qanastek/EMEA-V3 huggingface dataset:
Discard the syringe and any unused solution in accordance with appropriate clinical procedures.
Armi s- siringa u xi soluzzjoni mhux użata skond il- proċeduri kliniċi applikabbli.
Use the solution immediately within 1 hour of reconstitution.
Uża s- soluzzjoni immedjatament fi żmien siegħa minn meta tħallatha.
Parenteral medicines should be inspected visually for particulate matter prior to administration.
Mediċini parenterali għandhom ikunu miflija bir- reqqa għal xi frak qabel ma jintużaw.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL-3991 RA, Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1 - 5, NL- 3991 RA, Houten, L- Olanda.
10 vials
EU/ 1/ 96/ 022/ 016 – ZYPREXA - Trab għal soluzzjoni għall- injezzjoni, kunjett 1 EU/ 1/ 96/ 022/ 017 – ZYPREXA - Trab għal soluzzjoni għall- injezzjoni, 10 kunjetti
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott U
Coated Tablets:
U
Powder for solution for injection:
U
The Marketing Authorisation Holder will provide the PSUR annually.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq se jipprovdi l- PSUR kull sena.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jagħmel l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f- verżjoni 1. 1 tal - Pjan għall- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ aġġornamenti sussegwenti tal- RMP kif miftiehem mal- 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 dettaljat fil- Linji Gwida tal- CHMP fuq i- Sistemi għall- Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess mar- Rapport Perjodiku ta ’ Aġġornament Dwar Sigurta ’ (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Minn barra hekk, RMP aġġornat għandu għandu jiġi sottomess • Meta tiġi miġbura xi informazzjoni ġdida li tista taffetwa l- ispeċifikazzjoni attwali dwar is - Sigurta ’, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ Riskji • Fi żmien 60 ġurnata minn meta tkun intlaħqet xi ġrajja importanti (ta ’ farmakoviġilanza jew tnaqqis ta ’ riskju) • Meta jkun mitlub mill- EMEA
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
ZYPREXA 2.5 mg coated tablets olanzapine
ZYPREXA 2. 5 mg pilloli miksija olanzapine
Each coated tablet contains 2.5 mg olanzapine
Kull pillola miksija fiha 2. 5mg olanzapine
Contains lactose monohydrate see package leaflet for further information
Fiha lactose monohydrate ara l- fuljett ta 'tagħrif għal aktar informazzjoni
28 coated tablets 35 coated tablets 56 coated tablets 70 coated tablets
28 pillola miksija 35 pillola miksija 56 pillola miksija 70 pillola miksija
Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umdità
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1 - 5, NL- 3991 RA Houten, L- Olanda
EU/ 1/ 96/ 022/ 002 28 coated tablets EU/ 1/ 96/ 022/ 023 35 coated tablets EU/ 1/ 96/ 022/ 019 56 coated tablets EU/ 1/ 96/ 022/ 029 70 coated tablets
EU/ 1/ 96/ 022/ 002 28 pillola miksija EU/ 1/ 96/ 022/ 023 35 pillola miksija EU/ 1/ 96/ 022/ 019 56 pillola miksija EU/ 1/ 96/ 022/ 029 70 pillola miksija
105 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ZYPREXA 2.5 mg COATED TABLETS:
ZYPREXA 2. 5 mg PILLOLI MIKSIJA:
BLISTER FOIL LABEL
TIKKETTA TAL- FOLJA TAL- FOJL
ZYPREXA 2.5 mg coated tablets Olanzapine
ZYPREXA 2. 5 mg pilloli miksija Olanzapine
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ZYPREXA 5 mg coated tablets olanzapine
ZYPREXA 5 mg pilloli miksija olanzapine
Each coated tablet contains 5 mg olanzapine
Kull pillola miksija fiha 5 mg olanzapine
Store in the original package in order to protect from light and moisture
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umdità
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands
Eli Lilly Nederland BV, Grootslag 1 - 5, NL- 3991 RA Houten, L- Olanda
EU/ 1/ 96/ 022/ 004 28 coated tablets EU/ 1/ 96/ 022/ 024 35 coated tablets EU/ 1/ 96/ 022/ 020 56 coated tablets EU/ 1/ 96/ 022/ 030 70 coated tablets
EU/ 1/ 96/ 022/ 004 28 pillola miksija EU/ 1/ 96/ 022/ 024 35 pillola miksija EU/ 1/ 96/ 022/ 020 56 pillola miksija EU/ 1/ 96/ 022/ 030 70 pillola miksija
108 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ZYPREXA 5 mg COATED TABLETS:
ZYPREXA 5 mg PILLOLI MIKSIJA:
ZYPREXA 5 mg coated tablets Olanzapine
ZYPREXA 5 mg pilloli miksija Olanzapine
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ZYPREXA 7.5 mg coated tablets olanzapine
ZYPREXA 7. 5 mg pilloli miksija olanzapine
Each coated tablet contains 7.5 mg olanzapine
Kull pillola miksija fiha 7. 5mg olanzapine
Contains lactose monohydrate see package leaflet for further information
Fiha: lactose monohydrate ara l- fuljett ta 'tagħrif għal aktar informazzjoni
EU/ 1/ 96/ 022/ 01128 coated tablets EU/ 1/ 96/ 022/ 025 35 coated tablets EU/ 1/ 96/ 022/ 006 56 coated tablets EU/ 1/ 96/ 022/ 031 70 coated tablets
EU/ 1/ 96/ 022/ 011 28 pillola miksija EU/ 1/ 96/ 022/ 025 35 pillola miksija EU/ 1/ 96/ 022/ 006 56 pillola miksija EU/ 1/ 96/ 022/ 031 70 pillola miksija
111 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
112 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ZYPREXA 7.5 mg COATED TABLETS:
ZYPREXA 7. 5 mg PILLOLI MIKSIJA:
