qanastek/EMEA-V3 huggingface dataset:
Follow the instructions that come with the transfer set.
Segwi il- struzzjonijiet li jiġu mas- sett tat - trasferiment.
Do not shake
Iċċaqlaqx
- Transfer all of the dissolved solution back into the cartridge using
- Ittrasferixxi s- soluzzjoni kollha lura ġo l- iskartoċċ billi tuża s- sett
the transfer set.
tat- trasferiment.
Injecting Omnitrope
Kif tinjetta Omnitrope Poġġi l- iskartoċċ b’ Omnitrope maħlul ġol- pinna għall- injezzjoni.
- Put the cartridge with the dissolved Omnitrope into the pen for
-
Follow the Instructions for Use of the pen injector.
Segwi l- istruzzjonijiet għall- użu ta ’ l- injettur tal- pinna.
To setup the pen dial the dose.
Biex tissettja l- pinna, iddajlja d- doża.
- Eliminate any air bubbles.
- Neħħi kwalunkwe bżieżaq ta ’ l- arja.
- Make sure you inject at least 1 cm from your last injection site and
- Aċċerta ruħek li tinjetta mill- inqas 1 ċm ‘ il bogħod mis- sit ta ’ l -
- Insert the needle into the skin in the way your doctor has taught
- Daħħal il- labra fil- ġilda skond kif għallmek it- tabib tiegħek.
- Take the needle off the pen using the outer needle cap, and discard
- Neħħi l- labra minn ġol- pinna billi tuża l- għatu ta ’ barra tal- labra, u
the needle.
armi l- labra.
This will keep the Omnitrope solution sterile and prevent leaking.
Dan ser iżomm is- soluzzjoni Omnitrope sterili u jevita t- tnixxija.
It will also stop air going back into the pen and the needle clogging up.
Iwaqqaf ukoll l- arja milli tidħol lura fil- pinna u l- labra milli tinstadd.
Do not share your needles.
Taqsamx il- labar tiegħek ma ’ ħaddieħor.
Do not share your pen.
Taqsamx il - pinna tiegħek ma ’ ħaddieħor.
- Leave the cartridge in the pen, put the cap on the pen, and store it
- Ħalli l- iskartoċċ fil- pinna, poġġi l- għatu fuq il- pinna, u aħżnu fil -
in the refrigerator.
friġġ.
- The solution should be clear after removal from the refrigerator.
- Is- soluzzjoni għandha tkun ċara wara li titneħħa mill- friġġ.
Do
Tużax
not use if the solution is cloudy or contains particles.
jekk is- soluzzjoni tkun imċajpra jew fiha l- partikuli.
If you stop using Omnitrope
Jekk tieqaf tuża Omnitrope
Common (occurring in at least 1 of 100 but less than 1 of 10 patients) In infants/ children/ adolescents: transient local skin reactions
77 Rari Ħafna Rari Mhux Komuni Komuni (li jseħħu f’ inqas (li jseħħu f’ mill - (li jseħħu f’ mill - (li jseħħu f’ mill - minn 1 minn kull inqas 1 minn kull inqas 1 minn kull inqas 1 minn kull 10, 000 pazjent) 10, 000 iżda 1, 000 iżda f’ inqas 100 iżda f’ inqas f’ inqas minn 1 minn 1 minn kull minn 1 minn kull minn kull 100 pazjent) 10 pazjenti) 1, 000 pazjent) Fit- trabi/ tfal / Fit- trabi/ tfal / Disturbi ġenerali adolexxenti: adolexxenti: u kundizzjonijiet edema ħafifa reazzjonijiet ta ’ mnejn jingħata lokali tal- ġilda li jgħaddu malajr
Rare (occurring in at least 1 of 10,000 but less than 1 of 1,000 patients)
Fl- adulti: edema ħafifa Fit- trabi/ tfal / Disturbi muskolu -
Very Rare (occurring in less than 1 of 10,000 patients)
Fl- adulti:
In adults: mild oedema
adolexxenti:
In infants/ children/ adolescents: stiffness of the limbs, joint and muscle pain
ebusija tad - dirgħajn/ riġlejn, uġigħ tal- ġogi u tal- muskoli
In infants/ children/ adolescents: sensory disturbances
Fit- trabi/ tfal / adolexxenti: disturbi sensorjali Fl- adulti: sindrome tal - carpal tunnel
Musculoskeletal system, connective tissues, and bones
Disturbi muskolu- skeltrali u tal- connective tissue, u ta ’ l- għadam
74 Nervous system
78 Disturbi fis- sistema nervuża
They are common in adult patients, but uncommon in infants, children and adolescents.
Huma komuni f’ pazjenti adulti, iżda mhux komuni fit- trabi, tfal u adolexxenti.
- Muscular atrophy (reduction of muscular tissue) of the ball of the thumb and sensory
- Atrofija muskolari (tnaqqis fit- tessut tal- muskoli) tal- parti tonda tas- saba ’ l- kbir u disturbi
- After the first injection, the cartridge should remain in the pen injector and has to be stored in a
- Wara l- ewwel injezzjoni, l- iskartoċċ għandu jibqa ’ fl- injettur pinna u għandu jinżamm fi friġġ
refrigerator (2°C - 8°C) and only used for a maximum of 21 days.
(2°C - 8°C) u jintuża biss għal massimu ta ’ 21 jum.
The active substance of Omnitrope is somatropin (5 mg/ ml) in a vial.
Is- sustanza attiva ta ’ Omnitrope hi somatropin (5 mg/ ml) f’ kunjett.
One cartridge contains 5 mg (corresponding to 15 IU) of somatropin after reconstitution with 1 ml solvent.
Skartoċċ fih 5 mg (li jikkorrispondu għal 15 IU) ta ’ somatropin wara r- rikostituzzjoni b’ 1 ml ta ’ solvent.
Powder: glycine
Trab: glycine disodium hydrogen phosphate heptahydrate
75 disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
79 sodium dihydrogen phosphate dihydrate
Powder and solvent for solution for injection (powder in a vial (5 mg), solvent in a cartridge (1 ml)) Pack sizes of 1 and 5.
