FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Maltese: L-ogħla konċentrazzjonijiet osservati fil-plażma jintlaħqu fi żmien minn 30 għal 120 minuta (medjan ta' 60 minuta) ta' doża orali fl-istat sajjem.
English: Paediatric population Sildenafil ratiopharm is not indicated for individuals below 18 years of age.
Maltese: Popolazzjoni pedjatrika Sildenafil mhuwiex indikat għal individwi taħt l-età ta' 18-il sena.
English: The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
Maltese: Il-mekkaniżmu maħsub għal din il-bidla fid-diskriminazzjoni tal-kulur hu relatat mal-inibizzjoni ta' PDE6, li hu involut fil-phototransduction cascade tar-retina.
English: NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ ratiopharm
English: Healthy, elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'saħħithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li rriżultat f'madwar 90% ta' konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u l-metabolit attiv Ndesmethly, meta mqabbel ma' dawk li nstabu f'voluntiera żgħażagħ b'saħħithom (18-45 sena).
English: Chest pain, Fatigue, Feeling hot
Maltese: Prijapiżmu, Ematospermja, Erezzjoni fit-tul,
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Maltese: Nitric oxide mbagħad jattiva l-enzima guanylate cyclase, li jirriżulta f'livelli miżjuda ta' cyclic guanosine monophosphate (cGMP), u dan jipproduċi rilassament tal-muskoli lixxi fil-corpus cavernosum li jimtela bid-demm.
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Każijiet ta' difetti fil-vista relatati ma' l-amministrazzjoni ta' sildenafil u inibituri ta' PDE5 oħrajn ġew irrapportati b'mod spontanju (ara sezzjoni 4.8).
English: Concomitant use with alpha-blockers
Maltese: L-użu fl-istess ħin ma' alpha-blockers
English: - Seizures or fits - this occurs rarely.
Maltese: - Tnaqqis jew telf fil-vista f'daqqa - dan iseħħ b'mod rari.
English: The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Maltese: Is-sigurtà ta' sildenafil ma ġietx studjata f'dawn is-sottogruppi ta' pazjenti li ġejjin, u għalhekk l-użu tiegħu hu kontraindikat: indeboliment sever tal-fwied, pressjoni baxxa (pressjoni tad-demm ta' <90/50 mmHg), puplesija jew infart mijokardijaku reċenti, kif ukoll disturbi ereditarju magħrufa ta' deġenerazzjoni tar-retina, bħal retinitis pigmentosa (minoranza ta' dawn il-pazjenti għandhom disturbi ġenetiċi ta' phosphodiesterases retinali).
English: Vertigo, Tinnitus
Maltese: Vertigo, Żanżin filwidnejn
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Maltese: Ma kien hemm l-ebda effett fuq il-morfoloġija jew il-motilità tal-isperma wara dożi orali ta' 100 mg ta' sildenafil f'voluntiera b'saħħithom (ara sezzjoni 4.6).
English: - A sudden decrease or loss of vision - this occurs rarely.
Maltese: Reazzjonijiet serji tal-ġilda - dawn iseħħu b'mod rari.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Maltese: L-għoti flimkien tal-inibitur ta' HIV protease saquinavir, inibitur ta' CYP3A4, fl-istat fiss (1200 mg tliet darbiet kuljum) ma' sildenafil (100 mg doża waħda), irriżulta f'żieda ta' 140% fis-Cmax ta'
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets in blisters.
Maltese: Sildenafil ratiopharm hu fornut f'pakketti ta' 1, 2, 4, 8, 12, 24 jew 48 pillola miksija b'rita fil-folji.
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Maltese: 1 pillola miksija b'rita 2 pilloli miksija b'rita 4 pilloli miksija b'rita 8 pilloli miksija b'rita 12-il pillola miksija b'rita 24 pillola miksija b'rita
English: Vascular disorders
Maltese: Aċċident ċerebrovaskulari
English: Children and adolescents This medicine should NOT be given to children and adolescents under the age of 18.
Maltese: Tfal u adolexxenti Din il-mediċina m'għandhiex tingħata lil tfal u adolexxenti taħt l-età ta' 18-il sena.
English: Sildenafil ratiopharm 25 mg film-coated tablets
Maltese: Sildenafil ratiopharm 25 mg pilloli miksija b'rita
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ratiopharm GmbH
English: Sildenafil ratiopharm 25 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Maltese: Sildenafil ratiopharm 25 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 25 mg ta' sildenafil.
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 5.1).
Maltese: Ma kien hemm l-ebda effett fuq il-motilità jew il-morfoloġija tal-isperma wara dożi orali singoli ta' 100 mg ta' sildenafil f'voluntiera b'saħħithom (ara sezzjoni 5.1).