ZYPREXA 7.5 mg coated tablets Olanzapine
ZYPREXA 7. 5 mg pilloli miksija Olanzapine
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ZYPREXA 10 mg coated tablets olanzapine
ZYPREXA 10 mg pilloli miksija olanzapine
Each coated tablet contains 10 mg olanzapine
Kull pillola miksija fiha 10 mg olanzapine
7 coated tablets 28 coated tablets 35 coated tablets 56 coated tablets 70 coated tablets
7 pilloli miksija 28 pillola miksija 35 pillola miksija 56 pillola miksija 70 pillola miksija
EU/ 1/ 96/ 022/ 008 7 coated tablets EU/ 1/ 96/ 022/ 009 28 coated tablets EU/ 1/ 96/ 022/ 026 35 coated tablets EU/ 1/ 96/ 022/ 010 56 coated tablets EU/ 1/ 96/ 022/ 032 70 coated tablets
EU/ 1/ 96/ 022/ 008 7 pillola miksija EU/ 1/ 96/ 022/ 009 28 pillola miksija EU/ 1/ 96/ 022/ 026 35 pillola miksija EU/ 1/ 96/ 022/ 010 56 pillola miksija EU/ 1/ 96/ 022/ 032 70 pillola miksija
114 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
115 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ZYPREXA 10 mg COATED TABLETS:
ZYPREXA 10 mg PILLOLI MIKSIJA:
ZYPREXA 10 mg coated tablets Olanzapine
ZYPREXA 10 mg pillola miksija Olanzapine
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ZYPREXA 15 mg coated tablets olanzapine
ZYPREXA 15 mg pilloli miksija olanzapine
Each coated tablet contains 15 mg olanzapine
Kull pillola miksija fiha 15 mg olanzapine
EU/ 1/ 96/ 022/ 012 28 coated tablets EU/ 1/ 96/ 022/ 027 35 coated tablets EU/ 1/ 96/ 022/ 021 56 coated tablets EU/ 1/ 96/ 022/ 033 70 coated tablets
EU/ 1/ 96/ 022/ 012 28 pillola miksija EU/ 1/ 96/ 022/ 027 35 pillola miksija EU/ 1/ 96/ 022/ 021 56 pillola miksija EU/ 1/ 96/ 022/ 033 70 pillola miksija
117 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
118 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ZYPREXA 15 mg COATED TABLETS:
ZYPREXA 15 mg PILLOLI MIKSIJA:
ZYPREXA 15 mg coated tablets Olanzapine
ZYPREXA 15 mg pillola miksija Olanzapine
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
119 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ZYPREXA 20 mg coated tablets olanzapine
ZYPREXA 20 mg pilloli miksija olanzapine
Each coated tablet contains 20 mg olanzapine
Kull pillola miksija fiha 20 mg olanzapine
EU/ 1/ 96/ 022/ 014 28 coated tablets EU/ 1/ 96/ 022/ 028 35 coated tablets EU/ 1/ 96/ 022/ 022 56 coated tablets EU/ 1/ 96/ 022/ 034 70 coated tablets
EU/ 1/ 96/ 022/ 014 28 pillola miksija EU/ 1/ 96/ 022/ 028 35 pillola miksija EU/ 1/ 96/ 022/ 022 56 pillola miksija EU/ 1/ 96/ 022/ 034 70 pillola miksija
120 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
121 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ZYPREXA 20 mg COATED TABLETS:
ZYPREXA 20 mg PILLOLI MIKSIJA:
ZYPREXA 20 mg coated tablets Olanzapine
ZYPREXA 20 mg pilloli miksija Olanzapine
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
122 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
CARTON OF VIAL OF POWDER
KARTUNA TA 'KUNJETT TA' TRAB
ZYPREXA 10 mg powder for solution for injection olanzapine
ZYPREXA 10 mg trab għal soluzzjoni għall- injezzjoni, Olanzapine
Each vial contains 10 mg olanzapine.
Kull kunjett fih 10 mg olanzapine.
After reconstitution each ml of the solution contains 5 mg olanzapine
Wara r- rikostituzzjoni kull ml ta 'soluzzjoni fih 5 mg olanzapine
Lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide
Lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide
1 vial Powder for solution for injection.
Kunjett 1 Trab għal soluzzjoni għall- injezzjoni.
Intramuscular use.
Għall- użu minn ġol- muskoli.
Single use vial.
Kunjett li jintuża darba.
EXP Use solution within 1 hour
JIS Uża s- soluzzjoni fi żmien siegħa
Do not store above 25º C.
Taħżinx f' temperatura 'l fuq minn 25°C.
Store in original package in order to protect from light
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl
Discard syringe and unused solution appropriately
Armi s- siringa u s- soluzzjoni mhux użata kif jixraq
EU/ 1/ 96/ 022/ 016 Powder for solution for injection.
EU/ 1/ 96/ 022/ 016 Trab għal soluzzjoni għall- injezzjoni.
1 vial EU/ 1/ 96/ 022/ 017 Powder for solution for injection.
Kunjett 1 EU/ 1/ 96/ 022/ 017 Trab għal soluzzjoni għall- injezzjoni.
LABEL ON VIAL OF 10 mg POWDER
TIKKETTA FUQ IL- KUNJETT TAT- TRAB TA ’ 10 mg
ZYPREXA 10 mg olanzapine powder for solution for injection IM use
ZYPREXA 10 mg olanzapine trab għal soluzzjoni għall- injezzjoni Għall- użu IM
10 mg olanzapine per vial
10 mg olanzapine f' kull kunjett
125 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
ZYPREXA 2.5 mg coated tablets ZYPREXA 5 mg coated tablets ZYPREXA 7.5 mg coated tablets ZYPREXA 10 mg coated tablets ZYPREXA 15 mg coated tablets ZYPREXA 20 mg coated tablets olanzapine
ZYPREXA 2. 5 mg, pilloli miksija ZYPREXA 5 mg, pilloli miksija ZYPREXA 7. 5 mg, pilloli miksija ZYPREXA 10 mg, pilloli miksija ZYPREXA 15 mg, pilloli miksija ZYPREXA 20 mg, pilloli miksija
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
M' għandekx tgħaddiha lill- persuni oħra.
Do not pass it on to others.
Tista 'tagħmlilhom il -
What ZYPREXA is and what it is used for 2.
X’ inhi ZYPREXA u għalxiex tintuża 2.
Before you take ZYPREXA 3.
3.
