FrancophonIA/ELRC3.0 huggingface dataset:
English: PegIntron 80 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: PegIntron 80 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: PegIntron 120 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: PegIntron 120 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: PegIntron 100 micrograms powder for injection peginterferon alfa-2b
Maltese: PegIntron 100 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: The reconstituted solution has a concentration of 50 micrograms in 0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 50 mikrogramma f'0.5 ml.
English: This may require combinations of various PegIntron dose strengths and volumes.
Maltese: Dan jista' jeħtieġ kombinazzjonijiet ta' diversi qawwiet ta' dożi u volumi ta' PegIntron.
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: PegIntron 50 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 50 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: PegIntron 100 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: PegIntron 100 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: PegIntron 50 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: PegIntron 50 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: Following single doses of PegIntron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Maltese: Wara dożi singoli ta' PegIntron ta' bejn 0,25 u 2,0 mikrogrammi/kg/ġimgħa, ilkonċentrazzjoni ta' neopterin fis-serum żdiedet b'mod li kien relatat mad-doża.
English: PegIntron 150 micrograms powder and solvent for injection peginterferon alfa-2b
Maltese: PegIntron 150 mikrogramma trab u solvent għall-injezzjoni. peginterferon alfa-2b
English: PegIntron 120 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: PegIntron 120 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett għandu jiġi rikostitwit b'0,7 ml ta' ilma għall-injezzjonijiet biex tingħata sa 0,5 ml ta' soluzzjoni.
English: PegIntron 150 micrograms powder for injection peginterferon alfa-2b
Maltese: PegIntron 150 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: PegIntron 120 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 120 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: PegIntron 50 micrograms powder and solvent for solution for injection PegIntron 80 micrograms powder and solvent for solution for injection PegIntron 100 micrograms powder and solvent for solution for injection PegIntron 120 micrograms powder and solvent for solution for injection PegIntron 150 micrograms powder and solvent for solution for injection
Maltese: PegIntron 50 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 80 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 100 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 120 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 150 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni
English: Caution should be used when adding PegIntron and ribavirin to HAART therapy (see ribavirin SmPC).
Maltese: Wieħed għandu joqgħod attent meta jżid PegIntron u ribavirin ma' terapija HAART (ara l-SmPC ta' ribavirin).
English: The reconstituted solution has a concentration of 100 micrograms in 0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 100 mikrogramma f'0.5 ml.
English: EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/131/002 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/131/003 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: PegIntron 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 150 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: Prior to initiation of PegIntron therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Maltese: Qabel tinbeda t-terapija b'PegIntron, il-livelli tat-TSH għandhom jiġu evalwati u kwalunkwe anormalità tattirojde li tinstab f'dak il-ħin għandha tiġi ikkurata b'terapija konvenzjonali.
English: EU/1/00/131/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/050 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/131/048 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/131/050 (12-il pinna, 12-il labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: PegIntron is supplied as: - 1 vial of powder for solution for injection and 1 ampoule of solvent for parenteral use; - 1 vial of powder for solution for injection, 1 ampoule of solvent for parenteral use, 1 injection syringe, 2 injection needles and 1 cleansing swab; - 4 vials of powder for solution for injection and 4 ampoules of solvent for parenteral use; - 4 vials of powder for solution for injection, 4 ampoules of solvent for parenteral use, 4 injection syringes, 8 injection needles and 4 cleansing swabs; - 6 vials of powder for solution for injection and 6 ampoules of solvent for parenteral use.
Maltese: PegIntron huwa fornut bħala: - kunjett wieħed ta' trab għal soluzzjoni għall-injezzjoni u ampulla waħda ta' solvent għall-użu parenterali; - kunjett wieħed ta' trab għal soluzzjoni għall-injezzjoni, ampulla waħda ta' solvent għall-użu parenterali, siringa għall-injezzjoni waħda, 2 labriet tal-injezzjoni u mselħa waħda għat-tindif;
English: PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: PegIntron 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 80 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: EU/1/00/131/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/131/024 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: - If you are also being treated for HIV (see section “Other medicines and PegIntron”).
