qanastek/EMEA-V3 huggingface dataset:
The overall M
Barra minn hekk, ma kienx hemm evidenza li l- effiċenza tat- trattament tnaqqset waqt il- prova klinika.
incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Il- frekwenza ta 'effetti avversi kellha t - tendenza li tonqos meta tkompla l- istudju, b’ mod indipendenti mill- età tagħhom.
Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
t za wara li tacrolimus ingwent jiġi applikat b’ mod topiku fuq il- ġilda, u, jekk il- livell ikun tant li jista 'jitkejjel, dan ikun biss għal żmien qasir.
16 Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
to wara applikazzjoni b’ mod topiku, ta 'darba jew iktar, ta' tacrolimus ingwent fuq il- ġilda.
Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03 - 0.1%), and infants from age of 5 months treated with tacrolimus ointment (0.03%) had blood concentrations < 1.0 ng/ ml.
aw Ħafna mill- pazjenti li jbatu minn dermatite atopika (kbar u żgħar) kkurati b’ applikazzjoni waħda jew ripetuta ta ’ ingwent tacrolimus (0. 03 - 0. 1%), kif ukoll trabi minn ħames xhur ikkurati bl- ingwent tacrolimus (0. 03%) kellhom konċentrazzjonijiet fid- demm ta ’ < 1. 0 ng/ ml.
However, both the extent and the rate of topical absorption of tacrolimus decrease as the skin heals.
du ukoll ir- rata ta ’ assorbiment ta ’ tacrolimus jonqsu aktar ma tfiq il- ġilda.
AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
AUC) ta ’ tacrolimus minn Protopy ħa hu madwar 30% inqas minn dak ta 'mediċina immunosuppressiva li tingħata mill- ħalq lill pazjenti li kellhom trapjant ta' kilwa jew fwied.
The lowest tacrolimus blood concentration at which systemic
Mhux magħruf kemm hi l- anqas konċentrazzjoni fid- demm li biha jkun hemm effett ġenerali fis- sistema tal- ġisem. ’ g Ma kienx hemm evidenza ta 'akkumulazzjoni ta' tacrolimus fid- demm wara trattament ta 'pazjenti (kbar m
There was no evidence of systemic accumulation of tacrolimus in patients (adults and children) treated for prolonged periods (up to one year) with tacrolimus ointment.
u tfal) b 'tacrolimus ingwent għal żmien twil (sa sena).
is or Distribution As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to
Distribuzzjoni li
Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin
Minħabba li meta tacrolimus ingwent ma jwassalx għal esponiment għoli fiċ- ċirkolazzjoni, l- irbit li
au with minimal diffusion into the systemic circulation.
qawwi ta ’ tacrolimus (> 98. 8%) mal- proteini tal- plażma mhuwiex meqjus bħala wieħed ta ’ rilevanza a
Metabolism
klinika. in
er Metabolism of tacrolimus by human skin was not detectable.
Metaboliżmu L- ammont ta ’ tacrolimus li jiġi metabolizzat mill- ġilda ma setgħax jitkejjel.
Systemically available tacrolimus is extensively metabolised in the liver via CYP3A4.
Fid- demm, tacrolimus jiġi metabolizzat bil- qawwa fil- fwied permezz ta ’ CYP3A4. tm
Elimination ng lo When administered intravenously, tacrolimus has been shown to have a low clearance rate.
Il- clearance ot
The average total body clearance is approximately 2.25 l/ h.
totali mill- ġisem hi bejn wieħed u ieħor 2. 25 l/ h.
The hepatic clearance of systemically available no
Ir- rata tal- clearance ta ’ tacrolimus fid- demm mill - fwied tista tonqos f’ pazjenti li jsofru minn indeboliment tal- fwied, jew inkella jekk il- pazjenti ikunu od
tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are co- treated with drugs that are potent inhibitors of CYP3A4.
jieħdu mediċini li jinibixxu bil- qawwa s- CYP3A4.
Following repeated topical application of the ointment the average half-life of tacrolimus was ct
Meta l- ingwent jiġi applikat ripetutament il- medja tal- half life ta 'tacrolimus kienet stmata li tkun 75 Pr
estimated to be 75 hours for adults and 65 hours for children. du
siegħa fil- kbar u 65 siegħa fit- tfal.
5.3 Preclinical safety data ro
17 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Tossiċità minn dożi ripetuti u tolleranza lokali Meta tacrolimus ingwent jew il- komponenti bażi ta ’ l- ingwent jingħataw ripetutament fuq il- ġilda ta 'firien, fniek u fniek ta ’ l- indja wieħed jista' jara tibdil ħafif tal- ġilda bħal ħmura, edema jew ponot (papules).
The changes were caused by high systemic exposure of a
Meta tacrolimus ingħata fit- tul fuq il- ġilda tal- firien, dawn kellhom sinjali ta 'tossiċità fis- sistema ġenerali b' tibdil fil- kliewi, pankrejas, għajnejn u s- sistema nervuża.
Slightly lower body weight gain in in
Dan it- tibdil seħħ minħabba l - esponiment għoli fiċ- ċirkolazzjoni tal- firien li rriżultat mill- assorbiment għoli ta ’ tacrolimus minn ġol - ġilda.
females was the only systemic change observed in micropigs at high ointment concentrations (3%). ic
Fil- fniek ta ’ l- indja l- unika bidla kienet li l- fniek ta ’ sess femminili żdiedu fil- piż b’ rata aktar baxxa meta l- ingwent ġie applikat b 'konċentrazzjonijiet għoljin (3%).
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed. ed
t za Il- fniek dehru li kienu speċjalment sensittivi għal tacrolimus mogħti b’ injezzjoni fil- vina, għax kellhom effetti kardjotossiċi reversibbli.
In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
riz Tibdil fil- geni (mutagenicity) Testijiet in vitro u in vivo ma wrewx li tacrolimus għandu xi effett ħażin fuq il- ġeni.
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
to aw Kanċeroġeniċità Studji sistemiċi kanċeroġeniċi fuq ġrieden (18 xahar) u firien (24 xahar) urew li tacrolimus m’ għandux potenzjal kanċeroġenu.
In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
x ingwent 0. 1%, ma dehrux tumuri tal- ġilda.
In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
Fl- istess studju, il- każijiet ta 'limfoma żdiedu meta l -
In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Fi studju dwar il- fotokanċeroġeniċità, tacrolimus ingwent u raġġi ta ’ l- UV ingħataw f’ daqqa għal ħa żmien twil ħafna fuq ġrieden albino bla xaghar.
It is unclear whether the effect of tacrolimus is due to systemic immunosuppression or a local effect.
kollox għax il- potenzjal għal immunosuppressjoni lokali meta jintuża fit- tul l- ingwent tacrolimus għadu mhux magħruf. li
The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of tacrolimus ointment is unknown.
