qanastek/EMEA-V3 huggingface dataset:
Paediatric population EMADINE may be used in paediatric patients (3 years of age and older) at the same posology as in adults.
Popolazzjoni pedjatrika EMADINE jista ’ jintuża fit- tfal (minn 3 snin ’ l fuq) bl- istess pożoloġija bħal fl- adulti.
Hepatic and Renal impairment Use EMADINE has not been studied in these patients and therefore, its use is not recommended in this population.
Użu f’ pazjenti b’ indeboliment tal- kliewi jew tal- fwied EMADINE ma ’ ġiex studjat f’ dawn il- pazjenti, għalhekk l- użu tiegħu f’ din il- popolazzjoni mhux irrakkomandat.
Method of administration
Metodu ta ’ l- għoti
For ocular use.
Użu għall- għajnejn.
To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Biex tiġi evitata kontaminazzjoni tat- tarf tal- qattara u tas- soluzzjoni, għandu jkun hemm attenzjoni biex il- kappell ta ’ l- għajnejn, il- postijiet tal- madwar jew xi superfiċji oħra ma jintmissux bit- tarf tal - qattara tal- flixkun.
2 4.3 Contra-indications
2 4. 3 Kontra- indikazzjonijiet
Hypersensitivity to emedastine or to any of the excipients.
Sensittività eċċessiva għal emedastine jew għal xi sustanzi mhux attivi.
4.4 Special warnings and special precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Ocular corneal infiltrates were reported in conjunction with the use of EMADINE.
Infiltrati fil- korneja ta ’ l- għajn Infiltrati fil- korneja ta ’ l- għajn kienu rrapportati flimkien ma ’ l- użu ta ’ EMADINE.
In case of corneal infiltrates, the product should be discontinued and appropriate management should be implemented.
F’ każ ta ’ infiltrati fil- korneja, il- prodott għandu jitwaqqaf u għandu jiġi implimentat immaniġġjar xieraq.
Excipients Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Sustanzi mhux attivi Benzalkonium chloride li jintuża b’ mod komuni bħala preservattiv fi prodotti għall- għajnejn, kien irrapportat li jikkawża punctate keratopathy u/ jew keratopatija ulċerattiva tossika.
Since EMADINE contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Peress li EMADINE fih benzalkonium chloride, hija meħtieġa sorveljanza mill- viċin jekk jintuża b’ mod frekwenti jew fit- tul.
In addition benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.
Barra dan benzalkonium chloride jista ’ jikkawża irritazzjoni fl- għajn u huwa magħruf li jbiddel il - kulur ta ’ lentijiet tal- kuntatt rotob.
Patients must be instructed to remove contact lenses prior to the application of EMADINE and wait 15 minutes after instillation of the dose before reinsertion.
Il- pazjenti għandhom jiġu rrakkomandati biex ineħħu l- lentijiet tal- kuntatt qabel l- applikazzjoni ta ’ EMADINE u jistennew 15- il minuta wara l- applikazzjoni tad- doża qabel ma jerġgħu jilbsu l- lentijiet tal- kuntatt.
Pregnancy There are no adequate data from the use of emedastine in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ emedastine waqt it- tqala.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali fuq in- nies mhux magħruf.
Nevertheless, considering the absence of effects of emedastine on adrenergic, dopaminergic and serotonin receptors, EMADINE can be used during pregnancy if the dosage recommendation in section 4.2 is respected.
Madankollu, meta wieħed iqis in- nuqqas ta ’ effetti ta ’ emedastine fuq riċetturi adrenerġiċi, dopaminerġiċi u ta ’ serotonin, EMADINE jista ’ jintuża waqt it- tqala jekk ir- rakkomandazzjoni tad- dożaġġ f’ sezzjoni 4. 2 tiġi mħarsa.
Lactation Emedastine has been identified in the milk of rats following oral administration.
Treddigħ Emedastine instab fil- ħalib tal- firien wara għoti mill- ħalq.
It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Mhux magħruf jekk l- għoti topiku lill - bnedmin jistax iwassal għall- assorbiment sistemiku suffiċjenti biex jipproduċi kwantitajiet li jistgħu jiġu osservati fil- ħalib tas- sider.
Caution should be exercised if EMADINE is administered during breast-feeding.
Għandu jkun hemm attenzjoni jekk EMADINE jingħata waqt it - treddigħ.
As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
Bħal b’ kull mediċina għall- għajnejn, jekk ma ’ l- applikazzjoni jkun hemm vista mċajpra għal xi ħin, il - pazjent għandu jistenna sakemm il- vista tiċċara qabel isuq jew iħaddem magni.
In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days.
Fi 13- il studju kliniku li nvolva 696 pazjent, Emadine ingħata minn darba sa erba ’ darbiet kuljum fiż - żewġ għajnejn għal tul sa 42 ġurnata.
In clinical trials, approximately 7% of patients experienced an adverse drug reaction associated with the use of Emadine; however, less than 1% of these patients discontinued therapy due to these adverse drug reactions.
Fi provi kliniċi, madwar 7% tal- pazjenti kellhom esperjenza ta ’ reazzjoni avversa tal- mediċina assoċjata ma ’ l- użu ta ’ Emadine; iżda, inqas minn 1% ta ’ dawn il - pazjenti waqqfu t- terapija minħabba dawn ir- reazzjonijiet avversi tal- mediċina.
No serious ophthalmic or systemic adverse drug reactions were reported in the clinical trials.
Fil- provi kliniċi ma kienux irrapportati reazzjonijiet avversi tal- mediċina fl- għajnejn jew sistemiċi serji.
The most frequent adverse drug reaction was eye pain, reported at an overall incidence of 2.0%.
L- aktar reazzjoni avversa tal- mediċina frekwenti kienet uġigħ fl- għajn, irrapportata b’ inċidenza globali ta ’ 2. 0%.
3 The following adverse reactions listed below were observed in clinical studies or with post marketing experience.
3 Ir- reazzjonijiet avversi mniżżla isfel kienu osservati fl- istudji kliniċi jew fl- esperjenza ta ’ wara t - tqegħid fis- suq.
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/ 1000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1000), very rare (< 1/ 10,000), or not known (cannot be estimated from the available data).