English: Effects on vision
Maltese: Effetti fuq il-vista
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Maltese: Kien hemm differenzi ħfief u temporanji ta' diskriminazzjoni tal-kulur (blu/aħdar) f'xi pazjenti li użaw il-Farnsworth-Munsell 100
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 25 mg ta' sildenafil.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 100 mg ta' sildenafil.
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Każijiet ta' newropatija anterjuri iskimika, mhux arteritika ta' l-għajn, kundizzjoni rari, relatati mal-amministrazzjoni ta' sildenafil u inibituri ta' PDE5 oħrajn ġew irrapportati b'mod spontanju fi studju ta' osservazzjoni (ara sezzjoni 4.8).
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
Maltese: 1 pillola miksija b'rita 2 pilloli miksija b'rita 4 pilloli miksija b'rita 8 pilloli miksija b'rita 12-il pillola miksija b'rita
English: Sildenafil ratiopharm 100 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Maltese: Sildenafil ratiopharm 100 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 100 mg ta' sildenafil.
English: Throat tightness, Nasal oedema, Nasal dryness
Maltese: Kloropsja, Kromatopsja, Sijanopsja, Eritropsja u Xantopsja
English: Sildenafil ratiopharm 25 mg film-coated tablets White to off-white, oblong film-coated tablet with edge.
Maltese: Sildenafil ratiopharm 25 mg pilloli miksija b'rita Pillola miksija b'rita, minn bajda sa bajda tagħti fil-griż, oblunga, bit-tarf.
English: Priapism
Maltese: Ematurja
English: Film-coated tablet
Maltese: Disturbi fil-qalb
English: Sildenafil ratiopharm 50 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Maltese: Sildenafil ratiopharm 50 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 50 mg ta' sildenafil.
English: Myalgia, Pain in extremity
Maltese: Studji in vitro
English: Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Maltese: Sustanzi għal kura ta' disfunzjoni erettili fosthom sildenafil, għandhom jintużaw b'kawtela f'pazjenti b'deformazzjoni anatomika tal-pene (bħal angulazzjoni, fibrosi fil-corpus cavernosum jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jagħmluhom predisposti għal prijapiżmu (bħal anemija tas-sickle cells, majeloma multipla jew lewkimja).
English: Sildenafil ratiopharm 50 mg film-coated tablets
Maltese: Sildenafil ratiopharm 50 mg pilloli miksija b'rita
English: Deafness
Maltese: Sturdament
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 50 mg ta' sildenafil.
English: If you are taking one of these medicines, your doctor may start you on the lowest dose (25 mg) of Sildenafil ratiopharm.
Maltese: Jekk qed tieħu waħda minn dawn il-mediċini, it-tabib tiegħek jista' jibdiek fuq l-inqas doża (25 mg) ta' Sildenafil ratiopharm.
English: Simultaneous intake of nitrates or nitric oxide donors with Sildenafil ratiopharm can have severe effects on your blood pressure.
Maltese: It-teħid fl-istess ħin ta' nitrates jew donaturi ta' nitric oxide ma' Sildenafil ratiopharm jista' jkollu effetti qawwija fuq il-pressjoni taddemm tiegħek.
English: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Maltese: M'hemmx dejta dwar l-interazzjoni bejn sildenafil u inibituri mhux speċifiċi ta' phosphodiesterase, bħal theophylline jew dipyridamole.
English: Sildenafil ratiopharm 100 mg film-coated tablets
Maltese: Sildenafil ratiopharm 100 mg pilloli miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil
Maltese: Sildenafil ratiopharm 25 mg pilloli miksija b'rita Sildenafil
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Maltese: Komuni (jistgħu' jaffettwaw sa persuna 1 minn kull 10): dardir, ħmura fil-wiċċ, fwawar talmenopawsa (sintomi jinkludu sensazzjoni f'daqqa ta' sħana fil-parti ta' fuq tal-ġisem), indiġestjoni, vista mżewwqa b'xi kulur, vista mċajpra, disturb viżiv,imnifsejn miżduda u sturdament.
