qanastek/EMEA-V3 huggingface dataset:
In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon polyps, the following additional side effects have been observed (side effects marked with an asterisk were more common in these studies than in arthritis studies):
Fi studji kliniċi fejn Onsenal ittieħed sa perjodu ta ’ 3 snin biex jiġu evitati polipi spontanji fil - musrana l- ħoxra, ġew osservati l- effetti sekondarji addizzjonali li ġejjin (l- effetti sekondarji mmarkati b’ asterisk kienu aktar komuni f’ dawn l- istudji milli fl- istudji dwar l- artrite):
Very Common side-effects (affecting more than 1 person in every 10): − High blood pressure*, diarrhoea*
Effetti sekondarji Komuni Ħafna (jaffettwaw aktar minn persuna waħda minn kull 10): − Pressjoni għolja tad- demm *, dijarea *
Common − Heart problems: heart attack*, angina (chest pain) − Stomach problems: nausea, heartburn, diverticulum (a problem with the stomach or intestine that can become painful or infected), vomiting*, irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion, wind) − Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine, increased creatinine (blood test result related to kidney function) − Difficulty breathing − Muscle spasms − Oedema (water retention that can cause swelling) − Enlarged or inflamed prostate, prostate specific antigen increased (lab test) − Infections of various types − Weight gain
Komuni − Problemi fil- qalb: attakk tal- qalb *, anġina (uġigħ fis- sider) − Problemi fl- istonku: dardir, qrusa fl- istonku, divertikulu (problema bl- istonku jew l- intestin li tista ’ tweġġgħek jew tinfetta), rimettar *, sindrome tal- imsaren irritabbli (tista ’ tinkludi wġigħ fl- istonku, dijarea, indiġestjoni, gass) − Ġebel fil- kliewi (li jistgħu jwasslu għal uġigħ fl- istonku jew fid- dahar, demm fl- awrina), diffikultà biex tagħmel l- awrina, żieda fil- kreatinina (riżultat ta ’ test tad- demm relatat mal - funzjoni tal- kliewi) − Diffikultà biex tieħu n- nifs − Spażmi fil- muskoli − Edema (żamma tal- ilma li tista ’ tikkawża nefħa) − Tkabbir jew infjammazzjoni fil- prostata, antiġen speċifiku għall- prostata (test tal- laboratorju) − Infezzjonijiet ta ’ diversi tipi − Żieda fil- piż
Uncommon − Stroke − Unstable angina (chest pain), troubles with heart valves, rhythm, or coronary arteries, or enlarged heart − Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems), bruising − Stomach infection(which can cause irritation and ulcers of the stomach and intestines), bleeding from piles/ haemorrhoids, frequent bowel movements, inflamed or bleeding gums/ mouth sores − Lower limb fracture, tendon rupture or inflammation − Shingles, skin infection, allergic dermatitis (dry itchy rash) − Floaters or haemorrhage in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, difficulty speaking − Difficulty sleeping, excessive urination at night − Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot) − Α bnormal or heavy bleeding from the vagina, painful menstruation, breast pain, ovarian cyst, menopausal symptoms − High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test results − Decreased hearing − Changes in blood counts
Mhux komuni − Puplesija − Anġina instabbli (uġigħ fis- sider), inkwiet bil- valvi tal- qalb, ir- ritmu, jew l- arterji koronarji, jew tkabbir fil- qalb − Trombożi fil- vini fondi (embolu fis- sieq, li jista ’ jikkawża tbatija, nefħa jew ħmura tal- qasba tas- sieq jew problemi tan- nifs), tbenġil − Infezzjoni fl- istonku (li tista ’ tikkawża irritazzjoni u ulċeri tal- istonku u l- intestini), fsada mill - murliti, movimenti frekwenti tal- imsaren, ħniek infjammati jew bid- demm/ feriti fil- ħalq − Ksur fir- riġlejn, ftuq jew infjammazzjoni tal- għeruq − Ħruq ta ’ Sant’ Antnin, infezzjoni tal- ġilda, dermatite allerġika (raxx xott li jieklok) − Għawwiema jew emorraġija fl- għajnejn li tikkawża vista mċajpra jew mgħarrqa, vertiġini minħabba inkwiet fil- widna ta ’ ġewwa, diffikultà biex titkellem − Diffikultà biex torqod, urinazzjoni eċċessiva billejl − Għoqdiet xaħmija fil- ġilda jew xi mkien ieħor, ċista (nefħiet mhux perikolużi fuq u madwar il - ġogi u l- għeruq fl- id jew fis- sieq) − Fsada abnormali jew qawwija mill- vaġina, mestrwazzjoni li tweġġa ’, uġigħ fis- sider, ċista fl - ovarju, sintomi tal- menopawsa
HOW TO STORE ONSENAL
KIF TAĦŻEN ONSENAL
Do not store your capsules above 30°C.
Taħżinx il- kapsuli tiegħek f’ temperatura ‘ l fuq minn 30°C
45 Do not take the capsule after the ‘ expiry date’ shown on the blister and carton.
Tiħux il- kapsula wara d - ‘ data ta ’ skadenza ’ li tidher fuq il- folja u l- kartuna.
If your capsules are out of date, take them to your pharmacist who will get rid of them safely.
Jekk il- kapsuli tiegħek skadew, ħudhom għand l- ispiżjar tiegħek li jeħles minnhom mingħajr periklu.
What ONSENAL contains
X’ fih ONSENAL
- The active substance is celecoxib
- Is- sustanza attiva hi celecoxib
- The other ingredients are gelatin, lactose monohydrate, sodium lauryl sulphate, povidone K30,
- Is- sustanzi l- oħra huma gelatin, lactose monohydrate, sodium lauryl sulphate, povidone K30,
croscarmellose sodium, magnesium stearate and the colouring agent titanium dioxide E171.
croscarmellose sodium, magnesium stearate u l- aġent tal- kulur titanium dioxide E171.
- The printing ink contains also shellac, propylene glycol and iron oxide E172.
- Il- linka ta ’ l- istampar fiha wkoll shellac, propylene glycol u iron oxide E172.