Kien hemm effett ħazin fuq l- embrijoni/ feti ta 'fniek u firien biss, meta d- doża ta' tacrolimus kienet a
Reproduction toxicity Embryo/ foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Tnaqqis fil- funzjoni ta ’ l- isperma dehret f’ firien ta ’ sess maskili b’ dożi in
Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
għolja mogħtija taħt il- ġilda. iċ ed
ed 6.1 List of excipients
6. 1 Lista ta 'sustanzi mhux attivi tm
is White soft paraffin
White soft paraffin Liquid paraffin ot
or Liquid paraffin Propylene carbonate
Propylene carbonate White beeswax od
th White beeswax Hard paraffin
Hard paraffin Pr
au 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
er Not applicable.
Ma jghoddx f' dan il- każ.
6.3
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years no
3 snin
Do not store above 25°C. ct
Taħżinx f' temperatura 'l fuq minn 25°C.
6.5 Nature and contents of container du
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene ro
Tubu li fuq ġewwa għandu saff ta 'low density polyethylene u li għandu kappa bajda b’ kamin tal - propylene.
Not all pack sizes may be marketed. a
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall -
6.6 Special precautions for disposal in
za 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
No special requirements. ic
riz L- ebda ħtiġijiet speċjali.
Any unused product or waste material should be disposed of in accordance with local requirements. ed
to jitolbu l- liġijiet lokali
MARKETING AUTHORISATION HOLDER M
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Astellas Pharma GmbH Neumarkter Str.
x Astellas Pharma GmbH
61 D-81673 München Germany
61 D- 81673 München ħa Il- Ġermanja ’ g 8.
MARKETING AUTHORISATION NUMBERS
NUMRI TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ m
EU/ 1/ 02/ 202/ 003 EU/ 1/ 02/ 202/ 004 18 EU/ 1/ 02/ 202/ 006
EU/ 1/ 02/ 202/ 004 EU/ 1/ 02/ 202/ 006 li a in
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI iċ
28/ 02/ 2002 Date of renewal:
28/ 02/ 2002 ed
20/ 11/ 2006
20/ 11/ 2006 tm
ed {DD/ MM/ YYYY}
{XX/ SSSS} ot od
or Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu Pr
19 ed is or th au er ANNEX II
19 t za riz to aw x du ANNESS II ħa
A. ng MANUFACTURING AUTHORISATION HOLDER lo RESPONSIBLE FOR BATCH RELEASE no
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - ’ g LOTT m
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - li
a
TQEGĦID FIS- SUQ li a in iċ ed tm ot od Pr
in ic ed M
20 A.
ed B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
riz • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product
to aw Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
th Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2
au • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU
er Not applicable.
x MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
ng lo no ct du ro ed M
du Ma jgħoddx f’ dan il- każ. ħa ’ g m li li a in iċ ed tm ot od Pr
21 ed is or th au er ANNEX III ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
21 t za riz to aw x du ANNESS III ħa TIKKETTA U FULJETT TA 'TAGĦRIF ’ g m li li a in iċ ed tm ot od Pr
22 M ed ic in alp ro du ct
22 Pr od ot tm ed iċ in ali
23 no
23 li m A.
ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA ’ g ħa du x aw to riz za t TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PROTOPY 0. 03% INGWENT (10 g, 30 g, 60 g KARTUN)
Protopy 0.03% Ointment Tacrolimus monohydrate
Protopy 0. 03% Ingwent Tacrolimus monohydrate
is 1 g ointment contains:
riz 1 g ingwent fih:
or th 3.
to aw 3.
au white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
er 4.
x du 4.
Ointment 10 g 30 g
GĦAMLA FARMAĊEWTIKA U KONTENUT ħa Ingwent ’ g 10 g m
60 g
30 g 60 g li li
METHOD AND ROUTE OF ADMINISTRATION du
MOD TA 'KIF U MNEJN JINGĦATA a in
Cutaneous use ro
Użu għall- ġilda iċ
Read the package leaflet before use. lp
Aqra l- fuljett ta ’ tagħrif qabel l- użu. ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT a
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA tm
OF THE REACH AND SIGHT OF CHILDREN in
JINTLAĦAQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children. ic ed
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. ot od
OTHER SPECIAL WARNING(S), IF NECESSARY M
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA Pr
ed Germany
za D- 81673 München Il- Ġermanja
is 12.
riz to 12.
th EU/ 1/ 02/ 202/ 001 30 g EU/ 1/ 02/ 202/ 002 60 g
aw EU/ 1/ 02/ 202/ 005 10 g EU/ 1/ 02/ 202/ 001 30 g EU/ 1/ 02/ 202/ 002 60 g
au 13.
x du 13.
er Lot:
ħa Lott:
{number} ng lo 14.
{numru} ’ g 14.
GENERAL CLASSIFICATION FOR SUPPLY no
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA m
Medicinal product subject to medical prescription. ct
Prodott mediċinali jingħata bir- riċetta tat- tabib. li li
INSTRUCTIONS ON USE du
STRUZZJONIJIET DWAR L- UŻU a in iċ
INFORMATION IN BRAILLE ro lp
INFORMAZZJONI BIL- BRAILLE ed
Protopy 0.03% a in ic ed M
Protopy 0. 03% tm ot od Pr
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻAGĦAR EWLENIN
PROTOPY 0.03% OINTMENT (10 g TUBE)
PROTOPY 0. 03% INGWENT (10 g TUBU)
Protopy 0.03% Ointment Tacrolimus monohydrate Cutaneous use
Protopy 0. 03% Ingwent Tacrolimus monohydrate
ed is 2.
za riz 2.
or Read the package leaflet before use.
to Aqra l- fuljett ta ’ tagħrif qabel l- użu.
au EXP:
x JIS:
er 4.
du 4.
