FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC concluded that the product information of products containing ferric maltol should be amended accordingly.
Maltese: IlPRAC ikkonkluda li l-informazzjoni tal-prodott ta' prodotti li fihom il-ferric maltol għandha tiġi emendata kif xieraq.
English: The median (min-max) time since last disease flare was around 7 months (0.0-450 months).
Maltese: Iż-żmien medjan (min-mass) millaħħar aggravar tal-marda kien ta' madwar 7 xhur (0.0-450 xahar).
English: These effects were not observable in a second study in dogs receiving up to 300 mg/kg/day.
Maltese: Dawn l-effetti ma kinux osservabbli fit-tieni studju fil-klieb li kienu qed jirċievu sa 300 mg/kg/kuljum.
English: Iron deficiency or iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron deficiency and to exclude underlying causes of anaemia other than iron deficiency.
Maltese: Id-dijanjożi ta' anemija kkawżata minn defiċjenza ta' ħadid (IDA) jew defiċjenza ta' ħadid għandha ssir abbażi ta' testijiet tad-demm; huwa importanti li tiġi investigata l-kawża tad-defiċjenza ta' ħadid u li jiġu esklużi kawżi sottostanti ta' anemija minbarra defiċjenza ta' ħadid.
English: Blood and urine samples were assayed for maltol and maltol glucuronide.
Maltese: Il-kampjuni tad-demm u tal-awrina ġew analizzati għal maltol u għal glucuronide maltol.
English: You should not take Feraccru if you are taking dimercaprol (a medicine used to remove toxic metals from the blood), chloramphenicol (used to treat bacterial infections), or methyldopa (used to treat high blood pressure).
Maltese: M'għandekx tieħu Feraccru jekk qed tieħu dimercaprol (mediċina li tintuża biex tneħħi metalli tossiċi middemm), chloramphenicol (jintuża għall-kura ta' infezzjonijiet batteriċi) jew methyldopa (jintuża għall-kura ta' pressjoni tad-demm għolja).
English: Absorption of both iron and antibiotic may be reduced if oral iron is given with tetracycline.
Maltese: L-assorbiment kemm tal-ħadid u tal-antibijotiċi jista' jitnaqqas jekk il-ħadid orali jingħata ma' tetracycline.
English: Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea.
Maltese: Sinjali u sintomi bikrija jinkludu dardir, rimettar, uġigħ addominali u dijarea.
English: Non-clinical studies revealed no special hazard for humans based on repeated dose toxicity and local tolerance studies conducted with ferric maltol.
Maltese: Studji mhux kliniċi ma wrew l-ebda periklu speċjali għall-bnedmin abbażi ta' tossiċità minn dożi ripetuti u minn studji ta' tolleranza lokali li saru b'ferric maltol.
English: 83 % of the patients with CD had a CDAI-score <150 and 17 % a CDAI-score >150-220.
Maltese: Il-pazjenti ħadu sehem fi studju kliniku uniku kkombinat, randomizzat u kkontrollat bi plaċebo (AEGIS 1/2). 69 % tal-pazjenti b'UC kellhom punteġġ SCCAI ta' ≤2 u 31 % punteġġ SCCAI ta' 3. 83 % tal-pazjenti b'CD kellhom punteġġ CDAI ta' ≤150 u 17 % punteġġ CDAI ta' >150-220.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Feraccru in one or more subsets of the paediatric population in iron deficient anaemia (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Swallow the capsules whole.
Maltese: Ibla' l-kapsuli sħaħ.
English: Norgine Pharmaceuticals Ltd. MedInfo@norgine.com
Maltese: Norgine Italia S.r.l. medinfoitaly@norgine.com
English: Other medicines and Feraccru
Maltese: X'fih Feraccru
English: See package leaflet for further information PHARMACEUTICAL FORM AND CONTENTS 56 capsules METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: Għal aktar informazzjoni ara l-fuljett ta' tagħrif GĦAMLA FARMAĊEWTIKA U KONTENUT 56 kapsula MOD TA' KIF U MNEJN JINGĦATA
English: This leaflet was last revised in xxx <Other sources of information>
Maltese: Dan il-fuljett kien rivedut l-aħħar f'xxx <Sorsi oħra ta' informazzjoni>
English: Black discolouration of the stool is a well-known ADR of oral iron formulations.
