qanastek/EMEA-V3 huggingface dataset:
tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders 36
rogħda, uġigħ ta ’ ras attakk ta ’ puplesija, disturbi meta f’ sensik, parestesija u disestesija, newropatiji periferali, sturdamenti, nuqqas ta ’ ħila fil- kitba, disturbi fis- sistema nervuża kôma, emorragiji fis- sistema nervuża ċentrali u diżgrazzji ċerebrovaskolari, paraliżi u pareżi, enċefalopatija, anormalitajiet fil- lingwa u d- diskors, amneżija
dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations
39 dispnoea, disturbi parenkimali pulmonari, effuzzjoni pleurali, farinġite, sogħla, komuni: konġestjoni ta ’ l- imnieħer u infjammazzjonijiet nuqqasijiet respiratorji, taħwid fil- kanal tan- nifs, ażma mhux komuni: rari: sindrome ta ’ għeja respiratorja akuta
37 metabolic acidoses, hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, other electrolyte abnormalities
kondizzjonijiet ipergliċemiċi, dijabete, iperkalemija ipomagnesemija, ipofosfatemija, ipokalemija, ipokalċemija, iponatremija, fluwidu żejjed, iperuriċemija, nuqqas ta ’ aptit, anoressija, aċidożi metabolika, iperlipidemija, iperkolesterolemija, ipertrigliċeridemija, anormalitajiet elektroliti oħra
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Il- pazjenti li qed jieħdu kura immunosuppressiva għandhom riskju akbar li jiżviluppaw tkabbir malinn.
psychotic disorder
disturbi psikotiċi
38 4.9 Overdose
Doża eċċessiva 4. 9
PHARMACOLOGICAL PROPERTIES
41 TAGĦRIF FARMAKOLOĠIKU 5.
The efficacy and safety of Prograf, ciclosporin and Advagraf, all in combination with basiliximab antibody induction, MMF and corticosteroids, was compared in 638 de novo kidney transplant
L- effikaċja u s- sigurta ’ ta ’ Prograf, Ciclosporin u Advagraf, meta ngћataw flimkien ma ’ l- antikorp basiliximab indott, MMF u kortikosterojdi, ġie mqabbel f ’ 638 riċevitur de novo ta ’ trapjant tal - kliewi.
Results from published data of tacrolimus administered twice daily as Prograf capsules in other primary organ transplantation Prograf has evolved into an accepted treatment as primary immunosuppressive medicinal product following pancreas, lung and intestinal transplantation.
42 Riżultati pubblikati minn tagħrif dwar l- għoti darbtejn kuljum ta ’ tacrolimus bħala kapsuli Prograf fi trapjanti ta ’ organi primarji Prograf żviluppa f’ kura aċċettata bħala prodott mediċinali immunosuppressiv primarju wara trapjant tal- pankreas, tal- pulmun u ta ’ l- intestini.
40 Intestinal transplantation Published clinical experience from a single centre on the use of oral Prograf for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
43 biss, 75 l- fwied u l- intestini, u 25 multivixxerali) jieħdu tacrolimus u prednisone kienet ta ’ 75% f’ sena, 54% f’ 5 snin, u 42% f’ 10 snin.
Excretion Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Tneħħija mill- ġisem Wara li ngħata ġol- vini u ġol- ħalq tacrolimus 14C -, il- parti l- kbira tar- radjoattività tneħħiet mal- purgar.
Less
Bejn wieħed u ieħor 2% tar- radjoattività tneħħiet ma ’ l- awrina.
41 than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination.
Inqas minn 1% ta ’ tacrolimus mhux mibdul deher fl- awrina u fil- ħmieġ (faeces), li kien ifisser li tacrolimus hu kważi kompletament metabolizzat qabel ma jkun eliminat: il- bili jidhru l- mod ewlieni kif jitneħħa.
5.3 Preclinical safety data
44 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina 5. 3
Transparent PVC/ PVDC aluminium blister wrapped in an aluminium pouch with a desiccant.
Folja transparenti PVC/ PVDC ta ’ l- aluminju mgeżwer f’ borża ta ’ l- aluminju pouch b ’ desikkant.
42 Pack sizes:
Pakketti ta ’:
Not all pack sizes may be marketed.
45 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
43 ANNEX II
46 ANNESS II
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ B.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan tat- treġija ta ’ Riskju Id- detentur ta ’ l- awtorizzazzjoni gћat- tqegћid fis- suq jikkometti ruћu li jagћmel studji u attivitajiet Farmacoviġilanti oћra kif mniżżel fil- Pjan Farmacoviġilanza, u kif aċċetat fil- verżjoni 3. 2 tal- Pjan tat - treġija ta ’ Riskju (RMP) u preżentat f’ Module 1. 8. 2. tal- applikazzjoni gћall- awtorizzazzjoni gћat - tqegћid fis- suq kif ukoll tibdiliet li jsegwu ta ’ l- RMP li jiġu aċċetati mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kif imsemmi fil- linji gwida tal- CHMP fuq Sistemi tat- treġija ta ’ Riskju gћal prodotti mediċinali gћal konsum mil- bniedem, l- RMP il- ġdid gћandu jiġi sottomess flimkien mal- Periodic Safety Update Report (PSUR) li jmiss.
In addition, an updated RMP should be submitted
RMP mibdul gћandu jiġi sottomess ukoll:
- When new information is received that may impact on the current Safety Specification,
- meta jkun hemm informazzjoni ġdida li tista tћalli impatt fuq is- speċifikazzjonijiet ta ’ sigurta ’
Pharmacovigilance Plan or risk minimisation activities
kurrenti, Pjan Farmacoviġilanza jew fuq l- attivitajiet li jnaqqsu ir- riskju
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- fi żmien 60 ġurnata li jkun ћa jintlaћaq gћan importanti (Pharmacovigilance or Risk
reached
Minimisation)
- At the request of the EMEA
- Fuq rikjesta ta ’ l- EMEA
45 ANNEX III
48 ANNESS III
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Advagraf 0.5 mg Prolonged-Release Capsules (30, 50, 100 Box)
Advagraf 0. 5 mg Kapsuli li jerћu l- mediċina bil- mod (kaxxi ta ’ 30, 50, 100)
Advagraf 0.5 mg Prolonged-release hard capsules Tacrolimus
Advagraf 0. 5 mg kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TA ’ SUSTANZA( I) ATTIVA( I)
0.5 mg tacrolimus.
