qanastek/EMEA-V3 huggingface dataset:
However; post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts (for example, VZV- susceptible infant grandchildren).
Madankollu; l- esperjenza ta 'wara l- kummerċjalizzazzjoni b' tilqim kontra l- ġidri r- riħ tissuġġerixxi li t- trasmissjoni tal- virus tat- tilqima tista' sseħħ f' każijiet rari bejn dawk il- persuni li jkunu rċevew it- tilqima li jiżviluppaw raxx simili għal dak tal- ġidri r- riħ u persuni suxxettibbli li setgħu ġew f' kuntatti (per eżempju, neputijiet żgħar suxxettibbli għal VZV).
12 4.6 Pregnancy and lactation
12 4. 6 Tqala u Treddigħ
13 The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards.
13 Il- bqija tas- suġġetti fl- SPS irċevew monitoraġġ tas- sigurtà ta 'rutina, iżda ma ngħatawx kards tar - rapporti.
The types of events reported in these patients were generally similar to the subgroup of patients in the Adverse Event Monitoring Substudy.
It- tipi ta 'avvenimenti rrapportati f' dawn il- pazjenti kienu ġeneralment simili għal dawk irrappurtati mis- subgrupp ta' pazjenti fis- Substudju tal- Monitoraġġ tal- Każ Avvers.
In other clinical trials in support of the initial licensure of the frozen formulation of ZOSTAVAX, the reported rates of noninjection-site zosteriform and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine recipients and placebo recipients.
Fil- provi kliniċi l- oħra kollha li jappoġġjaw il- liċenzjar inizjali tal- formolazzjoni ffriżata ta 'ZOSTAVAX, ir- rati rrapportati ta' raxx zosteriform mhux fil- post tal- injezzjoni u raxxijiet simili għall- ġidri r- riħ fi żmien 42 jum wara t- tilqima kienu wkoll baxxi kemm fir- riċevituri tal- vaċċin zoster kif ukoll fir- riċevituri tal- placebo.
Of the 17 reported noninjection-site zosteriform and varicella-like rashes, 10 specimens were available and adequate for PCR testing.
Mis- 17 il- zosteriform mhux fil- post tal- injezzjoni u raxxijiet simili għall- ġidri r- riħ irrapportati, kien hemm 10 kampjuni disponibbli u adegwati għal PCR testing.
The Oka/ Merck strain was identified by PCR analysis from the lesion specimens of only two subjects who reported varicella-like rashes (onset on Day 8 and 17).
Ir - razza Oka/ Merck ġiet identifikata b' analiżi PCR mill- kampjuni tal- leżjoni ta 'żewġ suġġetti biss li rrapportaw raxxijiet simili għall- ġidri r- riħ (bidu f' Jum 8 u 17).
However, in these trials, a higher rate of injection-site adverse experiences of mild-to-moderate intensity was reported among subjects 50-59 years of age compared with subjects ≥ 60 years of age (see section5.1).
Madankollu, f’ dawn il- provi, ġiet reġistrata rata ogħla ta 'esperjenzi avversi fil- post ta' injezzjoni ta 'intensità ħafifa għal moderata fost suġġetti ta' 50- 59 sena meta mqabbel ma 'suġġetti ta' ≥60 sena (ara sezzjoni 5. 1).
Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation is generally well tolerated with a safety profile comparable to that of the frozen formulation.
Tagħrif minn prova klinika (n=368) wera li l- formulazzjoni mkessħa preżenti hija ġeneralment ittollerata sewwa bi profil ta 'sigurtà komparabbli ma' dik tal- formolazzjoni ffriżata.
No serious vaccine-related adverse experiences were reported.
Ma ġiet irrapportata ebda esperjenza avversa serja relatata mal- vaċċin..