Maltese: Skolorazzjoni fl-iswed tal-ippurgar hija reazzjoni avversa għall-mediċina magħrufa sew fil-formulazzjonijiet orali tal-ħadid.
English: The complex is designed to provide, in a controlled way, utilisable iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body (transferrin and ferritin, respectively).
Maltese: Il-kumpless huwa maħsub biex jipprovdi, b'mod ikkontrollat, ħadid li jista' jintuża biex jiġi assorbit mill-ħajt talmusrana u jiġi trasferit lill-proteini li jittrasportaw u jaħżnu l-ħadid fil-ġisem (transferrin u ferritin, rispettivament).
English: Small intestinal bacterial overgrowth
Maltese: Lactose monohydrate
English: Uncommon side effects (may affect up to 1 in 100 people) are: thirst, stiff joints, pain in fingers/toes, headache, acne, skin redness, vomiting and increase in bacteria in the small intestine.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) huma: għatx, ebusija filġogi, uġigħ fis-swaba tal-idejn/swaba tas-saqajn, uġigħ ta' ras, akne, ħmura fil-ġilda, rimettar u żieda filbatterji fil-musrana ż-żgħira.
English: The full EPAR for Sialanar 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: Sialanar glycopyrronium bromide
Maltese: Sialanar bromur tal-glikopirronju
English: This is a summary of the European public assessment report (EPAR) for Sialanar.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sialanar.
English: It contains the active substance glycopyrronium bromide.
Maltese: Fih is-sustanza attiva bromur tal-glikopirronju.
English: Other information about Sialanar
Maltese: Informazzjoni oħra dwar Sialanar
English: In one of the studies in 38 children and adolescents with severe drooling, around 74% of those taking glycopyrronium bromide after 8 weeks had their scores reduced by 3 points or more compared with 18% of those taking placebo (a dummy treatment).
Maltese: F'wieħed mill-istudji fi 38 tifel/tifla u adolexxenti bi tlegħib sever, madwar 74% ta' dawk li jieħdu lbromur tal-glikopirronju wara 8 ġimgħat kellhom tnaqqis fil-punteġġi ta' 3 punti jew aktar meta mqabbla ma' 18 % ta' dawk li ħadu plaċebo (kura finta).
English: This study focused on the average final drooling scores after 8 weeks of treatment, which were 1.9 in patients on glycopyrronium bromide and 6.3 in patients on placebo.
Maltese: Dan l-istudju ffoka fuq il-medja tal-punteġġi ta' tlegħib finali wara 8 ġimgħat ta' kura, li kienu 1.9 f'pazjenti fuq il-bromur tal-glikopirronju u 6.3 f'pazjenti fuq plaċebo.
English: Why is Sialanar approved?
Maltese: Għaliex ġie approvat Sialanar?
English: The most common side effects with Sialanar (which may affect more than 1 in 10 people) are irritability, flushing, blocked nose, reduced secretions in the airways, dry mouth, constipation, diarrhoea, vomiting and inability to completely empty the bladder (urinary retention).
Maltese: L-effetti sekondarji l-aktar komuni b'Sialanar (li jistgħu jaffetwaw aktar minn persuna 1 minn kull 10) huma irritabbiltà, fwawar, imnieħer imblukkat, tnaqqis fit-tnixxija fil-passaġġi tal-arja, ħalq xott, stitikezza, dijarea, rimettar u inkapaċità li tbattal il-bużżieqa tal-awrina kompletament (żamma talawrina).
English: What are the risks associated with Sialanar?
Maltese: X'inhuma r-riskji assoċjati ma' Sialanar?
English: The second study involved 27 children and adolescents with severe drooling who took either glycopyrronium bromide or placebo for 8 weeks and then had their treatment switched for another 8 weeks.
Maltese: It-tieni studju involva 27 tifel/tifla u adolexxenti bi tlegħib sever li ħadu jew il-bromur tal-glikopirronju jew plaċebo għal 8 ġimgħat u mbagħad inqalbitilhom il-kura għal 8 ġimgħat oħra.