Maltese: - jekk qed tingħataw ukoll kura għall-HIV (ara sezzjoni “Mediċini oħra u PegIntron”).
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: PegIntron 50 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett għandu jiġi rikostitwit b'0,7 ml ta' ilma għall-injezzjonijiet biex tingħata sa 0,5 ml ta' soluzzjoni.
English: EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/131/032 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/131/034 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
Maltese: PegIntron 100 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett fih 100 mikrogramma ta' peginterferon alfa-2b imkejjel fuq bażi ta' proteina.
English: EU/1/00/131/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/131/009 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: EU/1/00/131/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/131/007 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/131/008 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: The intended dose of 1.5 g/kg of PegIntron to be used in combination with ribavirin may be delivered in weight categories with the PegIntron strengths according to Table 1.
Maltese: Id-doża intenzjonata ta' 1,5 g/kg ta' PegIntron li għandha tintuża flimkien ma' ribavirin tista' tingħata f'kategoriji ta' piż bil-qawwiet ta' PegIntron skont Tabella 1.
English: EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/131/022 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/131/023 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: EU/1/00/131/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/131/014 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/131/004 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen EU/1/00/131/035
Maltese: PegIntron 80 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/00/131/035
English: EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/131/040 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/131/042 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: Description of selected adverse reactions in children and adolescents Most of the changes in laboratory values in the PegIntron/ribavirin clinical trial were mild or moderate.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula fi tfal u adolexxenti Ħafna mill-bidliet fil-valuri tal-laboratorju fil-prova klinika b'PegIntron/ribavirin kienu ħfief jew moderati.
English: EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/131/030 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: In general, the adverse events seen in overdose cases involving PegIntron are consistent with the known safety profile for PegIntron; however, the severity of the events may be increased.
Maltese: B'mod ġenerali, l-avvenimenti avversi li dehru f'każijiet ta' doża eċċessiva li kienu jinvolvu PegIntron huma konsistenti mal-profil ta' sigurtà magħruf għal PegIntron; madankollu, is-severità tal-avvenimenti tista' tiżdied.
English: EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/131/028 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of PegIntron and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Maltese: Fi prova klinika b'107 pazjent tifel u tifla u adolexxenti (3 sa 17-il sena) ikkurati b'terapija kombinata ta' PegIntron u ribavirin, bidliet fid-doża kienu meħtieġa f'25% tal-pazjenti, l-aktar komuni minħabba anemija, newtropenija jew telf tal-piż.
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: PegIntron 100 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett għandu jiġi rikostitwit b'0,7 ml ta' ilma għall-injezzjonijiet biex tingħata sa 0,5 ml ta' soluzzjoni.
English: EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
Maltese: EU/1/00/131/036 (4 pinen, 4 labriet tal-injezzjoni u 8 imsielaħ biex tnaddaf) EU/1/00/131/038 (12-il pinna, 12-labra tal-injezzjoni u 24 imselħa biex tnaddaf)
English: PegIntron 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: PegIntron 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: EU/1/00/131/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Maltese: EU/1/00/131/019 (4 kunjetti ta' trab, 4 ampulli ta' solvent, 4 siringi għall-injezzjoni, 8 labriet talinjezzjoni u 4 imsielaħ biex tnaddaf)
English: - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Maltese: - jekk għandkom infezzjoni attwali jew preċedenti bil-virus tal-epatite B, peress li t-tabib tagħkom jista' jkun jixtieq jimmonitorjakom aktar mill-qrib.
English: Wheezing, nasal discomfort, rhinorrhoea Gastrointestinal disorders Very common:
Maltese: Tħarħir, skumdità fl-imnieħer, rinoreja Disturbi gastro-intestinali
English: The use of PegIntron in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Maltese: L-użu ta' PegIntron flimkien ma' ribavirin ma kellux impatt negattiv li jidher fuq il-kontroll ta' viremija bl-HIV waqt it-terapija jew fiżżmien ta' follow-up.
