FrancophonIA/ELRC3.0 huggingface dataset:
English: Thymanax contains sodium
Maltese: Livell ta' sodium
English: Migraine
Maltese: Epatite
English: Thymanax with alcohol
Maltese: L-alkoħol
English: Level of sodium
Maltese: TNE TLI ERB
English: Following discontinuation of Thymanax therapy liver function tests should be repeated until serum transaminases return to normal.
Maltese: Wara l-waqfien tal-kura b'Thymanax, it-testijiet tal-funzjoni tal-fwied għandhom jiġu ripetuti sakemm it transaminażi fis-serum tirritorna għan-normal.
English: OXERVATE 56.5 % 69.6 % 58.0 % 74.0 % vehicle 37.5 % 29.2 % 19.6 % 43.1 % (p value) (0.191) (0.006) (0.001) (0.002)
Maltese: OXERVATE 56.5 % 69.6 % 58.0 % 74.0 % vettur 37.5 % 29.2 % 19.6 % 43.1 % (valur p) (0.191) (0.006) (0.001) (0.002)
English: 20122 Milano Italy
Maltese: 20122 Milano
English: Fax +39 02 58383215
Maltese: Faks +39 02 58383215
English: Via Campo di Pile 67100 L'Aquila Italy
Maltese: Via Campo di Pile 67100 L'Aquila
English: Via Campo di Pile, 67100 L'Aquila, Italy
Maltese: Via Campo di Pile, 67100 L'Aquila, L-Italja
English: pH 7.0-7.4 and osmolarity 280-320 mOsm/kg.
Maltese: Soluzzjoni ċara, u mingħajr kulur. pH 7.0-7.4 u osmolarità 280-320 mOsm/kg.
English: System organ class
Maltese: Sistema tal-Klassifika tal-Organi
English: PHARMACEUTICAL PARTICULARS 6.1 List of Excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: OXERVATE Vehicle (p value)
Maltese: OXERVATE Vettur (valur p)
English: Sodium hydroxide Nitrogen
Maltese: Sodium hydroxide
English: OXERVATE 22.7 % Vehicle (p value)
Maltese: OXERVATE 22.7 % Vettur (valur p)
English: OXERVATE 72.2 % Vehicle (p value)
Maltese: OXERVATE 72.2 % Vettur (valur p)
English: 4.6 Fertility, pregnancy, and lactation
Maltese: 4.6 Fertilità, tqala u treddigħ
English: Trehalose dihydrate
Maltese: Trehalose dihydrate Mannitol
English: Study NGF0214
Maltese: Studju NGF0214
English: Study NGF0212
Maltese: Studju NGF0212
English: Disodium hydrogen phosphate, anhydrous Sodium dihydrogen phosphate, dihydrate Hydroxypropylmethylcellulose Polyethylene glycol 6000
Maltese: Disodium hydrogen phosphate, anidru Disodium hydrogen phosphate, diidrat Hydroxypropylmethylcellulose Polyethylene glycol 6000
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE oxervate
English: Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
Maltese: Trattament ta' keratite newrotrofika moderata (difett epiteljali persistenti) jew severa (ulċera korneali) fl-adulti.
English: Study NGF0214 Study NGF0212
Maltese: Studju NGF0214 Studju NGF0212
English: They are ranked according to system organ class and classified according to 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 (<1/10,000), or not known (cannot be estimated from the available data).
Maltese: Huma kklassifikati skont is-sistema tal-klassifika tal-organi skont il-konvenzjoni li ġejja: 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)) jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Complete corneal healing rate
Maltese: Ċarezza korneali kompleta
English: Extra adapter (1), pipettes (3) and wipes (3) are included as spares.
Maltese: Adapter (1), pipetti (3) u mselħa (3) addizzjonali huma inklużi bħala spares.
English: EU/1/17/1197/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1197/001
English: Study NGF0212 enrolled a total of 174 patients (mean age 61±16 years, range 18-95 years), who have been exposed to OXERVATE and vehicle without the L-methionine excipient; 156 patients were assessed independently for efficacy, comparing two different dosages of the medicinal product with 20 and 10 µg/ml cenegermin to vehicle (52 patients per arm).
Maltese: L-istudju NGF0212 irrekluta total ta' 174 pazjent (età medja ta' 61±16-il sena, medda 18-95 sena), li kienu esposti għal OXERVATE u vettur mingħajr l-eċċipjent L-methionine; 156 pazjent ġew ivvalutati indipendentement għal effikaċja, bi tqabbil ta' żewġ dożaġġi tal-prodott mediċinali differenti b'20 u 10 µg/ml cenegermin għal vettur (52 pazjent f'kull grupp).
