qanastek/EMEA-V3 huggingface dataset:
Thereafter, steady concentrations are maintained for up to 96 hours.
Minn hemm ’ l quddiem, kon entrazzjonijiet kostanti jin ammu sa 96 sieg a.
The difference in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following transdermal administration of Kentera on either the abdomen, buttocks or hip is not clinically relevant.
Id- differenza fl- AUC u fis- Cmax ta ’ oxybutynin u l- metabolu attiv N- desethyloxybutynin wara l- applikazzjoni transdermali ta ’ Kentera fuq l- addome, il- warrani jew il - enbejn mhijiex klinikament relevanti.
Distribution Oxybutynin is widely distributed in body tissues following systemic absorption.
Distribuzzjoni Oxybutynin huwa mqassam afna fit- tessuti tal - isem wara l- assorbiment sistematiku.
The volume of distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin hydrochloride.
Il- volum tad - distribuzzjoni kien stmat li hu ta ’ 193 l wara l- g oti ol- vini ta ’ 5 mg ta ’ oxybutynin hydrochloride.
Metabolism Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall.
Metaboli mu Oxybutynin mog ti mill - alq huwa metabolizzat primarjament mis- sistemi ta ’ l- en imi ta - itokromju P450, b’ mod partikulari mis- CYP3A4, li fil- bi a l- kbira tinsab fil- fwied u fis- superfi je ta ’ ewwa ta ’ l- imsaren.
Metabolites include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, which is pharmacologically active.
Il- metaboli jinkludu phenylcyclohexylglycolic acid, li huwa farmakolo ikament inattiv, u N- desethyloxybutynin, li huwa farmakolo ikament attiv.
Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.
L- g oti transdermali ta ’ oxybutynin tiskanza l- ewwel passa tal- metaboli mu gastrointestinali u epatiku, u b’ hekk inaqqas il- formazzjoni tal - metabolit N- desethyl.
Excretion Oxybutynin is extensively metabolised by the liver, see above with less than 0.1% of the administered dose excreted unchanged in the urine.
Eskrezzjoni Oxybutynin huwa metabolizzat b’ mod estensiv mill- fwied, (ara fuq) b’ inqas minn 0. 1% tad- do a mog tija li hi mne ija mhux mibdula fl- awrina.
Also, less than 0.1% of the administered dose is excreted as the metabolite N-desethyloxybutynin.
Barra dan, inqas minn 0. 1% tad- do a mog tija hija mne ija mill- metabolit N- desethyloxybutynin.
5.3 Preclinical Safety Data
5. 3 Tag rif qabel l- u u kliniku dwar is- sigurta ’ tal- medicina
Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat dose toxicity, genotoxicity, carcinogenic potential and local toxicity.
L- ebda periklu spe jali g all- bnedmin ma nstab mit- tag rif ta ’ qabel l- u u kliniku ba at fuq studji dwar tossikolo ija akuta, tossi ità ta ’ do i ripetuti, enotossi ità, ir- riskju ta ’ kan er u tossi ità lokali.
At a concentration of 0.4 mg/ kg/ day oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in the presence of maternal toxicity.
F’ kon entrazzjoni ta ’ 0. 4 mg/ kg/ kuljum ta ’ oxybutynin mog tija ta t il - ilda, l- okkorrenza ta ’ anomaliji ta ’ l- organi ti died b’ mod sinifikattiv, i da din hija osservata biss fil- pre enza ta ’ tossi ità materna.
Kentera delivers approximately 0.08 mg/ kg/ day.
Kentera ter i madwar 0. 08 mg/ kg/ kuljum.
However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Madankollu, min abba li l- asso jazzjoni bejn it - tossi ità materna u l- effett fuq l- i vilupp g adu mhux ar, ir- rilevanza g as- sigurtà fil- bniedem ma tistax tkun a ertata.
In the subcutaneous fertility study in rats, while no effects were reported in males, in females, fertility was impaired and a NOAEL (no observed adverse effect level) of 5 mg/ kg was identified.
6 f’ firien tas- sess maskili, il- fertilità fil- firien tas- sess femminili arrbet sara u NOAEL (livell li fih ma jkun osservat l- ebda effett avvers) ta ’ 5 mg/ kg kien identifikat.
6 PHARMACEUTICAL PARTICULARS
6 TAG RIF FARMA EWTIKU
6.1 List of Excipients
6. 1 Lista ta ’ sustanzi mhux attivi
The transdermal patch is composed of three layers: a backing film, an adhesive/ drug layer and a release liner.
Il- gar a li tipprovdi medi ina li tg addi minn ol - ilda hija mag mula minn tlett saffi: rita ta ’ rinforz fid- dahar ta ’ l- impjastru, saff ta ’ sustanza li te el/ medi ina u inforra li ter i.
The backing film provides the matrix system with occlusivity and physical integrity and protects the adhesive/ drug layer.
Ir- rita ta ’ rinforz fid- dahar ta ’ l- impjastru tipprovdi s- sistema matri i b’ okklusività u integrità fi ika u tipprote i s- saff tas - sustanza li te el/ medi ina.
The adhesive/ drug layer contains oxybutynin and triacetin.
Is- saff tas- sustanza li te el/ medi ina fih oxybutynin u triacetin.
The release liner is two overlapped siliconised polyester strips that are peeled off and discarded by the patient prior to applying the patch.
L- inforra li ter i huma ew strixxi imrikkbin ta ’ polijester silikonizzat li jitqaxxru minn ma ’ xulxin u jintremew mill- pazjent qabel l- applikazzjoni ta ’ l- impjastru.
Backing Film:
Rita ta ’ rinforz fid- dahar ta ’ l- impjastru:
Polyethylene/ ethyl vinyl acetate (PET/ EVA), clear
Polyethylene/ ethyl vinyl acetate (PET/ EVA), ar
Triacetin Acrylic Copolymer Adhesive Solution containing 2-ethylhexyl acrylate N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains
Saff tan- nofs: triacetin Ta lita tal- kolla Kopolimer Akriliku li fiha 2- ethylhexyl acrylate N- vinyl pyrrolidone u dominji tal - polimer hexamethyleneglycol dimethacrylate.
Release Liner:
Inforra li ter i:
Siliconised Polyester
Polyester Silikonizzat
Store in the original package.