Daqsijiet tal- pakkett ta ’ 1 u 5.
76 Eesti Österreich Sandoz d. d.
80 Österreich Eesti Sandoz GmbH Sandoz d. d.
10 A-6250 Kundl Tel: + 43-(0)5338 2000
Polska Ελλάδα Lek Polska Sp. z o. o.
77 Latvija Sandoz d. d.
81 United Kingdom Latvija Sandoz Limited Sandoz d. d.
Further information
Kif taħżen Omnitrope Aktar tagħrif 6.
- with growth disturbance in short children/ adolescents born small for gestational age (SGA),
- b’ disturb tat- tkabbir fi tfal/ adolexxenti qosra li twieldu żgħar għaż- żmien tat- tqala (small for
who failed to show catch-up growth by 4 years of age or later.
gestational age - SGA), li ma jkunx irnexxielhom juru li laħqu tkabbir (veloċita ’ ta ’ tul/ height velocity (HV) SDS < 0 matul l- aħħar sena) sa l- età ta ’ 4 snin jew iktar tard.
- If you are allergic (hypersensitive) to somatropin or to any of the other ingredients of
- Jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal somatropin jew sustanzi oħra ta ’
abdominal surgery, multiple trauma caused by an accident, acute respiratory failure, or similar conditions.
tal- qalb miftuħa, operazzjoni fiż- żaqq, trawma aċċidentali multipla kkawżata minn inċident, waqfien akut tan- nifs jew kundizzjonijiet simili,
If you develop a limp or pain in the hip, please ask your doctor for advice.
Jekk tibda zzappap jew jekk tiżviluppa uġigħ fil- ġenbejn, jekk jogħġbok staqsi lit- tabib għal parir.
Patients with chronic renal insufficiency (CRI)
Pazjenti li għandhom insuffiċjenza kronika tal- kliewi (CRI) F’ pazjenti li għandhom CRI, it- terapija b’ somatropin m’ għandhiex tinbeda ħlief jekk il- funzjoni
- In patients with CRI, somatropin therapy should not be started unless the function of the kidney
-
- There have been reports of deaths associated with the use of growth hormone in patients with
- Kien hemm rapporti ta ’ mwiet marbuta ma ’ l- użu ta l- ormon tat- tkabbir f’ pazjenti li kellhom il -
It is especially important to tell your doctor if you are taking any medicine for diabetes, thyroid disorder or any anticonvulsants, ciclosporin or steroid hormones such as oestrogens, progesterone or corticosteroids.
Hu importanti ħafna li tgħid it- tabib tiegħek jekk qed tieħu kwalunkwe mediċina għall- mard tat- tirojde għad- dijabete jew kwalunkwe mediċini kontra l- konvulżjoni, ciclosporin jew ormoni sterojdi bħal estroġeni, progesterone jew kortikosterojdi.
Treatment with Omnitrope should be interrupted during pregnancy.
Il- kura b’ Omnitrope għandha tiġi interrotta jekk isseħħ it- tqala.
No studies of the effects on the ability to drive and use machines have been performed.
Ma saru l- ebda studji dwar l- effetti fuq il- ħila biex issuq u tuża l- magni.
One ml contains 9 mg benzyl alcohol.
Kull ml fih 9 mg ta ’ benzyl alkoħol.
Omnitrope 3.3 mg/ ml is intended for multiple use.
Omnitrope 3. 3 mg/ ml hija maħsuba biex tintuża diversi drabi.
Omnitrope is given through a short injection needle into the fatty tissue just under your skin.
Omnitrope tingħata minn ġo labra qasira ta ’ l- injezzjoni ġot- tessut tax- xaħam kemm kemm taħt il - ġilda tiegħek.
Treatment with somatropin is a long-term treatment.
85 Il- kura b’ somatropin hi kura fit- tul.
81 How much and how often to use Omnitrope
Kemm għandek tuża Omnitrope, u kemm ta ’ spiss
Acute overdose may lead initially to hypoglycaemia (decrease in blood glucose) and subsequently to hyperglycaemia (increase in blood glucose).
Doża eċċessiva akuta tista ’ twassal, inizjalment, għal ipogliċemija (tnaqqis fil- glukows tad- demm) u, sussegwentement, għal ipergliċemija (żieda fil- glukows tad- demm).
Long-term overdosage could result in signs and symptoms of gigantism or acromegaly (enhanced growth of ears, nose, lips, tongue, and cheekbones).
Doża eċċessiva fit- tul tista ’ tirriżulta f’ sinjali ta ’ ġgantiżmu jew akromegalija (tkabbir esaġerat tal- widnejn, imnieħer, xufftejn, ilsien, u l- għadam ta ’ taħt l- għajn).
Continue with the prescribed dosage regimen.
L- interruzzjoni jew it- temmija bikrija tal- kura b’ somatropin tista ’ tagħmel ħsara lis- suċċess tat- terapija bl- ormon tat- tkabbir.
If you forget to take Omnitrope, please ask your doctor for advice.
Jekk jogħġbok staqsi lit- tabib tiegħek għal parir qabel twaqqaf il- kura.
How to inject Omnitrope 3.3 mg/ ml
Kif tinjetta Omnitrope 3. 3 mg/ ml
The following instructions explain how to inject Omnitrope 3.3 mg/ ml yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif inti stess għandek tinjetta Omnitrope 3. 3 mg/ ml.
- Omnitrope is given as an injection under the skin.
- Omnitrope jingħata bħala injezzjoni taħt il- ġilda
- a cartridge with Omnitrope 3.3 mg/ ml solution for injection.
- skartoċċ b’ Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni
- the Omnitrope Pen 5, an injection device specifically developed for
- Omnitrope Pen 5, tagħmir ta ’ l- injezzjoni li kien żviluppat
use with Omnitrope 3.3 mg/ ml solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen 5).
(mhux fornut fil- pakkett; ara l- istruzzjonijiet għall- użu pprovduti ma ’ Omnitrope Pen 5).
- With a cleansing swab, disinfect the rubber membrane of the
- Billi tuża biċċa li tnaddaf, iddiżinfetta l- membrana tal- lastku ta ’ l -
cartridge.
iskartoċċ.