How to take ZYPREXA 4.
Kif għandek tieħu ZYPREXA.
Possible side effects 5.
Kif taħżen ZYPREXA.
WHAT ZYPREXA IS AND WHAT IT IS USED FOR
X’ INHI ZYPREXA U GĦALXIEX TINTUŻA
ZYPREXA belongs to a group of medicines called antipsychotics.
ZYPREXA tappartjeni għall- grupp ta 'mediċini msejħa antipsikotiċi.
ZYPREXA is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
ZYPREXA hija użata biex tiġi kurata marda b' sintomi bħal li tisma ', li tara jew li tħoss affarijiet li mhux qegħdin hemm, twemmin żbaljat, suspetti mhux tas- soltu, u li tingħalaq fik innifsek.
ZYPREXA is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
ZYPREXA hija użata biex tiġi kkurata kundizzjoni b' sintomi bħal li tħossok fi stat ta 'ferħ eċċessiv, li jkollok ammonti ta' enerġija eċċessiva, li jkollok bżonn ħafna anqas irqgħad mis- soltu, li titkellem mgħaġġel b' ħafna ħsibijiet jiġru f' moħħok u xi kultant tista 'tirrita ruħek ħafna.
BEFORE YOU TAKE ZYPREXA
QABEL MA TIEĦU ZYPREXA
Do not take ZYPREXA • if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal olanzapine jew għal xi sustanzi oħra
If this has happened to you, tell your doctor. • if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- jekk kont issofri qabel bi problemi fl- għajnejn bħal xi tipi ta 'glawkoma (żieda fil- pressjoni ġewwa
Take special care with ZYPREXA • Medicines of this type may cause unusual movements mainly of the face or tongue.
Jekk
If this happens after you have been given ZYPREXA tell your doctor. • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
jiġri hekk wara li tkun ingħatajt ZYPREXA għid lit- tabib tiegħek.
126 • The use of ZYPREXA in elderly patients with dementia is not recommended as it may have serious side effects.
- L- użu ta ’ ZYPREXA f’ pazjenti anzjani bid- demenzja mhux irrakkomandat għax jista ’ jkollu
ZYPREXA is not for patients who are under 18 years.
ZYPREXA mhux għal pazjenti li għandhom anqas minn 18- il sena.
Taking other medicines Only take other medicines while you are on ZYPREXA if your doctor tells you that you can.
Ħu biss mediċini oħra waqt li qed tieħu ZYPREXA jekk it- tabib tiegħek jgħidlek li tista ’.
You might feel drowsy if ZYPREXA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Jista 'jkun li tħossok imħeddel jekk tieħu ZYPREXA flimkien ma' anti- dipressanti jew mediċini għall- ansjetà jew biex jgħinuk torqod (kalmanti).
You should tell your doctor if you are taking fluvoxamine (an antidepressant or ciprofloxacin (an antibiotic), as it may be necessary to change your ZYPREXA dose.
Għandek tgħarraf lit- tabib tiegħek jekk qed tieħu fluvoxamine (anti- dipressant), jew ciprofloxacin (antibijotiku), għax jista 'jkun hemm bżonn li tbiddel id- doża tiegħek ta' ZYPREXA.
Taking ZYPREXA with food and drink Do not drink any alcohol if you have been given ZYPREXA as ZYPREXA and alcohol together may make you feel drowsy.
Tixrobx alkoħol jekk qed tieħu ZYPREXA għax ZYPREXA u l- alkoħol flimkien jistgħu iħeddluk.
You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA can pass into breast milk.
M' għandekx tingħata din il- mediċina meta tkun qed tredda ’, għax ammonti żgħar ta ’ ZYPREXA jistgħu jgħaddu fil- ħalib tas- sider.
Driving and using machines There is a risk of feeling drowsy when you are given ZYPREXA.
Sewqan u tħaddim ta 'magni Hemm ir- riskju li tħossok imħeddel meta tingħata ZYPREXA.
Important information about some of the ingredients of ZYPREXA ZYPREXA contains lactose.
ZYPREXA fiha lactose.
HOW TO TAKE ZYPREXA
KIF GĦANDEK TIEĦU ZYPREXA
Always take ZYPREXA exactly as your doctor has told you.
Dejjem għandek tieħu ZYPREXA skond il- parir tat- tabib.
Your doctor will tell you how many ZYPREXA tablets to take and how long you should continue to take them.
It- tabib tiegħek għandu jgħidlek kemm tieħu pilloli ta ’ ZYPREXA u kemm għandek iddum tieħodhom.
The daily dose of ZYPREXA is between 5 and 20 mg.
Id- doża ta 'kuljum ta ’ ZYPREXA hija bejn 5 u 20 mg.
Consult your doctor if your symptoms return but do not stop taking ZYPREXA unless your doctor tells you to.
Ikkonsulta mat- tabib tiegħek jekk jerġgħu jiġuk is- sintomi imma tieqafx tieħu ZYPREXA sakemm ma jgħidlekx it- tabib tiegħek.
You should take your ZYPREXA tablets once a day following the advice of your doctor.
Għandek tieħu l- pilloli ZYPREXA darba kuljum wara li tingħata parir mit- tabib tiegħek.
Try to take your tablets at the same time each day.
Ipprova ħu l - pilloli tiegħek kuljum fl- istess ħin.
ZYPREXA coated tablets are for oral use.
Il- pilloli miksija ta ’ ZYPREXA huma għall- użu orali.
You should swallow the ZYPREXA tablets whole with water.
Għandek tibla 'l- pilloli ZYPREXA sħaħ bl- ilma.
If you take more ZYPREXA than you should Patients who have taken more ZYPREXA than they should, have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Jekk tieħu ZYPREXA aktar milli suppost Pazjenti li ħadu iżjed ZYPREXA milli suppost kellhom dawn is- sintomi li ġejjin: tħabbit mgħaġġel tal- qalb, aġitazzjoni/ aggressività, problemi biex jitkellmu, movimenti mhux tas- soltu (speċjalment tal - ħalq u ta ’ l- ilsien) u tnaqqis fil- livell ta ’ koxjenza.
If you forget to take ZYPREXA Take your tablets as soon as you remember.