A en fil- pakkett ori inali.
Do not refrigerate.
Tag mlux fil- fri.
Do not freeze.
Tag mlux fil- fri a.
The transdermal patches are individually contained in LDPE/ paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.
L - gar a li tipprovdi medi ina li tg addi minn ol - ilda huma mqeg din individwalment f’ LDPE / qratas g ar tal- karta laminati u pprovduti f’ Kaxxi g all- Pazjent bil- Kalendarju ta ’ 2, 8 jew 24 impjastru.
6.6 Instructions for use and handling
6. 6 Struzzjonijiet g all- u u u mani ar
Apply immediately upon removal from the protective sachet.
Applika immedjatament hekk kif tne i minn ol- qartas protettiv.
After use the patch still contains substantial quantities of active ingredients.
Wara l- u u, l- impjastru jkun g ad fih kwantitajiet sostanzjali ta ’ ingredjenti attivi.
Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
L- ingredjenti attivi ta ’ l- impjastru li jkun baqa ’ jista ’ jkollhom effetti li jag mlu l - sara jekk jil qu l- ilma ambjentali.
Hence, after removal, the used patch should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of reach of children.
G alhekk, wara li jitne a, ll - impjastru w at g andu jintewa min- nofs, bin- na a tas- sustanza li te el t ares ’ il ewwa sabiex il - membrana li ter i ma tkunx esposta, mqieg da fil- qartas ori inali u wara mormi ming ajr periklu fejn ma tintla aqx mit- tfal.
Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
L- impjastri w ati jew li ma jintu awx g andhom jintremew kif jitolbu l- li ijet lokali jew irritornati fl- ispi erija.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
L- impjastri w ati m’ g andhomx jkunu ifflaxxjati fit- tojlit u lanqas mqieg da f’ sistemi ta ’ rimi ta ’ skart likwidu.
Activities that may lead to excessive sweating, or exposure to water or extreme temperature may contribute to adhesion problems.
Attivitajiet li jistg u jwasslu g all- g araq e essiv, jew g all- espo izzjoni g all- ilma jew g al temperatura estrema, jistg u jwasslu g al problemi ta ’ ade joni.
Do not expose the patch to the sun.
Tesponix l- impjastru g ax- xemx.
MARKETING AUTHORISATION HOLDER
SID TA ’ L- AWTORIZZAZZJONI G ALL- KUMMER
Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3RP
Nicobrand Limited 189 Castleroe Road Coleraine L- Irlanda ta ’ Fuq BT51 3RP
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI G ALL- KUMMER
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - RU TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL - KUMMER
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - RU TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli mill - ru tal- lott
B CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMER
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- U U IMPOSTI FUQ SID L- AWTORIZZAZZJONI TAL- KUMMER
Medicinal product subject to medical prescription
Prodott medi inali jing ata b’ ri etta tat- tabib
• OTHER CONDITIONS
• KUNDIZZJONIJIET O RA
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Sid ta ’ din l- awtorizzazzjoni tal- kummer g andu jag ti tag rif lill- Kummissjoni Ewropea dwar il - pjanijiet kummer jali tal- prodott medi inali awtorizzat b’ din id- de i joni.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
12 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA' DAN, FUQ IL PAKKETT LI JMISS MAL- PRODOTT
CARTON (Containing 8 transdermal patches)
KARTUNA (Li fiha 8 gar i li tipprovdu medi ina li tg addi minn ol - ilda)
Kentera 3.9 mg / 24 hours transdermal patch Oxybutynin
Kentera 3. 9 mg / 24 sieg a gar a li tipprovdi medi ina li tg addi minn ol - ilda (impjastru transdermali) Oxybutynin
Each patch contains 36 mg oxybutynin.
Kull impjastru fih 36 mg ta ’ oxybutynin.
The area of the patch is 39 cm2 releasing a nominal 3.9 mg of oxybutynin per 24 hours.
L- erja ta ’ l- impjastru hija ta ’ 39 cm2, li ter i 3. 9 mg nominali ta ’ oxybutynin kull 24 sieg a.
Triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate; N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
Sustanzi mhux attivi: triacetin; kolla akrilika (li fiha ethylhexyl acrylate; N- vinyl pyrrolidone u dominji tal- polimer hexamethyleneglycol dimethacrylate).
Backing: polyester/ ethylene-vinyl acetate film; siliconised polyester film.
Rita ta ’ rinforz fid- dahar ta ’ l- impjastru: rita ta ’ polyester/ ethylene- vinyl acetate; rita ta ’ polyester silikonizzat.
8 transdermal patches
8 gar i li jipprovdu medi ina li tg addi minn ol - ilda
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JING ATA
For transdermal use only.
G all- u u transdermali biss.
Do not use if seal on sachet is broken
Tu ax jekk is- si ill madwar il- qartas jkun miksur
Apply immediately upon removal from sachet.
Applika immedjatament hekk kif titne Aqra l- fuljett ta ’ tag rif qabel l- u u.
Read the package leaflet before use.
a minn ol- qartas.
Keep out of the reach and sight of children.
omm fejn ma jintla aqx u fejn ma jidhirx mit- tfal.
Date :< MM/YYYY >
JIS [XX/ SSSS]
Store in original package.
A en fil- pakkett ori inali.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPE JALI G AR - RIMI TA ’ PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINN DAWN IL- PRODOTTI MEDI INALI, JEKK HEMM B ONN
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI G ALL- KUMMER
MARKETING AUTHORISATION NUMBER (S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI G ALL- KUMMER
Batch No. :< >
< Lott > [numru]
Sun/ Wed Mon/ Thu Tue/ Fri Wed/ Sat Thu/ Sun Fri/ Mon Sat/ Tue
add/ Erbg Tnej / ami Tliet / img Erbg / Sibt ami / add img / Tnej Sibt/ Tliet
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
14 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA' DAN, FUQ IL PAKKETT LI JMISS MAL- PRODOTT
CARTON (Containing 24 transdermal patches)
KARTUNA (Li fiha 24 gar a li tipprovdi medi ina li tg addi minn ol - ilda)
STATEMENT OF ACTIVE SUBSTANCE(S)
U U TAS- SUSTANZA( I) ATTIVA
Each patch contains 36 mg oxybutynin.
