qanastek/EMEA-V3 huggingface dataset:
Slightly lower body weight gain in females was the only systemic change observed in micropigs at high ointment concentrations (3%).
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.
Il- fniek dehru li kienu speċjalment sensittivi għal tacrolimus mogħti b’ injezzjoni fil- vina, għax kellhom effetti kardjotossiċi reversibbli.
Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
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.
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.
Fi studju dwar il- potenzjal kanċeroġenu fil- ġilda li dam sejjer 24 xahar, fi ġrieden li rċevew tacrolimus 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 - esponimenti fiċ- ċirkolazzjoni kienu għoljin ħafna.
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 żmien twil ħafna fuq ġrieden albino bla xaghar.
Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the
Fl- annimali li rċevew tacrolimus ingwent il- kanċer tal - ġilda (squamous cell carcinoma) żviluppa iktar malajr b’ mod statistikament sinifikanti u l- annimali kellhom ukoll numru akbar ta ’ tumuri.
It is unclear whether the effect of tacrolimus is due to systemic immunosuppression or a local effect.
Mhux ċar jekk l- effett ta 'tacrolimus hux effett lokali jew effett minħabba suppressjoni tas- sistema immunitarja.
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.
Ir- riskju għal bniedem ma jistax jitħalla barra għal kollox għax il- potenzjal għal immunosuppressjoni lokali meta jintuża fit- tul l- ingwent tacrolimus għadu mhux magħruf.
Reproduction toxicity Embryo/ foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Effett tossiku fuq is- sistema riproduttiva Kien hemm effett ħazin fuq l- embrijoni/ feti ta 'fniek u firien biss, meta d- doża ta' tacrolimus kienet tossika fl- annimali li kienu tqal.
Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Tnaqqis fil- funzjoni ta ’ l- isperma dehret f’ firien ta ’ sess maskili b’ dożi għolja mogħtija taħt il- ġilda.
6.1 List of excipients
9 6. 1 Lista ta 'sustanzi mhux attivi
White soft paraffin Liquid paraffin Propylene carbonate White beeswax Hard paraffin
White soft paraffin Liquid paraffin Propylene carbonate White beeswax Hard paraffin
Not applicable.
Ma jghoddx f' dan il- każ.
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Tubu li fuq ġewwa għandu saff ta 'low density polyethylene u li għandu kappa bajda b’ kamin tal - propylene.
10 g, 30 g and 60 g.
10 g, 30 g, u 60 g.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall - skop kummerċjali.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
61 D-81673 München Germany
61 D- 81673 München Il- Ġermanja
28/ 02/ 2002 Date of renewal:
28/ 02/ 2002 Data ta ’ tiġdid ta ’ l- awtorizzazzjoni:
{DD/ MM/ YYYY}
{XX/ SSSS}
Detailed information on this medicinal product is available on the website of the European Medicines 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
Protopic 0.1% ointment
Protopic 0. 1% ingwent
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
1 g ta 'Protopic 0. 1% ingwent fih 1. 0 mg ta' Tacrolimus bħala tacrolimus monohydrate (0. 1%).
Use in adults (16 years of age and above) Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Użu f 'persuni kbar (16 il- sena' l fuq) Protopic jiġi bħala ingwent fil- qawwa ta 'Protopic 0. 03% u ta' Protopic 0. 1%.
Use in elderly (65 years of age and above) Specific studies have not been conducted in elderly patients.
12 Użu fl- anzjani (65 sena u akbar) Għad m 'hemmx studji speċifiċi f’ pazjenti anzjani.
11 As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.
L- istudji kliniċi dwar l- effikaċja li saru ġew mwaqqfa f 'salt u għalhekk m' hemmx informazzjoni jekk ir- rata ta' rikorrenza tkunx anqas jekk it- trattament titwaqqaf bil- mod il- mod.
Transplant patients receiving immunosuppressive regimens (e. g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopic and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Pazjenti, li kellhom trapjant ta 'xi organu u għalhekk jieħdu mediċini immunosuppressivi (per ezempju injezzjoni ta' tacrolimus), għandhom ċans akbar li jiżviluppaw limfoma; Għalhekk pazjenti li qed jieħdu Protopic u tiżviluppalhom limfadenopatija għandhom jibqgħu taħt osservazzjoni biex jiġi aċċertat li l- limadenopatija tfieq.
In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated.
Fil- każ li l- limfadenopatija ma tfieqx, il- kawża tal- limfadenopatija għandha tkun mistħarrġa.
In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
Jekk il- kawża tal- limfadenopatija ma tkunx ċara, jew jekk ikun hemm il- marda infectious mononucleosis akuta, wieħed għandu jikkonsidra li jwaqqaf it- trattament bi Protopic.
Care should be taken to avoid contact with eyes and mucous membranes.
13 Għandha tingħata attenzjoni biex ma jseħħx kuntatt ma 'l- għajnejn jew ma ’ membrani mukużi.
12 Tacrolimus is extensively metabolised in the liver and although blood concentrations are low following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Ħafna minn tacrolimus jigi metabolizzat fil- fwied u għalkemm il- konċentrazzjoni fid- demm hi baxxa, l- ingwent għandu jiġi wżat b 'kawtela f' każ fejn ikun hemm insuffiċjenza tal- fwied (ara sezzjoni 5. 2).
Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Tagħrif minn pazjenti juri li tacrolimus jinsab fil- ħalib tas- sider meta jingħata permezz ta 'injezzjoni.
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended.
Għalkemm tagħrif kliniku juri li l- konċentrazzjoni ta 'tacrolimus fid- demm tkun baxxa wara li tacrolimus jintuża bħala ingwent fuq il- ġilda, mhux rakkomandat li Protopic ingwent jintuża f' pazjenti nisa li jkunu għadhom jreddu.
No studies on the effects on the ability to drive and use machines have been performed.
Dawn l- effetti għadhom ma ġewx studjati.
In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
14 Madwar 50% tal- pazjenti kellhom xi tip ta ’ irritazzjoni avversa tal- ġilda fil- parti fejn ġie applikat l - ingwent.
Sensation of warmth, pain, paraesthesia and rash at the site of
Ħafna drabi seħħew ukoll sensazzjoni ta ’ sħana, uġigħ, paraesthesia (wieħed ma jkunx iħoss) u raxx fil- partijiet fejn ġie applikat l- ingwent.
Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
15 Il- mod ta 'l- azzjoni ta' tacrolimus f 'każ ta' dermatite atopica għadu mhux mifhum għal kollox.
14 In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
In vitro, f 'ċelluli ta' Langerhans li nkisbu minn ġilda normali, tacrolimus naqqas l- attività stimulatorja lejn it- T cells.
The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p < 0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
16 0. 03% u ta '0. 1% hu sinifikament aktar effettiv (p < 0. 001 għat- tnejn) minn ingwent ta' 1% hydrocortisone acetate (Tabella 2).
5.2 Pharmacokinetic properties
17 5. 2 Tagħrif farmakokinetiku
Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus 16 following single or repeated topical application of tacrolimus ointment.
Assorbiment Tagħrif kliniku li nkiseb minn bnedmin b’ saħħithom juri li jinstab ftit jew xejn tacrolimus fid- demm wara applikazzjoni b’ mod topiku, ta 'darba jew iktar, ta' tacrolimus ingwent fuq il- ġilda.
Distribution As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to plasma proteins is considered not to be clinically relevant.
Distribuzzjoni Minħabba li meta tacrolimus ingwent ma jwassalx għal esponiment għoli fiċ- ċirkolazzjoni, l- irbit qawwi ta ’ tacrolimus (> 98. 8%) mal- proteini tal- plażma mhuwiex meqjus bħala wieħed ta ’ rilevanza klinika.
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
18 Kanċeroġeniċità Studji sistemiċi kanċeroġeniċi fuq ġrieden (18 xahar) u firien (24 xahar) urew li tacrolimus m’ għandux potenzjal kanċeroġenu.
It is unclear whether the effect of tacrolimus is due to systemic
Fl- annimali li rċevew tacrolimus ingwent il- kanċer tal - ġilda (squamous cell carcinoma) żviluppa iktar malajr b’ mod statistikament sinifikanti u l- annimali kellhom ukoll numru akbar ta ’ tumuri.
17 immunosuppression or a local effect.
Mhux ċar jekk l- effett ta 'tacrolimus hux effett lokali jew effett minħabba suppressjoni tas- sistema immunitarja.
6.5 Nature and contents of container
19 6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
20 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Ltd., Killorglin, Co.
Fujisawa Ireland Ltd., Killorglin, Co.
Kerry, Ireland
Kerry, L- Irlanda
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2
PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PROTOPIC 0. 03% INGWENT (10 g, 30 g, 60 g KARTUN)
Protopic 0.03% Ointment Tacrolimus monohydrate
Protopic 0. 03% Ingwent Tacrolimus monohydrate
1 g ointment contains:
1 g ingwent fih:
0.3 mg tacrolimus (as monohydrate),
0. 3 mg tacrolimus (bħala monohydrate),
white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
METHOD AND ROUTE OF ADMINISTRATION
MOD TA 'KIF U MNEJN JINGĦATA
Cutaneous use
Użu għall- ġilda
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻAGĦAR EWLENIN
PROTOPIC 0.03% OINTMENT (10 g TUBE)
PROTOPIC 0. 03% INGWENT (10 g TUBU)
Protopic 0.03% Ointment Tacrolimus monohydrate Cutaneous use
Protopic 0. 03% Ingwent Tacrolimus monohydrate Użu għall- ġilda
26 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
PROTOPIC 0.03% OINTMENT (30 g, 60 g TUBE)
PROTOPIC 0. 03% INGWENT (30 g, 60 g TUBU)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
PROTOPIC 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
PROTOPIC 0. 1% INGWENT (10 g, 30 g, 60 g KARTUN)
Protopic 0.1% Ointment Tacrolimus monohydrate
Protopic 0. 1% Ingwent Tacrolimus monohydrate
1.0 mg tacrolimus (as monohydrate),
1. 0 mg tacrolimus (bħala monohydrate),
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻAGĦAR EWLENIN
PROTOPIC 0.1% OINTMENT (10 g TUBE)
PROTOPIC 0. 1% INGWENT (10 g TUBU)
Protopic 0.1% Ointment Tacrolimus monohydrate Cutaneous use
Protopic 0. 1% Ingwent Tacrolimus monohydrate Użu għall- ġilda
31 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
PROTOPIC 0.1% OINTMENT (30 g, 60 g TUBE)
PROTOPIC 0. 1% INGWENT (30 g, 60 g TUBU)
Protopic 0.03% Ointment Tacrolimus monohydrate
Protopic 0. 03% ingwent Tacrolimus monohydrate
What Protopic is and what it is used for 2.