What ONSENAL looks like and contents of the pack
Id- dehra ta ’ ONSENAL u d- daqs tal- pakkett
The capsules are white with ‘ 7767‘ and ‘ 200‘ marked in gold ink.
Il- kapsuli huma bojod bin- numru ‘ 7767 ’ u ‘ 200 ’ immarkati b’ linka kulur id- deheb.
Onsenal is packed in blisters and supplied in boxes of 10 or 60 capsules.
Onsenal huwa ppakkjat f’ folji u fornut f’ kaxxi ta ’ 10 jew 60 kapsula.
Marketing Authrisation Holder
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Germany
Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Strasse 35 89257 Illertissen Il- Ġermanja
46 For any information about this medicine, please contact the 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.
България Pfizer HCP Corporation Тел.: +359 2 970 4333
50 България Pfizer HCP Corporation Тел.: +359 2 970 4333
This medicine has been authorised under “ exceptional circumstances”.
Din il- mediċina kienet awtorizzata taħt “ ċirkustanzi ta ’ eċċezzjoni ”.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
48 PACKAGE LEAFLET:
52 FULJETT TA ’ TAGĦRIF:
Onsenal 400 mg hard capsules celecoxib
Onsenal 400 mg kapsuli iebsin celecoxib
Possible side effects 5 How to store Onsenal 6.
Kif taħżen Onsenal 6.
FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer.
Il- FAP hija disturb ereditarju li fih ir- rektum u l- kolon ikunu miksija b’ ħafna polipi li jistgħu jiżviluppaw kanċer kolorettali.
- if you have had an allergic reaction to a group of medicines called “ sulphonamides”.
- jekk kellek reazzjoni allerġika għal grupp ta ’ mediċini msejħa “ sulfonamidi ”.
some antibiotics (Bactrim and Septra used in combination with sulfamethoxole and trimethoprim), which can be used to treat infections
ċerti antibijotiċi (Bactrim u Septra użati f’ taħlita ta ’ sulfamethoxazole u trimethoprim), li jistgħu jintużaw għall- kura ta ’ l- infezzjonijiet
had a heart attack, stroke, mini-stroke (TIA) or blockages of blood vessels to the heart or brain if you have had an operation to clear or bypass blockages
jekk kellek attakk tal- qalb, puplesija, puplesija ħafifa (TIA) jew imblokkar tal- vini u l- arterji għall- qalb jew il- moħħ
- or if you have or have had problems with blood circulation (peripheral arterial disease) or if you
- jew jekk għandek jew kellek problemi biċ- ċirkolazzjoni tad- demm (mard ta ’ l- arterji periferali)
have had surgery on the arteries of your legs
jew jekk għamilt operazzjoni fl- arterji ta ’ riġlejk
Take special care with ONSENAL
Oqgħod attent ħafna b’ Onsenal:
- Some people will need special care from their doctors when they are taking Onsenal.
- Xi nies ikollhom bżonn kura speċjali mit- tobba tagħhom meta jieħdu Onsenal.
Make sure that
Kun żgur li t -
your doctor knows before you start taking Onsenal:
tabib tiegħek ikun jaf qabel ma tibda tieħu Onsenal:
- Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
- Mediċini ohra għall- kura tad- depresjoni, problemi ta ’ l- irqad, pressjoni għolja tad- demm jew
Pregnancy and breast-feeding You must not take Onsenal if you are pregnant or if it is possible that you become pregnant.
54 Tqala u treddigħ M’ għandekx tieħu Onsenal jekk inti tqila jew jekk hu possibbli li toħroġ tqila.
50 You must not take Onsenal if you are breast feeding.
M’ għandekx tieħu Onsenal jekk qed tredda ’.
Driving and using machines If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling normal again.
Sewqan u tħaddim ta ’ magni Jekk tħossok stordut/ a jew għajjien/ a wara li tieħu Onsenal, issuqx jew tuża makkinarju sakemm terġa ’ tħossok normali.
You will usually take one 400 mg capsule twice a day.
Ġeneralment ser tieħu żewġ kapsuli ta 200 mg darbtejn kuljum.
Stop taking the capsules and tell your doctor immediately… If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing If you have heart problems such as pain in the chest If you have liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow) If you have blistering or peeling of the skin If you have severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood
Ieqaf ħu l- kapsuli u għid lit- tabib tiegħek immedjatament Jekk għandek reazzjoni allerġika bħal raxx fil- gilda, nefħa tal- wiċċ, tħarħir jew diffikulta biex tieħu n- nifs Jekk għandek problemi fil- qalb bħal uġigħ f’ sidrek Jekk għandek insuffiċjenza tal- fwied (is- sintomi jistgħu jinkludu dardir (tħossok ma tiflaħx), dijarea, suffejra (il- ġilda jew l- abjad ta ’ għajnejk jidhru sofor) Jekk għandek infafet jew qed titqaxxarlek il- ġilda Jekk għandek uġigħ qawwi fl- istonku jew xi sinjali ta ’ fsada fl- istonku jew fl- intestini, jekk tipporga iswed jew imtebba ’ bid- demm jew qed tirremetti d- demm
- Fluid build up with swollen ankles, legs and/ or hands
- Akkumulazzjoni ta ’ fluwidu b’ għekiesi, saqajn u/ jew idejn minfuħin
- Urinary infections
- Infezzjonijiet urinarj
- Sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore
- Sinożite (infjammazzjoni tas- sinus, infezzjoni tas- sinus, sinus imblukkati jew juġgħu), imnieħer
throat, coughs, colds, flu-like symptoms
imblukkat jew iqattar, uġigħ fil- griżmejn, sogħla, irjiħat, sintomi bħall- influwenza
- Dizziness, difficulty sleeping
- Sturdament, diffikultà biex torqod
- stomach ache, diarrhoea, indigestion, wind
- Uġigħ fl- istonku, dijarea, indiġestjoni, gass
- Rash, itching
- Raxx, ħakk
- Muscle stiffness
- Ebusija fil- muskoli
- Worsening of existing allergies
- Taħżin ta ’ allerġiji eżistenti
51 Uncommon side effects which may affect more than 1 person in a 1000, are listed below − Heart failure, palpitations (awareness of heart beat), fast heart rate − Worsening of existing high blood pressure − Abnormalities in liver-related blood tests − Abnormalities in kidney-related blood tests − Anaemia (changes in red blood cells that can cause fatigue and breathlessness) − Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles) − High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle weakness or palpitations) − Impaired or blurred vision, ringing in the ears, mouth pain and sores − Constipation, burping, stomach inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine. − Leg cramps − Raised itchy rash (hives)