Kull gar a li tipprovdi medi ina li tg addi minn ol - ilda fiha 36 mg ta ’ oxybutynin.
The area of the patch is 39 cm2 releasing a nominal 3.9 mg of oxybutynin per 24 hours.
L- erja ta ’ l - impjastru hija ta ’ 39 cm2, li ter i 3. 9 mg nominali ta ’ oxybutynin kull 24 sieg a.
Triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate, N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
Sustanzi mhux attivi: tria etin; sustanza akrilika li te el (li fiha 2- ethylhexyl acrylate; N- vinyl pyrrolidone u dominji tal- polimer hexamethyleneglycol dimethacrylate.
Backing: polyester/ ethylene-vinyl acetate film; siliconised polyester film.
Rita ta ’ rinforz fid- dahar ta ’ l- impjastru: rita ta ’ polyester/ ethylene- vinyl acetate; rita ta ’ polyjester silikonizzat.
24 transdermal patches
24 gar a li tipprovdi medi ina li tg addi minn ol - ilda
For transdermal use only Do not use if seal on sachet is broken.
Tu ax jekk is- si ill madwar il- qartas ikun miksur
Apply immediately upon removal from sachet.
Applika immedjatament hekk kif titne Aqra l- fuljett fil- pakkett qabel l- u u.
Read package leaflet before use.
a minn ol- qartas.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPE JALI LI L- PRODOTT MEDI INALI G ANDU JIN AMM FEJN MA ’ JINTLA AQX U MA ’ JIDHIRX MIT- TFAL
Keep out of the reach and sight of children.
omm fejn ma ’ jintla aqx u fejn ma ’ jidhirx mit- tfal.
Exp.
JIS.:
Date :< MM/YYYY >
[XX/ SSSS]
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
TWISSIJA SPE JALI G AR - RIMI TA ’ PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINNDAWN IL- PRODOTTI MEDI INALI, FEJN JIXRAQ
MANUFACTURER’ S BATCH NUMBER
NUMRU TAL- LOT TAL- MANIFATTUR
Batch No. :< >
< Lot > [numru]
GENERAL CLASSIFICATION FOR SUPPLY
ENERALI TA ’ KIF JING ATA LILL- PAZJENT
Medicinal product subject to medical prescription
Prodott medi inali jing ata bir- ri etta tat- tabib.
INSTRUCTIONS ON USE
TAG RIF TA ’ KIF G ANDU JINTU A
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
16 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA' DAN, FUQ IL PAKKETT LI JMISS MAL_ PRODOTT
CARTON (Containing 2 transdermal patches)
KARTUNA (Li fiha 2 gar i li jipprovdu medi ina li tg addi minn ol - ilda)
Backing: polyester/ ethylene-vinyl acetate film; siliconised polyester film.
Rita ta ’ rinforz fid- dahar ta ’ l- impjastru: rita ta ‘ polyester/ ethylene- vinyl acetate); rita ta ’ polyester silikonizzat.
2 transdermal patches
2 gar i li jipprovdu medi ina li tg addi minn ol - ilda
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
SACHET (Contains 1 transdermal patch)
QARTAS G IR (Fih impjastru 1 transdermali)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDI INALI U MNEJN JING ATA
Kentera 3.9 mg / 24 hours transdermal patch Oxybutynin
Kentera 3. 9 mg / 24 sieg a gar a li tipprovdi medi ina li tg addi minn ol - ilda) impjastru transdermali) Oxybutynin
For transdermal use only
G all- u u transdermali biss.
Date :< MM/YYYY >
JIS {XX/ SSSS}
Batch No. :< >
< Lott > {numru}
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
KONTENUT SKOND IL- PI, VOLUM JEW PARTI INDIVIDWALI
Contains 1 transdermal patch.
Fih gar a 1 li tipprovdi medi ina li tg addi minn ol - ilda
PACKAGE LEAFLET
FULJETT TA ’ TAG RIF
20 PACKAGE LEAFLET
20 FULJETT TA ’ TAG RIF
Read all of this leaflet carefully before you start using Kentera
Aqra dan il- fuljett kollu b’ attenzjoni qabel tibda tie u Kentera.
- Keep this leaflet.
- omm dan fuljett.
You may need to read it again.
Jista ’ jkollok b onn ter a ’ taqrah.
- If you have further questions, please ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jog bok staqsi lit- tabib jew l- ispi jar tieg ek.
It may
- Din il- medi ina iet mog tija g all- u u personali tieg ek u m’ g andekx tag tiha lil persuna o ra.
harm them even if their symptoms are the same as yours.
Tista ’ tag mlilhom il - sara, anki jekk ikollom l- istess sintomi b al tieg ek.
1. What Kentera is and what it is used for 2. Before you use Kentera 3. How to use Kentera 4. Possible side effects 5. Storing Kentera 6.
X’ effetti o ra jista ’ jkollu 5.
Further Information
Kif ta en Kentera 6.
Kentera 3.9 mg / 24 h transdermal patch
Kentera 3. 9 mg / 24 sieg a, gar a li tipprovdi medi ina li tg addi minn ol - ilda (impjastru transdermali)
The active substance is oxybutynin.
Is- sustanza attiva hija oxybutynin.
Each transdermal patch contains 36 mg of oxybutynin.
Kull gar a li tipprovdi medi ina li tg addi minn ol - ilda (impjastru transdermali) fiha 36 mg ta ’ oxybutynin.
The other ingredients are triacetin, acrylic adhesive solution (containing 2-ethylhexyl acrylate, N- vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains), clear backing film of polyester/ ethylene vinyl acetate (PET/ EVA), and siliconised polyester release liner (PET).
L- ingredjenti l- o rajn huma tria etin; kolla akrilika (li fiha 2- ethylhexyl acrylate; N- vinyl pyrrolidone u dominji tal- polimer hexamethyleneglycol dimethacrylate), rita ara ta ’ rinforz fid- dahar ta ’ l - impjastru ta ’ polyester/ ethylene vinyl acetate (PET/ EVA), u inforra ta ’ polyester silikonizzat li ter i (PET).
