qanastek/EMEA-V3 huggingface dataset:
In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Fil- frieħ tal- firien mogħtija olanzapine, kienu osservati dewmien fl - iżvilupp tal- fetu u tnaqqis temporanju fil- livelli ta ’ attività tal- frieħ.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Mutaġeniċità Olanzapine ma kienx mutaġeniku jew klastoġeniku f' firxa sħiħa ta 'testijiet standard, li inkludew testijiet ta' mutazzjoni tal- batteri kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo mill- ħalq.
Carcinogenicity Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Karċinoġeniċità Fuq bazi ta ’ riżultati minn studji orali fuq il- ġrieden u l- firien, ġie konkluż li olanzapine m’ huwiex karċinoġenu.
Powder No excipients.
Trab L- ebda sustanza mhux attiva.
Solvent Croscarmellose sodium Mannitol Polysorbate 80 Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
(għall- aġġustament tal- pH)
2 years
16 Sentejn
After reconstitution in the vial:
Wara r- rikostituzzjoni fil- kunjett:
If the product is not used right away, it should be shaken vigorously to re-suspend.
Jekk il- prodott mhux ser jintuża minnufih, għandu jiġi mħawwad vigorożament sabiex jerġa ’ jiġi sospiż.
Once withdrawn from vial into syringe, the suspension should be used immediately.
Ladarba tinġibed mill- kunjett ġos- siringa, is - suspensjoni għandha tintuża minnufih.
Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 20-25 °C.
L- istabilità kimika u fiżika tas- suspensjoni fil- kunjetti ġiet ipprovata għal 24 siegħa f’ 20- 25 °C.
From a microbiological point of view, the product should be used immediately.
Mil - lat mikrobijoloġiku, il- prodott għandu jintuża minnufih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
Jekk ma jintużax minnufih, il- ħinijiet u l - kundizzjonijiet tal- ħażna tal- prodott qabel l- użu huma r- responsabbilità ta ’ minn qed jużah u normalment ma jkunux aktar minn 24 siegħa f’ 20- 25°C.
210 mg powder:
Trab ta ’ 210 mg:
Type I glass vial.
Kunjett tal- ħġieġ Tip I.
Bromobutyl stopper with rust colour seal.
Tapp ta ’ bromobutyl b’ siġill kulur kannella fl- aħmar.
3 ml solvent:
Solvent ta ’ 3 ml:
Butyl stopper with purple seal.
Tapp ta ’ butyl b’ siġill vjola.
One carton contains one vial of powder and one vial of solvent.
Kaxxa fiha kunjett wieħed bit- trab u kunjett wieħed bis- solvent.
16 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
FOR INTRAMUSCULAR GLUTEAL INJECTION ONLY.
GĦALL- INJEZZJONI MINN ĠOL- MUSKOLI GLUTEJALI BISS.
DO NOT ADMINSTER INTRAVENOUSLY OR SUBCUTANEOUSLY.
TAGĦTIX ĠOL- VINI JEW TAĦT IL- ĠILDA.
RECONSTITUTION STEP 1:
RIKOSTITUZZJONI PASS 1:
Assembling and preparing materials
Kif tiġbor u tipprepara l- materjal
Other materials needed:
Materjal ieħor meħtieg:
One 3 ml syringe Three 19-gauge, 35 mm needles for injection (For obese patients, 19-gauge, 50 mm needles are recommended)
Siringa waħda ta ’ 3 ml Tliet labriet 19- gejġ, 35 mm għall- injezzjoni (Għal pazjenti obeżi, labar 19- gejġ, 50 mm huma rrakkomandati)
It is recommended that gloves are used as ZYPADHERA may irritate the skin.
Huwa rrakkomandat li jintużaw l- ingwanti billi ZYPADHERA jista ’ jirrita l- ġilda.
Reconstitute ZYPADHERA powder for suspension for injection only with the solvent for parenteral use provided in the pack using standard aseptic techniques for reconstitution of parenteral products.
Irrikostitwixxi t- trab ta ’ ZYPADHERA għal suspensjoni għall- injezzjoni biss bis- solvent għall- użu parenterali li jinstab fil- pakkett u uża t- teknika asettika li normalment tintuża għar- rikostituzzjoni ta ’ prodotti parenterali.
ZYPADHERA powder for suspension for injection must not be combined in the syringe with any substance other than the solvent for parenteral use.
Trab ta ’ ZYPADHERA għal suspensjoni għall- injezzjoni m’ għandux jitħallat fis- siringa ma ’ xi sustanza oħra jekk mhux mas- solvent għall- użu parenterali.
Determining solvent volume for reconstitution This table provides the amount of solvent required to reconstitute ZYPADHERA powder for suspension for injection.
Kif tikkalkula l- volum tas- solvent għar- rikostituzzjoni Din it- tabella tipprovdi l- ammont ta ’ solvent meħtieġ biex tirrikostitwixxi t- trab ta ’ ZYPADHERA għal suspensjoni għall- injezzjoni.
Volume of solvent to add
Volum ta ’ solvent li għandu
(ml) 1.3 1.8 2.3
1. 3 1. 8 2. 3
It is important to note that there is more solvent in the vial to reconstitute than is needed.