Kull kapsula fiha 0. 5 mg ta 'tacrolimus
Also contains: lactose, see package leaflet for further information.
Fih ukoll: lactose, għal aktar tagħrif ara l- fuljett tal- pakkett.
30 prolonged-release hard capsules 50 prolonged-release hard capsules 100 prolonged-release hard capsules
30 kapsula iebsin li jerћu l- mediċina bil- mod 50 kapsula iebsin li jerћu l- mediċina bil- mod 100 kapsula iebsin li jerћu l- mediċina bil- mod
Oral use.
Użu mill- ħalq.
Once daily.
Darba kuljum.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) OĦRA SPEĊJALI, JEKK MEĦTIEĠA
Do not swallow the desiccant.
Tiblax id- desikkant
{MM/ YYYY} Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.
JIS [xahar/ sena] Uża l- kapsuli kollha fi żmien sena minn mindu tneħħi l- qartas ta ’ l- aluminju u qabel ma jiskadi.
48 Store in the original package and in a dry place in order to protect from moisture.
51 Aħżen fil- pakkett oriġinali u f’ post xott sabiex tilqa ’ mill- umdità.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 07/ 387/ 001 30 capsules EU/ 1/ 07/ 387/ 002 50 capsules EU/ 1/ 07/ 387/ 009 100 capsules
EU/ 1/ 07/ 387/ 001 30 kapsula EU/ 1/ 07/ 387/ 002 50 kapsula EU/ 1/ 07/ 387/ 009 100 kapsula
{number}
Lot [numru]
Advagraf 0.5 mg
Advagraf 0. 5 mg
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Advagraf 0.5 mg Prolonged-Release Capsules (Blister)
Advagraf 0. 5 mg Kapsuli li jerћu l- mediċina bil- mod (Folja)
NAME OF THE MEDICINAL PRODUCT
L- ISEM TAL- PRODOTT MEDIĊINALI
Advagraf 0.5 mg Prolonged-release hard capsules Tacrolimus
Advagraf 0. 5 mg Kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus
{MM/ YYYY}
JIS [xahar/ sena] >
Once daily.
Darba kuljum
50 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Advagraf 0.5 mg Prolonged-Release Capsules (30, 50 Aluminium Wrapper)
Advagraf 0. 5 mg Kapsuli li jerћu l- mediċina bil- mod (30, 50 f’ Qartas ta ’ l- Aluminju)
Advagraf 0.5 mg Prolonged-release hard capsules Tacrolimus Oral use.
Advagraf 0. 5 mg kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus Jingħata mill- ħalq
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel ma tibda tieħu l- mediċina
{MM/ YYYY} Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.
JIS [xahar/ sena] Uża l- kapsuli kollha fi żmien sena minn mindu tneħħi l- qartas ta ’ l- aluminju u qabel ma jiskadi
30 prolonged-release hard capsules 50 prolonged-release hard capsules
30 kapsula iebsin li jerћu l- mediċina bil- mod 50 kapsula iebsin li jerћu l- mediċina bil- mod
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Advagraf 1 mg Prolonged-Release Capsules (30, 50, 60, 100 Box)
Advagraf 1 mg Kapsuli li jerћu l- mediċina bil- mod (kaxxi ta ’ 30, 50, 60 u 100)
Advagraf 1 mg Prolonged-release hard capsules Tacrolimus
Advagraf 1 mg kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TA ’ SUSTANZI ATTIVI
1 mg tacrolimus.
Kull kapsula fiha 1 mg tacrolimus
Also contains: lactose, see package leaflet for further information.
Fiha ukoll: lactose, għal aktar tagħrif ara l- fuljett tal- pakkett
30 prolonged-release hard capsules 50 prolonged-release hard capsules 60 prolonged-release hard capsules 100 prolonged-release hard capsules
30 kapsula iebsin li jerћu l- mediċina bil- mod 50 kapsula iebsin li jerћu l- mediċina bil- mod 60 kapsula iebsin li jerћu l- mediċina bil- mod 100 kapsula iebsin li jerћu l- mediċina bil- mod
Oral use.
Mill- ħalq.
Read the package leaflet before use.
Aqra l- fuljett kollu qabel tibda tieħu l- mediċina
Store in the original package and in a dry place in order to protect from moisture.
55 Aħżen fil- pakkett oriġinali u f’ post xott sabiex tilqa ’ mill- umdità.
EU/ 1/ 07/ 387/ 003 30 capsules EU/ 1/ 07/ 387/ 004 50 capsules EU/ 1/ 07/ 387/ 005 60 capsules EU/ 1/ 07/ 387/ 006 100 capsules
EU/ 1/ 07/ 387/ 003 30 kapsula EU/ 1/ 07/ 387/ 004 50 kapsula EU/ 1/ 07/ 387/ 005 60 kapsula EU/ 1/ 07/ 387/ 006 100 kapsula
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
56 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Advagraf 1 mg Prolonged-Release Capsules (Blister)
Advagraf 1 mg Kapsuli li jerћu l- mediċina bil- mod (Folja)
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 2.
{MM/ YYYY}
JIS [xahar/ sena]
54 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Advagraf 1 mg Prolonged-Release Capsules (30, 50, 60, 100 Aluminium Wrapper)
Advagraf 1 mg Kapsuli li jerћu l- mediċina bil- mod (30, 50, 60, 100 f’ Qartas ta ’ l- Aluminju)
Advagraf 1 mg Prolonged-release hard capsules Tacrolimus Oral use.
Advagraf 1 mg kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus Mill- ħalq.
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel tużah.
{number}
Lot{ numru}
Advagraf 5 mg Prolonged-Release Capsules (30, 50, 100 Box)
Advagraf 5 mg Kapsuli li jerћu l- mediċina bil- mod (f’ kaxxi ta ’ 30, 50, 100)
Advagraf 5 mg Prolonged-release hard capsules Tacrolimus
Advagraf 5 mg kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus
5 mg tacrolimus.
Kull kapsula fiha 5 mg ta 'tacrolimus
Also contains: lactose, see package leaflet for further information.