Marketing Authorisation Holder and Manufacturer:
Sid l- Awtorizzazzjoni g all- kummer u l- Manifattur
Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3RP
Nicobrand Limited 189 Castleroe Road Coleraine L- Irlanda Ta ’ Fuq BT51 3RP
WHAT KENTERA IS AND WHAT IT IS USED FOR
X’ INHI KENTERA U G ALXHIEX TINTU A
Kentera is a thin, flexible, translucent transdermal patch that you apply to your skin.
Kentera hija gar a li tipprovdi medi ina li tg addi minn ol - ilda rqiqa, flessibbli u translu idu li tapplika fuq il - ilda tieg ek.
Oxybutynin, the active substance in the patch, is dissolved in the thin layer of adhesive, which is used to stick the patch to your skin.
Oxybutynin, is- sustanza attiva fl- impjastru, jin all fis- saff irqiq tal- kolla, li tintu a biex twa al l- impjastru mal - ilda tieg ek.
Each pack contains either 2, 8 or 24 patches.
Kull pakkett fih jew 2, 8 jew 24 impjastru.
Kentera controls the symptoms of urge incontinence and/ or increased urinary frequency and urgency.
Kentera tikkontrolla s- sintomi ta ’ impuls ta ’ l- inkontinenza u/ jew ta ’ ieda fil- frekwenza u fl- ur enza urinarja.
BEFORE YOU USE KENTERA
QABEL MA ’ TU A KENTERA
Do not use Kentera:
Tu ax Kentera:
If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
Jekk tbati minn sensittività e essiva (aller ija) g al oxybutynin jew g al xi wie ed mill- ingredjenti ta ’ Kentera.
If you have allergies to medical tape or other transdermal patches, consult your doctor before using Kentera.
21 Jekk g andek aller iji g at- tejp mediku jew g all- gar a li tipprovdi medi ina li tg addi minn ol - ilda, kellem lit- tabib tieg ek qabel tu a Kentera.
If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem.
Jekk inti jkollok tbattil inkomplet tal- bu ieqa ta ’ l- awrina waqt li tkun qed tag mel l- awrina, l- u u ta ’ oxybutynin jista ’ j id din il- problema.
You should discuss this problem with your doctor before using Kentera.
G andek tiddiskuti din il- problema mat- tabib tieg ek qabel tu a Kentera.
21 If you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
Jekk g andek problemi fid- di estjoni kkaw ati minn tnaqqis fit- tbattil ta ’ l- istonku wara l- ikel, inti g andek tkellem lit- tabib tieg ek qabel tu a Kentera.
If you have glaucoma or a family history of glaucoma, tell your doctor.
Jekk g andek glawkoma jew jekk membri tal- familja tieg ek kellhom il- glawkoma, g id lit- tabib tieg ek.
Take special care with Kentera:
Oqg od attent afna b’ Kentera:
If you have any of the following: • Liver disease • Kidney disease • Bladder obstruction • Gastrointestinal obstruction • Ulcerative colitis • Generalized muscle weakness • Inflammation of the oesophagus
• Mard tal- fwied • Mard tal- kliewi • Ostruzzjoni fil- bu ieqa ta ’ l- awrina • Ostruzzjoni gastrointestinali • Kolite ul erattiva • Dg jufija eneralizzata fil- muskoli • Infjammazzjoni ta ’ l- esofagu
Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures.
Billi l- kura b’ oxybutynin tista ’ tikkaw a nuqqas ta ’ g araq, hemm ieda fir- riskju ta ’ deni u heat stroke jekk inti tkun espost g al temperaturi ambjentali g oljin.
Kentera is not recommended for use in children or adolescents.
Kentera mhiex rakkomandata g all- u u fit- tfal jew fl- adolexxenti.
Kentera with food and drink:
Meta tie u Kentera ma ’ l- ikel u max - xorb:
Oxybutynin may cause drowsiness or blurred vision.
Oxybutynin jista ’ jikkaw a edla jew vista m ajpra.
Drowsiness may be increased by consumption of alcohol.
Il - edla tista ’ ti died mal- konsum ta ’ l- alko ol.
Pregnancy
It- Tqala
Ask your doctor for advice before taking any medicine.
Itlob g all- parir tat- tabib jew l- ispi jar tieg ek qabel tie u xi medi ina.
Kentera should not to be used during pregnancy unless clearly necessary
Kentera m’ g andiex tintu a waqt it- tqala lief jekk verament me tie.
Lactation
Jekk qed tredda ’
Ask your doctor for advice before taking any medicine
Itlob g all- parir tat- tabib tieg ek qabel tie u xi medi ina.
It is not known whether oxybutynin is excreted in human milk.
Mhuwiex mag ruf jekk oxybutynin huwiex mne meta Kentera tintu a meta inti qed tredda ’.
Caution should be exercised when using Kentera when you are breast feeding.
G andha ting ata attenzjoni
Driving and using machines:
Sewqan u t addim tal- magni:
Kentera may cause drowsiness or blurred vision, requiring caution when driving or operating machines.
Kentera g andu mnejn tikkaw a edla jew vista m ajpra, u wie ed irid joqg od attent waqt is- sewqan u l- u u tal- magni.
Taking other medicines:
L- u u ta ’ medi ini o ra:
Please inform your doctor or pharmacist if you are taking or have recently taken other medicinal products whether prescribed or not.
Jekk jog bok g arraf lit- tabib jew l- ispi jar tieg ek jekk int qed tie u jew adt dan l- a medi ini o ra, anki mhux bir- ri etta tat- tabib.
HOW TO USE KENTERA
KIF JINTU A KENTERA
Always take Kentera exactly as your doctor has instructed you.
Dejjem g andek tie u Kentera skond il- parir tat- tabib tieg ek.
You should check with your doctor or pharmacist if you are unsure.
Dejjem g andek ta erta ru ek mat - tabib jew l- spi jar tieg ek jekk ikollok xi dubju.
Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use.
Applika impjastru ta ’ Kentera did darbtejn fil - img a (kull 3 sa 4 ijiem) skond l- istruzzjonijiet g all - u u.
Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday.
Ibdel l- impjastru fl- istess jumejn kull img a, per e empju, kull nhar ta ’ add u l- Erbg a, jew it - Tnejn u l - amis.
Printed on the inside flap of your Kentera package, you will find a Kentera calendar checklist that will help you to remember your dosing schedule.