Huma mqassma skond is- sistema tal- klassifika tal- organi u kklassifikati skond il - konvenzjoni li ġejja: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1000), rari ħafna (< 1/ 10, 000), jew mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Cardiac disorders Not known: tachycardia
Disturbi fil- qalb Mhux magħruf: takikardija
Nervous system disorders Common: headache Uncommon: sinus headache, dysgeusia
Disturbi fis- sistema nervuża Komuni: uġigħ ta ’ ras Mhux komuni: uġigħ ta ’ ras mis- sinusis, disġewżja
Eye disorders Common: eye pain, eye irritation, blurred vision, eye pruritus, dry eye, corneal staining, conjunctival hyperaemia Uncommon: corneal infiltrates, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia
Disturbi fl- għajnejn Komuni: uġigħ fl- għajn, irritazzjoni fl- għajn, vista mċajpra, ħakk fl- għajn, għajn tinħass xotta, tbajja fil- korneja, iperimija tal- konġuntiva Mhux komuni: infiltrati fil- korneja, sensazzjoni ta ’ oġġett barrani fl- għajnejn, żjieda fid- dmugħ, astenopija, iperimija tal- għajn
Skin and subcutaneous tissue disorders Uncommon: rash
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: raxx
Psychiatric disorders Uncommon: abnormal dreams
Disturbi psikjatriċi Mhux komuni: ħolm mhux normali
No data are available in humans regarding overdose by accidental or deliberate ingestion.
M’ hemmx tagħrif disponibbli fil- bnedmin dwar doza eċċessiva ta ’ teħid aċċidentali jew apposta mill - ħalq.
In case of accidental ingestion of the content of a bottle of EMADINE, the potential of emedastine to increase the QT interval should be borne in mind and appropriate monitoring and management should be implemented.
F’ każ ta ’ teħid aċċidentali mill- ħalq tal- kontenut ta ’ flixkun ta ’ EMADINE, wieħed għandu jikkonsidra l- potenzjal li emedastine jista ’ jżid l- intervall QT u għandhom jiġu mplimentati monitoraġġ u mmaniġġjar xierqa.
Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics,
Kategorija farmakoterapewtika: dekonġestjonanti u mediċini kontra l- allerġiji; mediċini kontra l - allerġiji oħra.
Emedastine is a potent selective and topically effective histamine H1 antagonist (Ki = 1.3 nM).
Emedastine huwa antagonista ta ’ histamine H1 (Ki = 1. 3 nM) potenti, selettiv u effettiv b’ mod topiku.
In vitro examinations of emedastine’ s affinity for histamine receptors (H1, H2, and H3) demonstrate 10,000-fold selectivity for the H1 receptor, Ki’ s = 1.3 nM, 49,064 nM and 12, 430 nM, respectively.
Studji In vitro, dwar l- affinità ta ’ emedastine għal riċetturi ta ’ histamine (H1, H2, u H3) juru selettività ta ’ 10, 000 darba iktar għar- riċettur H1, Ki’ s=1. 3 nM, 49, 064 nM u 12, 430 nM rispettivament.
In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability.
In vivo, l- għoti topiku fl- għajnejn ta ’ emedastine jipproduċi inibizzjoni dipendenti mill- konċentrazzjoni tal - permeabilità vaskulari tal- konġuntiva li hija stimulata mill- istamina.
Studies with emedastine have not shown effects on adrenergic, dopaminergic, and serotonin receptors.
Studji b’ emedastine ma wrewx effetti fuq riċetturi adrenerġiċi, dopaminerġiċi, u ta ’ serotonin.
5.2 Pharmacokinetic properties
4 5. 2 Tagħrif farmakokinetiku
Absorption Emedastine is absorbed systemically, as are other topically administered drug substances.
Assorbiment Bħal prodotti mediċinali topiċi oħra, emedastine huwa assorbit fid- demm.
In a study involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 mg/ ml eye drops solution, plasma concentrations of the parent compound were generally below the quantitation limit of the assay (0.3 ng/ ml).
Fi studju li sar fuq għaxar voluntiera normali li ġew mogħtija EMADINE 0. 5 mg/ ml qtar għall- għajnejn darbtejn kuljum f’ għajnejhom it- tnejn għal 15- il ġurnata, l- konċentrazzjoni fil- plażma tas- sustanza oriġinali ġeneralment kienet inqas mil- limitu kwantitattiv ta ’ l- analiżi (0. 3 ng/ ml).
Samples in which emedastine was quantifiable ranged from 0.30 to 0.49 ng/ ml.
Kampjuni fejn emedastine seta ’ jiġi kwantifikat varjaw minn 0. 3 sa 0. 49 ng/ ml.
4 The human oral bioavailability of emedastine is approximately 50% and maximum plasma concentrations were achieved within one-two hours after dosing.
Il- bijodisponibiltà ta ’ emedastine meta jittieħed mill- ħalq fil- bnedmin hija madwar 50% u l - konċentrazzjonijiet massimi fil- plażma intlaħqu fi żmien siegħa sa sagħtejn wara l- għoti.
Metabolism Emedastine is principally metabolised by the liver.
Metaboliżmu Emedastine huwa metabolizzat prinċipalment mill- fwied.
The elimination half-life of topical emedastine is ten hours.
Il- half- life ta ’ l- eliminazzjoni ta ’ emedastine topiku hija għaxar sigħat.
Approximately 44% of an oral dose is recovered in the urine over 24 hours, with only 3.6% of the dose excreted as parent drug substance.
Kważi 44% tad- doża li tittieħed mill- ħalq tiġi rkuprata fl- awrina fuq medda ta ’ 24 siegħa, b’ 3. 6% biss tad- doża titneħħa bħala s- sustanza mediċinali oriġinali.
Two primary metabolites, 5-and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms.
Żewġ metaboliti primarji, 5 - u 6 - hydroxy- emedastine, jitneħħew fl- awrina kemm bħala forom ħielsa kif ukoll konjugati.
The 5′ -oxo analogues of 5-and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites.
L- analogi 5 '- oxo ta ’ 5 - u 6- hydroxyemedastine u l- N- Oxide wkoll huma iffurmati bħala metaboliti minuri.
5.3 Preclinical Safety Data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of administration.
Emedastine difumarate kellu tossiċità akuta baxxa f’ numru ta ’ speċi meta ingħata minn rotot differenti.
