qanastek/EMEA-V3 huggingface dataset:
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 (1 November 2007) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Imaniġġar tar- Riskju L- MAH jintrabat li jwettaq l- istudji u l- attivitajiet l- oħra dwar il- farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza, hekk kif miftihem fil- verżjoni 3 (1 Novembru 2007) tal- Pjan ta ’ l- Imaniġġar tar - Riskju (RMP) preżentat f’ modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis - Suq u kwalunkwe aġġornamenti ta ’ l- RMP li jkun hemm wara kif miftihem mis- CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Minbarra hekk, RMP aġġornat għandu jkun sottomess • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni kurrenti dwar is - Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet sabiex ikun imnaqqas għall- minimu r- riskju. • Fi żmien 60 jum minn meta jintlaħaq avveniment importanti (farmakoviġilanza jew tnaqqis tar - riskju għall- minimu). • Fuq talba ta ’ l- EMEA.
Galvus 50 mg tablets vildagliptin
Galvus 50 mg pilloli vildagliptin
Each tablet contains 50 mg vildagliptin.
Kull pillola fiha 50 mg vildagliptin
Contains lactose (see leaflet for further information).
Fih lactose (ara l- fuljett għal aktar informazzjoni).
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets
7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 60 pillola 90 pillola 112- il pillola 180 pillola 336 pillola
336 tablets Multipack comprising 3 packs, each containing 112 tablets.
336 pillola Pakkett b’ ħafna li jinkludi 3 pakketti, kull wieħed ikun fih 112- il pillola.
336 tablets (3x112)
336 pillola (3x112)
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
KARTUNA TAN- NOFS TAL- PAKKETT B’ ĦAFNA (MINGĦAJR IL- KAXXA Ċ- ĊELESTI)
112 tablets Component of a multipack comprising 3 packs, each containing 112 tablets.
112- il pillola Jagħmel parti minn pakkett b’ ħafna li jinkludi 3 pakketti, kull wieħed fih 112- il pillola.
22 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
24 PACKAGE LEAFLET:
24 FULJETT TA ’ TAGĦRIF:
Galvus 50 mg tablets Vildagliptin
Galvus 50 mg pilloli Vildagliptin
- If you have any further questions, ask your doctor, diabetes nurse or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- infermier tad- dijabete, jew lill- ispiżjar
What Galvus is and what it is used for 2.
X’ inhu Galvus u għalxiex jintuża 2.
Before you take Galvus 3.
Qabel ma tieħu Galvus 3.
How to take Galvus 4.
Kif għandek tieħu Galvus 4.
How to store Galvus 6.
Kif taħżen Galvus 6.
WHAT GALVUS IS AND WHAT IT IS USED FOR
X’ INHU GALVUS U GĦALXIEX JINTUŻA
Galvus belongs to a group of medicines called “ oral antidiabetics”.
Galvus jagħmel parti minn grupp ta ’ mediċini li jissejħu “ antidijabetiċi orali ”.
Galvus is used to treat patients with type 2 diabetes.
Galvus jintuża biex jikkura pazjenti b’ dijabete tat- tip 2.
It is used when diabetes cannot be controlled by diet and exercise alone.
Jintuża meta d- dijabete ma tkunx tista ’ tiġi kkontrollata bid- dieta u l- eżerċizzju waħidhom.
It helps to control the level of sugar in the blood.
Tgħin biex tikkontrolla l- livell ta ’ zokkor fid- demm.
Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Id- dijabete tat- tip 2 tiżviluppa jekk il- ġisem ma jkunx qed jgħamel biżżejjed insulina jew jekk l - insulina li jkun qed jgħamel il- ġisem ma jkunx qed jaħdem tajjeb kif suppost.
It can also develop if the body produces too much glucagon.
Tista ’ tiżviluppa wkoll jekk il- ġisem ikun qed jgħamel wisq glukagon.
Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals.
L- insulina hija sustanza li tgħin biex tbaxxi l- livell ta ’ zokkor fid- demm, l- aktar wara l- ikliet.
The pancreas makes both of these substances.
Glukagon huwa sustanza li tqanqal il- produzzjoni taz- zokkor mill- fwied, li tikkawża żieda fil- livell taz- zokkor fid- demm. Il- marrara tgħamel dawn iż- żewġ sustanzi.
Galvus works by making the pancreas produce more insulin and less glucagon.
Galvus jaħdem billi jġiegħel il- marrara tgħamel aktar insulina u anqas glukagon.
This helps to control the blood sugar level.
Dan jgħin biex ikun kontrollat il- livell ta ’ zokkor fid- demm.
Your doctor will prescribe Galvus together with certain other antidiabetic medicines which you will already be taking to control diabetes, if one medicine alone is not enough to control your blood sugar level.
I- tabib tiegħek ser jordnalek Galvus flimkien ma ’ ċerti mediċini oħra kontra d- dijabete li diġa kont qed tieħu biex tikkontrolla d- dijabete, jekk mediċina waħda ma tkunx biżżejjed biex tikkontrolla il- livell taz- zokkor fid- demm tiegħek.
Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/ or exercise which has been recommended for you.
Anki jekk issa sejjer tibda mediċina għad- dijabete tiegħek, huwa importanti li tkompli issegwi d- dieta u/ jew l- eżerċizzju li kien irrikkmandat għalik.
BEFORE YOU TAKE GALVUS
QABEL MA TIEĦU GALVUS
Further information).
Tieħux Galvus • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal vildagliptin jew sustanzi oħra ta ’ Galvus (ara sezzjoni 6 għal aktar tagħrif).
If you think you may be allergic to vildagliptin or any of the other ingredients of Galvus, do not take this medicine and talk to your doctor.
Jekk taħseb li tista ’ tkun allerġiku/ a għal vildagliptin jew kwalunkwe sustanza oħra ta ’ Galvus, tieħux din il- mediċina u tkellem mat- tabib tiegħek.