BATCH NUMBER
NUMRU TAL- LOTT ħa Lott:
{number} ng lo no
{numru} ’ g m
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI li
10 g ct du
10 g li a
OTHER ro
OĦRAJN in iċ
Do not store above 25°C. a
Taħżinx f' temperatura 'l fuq minn 25°C. tm
61 D-81673 München ic
61 D- 81673 München ot
Germany ed
Il- Ġermanja od
EU/ 1/ 02/ 202/ 005 M
EU/ 1/ 02/ 202/ 005 Pr
PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
PROTOPY 0. 03% INGWENT (30 g, 60 g TUBU)
PHARMACEUTICAL FORM AND CONTENTS
GĦAMLA FARMAĊEWTIKA U KONTENUT ħa Ingwent ’ g 30 g m
Ointment 30 g 60 g
60 g li
METHOD AND ROUTE OF ADMINISTRATION ct du
MOD TA 'KIF U MNEJN JINGĦATA li a
Cutaneous use ro
Użu għall- ġilda in
Read the package leaflet before use. lp
Aqra l- fuljett ta ’ tagħrif qabel l- użu. iċ ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN a in
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL tm
Keep out of the reach and sight of children. ic ed
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. ot
OTHER SPECIAL WARNING(S), IF NECESSARY M
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA od Pr
ed Germany
t D- 81673 München
is 12.
riz 12.
or EU/ 1/ 02/ 202/ 001 30 g
to EU/ 1/ 02/ 202/ 001 30 g
th EU/ 1/ 02/ 202/ 002 60 g
aw EU/ 1/ 02/ 202/ 002 60 g
au 13.
x 13.
er Lot:
du Lott:
14.
ħa 14.
GENERAL CLASSIFICATION FOR SUPPLY ng lo Medicinal product subject to medical prescription. no
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA ’ g Prodott mediċinali jingħata bir- riċetta tat- tabib. m li
INSTRUCTIONS ON USE ct du ro
STRUZZJONIJIET DWAR L- UŻU li a in iċ ed tm ot od Pr
PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
PROTOPY 0. 1% INGWENT (10 g, 30 g, 60 g KARTUN)
Protopy 0.1% Ointment Tacrolimus monohydrate
Protopy 0. 1% Ingwent Tacrolimus monohydrate
th EU/ 1/ 02/ 202/ 003 30 g EU/ 1/ 02/ 202/ 004 60 g
aw EU/ 1/ 02/ 202/ 006 10 g EU/ 1/ 02/ 202/ 003 30 g EU/ 1/ 02/ 202/ 004 60 g
Protopy 0.1% a in ic ed M
Protopy 0. 1% tm ot od Pr
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻAGĦAR EWLENIN
PROTOPY 0.1% OINTMENT (10 g TUBE)
PROTOPY 0. 1% INGWENT (10 g TUBU)
Protopy 0.1% Ointment Tacrolimus monohydrate Cutaneous use
Protopy 0. 1% Ingwent Tacrolimus monohydrate
er 4.
du ħa 4.
10 g ct du
10 g li a in
OTHER ro
OĦRAJN iċ
EU/ 1/ 02/ 202/ 006 M
EU/ 1/ 02/ 202/ 006 Pr
31 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
PROTOPY 0.1% OINTMENT (30 g, 60 g TUBE)
PROTOPY 0. 1% INGWENT (30 g, 60 g TUBU)
Cutaneous use
Użu għall- ġilda in
Read the package leaflet before use. ro lp
Aqra l- fuljett ta ’ tagħrif qabel l- użu. iċ ed
ed is 12.
za Il- Ġermanja
or EU/ 1/ 02/ 202/ 003 30 g EU/ 1/ 02/ 202/ 004 60 g
aw EU/ 1/ 02/ 202/ 004 60 g
th au 13.
x 13.
Lot:
du Lott:
er 14.
ħa 14.
Medicinal product subject to medical prescription. no
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA ’ g Prodott mediċinali jingħata bir- riċetta tat- tabib. m li
33 M ed ic in alp ro du ct
33 Pr od ot tm ed iċ in ali
34 no
34 li m
ng er au th or is ed PACKAGE LEAFLET:
ħa du x aw to riz za t FULJETT TA ’ TAGĦRIF:
Protopy 0.03% Ointment Tacrolimus monohydrate
Protopy 0. 03% ingwent Tacrolimus monohydrate
ed please tell your doctor or pharmacist.
za imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
is In this leaflet:
riz F' dan il- fuljett:
What Protopy is and what it is used for 2.
to 2.
Before you use Protopy
Qabel ma 'tuża Protopy
Possible side effects
Kif għandek tuża Protopy 4.
au 5.
Effetti sekondarji li jista ’ jkollu 5.
How to store Protopy 6.
Kif taħżen Protopy 6.
er 1.
x du 1.
WHAT PROTOPY IS AND WHAT IT IS USED FOR ng The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent. lo Protopy 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who no
X' INHU PROTOPY U GĦALXIEX JINTUŻA ħa Is- sustanza attiva ta ’ Protopy, tacrolimus monohydrate, huwa aġent immuno- modulatorju. ’ g L- ingwent Protopy 0. 03% jintuża biex jikkura dermatite atopika moderata għal severa (ekżema) fil - m
are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
kbar li ma jkunux adegwatament responsivi għal jew intolleranti mill- kuri konvenzjonali bħala ma huma il- kortikosterojdi topikali u fit- tfal (ta ’ sentejn jew akbar) li kura konvenzjonali bħalama huma il - kortikosterojdi topikali ma ħadmitx fuqhom biżżejjed.
In atopic dermatitis, an over-reaction of the ct
Fid - dermatite atopika, reazzjoni żejda tas - li
skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
sistema immunitarja tal- ġilda toħloq infjammazzjoni tal- ġilda (ħakk, ħmura, nixfa).
Protopy alters the abnormal immune response and relieves the skin inflammation and the itch. du ro
respons immunitarju anormali u jserraħ l- infjammazzjoni tal- ġilda kif ukoll il- ħakk. a in
BEFORE YOU USE PROTOPY lp
QABEL MA 'TUŻA PROTOPY iċ
Do not use Protopy
Tużax Protopy ed
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to
- Jekk int allerġiku (għandek sensitività eċċessiva) għal tacrolimus jew xi wieħed mill- ingredjenti
macrolide antibiotics (e. g. azithromycin, clarithromycin, erythromycin). in
oħra ta ’ Protopy jew ta ’ l - antibijotiċi macrolide (eż. azithromycin, clarithromycin, erythromycin). tm
Take special care with Protopy ic
Oqgħod attent ħafna b' Protopy
- Protopy ointment is not approved for children younger than 2 years of age.
- L- ingwent Protopy mhux approvat għat- tfal iżgħar minn (2) sentejn.
Please consult your doctor. ed
Jekk jogħġbok ikkonsulta t- tabib tiegħek. od
- The effect of treatment with Protopy on the developing immune system in children, especially
- L- effett ta 'Protopy fuq is- sistema immunitarja ta' tfal żgħar għadu ma ġiex stabbilit.
the young, has not been established.
- Is- sigurtà ta l- użu ta ’ Protopy fit- tul mhux magħrufa.
M
Numru żgħir minn dawk li użaw l- ingwent
- The safety of using Protopy for a long time is not known.
Protopy kellhom il- malinjitajiet (bħal, fil- ġilda jew limfoma).