Fih ukoll: lactose, għal aktar tagħrif ara l- fuljett tal- pakkett
30 prolonged-release hard capsules 50 prolonged-release hard capsules 100 prolonged-release hard capsules
30 kapsula li jerћu l- mediċina bil- mod 50 kapsula li jerћu l- mediċina bil- mod 100 kapsula li jerћu l- mediċina bil- mod
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel tuża dil- mediċina.
56 Store in the original package and in a dry place in order to protect from moisture.
59 Aħżen fil- pakkett oriġinali u f’ post xott sabiex tilqa ’ mill- umdità.
EU/ 1/ 07/ 387/ 007 30 capsules EU/ 1/ 07/ 387/ 008 50 capsules EU/ 1/ 07/ 387/ 010 100 capsules
EU/ 1/ 07/ 387/ 007 30 kapsula EU/ 1/ 07/ 387/ 008 50 kapsula EU/ 1/ 07/ 387/ 010 100 kapsula
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Advagraf 5 mg Prolonged-Release Capsules (Blister)
Advagraf 5 mg Kapsuli li jerћu l- mediċina bil- mod (Folja)
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
61 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Advagraf 5 mg Prolonged-Release Capsules (30, 50 Aluminium Wrapper)
Advagraf 5 mg Kapsuli li jerћu l- mediċina bil- mod (30, 50 f’ Qartas ta ’ l- Aluminju)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM IL- PRODOTT MEDIĊINALI U KIF JINGĦATA
Advagraf 5 mg Prolonged-release hard capsules Tacrolimus Oral use.
Advagraf 5 mg kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus Mill- ħalq
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel ma tuża dil- mediċina.
60 PACKAGE LEAFLET:
63 FULJETT TA ’ TAGĦRIF:
Advagraf 0.5 mg Prolonged-release hard capsules Advagraf 1 mg Prolonged-release hard capsules Advagraf 5 mg Prolonged-release hard capsules Tacrolimus
Advagraf 0. 5 mg Kapsuli iebsin li jerћu l- mediċina bil- mod Advagraf 1 mg Kapsuli iebsin li jerћu l- mediċina bil- mod Advagraf 5 mg Kapsuli iebsin li jerћu l- mediċina bil- mod Tacrolimus
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan- il fuljett kollu qabel tibda tuża din il- mediċina.
Do not pass it on to others.
M ’ gћandekx tgћaddiha lil persuni oћra.
1.
X’ inhu Advagraf u għalxiex jintuża 1.
What Advagraf is and what it is used for 2.
Qabel ma tuża Advagraf 2.
Before you take Advagraf 3.
Kif għandek tuża Advagraf 3.
How to store Advagraf 6.
Kif taħżen Advagraf 6.
WHAT ADVAGRAF IS AND WHAT IT IS USED FOR
X’ INHU ADVAGRAF U GĦALXIEX JINTUŻA 1.
Advagraf prolonged-release capsules are an additional oral pharmaceutical form of the already available product Prograf capsules.
Il- kapsuli Advagraf li jerћu l- mediċina bil- mod huma forma farmaċewtika orali oħra tal- kapsuli li ġa jeżistu tal- prodott Prograf.
Advagraf is taken once daily, while Prograf is taken twice daily.
Advagraf jittieħed darba kuljum, filwaqt li Prograf jittieħed darbtejn kuljum.
Advagraf belongs to a group of medicines called immunosuppressants.
Advagraf tagħmel parti minn grupp ta ’ mediċini msejħa immunosuppressanti.
Following your organ transplant (liver, kidney), your body’ s immune system will try to reject the new organ.
Wara t- trapjant ta ’ l - organu li tkun għamilt (tal- fwied, tal- kilwa), is- sistema immuni ta ’ ġismek tipprova tirriġetta l- organu l- ġdid.
Advagraf is used to control your body’ s immune response enabling your body to accept the transplanted organ.
Advagraf jintuża biex jikkontrolla r- respons immuni ta ’ ġismek billi jgħinu lil ġismek jaċcetta l- organu trapjantat.
Advagraf is often used in combination with other medicines that also suppress the immune system.
Advagraf sikwit jintuża f’ daqqa ma ’ mediċini oħra li jissopprimu wkoll is- sistema immuni.
You may also be given Advagraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.
Tista ’ wkoll tingħata Advagraf għal riġezzjoni li tkun qed issir tat- trapjant li tkun għamilt tal- fwied, tal- kliewi, tal- qalb jew ta ’ xi organu ieħor jew jekk xi kura li kont qed tieħu qabel ma kinitx biżżejjed biex tikkontrolla dan ir- respons immuni wara t- trapjant tiegħek..
BEFORE YOU TAKE ADVAGRAF
QABEL MA ’ TUŻA ADVAGRAF 2.
Do not take Advagraf
-
- if you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Advagraf.
sustanzi l- oħra ta ’ Advagraf. jekk int allerġiku/ a (tbati minn sensittivita ’ eċċessiva) għal kwalunkwe antibijotiku mis -
antibiotics (e. g. erythromycin, clarithromycin, josamycin).
subgrupp ta ’ antibijotiċi makrolidi (eż. erythromycin, clarithromycin, josamycin).
- You will need to take Advagraf every day as long as you need immunosuppression to prevent
Oqgħod attent/ a ħafna b’ Advagraf Tkun tinħtieġ tieħu Advagraf kuljum sa kemm tkun tinħtieġ l- immunosuppressjoni biex tevita r -
rejection of your transplanted organ.
riġezzjoni ta ’ l- organu trapjantat.
You should keep in regular contact with your doctor.
Għandek iżżomm kuntatt regolari mat- tabib tiegħek.
- Whilst you are taking Advagraf your doctor may want to carry out a number of tests (including
64 Waqt li tkun qed tieħu Advagraf it- tabib tiegħek għandu mnejn ikun irid, minn żmien għal
blood, urine, heart function, visual and neurological tests) from time to time.
żmien, jagħmel xi testijiet (inklużi tad- demm, ta ’ l- awrina, ta ’ kif qed taħdem il- qalb, u testijiet viżwali u newroloġiċi).
This is quite normal and will help your doctor to decide on the most appropriate dose of Advagraf for you.
Din hija ħaġa normali ħafna u tgħin lit- tabib tiegħek jiddeċiedi dwar l - aktar doża addattata għalik ta ’ Advagraf.
- Please avoid taking any herbal remedies, e. g.