No clinically significant local or systemic effects were observed in long-term topical ocular studies in rabbits.
Fi studji fit- tul dwar l- għoti topiku fl- għajnejn fil- fniek, ma kienux osservati effetti lokali jew sistemiċi ta ’ sinifikanza klinika.
Corneal limbal mononuclear cell infiltrates were noted in 1/ 4 male monkeys treated with 0.5 mg/ ml and in 4/ 4 males and 1/ 4 females treated with1.0 mg/ ml.
Kienu osservati corneal limbal mononuclear cell infiltrates f’ 1/ 4 tax- xadini maskili li ġew ikkurati b’ 0. 5 mg/ ml u f’ 4/ 4 ta ’ l- irġiel u f’ 1/ 4 tan- nisa li ġew ikkurati b’ 1. 0 mg/ ml.
Scleral mononuclear cell infiltrates were present in 1/ 4 males and 1/ 4 females treated with 0.5 mg/ ml and in 2/ 4 males and 1/ 4 females treated with1.0 mg/ ml.
Scleral mononuclear cell infiltrates kienu preżenti f’ 1/ 4 ta ’ l- irġiel u f’ 1/ 4 tan- nisa li ġew ikkurati b’ 0. 5 mg/ ml u f’ 2/ 4 ta ’ l- irġiel u f’ 1/ 4 tan- nisa li ġew ikkurati b’ 1. 0 mg/ ml.
Mean peak plasma levels were approximately 1 ng/ ml and 2 ng/ ml for the 0.5 and 1.0 mg/ ml treatments respectively.
Il- medja ta ’ l- għola livelli fil- plażma kienu kważi 1 ng/ ml u 2 ng/ ml għall- kura b’ 0. 5 u 1. 0 mg/ ml rispettivament.
Emedastine was found to increase the QT interval in dogs; the NOEL corresponds to levels 23-fold higher than those found in patients (7 ng/ ml as compared with 0.3 ng/ ml, i. e., the limit of detection for emedastine).
Emedastine instab li jżid l- intervall tal- QT fil- klieb; NOEL jikkorrispondi għal- livelli 23- darba ogħla minn dawk osservati f’ pazjenti (7 ng/ ml kif imqabbel ma ’ 0. 3 mg/ ml, i. e., il- limitu tal- livell biex jiġi identifikat emedastine).
Emedastine difumarate was not found to be carcinogenic in studies in mice and rats.
Fi studji fil- ġrieden u l- firien, emedastine difumarate ma nsabx li għandu effetti karċinoġeniċi.
Emedastine difumarate was not genotoxic in a standard battery of in vitro and in vivo genotoxicity assays.
F’ sensiela stàndard ta ’ analiżi in vitro u in vivo dwar l- effett tossiku fuq il- ġeni, emedastine difumerate ma ’ kienx ġenotossiku.
In a teratology study in rats, foetotoxic but not teratogenic effects were observed at the highest dose evaluated (140 mg/ kg/ day); no effects were observed at a lower level (40 mg/ kg/ day) which corresponds to an exposure well in excess of that produced by the therapeutic recommended dose.
Fi studju teratoloġiku fil- firien, fl- ogħla doża evalwata (140 mg/ kg/ kuljum), kienu osservati effetti tossiċi fil- fetu iżda ma kienux osservati effetti teratoġeniċi; f’ livell inqas (40 mg/ kg/ kuljum) li jikkorrispondi għall- esponiment ferm ogħla minn dak li jintlaħaq bid- doża terapewtika rrakkomandata, ma kienux osservati effetti.
No reproductive toxicity was observed in a study in rabbits.
Fi studju fil- fniek ma kienx osservat effett tossiku fuq is- sistema riproduttiva.
Benzalkonium chloride 0.1 mg/ ml Trometamol, Sodium chloride, Hypromellose, Hydrochloric acid/ sodium hydroxide (to adjust pH) Purified water.
Benzalkonium chloride 0. 1 mg/ ml, Trometamol, Sodium chloride, Hypromellose, Hydrochloric acid/ sodium hydroxide (għall- aġġustament tal- pH) Ilma ppurifikat.
30 months.
30 xahar.
EMADINE should not be used for longer than 4 weeks after first opening.
EMADINE m’ għandux jintuża għal aktar minn 4 ġimgħat wara li jinfetaħ l- ewwel darba.
EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.
EMADINE huwa disponibbli fi flixken opaki tal- plastik tal- għamla DROP- TAINER ta ’ volum ta ’ 5 ml u 10 ml.
6.6 Instructions for use and handling, and disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Alcon Laboratories (UK) Ltd.
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Alcon Laboratories (UK) Ltd.
Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom
Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD Ir- Renju Unit
27th January 1999.
27 ta ’ Jannar 1999.
29th January 2004
29 ta ’ Jannar 2004
EMADINE 0.5 mg/ ml Eye Drops, solution.
EMADINE 0. 5 mg/ ml, Qtar Għall- Għajnejn, soluzzjoni.
1 ml of solution contains emedastine 0.5 mg (as difumarate).
1 ml ta ’ soluzzjoni fih 0. 5 mg emedastine (bħala difumarate).
Eye drops, solution.
Qtar għall- għajnejn, soluzzjoni.
EMADINE has not been studied in clinical trials beyond six weeks.
EMADINE ma ’ ġiex studjat fi provi kliniċi għal iżjed minn sitt ġimgħat.
Posology The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily.
Pożoloġija Id- doża hija qatra waħda ta ’ EMADINE li għandha tiġi applikata fl- għajn( ejn) darbtejn kuljum.
For single use only; one container is sufficient to treat both eyes.
Għall- użu ta ’ darba biss; kontenitur wieħed huwa biżżejjed għall- kura taż- żewġ għajnejn.
Any unused solution should be discarded immediately after use.
Kull soluzzjoni li ma ntużatx għandha tintrema immedjatament wara l- użu.
Elderly Population EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not recommended in this population.
Popolazzjoni Anzjana EMADINE ma ’ ġiex studjat f’ pazjenti anzjani b’ età ’ l fuq minn 65 sena, għalhekk l- użu tiegħu f’ din il- popolazzjoni mhux irrakkomandat.
Paediatric Population EMADINE may be used in paediatric patients (3 years of age and older) at the same posology as in adults.