Fuq il - ‘ flap ’ ta ’ ewwa tal- pakkett tieg ek ta ’ Kentera, g andek issib stampata skeda b’ kalendarju ta ’ Kentera li ser tg inek biex tiftakar l- iskeda tad- do a tieg ek.
Mark the schedule you plan to follow and remember always to change your patch on the same two days of the week you have chosen on your calendar.
Immarka l- iskeda li ser issegwi u ftakar dejjem biex tibdel l- impjastru tieg ek fl- istess jumejn tal - img a li g a ilt fil - kalendarju tieg ek.
Make sure to wear only one patch at a time and wear your patch continuously, until it is time to apply a new one.
Kun gur li tag mel impjastru wie ed biss kull darba, u li jkollok l- impjastru f’ postu l - in kollu, sakemm jasal i - mien biex tapplika wie ed did.
Where to Apply
Fejn tapplika l- impjastru
Apply the patch to a clean, dry, smooth area of skin on your abdomen, hips or buttocks.
Applika l- impjastru fuq erja ta ’ ilda nadifa, xotta u lixxa fuq aqqek, il - enbejn jew il- warrani.
Avoid placing the patch in the waistline area to prevent tight clothing from rubbing against the patch.
Evita li tpo i l- impjastru fl- erja tal- qadd biex tevita li lbies issikkat j okk mal- impjastru.
Do not expose the patch the sun.
Tpo ix l - impjastru g ax- xemx.
Place the patch underneath your clothing.
Po i l- impjastru ta t l- ilbies tieg ek.
Rotate application sites with each new application.
Ibdel il- parti tal - isem fejn tpo i l - impjastru ma ’ kull applikazzjoni dida.
Do not apply a patch to the same place on your body for at least 1 week.
Tapplikax l- impjastru fl- istess post fuq ismek g al mill- anqas img a.
hips
i - aqq
buttocks
il - enbejnil- warrani
How to Apply
Kif tapplika
Each patch is individually sealed in a protective sachet.
Kull impjastru huwa individwalment issi illat f’ qartas protettiv.
Please read all the information below before you begin to apply Kentera.
Jekk jog bok aqra l- informazzjoni kollha hawn ta t qabel tibda tapplika Kentera.
To apply Kentera:
Biex tapplika Kentera:
Step 1:
Pass 1:
Choose a spot for the patch that is:
Ag el post g all- impjastru li:
• Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower). • Free of body powder, lotion, and oil. • Free of cuts, rashes or any other skin irritation.
• G adu kemm kien ma sul, i da xott u frisk (stenna ftit minuti wara li tie u banju jew do a s una). • M’ g andu l- ebda terra, lozjoni, u ejt li jintu a fuq il - isem. • M’ g andu l- ebda qatg a, raxx jew xi irritazzjoni o ra tal - ilda.
Step 2:
Pass 2:
Open the sachet that contains the patch.
Ifta il- qartas li fih l- impjastru.
• Tear open along arrows marked on the right side of the sachet as shown in drawing below. • Do not cut the sachet with scissors, which might damage the patch inside. • Pull the patch out. • Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
• Qatta ’ u ifta mal- vle e immarkati fuq in- na a tal- lemin tal- qartas kif muri fit- tpin ija hawn ta t. • Taqtax il- qartas b’ imqass, g ax jista ’ jag mel sara lil- impjastru ta ’ ewwa. • I bed l- impjastru ’ l barra. • Applika immedjatament fuq il - ilda tieg ek; i ommx jew ta inx l- impjastru barra mill- qartas ssi illat.
23 Step 3:
23 Pass 3:
Apply one half of the patch to your skin.
Applika nofs l- impjastru fuq il - ilda tieg ek.
• Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch. • Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
• Ilwi l- impjastru bil- mod u ne i l- ewwel bi a ta ’ l- inforra protettiva, li tg atti l- wi li je el ta ’ l- impjastru. • Ming ajr ma tmiss il- wi li je el, ag fas bis- sa a l- impjastru, bis- sustanza li te el wi ha ’ l isfel, fuq il- parti ta - aqq, tal - enbejn jew tal- warrani li g a ilt g all- applikazzjoni.
Step 4:
Pass 4:
Apply the second half of the patch to your skin.
Applika t- tieni nofs ta ’ l- impjastru fuq il - ilda tieg ek.
• Bend the patch back over itself.
• Ilwi l- impjastru lura fuqu nnifsu.
Press down on the liner firmly. • Push the liner forward a little to loosen the edge. • Grab the loose edge at either corner and peel off the second piece of the liner.
Ag fas ’ l isfel bis- sa a fuq l- inforra. • Imbotta l- inforra ftit il- quddiem biex t- tarf jer i. • Aqbad it- tarf li jkun re a f’ xi kantuniera minnhom u qaxxar it- tieni bi a ta ’ l - inforra.
Try not to touch the sticky surface of the patch. • Press the entire patch firmly onto the skin with your fingertips.
Ipprova tmissx il- wi li je el ta ’ l- impjastru. • Ag fas l- impjastru kollu bis- sa a fuq il - ilda tieg ek bil- ponot ta ’ subg ajk.
Press for at least 10 seconds to make sure the patch will stay in place.
Ag fas g all - mill- anqas 10 sekondi biex tkun gur/ a li l- impjastru joqg od f’ postu.
Be sure all of it sticks to your skin, even around the edges. • Discard the protective liners.
Kun gur/ a li l- impjastru kollu kemm hu je el mal - ilda tieg ek, anki madwar it- truf. • Armi l- inforor protettivi.
You should wear each patch all the time until you apply a new one.
Il - asil fil- banju, do o, l- g awm u l- e er izzju G andek tilbes kull impjastru l - in kollu sakemm tapplika wa da dida.
Baths, showers, swimming and exercise should not affect the patch as long as you don ’ t rub the patch as you wash.
Banjijiet, do o, g awm u e er izzju m’ g andhomx jaffettwaw lil- impjastru sakemm ma tog rokx l- impjastru waqt li tkun qed tin asel.
Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
Evita li toqg od f’ banju s un g all- perijodu twil ta ’ in, g ax dan jista ’ j ieg el lil- impjastru jinqala ’.
If the patch comes off:
Jekk l- impjastru jinqala ’:
If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips.