X' inhu Protopic u għalxiex jintuża 2.
Before you use Protopic 3.
Qabel ma 'tuża Protopic 3.
How to use Protopic 4.
Kif għandek tuża Protopic 4.
How to store Protopic 6.
Kif taħżen Protopic 6.
WHAT PROTOPIC IS AND WHAT IT IS USED FOR
X' INHU PROTOPIC U GĦALXIEX JINTUŻA
The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Is- sustanza attiva ta ’ Protopic, tacrolimus monohydrate, huwa aġent immuno- modulatorju.
Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who 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.
L- ingwent Protopic 0. 03% jintuża biex jikkura dermatite atopika moderata għal severa (ekżema) fil - 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 skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
Fid - dermatite atopika, reazzjoni żejda tas - sistema immunitarja tal- ġilda toħloq infjammazzjoni tal- ġilda (ħakk, ħmura, nixfa).
Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.
Protopic jibdel ir - respons immunitarju anormali u jserraħ l- infjammazzjoni tal- ġilda kif ukoll il- ħakk.
BEFORE YOU USE PROTOPIC
QABEL MA 'TUŻA PROTOPIC
Do not use Protopic
Tużax Protopic
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopic or to
- Jekk int allerġiku (għandek sensitività eċċessiva) għal tacrolimus jew xi wieħed mill- ingredjenti
macrolide antibiotics (e. g. azithromycin, clarithromycin, erythromycin).
oħra ta ’ Protopic jew ta ’ l - antibijotiċi macrolide (eż. azithromycin, clarithromycin, erythromycin).
Take special care with Protopic
Oqgħod attent ħafna b' Protopic
- Protopic ointment is not approved for children younger than 2 years of age.
- L- ingwent Protopic mhux approvat għat- tfal iżgħar minn (2) sentejn.
Therefore it should
Għaldaqstant ma għandux
not be used in this age group.
jintuża f’ din l- eta ’.
Please consult your doctor.
Jekk jogħġbok ikkonsulta t- tabib tiegħek.
- The effect of treatment with Protopic on the developing immune system in children, especially
- L- effett ta 'Protopic fuq is- sistema immunitarja ta' tfal żgħar għadu ma ġiex stabbilit.
- The safety of using Protopic for a long time is not known.
- Is- sigurtà ta l- użu ta ’ Protopic fit- tul mhux magħrufa.
A very small number of people who
Numru żgħir minn dawk li użaw l- ingwent
have used Protopic ointment have had malignancies (for example, skin or lymphoma).
Protopic kellhom il- malinjitajiet (bħal, fil- ġilda jew limfoma).
However, a link to Protopic ointment treatment has not been shown.
Madankollu ma nstabitx ir- rabta mal- kura bl- ingwent Protopic.
- If you have infected lesions.
- Jekk għandek xi infezzjoni.
Do not apply the ointment to infected lesions.
M' għandekx iddellek l- ingwent fuq ġilda b' infezzjoni.
Talk to your doctor before using Protopic.
- Jekk il- fwied tiegħek mhux jaħdem tajjeb, kellem it- tabib qabel ma tuża Protopic.
- Also speak to your doctor before using Protopic 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 Protopic
- If you have an inherited skin barrier disease such as Netherton’ s syndrome or if you suffer from
- Jekk għandek xi marda ġenetika tal- ġilda bħas- sindrome ta 'Netherton jew jekk għandek
Talk to your doctor before using Protopic.
erythroderma ġeneralizzata (il- ġilda infjammata, ħamra u titqaxxar) kellem it- tabib qabel ma tuża Protopic.
If
- Jekk għandek xi għeqiedi limfatiċi minfuħa għandek ukoll tinforma t- tabib tiegħek qabel ma
your lymph nodes become swollen during treatment with Protopic, consult your doctor.
Jekk il- glandoli tas- sistema limfatika jintefħu waqt trattament b' Protopic, kellem lit - tabib.
- Before receiving a vaccination tell your doctor that you are using Protopic.
- Qabel ma titlaqqam għid lit- tabib li qed tuża Protopic.
Vaccinations should
Wieħed ma jistgħax jitlaqqam waqt
not be given during treatment and for a certain time after treatment with Protopic.
trattament b' Protopic u għal ċertu żmien wara trattament b' Protopic.
For live attenuated vaccinations (e. g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e. g. tetanus, diphtheria, pertussis or influenza) 14 days.
Għat- tilqim attiv (measels, mumps, rubella, jew polio li jittieħed mill- ħalq) wieħed jistenna 28 ġurnata u għat- tilqim inattiv (tetanu, diphteria, pertussis jew influwenza) wieħed jistenna 14- il ġurnata.