Vaccine
Effikaċja tat -
efficacy*
tilqima *
Incidence of Zoster
Inċidenza ta 'Zoster
44 to 58%
44 sa 58%
Incidence of PHN** HZ Pain BOI***
BOI ta 'l- Uġigħ b' HZ ***
48 to 79% 51 to 69%
51 sa 69%
The protective efficacy of ZOSTAVAX against zoster was 51% (95% CI:
L - effikaċja tal- protezzjoni ta 'ZOSTAVAX kontra zoster kienet ta' 51% (95% CI:
69 subjects who received placebo.
69 suġġett li irċevew placebo.
In the vaccine group, the risk of developing PHN after zoster was 9% (27/ 315), while in the placebo group it 15 was 13% (80/ 642).
Fil- grupp tal- vaċċin, ir- riskju ta 'żvilupp ta' zoster kien ta '9% (27/ 315), filwaqt li fil- grupp tal- placebo, dan kien ta' 13% (80/ 642).
19% for the placebo group.
15 fil- grupp ta 'suġġetti ikbar fl- età (≥70 sena), fejn ir- riskju li jiżviluppaw PHN wara zoster tnaqqas għal 10% fil- grupp tal- vaċċin meta mqabbel ma' 19% għall- grupp tal- placebo.
The effect was more pronounced in the younger age group (60 to 69 years) where the efficacy of ZOSTAVAX on HZ pain BOI was 66% compared to 55% in patients ≥ 70 years of age; however, this difference was not statistically significant (p=0.266).
L- effett kien jidher iktar fil- grupp ta' età iżgħar (60 sa 69 sena) fejn l - effikaċja ta 'ZOSTAVAX fuq il- BOI ta' l- uġigħ b' HZ kienet ta '66% meta mqabbla ma' 55% f' pazjenti ta '≥70 sena; madankollu, din id- differenza ma kinitx statistikament sinifikanti (p=0. 266).
Prevention of HZ cases with severe pain in the entire study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score > 600) by 73% (95% CI:
Il- prevenzjoni ta 'każijiet HZ b' uġigħ qawwi fil- popolazzjoni sħiħa ta' l- istudju ZOSTAVAX naqqas l- inċidenza ta 'zoster b' uġigħ qawwi u fit- tul (skor ta' severità skond it- tul ta 'żmien > 600) b’ 73% (95% CI:
Increases in both VZV antibody level, measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) (1.7-fold difference, geometric mean titer [GMT] of 479 vs.
Intwerew żjidiet kemm fil - livell ta 'antikorpi ta' VZV, imkejjla b' glycoprotein enzyme- linked immunosorbent assay (gpELISA) (differenza ta '1. 7- darba, geometric mean titer [GMT] ta' 479 vs.
Immunogenicity following concomitant administration In a double-blind, controlled clinical trial, 762 adults 50 years of age and older were randomized to receive a single dose of ZOSTAVAX administered either concomitantly (N=382) or nonconcomitantly (N=380) with inactivated split influenza vaccine.
Immunoġeniċità wara għoti konkomittanti Fi prova klinika kkontrollata, double- blind, 762 adult ta '50 sena u aktar ġew magħżula b' mod każwali biex jirċievu doża waħda ta' ZOSTAVAX mogħtija jew flimkien ma '(N=382) jew mhux flimkien ma' (N=380) vaċċin mhux attivat maqsum ta 'l- influwenza.
The antibody responses to both vaccines at 4 weeks postvaccination were similar, whether administered concomitantly or nonconcomitantly.
Ir- rispons ta 'l- antikorpi għaż- żewġ tilqimiet 4 ġimgħat wara t- tilqima kien wieħed simili, kemm meta mogħtija flimkien jew le.
16 Immunogenicity in subjects with a history of herpes zoster (HZ) prior to vaccination In a double-blind, placebo-controlled, randomized clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination to assess immunogenicity and safety (see section 4.8) of ZOSTAVAX.