A very small number of people who
Madankollu ma nstabitx ir- rabta Pr
have used Protopy ointment have had malignancies (for example, skin or lymphoma).
mal- kura bl- ingwent Protopy.
Talk to your doctor before using Protopy.
- Jekk il- fwied tiegħek mhux jaħdem tajjeb, kellem it- tabib qabel ma tuża Protopy.
- Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or
- Jekk tara li għandek xi malinjitajiet fil- ġilda (tumuri) jew jekk is- sistemi immunitarja tiegħek
if you have a weakened immune system (immuno-compromised) whatever the cause.
tkun fjakka (immuno- kompromessa) tkun xi tkun ir- raġuni, kellem ukoll lit- tabib tiegħek qabel ma tuża Protopy
Talk to your doctor before using Protopy.
erythroderma ġeneralizzata (il- ġilda infjammata, ħamra u titqaxxar) kellem it- tabib qabel ma tuża Protopy.
your lymph nodes become swollen during treatment with Protopy, consult your doctor.
Jekk il- glandoli tas- sistema limfatika jintefħu waqt trattament b' Protopy, kellem lit - tabib.
- Before receiving a vaccination tell your doctor that you are using Protopy.
- Qabel ma titlaqqam għid lit- tabib li qed tuża Protopy.
not be given during treatment and for a certain time after treatment with Protopy.
trattament b' Protopy u għal ċertu żmien wara trattament b' Protopy.
you spend time outdoors after applying Protopy, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Jekk toħroġ fix- xemx wara li tkun dlikt Protopy uża sunscreen u ilbes ħafif b' mod li l- ħwejjeġ jagħtuk protezzjoni mix- xemx.
If you are prescribed light therapy, inform your doctor that you are using Protopy as it is not recommended to use Protopy and light therapy at the same time.
Jekk qed tingħata trattament tad- dawl, għid lit- tabib,
ed
t za għax ma tistax tuża Protopy f' l- istess ħin ma 'trattament tad- dawl.
- Avoid contact with the eyes or mucous membranes (inside of your nose or mouth).
- Evita kuntatt ta 'Protopy ma' l- għajnejn u ma 'partijiet tal- ġisem bħan- naħa ta' ġewwa tal- ħalq
Taking or using other medicines and cosmetics
Meta tieħu jew tuża mediċini u kosmetiċi oħra
is Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
to Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi
or including medicines obtained without a prescription.
aw mediċini oħra, anki dawk mingħajr riċetta.
th You may use moisturising creams and lotions during treatment with Protopy but these products should not be used within two hours of applying Protopy.
Mal- kura ta ’ Protopy tista ’ tuża xi dlik rinfreskanti jew lozzjonijiet iżda dawn il- prodotti ma għandhomx jintużaw qabel ma jgħaddu sagħtejn minn meta tkun użajt Protopy.
au The use of Protopy at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e. g. cortisone) or medicines which affect the immune system has not been studied.
x du Ma sarx studju dwar l- użu ta ’ Protopy flimkien ma ’ preparazzjonijiet oħra għal fuq il- ġilda jew waqt li jittieħdu\ il- kortikosterojdi (eż. cortisone) mill- ħalq jew mediċini li jistgħu jolqtu s- sistema ħa immunitarja.
er Before receiving a vaccination tell your doctor that you are using Protopy (see Section “ Take special care with Protopy”). ng lo Using Protopy with food and drink While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel no
Qabel ma tieħu xi titqiba fakkar lit- tabib tiegħek li qed tieħu Protopy (ara Sezzjoni “ Oqgħod attent ’ g b’ Protopy ”). m
hot.
Meta tuża Protopy ma ’ l- ikel u max- xorb Meta tixrob alkoħol waqt li tkun qed tuża Protopy il- ġilda jew il- wiċċ jistgħu jiħmaru u jisħnu. li li
Pregnancy and breast-feeding ct
Tqala u Treddigħ a
Don’ t use Protopy if you are pregnant or breast-feeding.
Tiħux Protopy jekk tqila jew qed tradda ’. in
Ask your doctor or pharmacist for advice before taking any medicine. du ro
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina. iċ ed
HOW TO USE PROTOPY lp
KIF GĦANDEK TUŻA PROTOPY
Always use Protopy exactly as your doctor has told you.
Dejjem għandek tuża Protopy skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure. a
Dejjem għandek taċċerta ruħek mat- tabib jew tm
Apply Protopy as a thin layer to affected areas of your skin. in ic
Idlek Protopy ħafif fuq il- parti tal- ġilda li hi marida. ot
Protopy may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees. ed
Protopy jista 'jintuża kważi fil- partijiet kollha tal- ġisem, inklużi l- wiċċ u l- għonq kif ukoll il- minkeb u od
If the ointment gets on any of M
Pr
these areas, it should be thoroughly wiped off and/ or rinsed off with water.
Jekk jiġri dan, wieħed għandu jimsaħ l- ingwent u jlaħlaħ il- parti bl- ilma.
Wash your hands after applying Protopy unless your hands are also being treated.
Aħsel idejk wara użu ta 'Protopy jekk mhux qed tuża Protopy għall- ġilda ta' jdejk.
Before applying Protopy after a bath or shower, be sure your skin is completely dry.
Qabel ma tapplika Protopy wara banju jew doċċa, ħu ħsieb li l- ġilda tkun niexfa.
36 Children (2 years of age and older) Apply Protopy twice a day for up to three weeks, once in the morning and once in the evening.
36 Idlek Protopy darbtejn kuljum għal tliet ġimgħat, darba filgħodu u darba filgħaxija.
Adults (16 years of age and older) Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Kbar (16 il- sena u akbar) Għal- kbar Protopy jinstab f' żewġ konċentrazzjonijiet (Protopy 0. 03% u Protopy 0. 1% ingwent).
Usually, treatment is started with Protopy 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared.
It- trattament tibda s- soltu b' Protopy 0. 1% ingwent darbtejn kuljum, darba filgħodu u darba filgħaxija, sakemm il- ħmura ittaffi.
If symptoms reappear, treatment with Protopy 0.1% twice a day should be restarted.
Jekk is- sintomi jerġgħu jiġu, wieħed jerġgħa jibda trattament b' Protopy 0. 1% darbtejn kuljum.
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the
Wara dan iz- żmien jintuża Protopy 0. 03% ingwent darbtejn kuljum.
ed lower strength, Protopy 0.03% ointment, can be used.
It- tabib tiegħek jiddeċidi fuq il- frekwenza ta ’ l- użu skond kif ittaffi il - ħmura tal- ġilda jew jista 'jintuża Protopy ingwent ta' 0. 03%.
Improvement is usually seen
t za Uża t- trattament fuq il- parti marida tal- ġilda sakemm ittaffi l- ħmura.
is within one week.