Jekk jogħġbok evita li tieħu rimedji ta ’ ħxejjex, eż.
John´s Wort (Hypericum perforatum) or any
John´s wort (Hypericum perforatum)
61 need to receive.
jew xi prodott ieħor tal- ħaxix għax dan jista ’ jeffettwa l- effettività u d- doża ta ’ Advagraf li tkun tinħtieġ tieħu.
If in doubt please consult your doctor prior to taking any herbal products or remedies.
Jekk kollok xi dubju ħu parir tat- tabib tiegħek qabel tieħu kwalunkwe prodotti ta ’ ħxejjex jew rimedji oħra.
- If you have liver problems or have had a disease which may have affected your liver, please tell
Jekk għandek problemi fil- fwied jew kellek xi marda li setgħet effettwatlek il- fwied, jekk
- If you have diarrhoea for more than one day, please tell your doctor, because it might be
jogħġbok għid lit- tabib tiegħek għax din tista ’ teffettwalek id- doża li tieħu ta ’ Advagraf.
necessary to adapt the dose of Advagraf that you receive.
Jekk ikollok id- dijarrea għal aktar minn ġurnata, għid lit- tabib, għax jista ’ jkollok bżonn
- Limit your exposure to sunlight and UV light whilst taking Advagraf by wearing appropriate
Ilbes
protective clothing and using a sunscreen with a high sun protection factor.
ħwejjeġ addattati u protettivi u uża wkoll dlik li jkun fih fattur protettiv qawwi kontra r- raġġi tax- xemx.
This is because of the potential risk of malignant skin changes with immunosuppressive therapy.
Dan għaliex jista ’ jkun hemm potenzjal qawwi ta ’ bidliet malinji fil- ġilda waqt li tkun qed tieħu l- kura immunosuppressiva.
- If you need to have any vaccinations, please inform your doctor beforehand.
Jekk tkun tinħtieġ xi tilqim, jekk jogħġbok avża lit- tabib tiegħek minn qabel.
Your doctor will
It- tabib tiegħek
advise you on the best course of action.
jagħtik parir ta ’ x’ l- aħjar tagħmel.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Meta tuża mediċini 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 u xi kura tal- ħxejjex.
Advagraf must not be taken with ciclosporin.
Advagraf ma jistax jittieħed ma ’ ciclosporin.
Advagraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Advagraf which may require an increase or decrease in Advagraf dose.
Il- livelli tad- demm ta ’ Advagraf jistgħu jkunu effettwati minn mediċini oħra li tieħu, u l- livelli tad - demm ta’ mediċini oħra jistgħu jkunu effettwati bil- Advagraf u tkun tinħtieġ tinqis jew żieda fid- doża ta ’ Advagraf.
In particular, you should tell your doctor if you are taking or have recently taken medicines with active substances like:
B’ mod partikolari għandek tgħid lit- tabib tiegħek jekk tkunx qed tieħu jew jekk ħadtx reċentement xi mediċini b’ sustanzi attivi bħal: mediċini antifungali u antibijotiċi, partikolarment dawk imsejħa antibiotiċi makrolidi, li
infections e. g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin, and rifampicin
jintużaw kontra l- infezzjonijiet eż. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin, u rifampicin inibituri protesi HIV eż. ritonavir
- omeprazol, lansoprazol or cimetidine, used to prevent and to treat stomach ulcers
omeprazol, lansoprazol jew cimetidine, li jintużaw biex jipprevjenu u jikkuraw l- ulċeri fl -
- metoclopramide, used to treat nausea and vomiting
istonku metoclopramide li jintuża għal- kura tad- dardir u r- riġettar
- cisapride or magnesium-aluminium-hydroxide, used to treat heartburn
cisapride jew magnesium- aluminium- hydroxide, li jintuża għal ħruq fl- istonku
- the contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments
il- pillola kontraċettiva jew xi kura oħra ormonali b ’ ethinylestradiol, kura ormonali b’ danazol
- nifedipine, nicardipine, diltiazem and verapamil or other medicines used to treat high blood
nifedipine, nicardipine, diltiazem u verapamil jew mediċini oħra użati fil- kura tal- pressjoni
- medicines known as “ statins” used to treat elevated cholesterol and triglycerides
għolja fid- demm jew għall- problemi kardijaċi mediċini magħrufa bħala “ statins ” jintużaw fil- kura ta ’ min għandu kolesterol għoli u
- phenytoin or phenobarbital, used to treat epilepsy
- phenytoin jew phenobarbital, biex jikkuraw l- epilessija
- prednisolone and methylprednisolone, belonging to the class of corticosteroids
prednisolone u methylprednisolone, jagħmlu mal- klassi tal- kortikosterojdi
- nefazodone, used to treat depression
- nefazodone, kura għad- depressjoni
John’ s Wort (Hypericum perforatum)
John’ s wort (hypericum perforatum)
Tell your doctor if you are taking or need to take ibuprofen, amphotericin B or antivirals (e. g. aciclovir).
Għid lit- tabib tiegħek jekk qed tieħu jew tinħtieġ tieħu ibuprofen, amphotericin B jew antivirali (eż. aciclovir).
These may worsen kidney or nervous system problems when taken together with Advagraf.
Dawn jistgħu jżidulek il- problemi fil- kliewi jew fis- sistema nervuża meta toħodhom flimkien ma ’ Advagraf.
Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e. g. amiloride, triamterene, or spironolactone), certain pain killers (so-called NSAIDs, e. g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you take Advagraf.
It- tabib tiegħek jinħtieġ ukoll ikun jaf jekk, waqt li qed tieħu Advagraf, intix qed tieħu wkoll supplementi ta ’ potassium jew dijuretiċi potassium- sparing (eż. amiloride, triamterene, jew spironolactone), ċerti pilloli għall- uġigħ (msejħa NSAIDs, eż.. ibuprofen), antikoagulanti, jew mediċini orali għall- kura tad- dijabete.
If you need to have any vaccinations, please inform your doctor beforehand.
65 Jekk tinħtieġ xi tilqim, informa lit- tabib minn qabel, jekk jogħġbok.
Taking Advagraf with food and drink You should generally take Advagraf on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal.
Meta tieħu l- Advagraf ma ’ l- ikel u max- xorb Ġeneralment għandek tieħu Advagraf fuq stonku vojt jew għallinqas siegħa qabel jew sagħtejn għal tliet sigħat wara li tiekol.