16 Immunoġeniċità f’ suġġetti bi storja ta ’ ħerpes zoster (HZ) qabel it- tilqima Fi prova klinika randomizzata, ikkontrollata bi plaċebo, double- blind, ZOSTAVAX ingħata lil 100 suġġett ta ’ 50 sena jew aktar bi storja ta ’ ħerpes zoster (HZ) qabel tilqima, biex tkun ivvalutata l - immunoġeniċità u s- sigurtà (ara sezzjoni 4. 8) ta ’ ZOSTAVAX.
[1.5 to 2.9]), p < 0.001), GMT of 812 vs.
[1. 5 to 2. 9]), p < 0. 001, GMT ta ’ 812 vs.
393 gpELISA units/ ml.
393 gpELISA unitajiet/ ml).
Immunocompromised subjects The vaccine has not been studied in subjects with impaired immunity.
Suġġetti immunokompromessi It- tilqima ma ġietx studjata f' suġġetti b' immunità dgħajfa.
Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the SPC.
Ma sarux studji non- kliniċi tradizzjonali, iżda ma 'hemm ebda tħassib relevanti dwar dan għas- sigurtà klinika barra mill- informazzjoni inkluża f' sezzjonijiet oħra tal- SPC.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same syringe.
Minħabba li ma sarux studji li juru liema huma il- prodotti li ma jaqblux miegħu, dan il- prodott medċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (chlorobutyl natural rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u kappa tat- tip flip off (aluminju) u solvent f' siringa mimlija għal- lest (ħġieġ ta' Tip I) bi planger- stopper (chlorobutyl rubber) u kappa tat- tarf (chlorobutyl natural rubber) b' labra waħda jew tnejn mhux imwaħħla/ imwaħħlin f' pakkett ta 'daqs 1, 10 jew 20.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (chlorobutyl natural rubber) without needle in pack size of 1, 10 or 20.
Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u kappa tat- tip flip off (aluminju) u solvent f' siringa mimlija għal- lest (ħġieġ ta' Tip I) bi planger- stopper (chlorobutyl rubber) u kappa tat- tarf (chlorobutyl natural rubber) mingħajr labra f' pakkett ta 'daqs 1, 10 jew 20.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber), in a pack size of 1 or 10.
Trab f' kunjett (ħġieġ ta 'Tip I) b' tapp (butyl rubber) u kappa tat- tip flip off (aluminju) u solvent f' siringa mimlija għal- lest (ħġieġ ta' Tip I) bi planger- stopper (chlorobutyl rubber) u bi protezzjoni għal- labra (gomma naturali) f' pakkett ta 'daqs 1 jew 10.
Reconstitution instructions To reconstitute the vaccine, inject all the solvent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
Struzzjonijiet ta 'rikostituzzjoni Biex tirrikonstitwixxi t- tilqima, injetta s- solvent kollu fis- siringa fil- kunjett tal- vaċċin lyophilized u ħawwad bil- mod sabiex tħallat sewwa.
Withdraw the entire contents into a syringe for injection.
Iġbed il- kontenut kollu f' siringa għall- injezzjoni.
One or 2 separate needles may be available in the secondary packaging of the presentation containing the pre-filled syringe without the attached needle.
Jista 'jkun hemm labra waħda jew tnejn separati fil- pakkett sekondarju tal- preżentazzjoni li jkun fih is- siringa mimlija għal- lest mingħajr il- labra mwaħħla.
The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90°) to secure the connection.
Il- labra għandha tiġi mbuttata fl- estremità tas- siringa u mdawwra kwart ta 'dawra (90°) biex titqabbad tajjeb.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
HUWA RRAKOMANDAT LI L- VAĊĊIN JINGĦATA MINNUFIH WARA IR - RIKOSTITUZZJONI, SABIEX JITNAQQAS IT- TELF TAS- SAĦĦA.