If
- Tmurx fix- xemx għal- żmien twil u evita d- dawl b’ raġġi artifiċjali bħas- sodda tad- dawl biex
you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Jekk toħroġ fix- xemx wara li tkun dlikt Protopic uża sunscreen u ilbes ħafif b' mod li l- ħwejjeġ jagħtuk protezzjoni mix- xemx.
In addition, ask your doctor for advice on other appropriate sun protection methods.
Itlob lit- tabib jagħtik parir dwar mezzi ta ’ protezzjoni mix- xemx oħrajn li tista ’ tuża.
If you are prescribed light therapy, inform your doctor that you are using Protopic as it is not recommended to use Protopic and light therapy at the same time.
Jekk qed tingħata trattament tad- dawl, għid lit - tabib, għax ma tistax tuża Protopic 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 'Protopic ma' l- għajnejn u ma 'partijiet tal- ġisem bħan- naħa ta' ġewwa tal- ħalq
Taking or using other medicines and cosmetics Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu jew tuża mediċini u kosmetiċi oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.
Mal- kura ta ’ Protopic tista ’ tuża xi dlik rinfreskanti jew lozzjonijiet iżda dawn il- prodotti ma għandhomx jintużaw qabel ma jgħaddu sagħtejn minn meta tkun użajt Protopic.
The use of Protopic 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.
Ma sarx studju dwar l- użu ta ’ Protopic 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 immunitarja.
Before receiving a vaccination tell your doctor that you are using Protopic (see Section “ Take special care with Protopic”).
Qabel ma tieħu xi titqiba fakkar lit- tabib tiegħek li qed tieħu Protopic (ara Sezzjoni “ Oqgħod attent b’ Protopic ”).
Using Protopic with food and drink While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Meta tuża Protopic ma ’ l- ikel u max- xorb Meta tixrob alkoħol waqt li tkun qed tuża Protopic il- ġilda jew il- wiċċ jistgħu jiħmaru u jisħnu.
Pregnancy and breast-feeding Don’ t use Protopic if you are pregnant or breast-feeding.
Tqala u Treddigħ Tiħux Protopic jekk tqila jew qed tradda ’.
HOW TO USE PROTOPIC
KIF GĦANDEK TUŻA PROTOPIC
Always use Protopic exactly as your doctor has told you.
Dejjem għandek tuża Protopic skond il- parir tat- tabib.
Apply Protopic as a thin layer to affected areas of your skin.
Idlek Protopic ħafif fuq il- parti tal- ġilda li hi marida.
Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Protopic jista 'jintuża kważi fil- partijiet kollha tal- ġisem, inklużi l- wiċċ u l- għonq kif ukoll il- minkeb u l- irkoppa.
Avoid using the ointment inside your nose or mouth or in your eyes.
Evita l- ingwent milli jidħol fl- imnieħer, fil- ħalq jew fl- għajnejn.
If the ointment gets on any of 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.
Do not cover the skin being treated with bandages or wraps.
Tattix il- ġilda li qed tikkura b' faxxex jew garżi.
Wash your hands after applying Protopic unless your hands are also being treated.
Aħsel idejk wara użu ta 'Protopic jekk mhux qed tuża Protopic għall- ġilda ta' jdejk.
Before applying Protopic after a bath or shower, be sure your skin is completely dry.
Qabel ma tapplika Protopic wara banju jew doċċa, ħu ħsieb li l- ġilda tkun niexfa.
36 Children (2 years of age and older) Apply Protopic twice a day for up to three weeks, once in the morning and once in the evening.
37 Idlek Protopic darbtejn kuljum għal tliet ġimgħat, darba filgħodu u darba filgħaxija.
Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
Wara dan iz- żmien imbagħad darba kuljum fuq il- parti marida tal- ġilda sakemm il- ħmura ittaffi.
Adults (16 years of age and older) Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients.
Kbar (16 il- sena u akbar) Għal- kbar Protopic jinstab f' żewġ konċentrazzjonijiet (Protopic 0. 03% u Protopic 0. 1% ingwent).
Your doctor will decide which strength is best for you.
It - tabib tiegħek jiddeċidi liema aħjar għalik.
Usually, treatment is started with Protopic 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' Protopic 0. 1% ingwent darbtejn kuljum, darba filgħodu u darba filgħaxija, sakemm il- ħmura ittaffi.
If symptoms reappear, treatment with Protopic 0.1% twice a day should be restarted.
Wara dan iz- żmien jintuża Protopic 0. 03% ingwent darbtejn kuljum.
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 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 Protopic ingwent ta' 0. 03%.
Treat each affected region of your skin until the eczema has gone away.
Uża t- trattament fuq il- parti marida tal- ġilda sakemm ittaffi l- ħmura.
Improvement is usually seen 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 possible treatments.
Jekk wara ħmistax ma jkunx hemm tibdil għal- aħjar, kellem lit- tabib biex jara hemmx bżonn ta 'trattament oħra.
Treatment with Protopic may be repeated if symptoms reappear.
Protopic jista 'jerġa jintuża jekk is- sintomi jerġgħu jidhru.
If you accidentally swallow some ointment If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
Jekk forsi b' aċċident tibla ftit ingwent Jekk tibla xi ftit ingwent b' aċċident, kellem malajr lit- tabib jew l- ispizjar.
Do not try to induce vomiting.
Tipprovax tirremetti.