Ħu l- pilloli tiegħek eżatt kif tiftakar.
If you stop taking ZYPREXA Do not stop taking your tablets just because you feel better.
Jekk tieqaf tieħu ZYPREX Tieqafx tieħu l- pilloli tiegħek sempliċement għaliex tħossok aħjar.
It is important that you carry on taking ZYPREXA for as long as your doctor tells you.
Huwa importanti li tibqa 'tieħu ZYPREXA sakemm jgħidlek it- tabib tiegħek.
If you suddenly stop taking ZYPREXA, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Jekk tieqaf tieħu ZYPREXA f' daqqa, jista 'jkollok sintomi bħal għaraq, ma tkunx tista' torqod, rogħda, ansjetà jew tqalligħ u rimettar.
Like all medicines, ZYPREXA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ZYPREXA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects: affect 1 to 10 users in 100 • Changes in the levels of some blood cells and circulating fats. • Increases in the level of sugars in the blood and urine. • Feeling more hungry. • Dizziness. • Restlessness. • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue).
Effetti sekondarji komuni: jaffettwaw 1 sa 10 minn kull 100 pazjent • Tibdil fil- livelli ta 'xi ċelluli tad- demm u xaħmijiet fid- demm. • Żidiet fil- livelli ta' zokkor fid- demm u fl- awrina. • Tħossok aktar bil- ġuħ. • Sturdament. • Irrekwitezza. • Rogħda. • Ebusija tal- muskoli jew spażmi (inklużi movimenti fl- għajnejn). • Problemi fil- mod kif titkellem. • Moviment mhux tas- soltu (speċjalment tal- wiċċ jew ta ’ l- ilsien). • Stitikezza.
Dry mouth.
Ħalq xott.
Rash.
Raxx.
Loss of strength.
Titlef il- forzi.
Extreme tiredness.
Għeja esaġerata.
Water retention leading to swelling of the hands, ankles or feet.
Retenzjoni ta 'l- ilma li twassal għal nefħa fl- idejn, għekiesi jew saqajn.
In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Fl- ewwel stadji tal- kura, xi persuni jistgħu jħossuhom sturduti jew mhux f' sikkithom (il- qalb tħabbat bil- mod), speċjalment waqt li jkunu qegħdin iqumu minn pożizzjoni mimduda jew minn bil- qiegħda.
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/or painful erection.
Effetti sekondarji oħra possibbli: ma tistax tiġi stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet allerġiċi (eż. nefħa fil- ħalq u l- gerżuma, ħakk, raxx). • Dijabete jew dijabete li tmur għall- agħar, kultant assoċjata ma 'ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal- ġisem. • Aċċessjonijiet, normalment assoċjati ma' storja ta 'aċċessjonijiet (epilessija). • Taħlita ta' deni, nifs mgħaġġel, tegħreq, ebusija tal- muskoli u ħedla jew ngħas. • Spażmi tal- muskolu ta 'l- għajn li jikkawża taqlib ta' l- għajn. • Ritmi mhux normali tal- qalb. • Mewt għall- għarrieda u inspjegabbli. • Tagħqid tad- demm bħal trombożi fil- vini fondi tas- sieq jew tagħqid tad- demm fil- pulmun. • Infjammazjoni tal- frixa li tikkawża wġigħ qawwi fl- istonku, deni u taqlib. • Mard tal- fwied li jidher bħala sfurija tal- ġilda u ta 'l- abjad ta' l- għajnejn. • Mard tal- muskoli li jimmanifesta ruħu bħala wġigħ inspjegabbli. • Diffikultà biex tgħaddi l- awrina. • Erezzjoni mtawla u/ jew bl- uġigħ.
In patients with Parkinson's disease ZYPREXA may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson, ZYPREXA tista' tagħmel is- sintomi agħar.
Very rarely babies born to mothers who have taken ZYPREXA in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament ħafna trabi li jitwieldu lil ommijiet li ħadu ZYPREXA fl- aħħar stadju tat- tqala (fl- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
HOW TO STORE ZYPREXA
KIF TAĦŻEN ZYPREXA
Do not use ZYPREXA after the expiry date, which is stated on the carton.
Tużax ZYPREXA wara d- data ta ’ skadenza li tidher fuq il- kartuna
129 ZYPREXA should be stored in its original pack in order to protect from light and moisture.
130 ZYPREXA għandha tinħażen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umdità.
What ZYPREXA contains • The active substance is olanzapine.
X’ fiha ZYPREXA:
Each ZYPREXA tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance.
- Is- sustanza attiva hi olanzapine.
The exact amount is shown on your ZYPREXA tablet pack. • The other ingredients are
Kull pillola miksija ta ’ ZYPREXA għandha 2. 5 mg, 5 mg,
- (tablet core) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose,
L- ammont eżatt jidher fuq il- pakkett tiegħek tal- pilloli ZYPREXA.
magnesium stearate and
- Is- sustanzi l- oħra huma
- (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax.
(qalba tal- pillola) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose, magnesium stearate u (kisja tal- pillola) hypromellose, titanium dioxide (E171), carnauba wax.
• In addition the different ZYPREXA tablet strengths also contain the following ingredients:
-
TABLET STRENGTH
QAWWA TAL- PILLOLA
OTHER INGREDIENTS
INGREDJENTI OĦRA
ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets
Pilloli ZYPREXA 2. 5 mg, 5 mg, 7. 5 mg u 10 mg
(tablet coating) shellac, macrogol, propylene glycol, polysorbate 80 and indigo carmine colour (E132)
(kisja tal- pillola) shellac, macrogol, propylene glycol, polysorbate 80 u bħala sustanza li tagħti kulur indigo carmine (E132).
ZYPREXA 15 mg tablets
Pilloli ZYPREXA 15 mg
(tablet coating) triacetin and indigo carmine colour (E132)
(kisja tal- pillola) triacetin u bħala sustanza li tagħti kulur indigo carmine (E132).
ZYPREXA 20 mg tablets
Pilloli ZYPREXA 20 mg
(tablet coating) macrogol and synthetic red iron oxide (E172)
(kisja tal- pillola) macrogol u iron oxide aħmar sintetiku (E172)
What ZYPREXA looks like and contents of the pack ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg coated tablets are white.