Jekk l- impjastru jibda jinqala ’ minn mal - ilda, applika ftit pressjoni billi tu a l- ponot ta ’ subg ajk.
The patch is designed to re-stick.
L - impjastru huwa mag mul biex jer a ’ jitwa al.
Very rarely will the patch come off completely.
Rarament afna l- impjastru jinqala ’ kompletament.
If it does, try putting the same patch back on the same spot.
Jekk dan ji ri, ipprova po i l- istess impjastru lura fl- istess post.
If it sticks firmly all over, leave it on.
Jekk dan je el sewwa minn kull na a, allih fuqek.
If not, take it off and put a new patch on a new spot.
Jekk le, ne ih u po i impjastru did f’ parti tal - isem did.
No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
Ma jimpurtax f’ liema urnata dan ji ri, int kompli bl- iskeda tad- darbtejn fil - img a li immarkajt fuq il- kaxxa ta ’ l- impjastri.
If you forget to change the patch after 3-4 days:
Jekk inti tinsa tibdel l- impjastru wara 3- 4 ijiem:
As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, hips or buttocks.
Hekk kif tiftakar, ne i l- impjastru l- qadim u applika wie ed did fuq parti dida fuq aqqek, fuq il - enbejn jew fuq il- warrani.
No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4 days have elapsed.
24 darbtejn fil - img a g all- impjastru li jmiss, anki jekk dan ifisser li jkollok tibdel l- impjastru l - did qabel it- 3 jew l- 4 ijiem ikunu g addew.
24 How to Remove
Kif tne
When changing the patch, remove the old patch slowly.
Meta tkun qed tibdel l- impjastru, ne i l- impjastru l- qadim bil- mod.
Mild redness may be present at the application site.
Itwih min- nofs (bin- na at li je lu ma ’ xulxin) u armih biex ma ’ jsibuhiex it- tfal u l- annimali domesti i. mura afifa g andha mnejn tidher fil- parti ta ’ l- applikazzjoni.
This redness should disappear within several hours after removal of the patch.
Din il - mura g andha tisparixxi wara diversi sig at li jitne a l - impjastru.
If irritation persists, please contact your doctor.
Jekk l- irritazzjoni tippersisti, jekk jog bok ikkuntattja lit- tabib tieg ek.
Gently washing the application site with warm water and a mild soap should remove any adhesive that remains on your skin after removal of the patch.
Billi ta sel bil- mod il- parti ta ’ l- applikazzjoni b’ ilma s un u sapuna afifa, g andek tne i xi sustanza li te el li tibqa ’ mal - ilda tieg ek wara li l- impjastru jitne a.
Rings of adhesive that become soiled may require a medical adhesive removal pad that should be available from your pharmacist.
Ammont g ir ta ’ ejt tat- trabi jista ’ wkoll jintu a biex tne i xi fdalijiet ejda li jibqg u. rieki tal- kolla li jit amm u jistg u je tie u gar a ta ’ sustanza medika li tne i l- ade iv li tista ’ tixtriha ming and l- ispi jar tieg ek.
Alcohol or other strong solvents may cause skin irritation and should not be used.
L- alko ol jew solventi o ra qawwija jistg u jikkaw aw irritazzjoni tal - ilda u m’ g andhomx jintu aw.
Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
L- ingredjenti attivi ta ’ l- impjastru li jkun baqa ’ jista' jkollhom effetti li jag mlu l - sara jekk jil qu ambjent ta ’ l- ilma.
Hence, after removal, the used patch should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of reach of children.
G alhekk, wara li jitne a, l- impjastru u at g andu tintewa min- nofs, bin- na a tal- kolla t ares ’ il ewwa sabiex il- membrana li ter i ma tkunx esposta, mqieg da fil- qartas ori inali u wara mormija ming ajr periklu fejn ma tintla aqx mit- tfal.
Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
L- impjastri w ati jew li ma jintu awx g andhom jintremew skond kif jitolbu l- li ijiet lokali jew irritornati fl- ispi erija.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems
L- impjastri w ati m’ g andhomx ikunu ifflaxxjati fit- tojlit u lanqas mqieg da f’ sistemi ta ’ rimi ta ’ skart likwidu.
POSSIBLE SIDE EFFECTS
EFFETTI O RA LI JISTG U JIN ASSU
Like all medicines Kentera can have side effects.
B al kull medi ina o ra Kentera jista ’ jkollha effetti o ra.
Patients using Kentera may experience the following very common (1 in ten persons) side effect: itching around the site of patch application.
Pazjenti li ju aw Kentera g andhom mnejn ikollhom dawn l- effetti o ra li ejjin li huma komuni afna (1 minn kull 10 persuni): akk madwar il- parti ta ’ l- applikazzjoni ta ’ l- impjastru.
They may also experience the following common (1 in 100 persons) side effects: redness or rash at the site of patch application; dry mouth constipation, diarrhea, upset stomach, stomach pain, headache, or sleepiness, urinary tract infections, blurred vision, and dizziness.
Jista ’ wkoll ikollhom dawn l- effetti o ra komuni li ejjin (1 minn kull 100 persuna): mura jew raxx tal - ilda fil - parti ta ’ l- applikazzjoni ta ’ l- impjastru; alq xott, stitikezza, dijarrea, stonku mqalleb, u ig fl- istonku, u ig ta ’ ras, jew nhas, infezzjonijiet fl- apparat urinarju, vista m ajpra, u sturdament.
Finally, those using Kentera may experience the following uncommon (1 in 1000 persons): upper respiratory tract or fungal infections, palpitations, hot flashes, back pain, urinary retention, difficulty urinating, common cold, and accidental injury.
Finalment, dawk li ju aw Kentera jista ’ jkollhom l- effetti o ra mhux komuni li ejjin (1 minn kull 1000 persuna): infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq jew infezzjonijiet fungali, palpitazzjonijiet, fwawar, u ig fid- dahar, ritenzjoni ta ’ l- awrina, diffikultà biex tag mel l- awrina, ri komuni, u feriti a identali.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
Jekk tinduna b’ xi effetti o rajn li mhux imni lin f’ dan il- fuljett, jekk jog bok g arraf lit- tabib jew lill- spi jar tieg ek.