If you forget to use Protopic If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
Jekk tinsa tuża Protopic Jekk tinsa tuża Protopic fil- ħin li jmissek, użaħ kif tiftakar u kompli bħas- soltu.
Like all medicines, Protopic can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Protopic jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Approximately half of the patients who use Protopic have some type of skin irritation where they have applied the ointment.
Bejn wieħed u ieħor nofs il- pazjenti li jużaw Protopic ikollhom xi ftit irritazzjoni tal- ġilda fil- parti fejn japplikaw l- ingwent.
Burning sensation and itching are very common (> 10%).
Ħruq u ħakk huma komuni ħafna (> 10%).
These symptoms are usually mild to moderate and generally go away within one week of using Protopic.
Dawn is- sintomi huma ħfief għal moderati u ġeneralment jgħaddu wara xi ġimgħa li jintuża Protopic.
Other common (> 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 (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, infjammazzjoni tax- xagħar u infezzjoni bil- virus ta 'herpes (ħżiża lokalizzata jew ġeneralizzata).
Facial flushing or skin irritation after drinking alcohol is also common.
Komuni wkoll huma ħmura tal- wiċċ u irritazzjoni tal- ġilda wara xorb alkoħoliku.
Acne is an uncommon side effect.
L- akne mhux effett komuni ta 'Protopic.
Rosacea and rosacea-like dermatitis have also been reported.
Kien hemm ukoll każi ta ’ rosaċeja u dermatite bħal rosaċeja rrappurtati.
Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma).
Mindu sar jinxtara kummerċjalment numru żgħir ta ’ nies li użaw l- ingwent Protopic kellhom malinjitajiet (bħal fil- ġilda jew ukoll limfoma).
However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
Madankollu fuq it- tagħrif kollu miksub s’ issa, la kkonferma u lanqas innega rabta mal- kura ta ’ l- ingwent Protopic.
HOW TO STORE PROTOPIC
KIF TAĦŻEN PROTOPIC
Do not use Protopic after the expiry date which is stated on the tube and carton after EXP.
Tużax Protopic wara d- data ta ’ skadenza li tidher fuq it- tubu u ta 'fuq il- kaxxa wara JIS.
Do not store above 25ºC.
Taħżinx f' temperatura 'l fuq minn 25°C.
37 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Protopic contains
X’ fih Protopic
- The active substance is tacrolimus monohydrate.
- Is- sustanza attiva hi tacrolimus monohydrate.
One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Gramma waħda ta 'Protopic 0. 03% ingwent fiha 0. 3 mg tacrolimus (bħala tacrolimus monohydrate).
- The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white
- Sustanzi oħra jinkludu white soft paraffin, liquid paraffin, propylene carbonate, white beeswax u
beeswax and hard paraffin.
hard paraffin.
It is supplied in tubes containing 10, 30 or 60 grams of ointment.
Id- Dehra tal- prodott u d- daqs tal- pakkett Protopic 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.
Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
Protopic jinstab f' żewġ konċentrazzjonijiet (Protopic 0. 03% u Protopic 0. 1% ingwent).
Marketing Authorisation Holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
61, D-81673 München, Germany.
61, D- 81673 München, Il- Ġermanja.
Ltd., Killorglin, County Kerry, Ireland.
Ltd., Killorglin, County Kerry, L- Irlanda.
39 Eesti Österreich AS Sirowa Tallinn Salve 2c EE-11612 Tallinn Tel: +372 6 830700
Eesti AS Sirowa Tallinn
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu
Protopic 0.1% Ointment Tacrolimus monohydrate
Protopic 0. 1% ingwent Tacrolimus monohydrate
Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
L- ingwent Protopic 0. 1% jintuża biex jikkura dermatite atopika moderata għal severa (ekżema) fil- kbar 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 infjammazzjoni tal- ġilda (ħakk, ħmura, nixfa).
Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.
Protopic jibdel ir- respons immunitarju anormali u jserraħ l- infjammazzjoni tal- ġilda kif ukoll il- ħakk.
generalised erythroderma (inflammatory reddening and scaling of the entire skin).
erythroderma ġeneralizzata (il- ġilda infjammata, ħamra u titqaxxar) kellem it- tabib qabel ma tuża Protopic.
Talk to your doctor before using Protopic.
42
For live
trattament b' Protopic u għal ċertu żmien wara trattament b' Protopic.
42 attenuated vaccinations (e. g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e. g. tetanus, diphtheria, pertussis or influenza) 14 days.
Għat- tilqim attiv (measels, mumps, rubella, jew polio li jittieħed mill- ħalq) wieħed jistenna 28 ġurnata u għat- tilqim inattiv (tetanu, diphteria, pertussis jew influwenza) wieħed jistenna 14- il ġurnata.
Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older).
43 Għal- kbar Protopic jinstab f' żewġ konċentrazzjonijiet (Protopic 0. 03% u Protopic 0. 1% ingwent).
43 Treat each affected region of your skin until the eczema has gone away.
Uża t- trattament fuq il- parti marida tal- ġilda sakemm ittaffi l- ħmura.
One gram of Protopic 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Gramma waħda ta 'Protopic 0. 1% ingwent fiha 1. 0 mg tacrolimus (bħala tacrolimus monohydrate).