ZYPREXA 2. 5 mg, 5 mg, 7. 5 mg u 10 mg pilloli miksija huma bojod.
ZYPREXA 15 mg coated tablets are light blue.
ZYPREXA 15 mg pilloli miksija huma blu ċari.
ZYPREXA 20 mg coated tablets are pink.
ZYPREXA 20 mg pilloli miksija huma roża.
ZYPREXA tablets are available in 28, 35, 56 and 70 tablet packs.
Il- pilloli ta ’ ZYPREXA huma disponibbli f’ pakketti ta ’ 28, 35, 56 u 70 pillola.
ZYPREXA 10 mg may also be available in 7 tablet packs.
ZYPREXA 10 mg jista ’ ukoll ikun disponibbli f’ pakketti ta ’ 7 pilloli.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL-3991 RA, Houten, The Netherlands.
Manifattur:
Manufacturer:
Lilly S. A., Avda.
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
De la Industria 30, 28108 Alcobendas, Madrid Spanja.
België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
131 België/ Belgique/ Belgien Eli Lilly Benelux S. A. / N. V.
130
Norge Eli Lilly Norge A. STlf: +47 22 88 18 00
Nederland Eli Lilly Nederland B.V.
Österreich Eli Lilly Ges. m. b. H.
Tel: + 40 21 4023000 Slovenija Eli Lilly farmacevtska družba, d.o.o.
Tél: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: +353 (0) 1 661 4377 Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi Sími: + 354 520 34 00 Italia Eli Lilly Italia S. p. A.
Tel: + 386 (0)1 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o.
Tel: + 40 21 4023000 Slovenija Eli Lilly farmacevtska družba, d. o. o Tel: +386 (0) 1 580 00 10 Slovenská republika Eli Lilly Slovakia, s. r. o.
This leaflet was last approved in
Dan il- fuljett kien approvat l' aħħar f '
131 PACKAGE LEAFLET:
132 FULJETT TA ’ TAGĦRIF:
ZYPREXA 10 mg powder for solution for injection olanzapine
ZYPREXA 10 mg trab għal soluzzjoni għall- injezzjoni olanzapine
please tell your doctor.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek. >
What ZYPREXA is and what it is used for 2.
X' inhi ZYPREXA u għalxiex tintuża 2.
Before you are given ZYPREXA 3.
Qabel ma 'tieħu ZYPREXA 3.
How ZYPREXA is given 4.
Kif għandek tieħu ZYPREXA 4.
WHAT ZYPREXA IS AND WHAT IT IS USED FOR
X' INHI ZYPREXA U GĦALXIEX TINTUŻA
ZYPREXA belongs to a group of medicines called antipsychotics.
ZYPREXA hija waħda minn grupp ta 'mediċini li jissejħu antipsikotiċi.
ZYPREXA Injection is used to treat quickly symptoms of agitation and distressing behaviour that may occur in diseases with symptoms such as: • hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
L- injezzjoni ta ’ ZYPREXA tintuża biex jiġu trattati malajr sintomi ta 'aġitazzjoni u mġieba distressanti li jistgħu jidhru f' mard b' sintomi bħal ma huma:
People with this disease may also feel depressed, anxious or tense. • feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Nies b' din il- marda jistgħu ukoll iħossuhom imdejjqin, anzjużi jew taħt tensjoni.
ZYPREXA Injection is given when treatment with ZYPREXA tablets is not appropriate.
L- injezzjoni ta ’ ZYPREXA tingħata meta t- trattament bil- pilloli ta ’ ZYPREXA mhux xieraq.
Your doctor will change your treatment to ZYPREXA tablets, as soon as appropriate.
It- tabib tiegħek jibdillek it- trattament għall- pilloli ta ’ ZYPREXA, hekk kif ikun xieraq.
BEFORE YOU ARE GIVEN ZYPREXA
QABEL MA TIEĦU ZYPREXA
You should not be given ZYPREXA • if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal olanzapine jew sustanzi oħra ta ’
Take special care with ZYPREXA Powder for Solution for Injection • Tell the doctor or nurse if you feel dizzy or faint after the injection.
- Għid lit- tabib tiegħek jew lin- nurse jekk tħossok sturdut jew ma tiflaħx wara l- injezzjoni.
You will probably need to lie down until you feel better.
Probabli li jkollok bżonn timtedd sakemm tħossok aħjar.
The doctor may also want to measure your blood pressure and pulse. • Medicines of this type may cause unusual movements mainly of the face or tongue.
Jekk
If this happens after you have been given ZYPREXA, talk to your doctor. • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
jiġri hekk wara li tkun ingħatajt ZYPREXA għid lit- tabib tiegħek.
If this happens, contact your doctor at once.
Jekk jiġrilek hekk għid lit- tabib tiegħek minnufih.
No more injections will be given to you. • The use of ZYPREXA in elderly patients with dementia is not recommended as it may have serious side effects.
- L- użu ta ’ ZYPREXA f’ pazjenti anzjani bid- demenzja mhux irrakkomandat għax jista ’ jkollu
132 If you suffer from any of the following illnesses tell your doctor as soon as possible: • If you have had a recent heart attack, or have heart disease, including sick sinus syndrome, unstable angina or suffer from low blood pressure. • Diabetes • Liver or kidney disease • Parkinson’s disease • Epilepsy • Prostate problems • A blocked intestine (Paralytic ileus) • Blood disorders • Stroke or “mini” stroke (temporary symptoms of stroke)
Jekk issoffri minn xi mard li ġej għid lit- tabib tiegħek kemm jista 'jkun malajr: • Jekk kellek xi attakk tal- qalb dan l- aħħar, jew għandek mard tal- qalb, inkluża s- sindromu tas - sinus, mard tal- qalb anġina mhux stabbli jew issofri minn pressjoni baxxa. • Dijabete • Mard tal- fwied jew tal- kliewi • Il- mard ta' Parkinson • Epilessija • Problemi tal- prostata • Intestin ibblokkat (Ileus paralitiku) • Disturbi fid- demm • Puplesija jew puplesija “ ħafifa ” (sintomi temporanji ta 'puplesija)
As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.