Huwa importanti li tinnota li għar- rikostituzzjoni hemm iżjed solvent fil- kunjett milli huwa meħtieġ.
STEP 3:
17 PASS 3:
Reconstituting ZYPADHERA 1.
Kit tirrikostitwixxi ZYPADHERA 1.
Loosen the powder by lightly tapping the vial.
Ħoll it- trab billi ttaptap il- kunjett b’ mod ħafif.
Inject the required solvent volume into the ZYPADHERA powder vial.
Injetta l- volum ta ’ solvent meħtieġ fil- kunjett tat - trab ta ’ ZYPADHERA.
Withdraw air to equalize the pressure in the vial.
Iġbed l- arja sabiex iġġib indaqs il- pressjoni fil- kunjett.
Remove the needle, holding the vial upright to prevent any loss of solvent.
Neħħi l- labra, u żomm il- kunjett wieqaf sabiex ma jkunx hemm telf ta ’ solvent.
Tap the vial firmly and repeatedly on a hard surface, protected to cushion impact, until no powder is visible.
Waqt li protett biex jilqa ’ għall- impatt, taptap il- kunjett b’ mod ferm u ripetut fuq wiċċ iebes, sakemm it- trab ma jibqax jidher.
Tap firmly to mix
Taptap b’ mod ferm biex tħallat
The suspended product will be yellow and opaque.
Il- prodott f’ suspensjoni ikun isfar u opak.
Visually check the vial for clumps.
Iċċekkja l- kunjett viżwalment għal xi ċapep.
Unsuspended powder appears as light yellow, dry clumps clinging to the bottom of the vial.
Trab li ma jkunx f’ suspensjoni jidher bħala ċapep xotti ta ’ lewn isfar ċar imwaħħlin mal- qiegħ tal- kunjett.
Additional tapping may be required if clumps remain.
Ikun meħtieġ aktar taptip jekk jibqgħu ċ- ċapep.
Check for unsuspended powder
Iċċekkja għal trab li ma jkunx f’ suspensjoni
Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture.
Ħawwad il- kunjett vigorożament sakemm is- suspensjoni tidher bla biċċiet u tkun uniformi fil - kulur u l- konsistenza.
Figure C:
Figura Ċ:
Vigorously shake vial
Ħawwad il- kunjett b’ mod vivaċi
If foam forms, let vial stand to allow foam to dissipate.
Jekk tifforma r- ragħwa, ħalli l- kunjett jogħqod sakemm ir- ragħwa tiġi fix- xejn.
Reconstituted ZYPADHERA remains stable for up to 24 hours in the vial.
ZYPADHERA rrikostitwit jibqa ’ stabbli sa 24 siegħa fil- kunjett.
If the product is not used right away, it should be shaken vigorously to re-suspend.
Jekk il- prodott ma jintużax minnufih, għandu jiġi mħawwad b’ mod vigoruż biex jerġa ’ jiġi magħmul f’ suspensjoni.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn kundizzjonijiet speċjali għall- ħażna.
ADMINISTRATION STEP 1:
KIF JINGĦATA PASS 1:
Injecting ZYPADHERA This table confirms the final ZYPADHERA suspension volume to inject.
Kif tinjetta ZYPADHERA Din it- tabella tikkonferma l- volum finali tas- suspensjoni ta ’ ZYPADHERA li għandu jiġi injettat.
Suspension concentration is 150 mg/ ml.
Il - konċentrazzjoni tas- suspensjoni hija 150 mg/ ml.
Final volume to inject
qawwa tal- kunjett (mg)
(ml) 1.0 1.4 2.0 2.7
1. 0 1. 4 2. 0 2. 7
Use a second needle and slowly withdraw the desired amount.
Uża l- labra l- oħra u iġbed bil- mod l- ammont mixtieq.
Some excess product will remain in the vial.
Xi prodott żejjed ser jibqa ’ fil- kunjett.
Remove air bubbles to ensure a full dose.
Neħħi l- bżieżaq ta ’ l- arja biex tiżgura li hemm doża sħiha.
Change to the third 19-gauge (35 mm or 50 mm) needle prior to injection.
Qabel l- injezzjoni ibdel il- labra u uża t- tielet labra 19- gejġ (35 mm jew 50 mm).
Once ZYPADHERA has been removed from the vial into the syringe, it should be injected immediately.
Ladarba ZYPADHERA jitneħħa mill- kunjett għal ġos- siringa, għandu jiġi injettat minnufih.
Select and prepare a site for injection in the gluteal area.
Għażel u pprepara sit għall- injezzjoni fiż- żona glutejali.
DO NOT INJECT INTRAVENOUSLY.
TINJETTAX ĠOL- VINI.
Aspirate for several seconds to ensure no blood appears after insertion of the needle into the muscle.
Iġbed għal diversi sekondi biex tiżgura li ma jidher l- ebda demm wara li tidħol il- labra fil- muskolu.
If any blood is drawn into the syringe, the syringe and the dose should be discarded and fresh drug prepared.