- The contents must be clear and colourless.
- Il- kontenut għandu jkun ċar u bla kulur.
- Insert the cartridge into the pen for injection.
- Daħħal l- iskartoċċ fil- pinna għall- injezzjoni.
Follow the
Segwi l- istruzzjonijiet
Instructions for Use of the pen injector.
għall- użu ta ’ l- injettur tal- pinna.
To setup the pen dial the dose.
Biex tissettja l- pinna, iddajlja d - doża.
with a layer of fat between skin and muscle, such as the thigh or belly (except the navel or waistline).
86 tessuti b’ saff ta ’ xaħam bejn il- ġilda u l- muskoli, bħal koxxa jew iż- żaqq (ħlief iż- żokra jew il- qadd).
A disruption or early ending of treatment with somatropin may impair the success of growth hormone therapy.
L- interruzzjoni jew it- temmija bikrija tal- kura b’ somatropin tista ’ tagħmel ħsara lis- suċċess tat- terapija bl- ormon tat- tkabbir.
83 General disorders and reactions at the injection site
u kundizzjonijiet
General disorders and reactions at the injection site
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
These side effects occur only at the start of treatment with somatropin and are dose- dependent.
Dawn l- effetti sekondarji normalment iseħħu fil- bidu tal- kura b’ somatropin u jiddependu mid- doża.
84 Nervous system
Disturbi fis- sistema nervuża
at the start of treatment with somatropin and are dose-dependent.
normalment iseħħu biss fil- bidu tal- kura b’ somatropin u jiddependu mid- doża.
They are common in adult patients, but uncommon in infants, children and adolescents.
88
- Muscular atrophy (reduction of muscular tissue) of the ball of the thumb and sensory
- Atrofija muskolari (tnaqqis tat- tessut muskolari) tal- parti tonda tas- saba ’ l- kbir u disturbi
- After the first injection, the cartridge should remain in the pen injector and has to be stored in a
- Wara l- ewwel injezzjoni, l- iskartoċċ għandu jibqa ’ fl- injettur pinna u għandu jinħażen fi friġġ
refrigerator (2°C - 8°C) and only used for a maximum of 28 days.
(2°C - 8°C) u jintuża biss għal massimu ta ’ 28 jum.
The active substance of Omnitrope is somatropin (3.3 mg/ ml) in a cartridge.
Is- sustanza attiva ta ’ Omnitrope hi somatropin (3. 3 mg/ ml) fi skartoċċ.
One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
Skartoċċ fih 5. 0 mg (li jikkorrispondu għal 15 IU) ta ’ somatropin f’ 1. 5 ml.
The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol
Is- sustanzi l- oħra huma: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol ilma għall- injezzjonijiet.
What Omnitrope looks like and contents of the pack
89 Id- dehra ta ’ Omnitrope u l- kontenuti tal- pakkett
Omnitrope is presented as a solution for injection.
Omnitrope hu ppreżentat bħala soluzzjoni għall- injezzjoni.
Pack sizes of 1, 5 or 10.
Daqsijiet tal- pakkett ta ’ 1, 5 jew 10.
Omnitrope is a clear and colourless solution.
Omnitrope hi soluzzjoni ċara u bla kulur.
Lietuva Sandoz Pharmaceuticals d. d.
91 Lietuva Sandoz Pharmaceuticals d. d.
who failed to show catch-up growth by 4 years of age or later.
gestational age - SGA), li ma jkunx irnexxielhom juru li laħqu tkabbir sa l- età ta ’ 4 snin jew iktar tard
- If you are allergic (hypersensitive) to somatropin or to any of the other ingredients of
- Jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal somatropin jew għal sustanzi oħra ta ’
- Experience in patients above 60 years of age is limited.
- L- esperjenza f’ pazjenti li għandhom iktar minn 60 sena hi limitata.
Patients with chronic renal insufficiency (CRI)
Pazjenti li għandhom insuffiċjenza kronika tal- kliewi (CRI)
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i. e. essentially ‘ sodium- free’.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodium (23 mg) f’ kull 1 ml, i. e. hu essenzjalment ‘ mingħajr sodium ’.
Omnitrope 6.7 mg/ ml is intended for multiple use.
Omnitrope 6. 7 mg/ ml hija maħsuba biex tintuża diversi drabi.
How much and how often to use Omnitrope
95 Kemm għandek tuża Omnitrope, u kemm ta ’ spiss
91 Dose adjustments may be required over time, depending on your increase in body weight and response.
Aġġustamenti fid- doża jistgħu jkunu meħtieġa matul iż- żmien tal- kura, skond iż- żieda fil- piż u r - rispons ta ’ ġismek.
How to inject Omnitrope 6.7 mg/ ml
Kif tinjetta Omnitrope 6. 7 mg/ ml
The following instructions explain how to inject Omnitrope 6.7 mg/ ml yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif inti stess għandek tinjetta Omnitrope 6. 7 mg/ ml.
- a cartridge with Omnitrope 6.7 mg/ ml solution for injection.
- skartoċċ b’ Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni
- the Omnitrope Pen 10, an injection device specifically developed
- Omnitrope Pen 10, tagħmir ta ’ l- injezzjoni li kien żviluppat
for use with Omnitrope 6.7 mg/ ml solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen 10).
(mhux fornut fil- pakkett; ara l- istruzzjonijiet għall- użu pprovduti ma ’ Omnitrope Pen 10).
with a layer of fat between skin and muscle, such as the thigh or belly (except the navel or waistline).
tessuti b’ saff ta ’ xaħam bejn il- ġilda u l- muskoli, bħal koxxa jew
- Make sure you inject at least 1 cm from your last injection site and
96 iż- żaqq (ħlief iż- żokra jew il- qadd).
that you change the places where you inject, as you have been taught.
- Aċċerta ruħek li tinjetta mill- inqas 1 ċm ’ il bogħod mis- sit ta ’ l -
92
aħħar injezzjoni tiegħek u li tibdel il- postijiet fejn tinjetta, kif għallmuk tagħmel.