STORING KENTERA
EN KENTERA
Do not use Kentera after the date shown on the sachet and the carton.
M’ g andekx tu a Kentera wara d- data li tiskadi li tidher fuq il- qartas u l- kartuna.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok g amel kuntatt mar- rappre entant lokali tas- Sid ta ’ l- Awtorizzazzjoni g all- Kummer.
Ve ká Británia Tel: +44 (0)28 7086 8733
Ve" ká Británia Tel: +44 (0) 28 7086 8733
This leaflet was approved in
ar f ’
Kepivance 6.25 mg powder for solution for injection.
Kepivance 6. 25 mg trab għal soluzzjoni għall- injezzjoni.
Each vial contains 6.25 mg of palifermin.
Kull kunjett fih 6. 25 mg ta ’ palifermin.
Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology in Escherichia coli.
Palifermin huwa fattur tat- tkabbir tal- keratinoċiti (KGF) uman, magħmul minn teknoloġija ta ’ DNA rikombinata f’ Escherichia coli.
Reconstituted Kepivance contains 5 mg/ ml of palifermin.
Kepivance rikostitwit fih 5 mg/ ml ta ’ palifermin.
Powder for solution for injection (powder for injection).
Trab għal soluzzjoni għall- injezzjoni (trab għall- injezzjoni).
White lyophilised powder.
Trab lajofilizzat abjad.
Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in patients with haematological malignancies receiving myeloablative therapy associated with a high incidence of severe mucositis and requiring autologous haemopoietic stem cell support.
Kepivance huwa ndikat biex inaqqas l- inċidenza, t- tul u s- severità ta ’ mukosite orali f’ pazjenti b’ tumuri ematoloġiċi malinni li qed jirċievu terapija mijeloablattiva assoċjata ma ’ inċidenza għolja ta ’ mukosite severa u li teħtieġ appoġġ ta ’ ċelluli staminali emopojetiċi tal- pazjent innifsu.
Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Kura b’ Kepivance għandha tiġi sorveljata minn tabib b’ esperjenza fl- użu ta ’ terapija kontra l- kanċer.
The recommended dosage of Kepivance is 60 micrograms/ kg/ day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative therapy for a total of six doses (see below).
Id- dożaġġ rakkomandat ta ’ Kepivance huwa ta ’ 60 mikrogramma/ kg/ kuljum, mogħti bħala injezzjoni bolus ġol- vini għal tlett ijiem konsekuttivi qabel u tlett ijiem konsekuttivi wara terapija mijeloablattiva għal total ta ’ sitt dożi (ara isfel).
Kepivance should not be administered subcutaneously due to poor local tolerability.
Kepivance m’ għandux jingħata taħt il- ġilda minħabba tollerabilità lokali baxxa.
Reconstituted Kepivance should not be left at room temperature for more than one hour, and should be protected from light.
Kepivance rikostitwit m’ għandux jitħalla f’ temperatura tal- kamra għal aktar minn siegħa, u għandu jiġi protett mid- dawl.
Prior to administration, visually inspect the solution for discolouration and particulate matter before administration, see section 6.6.
Qabel l- għotja, spezzjona viżwalment is- soluzzjoni għal xi bidla fil- kulur u frak qabel l- għotja, ara sezzjoni 6. 6.
Pre- myeloablative therapy:
Terapija pre - mijeloablattiva:
The first three doses should be administered prior to myeloablative therapy, with the third dose 24 to 48 hours before myeloablative therapy.
L- ewwel tliet dożi għandhom jingħataw qabel it- terapija mijeloablattiva, bit- tielet doża 24 sa 48 siegħa qabel it- terapija mijeloablattiva.
Post- myeloablative therapy:
Terapija post - mijeloablattiva:
The last three doses should be administered post myeloablative therapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least four days after the most recent Kepivance administration.
L- aħħar tliet dożi għandhom jingħataw wara t- terapija mijeloablattiva; l- ewwel waħda ta ’ dawn id- dożi għandha tingħata wara, iżda fl- istess ġurnata ta ’ l- infużjoni taċ- ċelluli staminali ematopojetiċi u ta ’ l- inqas erbat ijiem wara l- għotja l- aktar reċenti ta ’ Kepivance.
2 Children and adolescents
2 Tfal u adolexxenti
The safety and efficacy of Kepivance in children and adolescent patients have not been established, Kepivance should not be used in children or adolescents until further data become available.
Kepivance m’ għandux jintuża fi tfal u adolexxenti sakemm ma jkunx disponibbli aktar tagħrif.
Dose adjustment in patients with renal impairment is not necessary (see section 5.2).
Mhux meħtieġ aġġustament fid- doża f’ pazjenti b’ indeboliment renali (ara sezzjoni 5. 2).
Hepatic impairment
Indeboliment epatiku
Safety and efficacy has not been evaluated in patients with hepatic impairment (see section 5.2).
Is- sigurtà u l- effikaċja ma ġewx evalwati f’ pazjenti b’ indeboliment epatiku (ara sezzjoni 5. 2).
Safety and efficacy has not been evaluated in the elderly (see section 5.2).
Is- sigurtà u l- effikaċja ma ġewx evalwati fl- anzjani (ara sezzjoni 5. 2).
Hypersensitivity to palifermin or to any of the excipients, or to Escherichia coli-derived proteins.
Sensittività eċċessiva għal palifermin jew għal xi sustanzi mhux attivi, jew għall- proteini ġejjn minn Escherichia coli.
Kepivance should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of cytotoxic chemotherapy.
Kepivance m’ għandux jingħata sa 24 siegħa qabel, waqt jew wara 24 siegħa mill- għotja b’ infużjoni ta ’ kimoterapija ċitotossika.
In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in an increased severity and duration of oral mucositis.
Fi prova klinika, l- għotja ta ’ Kepivance sa 24 siegħa mill- kimoterapija wasslet għal żieda fis- severità u t- tul tal- mukosite orali.
If heparin is used to maintain an intravenous line, sodium chloride solution should be used to rinse the line prior to and after Kepivance administration, see section 6.2.
Jekk eparina tintuża biex jinżamm pajp ġol- vina, għandha tintuża soluzzjoni ta ’ sodium chloride biex jitlaħlaħ il- pajp qabel u wara għotja ta ’ Kepivance, ara sezzjoni 6. 2.