English: Uncommon (may affect up to 1 in 100 people): vomiting, skin rash eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Maltese: Rari (jistgħu' jaffettwaw sa persuna 1 minn kull 1,000): ħass ħażin, puplesija, attakk tal-qalb, taħbit irregolari tal-qalb, fluss tad-demm temporanjament imnaqqas għal partijiet tal-moħħ, sensazzjoni ta' ssikkar tal-gerżuma, telf ta' sensazzjoni fil-ħalq, fsada fuq wara tal-għajnejn, tara doppju, tnaqqis filpreċiżjoni viżiva, sensazzjoni mhux normali fl-għajnejn, nefħa tal-għajn jew tal-kappell tal-għajn, frak jew tikek żgħar fil-vista tiegħek, tara dijademi madwar id-dwal, dilatazzjoni tal-ħabba tal-għajn, telf ta' kulur tal-abjad tal-għajnejn, fsada fil-pene, preżenza ta' demm fis-semen, imnieħer xott, nefħa fuq ġewwa tal-imnieħer, tħossok irritabbli u telf f'daqqa tas-smigħ.
English: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Maltese: Dan it-tnaqqis addizzjonali fil-pressjoni tad-demm kien jixbah lil dak li seħħ meta sildenafil ingħata waħdu lil voluntiera b'saħħithom (ara sezzjoni 5.1).
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Maltese: B'mod konformi mal-effetti magħrufin ta' sildenafil fuq il-passaġġ tan-nitric oxide/cGMP (ara sezzjoni 5.1), intwera li sildenofil iżid l-effetti tan-nitrati li jnaqqsu l-pressjoni, u għaldaqstant l-għoti flimkien ta' sildenofil u donaturi ta' nitric oxide jew nitrati fi kwalunkwe forma hu kontraindikat (ara sezzjoni 4.3).
English: In a medical emergency, you must tell anyone treating you that you have taken Sildenafil ratiopharm.
Maltese: F'emerġenza medika, għandek tgħid lil xi persuna li tkun qed tieħu ħsiebek li ħadt Sildenafil ratiopharm.
English: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Maltese: Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 25 mg ta' sildenafil.
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
Maltese: L-aktar reazzjonijiet avversi li ġew irrappurtati minn fost il-pazjenti li kienu kkurati b'sildenafil fl-istudji kliniċi kienu wġigħ ta' ras, fwawar, dispepsja, kongestjoni fl-imnieħer, sturdament, dardir, fwawar tal-menopawsa, disturb viziv, ċjanopsija u vista mċajpra.
English: Non-arteritic anterior ischaemic optic neuropathy (NAION)*, Retinal vascular occlusion*,
Maltese: Dawn il-mediċini ta' spiss jintużaw biex itaffu s-sintomi ta' wġigħ fis-sider (anġina pectoris).
English: The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Maltese: Wara jew l-għoti orali jew fil-vina, sildenafil jitneħħa bħala metaboliti b'mod predominanti fl-ippurgar (madwar 80% tad-doża orali mogħtija) u fi proporzjon inqas fl-awrina (madwar 13% taddoża orali mogħtija).
English: Sildenafil ratiopharm 25 mg film-coated tablets Pack sizes of 1, 2, 4, 8, or 12 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-fojl tal-PVC/PVDC/aluminju Sildenafil ratiopharm 25 mg pilloli miksija b'rita Daqs tal-pakketti ta' 1, 2, 4, 8, jew 12 pilloli miksija b'rita.
English: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Maltese: Studji in vitro wrew li sildenafil hu selettiv għal PDE5, li hu involut fil-proċess tal-erezzjoni.
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil
Maltese: Sildenafil ratiopharm 50 mg pilloli miksija b'rita Sildenafil
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12 or 24 film-coated tablets in blisters.
Maltese: Sildenafil ratiopharm hu fornut f'pakketti ta' 1, 2, 4, 8, 12 jew 24 pillola miksija b'rita fil-folji.
English: This is most likely to occur within 4 hours post sildenafil dosing.
Maltese: Dan hu l-aktar probabbli li jseħħ fi żmien 4 sigħat wara li tittieħed id-doża ta' sildenafil.
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 100 mg film-coated tablets Sildenafil
Maltese: Sildenafil ratiopharm 100 mg pilloli miksija b'rita Sildenafil
English: Sildenafil ratiopharm is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Maltese: Sildenafil ratiopharm hu indikat f'irġiel adulti b'disfunzjoni erettili.
English: Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Maltese: Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 100 mg ta' sildenafil.
English: Further information on clinical trials
Maltese: Aktar informazzjoni fuq provi kliniċi
English: This leaflet was last revised in {MM/YYYY}.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: - if you suffer from any of the following disorders or symptoms, as you may experience more side effects: an abnormality of the red blood cells (sickle cell anaemia); cancer of the blood (leukaemia); a cancer of the bone marrow (multiple myeloma); any disease or deformity of the penis.
Maltese: - jekk tbati minn kwalunkwe minn dawn id-disturbi jew sintomi li ġejjin, għax jista' jkollok iktar effetti sekondarji: anormalità taċ-ċelluli tad-demm ħomor (anemija taċ-ċelluli sickle); kanċer tad-demm (lewkimja); kanċer tal-mudullun (majeloma multipla); kwalunkwe marda jew deformità tal-pene.