25 Take special care with Galvus:
25 Oqgħod attent ħafna b’ Galvus:
If any of these apply to you, tell your doctor before taking Galvus. • if you have type 1 diabetes (i. e. your body does not produce insulin). • if you have moderate or severe kidney disease. • if you are on dialysis. • if you have liver disease. • if you suffer from heart failure.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Galvus. • jekk għandek dijabete tat- tip 1 (i. e. jekk ġismek ma jipproduċix insulina). • jekk għandek mard moderat jew serju tal- kliewi. • jekk qiegħed/ qiegħda fuq dijalisi. • jekk għandek mard tal- fwied. • jekk għandek insuffiċjenza tal- qalb.
If you have previously taken Galvus but had to stop taking it because of side effects (liver disease), you should not take Galvus again.
Jekk xi darba hadt Galvus iżda kellek twaqqfu minħabba l- effetti sekondarji (mard tal- fwied), m’ għandekx terġa tieħu Galvus mill- ġdid.
Diabetic skin lesions are a common complication of diabetes.
Feriti fil- ġilda bid- dijabete huma kumplikazzjoni komuni tad- dijabete.
You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Għandek issegwi r - rakkomandazzjonijiet għall- kura tal- ġilda u tas - saqajn li tingħata mit- tabib jew infermier tiegħek.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Galvus.
Għandek ukoll toqgħod attent b’ mod partikolari għal bżieżaq jew ulċeri li jitfaċċaw meta tkun qed tieħu Galvus.
The use of Galvus in children and adolescents is not recommended.
L- użu ta ’ Galvus fi tfal u adolexxenti mhux rakkomandat.
Your doctor may wish to alter your dose of Galvus if you are taking other medicines (such as medicines so called thiazides, corticosteroids, thyroid products and certain products affecting the nervous system).
Jista ’ jkun li t- tabib tiegħek ikun jixtieq jibdillek id- doża tiegħek ta ’ Galvus jekk qed tieħu mediċini oħrajn (bħal mediċini hekk imsejjħa tajażajds, kortikosterojdi, prodotti tat- tirojde u ċerti prodotti li jeffettwaw is- sistema nervuża).
Taking Galvus with food and drink You can take Galvus with or without food.
Meta tieħu Galvus ma ’ l- ikel u max- xorb Tista ’ tieħu Galvus ma ’ l- ikel jew mingħajr ikel.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking Galvus.
Tqala u Treddigħ Nisa li ħarġu tqal jew qed jaħsbu għat- tqala għandhom jikkonsultaw mat- tabib tagħhom qabel ma jieħdu Galvus.
You should not use Galvus during pregnancy.
M’ għandekx tuża Galvus waqt it- tqala.
It is not known if Galvus passes into breast milk.
Mhux magħruf jekk Galvus jgħaddix mal- ħalib tas- sider.
You should not use Galvus if you are breast-feeding or plan to breast-feed.
M’ għandekx tuża Galvux jekk qed tredda ’ jew qed taħseb biex tredda ’.
Driving and using machines If you feel dizzy while taking Galvus, do not drive or use machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut meta tkun qed tieħu Galvus, m’ għandekx issuq jew tħaddem magni.
Important information about some of the ingredients of Galvus Galvus contains lactose (milk sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Galvus Galvus fih lactose (zokkor tal- ħalib).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, għamel kuntatt mat- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO TAKE GALVUS
KIF GĦANDEK TIEĦU GALVUS
Always take Galvus exactly as your doctor has told you.
Dejjem għandek tieħu Galvus skond il- parir tat- tabib.
How much to take The amount of Galvus people have to take varies depending on their condition.
Kemm għandek tieħu L- ammont ta ’ Galvus li għandhom jieħdu n- nies tvarja skond il- kundizzjoni tagħhom.
Your doctor will tell you exactly how many tablets of Galvus to take.
It- tabib tiegħek sejjer jgħidlek eżattament kemm għandek tieħu pilloli Galvus.
26 The usual dose of Galvus is either: • 50 mg daily taken as one dose in the morning if you are taking Galvus with another medicine called a sulphonylurea, or • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Galvus with another medicine called metformin or a glitazone.
Id- doża tas- soltu hija: • 50 mg kuljum li tittieħed bħala doża waħda filgħodu jekk qed tieħu Galvus ma ’ mediċina oħra li tissejjaħ sulphonylurea, jew • 100 mg kuljum li tittieħed bħala 50 mg filgħodu u 50 mg filgħaxija jekk qed tieħu Galvus ma ’ mediċina oħra li tissejjaħ metformin jew xi glitazone.
Your doctor will prescribe Galvus together with another medicine to control your blood sugar level.
26 It- tabib tiegħek sejjer jordnalek Galvus ma ’ mediċina oħra biex tikkontrolla l- livell taz- zokkor fid - demm tiegħek.
When and how to take Galvus • Take this medicine in the morning or in the morning and evening. • Swallow the tablets whole with some water.
Meta u kif għandek tieħu Galvus • Ħu din il- mediċina filgħodu jew filgħodu u filgħaxija. • Ibla ’ l- pilloli sħaħ bi ftit ilma.
How long to take Galvus • Take Galvus every day for as long as your doctor tells you.
Kemm għandek iddum tieħu Galvus • Ħu Galvus kuljum sakemm jgħidlek it- tabib tiegħek.
You may have to take this treatment over a long period of time. • Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. • Do not stop taking Galvus unless your doctor tells you to.
Jista ’ jkollok bżonn tieħu din il- kura fuq perijodu twil ta ’ żmien. • It- tabib tiegħek sejjer jimmontora l- kundizzjoni tiegħek sabiex jara li l- kura qed ikollha l- effett mixtieq. • Tieqafx tieħu Galvus sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
If you have questions about how long to take this medicine, talk to your doctor.
Jekk għandek mistoqsijiet dwar kemm għandek iddum tieħu din il- mediċina, tkellem mat- tabib tiegħek.
If you take more Galvus than you should If you take too many Galvus tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Jekk tieħu Galvus aktar milli suppost Jekk tieħu wisq pilloli Galvus jew jekk xi ħadd ieħor ħa l- mediċina tiegħek, tkellem mat- tabib tiegħek mill- ewwel.