Bħala prekawzjoni ta 'rutina, jekk għandek' l fuq minn 65 sena l- pressjoni tad- demm tiegħek tista 'tkun eżaminata mit- tabib tiegħek.
Taking other medicines A combination of ZYPREXA with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers), antidepressants.
Taħlita ta 'ZYPREXA mal- mediċini li ġejjin jistgħu jħeddluk: mediċini meħuda għall- anzjetà jew biex jgħinuk torqod (kalmanti), antidepressanti.
Only take other medicines while you are on ZYPREXA if your doctor tells you that you can.
Ħu mediċini oħra waqt li qed tieħu ZYPREXA jekk it - tabib tiegħek jgħidlek li tista '.
Especially tell your doctor if you are taking medicines for Parkinson’s disease.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta. Speċjalment għarraf lit- tabib tiegħek jekk qed tieħu mediċini għall- marda ta 'Parkinson.
Taking ZYPREXA with food and drink Do not drink any alcohol if you have been given ZYPREXA as ZYPREXA and alcohol together may make you feel drowsy.
Meta tieħu ZYPREXA ma ’ l- ikel u max- xorb Tixrobx alkoħol jekk qed tieħu ZYPREXA għax ZYPREXA u l- alkoħol flimkien jistgħu jħeddluk.
HOW ZYPREXA IS GIVEN
KIF GĦANDEK TIEĦU ZYPREXA
Information on reconstitution and administration is provided in a detachable section at the end of this leaflet.
Tagħrif dwar ir- rikostituzzjoni u t- teħid huwa pprovdut f' sezzjoni li tista 'tinqata' fl- aħħar ta 'dan il - fuljett.
Your doctor will decide how much ZYPREXA you need and how long you need it for.
It- tabib tiegħek jgħidlek kemm għandek bżonn ZYPREXA u għal kemm għandek bżonnha.
The dose is usually 10 mg in for the first injection, but it may be less than this.
Id- doża s - soltu hija 10 mg għall- ewwel injezzjoni, imma tista 'tkun anqas minn din.
Up to 20 mg in 24 hours may be given.
Sa 20 mg f' 24 siegħa tista 'tingħata.
The dose for patients aged over 65 years is 2.5 or 5 mg.
Id- doża għall- pazjenti 'l fuq minn 65 sena hija 2. 5 jew 5 mg.
ZYPREXA comes as a powder.
ZYPREXA tiġi bħala trab.
Your doctor or nurse will make it up into a solution.
It- tabib jew n- nurse tiegħek iħawduha f' likwidu.
ZYPREXA Injection is for intramuscular use.
L- injezzjoni ta ’ ZYPREXA hija għall- użu minn ġol- muskoli.
The correct amount of solution will be injected into your muscle.
L- ammont tajjeb tal- likwidu jiġi injettat fil- muskolu tiegħek.
If you are given more ZYPREXA than you think you should be Patients who have been given more ZYPREXA than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Pazjenti li ħadu iżjed ZYPREXA milli suppost kellhom dawn is- sintomi li ġejjin: tħabbit mgħaġġel tal- qalb, aġitazzjoni/ aggressività, problemi biex jitkellmu, movimenti mhux tas- soltu (speċjalment tal - ħalq u ta ’ l- ilsien) u tnaqqis fil- livell ta ’ koxjenza.
Other symptoms 133 may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Sintomi oħra jistgħu jkunu: konfużjoni akuta, aċċessjonijiet (epilessija), koma, taħlita ta ’ dawn is- sintomi, deni, nifs aktar mgħaġġel, għaraq, ebusija tal- muskoli u ħedla jew ngħas, tnaqqis fil- frekwenza ta ’ nifsijiet, aspirazzjoni, pressjoni tad- demm għolja jew baxxa, ritmi mhux normali tal- qalb.
Tell your doctor or nurse of your concern.
Għid lit- tabib jew n- nurse tiegħek dwar il- ħsibijiet tiegħek li qed jinkwetawk.
Only a few doses of ZYPREXA Injection are needed.
Hemm bżonn biss ta ’ ftit dożi ta 'l- injezzjoni ta ’ ZYPREXA.
Your doctor will decide when you need a dose of ZYPREXA Injection.
It- tabib tiegħek jiddeċiedi meta għandek bżonn doża ta 'l- injezzjoni ta ’ ZYPREXA.
Like all medicines, ZYPREXA Injection can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, l- Injezzjoni ta ’ ZYPREXA jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects with ZYPREXA Injection: affect 1 to 10 users in 100 • Slower or faster heart rate. • Sleelpiness. • Low blood pressure. • Discomfort at the site of injection. • Some people may feel dizzy or faint (with a slow heart rate) after injection, especially when getting up from a lying or sitting position.
Effetti sekondarji komuni b' injezzjoni ta 'ZYPREXA: jaffettwaw 1 sa 10 minn kull 100 pazjent • Tħabbit tal- qalb aktar bil- mod jew aktar mgħaġġel. • Ngħas. • Pressjoni baxxa tad- demm. • Ftit uġigħ fis- sit ta' l- injezzjoni. • Xi persuni jistgħu jħossuhom sturduti jew mhux f' sikkithom (il- qalb tħabbat bil- mod) wara l - injezzjoni, speċjalment waqt li jkunu qegħdin iqumu minn pożizzjoni mimduda jew minn bilqiegħda.
This will usually pass on its own but if it does not, tell your doctor or a nurse as soon as possible.
Dan normalment jgħaddi waħdu iżda jekk le għid lit- tabib jew lill- infermier/ a tiegħek kemm jista 'jkun malajr.
Uncommon side effects: affect 1 to 10 users in 1,000 • Breathing more slowly. • Abnormal rhythms of the heart, which can be serious.
Effetti sekondarji mhux komuni: jaffettwaw 1 sa 10 minn kull 1, 000 pazjent • Tieħu nifs aktar bil- mod. • Ritmi mhux normali tal- qalb, li jistgħu jkunu serji.
In addition, the following side effects have been seen after patients have taken ZYPREXA orally.