English: Risk of corneal melting or impending perforation
Maltese: Riskju ta' tidwib korneali jew perforazzjoni imminenti
English: * Recombinant form of human nerve growth factor produced in Escherichia Coli.
Maltese: * Għamla rikombinanti ta' fattur tal-iżvilupp tan-nerv uman prodott f'Escherichia coli.
English: 7 vial adapters, 42 pipettes, 42 disinfectant wipes and a dose recording card are provided separately from the vials.
Maltese: 7 adapters tal-kunjetti, 42 pipetta, 42 mselħa b'disinfettant u kard biex tirreġistra d-doża meħuda jiġu pprovduti separatament mill-kunjetti.
English: Study NGF0214 enrolled 48 patients (mean age 65±14 years, range 33-94 years) treated with OXERVATE 20 µg/ml or vehicle (24 patients per arm).
Maltese: L-istudju NGF0214 irrekluta 48 pazjent (età medja 65±14-il sena, medda 33-94 sena) trattati b'OXERVATE 20 µg/ml jew vettur (24 pazjent kull fergħa).
English: - if you are taking any eye drops containing corticosteroids (e.g. to treat an ocular inflammation) or preservatives (e.g. benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide).
Maltese: - jekk qed tuża xi qtar tal-għajnejn li fihom kortikosterojdi (eż. tittratta infjammazjoni okulari) jew preservattivi (eż. benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide).
English: Excipients: trehalose dihydrate, mannitol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine, water for injections, hydrochloric acid, sodium hydroxide, nitrogen.
Maltese: Eċċipjenti: trehalose dihydrate, mannitol, disodium hydrogen phosphate anidru, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine, ilma għall-injezzjonijiet, hydrochloric acid, sodium hydroxide, nitrogen.
English: Adverse drug reactions are presented below according to MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: Reazzjonijiet avversi tal-mediċina huma ppreżentati hawn taħt skont is-sistema tal-klassifika tal-organi ta' MedDRA (SOC u Livell ta' Terminu Ppreferut).
English: Best corrected distance visual acuity
Maltese: L-aħjar distanza kkoreġuta għal akutezza visiva
English: Use only with the vial adapters, pipettes and disinfectant wipes provided separately.
Maltese: Uża biss b'adapters ta' kunjetti, pipetti u mselħa b'disinfettanti pprovduti separatament.
English: The efficacy and safety of OXERVATE were evaluated in two multicentre, randomised, doublemasked, vehicle-controlled clinical studies (NGF0212 and NGF0214) in patients with moderate (persisted epithelial defect) or severe (corneal ulcer) neurotropic keratitis refractory to non-surgical treatments.
Maltese: L-effikaċja u s-sigurtà ta' OXERVATE ġew ivvalutati f'żewġ studji kliniċi, multiċentriċi, każwali, double masked u b'vettur bħala kontroll (NGF0212 u NGF0214) f'pazjenti b'keratite newrotrofika refrattorja moderata (difett epiteljali li ppersista) jew severa (ulċera korneali) għal trattamenti mhux kirurġiċi.
English: Store the weekly carton containing 7 vials of OXERVATE in the fridge (2-8 °C).
Maltese: Aħżen il-kartuna ta' kull ġimgħa li fiha 7 kunjetti ta' OXERVATE fil-friġġ (2-8°C).
English: The most commonly reported adverse reactions in patients suffering from neurotrophic keratitis and treated with OXERVATE during clinical studies include eye pain (11.1 %), eye inflammation (8.3 %), which may include anterior chamber inflammation and hyphaema; lacrimation increased (5.6 %), with symptoms such as eye discharge; eyelid pain (5.6 %) and foreign body sensation in the eye (5.6 %).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni rrapportati f'pazjenti li jbatu minn keratite newrotrofika u kkurati b'OXERVATE waqt studji kliniċi jinkludu uġigħ fl-għajn (11.1 %), infjamazzjoni tal-għajn (8.3 %), li tista' tinkludi infjammazzjoni tal-kompartiment anterjuri u hyphaema; żieda fid-dmugħ (5.6 %), b'sintomi bħal nixxiegħa tal-għajn; uġigħ fil-kappell tal-għajn (5.6 %) u sensazzjoni ta' korp barrani fl-għajnejn (5.6 %).