Popolazzjoni Pedjatrika EMADINE jista ’ jintuża fit- tfal (minn 3 snin ’ l fuq) bl- istess pożoloġija bħal fl- adulti.
For ocular use
Użu għall- għajnejn.
7 4.4 Special warnings and special precautions for use
8 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Ocular corneal infiltrates:
Infiltrati fil- korneja ta ’ l- għajn:
Ocular corneal infiltrates were reported in conjunction with the use of EMADINE.
Infiltrati fil- korneja ta ’ l- għajn kienu rrapportati flimkien ma ’ l- użu ta ’ EMADINE.
The following adverse reactions listed below were observed in clinical studies or with post marketing experience.
Ir- reazzjonijiet avversi mniżżla isfel kienu osservati fl- istudji kliniċi jew fl- esperjenza ta ’ wara t - tqegħid fis- suq.
8 Eye disorders Common: eye pain, eye irritation, blurred vision, eye pruritus, dry eye, corneal staining, conjunctival hyperaemia Uncommon: corneal infiltrates, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia
9 Disturbi fl- għajnejn Komuni: uġigħ fl- għajn, irritazzjoni fl- għajn, vista mċajpra, ħakk fl- għajn, għajn tinħass xotta, tbajja fil- korneja, iperimija tal- konġuntiva Mhux komuni: infiltrati fil- korneja, sensazzjoni ta ’ oġġett barrani fl- għajnejn, żjieda fid- dmugħ, astenopija, iperimija tal- għajn
In case of the deliberate ingestion of the contents of many unit doses of EMADINE, the potential of emedastine to increase the QT interval should be borne in mind and appropriate monitoring and management should be implemented.
F’ każ ta ’ teħid aċċidentali mill- ħalq tal- kontenut ta ’ flixkun ta ’ EMADINE, wieħed għandu jikkonsidra l- potenzjal li emedastine jista ’ jżid l- intervall QT u għandhom jiġu mplimentati monitoraġġ u mmaniġġjar xierqa.
Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics.
Kategorija farmakoterapewtika: dekonġestjonanti u mediċini kontra l- allerġiji; mediċini kontra l - allerġiji oħra.
In vitro examinations of emedastine’ s affinity for histamine receptors (H1, H2, and H3) demonstrate 10,000-fold selectivity for the H1 receptor, Kis = 1.3 nM, 49,064 nM and 12, 430 nM, respectively.
Studji In vitro, dwar l- affinità ta ’ emedastine għal riċċeturi ta ’ histamine (H1, H2, u H3) juru selettività ta ’ 10, 000 darba iktar għar- riċċettur tat- tip H1, Kis=1. 3 nM, 49, 064 nM u 12, 430 nM rispettivament.
In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability.
In vivo, l- għoti topiku fl- għajnejn ta ’ emedastine jipproduċi inibizzjoni dipendenti mill - konċentrazzjoni tal- permeabilità vaskulari tal- konġuntiva li hija stimulata mill- istamina.
In a study involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 mg/ ml eye drops, solution, plasma concentrations of the parent compound were generally below the quantitation limit of the assay (0.3 ng/ ml).
Fi studju li sar fuq għaxar voluntiera normali li ġew mogħtija EMADINE 0. 5 mg/ ml qtar għall- għajnejn darbtejn kuljum f’ għajnejhom it- tnejn għal 15- il ġurnata, l- konċentrazzjoni fil- plażma tas- sustanza oriġinali ġeneralment kienet inqas mil- limitu kwantitattiv ta ’ l- analiżi (0. 3 ng/ ml).
The human oral bioavailability of emedastine is approximately 50% and maximum plasma concentrations were achieved within one-two hours after dosing.
Il- bijodisponibiltà ta ’ emedastine meta jittieħed mill- ħalq fil- bnedmin hija madwar 50% u l - konċentrazzjonijiet massimi fil- plażma intlaħqu fi żmien siegħa sa sagħtejn wara l- għoti.
9 5.3 Preclinical Safety Data
10 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Corneal limbal mononuclear cell infiltrates were noted in 1/ 4 male monkeys treated with 0.5 mg/ ml and in 4/ 4 males and 1/ 4 females treated with 1.0 mg/ ml.
Kienu osservati corneal limbal mononuclear cell infiltrates f’ 1/ 4 tax- xadini maskili li ġew ikkurati b’ 0. 5 mg/ ml u f’ 4/ 4 ta ’ l- irġiel u f’ 1/ 4 tan- nisa li ġew ikkurati b’ 1. 0 mg/ ml.
Scleral mononuclear cell infiltrates were present in 1/ 4 males and 1/ 4 females treated with 0.5 mg/ ml and in 2/ 4 males and 1/ 4 females treated with 1.0 mg/ ml.
Scleral mononuclear cell infiltrates kienu preżenti f’ 1/ 4 ta ’ l- irġiel u f’ 1/ 4 tan- nisa li ġew ikkurati b’ 0. 5 mg/ ml u f’ 2/ 4 ta ’ l- irġiel u f’ 1/ 4 tan- nisa li ġew ikkurati b’ 1. 0 mg/ ml.
Emedastine was found to increase the QT interval in dogs; the NOEL corresponds to levels 23 fold higher than those found in patients (7 ng/ ml as compared with 0.3 ng/ ml, i. e., the limit of detection for emedastine).
Emedastine instab li jżid l- intervall tal- QT fil- klieb; NOEL jikkorrispondi għal- livelli 23- darba ogħla minn dawk osservati f’ pazjenti (7 ng/ ml kif imqabbel ma ’ 0. 3 mg/ ml, i. e., il- limitu tal- livell biex jiġi identifikat emedastine).
Emedastine difumarate was not found to be carcinogenic in studies in mice and rats.
Fi studji fil- ġrieden u l- firien emedastine difumarate ma nsabx li għandu effetti karċinoġeniċi.
Trometamol Sodium chloride Hypromellose Hydrochloric acid/ sodium hydroxide (to adjust pH) Purified water
Trometamol Sodium chloride Hypromellose Hydrochloric acid/ sodium hydroxide (għall- aġġustament tal- pH) Ilma ppurifikat.
After first opening a foil pouch:
Wara li jinfetaħ għall- ewwel darba l- pakkett tal- fojl:
7 days.