Grapefruit and grapefruit juice should be avoided while taking Advagraf.
Għandek tevita li tieħu l- grejpfrut kif ukoll is- sugu tal- grejpfrut waqt li tkun qed tieħu Advagraf.
Pregnancy and breast-feeding If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Tqala u treddigħ Jekk tkun qed tippjana tqala jew taħseb li int tqila itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Advagraf is excreted into breast milk.
Advagraf jidħol fil- ħalib tas- sider.
Therefore you should not breast-feed whilst receiving Advagraf.
Għaldaqstant ma għandekx tradda ’ waqt li qed tieħu Advagraf.
62 Driving and using machines Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Advagraf.
Sewqan u tħaddim ta ’ magni Issuqx jew tuża xi għodda jew magni jekk tħoss sturdamenti jew ngħas jew ikollok xi problemi li tara sewwa wara li tieħu Advagraf.
These effects are more frequently observed if Advagraf is taken in conjunction with alcohol use.
Dawn l- effetti jidhru aktar sikwit jekk tieħu Advagraf ma ’ l- alkoħol.
Important information about some of the ingredients of Advagraf If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Advagraf Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi xorta ta ’ zokkor, kellem lit- tabib qabel ma tibda tieħu din il- mediċina.
Always take Advagraf exactly as your doctor has told you.
KIF GĦANDEK TIEĦU ADVAGRAF 3.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk ikkolok xi dubju.
Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Kun ċert li dejjem tingћata l- istess mediċina ta ’ tacrolimus kull meta tiġbor ir- riċetta tiegћek, sakemm l- ispeċjalista tat- trapjanti tiegћek jaqbel li tbidel gћall- mediċina differenti ta ’ tacrolimus.
This medicine should be taken once a day.
Gћandek tieћu din il- mediċina darba kuljum.
If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Jekk id- dehra tal- mediċina mhux l- istess bћal tas- soltu, jew jekk l - istruzzjonijiet tad- dożaġġ inbidlu, kellem lit- tabib jew l- ispiżjar tiegћek mill- aktar fis possibli ћalli tkun ċert li gћandek il- mediċina it- tajba.
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Id- doża li ssoltu tibda biha biex tevita riġezzjoni ta ’ l- organu trapjantat jiddeċidiha t- tabib skond il- piż ta ’ ġismek.
Initial daily doses just after transplantation will generally be in the range of 0.10 – 0.30 mg per kg body weight per day
0. 10 – 0. 30 mg kuljum għal kull kg ta ’ piż tal- ġisem
depending on the transplanted organ.
imma dan jiddependi mill- organu trapjantat.
Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Id- doża tiddependi mill- kondizzjoni ġenerali tiegħek u fuq liema xorta ta ’ kura oħra immunosuppressiva tkun qed tieħu.
Following the initiation of your treatment with Advagraf frequent blood tests will be taken by your doctor to define the correct dose.
Wara li tkun bdejt il- kura b’ Advagraf it- tabib joħodlok sikwit testijiet tad- demm biex ikun jista ’ jasal għad- doża korretta.
Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Wara dan ikun jinħtieġ li t- tabib tiegħek jagħmillek testijiet regolari tad- demm biex jiddefinixxi d- doża korretta u jaġġustha minn żmien għal żmien.
Your doctor will usually reduce your Advagraf dose once your condition has stabilised.
It- tabib tiegħek aktarx li jnaqqaslek id- doża ta ’ Advagraf jekk jara li l- kondizzjoni tiegħek tkun stabbilit ruħha.
Your doctor will tell you exactly how many capsules to take and how often.
It- tabib tiegħek jgħidlek eżatt kemm u kulmeta għandek tieħu kapsuli.
Advagraf is taken orally once daily in the morning.
Advagraf tittieħed mill- ħalq filgħodu darba kuljum.
You should generally take Advagraf on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal.
Ġeneralment għandek tieħu Advagraf fuq stonku vojt jew għallinqas siegħa qabel jew sagħtejn għal tliet sigħat wara li tiekol.
Avoid grapefruit and grapefruit juice while taking Advagraf.
Il- kapsuli għandhom jinbelgħu sħaħ ma ’ tazza ilma. Għandek tevita li tieħu l- grejpfrut kif ukoll is- sugu tal- grejpfrut waqt li tkun qed tieħu Advagraf.
Do not swallow the desiccant contained in the foil wrapper.
Tiblax id- desikkant li jkun hemm fil- qartas tal- fidda.
If you take more Advagraf than you should If you have accidentally taken too much Advagraf see your doctor or contact your nearest hospital emergency department immediately.
Jekk tieħu aktar Advagraf milli suppost Jekk bi żball ħadt Advagraf aktar milli jmissek kellem lit- tabib tiegħek jew aqbad filpront mad - dipartiment ta ’ l- emerġenza ta ’ l- eqreb sptar.
If you forget to take Advagraf If you have forgotten to take your Advagraf capsules in the morning, take them as soon as possible on the same day.
66 Jekk filgħodu nsejt tieħu l- kapsuli ta ’ Advagraf, ħudhom mill- aktar fis possibbli dakinhar stess.
Do not take a double dose the next morning.
Tiħux doża doppja l- għada filgħodu.
If you stop taking Advagraf Stopping your treatment with Advagraf may increase the risk of rejection of your transplanted organ.
Jekk tieqaf tieħu Advagraf Jekk twaqqaf il- kura ta ’ Advagraf tista ’ tkabbar ir- riskju ta ’ riġezzjoni ta ’ l- organu trapjantat.
Do not stop your treatment unless your doctor tells you to do so.
Twaqqafx il- kura jekk it- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
Like all medicines, Advagraf can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Advagraf jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Immunosuppressants, including Advagraf, reduce your body´s own defence mechanisms to stop you rejecting your transplanted organ.
Immunosuppressanti, inkluż Advagraf, inaqqsu l- mekkaniżmi ta ’ difiża tal- ġisem tiegħek stess sabiex iwaqqfuk milli tirrifjuta l- organu trapjantat tiegħek.
Consequently your body will not be as good as normal at fighting infections.
Konsegwentament, il- ġisem tiegħek ma jibqax daqstant tajjeb daqs is- soltu fil- ġlieda tiegħu kontra l- infezzjonijiet.
