution for infusion Dissolve the Carmustine (100 mg powder) with 3 ml of the supplied sterile refrigerated ethanol solvent in the primary packaging (brown glass vial).
Maltese: Dewweb Carmustine (100 mg ta' trab) fi 3 ml ta' solvent tal-ethanol sterili u mkessaħ provdut fl-imballaġġ primarju (il-kunjett tal-ħġieġ kannella).
English: The incidence of adverse reactions is probably doserelated; cumulative doses of 1200-1500 mg/m2 have been associated with an increased likelihood of pulmonary fibrosis.
Maltese: 1500 mg/m2 ġew assoċjati ma' probabbiltà miżjuda ta' fibrożi pulmonari.
English: There are no limits for the period of application of carmustine therapy.
Maltese: Ma jeżistux limiti għall-perjodu ta' applikazzjoni tat-terapija b'carmustine.
English: Carmustine crosses the blood-brain barrier readily because of its lipophilic nature.
Maltese: Carmustine jaqsam il-barriera ematoenċefalika (blood-brain barrier) faċilment minħabba nnatura lipofilika tagħha.
English: The pH and osmolarity of ready-to-use solutions for infusion: pH 4.0 to 5.0 and 385-397 mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection) and pH 4.0 to 6.8 and 370-378 mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Maltese: Il-pH u l-osmolarity ta' soluzzjonijiet għall-infużjoni lesti għall-użu: pH 4.0 sa 5.0 u 385-397mOsm/l (jekk jiġu dilwiti f'soluzzjoni għall-injezzjoni ta' 50 mg/ml
English: Hypersensitivity to the active substance, to other nitrosoureas or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal nitrosoureas oħrajn jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: By following the recommended storage conditions it is possible to avoid any decomposition of the unopened vial until the date of expiry mentioned on the packaging.
Maltese: Ir-rikostituzzjoni u ddilwizzjoni ulterjuri għandhom isiru taħt kondizzjonijiet asettiċiJekk timxi mal-kondizzjonijiet ta' ħażna rakkomandati, huwa possibbli li tiġi evitata d-dekompożizzjoni tal-kunjett mhux miftuħ sad-data ta' skadenza indikata fuq il-pakkett.
English: Medicinal product subject to restricted medical prescription.
Maltese: prodotti mediċinali majelosuppressivi oħrajn.
English: Carmustine may impair male fertility.
Maltese: Aħżen u ġorr fi friġġ.
English: The recommended dose of Carmustine Obvius as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks.
Maltese: Id-doża rakkomandata ta' Carmustine Obvius bħala aġent uniku f'pazjenti li ma jkunux ġew trattati qabel hija ta' bejn 150 u 200 mg/m2 mogħtija ġol-vini kull sitt ġimgħat.
English: Solvent Clear type I glass ampoule (5 ml).
Maltese: Solvent Ampolla (5 ml) tal-ħġieġ ċar tat-tip I.
English: The pH and osmolarity of ready-to-use solutions for infusion are: pH 4.0 to 5.0 and 385-397mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection), and pH 4.0 to 6.8 and 370-378mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Maltese: [5 %] ta' glucose), u pH 4.0 sa 6.8 u 370-378mOsm/l (jekk jiġu dilwiti f'soluzzjoni għall-injezzjoni ta' 9 mg/ml [0.9 %] ta' sodium chloride).
English: HUNGARY
Maltese: L-Ungerija
English: 1 ampoule of 3 ml solvent
Maltese: Kunjett ta' 100 mg ta' trab Ampolla ta' 3 ml ta' solvent
English: Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):
Maltese: Carmustine huwa effettiv fin-neoplażmi malinni li ġejjin bħala aġent waħdieni jew f'kombinazzjoni ma' aġenti antineoplastiċi oħra u/jew miżuri terapewtiċi oħra (radjoterapija, kirurġija):
English: Carmustine Obvius is contraindicated during breastfeeding and up to seven days post-treatment (see section 4.3).
Maltese: Irriskju għat-trabi tat-twelid mhux eskluż. Carmustine Obvius huwa kontraindikat waqt it treddigħ u sa sebat ijiem wara t-trattament (ara s-sezzjoni 4.3).
English: Ocular toxicities, transient conjunctival flushing and blurred vision due to retinal haemorrhages.
Maltese: Tossiċità fl-għajnejn, flaxxjar konġuntivali temporanju u viżta mċajpra minħabba emorraġiji retinali.
English: Further, the ready-to-use solution solution needs to be protected from light (e.g. using alu-foil wrapped around the container of the ready-to-use solution) and preferably kept at temperatures below 20-22°C as Carmustine degrades faster at higher temperatures.
Maltese: Barra minn hekk, is-soluzzjoni lesta għall-użu jeħtieġ li tiġi protetta mid-dawl (pereżempju billi tiddawwar biċċa alu-foil mal-kontenitur tas-soluzzjoni lesta għall-użu) u preferibbilment tinħażen f'temperaturi aktar baxxi minn 20-22°C minħabba li Carmustine jiddegrada aktar malajr f'temperaturi ogħla.
English: Carmustine and related nitrosoureas are unstable in aqueous solutions and degrade spontaneously to reactive intermediates that are capable of alkylation and carbamoylation.
Maltese: Carmustine u nitrosoureas relatati mhumiex stabbli f'soluzzjoni ta' ilma u jiddegradaw b'mod spontanju f'intermedjarji reattivi li kapaċi jagħmlu attività ta' alkylation u carbamoylation.
English: Then aseptically add 27 ml of sterile water for injection to the alcohol solution.
Maltese: Imbagħad, b'mod asettiku, żid 27 ml ta' ilma sterili għall-injezzjoni mas-soluzzjoni tal-alkoħol.