Flimkien ma 'dawn, l- effetti mhux mixtieqa li ġejjin dehru wara li pazjenti ħadu Zyprexa mill- ħalq.
Common side effects: affect 1 to 10 users in 100 • Changes in the levels of some blood cells and circulating fats. • Increases in the level of sugars in the blood and urine. • Feeling more hungry. • Dizziness. • Restlessness. • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue). • Constipation. • Dry mouth. • Rash. • Loss of strength. • Extreme tiredness. • Water retention leading to swelling of the hands, ankles or feet. • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Effetti sekondarji komuni: jaffettwaw 1 sa 10 minn kull 100 pazjent • Tibdil fil- livelli ta 'xi ċelluli tad- demm u xaħmijiet fid- demm. • Żidiet fil- livelli ta' zokkor fid- demm u fl- awrina. • Tħossok aktar bil- ġuħ. • Sturdament. • Irrekwitezza. • Rogħda. • Ebusija tal- muskoli jew spażmi (inklużi movimenti fl- għajnejn). • Problemi fil- mod kif titkellem. • Moviment mhux tas- soltu (speċjalment tal- wiċċ jew ilsien). • Stitikezza. • Ħalq xott. • Raxx. • Titlef il- forzi.
Uncommon side effects: affect 1 to 10 users in 1,000 134 • Slow heart rate. • Make you sensitive to sunlight. • Hair loss.
Effetti sekondarji mhux komuni: jaffettwaw 1 sa 10 minn kull 1, 000 pazjent • Il- qalb tħabbat bil- mod. • Issir sensittiv għad- dawl tax- xemx. • Jaqa 'x- xagħar.
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/or painful erection.
Effetti sekondarji oħra possibbli: ma tistax tiġi stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet allerġiċi (eż. nefħa fil- ħalq u l- gerżuma, ħakk, raxx). • Dijabete jew dijabete li tmur għall- agħar, kultant assoċjata ma 'ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal- ġisem. • Aċċessjonijiet, normalment assoċjati ma' storja ta 'aċċessjonijiet (epilessija). • Taħlita ta' deni, nifs mgħaġġel, għaraq, ebusija tal- muskoli u ħedla jew ngħas. • Spażmi tal- muskolu ta 'l- għajn li jikkawża taqlib ta' l- għajn. • Ritmi mhux normali tal- qalb. • Mewt għal għarrieda u inspjegabbli. • Tagħqid tad- demm bħal trombożi fil- vini fondi tas- sieq jew tagħqid tad- demm fil- pulmun. • Infjammazjoni tal- frixa li tikkawża wġigħ qawwi fl- istonku, deni u taqlib. • Mard tal- fwied li jidher bħala sfurija tal- ġilda u ta 'l- abjad ta' l- għajnejn. • Mard tal- muskoli li jimmanifesta ruħu bħala wġigħ inspjegabbli. • Diffikultà biex tgħaddi l- awrina. • Erezzjoni mtawla u/ jew bl- uġigħ.
In patients with Parkinson's disease ZYPREXA may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson ZYPREXA tista' tagħmel is- sintomi agħar.
Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Rari, nisa li kienu qed jieħdu mediċini ta 'dawn it- tip għal żmien twil bdew inixxu ħalib mis- sider u tilfu xi pirjid jew kellhom pirjid rregolari.
Very rarely babies born to mothers who have taken ZYPREXA in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament ħafna trabi li jitwieldu lil ommijiet li ħadu ZYPREXA fl- aħħar stadju tat- tqala (l- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
Do not use ZYPREXA Injection after the expiry date, which is stated on the carton.
Tużax l- Injezzjoni ta ’ ZYPREXA wara d- data ta ’ skadenza li tidher fuq il- kartuna
Store in original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
After ZYPREXA Injection is made into a solution, use within one hour.
136 Wara li l- Injezzjoni ta ’ ZYPREXA titħallat f' likwidu, użha fi żmien siegħa.
Do not freeze after reconstitution.
Tagħmilhiex fil- friża wara li tħallatha.
Discard any unused contents.
Armi kull kontenut mhux użat.
What ZYPREXA Injection contains • The active substance is olanzapine.
Kull kunjett fih10 mg tas- sustanza attiva.
Each vial contains 10 mg of the active substance. • The other ingredients are lactose monohydrate, tartaric acid, hydrochloric acid and sodium hydroxide.
- Is- sustanzi l- oħra huma lactose monohydrate, tartaric acid, hydrochloric acid u sodium
What ZYPREX A Injection looks like and contents of the pack ZYPREXA comes as a yellow powder in a vial.
Zyprexa tiġi bħala trab isfar ġo kunjett.
A vial of ZYPREXA can provide you with 10 mg of olanzapine.
Kunjett ta ’ ZYPREXA tista 'tipprovdik b' 10 mg ta' olanzapine.
Your doctor or nurse will make it up into a solution that will be given as an injection.
It- tabib jew in- nurse jagħmluha f' soluzzjoni li tingħata bħala injezzjoni.
ZYPREXA Injection is available in a pack containing 1 or 10 vial(s).
L- injezzjoni ta ’ ZYPREXA hija disponibbli f’ pakkett ta ’ 1 jew 10 kunjetti.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL-3991 RA, Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1 - 5, NL - 3991 RA, Houten, L- Olanda.
KG, Teichweg 3, D-35396 Giessen, Germany.
KG, Teichweg 3, D- 35396 Giessen, Il- Ġermanja.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
137 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Tél/ Tel: + 32-(0)2 548 84 84 Magyarország Lilly Hungária Kft.
Tel: + 420 234 664 111 Danmark Eli Lilly Danmark A/ STlf.: +45 45 26 60 00
Tel: + 31(0)30 6025800 Norge Eli Lilly Norge A.S Tlf: + 47 22 88 18 00 Österreich Eli Lilly Ges. m.b.H.
Tel: + 31( 0) 30 6025800
Tel: + 43-(0) 1 711 780 Polska Eli Lilly Polska Sp. z o.o.
Deutschland Lilly Deutschland GmbH Tel. + 49 - (0) 6172 273 2222
Tel. + 48 (0) 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351 21 412 66 00 România Eli Lilly România S.R.L.