Effetti sekondarji mhux komuni li jistgħu jaffettwaw iżjed minn persuna minn kull 1000, huma elenkati hawn taħt
Rare side effects which may affect more than 1 person in a 10,000, are listed below
- Insuffiċjenza tal- qalb, palpitazzjonijiet (konxju tat- taħbita ta ’ qalbek), taħbita tal- qalb mgħaġġla
- Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach
- Anemija (bidliet fiċ- ċelloli ħomor tad- demm li jistgħu jikkawżaw għeja u qtugħ ta ’ nifs)
ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to stomach pain)
- Ansjetà, depressjoni, għeja, ngħas, sensazzjonijiet ta ’ tnemnim (tingiż)
- Reduced number of white blood cells (which help protect the body from infection) and blood platelets
- Livelli għoljin ta ’ potassium fir- riżultati ta ’ testijiet tad- demm (jistgħu jikkawżaw dardir
(increased chance of bleeding or bruising)
(tħossok ma tiflaħx), għeja, dgħufija fil- muskoli jew palpitazzjonijiet)
- Difficulty coordinating muscular movements
- Indeboliment fil- vista jew vista mċajpra, żarżir fil- widnejn, uġigħ u feriti fil- ħalq
- Feeling confused, changes in the way things taste
- Stitikezza, tifwiq, infjammazzjoni fl- istonku (indiġestjoni, uġigħ fl- istonku jew rimettar), taħżin
- Increased sensitivity to light
tal- infjammazzjoni fl- istonku jew fl- intestini
- Loss of hair
- Bugħawwieġ fis- saqajn
-
- Raxx jieklok (ħorriqija)
The frequencies of these reactions are difficult to determine but are generally considered to be very rare (affecting less than 1 person in every 10,000) − Bleeding within the brain causing death
Effetti sekondarji rari li jistgħu jaffettwaw iżjed minn persuna minn kull 10, 000, huma hawn elenkati hawn taħt:
- Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash,
- Ulċeri (fsada) fl- istonku, fil- gerżuma jew fl- intestini; jew ftuq tal- intestini (jista ’ jikkawża
swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing − Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon, inflammation of the pancreas, nausea (feeling sick) − Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) − Liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant).
wġigħ fl- istonku, deni, dardir, rimettar, imblokk intestinali), ippurgar skur jew iswed, infjammazzjoni tal- gerżuma (tista ’ tikkaġuna diffikultà biex tibla ’), infjammazzjoni tal- frixa (tista ’ twassal għal uġigħ fl- istonku)
- A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy
- Tnaqqis fin- numru ta ’ ċelloli bojod tad- demm (li jgħinu biex jipproteġu lill- ġisem mill -
bruising, frequent nose bleeds and increased risk of infections) − Impaired sense of smell − Skin discolouration (bruising), muscle pain and weakness, painful joints − Menstrual disturbances
infezzjonijiet) u ta ’ plejtlits tad- demm (ċans akbar ta ’ fsada jew tbenġil)
52 − Headache, flushing
- Tħossok konfuż, bidliet fil- mod kif itiegħmu l- affarijiet
- Low levels of sodium in blood test results (can cause loss of appetite, headache, nausea (feeling sick),
56 − Vini u arterji infjammati (jistgħu jikkawżaw deni, uġigħ, tbajja ’ vjola fuq il- ġilda) − Imblokk ta ’ arterja jew vina fl- għajn li jwassal għat- telf parzjali jew komplet tal- vista, konġuntivite, infezzjoni fl- għajn (għajn roża), fsada fl- għajn
muscle cramps and weakness)
- Tnaqqis fin- numru ta ’ ċelloli ħomor u bojod tad- demm u tal- plejtlits (jista ’ jikkawża għeja,
Uncommon − Stroke − Unstable angina (chest pain), troubles with heart valves, rhythm, or coronary arteries, or enlarged heart − Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems), bruising − Stomach infection (which can cause irritation and ulcers of the stomach and intestines), bleeding from piles/ haemorrhoids, frequent bowel movements, inflamed or bleeding gums/ mouth sores − Lower limb fracture, tendon rupture or inflammation − Shingles, skin infection, allergic dermatitis (dry itchy rash) − Floaters or haemorrhage in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, difficulty speaking − Difficulty sleeping, excessive urination at night − Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot) − Α bnormal or heavy bleeding from the vagina, painful menstruation, breast pain, ovarian cyst, menopausal symptoms − High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test results
Mhux komuni − Puplesija − Anġina instabbli (uġigħ fis- sider), inkwiet bil- valvi tal- qalb, ir- ritmu, jew l- arterji koronarji, jew tkabbir fil- qalb − Trombożi fil- vini fondi (embolu fis- sieq, li jista ’ jikkawża tbatija, nefħa jew ħmura tal- qasba tas- sieq jew problemi tan- nifs), tbenġil − Infezzjoni fl- istonku (li tista ’ tikkawża irritazzjoni u ulċeri tal- istonku u l- intestini), fsada mill - murliti, movimenti frekwenti tal- imsaren, ħniek infjammati jew bid- demm/ feriti fil- ħalq − Ksur fir- riġlejn, ftuq jew infjammazzjoni tal- għeruq − Ħruq ta ’ Sant’ Antnin, infezzjoni tal- ġilda, dermatite allerġika (raxx xott li jieklok) − Għawwiema jew emorraġija fl- għajnejn li tikkawża vista mċajpra jew mgħarrqa, vertiġini minħabba inkwiet fil- widna ta ’ ġewwa, diffikultà biex titkellem − Diffikultà biex torqod, urinazzjoni eċċessiva billejl − Għoqdiet xaħmija fil- ġilda jew xi mkien ieħor, ċista (nefħiet mhux perikolużi fuq u madwar il - ġogi u l- għeruq fl- id jew fis- sieq) − Fsada abnormali jew qawwija mill- vaġina, mestrwazzjoni li tweġġa ’, uġigħ fis- sider, ċista fl - ovarju, sintomi tal- menopawsa − Livelli għoljin ta ’ sodium jew emoglobina u livelli baxxi ta ’ ematokrit jew testosteron fir - riżultati ta ’ testijiet tad- demm