Is- soltu l- ġilda ssir aħjar f’ perijodu ta 'ġimgħa.
If you do not see any improvement after two weeks, see your doctor about other
Jekk wara ħmistax ma jkunx hemm tibdil għal- aħjar, kellem lit- tabib biex jara
or possible treatments.
riz hemmx bżonn ta 'trattament oħra.
Treatment with Protopy may be repeated if symptoms reappear.
Protopy jista 'jerġa jintuża jekk is- sintomi jerġgħu jidhru.
Do
Jekk forsi b' aċċident tibla ftit ingwent
au not try to induce vomiting.
Tipprovax tirremetti.
If you forget to use Protopy
aw Jekk tinsa tuża Protopy Jekk tinsa tuża Protopy fil- ħin li jmissek, użaħ kif tiftakar u kompli bħas- soltu.
er If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before. ng If you have any further questions on the use of this product, ask your doctor or pharmacist. lo no
x Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
4.
du ħa 4.
Like all medicines, Protopy can cause side effects, although not everybody gets them. ct
Bħal kull mediċina oħra, Protopy jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd. ’ g m
Approximately half of the patients who use Protopy have some type of skin irritation where they have du
Bejn wieħed u ieħor nofs il- pazjenti li jużaw Protopy ikollhom xi ftit irritazzjoni tal- ġilda fil- parti fejn japplikaw l- ingwent.
Other common ro
Dawn is- sintomi huma ħfief għal moderati u ġeneralment jgħaddu wara xi ġimgħa li jintuża Protopy.
(> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections lp
Effetti oħra li huma komuni (> 1%) li
(e. g. cold sores, generalised herpes simplex infections).
infjammazzjoni tax- xagħar u infezzjoni bil- virus ta 'herpes (ħżiża lokalizzata jew ġeneralizzata). a
Acne is an uncommon side effect.
L- akne mhux effett in
also been reported.
komuni ta 'Protopy.
Since commercial availability a very small number of people who have used Protopy ointment have in
Mindu sar jinxtara kummerċjalment numru żgħir ta ’ nies li użaw l- ingwent Protopy kellhom iċ
had malignancies (for example, skin or lymphoma).
malinjitajiet (bħal fil- ġilda jew ukoll limfoma).
However, a link to Protopy ointment treatment has ic
Madankollu fuq it- tagħrif kollu miksub s’ issa, la ed
not been confirmed or refuted on the available evidence so far. ed
kkonferma u lanqas innega rabta mal- kura ta ’ l- ingwent Protopy.
M
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. ot
HOW TO STORE PROTOPY
KIF TAĦŻEN PROTOPY od
Do not use Protopy after the expiry date which is stated on the tube and carton after EXP.
Tużax Protopy wara d- data ta ’ skadenza li tidher fuq it- tubu u ta 'fuq il- kaxxa wara JIS.
What Protopy contains
37 X’ fih Protopy
One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Gramma waħda ta 'Protopy 0. 03% ingwent fiha 0. 3 mg tacrolimus (bħala tacrolimus monohydrate).
It is supplied in tubes containing 10, 30 or 60 grams of ointment.
Id- Dehra tal- prodott u d- daqs tal- pakkett Protopy hu ingwent abjad ikanġi fl- isfar li jiġi f' tubi ta '10, 30 jew 60 grammi ta ’ ingwent.
Not all pack sizes may be marketed.
Dawn it- tubi mhux bilfors kollha jinstabu għall- użu kummerċjali.
Protopy is available in two strengths (Protopy 0.03%
Protopy jinstab f' żewġ konċentrazzjonijiet
ed and Protopy 0.1% ointment).
t za (Protopy 0. 03% u Protopy 0. 1% ingwent).
Marketing Authorisation Holder:
riz Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
61, D-81673 München,
61, D- 81673 München, Il- Ġermanja.
or Manufacturer:
to Manifattur:
th For any information about this medicinal product, please contact the local representative of the
aw Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
België/ Belgique/ Belgien
x België/ Belgique/ Belgien
er Astellas Pharma B. V.
du Astellas Pharma B. V.
Branch Erasmus Park/ Parc Erasme ng Square Marie Curie 50 B-1070 Brüssel/ Bruxelles
Branch Erasmus Park/ Parc Erasme ħa
Tél/ Tel: +32 (0)2 5580737
Square Marie Curie 50 B- 1070 Brüssel/ Bruxelles Tél/ Tel: +32 (0) 2 5580737
no
’ g
ct
li
du
li
Astellas Pharma
Astellas Pharma
s. r. o. lp
s. r. o. ed
Meteor Centre Office Park Sokolovskà 100/ 94 a
Meteor Centre Office Park Sokolovskà 100/ 94 CZ- 18600 Praha 8 tm
Danmark Astellas Pharma a/ s ed
Danmark ot
Naverland 4 DK-2600 Glostrup M
Astellas Pharma a/ s Naverland 4 od
Tlf: +45 43 430355
DK- 2600 Glostrup Tlf: +45 43 430355 Pr
Deutschland Astellas Pharma GmbH Neumarkter Str.
Norge Deutschland Astellas Pharma GmbH Neumarkter Str.
39 Eesti Österreich AS Sirowa Tallinn Salve 2c EE-11612 Tallinn Tel: +372 6 830700
Eesti AS Sirowa Tallinn Salve 2c
Linzer Straße 221/ E02 A-1140 Wien Tel: +43 (0)1 8772668
Linzer Straße 221/ E02
or Paseo del Club Deportivo n° 1 Bloque 14-2a
t za Paseo del Club Deportivo n° 1 Bloque 14- 2a
th E-28223 Pozuelo de Alarcón, Madrid Tel: +34 91 4952700
riz E- 28223 Pozuelo de Alarcón, Madrid Tel: +34 91 4952700
au France Astellas Pharma S. A. S.
to France
România Astellas Pharma International
România
er 114 rue Victor Hugo F-92300 Levallois Perret Tél: +33 (0)1 55917500
114 rue Victor Hugo F- 92300 Levallois Perret Tél: +33 (0) 1 55917500
Detalii de contact pentru Romania Calea Bucurestilor 283 ng Otopeni 075100 - RO Tel: +40 350 37 42
Astellas Pharma International Detalii de contact pentru Romania Calea Bucurestilor 283 Otopeni 075100 - RO
Ireland
du Ireland
Slovenija
Slovenija ħa
25, The Courtyard Kilcarbery Business Park, Clondalkin ct
25, The Courtyard Kilcarbery Business Park, Clondalkin
IRL-Dublin 22 Tel: +353 (0)1 4671555
IRL- Dublin 22
ro
li
lp
a
Via delle Industrie 1 I-20061 Carugate (Milano) ed
Via delle Industrie 1 I- 20061 Carugate (Milano) tm
Tel: +39 (0)2 921381 M
Tel: +39 (0) 2 921381
Εθνικής Οδού Αθηνών -Λαμίας GR-144 51, Μεταμόρφωση Αττικής Τηλ: + 30 210 2812640
Εθνικής Οδού Αθηνών- Λαμίας od
Sverige Astellas Pharma AB Haraldsgatan 5 S-41314 Göteborg Tel: +46 (0)31 7416160
Astellas Pharma AB Haraldsgatan 5
Lietuva UAB Sirowa Vilnius Š vitrigailos g.