Norge Eli Lilly Norge A. STlf: +47 22 88 18 00
Tel: + 40 21 4023000 Slovenija Eli Lilly farmacevtska družba, d.o.o.
Eesti Eli Lilly Holdings Limited.
Tel: + 386 (0)1 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o.
Eesti filiaal Tel: +372 6441100 Ελλάda ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
Eli Lilly Italia S.p.A.
France Lilly France S. A. S.
137 --------------------------------------------------------------------------------------------------------------------------- (Perforation to allow health care provider information to be detached)
138 --------------------------------------------------------------------------------------------------------------------------- (Perforazzjoni biex tħalli lill- dawk li jipprovdu l- kura tas- saħħa, it- tagħrif li jinqala ')
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
STRUZZJONIJIET GĦALL- PROFESSJONISTI TAL- KURA TAS- SAĦĦA
Reconstitution and administration of ZYPREXA
Taħlit u għotja ta 'ZYPREXA
Reconstitute ZYPREXA Powder for Solution for Injection only with water for injections
Ħallat ZYPREXA Trab għal Soluzzjoni għall- Injezzjoni biss ma ’ ilma għall- injezzjonijiet.
ZYPREXA Powder for Solution for Injection must not be combined in the syringe with any commercially available medicinal products.
ZYPREXA Trab għal Soluzzjoni għall- Injezzjoni m’ għandiex titħallat fis- siringa ma ’ ebda prodott medicinali ieħor li jinsab fis- suq.
See examples of incompatibilities below
Ara eżempji ta ’ inkompatibilitajiet hawn taħt:
Powder for Solution for Injection
Trab għal Soluzzjoni għall- Injezzjoni
Reconstitute ZYPREXA Powder for Solution for Injection using standard aseptic techniques for reconstitution of parenteral products.
Ħallat ZYPREXA Trab jinħall f’ soluzzjoni għall- injezzjoni billi tuża metodu asettiku tas- soltu għat - taħlit ta 'prodotti parenterali.
Withdraw 2.1 ml of water for injections into a sterile syringe.
Iġbed 2. 1 ml ta 'ilma għall- injezzjonijiet f' siringa sterilizzata.
Inject into a vial of ZYPREXA Powder for Solution for Injection.
Injetta fi fjala ta 'ZYPREXA Trab jinħall f’ soluzzjoni għall- injezzjoni.
Rotate the vial until the contents have completely dissolved, giving a yellow coloured solution.
Dawwar il- fjala sakemm il- kontenuti jinħallu kompletament, f' soluzzjoni ta 'kulur isfar.
The vial contains 11.0 mg olanzapine as a solution of 5 mg/ml.
Il- fjala għandha 11. 0 mg olanzapine bħala soluzzjoni ta '5 mg/ ml.
If 2.0 ml solution is withdrawn, 1 mg olanzapine is retained in the vial and syringe, thus allowing delivery of 10mg olanzapine.
Jekk 2. 0 ml tal- likwidu jinġibed, 1 mg olanzapine tinżamm fil- fjala u fis- siringa, għalhekk tħalli 10 mg ta 'olanzapine.
Administer the solution intramuscularly.
Agħti is- soluzzjoni b’ mod intramuskolari.
Do not administer intravenously or subcutaneously.
Tagħtihiex ġol- vina jew taħt il- ġilda.
Discard the syringe and any unused solution in accordance with appropriate clinical procedures.
Armi s- siringa u xi soluzzjoni mhux użata skond il- proċeduri kliniċi indikati.
Do not store above 25º C.
Taħżinx 'l fuq minn 25°C.
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Fih jinsab spjegat kif il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa sabiex jagħti rakkomandazzjonijiet ta ’ kif din il- mediċina għandha tintuża.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l - Fuljett ta ’ Illustrazzjoni (li jagħmel ukoll parti mill- EPAR) jew ikkuntattja t- tabib jew l- ispiżjar tiegħek.
What is ZYPREXA VELOTAB?
X’ inhi ZYPREXA VELOTAB?
ZYPREXA VELOTAB is a medicine that contains the active substance olanzapine.
ZYPREXA VELOTAB hija mediċina li fiha s- sustanza attiva olanzapine.
It is available as 5, 10, 15, and 20 mg orodispersible tablets (that dissolve in the mouth).
Tiġi f’ kapsuli ta ’ 5, 10, 15 jew 20 mg li jdubu fil- ħalq.
What is ZYPREXA VELOTAB used for?
Għal xiex jintuża ZYPREXA VELOTAB?
ZYPREXA VELOTAB is used to treat schizophrenia.
ZYPREXA VELOTAB tintuża fit- trattament ta ’ l- iskiżofrenija.
This is a mental illness, which has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Din hija marda mentali li għandha għadd ta ’ sintomi, inkluż taħdit u ħsieb diżorganizzat, alluċinazzjonijiet (jiġifieri d- dehra u s- smigħ ta ’ oġġetti li jkunu immaġinarji), suspetti u delużjonijiet (ħsibijiet żbaljati).
ZYPREXA VELOTAB is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
ZYPREXA VELOTAB hija effettiva wkoll sabiex iżżomm it- titjib li jkun sar f’ pazjenti li jkunu rrispondew għal kors inizzjali ta ’ trattament.
ZYPREXA VELOTAB is also used to treat moderate to severe manic episodes (extremely high mood).
ZYPREXA VELOTAB tintuża wkoll fit- trattament ta ’ episodji moderati jew severi tal- manija (burdata estremament tajba).
It can also be used to prevent the recurrence (when symptoms come back) of these episodes in patients with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Tista ’ wkoll tintuża sabiex tipprevjeni l- feġġa mill- ġdid (meta jerġgħu jibdew jitfaċċaw is- sintomi) ta ’ dawn l- episodji f’ pazjenti b’ disturbi polari (marda mentali b’ perjodi jalternaw bejn burdata tajba ħafna u dipressjoni) u li jkunu rrispondew għal kors inizzjali ta ’ trattament.
How is ZYPREXA VELOTAB used?
Kif tintuża ZYPREXA VELOTAB?