18 The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the vaccine differs from that described above.
18 Il- vaċċin rikonstitwit m’ għandux jintuża jekk tiġi nnotata xi materja ta 'partikulati jew jekk id- dehra tal- vaċċin tkun differenti minn dik deskritta fuq.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR (I) TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali isir minn laboratorju ta ’ l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version [submitted on August 15th, 2006] 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.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jintrabat li jwettaq studji u attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni [ippreżentata fil- 15 ta ’ Awwissu, 2006] tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ippreżentat fil - Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament tal- RMP miftiehem mal- CHMP.
ZOSTAVAX - Powder in vial and solvent in vial - Pack of 1, 10
ZOSTAVAX - trab f' kunjett u solvent f' kunjett - Pakkett ta '1, 10
ZOSTAVAX powder and solvent for suspension for injection zoster vaccine (live)
ZOSTAVAX trab u solvent għal sospensjoni għal injezzjoni vaċċin zoster (ħaj)
After reconstitution, 1 dose (0.65 ml) contains:
Wara ir- rikonstituzzjoni, doża 1 (0. 65 ml) fiha:
Varicella-zoster virus, Oka/ Merck strain, (live, attenuated) ≥ 19400 PFU* *PFU = Plaque-forming units
Virus variċella- zoster, razza Oka/ Merck, (ħaj, attenwat) ≥19400 PFU * * PFU = Unitajiet li jiffurmaw plakka
Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate, anhydrous disodium phosphate, sodium hydroxide.
Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L- glutamate, anhydrous disodium phosphate, sodium hydroxide.
Powder and solvent for suspension for injection Pack of 1 single dose vial (powder) + 1 single dose vial (solvent) Pack of 10 single dose vials (powder) + 10 single dose vials (solvent)
Trab u solvent għal sospensjoni għal injezzjoni Pakkett ta 'doża waħda singola (trab) + kunjett 1 ta' doża waħda (solvent) Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 kunjetti ta 'doża waħda (solvent)
STORE AND TRANSPORT REFRIGERATED.
AĦŻEN U TTRASPORTA IMKESSAĦ.
Keep the vial of powder in the outer carton to protect from light.
Żomm il- kunjett tat- trab fil- kaxxa ta ’ barra sabiex tilqa ’ mid- dawl.
After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.
Wara rikonstituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun bejn l- 20°C- 25°C.
Read the package leaflet for disposal of medicines no longer required
Aqra l- fuljett ta 'tagħrif dwar kif għandek tarmi l- mediċini li mhumiex aktar meħtieġa
EU/ 1/ 06/ 341/ 001 – pack of 1 EU/ 1/ 06/ 341/ 002 – pack of 10
EU/ 1/ 06/ 341/ 001 – pakkett ta '1 EU/ 1/ 06/ 341/ 002 – pakkett ta' 10
ZOSTAVAX powder for suspension for injection.
ZOSTAVAX Trab għal sospensjoni għal injezzjoni.