English: EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/131/029 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Maltese: EU/1/00/131/027 (12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf)
English: Table 2b Two-step dose reduction of PegIntron in combination therapy in adults First dose reduction to PegIntron 1 µg/kg
Maltese: Tabella 2b Tnaqqis f'żewġ fażijiet fid-doża ta' PegIntron f'terapija kkombinata fl-adulti
English: Interferon alfa-2b has been shown to be abortifacient in primates.
Maltese: Intwera illi interferon alfa-2b jikkawża abort fix-xadini.
English: Boceprevir must not be administered in the absence of PegIntron and ribavirin.
Maltese: Boceprevir m'għandux jingħata mingħajr PegIntron u ribavirin.
English: PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Maltese: PegIntron 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: ** For patients > 120 kg, the PegIntron dose should be calculated based on the individual patient weight.
Maltese: ** Għal pazjenti > 120 kg, id-doża ta' PegIntron għandha tiġi kkalkulata skont il-piż tal-pazjent individwali.
English: The full EPAR and risk management plan summary for Omidria 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: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Il-ketorolak hija sustanza anti-infjammatorja mhux sterojdi (NSAID).
English: In addition, 7% (29 out of 403) of patients receiving Omidria experienced moderate-to-severe pain compared with 14% (57 out of 403) of patients given placebo, and 25% (104 out of 403) were painfree in the early period following surgery, compared with 17% (69 out of 403) of patients receiving placebo.
Maltese: Barra minn hekk, 7% (29 minn 403) tal-pazjenti li rċevew Omidria esperjenzaw uġigħ moderat sa sever meta mqabbel ma' 14% (57 minn 403) tal-pazjenti li ngħataw plaċebo, u 25% (104 minn 403) ma kellhomx uġigħ fl-ewwel perjodu wara l-kirurġija, meta mqabbel ma' 17% (69 minn 403) tal-pazjenti li rċevew plaċebo.
English: Other information about Omidria
Maltese: Informazzjoni oħra dwar Omidria
English: Omidria phenylephrine / ketorolac
Maltese: Omidria fenilefrina / ketorolak
English: With regard to the safety of Omidria, the medicine was generally well tolerated.
Maltese: Firrigward tas-sigurtà ta' Omidria, il-mediċina normalment hija ttollerata sew.
English: This is a summary of the European public assessment report (EPAR) for Omidria.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Omidria.
English: Phenylephrine is a ‘selective alpha-1 adrenergic receptor agonist', which attaches to and activates alpha-1 adrenergic receptors that are found on smooth muscle cells, causing these muscles to contract.
Maltese: Il-fenilefrina huwa "agonist selettiv tar-riċetturi adrenerġiċi alfa-1", li jeħel ma' u jattiva riċetturi adrenerġiċi alfa-1 li jinsabu fuq iċ-ċelloli tal-muskoli lixxi, u jġiegħel dawn il-muskoli jikkuntrattaw.
English: The most common side effects with Omidria (which may affect up to 1 in 10 people) are eye pain, anterior chamber inflammation (inflammation of the fluid-filled space inside the eye between the iris and the cornea), conjunctival hyperaemia (redness of the membrane that lies over the white part of the eye), photophobia (increased sensitivity of the eyes to light), corneal oedema (swelling of the transparent layer in front of the eye that covers the pupil and iris) and inflammation.
Maltese: L-effetti sekondarji l-aktar komuni b'Omidria (li jistgħu jaffettwaw sa 1 minn kull 10) huma uġigħ flgħajn, infjamazzjoni tal-kompartiment anterjuri (infjammazzjoni tal-ispazju mimli bi fluwidu ġewwa lgħajn bejn l-iris u l-kornea), iperimija konġunktivali (ħmura tal-membrana li qiegħda fuq il-parti bajda tal-għajn), fotofobija (żieda fis-sensittività tal-għajnejn għad-dawl), edema tal-kornea (nefħa tas-saff trasparenti quddiem l-għajn li jgħatti il-ħabba u l-iris) u infjammazzjoni.
English: Omidria has been investigated in two main studies involving a total of 821 patients undergoing lens replacement surgery, in which it was compared with placebo (a dummy treatment).