7 ijiem.
Do not store above 30°C.
Taħżinx f’ temperatura ‘ l fuq minn 30°C.
EMADINE is supplied in low density polyethylene single-dose containers which contain 0.35 ml.
Emadine huwa disponibbli f’ kontenituri b’ doża waħda b’ volum ta ’ 0. 35 ml magħmula minn polyethylene ta ’ densità baxxa.
Five single-dose containers are then presented in a foil pouch.
Hemm ħames kontenituri b’ doża waħda ġewwa pakkett tal- fojl.
The following pack sizes are available:
11 Hemm disponibbli dawn id- daqsijiet tal- pakkett:
30 x 0.35 ml single-dose containers and 60 x 0.35 ml single-dose containers.
30 kontenitur ta ’ 0. 35 ml b’ doża waħda; u 60 kontenitur ta ’ 0. 35 ml b’ doża waħda.
10 6.6 Instructions for use and handling, and disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD United Kingdom
Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD Ir- Renju Unit
(30th May 2002 SD MAA) 27th January 1999 Date of last renewal:
Data ta ’ l- aħħar tiġdid:
12
12 ANNESS II
Names and addresses of the manufacturers responsible for batch release
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott.
EMADINE 0.5 mg/ ml Eye Drops, solution in multidose container S. A.
EMADINE 0. 05 mg/ ml Qtar Għall- Għajnejn, soluzzjoni f’ kontenitur b’ ħafna dożi S. A.
Alcon-Couvreur N. V., Rijksweg 14, B-2870 Puurs, Belgium.
Alcon- Couvreur N. V., Rijksweg 14, B- 2870 Puurs, Il- Belġju.
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanja.
EMADINE 0.5 mg/ ml Eye Drops, solution Laboratoires Alcon, 23 Rue Georges Ferrenbach, F-68240 Kaysersberg France
EMADINE 0. 05 mg/ ml Qtar Għall- Għajnejn, soluzzjoni Laboratoires Alcon, 23 Rue Georges Ferrenbach, F- 68240 Kaysersberg Franza
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli għall- ħruġ tal- lott konċernat.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 BOTTLE, 5 ml & 10 ml.
KAXXA TA ’ FLIXKUN WIEĦED, 5 ml & 10 ml.
EMADINE 0.5 mg/ml Eye Drops, solution in multidose container.
EMADINE 0. 5 mg/ ml Qtar Għall- Għajnejn, soluzzjoni f’ kontenitur b’ ħafna dożi.
Emedastine 0.5 mg/ml as difumarate
Emedastine 0. 5 mg/ ml bħala difumarate
Contains: benzalkonium chloride 0.1 mg/ml, trometamol, sodium chloride, hypromellose, hydrochloric acid/sodium hydroxide (to adjust pH), purified water.
Fih: benzalkonium chloride 0. 1 mg/ ml, trometamol, sodium chloride, hypromellose, hydrochloric acid/ sodium hydroxide (għall- aġġustament tal- pH), ilma ppurifikat.
Eye drops, solution; 1 x 5 ml 1 x 10 ml
Qtar għall- għajnejn, soluzzjoni; 1 x 5 ml 1 x 10 ml
Ocular use.
Użu għall- għajnejn.
OTHER SPECIAL WARNINGS, IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXP IRY DATE
DATA TA ’ META JISKADI
Discard four weeks after first opening.
EXP Armi erba ’ ġimgħat wara li jinfetaħ għall- ewwel darba.
Opened:
Miftuħ:
Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD United Kingdom
Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD Ir- Renju Unit
EU/1/98/095/001 1 x 5 ml EU/1/98/095/002 1 x 10 ml
EU/ 1/ 98/ 095/ 0011 x 5 ml EU/ 1/ 98/ 095/ 002 1 x 10 ml
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BOTTLE LABEL 5 ml & 10 ml
TIKKETTA TAL- FLIXKUN 5 ml & 10 ml
EXP IRY DATE
DATA META JISKADI
Discard four weeks after first opening.
Armi erba ’ ġimgħat wara li jinfetaħ l- ewwel darba.
Carton for 30 x 0.35 ml containers & carton of 60 x 0.35 ml containers
Kartuna għal 30 kontenitur ta ’ 0. 35 ml & kartuna għal 60 kontenitur ta ’ 0. 35 ml
1 NAME OF MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI
EMADINE 0.5 mg/ml Eye Drops, solution.
EMADINE 0. 05 mg/ ml, Qtar Għall- Għajnejn, soluzzjoni.
2 STATEMENT OF ACTIVE SUBSTANCE
DIKJARAZZJONI TAS- SUSTANZA ATTIVA
Emedastine 0.5 mg/ml as difumarate.
Emedastine 0. 5 mg/ ml bħala difumarate
3 LIST OF EXCIPIENTS
LISTA TA ’ SUSTANZI MHUX ATTIVI
Contains: trometamol, sodium chloride, hypromellose, hydrochloric acid, sodium hydroxide and purified water.
Trometamol, sodium chloride, hypromellose, hydrochloric acid/ sodium hydroxide u ilma ppurifikat.
4 PHARMACEUTICAL FORM AND CONTENTS
GĦAMLA FARMAĊEWTIKA U KONTENUT
Eye drops, solution; 0.35 ml x 30.
Qtar għall- għajnejn, soluzzjoni; 0. 35 ml x 30 0. 35 ml x 60
5 METHOD AND ROUTE OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
7 OTHER SPECIAL WARNINGS, IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
For single use only; one container is sufficient to treat both eyes.
Għall- użu ta ’ darba biss; kontenitur wieħed huwa biżżejjed għaż- żewġ għajnejn.
Preservative free..
Ma fihx preservattivi.
8 EXPIRY DATE
DATA TA ’ META JISKADI
Discard any unused contents of a single use container immediately after use.
Armi l- kontenut fil- kontenitur għall- użu ta ’ darba li ma ntużax immedjatament wara l- użu.
Discard any unused containers one week after first opening pouch.
Armi l- kontenituri li ma ntużawx ġimgħa wara li nfetaħ għall- ewwel darba il- pakkett tal- fojl.
19 9 SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD United Kingdom.
Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD Ir- Renju Unit
12 MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/1/98/095/003 0.35 ml x 30 EU/1/98/095/004 0.35 ml x 60
EU/ 1/ 98/ 095/ 003 0. 35 ml x 30 EU/ 1/ 98/ 095/ 004 0. 35 ml x 60
13 BATCH NUMBER
NUMRU TAL- LOTT
14 GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
15 INSTRUCTIONS ON USE
ISTRUZZJONIJIET DWAR L- UŻU
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Foil Pouch
Pakkett tal- fojl
EMADINE 0.5 mg/ml Eye Drops, solution.
EMADINE 0. 5 mg/ ml Qtar Għall- Għajnejn, soluzzjoni.
Eye drops, solution; 0.35 ml x 5.
Qtar għall- għajnejn, soluzzjoni; 0. 35 ml x 5
Preservative free.
Ma fihx preservattivi
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINNDAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Tear open pouch at level of cut.
Iftaħ il- pakkett tal- fojl fejn huwa immarkat.
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Single-dose container
Kontenitur b’ doża waħda
EMADINE 0.5 mg/ml Eye Drops, solution Ocular use
EMADINE 0. 5 mg/ ml Qtar Għall- Għajnejn, soluzzjoni Użu għall- għajnejn
23 B.
OĦRAJN
24 PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
Emedastine
Emedastine.
If you have any further questions, ask your doctor or your pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What EMADINE is and what it is used for 2.
X’ inhu EMADINE u għalxiex jintuża 2.
Before you use EMADINE 3.
Qabel ma tuża EMADINE 3.
How to use EMADINE 4.
Kif għandek tuża EMADINE 4.
How to Store EMADINE 6.
Kif taħżen EMADINE 6.
WHAT EMADINE IS AND WHAT IT IS USED FOR
X’ INHU EMADINE U GĦALXIEX JINTUŻA
EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis of the eye (allergic conditions of the eye).
EMADINE huwa mediċina għall- kura ta ’ konġuntivite allerġika ta ’ l- istaġun fl- għajnejn (kundizzjonijiet allerġiċi ta ’ l- għajnejn).
It works by reducing the intensity of the allergic reaction.
Huwa jaħdem billi jnaqqas l- intensità tar- reazzjoni allerġika.
Allergic conjunctivitis.
Allerġija fil- konġuntiva:
Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
Xi materjali (allerġeni) bħal polline, trabijiet u suf tal- annimali jistgħu jikkawżaw reazzjonijiet allerġiċi li jirriżultaw f’ ħakk, ħmura, kif ukoll nefħa fis- superfiċje ta ’ l- għajn.
BEFORE YOU USE EMADINE
QABEL MA ’ TUŻA EMADINE
Do not use EMADINE...
Tużax EMADINE...
• if you are allergic to emedastine or any of the other ingredients.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal emedastine jew sustanzi oħra ta ’ EMADINE.
Ask your doctor for advice.
Staqsi lit- tabib tiegħek għall- parir.
Take special care with EMADINE...
Oqgħod attent ħafna b’ EMADINE...
• Do not use EMADINE in children under the age of 3 years.
• Tużax EMADINE fi tfal taħt it- 3 snin.
• If you wear contact lenses please see section ‘Important information about some of the eingredients of Emadine below’.
• Jekk tuża lentijiet tal- kuntatt jekk jogħġbok ara s- sezzjoni ‘ Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Emadine ’ taħt..
• EMADINE is not recommended for use in patients over 65 years of age, as it has not been studied in clinical trials in this age group.
• EMADINE mhux irrakkomandat għall- użu f’ pazjenti b’ età ’ l fuq minn 65 sena għax fl- istudji kliniċi ma kienx studjat f’ pazjenti ta ’ din l- età.
• EMADINE is not recommended for use in patients with kidney or liver problems.
• EMADINE mhux irrakkomandat għall- użu f’ pazjenti bi problemi tal- kliewi jew tal- fwied.
Using other medicines.
26 Meta tuża mediċini oħra.
25 Please tell your doctor or pharmacist if you are taking (or have recently taken) any other medicines including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you are using other eye drops at the same time as EMADINE, follow the advice at the end of section 3 “How to use EMADINE”.
Jekk qed tuża qtar għall- għajnejn oħra fl- istess waqt ma ’ EMADINE, segwi l- pariri fl- aħħar ta ’ sezzjoni 3 “ Kif għandek tuża EMADINE ”.
Pregnancy and breast feeding
Tqala u treddigħ
• If you are pregnant, or might get pregnant, if you are breast-feeding.
• Jekk inti tqila, jew tista ’ toħroġ tqila, jekk qed tredda ’.
You may find that your vision is blurred for a time just after you use EMADINE.
Għandek mnejn issib li l- vista tiegħek tkun imċajpra għal xi ħin hekk kif tuża EMADINE.
Do not drive or use machines until your vision is clear.
M’ għandekx issuq jew tħaddem magni qabel il- vista tiegħek tiċċara.
Important information about some of the ingredients of EM ADINE
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ EMADINE
A preservative in EMADINE (benzalkonium chloride) may cause eye irritation and is known to discolour soft contact lenses.
Preservattiv f’ EMADINE (benzalkonium chloride) jista ’ jikkawża irritazzjoni fl- għajn u huwa magħruf li jbiddel il- kulur ta ’ lentijiet tal- kuntatt rotob.
Therefore do not wear contact lenses whilst using EMADINE.
Għalhekk tilbisx lentijiet tal- kuntatt waqt li qed tuża EMADINE.
Wait 15 minutes after using EMADINE before putting your lenses back in.
Stenna 15- il minuta wara li tuża EMADINE qabel ma terġa ’ tilbes il- lentijiet tiegħek.
HOW TO USE EMADINE
KIF GĦANDEK TUŻA EMADINE
Always use EMADINE exactly as your doctor has told you.
Dejjem għandek tuża EMADINE skond il- parir eżatt tat- tabib.
How much to use
Kemm għandek tuża
Adults and children over 3 years:
Adulti u tfal minn 3 snin ’ l fuq:
One drop in the eye, twice a day.
Qatra waħda ġo l- għajn, darbtejn kuljum.
Use this much unless your doctor tells you something differently.
Uża din il- kwantità sakemm ma jgħidlekx mod ieħor it- tabib tiegħek.