English: Results after 4 and 8 weeks of treatment
Maltese: Riżultati wara 4 u 8 ġimgħat ta' trattament
English: Use of ophthalmic topical agents known to inhibit epithelial healing, including corticosteroids or eye drops containing preservatives such as benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide and other quaternary ammonium derivatives, should be avoided during treatment of neurotrophic keratitis, as they could interfere with corneal healing (see section 4.5).
Maltese: L-użu ta' sustanzi topiċi oftalmiċi magħrufa li jimpedixxu l-fejqan epiteljali, inkluż kortikosterojdi jew qtar tal-għajnejn li jkun fihom preservattivi bħal benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide u derivattivi tal-ammonju kwaternarji oħrajn, għandhom jiġu evitati waqt it-trattament ta' keratite newrotrofika, peress li dawn jistgħu jinterferixxu mal-fejqan korneali (ara sezzjoni 4.5).
English: Pack size: 7 multi-dose vials.
Maltese: Daqs tal-pakkett: 7 kunjetti ta' ħafna dożi.
English: PC: {number} SN: {number} NN: {number}
Maltese: M'hemmx tagħrif dwar l-użu ta' cenegermin f'nisa tqal.
English: • headache.
Maltese: (mhux assenjat).
English: Other topical ophthalmic products may be used during treatment with OXERVATE when used 15 minutes apart, with the exception of agents known to inhibit epithelial healing (e.g. corticosteroids or eye drops containing preservatives such as benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide and other quaternary ammonium derivatives) (see sections 4.2 and 4.4).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Prodotti oftalmiċi topiċi oħra jistgħu jintużaw waqt it-trattament b'OXERVATE meta jintużaw f'intervall ta' 15-il minuta bejnithom għajr sustanzi magħrufa li jimpedixxu l-fejqan epiteljali (eż. kortikosterojdi jew qtar għall-għajnejn li fihom preservattivi bħal benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide u derivattivi tal-ammonju kwaternarji oħrajn) (ara sezzjonijiet 4.2 u 4.4).
English: Pharmacy:
Maltese: FARMAĊEWTIKU
English: It is important that the risk of corneal melting or impending perforation, and the need to undergo emergency surgery or another procedure is assessed before starting therapy with OXERVATE as cenegermin should not be used in patients requiring immediate surgery.
Maltese: Huwa importanti li r-riskju ta' tidwib korneali jew perforazzjoni imminenti, u l-ħtieġa ta' kirurġija ta' emerġenza jew proċedura oħra tiġi valutata qabel tinbeda t-terapija b'OXERVATE peress li cenegermin m'għandux jintuża f'pazjenti li jeħtieġu kirurġija immedjata.
English: Patient:
Maltese: Pazjent:
English: OXERVATE contains the active ingredient cenegermin.
Maltese: X'fih OXERVATE - Is-sustanza attiva hija cenegermin.
English: Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors.
Maltese: Il-fattur tal-iżvilupp tan-nerv huwa proteina endoġena involuta fid-divrenzjar u fil-manteniment ta' newroni, li jaġixxi permezz ta' riċetturi speċifiċi tal-fattur tal-iżvilupp tan-nerv ta' affinità għolja (i.e TrkA) u ta' affinità baxxa (jiġifieri p75NTR).
English: Hydrochloric acid
Maltese: Ilma għall-injezzjonijiet Hydrochloric acid
English: How to store OXERVATE Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: 6) Take a pipette and remove it from the protective packaging.
Maltese: Ħu pipetta u neħħiha mill-ippakkjar protettiv.
English: Pack size: 7 multi-dose vials per carton
Maltese: Daqs tal-pakkett: 7 kunjetti ta' ħafna dożi f'kull kartuna.
English: • Screw the pipette (clockwise) into the connector part of the vial adapter (picture 5).
Maltese: • Invita l-pipetta (dawwar fid-direzzjoni tal-arloġġ) ġol-konnettur parti mill-adapter tal-kunjett (stampa 5).
English: Pharmacotherapeutic Group: {not yet assigned}, ATC code: {not yet assigned}.
Maltese: Kodiċi ATC:
English: 1 ml of solution contains 20 micrograms of cenegermin.
Maltese: 1 ml ta' OXERVATE fih 20 mikrogramma ta' cenegermin.