English: The active substance in Sialanar, glycopyrronium bromide, blocks receptors in the salivary glands known as muscarinic receptors.
Maltese: Is-sustanza attiva f'Sialanar, il-bromur tal-glikopirronju, timblokka r-riċetturi fil-glandoli tal-bżieq magħrufa bħala riċetturi muskariniċi.
English: Sialanar must not be used in patients with glaucoma (an eye condition), urinary retention, severe kidney impairment or a history of certain intestinal conditions or myasthenia gravis (a condition affecting muscles).
Maltese: Sialanar m'għandux jintuża f'pazjenti bi glawkoma (kundizzjoni tal-għajnejn), żamma tal-awrina, indeboliment sever tal-kliewi jew storja ta' ċerti kundizzjonijiet intestinali jew mijastenija gravis (kundizzjoni li taffettwa l-muskoli).
English: Two published studies showed that glycopyrronium bromide was effective at reducing drooling in children and adolescents with nervous system conditions, using a standard rating scale known as mTDS (where a score of 1 means no drooling and a score of 9 means profuse drooling).
Maltese: Żewġ studji ppubblikati juru li l-bromur tal-glikopirronju kien effikaċi fit-tnaqqis tat-tlegħib fit-tfal u fladolexxenti b'kundizzjonijiet tas-sistema nervuża, permezz ta' skala ta' klassifikazzjoni standard magħrufa bħala mTDS (fejn punteġġ ta' 1 ifisser l-ebda tlegħib u punteġġ ta' 9 jfisser ħafna tlegħib).
English: These receptors trigger the production of saliva when activated by nerves from the brain.
Maltese: Dawn ir-riċetturi jistimulaw il-produzzjoni tal-bżieq meta attivati min-nervituri tal-moħħ.
English: Sialanar is a medicine for treating severe drooling of saliva in children and adolescents (aged 3 years and above) with conditions affecting the nervous system, such as cerebral palsy, epilepsy and neurodegenerative diseases.
Maltese: Sialanar huwa mediċina għall-kura ta' tlegħib sever ta' bżieq fit-tfal u fl-adolexxenti (li għandhom minn 3 snin 'il fuq) b'kundizzjonijiet li jaffetwaw is-sistema nervuża bħall-paraliżi ċerebrali, epilessija u mard newrodeġenerattiv.
English: How does Sialanar work?
Maltese: Kif jintuża Sialanar?
English: Glycopyrronium bromide is well established in the EU as a treatment for drooling, and published studies show that it is effective in treating severe drooling in children and adolescents with nervous system conditions which can affect their quality of life.
Maltese: Il-bromur tal-glikopirronju huwa stabbilit sew fl-UE bħala kura għat-tlegħib, u studji ppubblikati juru li huwa effikaċi fil-kura ta' tlegħib sever fit-tfal u fl-adolexxenti b'kundizzjonijiet tas-sistema nervuża li jistgħu jaffettwaw il-kwalità tal-ħajja tagħhom.
English: 82319 Starnberg Germany
Maltese: D-82319 Starnberg
English: PARI Pharma GmbH Lochhamer Schlag 21 82166 Graefelfing GERMANY
Maltese: PARI Pharma GmbH Lochhamer Schlag 21 82166 Graefelfing
English: ATC code: J01GB01
Maltese: J01GB01
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1350/001
Maltese: EU/1/18/1350/001
English: Insusceptible Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
Maltese: Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
English: • furosemide, a diuretic (“water tablet”);
Maltese: • furosemide, dijuretiku (“pillola tal-pipi`”);
English: • The active substance is tobramycin.
Maltese: - Is-sustanza attiva hi tobramycin.
English: Table 1 Adverse reactions
Maltese: Tabella 1 Reazzjonijiet avversi
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2 ° C - 8 ° C).
English: Sputum concentrations were higher and more variable with Cmax of 1,951 + 2,187 µg/g.
Maltese: Konċentrazzjonijiet fl-isputum kienu ogħla u aktar varjabbli b'Cmax ta' 1,951 + 2,187 µg/g.