45 Eesti Österreich AS Sirowa Tallinn Salve 2c EE-11612 Tallinn Tel: +372 6 830700
Eesti AS Sirowa Tallinn
ed is or th au er ANNEX I ng SUMMARY OF PRODUCT CHARACTERISTICS lo no ct du ro lp a in ic ed M
t za riz to aw x du ANNESS I ħa SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT ’ g m li li a in iċ ed tm ot od Pr
Protopy 0.03% ointment
Protopy 0. 03% ingwent
1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
1 g ta 'Protopy 0. 03% ingwent fih 0. 3 mg ta' Tacrolimus bħala tacrolimus monohydrate (0. 03%).
is Ointment
riz Ingwent
or A white to slightly yellowish ointment.
to Ingwent abjad jagħti fl- isfar.
4.1 Therapeutic indications
x 4. 1 Indikazzjonijiet terapewtiċi
er Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or ng are intolerant of conventional therapies such as topical corticosteroids.
du Il- kura ta ’ dermatite atopika moderata jew severa fl- adulti li ma jkunux adegwatament responsivi għal ħa jew intolleranti għal terapiji konvenzjonali bħalma huma l- kortikosterojdi topikali.
Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to lo conventional therapies such as topical corticosteroids. no
Kura moderata għal severa ta ’ dermatite atopika fit tfal (minn sentejn ‘ il fuq) li ma kellhomx respons adegwat għal kura ’ g konvenzjonali bħalma huma l- kortikosterojdi topikali. m
Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic ct
Kura bi Protopy għandu jinbeda minn tabib li jkollu esperjenza fid- dijanjosi u l- kura tad- dermatite li
dermatitis. du
atopika. li a
Treatment should be intermittent and not continuous. ro
Il- kura ma tridx tkun kontinwa iżda intermittenti. in
Protopy ointment should be applied as a thin layer to affected areas of the skin.
Protopy forma ta 'ingwent jiġi mdellek ħafif fuq il- parti tal- ġilda affettwata.
Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. lp
jista 'jiġi użat f' kull parti tal- ġisem, inklużi l- wiċċ, l- għonq, u partijiet fejn il- ġilda tintlewa, minbarra ed
Protopy ointment should not be applied under occlusion (see section 4.4). a
Protopy forma ta 'ingwent m' għandux jintuża taħt faxxex (ara sezzjoni 4. 4).
Each affected region of the skin should be treated with Protopy until clearance occurs and then treatment should be discontinued.
Kull parti tal- ġilda affettwata għandha tiġi trattata bi Protopy sakemm il- marda tfieq, imbagħad it - tm
treatment.
trattament għandha tiġi mwaqqfa.
If no signs of improvement are seen after two weeks of treatment, further treatment options ic
Jekk wara ħmistax il- ġurnata ma jkunx hemm progress, wieħed għandu jaħseb f 'terapiji oħra.
Protopy can be used for short term and intermittent long term treatment.
ikun hemm twaqqif għal xi perijodu żgħir.
At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. ed
Malli jidher li ser jerġgħu jibdew is- sintomi (flares) tas - sintomi tal- marda, il- kura trid terġa ’ tibda. od
Protopy is not recommended for use in children below age of 2 years until further data are available.
Protopy mhux rakkomandat għat- tfal taħt l- età ta ’ sentejn qabel ma jkun hemm aktar informazzjoni Pr
M
dwaru.
Use in adults (16 years of age and above) Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
2 Użu f 'persuni kbar (16 il- sena' l fuq) Protopy jiġi bħala ingwent fil- qawwa ta 'Protopy 0. 03% u ta' Protopy 0. 1%.
Treatment should be started with Protopy 0.1% twice a day and treatment should be continued until clearance of the lesion.
It- trattament tinbeda bi Protopy 0. 1% darbtejn kuljum sakemm il- ferita tfiq.
If symptoms recur, twice daily treatment with Protopy 0.1% should be restarted.
Jekk is- sintomi jergħu jiġu, wieħed jerġa jibda trattament b' Protopy 0. 1% darbtejn kuljum.
An attempt should be made to reduce the frequency of application or to use the lower strength Protopy 0.03% ointment if the clinical condition allows.
Wieħed għandu jipprova inaqqas il- frekwenza ta ’ l- użu, jew juża Protopy 0. 03%, jekk il- kondizzjoni klinika tippermetti.
As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.
L- istudji kliniċi dwar l- effikaċja li saru ġew mwaqqfa f 'salt u għalhekk m' hemmx informazzjoni jekk
Hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.
t za ir- rata ta 'rikorrenza tkunx anqas jekk it- trattament titwaqqaf bil- mod il- mod.
ed 4.4 Special warnings and precautions for use
riz 4. 3 Kontra- indikazzjonijiet
is Protopy should not be used in patients with congenital or acquired immunodeficiencies or in patients
Sensittività eċċessiva għal macrolides, għal tacrolimus jew għal xi sustanzi ohrajn.
or on therapy that cause immunosuppression.
to aw 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
th The effect of treatment with Protopy ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when
Protopy ma għandhiex tintuża fuq pazjenti li jkollhom immunodefiċjenzi konġenitali jew li jkunu ħaduhom jew f’ pazjenti li jkunu għaddejjin b’ kura li tista ’ tikkaġuna l- immunosuppressjoni.
au prescribing to this age group (see section 4.1).
x du L- effett tat- trattament bi Protopy ingwent fuq is- sistema immunitarja fit- tfal, speċjalment f 'tfal żgħar, għadu ma ġiex stabilit, u għalhekk wieħed għandu jaħseb f' dan il- fatt f' dan il- grupp ta 'pazjenti (ara ħa sezzjoni 4. 1).
Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a
Waqt l- użu ta 'Protopy ingwent wieħed għandu jevita li joqgħod espost għax- xemx u raġġi ultravjoletti ’ g (UV) ta' solarju kif ukoll dawk fit- trattament b 'UVB jew UVA b' kombinazzjoni ma 'psoralens m
er solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopy ointment (see section 5.3).
(PUVA) (ara sezzjoni 5. 3).
Physicians should advise patients on appropriate sun ng protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
It- tobba għandhom jagħtu parir lil- pazjenti biex jużaw protezzjoni xierqa kontra x- xemx, bħal żmien qasir fix- xemx, użu ta 'xi prodott li jilqa ’ mir- raġġi tax- xemx (sunscreen) kif ukoll ilbies xieraq.
Protopy ointment should not be applied to lesions that lo are considered to be potentially malignant or pre-malignant. no
L- ingwent Protopy ma għandux jintuża fuq leżjonijiet meqjusa bħala li
Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
Emoljenti ma jistgħux jintużaw fl- ewwel sagħtejn wara applikazzjoni ta 'Protopy.
Concomitant use of other topical preparations has not been assessed.
L- użu ta 'ingwenti in
There is no experience with concomitant use of systemic steroids or immunosuppressive agents. ct
Għad m' hemmx tagħrif dwar l- użu ta 'Protopy ma' steroids sistemiċi jew ma 'mediċini immunosuppressivi. iċ ed
Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically du
Is- sigurtà u l- effiċenza ta 'Protopy ingwent għadhom ma ġewx eżaminati fit- trattament tad- dermatite atopika klinikament infettata.
Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.
Qabel ma tibda trattament bi Protopy ingwent, wieħed għandu jara li infezzjoni tal- ġilda fil- partijiet relevanti tiġi mfejqa qabel.
Patients with atopic dermatitis are predisposed to superficial skin ro
Pazjenti b 'dermatite atopika jista' jkollom tm
infections.
ukoll infezzjoni superfiċjali tal- ġilda.
Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform lp
Waqt it- trattament bi Protopy ir- riskju ta 'infezzjoni bil- herpes (dermatite sempliċi tal- herpes [eczema herpeticum], herpes simplex [ħżiża], eruzzjoni variċelliforma ta' Kaposi).
eruption).
Protopy.
In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated. a
Il- potenzjal għall- immunosuppressjoni lokali (li aktarx toħloq infezzjonijiet jew ġilda malinja) ma od
Protopy contains the active substance tacrolimus, a calcineurin inhibitor.
Protopy fih is- sustanza attiva tacrolimus, inibitur kalċinewriniku.
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and M
F’ pazjenti bi trapjant, l- esponiment sistemiku fit- tul għall- immunosuppressjoni intensa wara għoti sistemika ta ’ inibituri kalċinewriniċi ġiet assoċjata ma ’ żieda fir- riskju li jiżviluppaw limfomi u malinjitajiet fil- ġilda.
other types of lymphoma, and skin cancers have been reported (see section 4.8).
F’ pazjenti li jużaw l - ingwent tacrolimus, kien hemm rapportati każi ta ’ malinjitajiet, inklużi l- limfoma fil- ġilda u tipi oħra ta ’ limfoma, kif ukoll kanċer tal- ġilda (ara sezzjoni 4. 8).
Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels.
Ma nstabx li dawk il- pazjenti b’ dermatite atopika kkurati bi Protopy kellhom livelli sistemiċi sinifikanti ta ’ tacrolimus.
Transplant patients receiving immunosuppressive regimens (e. g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
3 immunosuppressivi (per ezempju injezzjoni ta 'tacrolimus), għandhom ċans akbar li jiżviluppaw limfoma; Għalhekk pazjenti li qed jieħdu Protopy u tiżviluppalhom limfadenopatija għandhom jibqgħu taħt osservazzjoni biex jiġi aċċertat li l- limadenopatija tfieq.
3 the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopy should be considered.
Jekk il- kawża tal- limfadenopatija ma tkunx ċara, jew jekk ikun hemm il- marda infectious mononucleosis akuta, wieħed għandu jikkonsidra li jwaqqaf it- trattament bi Protopy.
The use of Protopy ointment under occlusion has not been studied in patients.
t za L- użu ta 'Protopy taħt faxxex għadu ma ġiex studjat f’ pazjenti.
As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for treatment.