So if you are taking Advagraf you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Għalhekk, jekk qed tieħu Advagraf, tista ’ tieħu aktar infezzjonijiet min- normal bħal infezzjonijiet tal- ġilda, tal- ħalq, ta ’ l - istonku u ta ’ l- intestini, tal- pulmun u tal- passaġġ ta ’ l- awrina.
Severe effects may occur, including allergic and anaphylactic reactions.
Jista ’ jkun hemm xi effetti serji, inklużi reazzjonijiet allerġiċi u anafilattiċi.
Benign and malignant tumours have been reported following Advagraf treatment as a result of immunosuppression.
Wara l- kura b’ Advagraf ġie li ġew rapportati tumuri beninji u malinji bħala riżultat ta ’ l- immunosuppressjoni.
Possible side effects are listed according to the following categories:
L- effetti sekondarji possibbli huma mniżżla hawn taħt skond il- kategorija msemmija:
Common side effects are experienced in less than 1 in 10 patients but in at least 1 per 100 patients.
Effetti sekondarji komuni ħafna li jħosshom mill- inqas 1 minn kull 10 pazjenti Effetti sekondarji komuni li jħosshom inqas minn pazjent 1 kull 10 pazjenti iżda f’ aktar minn 1 kull 100 pazjent.
Uncommon side effects are experienced in less than 1 in 100 patients but in at least 1 per 1,000 patients.
Effetti sekondarji mhux komuni li jħosshom inqas minn 1 kull 100 pazjent iżda f’ aktar minn 1 kull 1, 000 pazjent.
Rare side effects are experienced in less than 1 per 1,000 patients but in at least 1 per 10,000 patients.
Effetti sekondarji rari li jħosshom inqas minn 1 kull 1, 000 pazjent iżda aktar minn 1 kull 10, 000 pazjent.
Very rare side effects are experienced in less than 1 per 10,000 patients.
Effetti sekondarji rari ħafna li jħosshom inqas minn 1 kull 10, 000 pazjent.
- Increased blood sugar, diabetes mellitus, increased potassium in the blood
Żieda taz- zokkor fid- demm, dijabete, żieda ta ’ potassium fid- demm
- Difficulty in sleeping
- Diffikultà fl- irqad
- Trembling, headache
Rogħda, uġigħ ta ’ ras
- Increased blood pressure
Żieda fil- pressjoni tad- demm
- Diarrhoea, nausea
-
- Kidney problems
- Dijarrea, dardir
Common side effects:
- Problemi fil- kliewi
- Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell
Tinqis fil- għadd taċ- ċelluli tad- demm (platelits, ċelluli ħomor jew bojod tad- demm), żieda fil -
- Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
għadd taċ- ċelluli bojod tad- demm, tibdil fil- għadd taċ- ċelluli l- ħomor tad- demm Tinqis fid- demm ta ’ magnesium, phosphate, potassium, calcium jew sodium, fluwidu żejjed,
increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts
żieda fid- demm ta ’ aċidu uriku jew lipidi, nuqqas ta ’ aptit, żieda fl- aċidità tad- demm, bidliet oħra fil- melħ tad- demm Sintomi ta ’ anzjetà, taħwid u diżorjentazzjoni, depressjoni, tibdil fil- burdati, ħmar- il- lejl,
- Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
alluċinazzjonijiet, disturbi mentali Aċċessjonijiet, tfixkil meta f’ sensik, tnemnim u tirżiħ (nuqqas ta ’ ħass) (kultant li jwaġġa ’) fl -
- Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and
idejn u s- saqajn, sturdamenti, nuqqas ta ’ ħila fil- kitba, disturbi fis- sitema nervuża Viżjoni mċajpra, sensittività akbar għad- dawl, disturbi fil- għajnejn
- Blurred vision, increased sensitivity to light, eye disorders
Ħsejjes ta ’ ċenċil fil- widnejn
- Reduced blood flow in the heart vessels, faster heartbeat
Tinqis ta ’ ċirkolazzjoni ta ’ demm fil- vini tal- qalb, qalb tħabbat aktar malajr
- Bleeding, partial or complete blocking of blood vessels, reduced blood pressure
Fsad, sadda parzjali jew sħiħa tal- vini, tinqis ta ’ pressjoni fid- demm
- Shortness in breath, changes in the lung tissue, collection of liquid around the lung,
67 Qtugħ ta ’ nifs, tibdil fit- tessut tal- pulmun, ġbir ta ’ likwidu madwar il- pulmun, infjammazzjoni
- Inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach,
tat- tefarinġi, sogħla, sintomi bħal ta ’ l- influwenza Infjammazzjonijiet jew ulċeri li jikkaġunaw uġigħ addomenali jew dijarrea, fsad fl- istonku,
inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, flatulence, bloating, loose stools, stomach problems
infjammazzjonijiet jew ulċeri fil- ħalq, ġabra ta ’ fluwidu fiż- żaqq, riġettar, uġigħ addomenali, indiġistjoni, kostipazzjoni, uġigħ ta ’ gas fl- istonku, nefħa, purgar maħlul, problemi ta ’ l- istonku Tibdil fil- funzjoni u fl- enżimi tal- fwied, sfura fil- ġilda minħabba problemi tal- fwied, ħsara fit -
- Changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue
tessut tal- fwied u infjammazzjoni tal- fwied Ħakk, raxx, telf ta ’ xagħar, akne, żieda fl- għaraq
- Itching, rash, hair loss, acne, increased sweating
Uġigħ fil- ġogi, dirgħajn, riġlejn jew dahar, krampi muskolari (bugħawieġ)
- Insufficient function of the kidneys, reduced production of urine, impaired or painful urination
Nuqqas ta ’ ħidma tal- kliewi, tinqis fil- produzzjoni ta ’ l- awrina, urinazzjoni batuta jew bl- uġigħ
- General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the
Debbulizza ġenerali, deni, ġabra ta ’ fluwidu fil- ġisem, uġigħ u skonfort, żieda ta ’ enżimi
enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed
alkalini fosfati fid- demm, żieda fil- piż, ħass ta ’ disturbi fit- temperatura Nuqqas ta ’ ħidma fl- organu trapjantat.