Maltese: Omidria kien investigat f'żewġ studji ewlenin li kienu jinvolvu total ta' 821 pazjent li kienet ser issirilhom kirurġija ta' sostituzzjoni tal-lenti, fejn tqabbel ma' plaċebo (kura finta).
English: Why is Omidria approved?
Maltese: Għaliex ġie approvat Omidria?
English: The recommended dose is 4 ml of Omidria diluted in 500 ml of irrigation solution, to be used during the surgery to replace the lens.
Maltese: Id-doża rakkomandata hija ta' 4 ml ta' Omidria mħallat f'500 ml ta' soluzzjoni għal irrigazzjoni, biex tintuża matul l-operazzjoni tas-sostituzzjoni tal-lenti.
English: Both studies showed that the pupil remained dilated during surgery in patients given Omidria (+0.1 mm), while it contracted in those given placebo (-0.5 mm).
Maltese: Iż-żewġ studji wrew li l-ħabba tal-għajn baqgħet miftuħa matul il-kirurġija f'pazjenti li ngħataw Omidria (+0.1 mm), filwaqt li ngħalqet f'dawk li ngħataw plaċebo (-0.5 mm).
English: What are the risks associated with Omidria?
Maltese: X'inhuma r-riskji assoċjati ma' Omidria?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Omidria valida fl-Unjoni Ewropea kollha fit-28 ta' Lulju 2015.
English: The incidence of side effects with Omidria was similar to that reported in patients receiving placebo.
Maltese: L-inċidenza ta' effetti sekondarji b'Omidria kienet simili għal dik irrapportata f'pazjenti li rċevew plaċebo.
English: Fewer than 1 in 10 of the patients given Omidria had a pupil diameter below 6 mm (which makes surgery more difficult), whereas about 4 patients in 10 experienced this after being given placebo.
Maltese: Anqas minn 1 minn kull 10 tal-pazjenti li ngħataw Omidria kellhom dijametru tal-ħabba iżgħar minn 6 mm (li jagħmel ilkirurġija aktar diffiċli), filwaqt li madwar 4 pazjenti minn kull 10 esperjenzaw dan wara li ngħataw plaċebo.
English: These side effects are typical following lens replacement surgery, and most were mild to moderate in severity and resolved spontaneously.
Maltese: Dawn l-effetti sekondarji huma tipiċi wara kirurġija ta' sostituzzjoni tal-lenti, u ħafna minnhom kienu ħfief sa moderati fisseverità u għaddew b'mod spontanju.
English: When applied to the eye, phenylephrine makes the muscle of the iris contract (tighten) and allows the pupil to widen.
Maltese: Meta jiġi applikat fl-għajn, il-fenilefrina jġiegħel lillmuskoli tal-iris jikkuntratta (jissikka) u jippermetti li titwessa' l-ħabba.
English: Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Maltese: Iż-żewg sustanzi attivi ilhom disponibbli fl-Unjoni Ewropea (UE) bħala preparazzjonijiet separati għal għadd ta' snin.
English: It can only be obtained with a prescription and must be given by a qualified ophthalmological surgeon (eye surgery specialist) experienced in lens replacement.
Maltese: Jista' jinkiseb biss b'riċetta ta' tabib u għandu jingħata minn kirurgu oftalmoloġiku kkwalifikat (speċjalista fil-kirurġija tal-għajnejn) b'esperjenza fis-sostituzzjoni tal-lenti.
English: When applied to the eye, ketorolac reduces the production of prostaglandins in the eye and thereby reduces the pain and inflammation caused by eye surgery.
Maltese: Meta jiġi applikat fl-għajn, il-keterolak tnaqqas il-produzzjoni ta' prostaglandini flgħajn u b'hekk jitnaqqas l-uġigħ u l-infjammazzjoni kkawżati mill-kirurġija tal-għajn.
English: Further information can be found in the summary of the risk management plan.
Maltese: Aktar informazzjoni tinstab fis-sommarju tal-pjan ta' ġestjoni tar-riskju.
English: This is a type of surgery in which a new lens is implanted into the eye.
Maltese: Din hija tip ta' kirurġija li fiha tiġi impjantata lenti ġdida fl-għajn.