Medical attention may be needed.
Jista ’ jkun hemm bżonn attenzjoni medika.
If you need to see a doctor or go to the hospital, take the pack with you.
Jekk ikollok bżonn tara tabib jew tmur l- isptar, ħu l- pakkett miegħek.
If you forget to take Galvus If you forget to take a dose of this medicine, take it as soon as you remember.
Jekk tinsa tieħu Galvus Jekk tinsa tieħu doża ta ’ din il- mediċina, ħudha malli tiftakar.
Then take your next dose at the usual time.
Imbagħad ħu d- doża li jmissek fil- ħin tas- soltu.
If it is almost time for your next dose, skip the dose you missed.
Jekk ikun kważi sar il- ħin tad- doża li jmissek, aqbeż id- doża li nsejt.
Do not take a double dose to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Galvus can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Galvus jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 patient in 10 • common: affects 1 to 10 patients in 100 • uncommon: affects 1 to 10 patients in 1,000 • rare: affects 1 to 10 patients in 10,000 • very rare: affects less than 1 patient in 10,000 • not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu iseħħu b’ ċerti frekwenzi, li huma imfissra kif ġej: • komuni ħafna: jaffettwaw aktar minn pazjent 1 f’ 10 • komuni: jaffettwaw 1 sa 10 pazjenti f’ 100 • mhux komuni: jaffettwaw 1 sa 10 pazjenti f’ 1, 000 • rari: jaffettwaw 1 sa 10 pazjenti f’ 10, 000 • rari ħafna: jaffettwaw anqas minn pazjent 1 f’ 10, 000 • mhux magħruf: il- frekwenza ma tistax tittieħed stima mid- data disponibbli.
Some symptoms need immediate medical attention:
Xi sintomi jista ’ jkollhom bżonn attenzjoni medika immedjata:
You should stop taking Galvus and see your doctor immediately if you experience the following side effects: • Angioedema (rare):
Għandek tieqaf tieħu Galvus u tara t- tabib tiegħek immedjatament jekk qed tħoss l- effetti sekondarji li ġejjin: • Anġjoedema (rari):
Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “ angioedema”. • Liver disease (hepatitis) (rare):
Sintomi jinkludu wiċċ, ilsien jew grieżem minfuħin, tbatija biex tibla ’, tbatija biex tieħu n- nifs, raxx jew ħorriqija li titfaċċa f’ daqqa, li tista ’ tindika reazzjoni msejjħa “ anġjoedema ”. • Mard tal- fwied (epatite) (rari).
Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
Sintomi jinkludu ġilda u għajnejn sofor, tqalligħ, telf ta ’ l- aptit jew awrina skura, li jista ’ jindika mard tal- fwied (epatite).
27 Other side effects Some patients have had the following side effects while taking Galvus and metformin: • Common:
Effetti sekondarji oħrajn Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Galvus u metformin: • Komuni:
Trembling, headache, dizziness, nausea, low blood glucose • Uncommon:
Tregħid, uġigħ ta ’ ras, sturdament, tqalligħ, zokkor fid- demm baxx • Mhux komuni:
Tiredness
Għeja
Some patients have had the following side effects while taking Galvus and a sulphonylurea: • Common:
Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Galvus u sulphonylurea: • Komuni:
Trembling, headache, dizziness, weakness, low blood glucose • Uncommon:
Stitikezza
Constipation • Very rare:
27 • Rari ħafna:
Sore throat, runny nose
Grieżem misluħin, imnieħer inixxi
Some patients have had the following side effects while taking Galvus and a glitazone: • Common:
Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Galvus u glitazone: • Komuni:
Weight increase, swollen hands, ankle or feet (oedema) • Uncommon:
Żieda fil- piż, nefħa ta ’ l- idejn, għaksa jew saqajn (edema) • Mhux komuni:
Headache, weakness, low blood glucose
Uġigħ ta ’ ras, dgħjufija, zokkor fid- demm baxx
Some patients have had the following side effects while taking Galvus alone: • Common:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin meta ħadu Galvus waħdu: • Komuni:
Dizziness • Uncommon:
Sturdament • Mhux komuni:
Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose • Very rare:
Uġigħ ta ’ ras, stitikezza, idejn, għaksa jew saqajn minfuħin (edema), uġigħ fil - ġogi, zokkor fid- demm baxx • Rari ħafna:
Sore throat, runny nose, fever
Grieżem misluħin, imnieħer inixxi, deni
HOW TO STORE GALVUS
KIF TAĦŻEN GALVUS
• Keep out of the reach and sight of children. • Do not use Galvus after the expiry date which is stated on the blister and the carton.
• Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal. • Tużax Galvus wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry date refers to the last day of that month. • Store in the original package in order to protect from moisture. • Do not use any Galvus pack that is damaged or shows signs of tampering.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. • Aħzen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità. • Tuża l- ebda pakkett ta ’ Galvus li jkun danneġġjat jew li juri sinjali ta ’ tbabis.
What Galvus contains • The active substance is vildagliptin.
X’ fih Galvus • Is- sustanza attiva hi vldagliptin.
Each tablet contains 50 mg vildagliptin. • The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.
Kull pillola fiha 50 mg vildagliptin. • Is- sustanzi l- oħra huma lactose anhydrous, microcrystalline cellulose, sodium starch glycolate (tip A) u magnesium stearat
What Galvus looks like and contents of the pack Galvus 50 mg tablets are round, white to light yellowish and flat, with “ NVR” on one side and “ FB” on the other.
Id- Dehra ta ’ Galvus u l- kontenuti tal- pakkett Galvus 50 mg pilloli huma tondi, bojod jagħtu fl- isfar ċar u ċatti, b ’ “ NVR ” fuq naħa u “ FB ” fuq l - oħra.
Galvus 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3x112) tablets.
Galvus 50 mg pilloli jiġu f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f’ pakketti b’ hafna li jkollhom 336 (3x112) pilloli.
Not all pack sizes may be marketed in your country.
Jista ’ jkun li mhux id- daqsijiet tal- pakketti kollha jkunu mqegħda fis- suq f’ pajjiżek.