- Insufficient function of your transplanted organ
Effetti sekondarji mhux komuni:
- Changes in blood clotting, reduction in all blood cell counts
Deidrazzjoni (nixfa), tinqis ta ’ proteini jew zokkor fid- demm, żieda fil- fusfati fid- demm
- Dehydration, reduced protein or sugar in the blood, increased phosphate in the blood
Kôma, emoraġġija fil- moħħ, attakk, paraliżi, disturbi fil- moħħ, anormalitajiet fil- kliem u fil -
- Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language
lingwa, problemi ta ’ memorja Lenti mżellġa/ mhux ċara
- Opacity of the lens
Smigħ mhux ċar
- Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart
Taħbit irregolari tal- qalb, waqfien tat- taħbit tal- qalb, tinqis fil- ħidma tal- qalb, taqlib fil -
muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal
muskolu tal- qalb, nefha tal- muskolu tal- qalb, taħbit aktar qawwi tal- qalb, ECG anormali, taħbit anormali tal- qalb u tal- polz Għoqda demm f’ vina ta ’ id jew ta ’ sieq, xokk
- Difficulties in breathing, respiratory tract disorders, asthma
Diffikultajiet fin- nifs, taqlib fil- kanal respiratorju, ażma
- Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content
Ostruzzjoni fil- musrana, żieda fil- livell tad- demm ta ’ l- enżima amylase, titligħ tal- kontenut ta ’
in your throat, delayed emptying of the stomach
l- istonku fil- grieżem, dewmien tad- tbattil tal- istonku
- Dermatitis, burning sensation in the sunlight
- Dermatite, sensazzjoni ta ’ hruq fix- xemx
- Joint disorders
- Disturbi tal- ġogi
- Inability to urinate, painful menstruation and abnormal menstrual bleeding
Nuqqas ta ’ ħila li tneħħi l- awrina, menstruazzjoni bl- uġigħ u tneħħija ta ’ demm anormal
- Failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of
Xi organi li ma jibqgħux jiffunzjonaw, xorta ta ’ mard qisu influwenza, sensittività akbar għas -
pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss
sħun u l- kiesaħ, ħass ta ’ pressjoni fuq is- sider, tferfir jew xi ħass ieħor mhux tas- soltu, żieda ta ’ l - enżima lactate dehydrogenase fid- demm, tinqis fil- piż
Rare side effects:
Effetti sekondarji rari:
- Small bleedings in your skin due to blood clots
-
- Increased muscle stiffness
Żieda fl- ebusija muskolari
- Blindness
- Għama
- Deafness
- Turxien
- Collection of fluid around the heart
Ġbir ta ’ fluwidu madwar il- qalb
- Acute breathlessness
-
- Cyst formation in your pancreas
- Qtigħ ta ’ nifs akuta
- Problems with blood flow in the liver
Formazzjoni ta ’ ċiste fil- pankreas
- Serious illness with blistering of skin, mouth, eyes and genitals; increased hairiness
Mard serju b’ infafet fil- ġilda, fil- ħalq, fl- ghajnejn u fil- ġenitali; żieda fil- pil
- Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Għatx, uqigħ, ħass ta ’ għefis fis- sider, nuqqas ta ’ mobbiltà, ulċera
- Muscular weakness
Dgħufija muskolari
- Echocardiogram abnormal
- Ekokardjogramma anormali
- Liver failure, narrowing of the bile vessel
Fwied ma jaħdimx, djuq tal- kanal tal- bili
- Painful urination with blood in the urine
- Tbatija biex turina bid- demm fl- awrina
- Increase of fat tissue
Żieda fit tessut xaħmi
HOW TO STORE ADVAGRAF
KIF TAĦŻEN ADVAGRAF
Store in the original package and in a dry place in order to protect from moisture.
Żommu fil- pakkett oriġinali u f’ post xott sabiex tilqa ’ mill- umdità
Take the prolonged-release capsules immediately following removal from the blister.
Ħu l- kapsuli li jerћu l- mediċina bil- mod filpront wara li tneħħihom mill- qartas.
Do not use Advagraf after the expiry date which is stated on the carton after “ Exp”.
Tużax Advagraf wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
Use all the prolonged-release capsules within 1 year of opening the aluminium wrapping.
Uża l- kapsuli li jerћu l- mediċina bil- mod fi żmien sena minn meta tiftaħ il- qartas tagħhom.
65 What Advagraf contains
X’ fih Advagraf
- The active substance is tacrolimus.
- Is- sustanza attiva hi tacrolimus
Each capsule of Advagraf 0.5 mg contains 0.5 mg of tacrolimus.
Kull kapsula Advagraf 0. 5mg: fiha 0. 5 mg ta ’ tacrolimus.
Each capsule of Advagraf 1 mg contains 1 mg of tacrolimus.
Kull kapsula Advagraf 1mg fiha 1 mg ta ’ tacrolimus.
Each capsule of Advagraf 5 mg contains 5 mg of tacrolimus.
Kull kapsula Advagraf 5mg fiha 5 mg ta ’ tacrolimus.
- The other ingredients are:
Is- sustanzi l- oħra huma:
Hypromellose, Ethylcellulose, Lactose, Magnesium stearate.
Hypromellose, Ethylcellulose, Lactose, Magnesium stearate.
Titanium dioxide (E171), Yellow iron oxide (E 172), Red iron oxide (E 172), Gelatin.
Titanium dioxide (E171), Yellow iron oxide (E 172), Red iron oxide (E 172), Gelatin.
Printing ink:
Stampat bil- linka:
Shellac, Lecithin (soya), Simethicone, Red iron oxide (E 172), Hydroxypropyl Cellulose.
Shellac, Lecithin (soya), Simethicone, Red iron oxide (E172), Hydroxypropyl Cellulose.
What Advagraf looks like and contents of the pack
Id- dehra ta ’ Advagraf u l- kontenuti tal- pakkett
Advagraf 0.5 mg Prolonged-release capsules are hard gelatin capsules imprinted in red with “ 0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder.
Il- kapsuli ta ’ Advagraf 0. 5 mg li jerћu l- mediċina bil- mod huma kapsuli iebsa tal- ġelatina stampati bl - aħmar b ’ “ 0. 5 mg ” fuq l- għatu isfar ċar tal- kapsula u b ’ “  647 ” fuq l- għatu aranġjo tal- kapsula, mimlija trab abjad.