English: • inflammation of the eye;
Maltese: • infjammazzjoni fl-għajn;
English: Nerve growth factor receptors are expressed in the anterior segment of the eye (cornea, conjunctiva, iris, ciliary body, and lens), by the lacrimal gland, and by posterior segment intraocular tissues.
Maltese: Riċetturi tal-fattur tal-iżvilupp tan-nerv jiġu espressi fis-segment anterjuri tal-għajn (kornea, konġunktiva, il-ħabba, il-korp ċiljari, u l-lenti), mill-glandola lakrimali u mit-tessuti intraokulari tas-segment posterjuri.
English: Other medicines and OXERVATE
Maltese: Mediċini oħra u OXERVATE
English: Specifically, more than 80 % of the 31 patients who were healed after initial OXERVATE 20 µg/ml treatment and for whom a response was available, remained completely healed at the end of the 12 months follow up period.
Maltese: Speċifikament, aktar minn 80 % tal-31 pazjent li fiequ wara trattament inizjali b'OXERVATE 20 µg/ml u li għalihom kien hemm rispons disponibbli, baqgħu kompletament mfejqa fi tmiem il-perjodu ta' follow-up ta' 12-il xahar.
English: OXERVATE 20 µg/ml eye drops cenegermin
Maltese: OXERVATE 20 mikrogramma/ml soluzzjoni ta' qtar għall-għajnejn cenegermin
English: 7) Screw the pipette clockwise into the luer lock connector of the vial adapter.
Maltese: 7) Invita l-pipetta billi ddawwar favur l-arloġġ ġol-luer lock connector tal-adapter tal-kunjett.
English: 5) Take an individual disinfectant wipe and gently clean the surface of the valve on the luer lock connector of the vial adapter.
Maltese: 5) Ħu mselħa b'disinfettant individwali u naddaf b'mod ġentili l-wiċċ tal-valv tal-luer lock connector tal-adapter tal-kunjett.
English: One ml of solution contains 20 micrograms of cenegermin*.
Maltese: U KWANTITATTIVA Millilitru wieħed ta' soluzzjoni fih 20 mikrogramma ta' cenegermin*.
English: • sensitivity to light;
Maltese: • sensittività għad-dawl;
English: The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity.
Maltese: It-trattament b'canegermin, mogħti bħala qtar tal-għajnejn, huwa maħsub biex jippermetti r-restawr ta' integrità korneali.
English: The patient will receive a weekly carton including 7 vials of OXERVATE in an insulated pack.
Maltese: Il-pazjent ser jirċievi kartuna ta' kull ġimgħa li tinkludi 7 kunjetti ta' OXERVATE f'pakkett insulat.
English: The percentage of patients experiencing complete corneal clearing (grade 0 on the modified Oxford scale), the least squares mean change in best corrected distance visual acuity score (Early Treatment Diabetic Retinopathy Study letters) from baseline and any improvement in corneal sensitivity as measured in millimetres by Cochet-Bonnet aesthesiometry (difference compared to baseline >0) was also measured after 8 weeks of treatment in both studies, and summarized in the table below.
Maltese: Il-perċentwal ta' pazjenti li esperjenzaw ċarezza korneali kompleta (grad 0 fuq l-iskala modifikata ta' Oxford), il-bidla medja tal-inqas kwadru fl-aħjar distanza kkoreġuta għal punteġġ ta' akutezza viżiva (ittri ta' Studju dwar ir-Retinopatija Dijabetika ta' Trattament Bikri) mil-linja bażi u kwalunkwe titjib fis-sensittività korneali kif imkejjel f'millimetri b'estesjometrija ta' Cochet-Bonnet (differenza mqabbla mal-linja bażi >0) ġie mkejjel ukoll wara 8 ġimgħat ta' trattament fiż-żewġ studji, u miġbur fil-qosor fit-tabella t'hawn isfel.
English: Patients considered completely healed at the end of 8 weeks of treatment with OXERVATE did not tend to have recurrences within the 12 months follow-up period of study NGF0212.
Maltese: Pazjenti li ġew ikkunsidrati li jkunu fiequ kompletament fi tmiem 8 ġimgħat bit-trattament b'OXERVATE ġeneralment ma kellhomx rikorrenza fi żmien il-perjodu ta' follow-up ta' 12-il xahar ta' studju NGF0212.
English: OXERVATE should only be administered using the associated delivery system (vial adapter and pipettes), according to the instructions presented in section 6.6.