28 Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution
GANFORT 300 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).
Ml wieħed ta ’ soluzzjoni fih 0. 3 mg ta ’ bimatoprost u 5 mg ta ’ timolol (bħala 6. 8 mg ta ’ timolol maleate).
Contains benzalkonium chloride 0.05 mg/ ml.
Fih benzalkonium chloride 0. 05 mg/ ml.
Colourless to slightly yellow solution.
Soluzzjoni mingħajr kulur, kemmxejn tagħti fl- isfar.
Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Tnaqqis ta ’ pressjoni għolja ġo l- għajn (IOP) f’ pazjenti b’ open- angle glawkoma jew pressjoni għolja fl- għajn li ma jirrispondux bizzejjed għal imblokkaturi tar- ricetturi beta, jew analogi ta ’ prostaglandin topikali.
Recommended dosage in adults (including the elderly)
Doża rakkommandata f’ adulti (inklużi l- anzjani)
The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered in the morning.
Id- doża rakkomandata hija qatra waħda ta ’ GANFORT fl- għajn( ejn) milquta darba kuljum, filgħodu.
If one dose is missed, treatment should continue with the next dose as planned.
Jekk tinqabeż doża waħda, it- trattament għandu jissokta bid- doża li tmiss kif ikun ippjanat.
The dose should not exceed one drop in the affected eye(s) daily.
Id- doża m' għandhiex tkun aktar minn qatra fl- għajn( ejn) milquta darba kuljum.
If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
Jekk qed jintuża aktar minn prodott wieħed topiku għall- għajn, kull wieħed għandu jittieħed mill - anqas 5 minuti wara ta ’ qablu.
Use in renal and hepatic impairment
Użu f’ indeboliment renali u tal- fwied
GANFORT has not been studied in patients with hepatic or renal impairment.
GANFORT ma kienx studjat f’ pazjenti b’ indeboliment tal- fwied jew renali.
Therefore caution should be used in treating such patients.
Għalhekk għandha tingħata attenzjoni meta jintuża fit- trattament ta 'dawn il- pazjenti.
Use in children and adolescents
Użu fit- tfal u fl- adoloxxenti
GANFORT has only been studied in adults and therefore its use is not recommended in children or adolescents.
GANFORT kien studjat biss fl- adulti u għalhekk l- użu tiegħu mhux rakkomandat fit- tfal jew fl - adoloxxenti.
Hypersensitivity to the active substances or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi jew għal xi wieħed mis- sustanzi mhux attivi.
Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
Marda rijattiva tal- passaġġ ta ’ l- arja inkluż l- ażżma tal- bronki jew passat ta ’ ażżma tal- bronki, marda kronika ta ’ ostruzzjoni severa tal- pulmun.
2 4.4 Special warnings and precautions for use
2 Bradikardja tas- sinus, ostaklu atrijoventikulari tat- tieni jew tat- tielet grad, insuffiċjenza kardijaka magħrufa, xokk kardjoġeniku.
Like other topically applied ophthalmic agents, GANFORT may be absorbed systemically.
Bħall- prodotti l- oħra li jiġu applikati b’ mod topiku fl- għajn, GANFORT jista ’ jiġi assorbit b’ mod sistemiku.
No enhancement of the systemic absorption of the individual active substances has been observed.
L- ebda titjib ta 'l- assorbiment sistemiku tas- sustanzi attivi individwali ma kien osservat.
Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur.
Minħabba il- komponent beta- adrenergiku, timolol, l- istess tipi ta ’ reazzjonijiet kardjovaskolari u pulminarji li ġew osservati minn imblokkaturi tar- ricetturi beta sistemiċi jistgħu iseħħu.
Cardiac failure should be adequately controlled before beginning GANFORT therapy.
Insuffiċjenza kardijaka għandha tkun kontrollata b’ mod adegwat qabel ma tinbeda l- kura b’ GANFORT.
Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked.
Pazjenti li fil- passat kellhom mard kardijaku sever għandhom jinżammu taħt osservazzjoni għal sinjali ta ’ insuffiċjenza kardijaka u għandha tiġi osservata r- rata tat- tektik tal- polz tagħhom.
Cardiac and respiratory reactions, including death due to bronchospasm in patients with asthma, and, rarely, death in association with cardiac failures have been reported following administration of timolol maleate.
Ġew rrappurtati reazzjonijiet kardijaċi u respiratorju, inkluż mewt minħabba, bronkospażmi f’ pazjenti bl- ażżma, u, f’ kazijiet rari, ġew rrappurtati mwiet assoċċjati ma ’ indeboliment kardijaku wara l- għoti ta ’ timolol maleate.
Beta-blockers may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.
Imblokkaturi tar- riċetturi beta jistgħu jgħattu sinjali ta ’ ipertirojdiżmu u jikkawżaw aggravament ta ’ Prinzmetal angina, mard sever taċ- ċirkolazzjoni periferali u ċentrali u pressjoni baxxa.
Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) as beta-blockers may mask the signs and symptoms of acute hypoglycemia.
Sustanzi li jimblokkaw ir- riċetturi beta- adrenerġiċi għandhom jingħataw b’ attenzjoni f’ pazjenti li huma soġġetti għal ipogliċemija spontanja jew pazjenti dijabetiċi (speċjalment dawk li għandhom dijabete mhux stabbli) peress illi imblokkaturi tar- ricetturi beta jistgħu jgħattu is- sinjali u s- sintomi ta ’ ipogliċemija akuta.
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Waqt li kienu qed jieħdu imblokkaturi tar- ricetturi beta, pazjenti li fil- passat kellhom atopija jew reazzjoni anafilattika severa għal varjetá ta ’ allerġeni jistgħu ma jirrispondux għad- doża normali ta ’ l - adrenalina li tintuża biex titratta reazzjonijiet anafilattiċi.
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/ or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months.
F’ pazjenti li fil- passat kellhom mard tal- fwied ħafif jew anormalita fl- alanine aminotransferase (ALT), aspartate aminotransferase (AST) u/ jew bilirubin fil- linja bażi, bimatoprost ma kellu ebda reazzjoni avversa fuq il- funzjoni tal- fwied fuq perijodu ta ’ 24 xahar.