Lietuva UAB Sirowa Vilnius
ed LT-03228 Vilnius Tel. +370 (5) 2394155
za LT- 03228 Vilnius Tel. +370 (5) 2394155
is or This leaflet was last approved in {MM/ YYYY}
riz Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
th Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
to aw Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu
au er ng lo no ct du ro ed M
x du ħa ’ g m li li a in iċ ed tm ot od Pr
41 PACKAGE LEAFLET:
40 FULJETT TA ’ TAGĦRIF:
Protopy 0.1% Ointment Tacrolimus monohydrate
Protopy 0. 1% ingwent Tacrolimus monohydrate
WHAT PROTOPY IS AND WHAT IT IS USED FOR ng The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent. lo Protopy 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are no
X' INHU PROTOPY U GĦALXIEX JINTUŻA ħa Is- sustanza attiva ta ’ Protopy, tacrolimus monohydrate, huwa aġent immuno- modulatorju. ’ g L- ingwent Protopy 0. 1% jintuża biex jikkura dermatite atopika moderata għal severa (ekżema) fil- kbar m
not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
li ma jkunux adegwatament responsivi għal jew intolleranti mill- kuri konvenzjonali bħala ma huma il - kortikosterojdi topikali.
In atopic dermatitis, an over-reaction of the skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
Fid - dermatite atopika, reazzjoni żejda tas- sistema immunitarja tal- ġilda toħloq li
inflammation and the itch. du
Protopy jibdel ir- respons immunitarju anormali u jserraħ l- infjammazzjoni tal- ġilda kif ukoll il- ħakk. li a in
BEFORE YOU USE PROTOPY ro
QABEL MA 'TUŻA PROTOPY iċ
Do not use Protopy lp
Tużax Protopy ed
macrolide antibiotics (e. g. azithromycin, clarithromycin, erythromycin). a
oħra ta ’ Protopy jew ta ’ l - antibijotiċi macrolide (eż. azithromycin, clarithromycin, erythromycin). tm
Take special care with Protopy in
Oqgħod attent ħafna b' Protopy
ic
ot
Please consult your doctor.
Jekk jogħġbok ikkonsulta t- tabib tiegħek. od
- The safety of using Protopy for a long time is not known.
- Is- sigurtà ta l- użu ta ’ Protopy fit- tul mhux magħrufa.
have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Protopy kellhom il- malinjitajiet (bħal, fil- ġilda jew limfoma).
However, a link to Protopy ointment treatment has not been shown.
Madankollu ma nstabitx ir- rabta mal- kura bl- ingwent Protopy.
- Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or
- Jekk il- fwied tiegħek mhux jaħdem tajjeb, kellem it- tabib qabel ma tuża Protopy.
if you have a weakened immune system (immuno-compromised) whatever the cause.
- Jekk tara li għandek xi malinjitajiet fil- ġilda (tumuri) jew jekk is- sistemi immunitarja tiegħek
Talk to your doctor before using Protopy.
tkun fjakka (immuno- kompromessa) tkun xi tkun ir- raġuni, kellem ukoll lit- tabib tiegħek qabel ma tuża Protopy
For live
trattament b' Protopy u għal ċertu żmien wara trattament b' Protopy.
In addition, ask your doctor for advice on other appropriate sun protection methods.
Jekk qed tingħata trattament tad- dawl, għid lit- tabib,
If you are prescribed light therapy, inform your doctor that you are using Protopy as it is not recommended to use Protopy and light therapy at the same time.
t za għax ma tistax tuża Protopy f' l- istess ħin ma 'trattament tad- dawl.
Taking or using other medicines and cosmetics Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
riz jew ta ’ l- imnieħer.
ed including medicines obtained without a prescription.
Meta tieħu jew tuża mediċini u kosmetiċi oħra
You may use moisturising creams and lotions during treatment with Protopy but these products should
to Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi
is not be used within two hours of applying Protopy.
aw mediċini oħra, anki dawk mingħajr riċetta.
or The use of Protopy at the same time as other preparations to be used on the skin or while taking oral
Mal- kura ta ’ Protopy tista ’ tuża xi dlik rinfreskanti jew lozzjonijiet iżda dawn il- prodotti ma għandhomx jintużaw qabel ma jgħaddu sagħtejn minn meta tkun użajt Protopy.
th corticosteroids (e. g. cortisone) or medicines which affect the immune system has not been studied.
x du Ma sarx studju dwar l- użu ta ’ Protopy flimkien ma ’ preparazzjonijiet oħra għal fuq il- ġilda jew waqt li jittieħdu\ il- kortikosterojdi (eż. cortisone) mill- ħalq jew mediċini li jistgħu jolqtu s- sistema ħa immunitarja.
au Before receiving a vaccination tell your doctor that you are using Protopy (see Section “ Take special care with Protopy”).
Qabel ma tieħu xi titqiba fakkar lit- tabib tiegħek li qed tieħu Protopy (ara Sezzjoni “ Oqgħod attent ’ g b’ Protopy ”). m
er Using Protopy with food and drink While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel hot. ng lo Pregnancy and breast-feeding Don’ t use Protopy if you are pregnant or breast-feeding. no
Meta tuża Protopy ma ’ l- ikel u max- xorb Meta tixrob alkoħol waqt li tkun qed tuża Protopy il- ġilda jew il- wiċċ jistgħu jiħmaru u jisħnu. li li
Ask your doctor or pharmacist for advice before taking any medicine. ct
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina. iċ ed
HOW TO USE PROTOPY du
KIF GĦANDEK TUŻA PROTOPY
You should check with your doctor or pharmacist if you are not sure. ro
Dejjem għandek taċċerta ruħek mat- tabib jew tm
Apply Protopy as a thin layer to affected areas of your skin. lp
Idlek Protopy ħafif fuq il- parti tal- ġilda li hi marida. ot
Protopy may be used on most parts of the body, including the face and neck and in the creases of your a
Protopy jista 'jintuża kważi fil- partijiet kollha tal- ġisem, inklużi l- wiċċ u l- għonq kif ukoll il- minkeb u od
elbows and knees. in
Pr
If the ointment gets on any of ic
Evita l- ingwent milli jidħol fl- imnieħer, fil- ħalq jew fl- għajnejn.
these areas, it should be thoroughly wiped off and/ or rinsed off with water. ed
Jekk jiġri dan, wieħed għandu jimsaħ l- ingwent u jlaħlaħ il- parti bl- ilma.