Jekk jinġibed xi demm fis- siringa, is- siringa u d- doża jridu jintremew u terġa ’ tiġi ppreparata il - mediċina mill- ġdid.
The injection should be performed with steady, continuous pressure.
L- injezzjoni għandha ssir bi pressjoni kostanti u kontiwa.
Do not massage the injection site.
Timmassaġġax is- sit ta ’ l- injezzjoni.
Discard the syringe, needles and any unused solvent in accordance with appropriate clinical procedures.
Armi s- siringa, il- labar u xi solvent li ma ntużax skont il- proċeduri kliniċi xierqa.
The vial is for single use only.
Il- kunjett jintuża darba waħda biss.
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.
EMEA/ H/ C/ 890/ 001 ZYPADHERA 210 mg - 1 vial + 1 vial
EMEA/ H/ C/ 890/ 001 ZYPADHERA 210 mg - kunjett 1 + kunjett 1
DD/ MM/ YYYY
JJ/ XX/ SSSS
ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection.
ZYPADHERA 300 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod.
Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 300 mg olanzapine.
Do not confuse ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection with olanzapine 10 mg powder for solution for injection.
Tifxilx ZYPADHERA 300 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil - mod ma ’ olanzapine 10 mg trab għal soluzzjoni għall- injezzjoni.
20 Table 1
20 Tabella 1 Skema ta ’ doża rrakkomandata bejn olanzapine mill- ħalq u ZYPADHERA
21 Paediatric patients ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
21 Pazjenti pedjatriċi ZYPADHERA mhux irrakkomandat għall- użu fit- tfal u adolexxenti taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
22 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
22 Psikożi relatata mad- demenzja u/ jew disturbi fl- imġiba Olanzapine mhux approvat għall- kura ta ’ psikożi relatata mad- demenzja u/ jew disturbi fl- imġiba u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti minħabba żieda fil- mortalità u r - riskju ta ’ puplesija.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
23 klinikamet adattat speċjalment f’ pazjenti b’ ammonti mhux normali ta ’ lipidi fid- demm u f’ pazjenti li għandhom fatturi ta ’ riskju għall- iżvilupp ta ’ disturbi fil- lipidi.
23 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Attività antikolinerġika Waqt li olanzapine wera attività antikolinerġika in vitro, esperjenza waqt l- istudji kliniċi wriet inċidenza baxxa ta ’ ġrajjiet relatati.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
24 antagoniżmu ma ’ dopamine, olanzapine jista ’ jantagonizza l- effetti diretti u indiretti ta ’ l- agonisti ta ’ dopamine.
24 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma ’ inċidenza mnaqqsa ta ’ diskajneżja minħabba l- kura, b’ mod statistikament sinifikanti.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
25 qed jużaw fluvoxamine jew xi inibituri oħra ta ’ CYP1A2, bħal ciprofloxacin.
25 metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Għalhekk, mhux mistenni li jseħħ xi effett partikolari ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ olanzapine kif ivverifikat minn studji in vitro fejn ma nstabet ebda inibizzjoni tal - metaboliżmu tas- sustanzi attivi li ġejjin: antidepressiv triċikliku (li jirrapreżenta l- aktar is- sensiela ta ’ reazzjonijiet ta ’ CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
27
27 Sonnolenza Disturbi fil- qalb
28 4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
4 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 56 mmol/ l) li żdiedu għal għoljin (≥ 7 mmol/ l).
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
29 b’ olanzapine għal żmien twil (sa 12- il xahar) bl- għan ta 'prevenzjoni ta' episodji oħra f' pazjenti b' mard bipolari kien assoċjat ma 'żieda ta' ≥ 7% mil- linja bażi tal- piż tal- ġisem f' 39. 9% tal- pazjenti.
29 magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
L- ammont ta ’ żieda fil- piż u l- proporzjon ta ’ pazjenti adolexxenti li kellhom żieda fil- piż klinikament sinifikanti kienu akbar b’ espożizzjoni fit- tul (għallinqas 24 ġimgħa) milli b’ espożizzjoni għal żmien qasir.
Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of ZYPADHERA (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).
31 endpoint (tibdil medju - 22. 57, - 26. 32, - 22. 49 rispettivament) ma ’ kull doża ta ’ ZYPADHERA (405 mg kull 4 ġimgħat, 300 mg kull ġimagħtejn, u 210 mg kull ġimagħtejn) meta mqabbel ma ’ plaċebo (tibdil medju - 8. 51).
Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/ hr) versus males (27.3 l/ hr), and in non-smokers (18.6 l/ hr) versus smokers (27.7 l/ hr).
32 It- tneħħija ta ’ olanzapine mill- plażma wara li olanzapine ttieħed mill- ħalq hija aktar baxxa fin- nisa (18. 9 l/ siegħa) kontra l- irġiel (27. 3 l/ siegħa), u f’ minn ma jpejjipx (18. 6 l/ siegħa) kontra minn ipejjep (27. 7 l/ siegħa).
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
33 Fix- xadini, dożi mill- ħalq b’ waħdiet sa 100 mg/ kg irriżultaw f' prostrazzjoni u, f' dożi ogħla, f’ telf parzjali mis- sensi.