There are no known adverse reactions of ocular timolol on liver function.
Ma hemm ebda reazzjoni avversa magħrufa ta ’ timolol għall- għajnejn fuq il- funzjoni tal- fwied.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with bimatoprost and GANFORT.
Qabel ma tingħata bidu għall- kura, il- pazjenti għandhom ikunu infurmati bil- possibilità ta ’ żjieda fit - tul tax- xagħar ta ’ xfar – il għajn, skurament tal- ġilda tal- kappell ta ’ l- għajn u żjieda fil- pigmentazzjoni tal- ħabba ta ’ l- għajn, billi dawn kienu osservati matul il- kura b ’ bimatoprost u b’ GANFORT.
Some of these changes may be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
Uħud minn dawn il- bidliet jistgħu jkunu permanenti, u jistgħu jwasslu għal differenzi fid- dehra bejn l - għajnejn meta l- kura ssir fuq għajn waħda biss.
After discontinuation of GANFORT, pigmentation of iris may be permanent.
Wara li jitwaqqaf GANFORT, il- pigmentazzjoni tal - ħabba ta ’ l- għajn tista tkun permamenti.
After 12 months treatment with GANFORT, the incidence of iris pigmentation was 0.2%.
Wara 12- il xahar ta ’ kura b’ GANFORT, l- inċidenza tal - pigmentazzjoni tal- ħabba ta ’ l- għajn kienet ta ’ 0. 2%.
After 12 months treatment with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years treatment.
Wara 12- il xahar ta ’ kura bil- qtar ta ’ l- għajnejn b’ bimatoprost biss, l- inċidenza kienet ta ’ 1. 5% u ma żdiedetx wara 3 snin ta ’ kura.
Cystoid macular oedema has been reported with GANFORT.
Edema makulari taċ- ċistojde kienet rappurtata wara kura b’ GANFORT..
Therefore, GANFORT should be used with caution in patients with known risk factors for macular oedema (e. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).
Għalhekk, GANFORT għandu jintuża b’ attenzjoni f’ pazjenti li hu magħruf li għandhom riskju ta ’ edema makulari (eż pazjenti afakiċi, pazjenti psewdofakiċi bil- kapsula tal- lenti ta ’ wara mċarrta).
The preservative in GANFORT, benzalkonium chloride, may cause eye irritation.
Il- preservattiv f’ GANFORT, benzalkonium chloride, jista ’ jikkawża iritazzjoni ta ’ l- għajnejn.
Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion.
Il - lentijiet tal- kuntatt għandhom jitneħħew qabel il- qtar, u ma jergħux jintlibsu qabel 15- il minuta wara il- qtar.
Benzalkonium chloride is known to discolour soft contact lenses.
Benzalkonium chloride huwa magħruf li jibdel il- kulur ta ’ lentijiet tal- kuntatt rotob.
Contact with soft contact lenses must be avoided.
Għandu jiġi evitat kuntatt ma ’ lentijiet tal- kuntatt rotob.
Benzalkonium chloride has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
3 Kien irrapurtat li benzalkonium chloride, jikkawża punctate keratopathy u/ jew ulcerative keratopathy tossika.
Therefore monitoring is required with frequent or prolonged use of GANFORT in dry eye patients or where the cornea is compromised.
Għalhekk, monitoraġġ huwa meħtieġ f’ pazjenti li jużaw GANFORT b’ mod regolari u fit- tul meta dawn ikollhom għajn xotta jew fejn il- korneja tkun qed titpoġġa f’ periklu.
GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
GANFORT ma kienx studjat f’ pazjenti b’ kundizzjonijiet infjammatorji fl- għajn, neovaskolari, infjammatorji, angle- closure glawkoma, glawkoma konġenitali jew narrow- angle glawkoma.
No interaction studies have been performed.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal prodott.
There is a potential for additive effects resulting in hypotension, and/ or marked bradycardia when eye drops containing timolol are administered concomitantly with oral calcium channel blockers, guanethidine, or beta-blocking agents, anti-arrhythmics, digitalis glycosides or parasympathomimetics.
Hemm il- potenzjali għal effetti additivi li jirriżultaw fi pressjoni baxxa, u/ jew bradikardja qawwija meta qtar ta ’ l- għajnejn li fihom timolol jingħataw flimkien ma ’ channel blockers tal- kalċju mill- ħalq, guanethidine, jew sustanzi li jimblukkaw ir- riċetturi beta, prodotti kontra l- arritmja, digitalis glycosides jew parasimpatomimetiċi.
Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents.
Imblokkaturi tar- ricetturi beta jistgħu iżidu l- effett ta ’ ipogliċemija ta ’ prodotti għal kontra d- dijabete.
Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Imblokkaturi tar- ricetturi beta jistgħu jgħattu s- sinjali u s- sintomi ta ’ ipogliċemija (ara s- sezzjoni 4. 4).
The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.
Ir- reazzjoni ta ’ pressjoni għolja għall- waqfien f’ daqqa ta ’ clonidine tista ’ tkun imsaħħa meta jkunu qed jittieħdu imblokkaturi tar- ricetturi beta.
Pregnancy There are no adequate data from the use of GANFORT in pregnant women.
Tqala Ma hemmx tagħrif adegwat għall- użu ta ’ GANFORT f’ nisa tqal.
Bimatoprost No adequate clinical data in exposed pregnancies are available.
Bimatoprost Ma hemmx tagħrif kliniku disponibbli dwar nisa tqal li ġew esposti għal bimatoprost.
Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Studji fl - annimali wrew tossiċità fis- sistema riproduttiva f’ dożi maternotossiċi għoljin (ara s- sezzjoni 5. 3).
Timolol Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Timolol Studji epidemjoloġiċi ma urewx effetti ta ’ formazzjoni difettuża iżda urew riskju ta ’ dewmien fl - iżvilupp ġo l- utru meta imblokkaturi tar- ricetturi beta jingħataw mill- ħalq.