1 dose
Doża 1
Solvent for ZOSTAVAX Water for injections
Solvent għal ZOSTAVAX Ilma għall- injezzjonijiet
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with attached needle Pack of 1, 10
ZOSTAVAX - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' labra mwaħħla Pakkett ta '1, 10
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe zoster vaccine (live)
ZOSTAVAX Trab u solvent għal sospensjoni għal injezzjoni f' siringa mimlija għal- lest vaċċin zoster (ħaj)
After reconstitution, 1 dose (0.65 ml) contains:
Wara rikonstituzzjoni, doża 1 (0. 65 ml) fiha:
Powder and solvent for suspension for injection in a pre-filled syringe Pack of 1single dose vial (powder) + 1 pre-filled syringe with attached needle (solvent) Pack of 10 single dose vials (powder) + 10 pre-filled syringes with attached needle (solvent)
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest b' labra mwaħħla (solvent)
EU/ 1/ 06/ 341/ 003 – pack of 1 EU/ 1/ 06/ 341/ 004 – pack of 10
EU/ 1/ 06/ 341/ 003 – pakkett ta '1 EU/ 1/ 06/ 341/ 004 – pakkett ta' 10
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20
ZOSTAVAX - Trab f' kunjett u solvent f' siringa mimlija għal- lest mingħajr labra - Pakkett ta '1, 10, 20
After reconstitution, 1dose (0.65 ml) contains:
Wara ir- rikonstituzzjoni, doża 1 (0. 65 ml) fiha:
Pack of 1single dose vial (powder) + 1 pre-filled syringe without needle (solvent) Pack of 10 single dose vials (powder) + 10 pre-filled syringes without needle (solvent) Pack of 20 single dose vials (powder) + 20 pre-filled syringes without needle (solvent)
Pakkett ta 'kunjett wieħed ta' doża waħda (trab) + siringa waħda mimlija għal- lest mingħajr labra mwaħħla (solvent) Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest mingħajr labra mwaħħla (solvent) Pakkett ta '20 kunjett ta' doża waħda (trab) + 20 siringi mimlijin għal- lest mingħajr labra mwaħħla (solvent)
After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.
Wara r- rikonstituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun f' 20°C- 25°C.
EU/ 1/ 06/ 341/ 005 – pack of 1 EU/ 1/ 06/ 341/ 006 – pack of 10 EU/ 1/ 06/ 341/ 007 – pack of 20
EU/ 1/ 06/ 341/ 005 – pakkett ta '1 EU/ 1/ 06/ 341/ 006 – pakkett ta' 10 EU/ 1/ 06/ 341/ 007 – pakkett ta '20
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with one unattached needle - Pack of 1, 10, 20
ZOSTAVAX - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' labra mhux imwaħħla - Pakkett ta '1, 10, 20
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe zoster vaccine (live)
ZOSTAVAX trab u solvent għal sospensjoni għal injezzjoni f' siringa mimlija għal- lest vaċċin zoster (ħaj)
After reconstitution, 1dose (0.65 ml) contains:
Wara rikostituzzjoni, doża 1 (0. 65 ml) fiha:
Varicella-zoster virus Oka/ Merck strain, (live, attenuated) ≥ 19400 PFU* *PFU = Plaque-forming units
Virus variċella- zoster, razza Oka/ Merck, (ħaj, attenwat) ≥19400 PFU * * PFU = Unitajiet li jiffurmaw plakka
Pack of 1single dose vial (powder) + 1 pre-filled syringe (solvent) + 1 needle unattached needle.
Pakkett ta 'kunjett ta' doża waħda (trab) + siringa waħda mimlija għal- lest (solvent) + labra waħda labra mhux imwaħħla.
Pack of 10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 10 unattached needles.
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest (solvent) + 10 labriet mhux imwaħħlin.
Pack of 20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 20 unattached needles.
Pakkett ta '20 kunjett ta' doża waħda (trab) + 20 siringa mimlijin għal- lest (solvent) + 20 labra mhux imwaħħla.
After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.
Wara rikostituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun bejn l- 20°C- 25°C.
EU/ 1/ 06/ 341/ 008 - pack of 1 EU/ 1/ 06/ 341/ 009 - pack of 10 EU/ 1/ 06/ 341/ 010 - pack of 20
EU/ 1/ 06/ 341/ 008 – pakkett ta '1 EU/ 1/ 06/ 341/ 009 – pakkett ta' 10 EU/ 1/ 06/ 341/ 010 – pakkett ta '20
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of 1, 10, 20
ZOSTAVAX - Trab f' kunjett u solvent f' siringa mimlija għal- lest b' żewġ labriet mhux imwaħħlin - Pakkett ta '1, 10, 20
After reconstitution, 1 dose (0.65 ml) contains:
Wara ir- rikostituzzjoni, doża 1 (0. 65 ml) fiha:
Pack of 1single dose vial (powder) + 1 pre-filled syringe (solvent) + 2 unattached needles.