M
Tattix il- ġilda li qed tikkura b' faxxex jew garżi.
Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients (16 years of age and older).
42 Għal- kbar Protopy jinstab f' żewġ konċentrazzjonijiet (Protopy 0. 03% u Protopy 0. 1% ingwent).
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopy 0.03% ointment, can be used.
It- tabib tiegħek jiddeċidi fuq il- frekwenza ta ’ l- użu skond kif ittaffi il - ħmura tal- ġilda jew jista 'jintuża Protopy ingwent ta' 0. 03%.
If you accidentally swallow some ointment If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
t za Jekk forsi b' aċċident tibla ftit ingwent Jekk tibla xi ftit ingwent b' aċċident, kellem malajr lit- tabib jew l- ispizjar.
If you forget to use Protopy If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
riz Jekk tinsa tuża Protopy Jekk tinsa tuża Protopy fil- ħin li jmissek, użaħ kif tiftakar u kompli bħas- soltu.
ed If you have any further questions on the use of this product, ask your doctor or pharmacist.
to aw Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
th Like all medicines, Protopy can cause side effects, although not everybody gets them.
x du Bħal kull mediċina oħra, Protopy jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
au Approximately half of the patients who use Protopy have some type of skin irritation where they have applied the ointment.
ħa Bejn wieħed u ieħor nofs il- pazjenti li jużaw Protopy ikollhom xi ftit irritazzjoni tal- ġilda fil- parti fejn japplikaw l- ingwent.
Other common
Dawn is- sintomi huma ħfief għal ’ g moderati u ġeneralment jgħaddu wara xi ġimgħa li jintuża Protopy.
er (> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections ng (e. g. cold sores, generalised herpes simplex infections).
Effetti oħra li huma komuni (> 1%) huma ħmura, ħruq ħafif, uġigħ, żjieda tas- sensività tal- ġilda għall- kesħa u għas- sħana, tingiż, fawra, m
Acne is an uncommon side effect.
L- akne mhux effett komuni ta 'Protopy.
Rosacea and rosacea-like dermatitis have lo also been reported.
Kien hemm ukoll każi ta ’ rosaċeja u dermatite bħal rosaċeja rrappurtati. li
Since commercial availability a very small number of people who have used Protopy ointment have no
Mindu sar jinxtara kummerċjalment numru żgħir ta ’ nies li użaw l- ingwent Protopy kellhom li
However, a link to Protopy ointment treatment has not been confirmed or refuted on the available evidence so far. ct
Madankollu fuq it- tagħrif kollu miksub s’ issa, la a
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. du ro
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. ed
HOW TO STORE PROTOPY lp
KIF TAĦŻEN PROTOPY tm
Keep out of the reach and sight of children. a
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal. ot
The expiry date refers to the last day of that month. in
Id- Data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar. od
Do not store above 25ºC. ic
Pr
Ask your pharmacist how to ed
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
M
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent.
What Protopy contains
X’ fih Protopy
One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Gramma waħda ta 'Protopy 0. 1% ingwent fiha 1. 0 mg tacrolimus (bħala tacrolimus monohydrate).
Not all pack sizes may be marketed.
Dawn it- tubi
ed and Protopy 0.1% ointment).
Protopy jinstab f' żewġ konċentrazzjonijiet (Protopy 0. 03% u Protopy 0. 1% ingwent).
or Manufacturer:
to aw Manifattur:
th For any information about this medicinal product, please contact the local representative of the
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
no
li
Teл.: + 359 2 862 53 72 ro
Teл.: + 359 2 862 53 72 iċ
Meteor Centre Office Park Sokolovskà 100/ 94 a
Meteor Centre Office Park Sokolovskà 100/ 94 tm
CZ-18600 Praha 8 Tel: +420 236 080300 in ic
CZ- 18600 Praha 8 Tel: +420 236 080300 ot
Danmark Astellas Pharma a/ s ed
Danmark od
Naverland 4 DK-2600 Glostrup M
Astellas Pharma a/ s Naverland 4 DK- 2600 Glostrup Pr
45 Eesti Österreich AS Sirowa Tallinn Salve 2c EE-11612 Tallinn Tel: +372 6 830700
44 Eesti AS Sirowa Tallinn Salve 2c EE- 11612 Tallinn Tel: +372 6 830700
Εθνικής Οδού Αθηνών -Λαμίας GR-144 51, Μεταμόρφωση Αττικής
Εθνικής Οδού Αθηνών- Λαμίας
Poleczki 21 PL-02-822 Warszawa
Poleczki 21
ed Τηλ: + 30 210 2812640
za Τηλ: + 30 210 2812640
is Astellas Pharma S. A.
riz España Astellas Pharma S. A.
th E-28223 Pozuelo de Alarcón, Madrid Tel: +34 91 4952700
aw E- 28223 Pozuelo de Alarcón, Madrid Tel: +34 91 4952700
au France Astellas Pharma S. A. S.
x Astellas Pharma S. A. S.