Kif jagħmlu wara l- użu ta ’ ingwenti u kremi mediċinali oħrajn, il- pazjenti għandhom jaħslu jdejhom
Tacrolimus is extensively metabolised in the liver and although blood concentrations are low
riz jekk ma jkunux iridu jitrattawhom apposta.
ed following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Ħafna minn tacrolimus jigi metabolizzat fil- fwied u għalkemm il- konċentrazzjoni fid- demm hi baxxa,
is The use of Protopy ointment in patients with genetic epidermal barrier defects such as Netherton’ s
to l- ingwent għandu jiġi wżat b 'kawtela f' każ fejn ikun hemm insuffiċjenza tal- fwied (ara sezzjoni 5. 2).
or syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
aw L- użu ta 'Protopy mhux rakkomandat f' pazjenti li jsofru minn difetti ġenetiċi li jaffettwaw l- ilqugħ tal - ġilda bħal Netherton' s syndrome minħabba il- periklu li tacrolimus jidħol b 'qawwa akbar fid- demm.
The safety of Protopy ointment has not been established in patients with generalised
Is - sigurtà ta 'l- użu ta' Protopy f 'pazjenti b' erythroderma ġeneralizzata għadha mhiex stabilita.
th erythroderma.
x du Wieħed irid joqgħod attent ħafna meta juża Protopy fuq pazjenti li jkollhom firxa kbira ta ’ ġilda involuta għal perijodu ta ’ żmien fit- tul, speċjalment fit- tfal (ara sezzjoni 4. 2). ħa 4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott ’ g m
au Care should be exercised if applying Protopy to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
L- interazzjoni topika ta 'tacrolimus ingwent għadha ma ġietx studjata formalment.
er 4.5 Interaction with other medicinal products and other forms of interaction
Tacrolimus ma jiġiex metabolizzat fil- ġilda umana, u għalhekk m’ hemmx periklu ta 'interazzjoni fil - li
ng Formal topical drug interaction studies with tacrolimus ointment have not been conducted. lo Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus. no
livell tal- ġilda li jista 'jaffettwa l- metaboliżmu ta' tacrolimus. li a
Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Il - in
Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ ml) and is unlikely ct
konċentrazzjoni ta 'tacrolimus fid- demm wara użu fuq il- ġilda hi baxxa (inqas minn 1. 0 ng/ ml) u għalhekk ma tiġiex affettwata minn sustanzi kontra CYP3A4.
However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known du
possibiltà ta 'interazzjoni u għalhekk hemm bżonn ta' attenzjoni fl- użu konkomitanti ta 'sustanzi kontra ed
CYP3A4 inhibitors (e. g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/ or erythrodermic disease should be done with caution. ro
CYP3A4 (erythromycin, itraconazole, ketoconazole u diltiazem) f 'pazjenti li għandhom mard tal- ġilda mifrux ħafna u/ jew f' pazjenti bil- marda eritrodermika. tm
A potential interaction between vaccination and application of Protopy ointment has not been lp
Il- possibilità ta 'interazzjoni bejn Protopy ingwent u t- tilqim għadha mhiex studjata.
In case of live attenuated vaccination, this a
Minħabba li t - tilqima tista ’ ma tirnexxix, it- tilqima għandha ssir qabel tibda t- trattament bi Protopy, jew inkella f ’ perijodu meta t- trattament bi Protopy tkun imwaqqfa u jkun hemm intervall ta ’ 14- il ġurnata bejn ot
period should be extended to 28 days or the use of alternative vaccines should be considered. in ic
Fil- każ ta 'tilqima bil- mikrobi newtralizzati (attenuated) ħajjin, dan l- spazju għandu jkun estiż għal 28 jum jew inkella wieħed għandu juża tipi ta ’ tilqim oħrajn. od
4.6 Pregnancy and lactation ed
4. 6 Tqala u Treddigħ Pr
The potential M
L- istudji fuq l- annimali wrew tossiċità riproduttiva wara li ngħata sistemikament (ara sezzjoni 5. 3).
risk for humans is unknown.
Ir- riskju li jista ’ jkun hemm għal bniedem mhux magħruf.
Protopy ointment should not be used during pregnancy unless clearly necessary.
Protopy ingwent m' għandux jintuża waqt it- tqala sakemm ma jkunx verament meħtieġ.
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopy ointment is not recommended.
4 tacrolimus jintuża bħala ingwent fuq il- ġilda, mhux rakkomandat li Protopy ingwent jintuża f 'pazjenti nisa li jkunu għadhom jreddu.
Protopy ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
L- ingwent Protopy jista ’ jintuża topikament u aktarx li ma jkollu ebda effett fuq il- ħila biex issuq u tħaddem magni.
In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
Madwar 50% tal- pazjenti kellhom xi tip ta ’ irritazzjoni avversa tal- ġilda fil- parti fejn ġie applikat l -
Erythema was a common skin irritation adverse reaction.
riz avversa tal- ġilda komuni wkoll.
Alcohol intolerance (facial flushing or skin irritation after
Ta ’ spiss kien hemm ukoll intolleranza lejn ix- xorb alkoħoliku (ħmura tal- wiċċ jew ħruq tal- ġilda wara xarba alkoħolika).
Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
to Il- pazjenti jista ’ jkollhom ukoll riskju akbar ta ’ follikulite, akne jew infezzjonijiet virali bil- herpes.
is Adverse reactions with suspected relationship to treatment are listed below by system organ class.
aw Reazzjonijiet avversi li dehru li kellhom x 'jaqsmu mat- trattament huma elenkati hawn taħt, skond il - klassi ta ’ l- organu tas- sistema.