33 Reproductive toxicity Olanzapine had no teratogenic effects.
Tossiċità fuq is- sistema riproduttiva Olanzapine ma kellu l- ebda effetti teratoġeniċi.
2 years
34 Sentejn
300 mg powder:
Trab ta ’ 300 mg:
Bromobutyl stopper with olive colour seal.
Tapp ta ’ bromobutyl b’ siġill ta ’ kulur iż- żebbuġa.
34 One carton contains one vial of powder and one vial of solvent.
Kaxxa fiha kunjett wieħed bit- trab u kunjett wieħed bis- solvent.
STEP 3:
3.
10.
36 4.
Do not massage the injection site.
Timmassaġġax is - sit ta ’ l- injezzjoni.
EMEA/ H/ C/ 890/ 002 ZYPADHERA 300 mg -1 vial + 1 vial
EMEA/ H/ C/ 890/ 002 ZYPADHERA 300 mg - kunjett 1 + kunjett 1
ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection.
ZYPADHERA 405 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod.
Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 405 mg olanzapine.
Do not confuse ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection with olanzapine 10 mg powder for solution for injection.
Tifxilx ZYPADHERA 405 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil - mod ma ’ olanzapine 10 mg trab għal soluzzjoni għall- injezzjoni.
38 Table 1
38 Tabella 1 Skema ta ’ doża rrakkomandata bejn olanzapine mill- ħalq u ZYPADHERA
39 Paediatric patients ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
39 Pazjenti pedjatriċi ZYPADHERA mhux irrakkomandat għall- użu fit- tfal u adolexxenti taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
40 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
40 Psikożi relatata mad- demenzja u/ jew disturbi fl- imġiba Olanzapine mhux approvat għall- kura ta ’ psikożi relatata mad- demenzja u/ jew disturbi fl- imġiba u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti minħabba żieda fil- mortalità u r - riskju ta ’ puplesija.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
41 klinikamet adattat speċjalment f’ pazjenti b’ ammonti mhux normali ta ’ lipidi fid- demm u f’ pazjenti li għandhom fatturi ta ’ riskju għall- iżvilupp ta ’ disturbi fil- lipidi.
41 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Attività antikolinerġika Waqt li olanzapine wera attività antikolinerġika in vitro, esperjenza waqt l- istudji kliniċi wriet inċidenza baxxa ta ’ ġrajjiet relatati.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
42 antagoniżmu ma ’ dopamine, olanzapine jista ’ jantagonizza l- effetti diretti u indiretti ta ’ l- agonisti ta ’ dopamine.
42 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma ’ inċidenza mnaqqsa ta ’ diskajneżja minħabba l- kura, b’ mod statistikament sinifikanti.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
43 qed jużaw fluvoxamine jew xi inibituri oħra ta ’ CYP1A2, bħal ciprofloxacin.
43 metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Għalhekk, mhux mistenni li jseħħ xi effett partikolari ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ olanzapine kif ivverifikat minn studji in vitro fejn ma nstabet ebda inibizzjoni tal - metaboliżmu tas- sustanzi attivi li ġejjin: antidepressiv triċikliku (li jirrapreżenta l- aktar is- sensiela ta ’ reazzjonijiet ta ’ CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
4.8 Undesirable effects
44 4. 8 Effetti mhux mixtieqa
45
45 Sonnolenza Disturbi fil- qalb
46 4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
4 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 56 mmol/ l) li żdiedu għal għoljin (≥ 7 mmol/ l).
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
47 b’ olanzapine għal żmien twil (sa 12- il xahar) bl- għan ta 'prevenzjoni ta' episodji oħra f' pazjenti b' mard bipolari kien assoċjat ma 'żieda ta' ≥ 7% mil- linja bażi tal- piż tal- ġisem f' 39. 9% tal- pazjenti.
47 magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
L- ammont ta ’ żieda fil- piż u l- proporzjon ta ’ pazjenti adolexxenti li kellhom żieda fil- piż klinikament sinifikanti kienu akbar b’ espożizzjoni fit- tul (għallinqas 24 ġimgħa) milli b’ espożizzjoni għal żmien qasir.
Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of ZYPADHERA (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).
49 endpoint (tibdil medju - 22. 57, - 26. 32, - 22. 49 rispettivament) ma ’ kull doża ta ’ ZYPADHERA (405 mg kull 4 ġimgħat, 300 mg kull ġimagħtejn, u 210 mg kull ġimagħtejn) meta mqabbel ma ’ plaċebo (tibdil medju - 8. 51).
Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/ hr) versus males (27.3 l/ hr), and in non-smokers (18.6 l/ hr) versus smokers (27.7 l/ hr).
50 It- tneħħija ta ’ olanzapine mill- plażma wara li olanzapine ttieħed mill- ħalq hija aktar baxxa fin- nisa (18. 9 l/ siegħa) kontra l- irġiel (27. 3 l/ siegħa), u f’ minn ma jpejjipx (18. 6 l/ siegħa) kontra minn ipejjep (27. 7 l/ siegħa).