er 114 rue Victor Hugo F-92300 Levallois Perret Tél: +33 (0)1 55917500
du 114 rue Victor Hugo F- 92300 Levallois Perret
ro
iċ
IS-210 Garðabæ Sími: +354 535 7000 a
IS- 210 Garðabæ Sími: +354 535 7000 tm
Via delle Industrie 1 I-20061 Carugate (Milano) ed
Via delle Industrie 1 ot
EU/ 1/ 96/ 008/ 001
UE/ 1/ 96/ 008/ 001
Puregon
Puregon 50 IU
Powder and solvent for solution for injection
Trab u solvent g soluzzjoni g all- injezzjoni
Subcutaneous and intramuscular use
U u ta t il - ilda u ol- muskoli
powder: ampoule (glass); solvent: ampoule (glass)
trab: ampulla (ie); solvent: ampulla (ie)
50 IU; solvent:
50 IU; solvent:
1 ampoule + 1 ampoule
ampulla + ampulla
EU/ 1/ 96/ 008/ 002
UE/ 1/ 96/ 008/ 002
EU/ 1/ 96/ 008/ 003
UE/ 1/ 96/ 008/ 003
EU/ 1/ 96/ 008/ 004
UE/ 1/ 96/ 008/ 004
EU/ 1/ 96/ 008/ 005
UE/ 1/ 96/ 008/ 005
powder: vial (glass); solvent: ampoule (glass)
trab: kunjett (ie); solvent: ampulla (ie)
75 IU; solvent:
75 IU; solvent:
EU/ 1/ 96/ 008/ 006
UE/ 1/ 96/ 008/ 006
3 vials + 3 ampoules
3 kunjetti + 3 ampulli
EU/ 1/ 96/ 008/ 007
UE/ 1/ 96/ 008/ 007
5 vials + 5 ampoules
5 kunjetti + 5 ampulli
EU/ 1/ 96/ 008/ 008
UE/ 1/ 96/ 008/ 008
10 vials + 10 ampoules
10 kunjetti + 10 ampulli
EU/ 1/ 96/ 008/ 009
UE/ 1/ 96/ 008/ 009
Subcutaneous and intramuscular use
al U u ta t il - ilda u ol- muskoli
100 IU; solvent:
100 IU; solvent:
1 ml (100 IU/ ml)
1 ml ampulla + ampulla (100 IU/ ml)
EU/ 1/ 96/ 008/ 010
UE/ 1/ 96/ 008/ 010
3 ampoules + 3 ampoules
1 ml 3 ampulli + 3 ampulli (100 IU/ ml)
1 EU/ 1/ 96/ 008/ 011
UE/ 1/ 96/ 008/ 011
50 IU; solvent:
100 IU; solvent:
5 ampoules + 5 ampoules
1 ml 5 ampulli + 5 ampulli (100 IU/ ml)
EU/ 1/ 96/ 008/ 012
UE/ 1/ 96/ 008/ 012
Powder and solvent for solution for injection
Trab u solvent g soluzzjoni
10 ampoules + 10 ampoules
1 ml 10 ampulli + 10 ampulli (100 IU/ ml)
EU/ 1/ 96/ 008/ 013
1/ 3 g all- injezzjoni UE/ 1/ 96/ 008/ 013
150 IU; solvent:
150 IU; solvent:
1 ml (150 IU/ ml)
1 ml ampulla + ampulla (150 IU/ ml)
EU/ 1/ 96/ 008/ 014
UE/ 1/ 96/ 008/ 014
3 ampoules + 3 ampoules
1 ml 3 ampulli + 3 ampulli (150 IU/ ml)
EU/ 1/ 96/ 008/ 015
UE/ 1/ 96/ 008/ 015
50 IU; solvent:
150 IU; solvent:
5 ampoules + 5 ampoules
1 ml 5 ampulli + 5 ampulli (150 IU/ ml)
EU/ 1/ 96/ 008/ 016
UE/ 1/ 96/ 008/ 016
10 ampoules + 10 ampoules
1 ml 10 ampulli + 10 ampulli (150 IU/ ml)
EU/ 1/ 96/ 008/ 017
UE/ 1/ 96/ 008/ 017
vial (glass)
kunjett (ie)
0.5 ml (100 IU/ ml)
0. 5 ml (100 IU/ ml) kunjett
EU/ 1/ 96/ 008/ 018
UE/ 1/ 96/ 008/ 018
0.5 ml (100 IU/ ml)
0. 5 ml (100 IU/ ml) 5 kunjetti
EU/ 1/ 96/ 008/ 019
UE/ 1/ 96/ 008/ 019
0.5 ml (100 IU/ ml)
0. 5 ml (100 IU/ ml) 10 kunjetti
EU/ 1/ 96/ 008/ 020
UE/ 1/ 96/ 008/ 020
0.5 ml (150 IU/ ml)
0. 5 ml (150 IU/ ml) kunjett
EU/ 1/ 96/ 008/ 021
UE/ 1/ 96/ 008/ 021
0.5 ml (150 IU/ ml)
0. 5 ml (150 IU/ ml) 5 kunjetti
EU/ 1/ 96/ 008/ 022
UE/ 1/ 96/ 008/ 022
0.5 ml (150 IU/ ml)
0. 5 ml (150 IU/ ml) 10 kunjetti
EU/ 1/ 96/ 008/ 023
UE/ 1/ 96/ 008/ 023
0.5 ml (200 IU/ ml)
0. 5 ml (200 IU/ ml) kunjett
EU/ 1/ 96/ 008/ 024
UE/ 1/ 96/ 008/ 024
0.5 ml (200 IU/ ml)
0. 5 ml (200 IU/ ml) 5 kunjetti
2 EU/ 1/ 96/ 008/ 025
UE/ 1/ 96/ 008/ 025
0.5 ml (200 IU/ ml)
0. 5 ml (200 IU/ ml) 10 kunjetti
EU/ 1/ 96/ 008/ 026
UE/ 1/ 96/ 008/ 026
0.5 ml (300 IU/ ml)
0. 5 ml (300 IU/ ml) kunjett
EU/ 1/ 96/ 008/ 027
UE/ 1/ 96/ 008/ 027
0.5 ml (300 IU/ ml)
0. 5 ml (300 IU/ ml) 5 kunjetti
EU/ 1/ 96/ 008/ 028
UE/ 1/ 96/ 008/ 028
0.5 ml (300 IU/ ml)
0. 5 ml (300 IU/ ml) 10 kunjetti
EU/ 1/ 96/ 008/ 029
UE/ 1/ 96/ 008/ 029
0.5 ml (400 IU/ ml)
0. 5 ml (400 IU/ ml) kunjett
EU/ 1/ 96/ 008/ 030
2/ 3 UE/ 1/ 96/ 008/ 030
vial (glass)
kunjett (
EU/ 1/ 96/ 008/ 031
UE/ 1/ 96/ 008/ 031
EU/ 1/ 96/ 008/ 032
UE/ 1/ 96/ 008/ 032
225 IU/ 0.5 ml
225 IU/ 0. 5 ml
0.5 ml (450 IU/ ml)
0. 5 ml (450 IU/ ml)
EU/ 1/ 96/ 008/ 033
UE/ 1/ 96/ 008/ 033
EU/ 1/ 96/ 008/ 034
UE/ 1/ 96/ 008/ 034
EU/ 1/ 96/ 008/ 035
UE/ 1/ 96/ 008/ 035
250 IU/ 0.5 ml
250 IU/ 0. 5 ml
0.5 ml (500 IU/ ml)
0. 5 ml (500 IU/ ml)
EU/ 1/ 96/ 008/ 036
UE/ 1/ 96/ 008/ 036
EU/ 1/ 96/ 008/ 037
UE/ 1/ 96/ 008/ 037
EU/ 1/ 96/ 008/ 038
UE/ 1/ 96/ 008/ 038
300 IU/ 0.36 ml
300 IU/ 0. 3 6 ml
Subcutaneous use
U u ta t il - ilda