In addition, signs and symptoms of beta-blockade (e. g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Barra minn hekk, sinjali u sintomi ta ’ beta- blockade (per eżempju bradikardja, pressjoni baxxa, diffikultajiet respiratorji u ipogliċemija) kienu osservati fit- trabi tat- twelid meta imblokkaturi tar- ricetturi beta ingħataw sat - twelid.
If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life.
Jekk GANFORT jingħata sat- twelid, it- tarbija tat- twelid għandha tkun monitorata bir- reqqa fl - ewwel ġranet ta ’ ħajjitha.
Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3).
Studji f’ annimali bit- timolol urew tossiċitiá fis- sistem riproduttiva meta ngħataw dożi ogħla b’ mod sinifikattiv minn dawk li għandhom jintużaw fil- prattika klinika (ara s - sezzjoni 5. 3).
Consequently, GANFORT should not be used during pregnancy unless clearly necessary.
B’ konsegwenza ta ’ dan, GANFORT ma għandux jintuża waqt it- tqala sakemm ma jkunx ċarament meħtieġ.
Lactation Timolol is excreted in breast milk.
Treddigħ Timolol jiġi eliminat fil- ħalib tas- sider.
It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat.
Mhux magħruf jekk bimatprost jiġix eliminat fil- ħalib uman iżda jiġi eliminat tal- firien li qed ireddgħu.
GANFORT should not be used by breast-feeding women.
GANFORT ma għandux jintuża minn nisa li qed ireddgħu.
GANFORT has negligible influence on the ability to drive and use machines.
GANFORT għandu effett negliġibbli fuq il- ħila biex issuq jew tħaddem magni.
As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
Bħal f’ kull każ ta ’ kura fl- għajn, jekk hekk kif tqattar tara mċajpar għal żmien qasir, il- pazjent għandu jistenna sakemm il- vista tiċċara qabel ma jsuq jew iħaddem magni.
No adverse drug reactions (ADRs) specific for GANFORT have been observed in clinical studies.
Fi studji kliniċi, ebda reazzjonijiet avversi tal- mediċina (ADRs) ma kienu osservati speċifikament għal GANFORT.
The ADRs have been limited to those earlier reported for bimatoprost and timolol.
L- ADRs kienu limitati għal dawk rapportati qabel għal bimatoprost u timolol.
The majority of ADRs were ocular, mild in severity and none were serious.
Il- maġġoranza ta ’ l- ADRs kienu fl- għajnejn, kienu ħfief fis- severità tagħhom u l- ebda wieħed ma kien serju.
Based on 12-month clinical data, the most commonly reported ADR was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients.
Ibbażat fuq tagħrif kliniku ta ’ 12- il xahar, l- iktar ADR li kien rapportat kien iperimija konġunktivali (il- biċċa l- kbira minn traċċa sa ħafifa u maħsuba li hi ta ’ natura mhux infjammatorja) f’ madwar 26% tal- pazjenti u wassal għal waqfien tal- kura f’ 1. 5% tal- pazjenti.
The following ADRs were reported during clinical trials with GANFORT (within each frequency grouping, undesirable effects are presented in order of decreasing seriousness):
L- ADRs segwenti kienu rrappurtati waqt provi kliniċi ta 'GANFORT (f’ kull sezzjoni ta ’ frekwenza, l - effetti mhux mixtieqa huma mniżżlin skond is- serjeta ’ tagħhom.
4 Nervous system disorders Uncommon (≥ 1/ 1000 to < 1/ 100): headache
Mard tais- sistema nervuża Mhux Komuni (≥1/ 1000 sa < 1/ 100): uġigħ ta ’ ras
Eye disorders Very common (≥ 1/ 10): conjunctival hyperaemia, growth of eyelashes.
Mard ta ’ l- għajejnn Komuni ħafna (≥1/ 10): iperimija konġunktivali, żjieda fid- daqs tax- xagħar ta ’ xfar il- għajn.
Uncommon (≥ 1/ 1000 to < 1/ 100): iritis, eye irritation, conjunctival oedema, blepharitis, epiphora, eyelid oedema, eyelid pain, visual acuity worsened, asthenopia, trichiasis.
Komuni (≥1/ 100 sa < 1/ 10): superficial punctuate keratitis, erożjoni tal- korneja, sensazzjoni ta ’ ħruq, ħakk fil- għajn, sensazzjoni ta ’ tingiż fl- għajn, sensazzjoni ta ’ xi ħaga li daħlet fl- għajn, nixfa fl- għajn, eritema tal- kappell ta ’ l- għajn, uġigħ fl- għajn, fotofobja, tħammiġ ta ’ l- għajn, disturbi fil- vista, ħakk fil- kappell ta ’ l- għajn Mhux komuni (≥1/ 1000 sa < 1/ 100): infjammazzjoni tal- ħabba ta ’ l- għajn, iritazzjoni ta 'l- għajn, edema konġunktivali, blerfarite, għajnejn idemmgħu ħafna, edema fil- kappell ta ’ l- għajn, uġigħ fil - kappell ta ’ l- għajn, tnaqqis fl- akutezza tal- vista, astenopja, trikjasi.
Not known: cystoid macular oedema.
Mhux magħruf: edema makulari fiċ- ċistojde.
Respiratory, thoracic and mediastinal disorders Uncommon (≥ 1/ 1000 to < 1/ 100): rhinitis
Mard respiratorju, toraċiku u medjastinali Mhux komuni (≥1/ 1000 sa < 1/ 100): rinite
Skin and subcutaneous tissue disorders Common (≥ 1/ 100 to < 1/ 10): blepharal pigmentation Uncommon (≥ 1/ 1000 to < 1/ 100): hirsutism
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda Komuni (≥1/ 100 sa < 1/ 10): pigmentazzjoni tal- kappell ta ’ l- għajn Mhux komuni (≥1/ 1000 sa < 1/ 100): tkabbir eċċessiv ta ’ xagħar fuq il- wiċċ u l- ġisem
Additional adverse events that have been seen with one of the components and may potentially occur also with GANFORT:
Reazzjonijiet avversi oħra li kienu osservati b’ wieħed mill- komponenti ta ’ GANFORT u potenzjalment jistgħu jseħħu b’ GANFORT ukoll:
Bimatoprost Infections and infestations: infection (primarily colds and upper respiratory symptoms).