English: However, opinion is divided over the role of the carbamoylating intermediates as mediators of the biological effects of the nitrosoureas.
Maltese: Madankollu, l-opinjoni hija maqsuma fir-rigward tar-rwol tal intermedjarji carbamoylating bħala medjaturi tal-effetti bijoloġiċi tan-nitrosoureas.
English: Infusion of Carmustine Obvius in less than one hour may produce intense pain and burning at the site of injection (see section 4.2).
Maltese: L-infużjoni ta' Carmustine Obvius f'inqas minn siegħa tista' tipproduċi wġigħ u ħruq intensi fil parti injettata (ara sezzjoni 4.2).
English: The patients were between 22 months and 72 years old.
Maltese: Il-pazjenti kellhom bejn 22 xahar u 72 sena.
English: Direct administration of carmustine into the carotid artery is regarded as experimental and has been associated with ocular toxicity.
Maltese: L-għoti dirett ta' carmustine fl-arterja karotide huwa meqjus bħala sperimentali u ġie assoċjat mat-tossiċità fl-għajnejn.
English: Adverse reactions are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials,
Maltese: Ir reazzjonijiet avversi ġeneralment jiġu inklużi jekk ikunu ġew irrapportati f'aktar minn 1 % talpazjenti fil-monografu tal-prodott jew fil-provi pivotali, u/jew jekk ikun ġie determinat li huma klinikament importanti.
English: Bone marrow toxicity is a common and severe toxic adverse reaction of carmustine.
Maltese: It-tossiċità tal-mudullun hija reazzjoni avversa tossika komuni u severa għal carmustine.
English: Phlebitis.
Maltese: Melphalan
English: A repeat course of Carmustine Obvius should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3, leukocytes above 4,000/mm3), and this is usually in six weeks.
Maltese: Kors ripetut ta' Carmustine Obvius ma għandux jingħata qabel ma l-elementi li jiċċirkolaw fiddemm jirritornaw għal livelli aċċettabbli (pjastrini 'l fuq minn 100,000/mm3, lewkoċiti'l fuq minn 4,000/mm3), u dan ikun ġeneralment fi żmien sitt ġimgħat.
English: Carmustine was embryotoxic and teratogenic in rats and embryotoxic in rabbits at dose levels equivalent to the human dose.
Maltese: Carmustine kien embrijotossiku u teratoġeniku fil-firien u embrijotossiku fil-fniek f'livelli ta' doża ekwivalenti għad-doża għall-bniedem.
English: Such products are not accepted for use due to the risk of temperature excursions to more than 30°C.
Maltese: Prodotti bħal dawn ma jiġux aċċettati għall-użu minħabba r-riskju ta' eskursjonijiet fit-temperatura għal aktar minn 30°C.
English: Pulmonary toxicity characterised by pulmonary infiltrates and/or fibrosis has been reported to occur with a frequency ranging up to 30%.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu It-tossiċità pulmonari kkaratterizzata minn infiltrati pulmonari u/jew fibrożi ġiet irrappurtata li sseħħ fi frekwenza li tlaħħaq sat-30 %.
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Maltese: TAL-PRODOTT MEDIĊINALI Carmustine Obvius 100 mg trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni carmustine
English: This can result in increased liver enzymes and bilirubin (detected by blood tests); - Alopecia (loss of hair); - Flushing of the skin; - Reactions on the injection site
Maltese: Din tista' tirriżulta f'żieda fl-enzimi fil fwied u l-bilirubin (jiġi ddeterminat minn testijiet tad-demm); - Alopeċja (twaqqigħ tax-xagħar); - Attakki ta' ħmura fil-ġilda;
English: Not known (frequency cannot be estimated from the available data) - Muscular pain; - Seizures (fits) including status epilepticus; - Tissue damage due to leakage in injection area; - Infertility; - Carmustine has been shown to adversely affect the development of unborn babies
Maltese: - Attakki ta' puplesija inkluż status epilepticus; - Ħsara fit-tessuti minħabba tnixxija fil-parti fejn tingħata l-injezzjoni;
English: Pulmonary toxicity also manifested in the post-marketing phase as pneumonitis and interstitial lung disease.
Maltese: It-tossiċità pulmonari mmanifestat ruħha wkoll fil-fażi ta' wara t-tqegħid fis-suq bħala pneumonite u marda interstizjali tal-pulmun.
English: The antineoplastic and toxic activities of carmustine may be due to its metabolites.
Maltese: L-attivitajiet antineoplastiċi u tossiċi ta' carmustine jistgħu jirriżultaw mill-metaboliti tiegħu.
English: All plastic coming into contact with the carmustine solution for infusion (e.g. infusion set etc.) should be PVC free polyethylene plastic, otherwise glass ware should be used.
Maltese: Il plastik kollu li jiġi f'kuntatt ma' carmustine soluzzjoni għall-infużjoni (pereżempju, is-sett talinfużjoni, eċċ.) għandu jkun plastik polyethylene ħieles mill-PVC, inkella għandu jintuża lħġieġ.
English: ≤250 mg/m2.
Maltese: 100 mg
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml 5% glucose or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Maltese: (0.9 %) ta' sodium chloride jew soluzzjoni għall-injezzjoni ta' 50 mg/ml (5 %) ta' glucose.
English: Each vial of powder for concentrate for solution for infusion contains 100 mg carmustine.
Maltese: Kull kunjett ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni fih 100 mg carmustine.
English: Then aseptically add 27 ml of sterile water for injections to the alcohol solution.
Maltese: 27 ml ieħor ta' ilma għall-injezzjonijiet.