- Decreased hearing
- Tnaqqis fis- smigħ
53 Do not take the capsule after the ‘ expiry date’ shown on the blister and carton.
Tiħux il- kapsula wara d - ‘ data ta ’ skadenza ’ li tidher fuq il- folja u l- kartuna.
- The printing ink contains also shellac, propylene glycol and iron oxide E172, Brilliant Blue FCF E
- Il- linka ta ’ l- istampar fiha wkoll shellac, propylene glycol u iron oxide E172.
The capsules are white with ‘ 7767‘ and ‘ 400‘ marked in green ink.
Il- kapsuli huma bojod bin- numru ‘ 7767 ’ u ‘ 400 ’ immarkati b’ linka kulur id- deheb.
For any information about this medicine, please contact the 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.
Danmark Pfizer ApS Tlf: +45 44 20 11 00
Danmark
Nederland Pfizer BV Tel: +31 (0)10 406 4301
Nederland
Deutschland Pfizer Pharma GmbH
58 Pfizer ApS Tlf: +45 44 20 11 00
Norge Pfizer AS 54
Pfizer BV Tel: +31 (0) 10 406 4301
Tel: +49 30 550055-51000.
Deutschland Pfizer Pharma GmbH Tel: +49 (0) 30 550055- 51000
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
59 L- Aġenzija Ewropea dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
55 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
What is OPATANOL?
X’ inhu OPATANOL?
OPATANOL is a clear eye drop solution, which contains the active substance olopatadine.
OPATANOL hu soluzzjoni ċara għat- taqtir fil- għajnejn, li fiha s- sustanza attiva olopatadine.
What is OPATANOL used for?
Għal x’ hiex jintuża OPATANOL?
OPATANOL is used to treat the eye symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
OPATANOL jintuża għat- trattament tas- sintomi relatati mal- għajnejn tal- konġuntivite allerġika staġjonali (infjammazzjoni fl- għajnejn ikkawżata mill- polline f’ pazjenti bil- hayfever.
These include itching, redness and swelling.
Dawn jinkludu ħakk, ħmura u nefħa.
How is OPATANOL used?
Kif jintuża OPATANOL?
OPATANOL is used in adults and children aged three years and older.
OPATANOL jintuża fl- adulti u fi tfal ta ’ tliet snin jew aktar.
It is given as one drop into the affected eye(s) twice a day, given eight hours apart.
Jingħata bħala qatra waħda fl- għajn( ejn) affettwata( i) darbtejn kuljum, bi tmien sigħat bejn waħda u oħra.
If another eye treatment is also being used, there should be a gap of five to 10 minutes between treatments.
Jekk ikun qed jintuża wkoll xi trattament ieħor tal- għajnejn għandhom jitħallew bejn ħames u 10 minuti bejn trattament u ieħor.
The eye drops can be used for up to four months, if needed.
Il - qtar tal- għajnejn jista ’ jintuża sa massimu ta ’ erba ’ xhur jekk ikun hemm bżonn.
How does OPATANOL work?
Kif jaħdem OPATANOL?
The active substance in OPATANOL, olopatadine, is an antihistamine.
Is- sustanza attiva f’ OPATANOL, olopatadine, hija prodott anti- istaminiku.
Olopatadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Olopatadine jaħdem billi jimblokka r- riċetturi li fuqhom normalment teħel l- istamina, sustanza fil- ġisem li tikkawża sintomi tal - allerġija.
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Meta r- riċetturi jiġu imblokkati, l- istamina ma tkunx tista ’ tikkawża effett, u dan iwassal għal tnaqqis fis- sintomi tal- allerġija.
How has OPATANOL been studied?
Kif ġie studjat OPATANOL?
OPATANOL has been studied in 688 patients in four main studies lasting between six and 14 weeks.
OPATANOL ġie studjat f’ 688 pazjent f’ erba ’ studji ewlenin li saru fuq sitta u 14- il ġimgħa.
Two of these studies included children.
Tnejn minn dawn l- istudji inkludew ukoll tfal.
OPATANOL was compared with cromolyn sodium (another anti-allergy medicine), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment).
OPATANOL tqabbel ma ’ cromolyn sodium (mediċina oħra ta ’ kontra l- allerġija), ma ’ levocabastine (prodott anti- istaminiku ieħor) u, f’ żewġ studji, ma ’ plaċebo (trattament finta).
In all of the studies, the main measure of effectiveness was based on the degree of itching and redness in the eye.
F’ dawn l- istudji kollha, il- mezz ewlieni tal- kejl tal- effettività kien ibbażat fuq l - ammont ta ’ ħakk u ħmura fl- għajn.
One of the placebo studies also looked at these symptoms in relation to pollen counts.
Wieħed mill- istudji ħares ukoll lejn dawn is- sintomi b’ rabta mal - indiċijiet tal- għadd tal- polline fl- arja.
What benefit has OPATANOL shown during the studies?
X’ inhuma l- benefiċċji ta ’ OPATANOL li ntwerew f’ dawn l- istudji?
OPATANOL was as effective as cromolyn sodium and as levocabastine.
OPATANOL kien effettiv daqs cromolyn sodium u levocabastine.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Meta mqabbel mal- plaċebo, OPATANOL kien iktar effettiv biss meta kienu kkunsidrati l- indiċijiet tal- għadd tal- polline fl- arja, li wrew li iktar ma ’ kien hemm polline fl- arja, iktar kienet kbira d- differenza bejn l- effetti ta ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2009 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged OPATANOL and those of placebo.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged OPATANOL u dawk tal- plaċebo.