Bimatoprost Infezzjonijiet u infestazzjonijiet: infezzjoni (primarjament irjiħat u sintomi fin- naħa ta ’ fuq tas- sistema respiratorja).
Nervous system disorders: dizziness Eye disorders: allergic conjunctivitis, cataract, eyelash darkening, increased iris pigmentation, blepharospasm, eyelid retraction, retinal haemorrhage, uveitis.
Mard tas- sistema nervuża: sturdament Mard ta ’ l- għajnejn: konġunktivite allerġika, katarretta, skurament tax- xagħar ta ’ xfar - il għajn, pigmentazzjoni ta’ l– ħabba ta ’ l- għajn, blefarospażmi, retrazzjoni tal- kappell ta ’ l- għajn, emorraġġija retinali, uvite.
Vascular disorders: hypertension.
Mard vaskulari: pressjoni għolja.
General disorders and administration site condition: asthenia, peripheral oedema.
Mard ġenerali u kundizzjonijiet fis- sit minn fejn tingħata l- mediċina: astenja, edema periferali.
Investigations: liver function tests (LFT) abnormal.
Investigazzjonijiet: eżami tal- funzjoni tal- fwied (LFT) abnormali.
Timolol Psychiatric disorders: insomnia, nightmares, decreased libido Nervous system disorders: dizziness, memory loss, increase in signs and symptoms of myasthenia gravis, paresthaesia, cerebral ischaemia Eye disorders: decreased corneal sensitivity, diplopia, ptosis, choroidal detachment (following filtration surgery), refractive changes (due to withdrawal of miotic therapy in some cases), keratitis.
Timolol Mard psikjatriku: insomnja, inkubi, libido mnaqqsa Mard tas- sistema nervuża: sturdament, telf ta ’ memorja, żjieda fi- sinjali u fis- sintomi ta ’ myasthenia gravis, paresthaesia, iskemija ċerebrali Mard ta ’ l- għajnejn: tnaqqis fis- sensittività tal- korneja, diplopja, ptosi, tinqala ’ l- korojd (wara kirurġija ta ’ filtrazzjoni), tibdil rifrattiv (minħabba l- waqfien ta ’ terapija mijotika f’ ċerti każi)), keratite.
Ear and labyrinth disorders: tinnitus.
5 Mard tal- widnejn u tas- sistema labirintika: żanżin fil- widnejn.
Cardiac disorders: heart block, cardiac arrest, arrhythmia, syncope, bradycardia, cardiac failure, congestive heart failure.
Mard tal- qalb: stadd fil- qalb, waqfien tal- qalb, arritmija, sinkope, bradikardja, insuffiċjenża kardijaka, insuffiċjenza kardijaka konġestiva.
Vascular disorders: hypotension, cerebrovascular accident, claudication, Raynaud’ s phenomenon, cold hands and feet, palpitation.
Mard vaskulari: pressjoni baxxa, inċident ċerebrovaskulari, claudication, il- fenomenu ta ’ Raynaud, idejn u saqajn kisħin, palpitazzjoni.
Respiratory, thoracic and mediastinal disorders: bronchospasm (predominantly in patients with pre- existing bronchospastic disease) dyspnoea, cough.
Mard respiratorju, toraċiku u medjastinali: bronkospażmi (l- aktar f’ pazjenti li diġa jsofru bi bronkospażmi) qtugħ ta ’ nifs, sogħla.
Gastrointestinal disorders: nausea, diarrhoea, dyspepsia, dry mouth.
Mard gastro- intestinali: nawżja, dijarrea, dispepsja, nixfa fil- ħalq.
Skin and subcutaneous tissue disorders: alopecia, psoriasiform rash or exacerbation of psoriasis.
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda: alopeċja, raxx ta ’ psorajiżi jew żjieda fis- psorajiżi.
Musculoskeletal and connective tissue disorders: systemic lupus erythematosus.
Mard muskolo- skeletrali u tat- tessut konnettiv: lupus erythematosus sistemiku.
Peyronie’ s disease.
Mard tal- kliewi u tas- sistema urinara: il- marda ta ’ Peyronie.
General disorders and administration site conditions: oedema, chest pain, fatigue.
Mard ġenerali u kundizzjonijiet fis- sit minn fejn tingħata l- mediċina: edima, uġigħ fis- sider, għejja.
No case of overdose has been reported, and is unlikely to occur after ocular administration.
L- ebda każ ta ’ doża eċċessiva ma ġie rrapurtat, u dan mhux mistenni li jseħħ wara li jingħata fl- għajn.
Bimatoprost If GANFORT is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses of bimatoprost up to 100 mg/ kg/ day did not produce any toxicity.
Bimatoprost Jekk GANFORT jittieħed bi żball mill- ħalq, din l- informazzjoni li ġejja għandha tkun utli: f’ studji orali ta ’ ħmistax fuq firien u ġrieden, dożi ta ’ bimatoprost sa 100 mg/ kg/ kuljum ma produċew l- ebda tossiċità.
This dose 5 expressed as mg/ m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in a 10 kg child.
Din id- doża espressa f’ mg/ m2 hi ta ’ mill- anqas 70 darba aktar mid- doża aċċidentali ta ’ flixkun ta ’ GANFORT f’ tifel ta ’ 10 kg.
Timolol Symptoms of systemic timolol overdose are: bradycardia, hypotension, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest.
Timolol Sintomi ta 'doża eċċessiva ta ’ timolol huma: bradikardja, pressjoni baxxa, bronkospażmi, uġigħ ta ’ ras, stordament, qtugħ ta ’ nifs, u waqfien tal- qalb.
A study of patients showed that timolol did not dialyse readily.
Studju li sar fuq pazjenti wera li timolol ma joħroġx malajr bid- dijaliżi Jekk tittieħed doża eċċessiva, il- kura għandha tkun sintomatika u ta ’ appoġġ.