Pakkett ta 'kunjett ta' doża waħda (trab) + siringa waħda mimlija għal- lest (solvent) + 2 labriet mhux imwaħħlin.
Pack of 10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 20 unattached needles.
Pakkett ta '10 kunjetti ta' doża waħda (trab) + 10 siringi mimlijin għal- lest (solvent) + 20 labra mhux imwaħħla.
Pack of 20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 40 unattached needles.
Pakkett ta '20 kunjett ta' doża waħda (trab) + 20 siringa mimlijin għal- lest (solvent) + 40 labra mhux imwaħħla.
EU/ 1/ 06/ 341/ 011– pack of 1 EU/ 1/ 06/ 341/ 012 – pack of 10 EU/ 1/ 06/ 341/ 013– pack of 20
EU/ 1/ 06/ 341/ 011 – pakkett ta '1 EU/ 1/ 06/ 341/ 012 – pakkett ta' 10 EU/ 1/ 06/ 341/ 013 – pakkett ta '20
ZOSTAVAX powder for suspension for injection.
Trab ta 'ZOSTAVAX għal sospensjoni għal injezzjoni.
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE OF SOLVENT
SIRINGA TA 'SOLVENT MIMLIJA GĦAL- LEST
ZOSTAVAX Powder and solvent for suspension for injection zoster vaccine (live)
ZOSTAVAX Trab u solvent għal sospensjoni għal injezzjoni vaċċin zoster (ħaj)
Read all of this leaflet before you are vaccinated.
Aqra dan il- fuljett kollu qabel ma titlaqqam.
- This vaccine has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek.
What ZOSTAVAX is and what it is used for 2.
X’ inhu ZOSTAVAX u għalxiex jintuża 2.
Before you receive ZOSTAVAX 3.
Qabel ma tuża ZOSTAVAX 3.
How to use ZOSTAVAX 4.
Kif għandek tuża ZOSTAVAX 4.
How to store ZOSTAVAX 6.
Kif taħżen ZOSTAVAX 6.
WHAT ZOSTAVAX IS AND WHAT IT IS USED FOR
X’ INHU ZOSTAVAX U GĦALXIEX JINTUŻA
ZOSTAVAX is a vaccine used to prevent shingles (zoster) and zoster-related post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.
ZOSTAVAX huwa vaċċin użat biex jimpedixxi l- ħruq ta 'Sant' Antnin (zoster) u post- herpetic neuralgia relatata ma' zoster (PHN), l- uġigħ fin- nervituri li jdum sewwa li jsegwi l- ħruq ta 'Sant' Antnin.
ZOSTAVAX is used to vaccinate individuals 50 years of age or older.
ZOSTAVAX huwa wżat għat- tilqim ta 'individwi ta' 50 sena jew aktar.
ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.
ZOSTAVAX ma jistax jintuża sabiex ifejjaq il- ħruq ta 'Sant' Antnin eżistenti jew l- uġigħ assoċjat ma' ħruq ta 'Sant' Antnin eżistenti.
Disease information on shingles:
Tagħrif tal- mard fuq ħruq ta 'Sant' Antnin:
What is shingles?
X' inhu ħruq ta 'Sant' Antnin?
Shingles is a painful, blistering rash.
Il- ħruq ta 'Sant' Antnin huwa raxx li jtella' nfafet u jikkawża uġigħ,.
It usually occurs in one part of the body and can last for several weeks.
Normalment dan ifeġġ f' parti waħda tal- ġisem u jista 'jibqa' preżenti għal bosta ġimgħat.
It may lead to severe and long-lasting pain and scarring.
Jista 'jwassal għal uġigħ qawwi u fit- tul u marki fuq il- ġilda.
Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur.
B' mod inqas komuni, jista 'jkun hemm infezzjonijiet tal- ġilda b' batterji, debbulizza, paraliżi tal- muskoli, telf tas- smigħ jew tal- vista.