93 General disorders and reactions at the injection site
u kundizzjonijiet
94 Nervous system
Disturbi fis- sistema nervuża
These usually occur
Dawn normalment iseħħu fil- bidu
at the start of treatment with somatropin and are dose-dependent.
tal- kura b’ somatropin u jiddependu mid- doża.
They are common in adult patients, but uncommon in infants, children and adolescents.
98
The active substance of Omnitrope is somatropin (6.7 mg/ ml) in a cartridge.
Is- sustanza attiva ta ’ Omnitrope hi somatropin (6. 7 mg/ ml) fi skartoċċ.
One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
Skartoċċ fih 10. 0 mg (li jikkorrispondu għal 30 IU) ta ’ somatropin f’ 1. 5 ml.
The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine
Is- sustanzi l- oħra huma: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol ilma għall- injezzjonijiet.
What Omnitrope looks like and contents of the pack
99 Id- dehra ta ’ Omnitrope u l- kontenuti tal- pakkett
What is Onsenal?
X’ inhu Onsenal?
Onsenal is a medicine that contains the active substance celecoxib.
Onsenal huwa mediċina li fiha s- sustanza attiva celecoxib.
It is available as white capsules (200 and 400 mg).
Il- mediċina hija disponibbli f’ pilloli bojod (200 u 400 mg).
What is Onsenal used for?
Għal xiex jintuża Onsenal?
Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).
Onsenal jintuża biex inaqqas l- għadd ta ’ polipi (polyps) f’ pazjenti bil- polipożi adenomatuża familjari (FAP).
This is a genetic disease that causes ‘ adenomatous intestinal polyps’, growths that project from the lining of the large intestine or rectum.
Din hija marda ġenetika li tikkawża ‘ polipi intestinali adenomatużi ’, formazzjoni li jisporġu ’ l barra mill- kisi intern tal- musrana l- għamja (l- intestin il- kbir) jew tar- rektum.
Onsenal is used in addition to surgery (to remove the polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube that allows a doctor to look inside the gut).
Onsenal jintuża flimkien mal- kirurġija (biex jitneħħew il- polipi) u mal- monitoraġġ endoskopiku (biex jiġi kkontrollat jekk qegħdin jiżviluppaw xi polipi, bl- użu ta ’ endoskopju, tubu rqiq li jippermetti lit- tabib jittawwal ġewwa l- musrana).
Because the number of patients with FAP is low, the disease is considered ‘ rare’, and Onsenal was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 20 November 2001.
Billi l- għadd ta ’ pazjenti bl- FAP huwa wieħed baxx, il- marda hija meqjusa ‘ rari ’, u Onsenal ingħatatlu l- kwalifika ta ’ ‘ mediċina orfni ’ (mediċina użata fil- mard rari) fl- 20 ta ’ Novembru 2001.
How is Onsenal used?
Kif jintuża Onsenal?
The recommended dose of Onsenal is 400 mg twice a day with food.
Id- doża rakkomandata ta ’ Onsenal hi 400 mg darbtejn kuljum mal- ikel.
The usual medical care for FAP patients should be continued.
Il- kuri mediċi tas- soltu għall - pazjenti bl- FAP għandhom jitkomplew.
In patients with moderate liver disease, the dose of Onsenal should be halved, and it should be used with caution in patients with mild or moderate kidney problems.
Fil- pazjenti b’ marda moderata fil- fwied, id- doża ta ’ Onsenal għandha titnaqqas bin- nofs u tintuża b’ kawtela f’ pazjenti bi problemi ħfief jew moderati fil- fwied.
Onsenal must not be given to patients with severe liver or kidney problems.
Onsenal ma għandux jingħata lil pazjenti bi problemi serji fil- fwied jew fil- kliewi.
It should be used with caution, possibly with a lower starting dose, in patients whose bodies may break Onsenal down slowly.
Għandu jintuża b’ kawtela, l- aħjar b’ doża baxxa fil - bidu f’ pazjenti li l- metabolizzazzjoni tagħhom għal Onsenal aktarx issir bil- mod.
Special care should be taken when it is used in the elderly.
Jeħtieġ li tingħata attenzjoni partikolari meta l- mediċina tintuża fil- pazjenti anzjani.
The maximum recommended daily dose of Onsenal is 800 mg.
Id- doża massima ta ’ kuljum rakkomandata ta ’ Onsenal hija 800 mg.
How does Onsenal work?
Kif jaħdem Onsenal?
The active substance in Onsenal, celecoxib, is a ‘ non-steroidal anti-inflammatory drug’ (NSAID) that belongs to the group ‘ cyclo-oxygenase-2 (COX-2) inhibitors’.
Is- sustanza attiva f’ Onsenal, celecoxib, hija mediċina antinfjammatorja mhux sterojdali (NSAID) li tappartjeni għall- grupp ‘ inibituri taċ- ċiklossiġenażi- 2 (COX2) ’ (‘ cyclo- oxygenase- 2 (COX- 2) inhibitors ’).
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in processes such as inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the opening and closing of blood vessels).
Is- sustanza timblokka l- enzima COX- 2 bil- konsegwenza li tnaqqas il- produzzjoni ta ’ prostaglandini, sustanzi involuti fil- proċessi bħall- infjammazzjoni u l- attività tal- muskolatura lixxa (muskoli li jwettqu funzjonijiet awtomatiċi bħall- ftuħ u l- għeluq tal- arterji u tal- vini).
How has Onsenal been studied?
Kif ġie studjat Onsenal?
Onsenal has been studied in one main study involving 83 adults with FAP, in which the effectiveness of two doses of Onsenal was compared with that of placebo (a dummy treatment).
Onsenal ġie eżaminat fi studju ewlieni wieħed li involva 83 adult bl- FAP, li fih l- effikaċja ta ’ żewġ dożi ta ’ Onsenal tqabblet ma ’ dik tal- plaċebo (trattament finta).
In the study, 25 patients had an intact colon (lower gut), but the remainder had had some or all of their colon removed through surgery.
Fl- istudju, 25 pazjent kellhom kolon (il- parti ta ’ isfel tal- musrana) intatt, iżda il- bqija tal- pazjenti kien tneħħielhom il- kolon tagħhom kollu jew parti minnu b’ intervent kirurġiku.