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
51 Fix- xadini, dożi mill- ħalq b’ waħdiet sa 100 mg/ kg irriżultaw f' prostrazzjoni u, f' dożi ogħla, f’ telf parzjali mis- sensi.
51 Reproductive toxicity Olanzapine had no teratogenic effects.
Tossiċità fuq is- sistema riproduttiva Olanzapine ma kellu l- ebda effetti teratoġeniċi.
2 years
52 Sentejn
405 mg powder:
Trab ta ’ 405 mg:
Bromobutyl stopper with steel blue colour seal.
Tapp ta ’ bromobutyl b’ siġill blu lewn l- azzar.
52 One carton contains one vial of powder and one vial of solvent.
Kaxxa fiha kunjett wieħed bit- trab u kunjett wieħed bis- solvent.
It is important to note that there is more solvent in the vial to reconstitute than is needed.
53 Huwa importanti li tinnota li għar- rikostituzzjoni hemm iżjed solvent fil- kunjett milli huwa meħtieġ.
STEP 3:
PASS 3:
Reconstituting ZYPADHERA 15.
Kit tirrikostitwixxi ZYPADHERA 1.
15.
54 3.
EMEA/ H/ C/ 890/ 003 ZYPADHERA 405 mg - 1 vial + 1 vial
EMEA/ H/ C/ 890/ 003 ZYPADHERA 405 mg - kunjett 1 + kunjett 1
55 ANNEX II
55 ANNESS II
KG Teichweg 3 D-35396 Giessen Germany
KG Teichweg 3 D- 35396 Giessen Il- Ġermanja
Summary of Product Characteristics, section 4.2).
Sommarju tal - Karatteristiċi tal - Prodott, sezzjoni 4. 2). >
An education program to the health care professionals (HCP) (doctors-nurses-pharmacists) shall address,
Programm edukattiv għall- professjonisti fil- kura tas- saħħa (PKS) għandu jindirizza:
1) Description of post injection syndrome – Education about the 2 intramuscular formulations of olanzapine, including packaging differences – Description of reconstitution and proper administration technique – Recommendation for a 3-hour on-site observation period post injection – Recommendation that prior to giving the injection, the HCP should determine that the patient will not travel alone to their destination – Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed – Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events – Recommendation for appropriate monitoring until the event resolves if an event should occur 2) Recommendations for monitoring of patients for glucose, lipids, and weight. – Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines.
2) Rakkomandazzjonijiet biex il- pazjenti jkunu ċċekkjati għaz- zokkor, lipidi u piż.
A patient card shall be distributed to all patients, including:
Biljett għall- pazjenti għandu jitqassam lill- pazjenti kollha u jkun fih:
– Description of post injection syndrome – Recommendation for a 3-hour on-site observation period post injection – Recommendation that prior to giving the injection, the HCP should determine that the patient will not travel alone to their destination – Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed – Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events – Recommendation for appropriate monitoring until the event resolves if an event should occur
Id- deskrizzjoni ta ’ l- aktar sintomi komuni rrapportati b’ doża eċċessiva ta ’ olanzapine li – jirrappreżentaw il- kwadru kliniku f’ avvenimenti ta ’ sindromu ta ’ wara l- injezzjoni
57 • OTHER CONDITIONS
57 Ir- rakkomandazzjoni li jkun hemm monitoraġġ xieraq sakemm l- avveniment jirriżolva ruħu fil- każ – li jseħħ avveniment.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni 2 ippreżentat fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda preżenti u qiegħda taħdem qabel ma jpoġġi l- prodott fuq is- suq u waqt li l- prodott qiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 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 dwar l- Immaniġġar tar- Riskju L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 3 tal- Pjan dwar l- Immaniġġar tar- Riskju (RMP) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ kull aġġornament ta ’ l - RMP li jista ’ jkun hemm u li jkun qabel miegħu is- CHMP.
58 ANNEX III
58 ANNESS III
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer Carton ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection
Kartuna ta ’ Barra ZYPADHERA 210 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l - mediċina bil- mod
ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Olanzapine
ZYPADHERA 210 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod Olanzapine
Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine.
150 mg/ ml olanzapine.
150 mg/ ml olanzapine
The powder for injection has no excipients.
It- trab għall- injezzjoni ma fihx sustanzi mhux attivi.
The solvent excipients are croscarmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.
Is- sustanzi mhux attivi tas- solvent huma croscarmellose sodium, mannitol, polysorbate 80, ilma għall- injezzjonijiet, hydrochloric acid, sodium hydroxide.
One vial of 3 ml solvent.
Kunjett wieħed ta ’ trab għal suspensjoni għall- injezzjoni Kunjett wieħed ta ’ 3 ml ta ’ solvent
Do not administer intravenously or subcutaneously.
Għall- użu minn ġol- muskoli M’ għandux jingħata minn ġol- vini jew minn taħt il- ġilda.
EXP {MM/ YYYY} Vial of suspension after reconstitution:
JIS {XX/ SSSS} Kunjett ta ’ suspensjoni wara r- rikostituzzjoni:
Once withdrawn from vial into syringe, suspension should be used immediately.