English: Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
Maltese: Diplopja, Preċiżjoni viżiva mnaqqsa, Mijopija, Astenopja, Frak f'wiċċ il-likwidu vitruż,
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Maltese: Fi studju speċifiku dwar linterazzjonijiet fejn sildenafil (100 mg) ingħata flimkien ma' amlodipine f'pazjenti bi pressjoni għolja, kien hemm tnaqqis addizzjonali fil-pressjoni sistolika tad-demm fil-pożizzjoni mimduda ta' 8 mmHg.
English: D-82319 Starnberg Germany
Maltese: D-82319 Starnberg
English: Elderly patients (≥65 years)
Maltese: Pazjenti anzjani (≥65 sena)
English: • kidney problems;
Maltese: • problemi fil-kliewi;
English: - The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate,
Maltese: - Is-sustanza(i) l-oħra (eċċipjent(i)) hi (huma): sodium chloride, calcium chloride, magnesium sulphate,
English: Bronchodilator therapy, such as salbutamol
Maltese: Terapija ta' bronkodilatatur, bħal salbutamol
English: - anticholinesterases, botulinum toxin (neuromuscular effects).
Maltese: - anticholinesterases, tossina ta' botulinum (effetti newromuskolari).
English: amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); platinum compounds (risk of increased nephrotoxicity and ototoxicity);
Maltese: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (riskju ta' nefrotossiċità miżjuda);
English: 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: Distribution Less than 10% of tobramycin is bound to plasma proteins.
Maltese: Inqas minn 10% ta' tobramycin jeħel mal-proteini fil-plażma.
English: Pulmonary function test decreased
Maltese: Telqa Test tal-funzjoni pulmonari mnaqqas
English: 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
English: Each ampoule of 1.7 ml contains 170 mg tobramycin.
Maltese: Kull ampulla ta' 1.7 ml fiha 170 mg tobramycin.
English: Patients with a P. aeruginosa isolate with MIC 128 µg/ml at baseline are less likely to show a clinical response.
Maltese: Pazjenti b'iżolat ta' P. aeruginosa b'MIC 128 µg/ml fil-linja bażi huma inqas probabbli li juru rispons kliniku.
English: water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Maltese: ilma għall-injezzjonijiet, sulphuric acid u sodium hydroxide għall-aġġustament tal-pH.
English: Rash Urticaria Pruritus
Maltese: Raxx Urtikarja
English: o amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin,
Maltese: o amphotericin B, cefalotin, polymyxins (użati biex jikkuraw infezzjonijiet bil-mikrobi), ciclosporin, tacrolimus (użati biex inaqqsu l-attività tas-sistema immuni).
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: Rari (≥ 1/10,000 sa < 1/1,000);
English: • One carton with a Tolero nebuliser handset.
Maltese: • Kartuna waħda b'handset ta' nebulizzatur Tolero.
English: Table 2: Comparative performance data for the clinical test and reference batches: Vantobra /Tolero nebuliser handset
Maltese: Tabella 2: Dejta komparattiva ta' eżekuzzjoni għal-lottijiet tat-test kliniku u ta' referenza:
English: *Results from breath simulation and cascade impactor measurements.
Maltese: * Riżultati minn simulazzjoni tan-nifs u kejl permezz ta' cascade impactor.
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution Tobramycin
Maltese: Vantobra 170 mg soluzzjoni għan-nebulizzatur Tobramycin
English: Tinnitus
Maltese: Rimettar
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: Tagħrif ieħor M'hemmx evidenza li pazjenti kkurati għal 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: However, seven of 13 patients (54%) in the placebo-controlled trials who acquired isolates with MICs of 128 µg/ml while using TOBI had improvement in pulmonary function.
Maltese: minn 13-il pazjent (54%) fil-provi kkontrollati bil-plaċebo li kisbu iżolati b'MICs ta' 128 µg/ ml waqt li kienu qed jużaw TOBI kellhom titjib fil-funzjoni pulmonari.
English: What Vantobra contains - The active substance is tobramycin.
Maltese: - Is-sustanza attiva hi tobramycin.
English: • One carton with the medicinal product: 56 ampoules with nebuliser solution in 7 pouches.
Maltese: • Kartuna waħda bil-prodott mediċinali: 56 ampulla b'soluzzjoni għan-nebulizzatur f'7 boroż.
English: Haemoptysis Epistaxis
Maltese: Popolazzjonijiet speċjali
English: Hypoxia Hyperventilation
Maltese: Iperventilazzjoni