The main measure of effectiveness was the reduction in the number of polyps in a defined area of the colon or rectum wall after six months of treatment.
Il- kejl ewlieni tal- effikaċja kien it- tnaqqis fl- għadd ta ’ polipi f’ żona definita tal- kolon jew tal- ħajt tar- rektum wara sitt xhur ta ’ trattament.
An additional study looked at the effects of Onsenal in 18 children with FAP.
Studju ieħor iffoka fuq l - effetti ta ’ Onsenal fi 18- il tifel u tifla bl- FAP.
What benefit has Onsenal shown during the studies?
X’ benefiċċju wera Onsenal fl- istudji mwettqa?
Onsenal at a dose of 400 mg twice a day was more effective than placebo.
Onsenal f’ doża ta ’ 400 mg darbtejn kuljum kien aktar effikaċi mill- plaċebo.
In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number fell by 5% in the patients taking placebo.
Fl- adulti Onsenal naqqas in- numru medju ta ’ polipi bi 28% wara sitt xhur, filwaqt li n- numru naqas b’ 5% fil- pazjenti ttrattati bil- plaċebo.
Onsenal also reduced the number of polyps in children with FAP.
Onsenal naqqas ukoll in- numru ta ’ polipi fit- tfal bl- FAP.
What is the risk associated with Onsenal?
X’ inhu r- riskju assoċjat ma ’ Onsenal?
The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhoea.
L- effetti sekondarji l- aktar komuni ta ’ Onsenal (li dehru f’ aktar minn pazjent 1 minn 10) huma l - ipertensjoni (pressjoni għolja) u d- dijarrea.
For the full list of all side effects reported with Onsenal, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati ma ’ Onsenal ara l- Fuljett ta ’ Tagħrif.
Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Onsenal ma għandux jintuża minn persuni li jista ’ jkunu ipersensittivi (allerġiċi) għal celecoxib, għal kwalunkwe mill- ingredjenti l- oħra, jew għas- sulfonamidi (eż. xi antibijotiċi).
It must not be used in patients who have an active ulcer or bleeding in the stomach or gut, or in patients who have had allergic-type reactions after taking aspirin or an NSAID, including another COX-2 inhibitor.
Ma għandux jintuża f’ pazjenti b’ ulċera attiva jew fsada fl- istonku jew fil- musrana jew f’ pazjenti li kellhom reazzjonijiet ta ’ tip allerġiku wara li ħadu aspirina jew NSAID, inkluż inibitur tal- COX- 2 ieħor).
Onsenal must not be given to pregnant women or women who could become pregnant unless they are using an effective method of contraception, or to women who are breast-feeding.
Onsenal ma għandux jingħata lil nisa tqal jew lil nisa f’ età fertili, ħlief jekk jagħmlu użu ta ’ metodu kontraċċettiv effikaċi, jew lil nisa li jreddgħu.
It must not be given to patients with severe liver or kidney disease, patients with a disease causing inflammation of the bowel, or patients with certain problems affecting the heart or blood vessels.
Ma għandux jingħata lil pazjenti b’ marda gravi tal- fwied jew tal- kliewi, lil pazjenti b’ marda li tikkawża infjammazzjoni tal- musrana jew lil pazjenti bi problemi determinati li jolqtu l- qalb jew l- arterji u l- vini.
Why has Onsenal been approved?
Għaliex ġie approvat Onsenal?
The Committee for Medicinal Products for Human Use (CHMP) decided that Onsenal’ s benefits are greater than its risks for the reduction of the number of adenomatous intestinal polyps in FAP as an adjunct to surgery and further endoscopic surveillance.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Onsenal huma ogħla mir- riskji tiegħu għat- tnaqqis tal- għadd ta ’ polipi intestinali adenomatużi fl- FAP, bħala trattament addizzjonali mal- kirurġija u monitoraġġ endoskopiku ulterjuri.
The Committee noted that no effect of the reduced number of polyps caused by Onsenal on the risk of developing cancer of the intestine had been shown.
Il- Kumitat innota li ma ntwera l- ebda effett tan- numru iżgħar ta ’ polipi kkawżat minn Onsenal fuq ir- riskju li jiżviluppa kanċer tal- musrana.
The Committee recommended that Onsenal be given marketing authorisation.
Il- Kumitat irrakkomanda li Onsenal jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Onsenal has been authorised under ‘ Exceptional Circumstances’.
Onsenal ġie awtorizzat f ’’ Ċirkostanzi Eċċezzjonali ’.
This means that because the disease is rare, it has not been possible to obtain complete information about Onsenal.
Dan ifisser li minħabba li l- marda hija rari, ma kienx possibbli li jinġabar it- tagħrif kollu dwar Onsenal.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall - Mediċini (EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista ’ jinkiseb u dan is- sommarju jiġi aġġornat kif meħtieġ.
What information is still awaited for Onsenal?
Liema informazzjoni għadha mistennija għal Onsenal?
The company that makes Onsenal will carry out a study in patients with FAP, in order to collect more information on the medicine ’ s safety and effectiveness.
Il- kumpanija li tipproduċi Onsenal se twettaq studju f’ pazjenti bl- FAP, bil- għan li tiġbor aktar tagħrif dwar is- sigurtà u l- effikaċja tal- mediċina.
Other information about Onsenal:
Aktar tagħrif dwar Onsenal:
The European Commission granted a marketing authorisation valid throughout the European Union for Onsenal on 17 October 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha, għal Onsenal fis- 17 ta ’ Ottubru 2003.
The marketing authorisation holder is Pfizer Limited.
Id- deterntur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Pfizer Limited.
The marketing authorisation was renewed on 17 October 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 17 ta ’ Ottubru 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Onsenal is available here.
Is- sommarju tal- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal Onsenal huwa disponibbli hawn.
The full EPAR for Onsenal can be found here.
L- EPAR sħiħ għal Onsenal jista ’ jiġi kkonsultat hawn.
Onsenal 200 mg hard capsules
Onsenal 200mg kapsuli iebsin
Each capsule contains 200 mg of celecoxib.