At lower pollen counts, there were no differences between the two treatments.
Meta l- għadd tal- polline fl- arja kien żgħir, ma kienx hemm differenzi bejn iż- żewġ trattamenti.
What is the risk associated with OPATANOL?
X’ riskji huma assoċjati ma ’ OPATANOL?
The most common side effects with OPATANOL (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances), eye pain, eye irritation, abnormal sensations in the eye, dry nose and fatigue (tiredness).
L- iżjed effetti sekondarji komuni ma ’ OPATANOL (dehru f’ pazjent wieħed minn kull mija) huma l - uġigħ ta ’ ras, disgweżja (disturbi biex ittiehem), uġigħ fl- għajnejn, irritazzjoni fl- għajnejn, sensazzjonijiet abnormali fl- għajnejn, nixfa fl- imnieħer u għejja.
For the full list of all side effects reported with OPATANOL, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma ’ OPATANOL, ara l- Fuljett ta ’ Tagħrif.
OPATANOL should not be used in people who may be hypersensitive (allergic) to olopatadine or any of the other ingredients.
OPATANOL m’ għandux jintuża minn persuni allerġiċi għal olopatadine jew sustanzi oħra.
OPATANOL contains benzalkonium chloride, which is known to discolour soft contact lenses.
OPATANOL fih benzalkonium chloride, li hu magħruf li jibdel il- kulur tal- contact lenses rotob.
Therefore care should be taken by people who wear soft contact lenses.
Għalhekk min juża contact lenses rotob għandu joqgħod attent ħafna.
Why has OPATANOL been approved?
Għaliex ġie approvat OPATANOL?
The Committee for Medicinal products for Human Use (CHMP) decided that OPATANOL’ s benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li OPATANOL għandu iktar benefiċċji milli riskji fit- trattament ta ’ sinjali u sintomi tal- konġuntive allerġika staġjonali.
The Committee recommended that OPATANOL be given marketing authorisation.
Il- Kumitat irrakkomanda li OPATANOL jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about OPATANOL:
Aktar tagħrif dwar OPATANOL:
The European Commission granted a marketing authorisation valid throughout the European Union for OPATANOL to Alcon Laboratories (UK) Limited on 17 May 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal OPATANOL lil Alcon Laboratories (UK) Limited fis- 17 ta ’ Mejju 2002.
The marketing authorisation was renewed on 17 May 2007.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 17 ta ’ Mejju 2007.
The full EPAR for OPATANOL is available here.
L- EPAR sħiħ għal OPATANOL huwa disponibbli hawn.
This summary was last updated in 08-2007.
Dan is- sommarju ġie aġġornat f’ 08- 2007.
OPATANOL 1 mg/ ml eye drops, solution
OPATANOL 1 mg/ ml, qtar għall- għajnejn, soluzzjoni.
One ml of solution contains 1 mg olopatadine (as hydrochloride).
1 ml ta ’ soluzzjoni fih 1 mg olopatadine (bħala hydrochloride).
For a full list of excipients, see section 6.1.
Għall- lista kompleta ta ’ sustanzi mhux attivi, ara 6. 1.
Eye drops, solution (eye drops).
Qtar għall- għajnejn, soluzzjoni (qtar għall- għajnejn)
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Kura ta ’ sinjali ta 'mard fl- għajnejn u sintomi ta' allerġija ta 'l- istaġun fil- konġuntiva ta' l- għajnejn.
The dose is one drop of OPATANOL in the conjunctival sac of the affected eye(s) twice daily (8 hourly).
Id- doża hija ta ’ qatra waħda ta ’ OPATANOL fil- borża tal- konġuntiva ta 'l- għajn( ejn) affettwata( i) darbtejn kuljum (kull 8 sigħat).
Treatment may be maintained for up to four months, if considered necessary.
Jekk ikun hemm bżonn, il- kura tista titkompla għall- erba ’ xhur.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle.
Biex tevita ’ kontaminazzjoni tat- tarf tal- qattara u tas- soluzzjoni, oqgħod attent li ma ’ tmisx il- kappell ta ’ l- għajnejn, l- erja ta ’ madwar l- għajnenjn jew xi superfiċji oħra bit- tarf tal- qattara tal- flixkun.
Keep the bottle tightly closed when not in use.
Żomm il- flixkun magħluq sewwa meta mhux qed tużah.
In case of concomitant therapy with other topical ocular medicines, an interval of five to ten minutes should be allowed between successive applications.
Jekk qed tieħu kura b’ xi mediċini oħra topiċi ta ’ l- għajnejn, fl- istess żmien, għandu jkun hemm interval ta ’ minn ħamsa sa għaxar minuti bejn aplikazzjoni u oħra.
Use in elderly No dosage adjustment in elderly patients is necessary.
Użu fl- anzjani Fl- anzjani m’ hemmx għalfejn tinbidel id- doża.
Paediatric patients OPATANOL may be used in paediatric patients (three years of age and older) at the same dose as in adults.
Pazjenti pedjatriċi OPATANOL jista jintuża fit- tfal (tlett snin jew akbar) bl- istess doża li jieħdu l- adulti.
Use in hepatic and renal impairment Olopatadine in the form of eye drops (OPATANOL) has not been studied in patients with renal or hepatic disease.
Użu f’ pazjenti b’ indeboliment fil- kliewi u fil- fwied Olopatadine taħt l- għamla ta ’ qtar għall- għajnejn (OPATANOL) ma ’ ġiex mistħarreġ f’ pazjenti li għandhom mard fil- kliewi jew fil- fwied.
However, no dosage adjustment is expected to be necessary in hepatic or renal impairment (see section 5.2).
Madankollu, mhux mistenni li jkun hemm bżonn tibdil fid - doża ta 'pazjenti li jsofru minn indeboliment tal- kliewi jew tal- fwied (ara sezzjoni 5. 2).
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita ’ eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi.