English: INFORMATION IN BRAILLE Vantobra 170 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Vantobra 170 mg
English: See also information on clinical benefit and tolerability in sections 4.4, 4.8 and
Maltese: Ara wkoll l-informazzjoni dwar il-benefiċċju kliniku u ttolleranza f'sezzjonijiet 4.4, 4.8 u 5
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Maltese: Tobramycin huwa antibijotiku aminoglycoside magħmul minn Streptomyces tenebrarius.
English: Parenteral aminoglycosides have been associated with hypersensitivity, ototoxicity and nephrotoxicity (see section 4.4).
Maltese: Aminoglycosides parenterali kienu assoċjati ma' sensittività eċċessiva, ototossiċità u nefrotossiċità (ara sezzjoni 4.4).
English: As a result of study 12012.101, lung function improvement FEV1% predicted relative to baseline increased by 8.2 ± 9.4% under Vantobra and by 4.8 ± 9.6% under the reference therapy in the first treatment cycle showing non-inferior (p=0.0005) efficacy.
Maltese: Bħala riżultat ta' studju 12012.101, titjib fil-funzjoni tal-pulmun FEV1 % imbassar imqabbel mal-linja bażi żdied b'8.2 ± 9.4% b'Vantobra u b'4.8 ± 9.6% bit-terapija ta' referenza fl-ewwel ċiklu ta' kura li juri effikaċja mhux inferjuri (p=0.0005).
English: Fungal infection Oral candidiasis
Maltese: Infezzjoni tal-fungu Kandidijasi orali
English: Safety and efficacy have not been studied in patients colonised with Burkholderia cepacia.
Maltese: Is-sigurtà u l-effikaċja ma ġewx studjati f'pazjenti kolonizzati b'Burkholderia cepacia.
English: The Tolero nebuliser handset can be operated either with an eBase controller or with the eFlow rapid control unit.
Maltese: Il-handset ta' nebulizzatur Tolero jista' jitħaddem permezz ta' kontrollatur eBase jew permezz ta' unità ta' kontroll eFlow rapid.
English: Excipients: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Maltese: Eċċipjenti: sodium chloride, calcium chloride, magnesium sulphate, ilma għall-injezzjonijiet, sulphuric acid u sodium hydroxide għall-aġġustament tal-pH.
English: Pulmonary function test decreased
Maltese: Test tal-funzjoni pulmonari mnaqqas
English: Vantobra contains an antibiotic medicine called tobramycin.
Maltese: Vantobra fih mediċina antibijotika li tissejjaħ tobramycin.
English: • other medicines with diuretic potential such as urea or mannitol;
Maltese: • mediċini oħra b'potenzjal dijuretiku bħal urea jew mannitol;
English: Less than 10% of tobramycin is bound to plasma proteins.
Maltese: Inqas minn 10% ta' tobramycin jeħel mall-proteini fil-plażma.
English: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).
Maltese: Vantobra huwa indikat għall-immaniġġjar ta' infezzjoni kronika fil-pulmun kkawżata minn Pseudomonas aeruginosa f'pazjenti b'età minn 6 snin 'il fuq b'fibrożi ċistika (CF - cystic fibrosis).
English: For comparative aerosol data please refer to Table 2 in section 5.1
Maltese: Għal dejta komparattiva tal-aerosol jekk jogħġbok irreferi għal Tabella 2 f'sezzjoni 5.1
English: Sodium chloride
Maltese: Sodium chloride Calcium chloride Magnesium sulphate
English: If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered.
Maltese: Jekk ikun evidenti deterjorament kliniku tal-istat pulmonari, għandha tiġi kkunsidrata terapija addizzjonali jew alternattiva kontra psewdomonas.
English: Patients with a P. aeruginosa isolate with MIC 128 µg/ml at baseline are less likely to show a clinical response.
Maltese: aeruginosa b'MIC 128 µg/ml fil-linja bażi huma inqas probabbli li juru rispons kliniku.
English: There is no evidence that patients treated with up to 18 months with tobramycin nebuliser solution were at a greater risk for acquiring B. cepacia, S. maltophilia or A. xylosoxidans, than would be expected in untreated patients.