KGF receptors are known to be expressed on the lens of the eye.
Huma magħrufa li riċetturi għal KGF huma espressi fil- lenti ta ’ l- għajn.
To date no evidence of an increase in lens opacities has been observed in patients treated with Kepivance in clinical studies.
S’ issa ma ġietx osservata evidenza ta ’ żieda f’ opaċitajiet fil- lenti f’ pazjenti kkurati b’ Kepivance fi studji kliniċi.
Long term effects are not yet known.
Effetti fit- tul għadhom mhux magħrufa.
The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies.
Is- sigurtà fit- tul ta ’ Kepivance għadha ma ġietx evalwata għal kollox f’ dak li għandu x’ jaqsam ma ’ sopravivenza totali, sopravivenza mingħajr progressjoni u tumuri malinni sekondarji.
Kepivance is a growth factor that stimulates the proliferation of KGF receptor expressing epithelial cells.
Kepivance huwa fattur tat- tkabbir li jistimola l- proliferazzjoni ta ’ ċelloli ta ’ l- epitilju li jesprimu riċettur għal KGF.
The safety and efficacy of Kepivance has not been established in patients with KGF receptor expressing non-haematological malignancies.
Is- sigurtà u l- effikaċja ta ’ Kepivance ma ġewx stabbiliti f’ pazjenti b’ tumuri malinni mhux ematoloġiċi li jesprimu riċettur għal KGF.
No interaction studies have been conducted with Kepivance.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low.
Bħala proteina terapewetika, ir- riskju li Kepivance ma jaqbilx ma ’ prodotti mediċinali oħra huwa baxx.
In-vitro and in-vivo data suggests that palifermin binds to unfractionated as well as low molecular weight heparins, which should be used with care in patients who are concomitantly administered palifermin.
Tagħrif in- vitro u in- vivo jissuġġerixxi li palifermin jeħel ma ’ eparini sħaħ kif ukoll ma ’ eparini b ’ piż molekulari baxx, li għandhom jintużaw b ’ attenzjoni f ’ pazjenti li qed jingħataw palifermin ukoll.
The clinical relevance is unclear.
Ir - rilevanza klinika mhix ċara.
There are no adequate data from the use of Kepivance in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Kepivance waqt it- tqala.
Studies in animals have shown reproductive and developmental toxicity (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva u l- iżvilupp (ara sezzjoni 5. 3).
The potential risk to the human embryo or foetus is unknown.
Mhux magħruf ir- riskju potenzjali għall- embriju jew fetu uman.
Kepivance should not be used during pregnancy unless clearly necessary.
Kepivance m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku.
3 It is not known whether Kepivance is excreted in human milk, therefore Kepivance should not be administered to women who are breast-feeding.
Mhux magħruf jekk Kepivance joħroġx fil- ħalib uman, għalhekk Kepivance m’ għandux jngħata lill - nisa li qed ireddgħu.
Safety data are based upon 650 patients with haematological malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study.
Tagħrif dwar is- sigurtà huwa bbażat fuq 650 pazjent b’ tumuri malinni ematoloġiċi li ddaħħlu fi 3 studji kliniċi randomised, ikkontrollati bil- plaċebo u fi studju farmakokinetiku.
Patients received Kepivance (n = 409) or placebo (n = 241) either before, or before and after, myelotoxic chemotherapy with or without total body irradiation and peripheral blood progenitor cell (PBPC) support.
Il- pazjenti rċevew Kepivance (n = 409) jew plaċebo (n = 241) qabel, jew qabel u wara, kemjoterapija mijelotossika bi jew bla irradjazzjoni tal- ġisem kollu u appoġġ ta ’ ċelluli proġenituri tad- demm periferali (PBPC).
Adverse reactions were consistent with the pharmacologic action of Kepivance on skin and oral epithelium (see Table 1).
Ir- reazzjonijiet avversi kienu konsistenti mal- azzjoni farmakoloġika ta ’ Kepivance fuq il- ġilda u l - epitilju orali (ara Tabella 1).
These reactions were primarily mild to moderate in severity and were reversible.
Dawn ir- reazzjonijiet ġeneralment kienu ħfief għal moderati fis- severità u kienu riversibbli.
Median time to onset was 6 days following the first of 3 consecutive daily doses of Kepivance, with a median duration of 5 days.
It- tul ta ’ żmien medjan għad- dehra kien ta ’ sitt ijiem wara l- ewwel mit- tlett dożi konsekuttivi ta ’ kuljum ta ’ Kepivance, b’ tul medjan ta ’ ħamest ijiem.
The adverse reactions of pain and arthralgia were consistent with Kepivance treated patients having received less opioid analgesia than placebo-treated patients (see Table 2).
Ir- reazzjonijiet avversi ta ’ uġigħ u atralġja kienu konsistenti mal- fatt li l- pazjenti kkurati b’ Kepivance rċevew inqas analġeżiċi opojdi minn pazjenti kkurati bil- plaċebo (ara Tabella 2).
Adverse reactions occurring with ≥ 5% higher incidence with Kepivance compared to placebo
Reazzjonijiet avversi li seħħew b’ inċidenza ogħla minn ≥ 5% b’ Kepivance meta mqabbel mal- plaċebo
System organ class
Sistema tal- klassifika tal- organi
Undesirable effect Very common (> 1/ 10)
Effett mhux mixtieq Komuni ħafna (> 1/ 10)
Nervous system disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders General disorders and administration site conditions
Disturbi fis- sistema nervuża Disturbi gastro- intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeletrali u tal- connective tissue Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Taste perversion Mouth/ tongue thickness or discolouration Rash, pruritus and erythema Arthralgia Oedema, pain and fever
Perverżjoni tat- togħma Ħxuna jew telf ta ’ kulur tal- ħalq/ ilsien Raxx, ħakk u eritema Artralġja Edima, uġigħ u deni
Kepivance or placebo, and there were no observed differences in disease progression or survival.
L- irkupru ematopojetiku wara infużjoni b’ PBPC kien simili bejn pazjenti li rċevew Kepivance jew plaċebo, u ma kienet osservata l- ebda differenza fil- progressjoni tal- marda jew fis- sopravivenza.