2 4.4 Special warnings and precautions for use
2 4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
OPATANOL is an antiallergic/ antihistaminic agent and, although administered topically, is absorbed systemically.
OPATANOL huwa sustanza kontra l- allerġija/ kontra l- istamina u għalkemm jingħata b' mod topiku, jiġi assorbit fid- demm.
If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment.
Jekk ikun hemm sinjali ta ’ reazzjonijiet serji jew ikun hemm sensittività eċċessiva, waqqaf din il- kura minnufih.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Benzalkonium chloride, li ġeneralment jintuża bħala preservattiv fil- prodotti ta ’ l- għajnejn, ġie rrapurtat li jikkawża punctate keratopathy u/ jew ulċera tossika keratopatika.
Since OPATANOL contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Pazjenti li jsofru minn għajnejn xotti, jew għandhom xi kundizzjoni li tista ’ taffettwa l- korneja, għandhom jiġu eżaminati bir - reqqa meta jkunu qed jużaw OPATANOLl regolarment jew għal tul ta ’ żmien, minħabba li fih benzalkonium chloride.
Contact lenses Patients should be instructed to wait 10-15 minutes after instillation of OPATANOL before inserting contact lenses.
Lentijiet tal- kuntatt Il- pazjenti għandhom jiġu mgħallma biex wara li jużaw OPATANOL, jistenew 10- 15 – il minuta qabel ma jilbsu l- lentijiet tal- kuntatt.
OPATANOL should not be administered while wearing contact lenses.
OPATANOL m’ għandux jintuża meta l- lentijiet tal- kuntatt ikunu fl - għajnejn.
In vitro studies have shown that olopatadine did not inhibit metabolic reactions which involve cytochrome P-450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Studji in vitro wrew li olopatadine ma waqqafx reazzjonijiet metaboliċi li jinvolvu l- iżożimi taċ - ċitokromju P- 450, 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4.
These results indicate that olopatadine is unlikely to result in metabolic interactions with other concomitantly administered active substances.
B' hekk jidher li olopatadine mhux probabbli li jkollu interazzjonijiet metaboliċi ma ’ sustanzi attivi oħra li jingħataw miegħu
Pregnancy For olopatadine, no clinical data on exposed pregnancies are available.
Tqala Għal olopatadine, m' hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji li saru fuq bhejjem ma wrewx ħsara diretta jew indiretta fuq it- tqala, fuq l- iżvilupp tal - embriju/ tal- fetu / fuq il- ħlas jew l- iżvilupp ta ’ wara t- tqala (ara sezzjoni 5. 3).
Caution should be exercised when prescribing to pregnant women.
Wieħed għandu joqgħod attent meta jikteb riċetta ta 'din il- mediċina għal nisa tqal.
Breast-feeding mothers OPATANOL is not recommended for breast-feeding mothers.
Nisa li qed ireddgħu OPATANOL mhux rakkomandat li jintuża min nisa li qed ireddgħu.
Olopatadine has been detected in the milk of nursing rats following oral administration.
Wara li ngħata mill- ħalq, olopatadine instab fil- ħalib tas- sider ta 'firien.
Studies in animals have shown reduced growth of nursing pups of dams receiving systemic doses of olopatadine well in excess of the maximum level recommended for human ocular use.
Il- ġriewi ta 'dawn il- bhejjem kibru bil- mod aktar mis- soltu.
It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in human breast milk.
M' hemmx evidenza jekk meta jintuża fil- bnedmin b' mod topiku, jilħaqx livelli fid- demm għolja biżżejjed biex jidher fil- ħalib tas - sider.
As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Bħal ma jista ’ jiġri bl- użu ta ’ kwalunkwe qtar ieħor tal- għajnejn, vista mċajpra jew xi tfixkil ieħor tal - vista jista ’ jaffetwa s- sewqan jew it- tħaddim ta ’ magni.
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Jekk il- vista tiċċajpar meta jitqattar il- qtar, il - pazjent għandu jistenna sakemm il- vista terġa ’ lura għan- normal qabel ma jsuq jew juża xi magni.
In clinical studies involving 1680 patients, OPATANOL was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg.
Fi studji kliniċi li fihom ħadu sehem bejn wieħed u ieħor 1680 pazjent, OPATANOL ingħata minn darba sa 'erba' darbiet kuljum fiż- żewġ għajnejn għal erba 'xhur waħdu jew ma' 10 mg loratadine.
Approximately 4.5% of patients can be expected to experience undesirable effects associated with the use of OPATANOL; however, only 1.6% of patients discontinued from the clinical studies due to these undesirable effects.
Huwa mistenni li bejn wieħed u ieħor 4. 5% tal- pazjenti jkollhom xi effetti mhux mixtieqa, assoċjati ma ’ l- użu ta ’ OPATANOL. madanakollu, 1. 6% biss ta ’ dawn il- pazjenti waqqfu mill- istudji kliniċi minħabba xi effetti mhux mixtieqa.
No serious ophthalmic or systemic undesirable effects related to OPATANOL were reported in clinical studies.
Ma ġi rrapurtat l- ebda effett mhux mixtieq serju fl- għajnejn jew sistemiku relatati mal- użu ta ’ OPATANOL matul l- istudji kliniċi.
The most frequent treatment-related undesirable effect was eye pain, reported at an overall incidence of 0.7%.
L- aktar effett mhux mixtieq li kien relatat ma ’ t- trattament kien ta ’ uġigħ fl- għajnejn, b- inċidenza totali ta ’ 0. 7%.
The following undesirable effects were assessed to be treatment-related and are classified according to the following convention: very common (≥ 1/ 10), common (> 1/ 100 to < 1/10), uncommon (> 1/1,000 to ≤ 1/100), rare (> 1/10,000 to ≤1/1000), or very rare (≤1/10,000).
L- effetti mhux mixtieqa hawn taħt imsemmija kienu relatati mal- kura u huma klassifikatiti skond din il- konvenzjoni: komuni ħafna( ≥1/ 10), komuni (> 1/ 100 sa < 1/ 10), mhux komuni (> 1/ 1000 sa ≤1/ 100), rari (> 1/ 10, 000 sa ≤1/ 1000) jew rari ħafna (≤1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom.