Kull kapsula fiha 200 mg celecoxib Sustanzi mhux attivi:
Excipients:
Lactose Monohydrate 49. 8 mg.
Lactose Monohydrate 49.8 mgFor a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara 6. 1.
White, opaque capsules with two gold bands marked 7767 and 200.
GĦAMLA FARMAĊEWTIKA Kapsula iebsa Bajda, kapsuli opaki b’ żewġ faxex tad- deheb immarkati b’ 7767 u 200
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).
Onsenal huwa indikat għat- tnaqqis tal- polipi intestinali adenomatuż f’ każijiet ta ’ polipi adenomatuż familjali (FAP) bħala aġġunt għal kirurġija u sorveljanza endoskopika fil- futur (ara sezzjoni 4. 4).
The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
L- effett tat- tnaqqis indott minn Onsenal ta ’ l- ammont ta ’ polipi fuq ir- riskju ta ’ kanċer intestinali għadu ma ntweriex (ara sezzjonijiet 4. 4 and 5. 1)
The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2).
Id- doża irrakomandata mill- ħalq hija ta ’ żewġ kapsuli ta ’ 200 mg darbtejn kuljum li tittieħed ma ’ l - ikel (ara sezzjoni 5. 2).
Usual medical care for FAP patients should be continued while on celecoxib.
Il- kura tas- soltu tal- pazjenti li jsofru minn FAP għandha tkompli waqt li qed jieħdu celecoxib.
The maximum recommended daily dose is 800 mg.
Id- doża massima ta ’ kuljum hija 800 mg.
Hepatic impairment:
Ħsara/ Indeboliment tal- Fwied:
In patients with moderate hepatic impairment (serum albumin of 25-35 g/ l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2).
F’ pazjenti bi ħsara moderata fil- fwied (serum albumina ta ’ 25- 35 gramma / litru) id- doża rakkomandata ta ’ celecoxib għandha titnaqqas b’ 50% (ara sezzjonijiet 4. 3 u 5. 2).
Caution should be used as there is no experience in such patients at doses higher than 200 mg.
Peress li ma hemmx esperjenza klinika f’ dawn il- pazjenti b’ dożi ikbar minn 200 mg għandha tintuża kawtela.
Renal impairment:
Ħsara/ Indeboliment fil- kliewi:
Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2).
L- esperjenza b’ celecoxib f’ pazjenti bi ħsara ħafifa fil- fwied jew bi ħsara moderata fil- fwied hija limitata, għalhekk dawn il- pazjenti għandhom jiġu ttratati b’ kawtela (ara sezzjonijiet 4. 3, 4. 4 and 5. 2).
Experience with celecoxib in FAP patients below the age of 18 years is limited to a single pilot study in a very small population, in which patients were treated with celecoxib at doses up to 16 mg/ kg daily, which corresponds to the recommended adult FAP dose of 800 mg daily (see section 5.1).
L- esperjenza b’ celecoxib f’ pazjenti FAP ta ’ inqas minn 18- il sena hija limitata għal studju pilota wieħed f’ popolazzjoni żgħira ħafna, li fih il- pazjenti kienu kkurati b’ celecoxib f’ dożi sa 16 mg/ kg kuljum, li tikkorrispondi mad- doża rakkomandata għall- adulti FAP ta ’ 800 mg kuljum (ara sezzjoni 5. 1).
CYP2C9 Poor Metabolizers:
Metabolizzaturi mhux daqstant tajbin ta ’ CYP2C9:
Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/ experience with other CYP2C9 substrates should be administered celecoxib with caution, as the risk of dose-dependent adverse effects is increased.
Pazjenti magħrufa jew issuspettati li huma metabolizzaturi mhux daqstant tajbin ta ’ CYP2C9 fuq il- bażi tal- ġenotip jew l- istorja/ esperjenza preċedenti b’ substrati oħra ta ’ CYP2C9 għandhom jingħataw celecoxib b’ kawtela, billi dawn għandhom riskju akbar ta ’ effetti ħżiena dipendenti fuq id- doża.
Consider starting treatment at a reduced dose (see section 5.2).
Wieħed għandu jikkunsidra li jibda t - trattament b’ doża mnaqqsa (ara sezzjoni 5. 2).
Elderly:
2 Anzjani:
The dose for elderly FAP patients has not been established.
Id- doża għal pazjenti anzjani li jbatu bl- FAP għadha ma ġietx stabbilita.
Special care should be used in such patients (see section 5.2).
Għandha tingħata attenzjoni spejali għal dawn il- pazjenti (ara sezzjoni 5. 2).
2 • Hypersensitivity to the active substance or to any of the excipients (see section 6.1). • Known hypersensitivity to sulphonamides. • Active peptic ulceration or gastrointestinal (GI) bleeding. • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors. • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3) • Breast feeding (see sections 4.6 and 5.3) • Severe hepatic dysfunction (serum albumin< 25 g/l or Child-Pugh score > 10) (Class C). • Patients with renal insufficiency with estimated creatinine clearance < 30 ml/ min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV). • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Mard tal- qalb iskematiku, mard arterjali periferali u/ jew mard ċerebrovaskulari.
Treatment with celecoxib in FAP has been studied for up to 6 months and has not been shown to reduce the risk of gastrointestinal or other form of cancer or the need for surgery.
Trattament b’ celecoxib f’ FAP ġie studjat għal 6 xhur u ma kienx hemm sinjali ta ’ tnaqqis fir- riskju ta ’ kanċer gastro- intestinali jew ta ’ xi tip ieħor ta ’ kanċer jew il- bżonn ta ’ kirurġija.
Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib.
Allura, l- kura normali ta ’ pazjenti bl- FAP ma għandhiex tinbidel minħabba l- amministrazzjoni fl- istess ħin ta ’ celecoxib.
In particular, the frequency of routine endoscopic surveillance should not be decreased and FAP-related surgery should not be delayed.
B’ mod partikolari, il- frekwenza ta ’ sorveljanza endeskopika ta ’ rutina ma għandhiex titnaqqas u l- kirurġiji relatati mal- FAP ma għandhomx jiddewwmu.