Advagraf 0.5 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Il- kapsuli ta ’ Advagraf 0. 5 mg li jerћu l- mediċina bil- mod issibhom fil- folji ta ’ 10 kapsuli mqarsta fil- fidda, b’ desikkant.
Packs of 30, 50 and 100 prolonged-release capsules are available.
Issib ukoll il- kapsuli li jerћu l- mediċina bil- mod f’ pakketti ta ’ 30, 50 u ta ’ 100.
Advagraf 1 mg Prolonged-release capsules are hard gelatin capsules imprinted in red with “ 1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder.
Advagraf 1 mg li jerћu l- mediċina bil- mod huma kapsuli iebsa tal- ġelatina stampati bl- aħmar “ 1 mg ” fuq l- għatu abjad tal- kapsula u b ’ “  677 ” fuq l- għatu aranġjo tal- kapsula, mimlija trab abjad.
Advagraf 1 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Il - kapsuli ta ’ Advagraf 1 mg li jerћu l- mediċina bil- mod issibhom fil- folji ta ’ 10 kapsuli mqarsta fil - fidda, b’ desikkant.
Packs of 30, 50, 60 and 100 prolonged-release capsules are available.
Issib ukoll il- kapsuli li jerћu l- mediċina bil- mod f’ pakketti ta ’ 30, 50, 60 u 100.
Advagraf 5 mg Prolonged-release capsules are hard gelatin capsules imprinted in red with “ 5 mg” on the greyish red capsule cap and “ 687” on the orange capsule body, containing white powder.
Il- kapsuli ta ’ Advagraf 5 mg li jerћu l- mediċina bil- mod huma kapsuli iebsa tal- ġelatina stampati bl - aħmar b ’ “ 5 mg ” fuq l- għatu aħmar jagħti fil- griż tal- kapsula u b ’ “ 687 ” fuq l- għatu aranġjo tal - kapsula, mimlija trab abjad.
Advagraf 5 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Il- kapsuli ta ’ Advagraf 5 mg li jerћu l- mediċina bil- mod issibhom fil- folji ta ’ 10 kapsuli mqarsta fil- fidda, b’ desikkant.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti qegħdin għal bejgħ.
Marketing Authorisation Holder:
Detentur ta ’ l- Awtorizzazzjoni għas- Suq:
Elisabethhof 19 2353 EW Leiderdorp Netherlands
69 2353 EW Leiderdorp L- Olanda
Ελλάδα Astellas Pharmaceuticals AEBE Θουκυδίδου 1 GR-14565 Άγιος Στέφανος Αττικής Τηλ: +30 210 8189900
70 Ελλάδα Astellas Pharmaceuticals AEBE Θουκυδίδου 1 GR- 14565 Άγιος Στέφανος Αττικής Τηλ: +30 210 8189900
What is Advate?
X’ inhu Advate?
Advate is a powder and solvent that are mixed together to make a solution for injection.
Advate huwa trab u solvent li jitħalltu flimkien biex jiffurmaw taħlita għall- injezzjoni.
Advate contains the active substance octocog alfa (human coagulation factor VIII).
Advate jikkonsisti fis- sustanza attiva octocog alfa (fattur tal- koagulazzjoni VIII fil- bniedem).
What is Advate used for?
Għal x’ hiex jintuża Advate?
Advate is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Advate jintuża għat- trattament ta ’ fsada f’ pazjenti li jbatu mill- emofilja A (marda li tintiret u tikkawża t- telf tad- demm ikkaġunata minnħabba fin- nuqqas tal- fattur VIII).
Advate is intended for either short-term or long-term use.
Advate jista ’ jintuża kemm fuq firxa ta ’ żmien qasir kif ukoll fuq firxa ta ’ żmien twil.
How is Advate used?
Kif jintuża Advate?
Advate should be started by a doctor who has experience in the treatment of haemophilia.
Advate għandu jinbeda minn tabib li għandu esperjenza fit- trattament tal- emofilja.
Advate is given by injection into a vein at a rate of up to 10 ml per minute.
Advate jingħata permezz ta ’ injezzjoni għal ġol- vina b’ rata ta ’ mhux aktar minn 10 ml kull minuta.
The dose and frequency depend on whether Advate is used to treat haemorrhage (bleeding) or to prevent it during surgery.
Id- doża u l - frekwenza jiddependu fuq jekk Advate jintużax għat- trattament ta ’ emorraġija (tnixxija tad- demm) jew biex jimpedixxiha waqt il- kirurġija.
The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Aġġustament fid- doża jiddependi wkoll mis- severità tal - emorraġija jew mit- tip ta ’ kirurġija.
Full details on how to calculate the doses are included in the Package Leaflet.
Dettalji sħaħ fuq kif tikkalkula d- dożi huma inklużi fil- Fuljett ta ’ Tagħrif mehmuż mal- pakkett.
How does Advate work?
Kif jaħdem Avate?
The active substance in Advate, octocog alfa, is a blood coagulation factor protein.
Octocog alfa, is- sustanza attiva f’ Advate, hija proteina fattur tal- koagulazzjoni tad- demm.
In the body, factor VIII is one of the substances (factors) involved in blood coagulation (clotting).
Fil- ġisem, il- fattur VIII huwa wieħed mis- sustanzi (fatturi) li jgħaqqdu d- demm (koagulazzjoni tad- demm).
Patients with haemophilia A lack factor VIII, and this causes blood coagulation problems, such as bleeding in the joints, muscles or internal organs.
Pazjenti bl- emofilja A għandhom nuqqas tal- fattur VIII, u dan jikkaġuna problemi ta ’ koagulazzjoni tad- demm, bħal tnixxija ta ’ demm fil- ġogi, muskoli jew organi interni.
Advate is used to replace the missing factor VIII.
Advate jintuża biex jissostitwixxi l- fattur VIII li jkun nieqes.
It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder.
Huwa jikkoreġi d- defiċjenza tal- fattur VIII u jikkontrolla l - fsad b’ mod temporanju.
Octocog alfa is not extracted from human plasma but produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
Octocog alfa ma huwiex estratt mill- plażma umana imma magħmul permezz ta ’ metodu magħruf bħala ‘ teknoloġija rikombitanti tad- DNA ’: huwa magħmul minn ċellola li ngħatat ġene (DNA), li ġġiegħlha tipproduċi l- fattur VIII tal- koagulazzjoni tal- bniedem.