Ophthalmological – beta-blocking agents – timolol, combinations, ATC code:
Oftalmoloġica – sustanzi li jimblokkaw ir- riċetturi beta – timolol, taħlitiet, Kodiċi ATC:
Mechanism of action:
Mekkaniżmu kif jaħdem:
GANFORT consists of two active substances: bimatoprost and timolol maleate.
GANFORT jikkonsisti f’ żewġ sustanzi attivi: bimatoprost u timolol maleate.
These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone.
Dawn iż- żewġ komponenti jnaqqsu l- pressjoni għolja ġewwa l- għajn (IOP) b’ mekkaniżmi li jaħdmu flimkien u r - riżultati tat- tnejn f’ daqqa jirriżulta fi tnaqqis ta ’ IOP meta mqabbel ma ’ l- effett ta ’ kull wieħed mill - komponenti meta jingħataw waħedhom.
GANFORT has a rapid onset of action.
GANFORT jibda jaħdem malajr.
Bimatoprost is a potent ocular hypotensive agent.
Bimatoprost hu sustanza qawwija li jbaxxi l- pressjoni fl- għajn.
It is a synthetic prostamide, structurally related to prostaglandin F2α (PGF2α) that does not act through any known prostaglandin receptors.
Huwa prostamide sintetiku, strutturalment relatat ma ’ prostaglandin F2α (PGF2α), li ma jaħdimx permezz ta ’ xi riċettur ta ’ prostaglandin magħruf.
The prostamide receptor, however, has not yet been structurally identified.
Bimatoprost selettivament jimita l- effetti tas- sustanzi biosintetizzati ġodda magħrufa bħala prostamidi Madankollu, l- istruttura tar- riċettur ta ’ prostamide, għadha ma kienetx identifikata.
The mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.
Il- mod kif bimatoprost inaqqas l- pressjoni fl- għajn fin- nies hu billi jżid il- ħruġ ta ’ aqueous humour mis- sistema trabekulari u jtejjeb il- ħruġ uvejosklerali.
Timolol is a beta1 and beta2 non-selective adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic (membrane-stabilising) activity.
Timolol huwa imblokkartur mhux selettiv tar- riċetturi adrenerġiċi beta1 u beta2 li ma għandux attività simpatomimetika intrinsika sinjifikanti, effett dippressanti fuq il- qalb dirett, jew effett ta’ anestesija lokali (stabilizzazzjoni tal- membrana).
Timolol lowers IOP by reducing aqueous humour formation.
Timolol inaqqas IOP billi inaqqas il- formazzjoni ta ’ aqueous humour.
The precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable.
Il- mekkaniżmu kif jaħdem preċiż m' huwiex kjarament stabbilit, iżda huwa probabbli li minħabba l- inibizzjoni tas- sinteżi ta ’ AMP ċiklika ikkawżat minn stimulazzjoni endoġenuża tar - riċetturi beta- adrenerġiċi.
Clinical effects:
6 Effetti kliniċi:
The IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily).
L- effett tat- tnaqqis ta 'IOP ta ’ GANFORT mhux inferjuri għal dak li ntlaħaq b’ terapija aġġuntiva ta ’ bimatoprost (darba kuljum) u timolol (darbtejn kuljum).
There are no studies with evening dosing of GANFORT.
Ma hemmx studji dwar l- għoti ta ’ GANFORT filgħaxija.
Morning dosing of GANFORT is therefore recommended to ensure maximal IOP-lowering effect at the time of the physiological IOP rise.
Għalhekk l- għoti ta ’ GANFORT filgħodu huwa rrakkommandat biex jassigura l- effett massimu tat- tnaqqis ta ’ IOP fil- ħin taż- żjieda fiżjoloġika ta ’ IOP.
However, if necessary for patient compliance, an evening dosing may be considered.
Iżda, l- għoti ta ’ GANFORT filgħaxija jista ’ jiġi kkunsidrat jekk ikun meħtieġ għall- pazjent għax ikun l- uniku ħin disponibbli għalih biex jagħmel il- qtar.
Once-daily dosing of timolol 0.5% has a rapid onset of maximal effect, corresponding with the time of this rise, and maintains clinically meaningful IOP-lowering over the 24-hour period.
L- għoti ta ’ timolol 0. 5% darba kuljum jibda jaħdem malajr bl- effett massimu, li jikkorrespondi mal- ħin taż- żjieda, u issostni effett tat- tnaqqis ta ’ IOP fuq perjodu ta ’ 24 siegħa.
Bimatoprost studies show comparable IOP control regardless of morning or evening dosing.
Studji b’ bimatoprost juru kontroll ta ’ IOP komparabbli irrispettivament jekk jittieħidx filgħodu jew filgħaxija.
Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the monotherapy treatments to GANFORT treatment in healthy subjects.
Konċentrazzjonijiet ta ’ bimatoprost u ta ’ timolol fil- plażma kienu determinati fi studju fejn kuri b’ terapija waħda ta ’ GANFORT f’ persuni b’ saħħithom kienu mqabbla.
Systemic absorption of the individual components was minimal and not affected by co-administration in a single formulation.
L- assorbiment sistemiku tal - komponenti individuali kien minimu u ma kienx affettwat mill- ko- amministrazzjoni b’ forma waħda
6 In two 12-month studies where systemic absorption was measured, no accumulation was observed with either of the individual components.
F’ żewġ studji ta ’ 12- il xahar fejn tkejjel l- assorbiment sistemiku, ma ġiet osservata l- ebda akkumulazzjoni bl- ebda komponent individwali.
Bimatoprost penetrates the human cornea and sclera well in vitro.
Bimatoprost jippenetra sew fil- korneja umana u fl- isklera in vitro.
After ocular administration, the systemic exposure of bimatoprost is very low with no accumulation over time.
Wara l- għotja fl- għajn, l - espożizzjoni sistemika ta ’ bimatoprost tkun baxxa ħafna u mingħajr akkumulazzjoni fuq tul ta ’ żmien.