Infections and infestations Uncommon: rhinitis
Infezzjonijiet u infestazzjonijiet Mhux komuni: rinite
Nervous system disorders Common: headache, dysgeusia Uncommon: dizziness, hypoaesthesia
Disturbi fis- sistema nervuża Komuni: uġigħ ta ’ ras, disgewżja Mhux Komuni: sturdament, ipoesteżja
Eye disorders Common: eye pain, eye irritation, dry eye, abnormal sensation in eyes Uncommon: corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, eyelids pruritus, erythema of eyelid, eyelid oedema, eyelid disorder, conjunctival hyperaemia, ocular hyperaemia
Komuni: uġigħ fl- għajnejn, irritazzjoni fl- għajnejn, għajn xotta, sensazzjoni mhux normali fl- għajnejn Mhux Komuni: erożjoni tal- korneja, diffett fl- epitiljum tal- korneja, disturbi fl- epitiljum tal- korneja, keratite panktejt, keratite, tittebba l- korneja, tnixxija ta ’ l- għajn, fotofobja, vista mċajpra, tnaqqis fil - visjoni akuta, blefarospażmu, skumdita fl- għajnejn, ħakk fl- għajnejn, follikuli konġuntivali, bidla fil - konġuntiva, sensazzjoni ta ’ xi ħaga ġewwa l- għajnejn, żieda fl- ammont ta ’ dmugħ, ħakk fil- kappell ta ’ l- għajn, ħmura fil- kappell ta ’ l- għajn, nefħa tal- kappell ta ’ l- għajn, disturbi fil- kappell ta ’ l- għajn, iperimja konġuntivali, iperimja ta ’ l- għajnejn.
Respiratory, thoracic, and mediastinal disorders Common: nasal dryness
Disturbi respiratorji, toraċiċi u medjastinali Komuni: nixfa fl- imnieħer
Skin and subcutaneous tissue disorders Uncommon: dermatitis contact, skin burning sensation, dry skin
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux Komuni: dermatite tal- kuntatt, sensazzjoni ta ’ ħruq fil- ġilda, ġilda xotta.
General disorders and administration site conditions Common: fatigue
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni:
Adverse reactions identified from post-marketing experience that have not been reported previously in clinical trials with OPATANOL include those detailed below.
Għeja Mhux Magħrufa (Ma jistgħux jiġu stimati minn informazzjoni miġbura) Reazzjonijiet avversi li ġew identifikati wara li l- prodott kien fis- suq u li ma ġewx irraputati fi studji kliniċi b’ OPATANOL jinkludu dawk msemmija hawn taħt.
Unlike data from clinical trials, due to the nature of post-marketing surveillance, the frequency at which these events occur is not known and cannot be estimated based upon the available data.
B’ differenza mit- tagħrif miġbur minn provi kliniċi, minħabba n- natura tas- sorveljanza wara li l- prodott tqiegħed fuq is- suq, il- frekwenza ta ’ kif jiġru dawn l- eventi mhux magħruf u ma jistax jiġi stmat mit- tagħrif miġbur.
Ocular: corneal oedema, conjunctivitis, eye oedema, eye swelling, mydriasis, visual disturbance, eyelid margin crusting Systemic: hypersensitivity, dyspnea, somnolence, swelling face, dermatitis, erythema, nausea, vomiting, sinusitis, asthenia, malaise
Sistemiku: sensittività eċċessiva, qtugħ ta ’ nifs, ħedla, nefħa tal- wiċċ, dermatite, eritema, tqalligħ, rimettar, sinusite, astenja, telqa.
No data are available in humans regarding overdose by accidental or deliberate ingestion.
M' hemmx tagħrif dwar x' jiġri meta bniedem jieħu doża mil- ħalq ogħla milli suppost bi żball jew apposta.
Olopatadine has a low order of acute toxicity in animals.
L- effetti tossiċi akuti ta 'Olopatadine f' bhejjem huma baxxi ħafna.
Accidental ingestion of the entire contents of a bottle of OPATANOL would deliver a maximum systemic exposure of 5 mg olopatadine.
Li kieku wieħed kellu jixrob flixkun OPATANOL sħiħ bi żball, l- ogħla ammont sistemiku ta ’ olopatadine ikun ta ’ 5 mg.
This exposure would result in a final dose of 0.5 mg/ kg in a 10 kg infant, assuming 100% absorption.
Dan l- ammont jissarraf f' doża ta '0. 5 mg/ kg f' tarbija ta' 10 kg jekk nassumu li jiġi assorbit 100%.
4 Prolongation of the QTc interval in dogs was observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
B' hekk jidher li dan l- effett għandu ftit relevanza għal l- użu kliniku.
A 5 mg oral dose was administered twice-daily for 2.5 days to 102 young and elderly male and female healthy volunteers with no significant prolongation of QTc interval compared to placebo.
Meta ngħatat doża ta '5 mg darbtejn kuljum għal 2. 5 ġranet lil 102 voluntiera nisa u rġiel f’ saħħithom żgħar u anzjani, ma kienx hemm differenza sinifikanti fit- tul ta' l- interval QTc meta mqabbel ma dawk li ngħataw plaċebo.
The range of peak steady-state olopatadine plasma concentrations (35 to 127 ng/ ml) seen in this study represents at least a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarisation.
L- ogħla livelli ta 'olopatadine fiss fil- plasma (35 sa 127 ng/ ml) li ntlaħqu waqt dan l- istudju jisarrfu f’ 70 darba il- marġini ta ’ sigurta fir- rigward tal- effetti fuq ir- ripolarizazzjoni tal- qalb.
In the case of overdose, appropriate monitoring and management of the patient should be implemented.
F’ każ ta ’ doża eċċessiva, il- pazjent għandu jiġi eżaminat u mdewwi bir- reqqa.
Pharmacotherapeutic Group: ophthalmologicals; decongestant and antiallergics; other antiallergics.