24 siegħa Ladarba tinġibed mill- kunjett għal ġos- siringa, is- suspensjoni għandha tintuża b’ mod immedjat.
61 Do not refrigerate or freeze.
61 Tagħmlux fil- friġġ jew fil- friża
Discard syringe, needles and unused suspension appropriately.
Armi b’ mod xieraq is- siringa, il- labar u s- suspensjoni li ma ntużatx.
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
MARKETING AUTHORISATION NUMBER (S)
NUMRU( I) TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
< Justification for not including Braille accepted >
< Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata >
62 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
62 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Vial Label ZYPADHERA 210 mg powder for prolonged release suspension for injection
Tikketta tal- Kunjett ZYPADHERA 210 mg trab għal suspensjoni għall- injezzjoni li terħi l - mediċina bil- mod
ZYPADHERA 210 mg powder for injection olanzapine IM
ZYPADHERA 210 mg trab għall- injezzjoni olanzapine IM
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
63 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer Carton ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection
Kartuna ta ’ Barra ZYPADHERA 300 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l - mediċina bil- mod
ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Olanzapine
ZYPADHERA 300 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod Olanzapine
Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Olanzapine pamoate monohydrate ekwivalenti għal 300 mg olanzapine.
Do not refrigerate or freeze.
64 Tagħmlux fil- friġġ jew fil- friża
65 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Vial Label ZYPADHERA 300 mg powder for prolonged release suspension for injection
Tikketta tal- Kunjett ZYPADHERA 300 mg trab għal suspensjoni għall- injezzjoni li terħi l - mediċina bil- mod
ZYPADHERA 300 mg powder for injection olanzapine IM
ZYPADHERA 300 mg trab għall- injezzjoni olanzapine IM
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
66 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Outer Carton ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
Kartuna ta ’ Barra ZYPADHERA 405 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l - mediċina bil- mod
ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Olanzapine
ZYPADHERA 405 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod Olanzapine
Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Olanzapine pamoate monohydrate ekwivalenti għal 405 mg olanzapine.
Do not refrigerate or freeze.
67 Tagħmlux fil- friġġ jew fil- friża
68 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Vial Label ZYPADHERA 405 mg powder for prolonged release suspension for injection
Tikketta tal- Kunjett ZYPADHERA 405 mg trab għal suspensjoni għall- injezzjoni li terħi l - mediċina bil- mod
ZYPADHERA 405 mg powder for injection olanzapine IM
ZYPADHERA 405 mg trab għall- injezzjoni olanzapine IM
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label Solvent for ZYPADHERA
69 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Solvent for ZYPADHERA IM
Solvent għal ZYPADHERA IM
ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
ZYPADHERA 210 mg, trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod ZYPADHERA 300 mg, trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod ZYPADHERA 405 mg, trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod
olanzapine
olanzapine
- If you have any further questions, ask your doctor or nurse.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tiegħek.
please tell your doctor or nurse.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
What ZYPADHERA is and what it is used for 2.
X' inhi ZYPADHERA u għalxiex tintuża 2.
Before you are given ZYPADHERA 3.
Qabel ma 'tingħata ZYPADHERA 3.
How ZYPADHERA is given 4.
Kif tingħata ZYPADHERA 4.
WHAT ZYPADHERA IS AND WHAT IT IS USED FOR
X' INHI ZYPADHERA U GĦALXIEX TINTUŻA
ZYPADHERA belongs to a group of medicines called antipsychotics and is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
ZYPADHERA tagħmel parti minn grupp ta 'mediċini li jissejħu antipsikotiċi u hija użata biex tikkura l- iskiżofrenija - marda b' sintomi bħal li tisma', li tara jew li tħoss affarijiet li mhux qegħdin hemm, opinjonijiet żbaljati, suspetti mhux ġustifikati u li tingħalaq fik innifsek.
People with this disease may also feel depressed, anxious or tense.
Nies b’ din il- marda jistgħu wkoll iħossuhom imdejqin, anzjużi jew taħt tensjoni.
BEFORE YOU ARE GIVEN ZYPADHERA
QABEL MA TINGĦATA ZYPADHERA
You should not be given ZYPADHERA if you have: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of ZYPADHERA.
M’ għandekx tingħata ZYPADHERA jekk: • għandek allerġija (tbati minn sensittività eċċessiva) għal olanzapine jew sustanzi oħra ta ’ ZYPADHERA.
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Reazzjoni allerġika tista 'tidher bħala raxx, ħakk, wiċċ minfuħ, xofftejn minfuħa jew qtugħ ta' nifs.
If this has happened to you, tell your nurse or doctor. • been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Jekk ġralek hekk, għid lin- ners jew lit- tabib tiegħek. • kont issofri qabel bi problemi fl- għajnejn bħal xi tipi ta 'glawkoma (żieda fil- pressjoni ġewwa l - għajn).
Take special care with ZYPADHERA • Prior to giving ZYPADHERA, your doctor or nurse should determine that you will not travel alone to your destination after each injection. • An uncommon but serious reaction might occur after you receive each injection.