Maltese: M'hemmx evidenza li pazjenti kkurati sa 18-il xahar b'soluzzjoni għan-nebulizzatur ta' tobramycin kienu f'riskju akbar li jiksbu B. cepacia, S. maltophilia jew A. xylosoxidans, milli jkun mistenni f'pazjenti mhux ikkurati.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials.
Maltese: Antibatteriċi għal użu sistemiku, antibatteriċi aminoglycoside.
English: The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substance.
Maltese: L-użu ta' sistema ta' nebulizzatur alternattiv mhux ittestjat jista' jbiddel id-depożizzjoni tas-sustanza attiva fil-pulmun.
English: After administering a single dose of Vantobra 170 mg to healthy volunteers Cmax of 1.1 + 0.4 µg/ml were reached after a tmax of approximately 4 hours.
Maltese: Wara għoti ta' doża waħda ta' Vantobra 170 mg lill-voluntieri f'saħħithom Cmax ta' 1.1 + 0.4 µg/ml intlaħqu wara tmax ta' madwar 4 sigħat.
English: amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity);
Maltese: o amphotericin B, cefalotin, polymyxins (użati biex jikkuraw infezzjonijiet bil-mikrobi), ciclosporin, tacrolimus (użati biex inaqqsu l-attività tas-sistema immuni).
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: At the end of a 4-weeks dosing cycle of Vantobra (170 mg/1.7 ml twice daily) in cystic fibrosis patients, maximum tobramycin plasma concentrations (Cmax) of 1.27 ± 0.81 µg/ml were reached at approximately one hour after inhalation.
Maltese: Fl-aħħar taċ-ċiklu ta' dożaġġ ta' 4 ġimgħat ta' Vantobra (170 mg/1.7 ml darbtejn kuljum) f'pazjenti b'fibrożi ċistika, konċentrazzjonijiet massimi ta' tobramycin fil-plażma (Cmax) ta' 1.27 ± 0.81 µg/ml intlaħqu f'madwar siegħa wara t-teħid man-nifs.
English: Vantobra is supplied in polyethylene (PE) ampoules that are packed in sealed aluminium foil sachets (8 ampoules per sachet).
Maltese: Vantobra huwa fornut f'ampulli tal-polyethylene (PE) li huma ppakkjati fi qratas issiġillati magħmula minn fojl tal-aluminju (8 ampulli f'kull qartas).
English: In the event of inadvertent administration of Vantobra by the intravenous route, signs and symptoms of parenteral tobramycin overdose may occur, including dizziness, tinnitus, vertigo, loss of hearing acuity, respiratory distress and/or neuromuscular blockage and renal impairment.
Maltese: F'każ ta' għoti bi żball ta' Vantobra fil-vini, jistgħu jseħħu sinjali u sintomi ta' doża eċċessiva ta' tobramycin parenterali, inkluż sturdament, żarżir fil-widnejn, vertigo, telf ta' akutezza tas-smigħ, distress respiratorju u/jew blokk newromuskolari u indeboliment tal-kliewi.
English: Aspergillus species were more frequently recovered from the sputum of treated patients; however, clinical sequelae such as Allergic Bronchopulmonary Aspergillosis (ABPA) were reported rarely and with similar frequency as in the control group.
Maltese: madankollu, sequelae kliniċi bħal Asperġillożi Bronkopulmonari Allerġika (ABPA - Allergic Bronchopulmonary Aspergillosis) kienu rrappurtati b'mod rari u bi frekwenza simili bħal fil-grupp ta'
English: • anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Maltese: • anticholinesterases bħal neostigmine u pyridostigmine (użati għall-kura ta' dgħjufija fil-muskoli), jew tossina tal-botulinum.
English: • The nebuliser handset must be kept horizontally during operation.
Maltese: • Il-handset ta' nebulizzatur għandu jinżamm b'mod orizzontali matul l-operazzjoni.
English: Dysgeusia
Maltese: Disfonija
English: In addition, the corresponding frequency category is provided using the following convention: 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
Maltese: Komuni ħafna (≥ 1/10); Komuni (≥ 1/100 sa < 1/10);
English: PHARMACEUTICAL FORM Nebuliser solution.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għan-nebulizzatur.