Maltese: OXERVATE għandu jingħata biss permezz tas-sistema ta' forniment assoċjat (adapter tal-kunjett u pipetti), skont l-istruzzjonijiet preżentati f'sezzjoni 6.6.
English: 11) Once it has been correctly filled, unscrew the pipette from the luer lock connector of the vial adapter.
Maltese: 11) Ġaladarba tkun imtliet b'mod korrett, ħoll il-pipetta minn mal-luer-lock connector tal-adapter tal-kunjett.
English: Eye inflammation, eyelid pain, foreign body sensation in the eye, lacrimation increased, blepharitis, conjunctival hyperaemia, photophobia, eye irritation Uncommon Corneal neovascularization
Maltese: Infjammazzjoni tal-għajn, , uġigħ fil-kappell tal-għajn, sensazzjoni ta' korp barrani fl-għajn, żieda fid-dmugħ, blefarite, iperaemja konġunktivali, fotofobija, irritazzjoni tal-għajn
English: 4) Remove and discard the vial adapter blister pack.
Maltese: 4) Neħħi u armi l-pakkett tal-folja tal-adapter tal-kunjett.
English: OXERVATE contains cenegermin, a recombinant form of human nerve growth factor.
Maltese: OXERVATE fih cenegermin, għamla rikombinanti ta' fattur tal-iżvilupp tan-nerv uman.
English: Complete corneal clearing
Maltese: Rata ta' fejqan korneali komplet
English: • Take a pipette (dropper) and remove it from its protective packaging.
Maltese: • Ħu pipetta (qattara) u neħħiha mill-ippakkjar protettiv tagħha.
English: • Peel-off the back of the vial adapter blister pack (picture 2).
Maltese: • Qaxxar in-naħa ta' wara tal-pakkett tal-folji tal-adapter tal-kunjett (stampa 2).
English: The table below summarizes the results for complete corneal healing of the persistent epithelial defect or corneal ulcer (the primary endpoint, defined as the greatest diameter of corneal fluorescein staining <0.5 mm) after 4 and 8 weeks of treatment for patients who received OXERVATE 20 µg/ml or vehicle in the two studies.
Maltese: It-tabella t'hawn taħt tiġbor fil-qosor ir-riżultati għal fejqan korneali komplet tad-difett epiteljali persistenti jew ulċera korneali (l-ewwel punt aħħari, imfisser bħala l-akbar dijametru ta' tbajja' ta' fluorescein korneali < 0.5 mm) wara 4 u 8 ġimgħat ta' trattament għal pazjenti li rċevew OXERVATE 20 µg/ml jew vettur fiż-żewġ studji.
English: The recommended dose is 1 drop in the affected eye 6 times a day at 2-hourly intervals, starting in the morning (i.e. 6 drops per day within 12 hours).
Maltese: Id-doża rakkomandata hija qatra 1 (jiġifieri qatra 1 fl-għajn affettwata 6 darbiet kuljum f'intervalli ta' sagħtejn, billi tibda filgħodu (jiġifieri, 6 qatriet kuljum fi żmien 12-il siegħa).
English: oxervate
Maltese: Bijotrasformazzjoni
English: • Remove the plastic flip-off cap from the vial (picture 1).
Maltese: • Aqla' l-għatu tal-plastik li jinqala' b'saba' minn mal-kunjett (stampa 1).
English: 13) Immediately discard the used pipette and wipe after instillation.
Maltese: 13) Minnufih armi l-pipetta użata u imsaħ wara l-instillazzjoni.
English: Cenegermin is mostly removed from the eye with the tear production and through the naso-lacrimal duct; the minor portion that is absorbed occurs mostly in the conjunctiva and peri-orbital tissue and to a minor extent through the cornea following ocular administration.
Maltese: Cenegermin jiġi prinċipalment eliminat mill-għajn bil-produzzjoni ta' dmugħ u permezz tal-passaġġ nażo-lakrimali; il-porzjon minuri li jiġi assorbit jidher prinċipalment fil-konġunktiva u t-tessut periorbitali u sa punt minuri permezz tal-kornea wara l-għoti okulari.
English: • Ensure that the pipette plunger is pushed all the way down.
Maltese: • Minnufih armi l-pipetta użata wara l-użu, anke jekk ikun baqa' xi ftit likwidu fiha.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (tista' taffettwa sa persuna 1 minn kull 100)
English: Uncommon Corneal abscess Nervous system disorders Common
Maltese: Disturbi fis-sistema nervuża
English: Package leaflet: Information for the patient OXERVATE 20 micrograms/ml eye drops, solution cenegermin ▼This medicine is subject to additional monitoring.