Oqgħod attent ħafna b' ZYPADHERA • Qabel ma tingħata ZYPADHERA, it- tabib jew in- ners tiegħek għandhom jaċċertaw ruħhom li wara kull injezzjoni ma tkunx se tivjaġġa lura lejn id- destinazzjoni tiegħek waħdek.
ZYPADHERA can sometimes enter the bloodstream too quickly.
Xi kultant ZYPADHERA tista ’ tidħol fiċ- ċirkolazzjoni tad- demm malajr wisq.
If this happens, you may have the symptoms listed below after your injection.
Jekk jiġri hekk, wara l- injezzjoni tiegħek jista ’ jkollok is- sintomi mniżżlin hawn taħt.
In some cases, these symptoms can lead to unconsciousness.
F’ xi każijiet dawn is - sintomi jistgħu jkunu l- kawża li tintilef minn sensik.
• • •
• ngħas esaġerat
dizziness disorientation anxiety
• sturdament
• • • •
• konfużjoni
aggression • difficulty talking • difficulty walking • convulsions
• diżorjentament
increase in blood pressure weakness muscle stiffness or shaking
• żieda fil- pressjoni tad- demm
These symptoms typically resolve within 24 to 72 hours after your injection.
Ħafna drabi, fi żmien 24 sa 72 siegħa mill- injezzjoni dawn is- sintomi ma jibqgħux jidhru.
After each injection you will be observed in your healthcare facility for at least 3 hours for the symptoms listed above.
Wara kull injezzjoni, tibqa ’ taħt osservazzjoni fil- faċilità fejn tkun qed tiġi kkurat għal mill- inqas 3 sigħat għas- sintomi mniżżla hawn fuq.
Although unlikely, you may get the symptoms more than 3 hours after the injection.
Għalkemm mhux probabbli, jista ’ jkollok dawn is- sintomi wara aktar minn 3 sigħat mill - injezzjoni.
If this happens, contact your doctor or nurse immediately.
Jekk jiġri hekk, ikkuntattja lit- tabib jew lin- ners tiegħek immedjatament.
Because of this risk, do not drive or operate machinery for the remainder of the day after each injection. • Tell the doctor or nurse if you feel dizzy or faint after the injection.
• Għid lit- tabib jew lin- ners tiegħek jekk wara l- injezzjoni tħossok qed tistordi jew li se jtik ħass ħażin.
You will probably need to lie down until you feel better.
Wisq probabbli se jkollok bżonn timtedd sakemm tħossok aħjar.
The doctor or nurse may also want to measure your blood pressure and pulse. • Very rarely, medicines of this type may cause unusual movements mainly of the face or tongue or a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Jista ’ jkun li t- tabib jew in- ners ikunu jridu jeħdulek il- pressjoni tad- demm u l- polz. • F’ xi każijiet rari ħafna, dawn it- tipi ta ’ mediċini jistgħu jikkawża movimenti mhux tas- soltu l - iżjed tal- wiċċ jew ta ’ l- ilsien jew ikun hemm taħlita ta ’ deni, nifs aktar mgħaġġel, għaraq, ebusija tal- muskoli u ħedla jew ngħas.
If this happens after you have been given ZYPADHERA, tell your doctor or nurse immediately. • The use of ZYPADHERA in elderly patients with dementia is not recommended as it may have serious side effects.
Jekk jiġri hekk wara li tkun ġejt mogħti ZYPADHERA, għid immedjatament lit- tabib jew ners. • F’ pazjenti anzjani li qed ibatu mid- demenzja, l- użu ta ’ ZYPADHERA m’ huwiex rakkomandat għax jista ’ jkun hemm effetti sekondarji serji.
Tell your doctor as soon as possible if any of the following applies to you: • a recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms), unstable angina or 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)
• attakk tal- qalb reċenti, mard tal- qalb, sindromu ta ’ sick sinus (ritmi mhux normali tal- qalb), anġina li m’ hijiex stabbli u pressjoni baxxa tad- demm • dijabete • mard tal- fwied jew tal- kliewi • marda tal- Parkinson • epilessija • problemi fil- prostata • intestin imblokkat (ileus paralitiku) • disturbi tad- demm • puplesija jew puplesija “ ħafifa ” (sintomi temporanji ta ’ puplesija)
ZYPADHERA is not for patients who are under 18 years.
ZYPADHERA mhuwiex għal pazjenti li għandhom inqas minn 18- il sena.
As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.
Bħala prekawzjoni ta ’ rutina, jekk għandek iżjed minn 65 sena it- tabib jista ’ jeħodlok il- pressjoni tad - demm.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In particular, tell your doctor if you are taking: • medicines for Parkinson’s disease. • fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
B’ mod partikolari għid lit- tabib tiegħek jekk qiegħed tieħu: • mediċini għall- marda tal- Parkinson
If you are already taking antidepressants, medicines for anxiety or to help you sleep (tranquillisers), you may feel drowsy if ZYPADHERA is given.
73 • fluvoxamine (antidipressiv) jew ciprofloxacin (antibijotiku) – jista ’ jkun hemm il- bżonn li tibdel id- doża tiegħek ta ’ ZYPADHERA
Using ZYPADHERA with food and drink Do not drink any alcohol if you have been given ZYPADHERA as together with alcohol it may make you feel drowsy.