English: Tobramycin did not impair fertility in male or female rats at subcutaneous doses up to 100 mg/kg/day.
Maltese: Tobramycin ma fixkilx il-fertilità f'firien maskili jew femminili f'dożi taħt il ġilda sa 100 mg/kg/kuljum.
English: The recommended dose is one ampoule (170 mg/1.7 ml) administered twice daily (i.e. total daily dose is 2 ampoules) for 28 days.
Maltese: Id-doża rrakkomandata hija ampulla waħda (170 mg/1.7 ml) mogħtija darbtejn kuljum (jiġifieri d-doża totali ta' kuljum hija 2 ampulli) għal 28 ġurnata.
English: Following intravenous administration, systemically absorbed tobramycin is eliminated by glomerular filtration.
Maltese: Wara għoti fil-vini, tobramycin assorbit b'mod sistemiku huwa eliminat permezz ta' filtrazzjoni glomerulari.
English: Magnesium sulphate Sulphuric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sulphuric acid (għal aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: PHARMACEUTICAL FORM AND CONTENTS Contains 8 ampoules.
Maltese: Fiha 8 ampulli.
English: In the absence of conventional susceptibility breakpoints for the nebulised route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to nebulised tobramycin.
Maltese: Fin-nuqqas ta' breakpoints konvenzjonali tas-suxxettibilità għar-rotta ta' għoti permezz ta' nebulizzatur, għandu jkun hemm attenzjoni fid-definizzjoni ta' organiżmi bħala suxxettibbli jew mhux suxxettibbli għal tobramycin nebulizzat.
English: 1 connected with an eBase controller or eFlow rapid controller 2 connected with a PARI Boy SX compressor
Maltese: * Riżultati minn simulazzjoni tan-nifs u kejl permezz ta' cascade impactor. imqabbad ma' kontrollur eBase jew eFlow rapid 2 imqabbad ma' kompressur PARI Boy SX
English: It is supplied in a box that contains two inner boxes, one with the medicine (56 ampoules with nebuliser solution in 7 sachets), and one with the nebuliser handset.
Maltese: Huwa disponibbli f'kaxxa li fiha żewġ kaxex fuq ġewwa, waħda bil-mediċina (56 ampulla b'soluzzjoni għan-nebulizzatur f'7 iqratas), u waħda bil-handset ta' nebulizzatur.
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Maltese: L-iżvilupp ta' P. aeruginosa reżistenti għall-antibijotiċi u superinfezzjoni b'patoġeni oħra jirrappreżentaw riskji potenzjali assoċjati ma' terapija b'antibijotiċi.
English: In controlled clinical trials, 97% of patients receiving tobramycin nebuliser solution achieved sputum concentrations 10-fold of the highest P. aeruginosa MIC cultured from the patient and 95% of patients receiving tobramycin nebuliser solution achieved 25-fold of the highest MIC.
Maltese: Fi provi kliniċi kkontrollati, 97% tal-pazjenti li rċevew soluzzjoni għan-nebulizzatur ta' tobramycin laħqu konċentrazzjonijiet fl-isputum 10 darbiet ogħla mill-ogħla
English: Long-term safety data are not available for Vantobra (see also section 5.1).
Maltese: Dejta dwar sigurtà fit-tul mhix disponibbli għal Vantobra (ara wkoll sezzjoni 5.1).
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution tobramycin
Maltese: Vantobra 170 mg soluzzjoni għan-nebulizzatur Tobramycin
English: There was no difference in the safety profile between pediatric and adult patient population treated with Vantobra.
Maltese: Ma kien hemm l-ebda differenza fil-profil tas-sigurtà bejn popolazzjoni ta' pazjenti pedjatriċi u adulti kkurati b'Vantobra.
English: Somnolence
Maltese: Sinożite
English: Other medicines and Vantobra
Maltese: Mediċini oħra u Vantobra
English: NAME OF THE MARKETING AUTHORISATION HOLDER PARI Pharma GmbH
Maltese: PARI Pharma GmbH
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose ampoule of 1.7 ml contains 170 mg tobramycin.
Maltese: U KWANTITATTIVA Kull ampulla ta' doża waħda ta' 1.7 ml fiha 170 mg tobramycin.