Gastro-intestinal disorder Upper gastrointestinal complications [perforations, ulcers or bleeds (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Kumplikazzjonijiet fil- parti gastro- intestinali ta ’ fuq, ulċeri u telf ta ’ demm (PUBs), xi wħud minnhom b’ konsegwenza fatali, seħħew f’ pazjenti li kienu qed jiġu ikkurati b’ celecoxib.
Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs: the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Għandha tintuża kawtela fit- trattament ta ’ pazjenti bl- akbar riskju li jiżviluppaw kumplikazzjonijiet gastro - intestinali bl- NSAIDs; l- anzjani, pazjenti li qed jużaw kwalunkwe NSAID ieħor jew acetylsalicylic acid flimkien ma ’ Celecoxib jew pazjenti bi storja ta ’ mard gastro- intestinali bħal ulċerazzjoni u telf ta ’ demm GI.
There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Hemm riskju akbar ta ’ effetti avversi gastro- intestinali (ulċerazzjoni gastro- intestinali jew kumplikazzjonijiet gastro- intestinali oħra) meta celocoxib jingħata flimkien ma ’ acetylsalicylic acid (anki f’ dożi baxxi).
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Ma ntwerietx differenza sinifikanti fis- sigurtà GI bejn inibituri COX- 2 selettivi + acetylsalicylic acid vs.
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1). The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
L - użu konkomitanti ta ’ celecoxib u NSAID li mhijiex aspirina għandu jiġi eivtat.
FAP patients carrying an ileorectal anastomosis or ileo pouch-anal anastomosis can develop anastomotic ulcerations.
F’ pazjenti FAP li jkollhom anastamożi ileorettali jew anastamożi ileo pouch- anali jistgħu jiżvillupaw ulċerazzjoni anastomotika.
If an anastomotic ulcer is present, patients should not receive concomitant treatment with anticoagulants or acetyl salicylic acid.
Fi preżenza ta ’ ulċera anastamotika, pazjenti m’ għandhomx jingħataw celecoxib fl- istess ħin ma antikoagulanti jew acetylsalicyclic acid.
Blood and lymphatic system disorder / Cardio-vascular disorder Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long- term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg BID and 400 mg BID compared to placebo (see section 5.1).
Disturbi tad- demm u tas- sistema limfatika / Disturbi fil- qalb u vaskulari Fi studju ikkontrollat bi plaċebo fuq perjodu ta ’ żmien twil, kien hemm numru akbar ta ’ episodji kardjo- vaskulari serji, l- aktar minħabba infart mijokardijaku, f’ suġġetti b’ polipi adenomatuż sporadiku ittrattati b’ celecoxib f’ dożi ta ’ 200 mg BID u 400 mg BID meta mqabbla ma ’ plaċebo (ara sezzjoni 5. 1).
As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1)
Billi r- riskji kardjovaskulari ta ’ celecoxib żdiedu bid- doża ta ’ 400 mg darbtejn kuljum fil- prova APC (sezzjoni 5. 1), ir- rispons tal- pazjent FAP għal celecoxib għandu jiġi eżaminat mill- ġdid b’ mod
Patients with significant risk factors for cardiovascular events (e. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see section 5.1).
Pazjenti b’ fatturi ta ’ riskju sinifikanti għal episodji karjo- vaskulari (eż. pressjoni għolja, iperlipidemija, diabetes mellitus, tipjip) għandhom jiġu ttrattati b’ celecoxib biss wara kunsiderazzjoni attenta (ara sezzjoni 5. 1).
3 COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
Inibituri selettivi COX- 2 mhumiex sostituti għal acetylsalicylic acid għal profilassi ta ’ mard kardjovaskulari trombo- emboliku minħabba n- nuqqas ta ’ effett tagħhom kontra l- plejtlits.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Għalhekk, terapiji kontra l- plejtlits m’ għandhomx jitwaqqfu (ara sezzjoni 5. 1).
As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking celecoxib.
Bħal f’ mediċini oħra li huma magħrufin li jinibixxu s- sinteżi prostaglandin, ġew osservati żamma ta ’ fluwidi u edema f’ pazjenti li qed jieħdu celecoxib.
Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Allura, celecoxib għandu jintuża b’ kawtela f’ pazjenti bi storja ta ’ indeboliment kardijaku, disfunzjoni tal- ventrikula tax- xellug jew pressjoni għolja b’ mod anormali u f’ pazjenti b’ edema li tkun diġà eżistenti minħabba xi raġuni oħra, minħabba li l- inibizzjoni ta ’ prostaglandini tista ’ tirriżulta fid- deterjorazzjoni tal- funjoni tal- kliewi u żamma ta ’ fluwidi.
Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Jeħtieġ li tingħata attenzjoni f’ pazjenti li jkunu qed jieħdu trattament dijuretiku jew inkella li jkollhom riskju ta ’ ipovolemija.
As with all NSAIDS, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Bħal kull NSAIDS oħra, celecoxib jista ’ jwassal għall- bidu ta ’ pressjoni għolja ġdida jew għat- taħżin ta ’ pressjoni għolja diġà eżistenti, li kull waħda minnhom tista ’ tikkontribwixxi għall- inċidenza akbar ta ’ episodji kardjovaskulari.
Therefore, blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.
Għaldaqstant, il- pressjoni tad- demm għandha tiġi mmonitorjata mill- qrib waqt il- bidu tat- terapija b’ celecoxib u matul it- terapija kollha.
In the event of elderly patients with mild to moderate cardiac dysfunction requiring therapy, special care and follow up is warranted.
Fil- każ ta ’ pazjenti anzjani b’ disfunzjoni kardijaka ħafifa għal moderata li tkun teħtieġ terapija, teħtieġ li tingħata kura speċjali kif ukoll li jsirilhom follow- up.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Funzjoni kompromessa renali jew epatika u speċjalment id- disfunzjoni tal- qalb huma aktar probabbli fl- anzjani u għalhekk għandha tinżamm superviżjoni medika adegwata.
Renal and hepatic disorders NSAIDs, including celecoxib, may cause renal toxicity.
Indeboliment tal- kliewi u tal- fwied In- NSAIDs, fosthom celecoxib, jistgħu jikkawżaw effett tossiku renali.
Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Provi kliniċi b’ celecoxib urew effetti renali simili għal dawk osservati b’ NSAIDs komparaturi.
Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly.
Il- pazjenti fl- akbar riskju ta ’ tossiċità renali huma dawk b’ indeboliment fil- funzjoni renali, insuffiċjenza tal- qalb, disfunzjoni tal- fwied, u l - anzjani.
Such patients should be carefully monitored while receiving treatment with celecoxib.
Dawn il- pazjenti għandhom jiġu mmonitorjati b’ attenzjoni waqt li jkunu qegħdin jirċievu t - trattament b’ celecoxib.
Experience with celecoxib in patients with mild or moderate renal or hepatic impairment is limited, therefore such patients should be treated with caution (see sections 4.2 and 5.2).
(ara sezzjonijiet 4. 2 u 5. 2).
If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
Jekk matul it- trattament, il- funzjonijiet tas- sistemi ta ’ l- organi deskritti fuq tal- pazjenti jmorru għall - agħar, għandhom jittieħdu miżuri xierqa u għandu jiġi kkunsidrat it- twaqqif tat- terapija b’ celecoxib.
Skin Reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8).
Reazzjonijiet tal- ġilda Reazzjonijiet qawwija fil- ġilda, uħud minnhom fatali, inkluż dermatite li tqaxxar il- ġilda, is- sindromu ta ’ Stevens- Johnson, kif ukoll meta l- ġilda tibda tmut u tinqala (‘ epidermal necrolysis ’) ġew irrapportati fuq pazjenti li ħadu celecoxib (ara sezzjoni 4. 8).
Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment.
Jidher li l- pazjenti jkunu l- aktar f’ riskju għal dawn ir- reazzjonijiet kmieni matul il- kors tat- trattament.
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see section 4.8).
Reazzjonijiet ta ’ sensittività eċċessiva serji (anafilassi u anġjodema) ġew irrapportati f’ pazjenti li kienu qegħdin jirċievu celecoxib (ara sezzjoni 4. 8).
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see section 4.3).
Pazjenti bi storja ta ’ allerġija sulfonamida jew ta ’ kwalunkwe allerġija għal mediċina, jistgħu jkunu f’ periklu ikbar li jsofru minn reazzjonijiet serji tal- ġilda jew minn reazzjonijiet ta ’ sensittività eċċessiva (ara sezzjoni 4. 3).
Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Celecoxib għandu jitwaqqaf ma l- ewwel sinjal ta ’ raxx tal - ġilda, feriti b’ mukus, jew ta ’ xi sinjal ieħor ta ’ sensittività eċċessiva.
Other Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).
Oħrajn Pazjenti li huma magħrufin li mhumiex metabolizzaturi daqstant tajbin ta ’ CYP2C9 għandhom jiġu ttrattati b’ kawtela (ara sezzjoni 5. 2).
Celecoxib may mask fever and other signs of inflammation.
4 Celecoxib jista ’ jaħbi deni u sinjali oħra ta ’ infjammazzjoni.
In patients on concurrent therapy with warfarin, serious bleeding events have been reported.
F’ pazjenti li jkunu qed jingħataw il- warfarina, ġew irrapportati episodji serji ta ’ telf ta ’ demm.
Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (see section 4.5).
Għandha tkun eżerċitata kawtela meta celecoxib u warfarin u antikoagulanti li jittieħdu mill- ħalq oħra jingħataw fl- istess ħin (ara sezzjoni 4. 5).
Onsenal 200 mg capsules contain lactose (49.8 mg).
Onsenal 200 mg kapsuli fih lactose (49. 8 mg).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, b’ defiċjenza Lapp lactase jew b’ assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
4 The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i. e. those used for osteoarthritis/ rheumatoid arthritis).
Interazzjonijiet Farmakodinamiċi Il- maġġoranza ta ’ l- istudji ta ’ interazzjoni saru b’ dożi ta ’ celecoxib 200 mg BID (i. e. dawk użati għall - artrite ta ’ l- għadam/ artrite rewmatika).
A more pronounced effect at 400 mg BID therefore cannot be excluded.
Effett iżjed evidenti b’ 400 mg BID ma jistax jiġi eskluż.
Anticoagulant activity should be monitored in patients taking warfarin or other anticoagulants, particularly in the first few days after initiating or changing the dose of celecoxib, since these patients have an increased risk of bleeding complications.
Attività antikoagulanti għandha tiġi mmonitorjata f’ pazjenti li jkunu qed jieħdu l- warfarina jew xi antikoagulanti oħra, b’ mod partikolari fl- ewwel ftit jiem wara li tinbeda jew titbiddel id- doża ta ’ celecoxib, minħabba li dawn il- pazjenti għandhom riskju akbar ta ’ kumplikazzjonijiet fit- telf ta ’ demm.
Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR.
Allura, pazjenti li qed jingħataw anti- koagulanti mill- ħalq għandhom jiġu mmonitorati bir - reqqa għal prothrombin time INR tagħhom.
Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4).
Ġew irrapportati episodji ta ’ telf ta ’ demm assoċjati ma ’ żieda fil- prothrombin time f’ pazjenti bl- artrite (l- iżjed fl- anzjani) li kienu qed jirċievu celecoxib flimkien mal- warfarina, xi uħud minnhom fatali (ara sezzjoni 4. 4).
NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
NSAIDs jistgħu jnaqqsu l- effett ta ’ dijuretiċi u ta ’ mediċini kontra l- pressjoni għolja.
As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e. g. dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Fir- rigward ta ’ NSAIDs, ir- riskju ta ’ indeboliment tal- kliewi akut jista ’ jiżdied f’ xi pazjenti b’ funzjoni tal- kliewi kompromessa (eż. pazjenti deidrati jew pazjenti anzjani) meta inibituri ACE jew angiotensin II receptor antagonists jittieħdu f’ kombinazzjoni ma ’ NSAIDs inkluż celecoxib.
Therefore, the combination should be administered with caution, especially in the elderly.
Għalhekk, kombinazzjoni bħal din għandha tingħata b’ kawtela, b’ mod speċjali f’ pazjenti anzjani.