Maltese: TAL-PRODOTT MEDIĊINALI OXERVATE 20 mikrogramma/ml soluzzjoni ta' qtar għall-għajnejn cenegermin
English: Nonclinical data reveal no hazard for humans based on conventional studies of safety pharmacology (central nervous system), single-dose toxicity, repeat-dose toxicity and toxicity to reproduction, embryo-foetal development, pre- and post-natal development using ocular (eye drop), intravenous, and/or subcutaneous administration.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika (sistema nervuża ċentrali), effett tossiku minn doża unika, effett tossiku minn dożi ripetuti, effett tossiku fuq is-sistema riproduttiva, l-iżvilupp embrijo-fetali, żvilupp ta' qabel u wara t-twelid permezz tal-għoti fl-għajnejn (qatra fl-għajn), ġol-vina, u/jew l-għoti taħt il-ġilda ma juri l-ebda periklu speċjali għall-bnedmin.
English: OXERVATE vials
Maltese: Mhux komuni
English: • abnormal sensation and discomfort in the eye, including feeling that there is something in the eye;
Maltese: • sensazzjoni abnormali u skumdità fl-għajn, inkluż sensazzjoni li hemm xi ħaġa fl-għajn;
English: You should continue your treatment for 8 weeks.
Maltese: Għandek tkompli ttrattament tiegħek għal 8 ġimgħat.
English: If more than one topical ophthalmic product is being used, the eye drops must be administered at least 15 minutes apart, to avoid diluting the other product.
Maltese: Jekk ikun qed jintuża aktar minn prodott oftalmiku topiku wieħed, il-qtar tal-għajnejn għandhom jingħataw f'intervall ta' mill-anqas 15-il minuta, sabiex jiġi evitat li l-prodott jiġi dilwit.
English: The weekly carton containing the vials must be stored in a freezer (-20 °C ±5 °C).
Maltese: Il-kartuna ta' kull ġimgħa li fiha l-kunjetti għandha tinħażen fi friżer (-20°C ±5°C).
English: • excessive ingrowth of blood vessels into the cornea; • infection of the cornea with pus and swelling.
Maltese: • infezzjoni fil-kornea b'materja u nefħa.
English: In general, the systemic absorption of OXERVATE is negligible.
Maltese: B'mod ġenerali, l-assorbiment sistemiku ta' OXERVATE huwa negliġibbli.
English: The spike of the vial adapter should pierce through the vial's rubber stopper.
Maltese: Għandha tintuża pipetta individwali għal kull applikazzjoni.
English: If eye ointment, gel or other viscous eye drops are used, they should be administered 15 minutes following OXERVATE treatment (see also section 4.5).
Maltese: Jekk ser jintuża xi ingwent tal-għajnejn, ġell jew qtar viskuż ieħor, dawn għandhom jingħataw 15-il minuta wara t-trattament b'OXERVATE (ara wkoll sezzjoni 4.5).
English: Cenegermin administered by eye drops is mostly eliminated with the tear secretion.
Maltese: Doża eċċessiva topika mhijiex probabbli li sseħħ jew li tkun assoċjata ma' tossiċità.
English: The following adverse reactions listed below were observed in clinical studies in patients suffering from neurotrophic keratitis, treated with OXERVATE 20 μg/ml.
Maltese: Ir-reazzjonijiet avversi li ġejjin elenkati hawn taħt kienu osservati fl-istudji kliniċi f'pazjenti li jbatu minn kerarite newtrofika, ikkurati b'OXERVATE 20 μg/ml.
English: Gently push the pipette plunger in until a single drop is instilled into the conjunctival fornix.
Maltese: Kull pipetta għandha tintrema minnufih wara li tintuża, anke jekk ikun baqa' xi ftit likwidu fiha.
English: OXERVATE 20 micrograms/ml eye drops, solution cenegermin
Maltese: M'hemmx tagħrif dwar l-effetti ta' cenegermin fuq il-fertilità tal-bniedem.
English: Contents of the pack and other information What OXERVATE contains
Maltese: Kif taħżen OXERVATE Kontenut tal-pakkett u informazzjoni oħra
English: Ocular cancer
Maltese: Kanċer okulari
English: • eye pain.
Maltese: • uġigħ fl-għajn.