Tista ’ tħossok imħeddel jekk tingħata ZYPADHERA u diġà qed tieħu xi antidipressivi, mediċini għall- ansjetà jew biex jgħinuk torqod (kalmanti).
Pregnancy and breast-feeding Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Meta tuża ZYPADHERA ma ’ l- ikel u max- xorb Tixrobx alkoħol jekk ġejt mogħti ZYPADHERA għax meta teħodha ma ’ l- alkoħol tista ’ tħeddlek.
73 You should not be given this injection if you are breast-feeding as small amounts of olanzapine can pass into breast milk.
M' għandekx tingħata din l - injezzjoni jekk tkun qed tredda ’, għax ammonti żgħar ta ’ olanzapine jistgħu jgħaddu fil- ħalib tas- sider.
Driving and using machines Do not drive or operate machinery for the remainder of the day after each injection.
Sewqan u tħaddim ta 'magni Wara kull injezzjoni, għal bqija tal- ġurnata m’ għandekx issuq jew tħaddem magni.
HOW ZYPADHERA IS GIVEN
KIF JINGĦATA ZYPADHERA
Your doctor will decide how much ZYPADHERA you need and how often you need to be given an injection.
It- tabib tiegħek se jiddeċiedi kemm għandek bżonn ZYPADHERA u kemm- il darba għandek tingħata l- injezzjoni.
ZYPADHERA is given in doses of 150 to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
ZYPADHERA jingħata f’ dożi ta ’ 150 għal 300 mg kull ġimgħatejn jew 300 għal 405 mg kull 4 ġimgħat.
ZYPADHERA comes as a powder which your doctor or nurse will make into a suspension that will then be injected into the muscle in your buttock.
ZYPADHERA tiġi bħala trab, li tiġi magħmula f’ suspensjoni mit- tabib jew ners li mbagħad tiġi mogħtija bħala injezzjoni fil- muskolu tal- warrani.
If you are given more ZYPADHERA than needed This medicine will be given to you under medical supervision, it is therefore unlikely that you will be given too much.
Din il- mediċina se tingħata lilek taħt superviżjoni medika u għalhekk m’ hijiex probabbli li se tingħata aktar milli suppost.
Patients who have been given too much olanzapine have also 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 ngħataw iżjed olanzapine milli suppost kellhom ukoll dawn is- sintomi li ġejjin: • tħabbit mgħaġġel tal- qalb, aġitazzjoni/ aggressività, problemi biex jitkellmu, movimenti mhux tas- soltu (speċjalment tal- ħalq jew ta ’ l- ilsien) u tnaqqis fil- livell ta ’ koxjenza.
Other symptoms may include: • acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness, and drowsiness or sleepiness; slower breathing, aspiration, high or low blood pressure, abnormal rhythms of the heart.
Sintomi oħra jistgħu jinkludu: • konfużjoni akuta, aċċessjonijiet (epilessija), koma, taħlita ta ’ 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.
Contact your doctor or hospital straight away if you experience any of the above.
Jekk tħoss xi ħaġa minn dawn t’ hawn fuq, ikkuntattja mill- ewwel lit- tabib tiegħek jew l- isptar.
If you miss an injection of ZYPADHERA Do not stop your treatment just because you feel better.
Jekk taqbeż injezzjoni ta ’ ZYPADHERA Twaqqafx il- kura tiegħek għax tħossok aħjar.
It is important that you carry on receiving ZYPADHERA for as long as your doctor has told you to.
Huwa importanti li tibqa ’ tirċievi ZYPADHERA sakemm ikun qallek it- tabib tiegħek.
If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Jekk taqbeż injezzjoni, għandek tikkuntattja t- tabib tiegħek mill- aktar fis possibbli biex itik l - injezzjoni li jmiss.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ din il- mediċina, staqsi lit- tabib jew lin- ners tiegħek.
Like all medicines, ZYPADHERA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ZYPADHERA jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects: affect 1 to 10 users in 100 • ZYPADHERA can sometimes enter the bloodstream too quickly and this may lead to the following side effects: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure, or convulsions and can lead to unconsciousness. • Sleepiness. • Injection site pain.
Effetti sekondarji komuni: jaffettwaw minn 1 sa 10 pazjenti minn kull 100.
The side effects listed below have been observed when oral olanzapine has been given but may occur following administration of ZYPADHERA.
L- effetti sekondarji mniżżlin hawn taħt seħħew meta ngħata olanzapine b’ mod orali iżda jistgħu jseħħu wara li jingħata ZYPADHERA.
Very common side effects: affect 1 user in 10 • Weight gain.
Effetti sekondarji komuni ħafna: jaffettwaw 1 minn kull 10 pazjenti • Żieda fil- piż. • Ngħas. • Żidiet fil- livelli ta 'prolactin fid- demm.
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. • Għeja esaġerata. • Retenzjoni ta 'l- ilma li twassal għal nefħa fl- idejn, għekiesi jew saqajn. • 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 bilqiegħda.