Use it for as long as your doctor tells you to.
Uża għat- tul ta ’ żmien li jgħidlek it- tabib tiegħek.
Only use drops in both eyes if your doctor tells you to.
Uża l- qtar f’ għajnejk it- tnejn biss, jekk jgħidlek it- tabib tiegħek.
Only use the drops in your eyes.
Uża l- qtar f’ għajnejk biss
Turn the page for more advice
Aqleb il- paġna għall- aktar tagħrif.
Now turn over >
Aqleb >
HOW TO USE EMADINE (continued)
KIF GĦANDEK TUŻA EMADINE (ikompli)
• Get the EMADINE bottle and a mirror. • Wash your hands. • Take the bottle and twist off the cap.
• Aqbad il- flixkun ta ’ EMADINE u mera. • Aħsel idejk.
26 • Hold the bottle, pointing down, between your thumb and middle finger. • Tilt your head back.
27 • Aqbad il- flixkun u neħħi l- għatu. • Żomm il- flixkun wiċċu ’ l isfel bejn subgħajk il- kbir u subgħajk tan- nofs. • Itfa ’ rasek lura.
Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye.
B’ seba ’ nadif, niżżel il- kappell ta ’ għajnejk sakemm ikun hemm ‘ spazju ’ bejn il- kappell t’ għajnejk u l- għajn tiegħek.
The drop will go in here (picture 1). • Bring the bottle tip close to the eye.
Il- qatra se tmur hawn (stampa 1). • Ġib it- tarf tal- flixkun viċin tal- għajn.
Use the mirror if it helps. • Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Jekk jgħin uża l- mera. • Tmissx għajnejk jew il- kappell ta ’ l- għajn, il- postijiet tal- madwar jew xi superfiċji oħra bil- qattara.
It could infect the drops left in the bottle. • Gently press on the base of the bottle to release one drop of EMADINE at a time. • Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed (picture 2). • If you use drops in both eyes, repeat the steps for your other eye. • Put the bottle cap back on firmly immediately after use.
Il- flixkun huwa maħsub biex għafsa żgħira fuq il- qiegħ tkun biżżejjed (stampa 2). • Jekk tuża l- qtar f’ għajnejk it- tnejn, irrepeti il- proċedura għal l- għajn l- oħra. • Agħlaq sew l- għatu tal- flixkun immedjatament wara l- użu.
If you accidentally swallow EMADINE or inject it contact a doctor immediately.
Jekk bi żball tibla ’ EMADINE jew tinjettah, ikkuntattja tabib immedjatament.
It may affect your heart rhythm.
Din il- mediċina tista ’ taffettwa r- ritmu ta ’ qalbek.
If a drop misses your eye, try again.
Jekk qatra ma tidħolx f’ għajnejk, erġa ’ pprova.
If you get too much in your eyes, rinse it all out preferably with sterile saline or, if not available, with warm water.
Jekk jidħlu qtar żejda f’ għajnejk, jekk jista ’ jkun laħlaħ b’ ilma mielaħ sterilizzat, jew jekk mhux disponibbli, b’ ilma fietel.
Don’t put in any more drops until it’s time for your next regular dose.
Tużax aktar qtar qabel isir il- ħin għad- doża tas- soltu li jmiss.
If you forget to use EMADINE, use one drop as soon as you remember, and then go back to your normal routine.
Jekk tinsa tuża EMADINE, applika qatra waħda hekk kif tiftakar, u wara kompli bir- rutina tas- soltu.
Do not use a double dose to make up for the one missed.
M’ għandekx tuża doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you are using other eye drops, leave at least 10 minutes between using EMADINE and the other drops.
Jekk qed tuża qtar għall- għajnejn ieħor, stenna mill- inqas 10 minuti bejn l- użu ta ’ EMADINE u l - qtar l- ieħor.
Like all medicines EMADINE can cause side effects although not everyone gets them.
Bħal kull mediċina oħra, Emadine jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These can be unpleasant, but most of them disappear quickly.
Dawn jista ’ jkunu skomdi, iżda l- biċċa l- kbira jgħaddu malajr.
You can carry on taking the drops, unless the effects are serious, If you are worried, talk to your doctor or pharmacist.
Jekk inti inkwetat/ a, kellem lit- tabib jew lill - ispiżjar tiegħek.
Common side effects (affects 1 to 10 users in 100)
Effetti sekondarji komuni (jaffettwaw 1 sa 10 persuni minn kull 100 li qed jużawh)
Effects in the eye: eye pain, eye irritation, blurred vision, corneal staining, dry eye, itchy eye, eye redness
Effetti fl- għajn: uġigħ fl- għajn, irritazzjoni fl- għajn, vista mċajpra, tebgħa fil- korneja, għajn tinħass xotta, ħakk fl- għajn, ħmura fl- għajn
General side effects: headache
Effetti sekondarji ġenerali: uġigħ ta ’ ras
Uncommon side effects (affects 1 to 10 users in 1,000)
Effetti sekondarji mhux komuni (jaffettwaw 1 sa 10 persuni minn kull 1, 000 li qed jużawh)
Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired eyes
Effetti fl- għajn: disturb fil- korneja, sensazzjoni mhux normali fl- għajn, żjieda fil- produzzjoni ta ’ dmugħ, għeja fl- għajnejn
General side effects: difficulty sleeping, sinus headache, bad taste, rash
Effetti sekondarji ġenerali: diffikultà biex torqod, uġigħ ta ’ ras mis- sinusis, togħma ħażina, raxx
Not Known (frequency cannot be estimated from the available data)
28 Mhux magħruf (il- frekwenza ma tistax tiġi stmata mid- data disponibbli)
General side effects: increased heart rate
Effetti sekondarji ġenerali: żjieda fir- rata tal- qalb
If any of these side effects gets serious or if you notice any side effects not listed, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE EMADINE
KIF TAĦŻEN EMADINE
Do not use EMADINE after the expiry date which is stated on the bottle and box after “EXP”.
Tużax EMADINE wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kaxxa wara “ EXP ”.
You must throw away the bottle four weeks after you first opened it, to prevent infections.
Għandek tarmi l- flixkun erba ’ ġimgħat wara li tkun ftaħtu l- ewwel darba, biex tipprevjeni infezzjonijiet.