Kategorija farmakoterapewtika: oftalmoloġiċi, sustanzi li jiftħu l- imnieħer misdud u li jaħdmu kontra l- allerġiji, antiallerġiċi oħra.
S01GX 09
S01G X 09
Olopatadine is a potent selective antiallergic/ antihistaminic agent that exerts its effects through multiple distinct mechanisms of action.
Olopatadine hu sustanza qawwija u selettiva kontra l- allerġiji u kontra l- istamina li jaħdem permezz ta 'ħafna proċessi distinti.
It antagonises histamine (the primary mediator of allergic response in humans) and prevents histamine induced inflammatory cytokine production by human conjunctival epithelial cells.
Jantagonizza l- istamina (li hija sustanza prinċipali li tiġi magħmula meta ikun hemm allerġija fil- bnedmin) u ma jħallix iċ- celluli ta 'l- epitilju tal- kinġuntiva umana jiproduċu cytokine infjammatorju, li ssoltu jiġi stimulat mill- istamina.
Data from in vitro studies suggest that it may act on human conjunctival mast cells to inhibit the release of pro-inflammatory mediators.
Minn tagħrif ta 'studji in vitro jidher li jista ’ jaħdem fuq iċ- ċelluli mast tal- konġuntiva umana biex jinibixxi sustanzi pro- infjammatorji.
In patients with patent nasolacrimal ducts, topical ocular administration of OPATANOL was suggested to reduce the nasal signs and symptoms that frequently accompany seasonal allergic conjunctivitis.
L- użu topiku ta 'OPATANOL fl- għajnejn ta' pazjenti li għandhom it- tubu ta 'bejn l- imnieħer u l- pajp tad - dmugħ miftuħ deher li naqqas is- sinjali u s- sintomi fl- imnieħer li ħafna drabi ikun hemm f' allerġija ta' l- istaġun fil- konġuntiva ta 'l- għajnejn.
It does not produce a clinically significant change in pupil diameter.
M' għandux effett kliniku sinifikanti fuq il- bidla fid- diametru tal- pupilla ta 'l- għajn.
Olopatadine is absorbed systemically, as are other topically administered medicinal products.
Bħall- mediċini l- oħra li jingħataw b' mod topiku, olopatadine jiġi assorbit b’ mod sistemiku.
However, systemic absorption of topically applied olopatadine is minimal with plasma concentrations ranging from below the assay quantitation limit (< 0.5 ng/ ml) up to 1.3 ng/ ml.
Madanakollu, meta jintuża b' mod topiku, l- ammont li jiġi assorbit b’ mod sistemiku huwa minimu b' livelli fil- plażma li ma jilħqux l- inqas livell li jista jiġi mkejjel - (< 0. 5 ng/ ml) sa 1. 3 ng/ ml.
These concentrations are 50-to 200-fold lower than those following well tolerated oral doses.
Dawn huma bejn 50 - u 200 - darba inqas minn dawk li jintlaħqu wara li tittieħed doża li tkun tollerata sew, mill- ħalq.
From oral pharmacokinetic studies, the half-life of olopatadine in plasma was approximately eight to 12 hours, and elimination was predominantly through renal excretion.
Minn studji farmakokinetiċi deher li meta olopatadine ittieħed mill- ħalq, il- half life ta ’ olopatadine fil- plażma kienet bejn wieħed u ieħor tmienja sa tnax- il siegħa u il- parti l- kbira tiegħu tneħħiet mill- kliewi.
Approximately 60-70% of the dose was recovered in the urine as active substance.
Madwar 60- 70% tad- doża nstabet fl- awrina bħala sustanza attiva.
Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.
Traċċi ta 'żewġ metaboli - mono- desmethyl u l- N- oxide, instabu fl- awrina.
Since olopatadine is excreted in urine primarily as unchanged active substance, impairment of renal function alters the pharmacokinetics of olopatadine with peak plasma concentrations 2.3-fold greater in patients with severe renal impairment (mean creatinine clearance of 13.0 ml/ min) compared to healthy adults.
Billi l- parti l- kbira ta 'olopatadine joħroġ fl- awrina mingħajr ma jinbidel bħala sustanza attiva, il - karatteristiċi farmakokinetiċi tiegħu jinbidlu f' pazjenti li għandhom indeboliment tal- kliewi u jispiċċaw b’ livelli fil- plasma 2. 3- darba ogħla meta jkollhom indeboliment serju tal- kliewi (mean creatinine clearance ta' 13. 0 ml/ min) meta mqabbla ma 'adulti b' saħħithom.
Following a 10 mg oral dose in patients undergoing haemodialysis (with no urinary output), plasma olopatadine concentrations were significantly lower on the haemodialysis day than on the non-haemodialysis day suggesting olopatadine can be removed by haemodialysis.
Dan juri li olopatadine jista jitneħħa bil- ħemodijaliżi.
Studies comparing the pharmacokinetics of 10 mg oral doses of olopatadine in young (mean age 21 years) and elderly (mean age 74 years) showed no significant differences in the plasma concentrations (AUC), protein binding or urinary excretion of unchanged parent drug and metabolites.
5 Studji li fihom tqabblu il- farmakokinetiċi ta 'meta 10 mg ta’ olopatadine jingħata mill- ħalq f' żagħżagħ (eta' medja ta '21 sena) u anzjani (eta' medja ta '74 sena) urew li ma kienx hemm differenza sinifikanti fil- konċentrazzjonijiet fil- plażma (AUC), fl- ammont li jintrabat mal- proteina jew li joħroġ fl- awrina bħala sustanza mhux mibdula kif tinsab fil- mediċina u l- metaboli.
A renal impairment study after oral dosing of olopatadine has been performed in patients with severe renal impairment.
Sar studju dwar l- indeboliment renali wara li olopatadine ngħata mill- ħalq lill- pazjenti li jsofru minn indeboliment serju tal- kliewi.
The results indicate that a somewhat higher plasma concentration can be expected with OPATANOL in this population.
Ir- risultati juru li f’ dawn il- pazjenti, l- konċentrazzjoni ta ’ OPATANOL fil- plażma hija mistennija li tkun xi ftit jew wisq ogħla.