Write down the date you opened each bottle in the space below and in the space on the bottle label and box.
Ikteb id- data meta ftaħt kull flixkun fl- ispazju taħt u fl- ispazju fuq it- tikketta tal- flixkun u l- kaxxa.
What EMADINE contains
X’ fih EMADINE
The active substance is emadastine 0.5 mg/ml as difumarate.
Is- sustanza attiva hi emedastine 0. 5 mg/ ml bħala difumarate.
The other ingredients are: benzalkonium chloride, trometamol; sodium chloride; hypromellose; purified water.
Is- sustanzi l- oħra huma: benzalkonium chloride, trometamol; sodium chloride; hypromellose; ilma ppurifikat.
Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal
Xi kultant jiżdiedu ammonti żgħar ta ’ hydrochloric acid jew sodium hydroxide biex iżommu l- livelli ta ’ l- aċidità (livelli tal- pH) normali
What EMADINE looks like and the contents of the pack
Id- Dehra ta ’ EMADINE u l- kontenuti tal- pakkett
EMADINE is a liquid (a solution) supplied in a pack containing a 5 ml or 10 ml plastic (DROP-TAINER) bottle with a screw cap.
EMADINE huwa likwidu (soluzzjoni) disponibbli f’ pakkett li fih flixkun tal- plastik (DROP- TAINER) ta ’ 5 ml jew 10 ml b’ għatu bil- kamin.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall - skop kummerċjali.
The marketing authorisation holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Alcon Laboratories (UK) Ltd., Pentagon Park Boundary Way, Hemel Hempstead, Herts., HP2 7UD, United Kingdom.
Alcon Laboratories (UK) Ltd., Pentagon Park Boundary Way, Hemel Hempstead, Herts., HP2 7UD, Ir- Renju Unit.
Alcon -Couvreur N.V., Rijksweg 14, B-2870 Puurs, Belgium
Alcon- Couvreur N. V., Rijksweg 14, B- 2870 Puurs, Il- Belġju
Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Spain
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Spanja
28 For any information about this medicine, please contactthe local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Nederland Česká republika Alcon Nederland BV Alcon Pharmaceuticals (Czech Republic) s.r.o. + 31 (0) 183 654321 + 420 225 377 300
Česká republika Nederland Alcon Pharmaceuticals (Czech Republic) s. r. o.
Danmark Alcon Danmark A/S + 45 3636 3434
Alcon Nederland BV + 420 225 377 300 + 31 (0) 183 654321 Norge Danmark Alcon Danmark A/ S + 45 3636 3434
29 Italia Alcon Italia S.p.A. + 39 02 81803.1
30 Italia Sverige Alcon Italia S. p. A.
This leaflet was last approved on xxxxxx
Dan il- fuljett kien approvat l- aħħar f’ xxxxxx
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: www.emea.europa.eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
30 PACKAGE LEAFLET
31 FULJETT TA ’ TAGĦRIF:
Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
Xi materjali (allerġeni) bħal polline, trabijiet u suf tal- annimali jistgħu jikkawżaw reazzjonijiet allerġiċi li jirriżultaw f’ ħakk, ħmura kif ukoll nefħa fis- superfijċe ta ’ l- għajn.
Do not use EMADINE …
Tużax EMADINE...
• if you are allergic to emedastine or any of the other ingredients.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal- emedastine jew sustanzi oħra ta ’ EMADINE.
Using other medicines.
Meta tuża mediċini oħra.
Please tell your doctor or pharmacist if you are taking (or have recently taken) any other medicines including medicines obtained without a prescription.
32 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
31 If you are using other eye drops at the same time as EMADINE, follow the advice at the end of section 3 (How to use EMADINE).
Jekk qed tuża qtar għall- għajnejn oħra fl- istess waqt ma ’ EMADINE, segwi l- pariri fl- aħħar ta ’ sezzjoni 3 “ Kif għandek tuża EMADINE ”.
If you are pregnant, or might get pregnant, if you are breast-feeding.
• Jekk inti tqila, jew tista ’ toħroġ tqila, jekk qed tredda ’.
Ask your doctor for advice
Staqsi lit- tabib tiegħek għall- parir.
How much to use Adults and children over 3 years:
Adulti u tfal minn 3 snin ’ l fuq:
Use it for as long as your doctor tells you.
Uża għat- tul ta ’ żmien li jgħidlek it- tabib tiegħek.
Do not use a container you’ve already opened.
Tużax kontenitur li tkun ftaħt qabel.
Do not use any sealed containers from a foil wrapper that was opened more than a week ago.
Tużax kontenituri issiġillati minn pakkett tal- fojl li jkun infetaħ aktar minn ġimgħa qabel.
• Tear off the foil wrapper and take out the strip of 5 containers. • Do not use if the solution is cloudy or has bits in it. • Hold the strip with the long flat end uppermost and separate off one container by pulling it towards you while holding the others firm.
• Iftaħ il- pakkett tal- fojl u oħroġ l- istrippa ta ’ ħames kontenituri. • Tużax jekk is- soluzjoni hija mdardra jew fiha xi frak. • Żomm l- istrippa bin- naħa ċ- ċatta wiċċha ’ l fuq, u ssepara kontenitur wieħed billi tiġbed lejk waqt li żżomm l- oħrajn.
You will need to snap it apart where it joins the others (picture 1). • Keep the single container out.
Se jkollok taqta ’ fejn il- kontenitur imiss ma ’ l- oħrajn (stampa 1) 33 • Ħalli l- kontenitur b’ doża waħda barra.
Put the others back in the foil wrapper. • Make sure you have a mirror handy and wash your hands. • Hold the long flat end of the container between your thumb and forefinger and open it by twisting off the other end (picture 2).
Poġġi l- kontenituri l- oħra li m’ intix ser tuża lura fil - pakkett tal- fojl. • Żomm mera fil- viċin u aħsel idejk • Żomm il- kontenitur min- naħa t- twila u ċatta bejn subgħajk il- kbir u l- werrej, u iftħu billi ddawwar in- naħa l- oħra (stampa 2). • Itfa ’ rasek lura.
Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye.
B’ seba ’ nadif, niżżel il- kappell ta ’ għajnejk sakemm ikun hemm ‘ spazju ’ bejn il- kappell t’ għajnek u l- għajn tiegħek.