Shingles is caused by the same virus that causes chickenpox.
Il- ħruq ta 'Sant' Antnin huwa kkawżat mill- istess virus tal- ġidri r- riħ.
After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Wara li tkun ħadt il- ġidri r- riħ, il- virus li jkun ikkawżah jibqa 'f' ġismek fiċ- ċelloli tan - nervituri.
Sometimes, after many years, the virus becomes active again and causes shingles.
Xi kultant, wara ħafna snin, il- virus jerġa 'jsir attiv u jikkawża l- ħruq ta' Sant' Antnin.
What is PHN?
X' inhu PHN?
After the shingles blisters heal, pain can last for months or years and may be severe.
Wara li l- infafet tal- ħruq ta 'Sant' Antnin ifiequ, l- uġigħ jista' jibqa 'preżenti għal xhur jew snin u dan jista' jkun qawwi.
This long-lasting nerve pain is called post-herpetic neuralgia or PHN.
Dan l- uġigħ fin- nervituri fit- tul huwa msejjaħ post- herpetic neuralgia jew PHN.
BEFORE YOU RECEIVE ZOSTAVAX
QABEL MA TUŻA ZOSTAVAX
Do not receive ZOSTAVAX • if you are allergic (hypersensitive) to any of the components (for example, neomycin) of ZOSTAVAX (including any of the ingredients listed under “ the other ingredients are” - see section 6.
Tieħux ZOSTAVAX • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal xi sustanza (per eżempju, neomycin) ta ’ ZOSTAVAX (inkluż xi ingredjent imniżżel taħt “ l- ingredjenti l- oħra huma ” - ara sezzjoni 6.
39 • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicines, or other treatment • if you have active untreated tuberculosis • if you are pregnant (see Pregnancy and breast-feeding)
Aktar tagħrif - x' fih ZOSTAVAX) • jekk tbati minn xi mard tad- demm jew minn xi tip ta 'kanċer li jdgħajjef is- sistema tal- immunità tiegħek • jekk it- tabib tiegħek qallek li inti għandek sistema tal- immunità mdgħajjfa minħabba marda, mediċini jew trattament ieħor • jekk għandek tuberkolożi attiva mhux trattata • jekk inti tqila (ara Tqala u Treddigħ)
Take special care with ZOSTAVAX
Oqgħod attent ħafna b' ZOSTAVAX
Talk to your doctor or pharmacist before being vaccinated with ZOSTAVAX: • if you have or have had any medical problems and about any allergies • if you have a fever • if you have HIV infection • if you are pregnant or think you could be pregnant, if you are planning to become pregnant, you should consult your doctor as pregnancy must be excluded before vaccination.
Kellem lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu tilqima ta 'ZOSTAVAX: • jekk għandek jew qatt kellek problemi mediċi u rigward xi allerġiji • jekk għandek id- deni • jekk inti infettat bl- HIV • jekk inti tqila jew taħseb li tista' tkun tqila, jekk qed tippjana li tkun tqila, għandek tkellem lit - tabib tiegħek minħabba li għandu jiġi żgurat li m' hemmx tqala qabel tingħata t- tilqima.
Women of child- bearing potential must use effective birth control to avoid pregnancy for 3 months following vaccination.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw mod effettiv ta 'kontraċezzjoni sabiex jevitaw tqala għat - tliet xhur ta' wara li jieħdu t- tilqima.
As with many vaccines, ZOSTAVAX may not completely protect all persons who are vaccinated.
Bħal ħafna tilqim, ZOSTAVAX mhux bilfors jagħti protezzjoni totali lill- persuni kollha li jieħdu t - tilqima.
ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.
ZOSTAVAX ma jistax jintuża sabiex jittratta ħruq ta 'Sant' Antnin eżistenti jew l- uġigħ assoċjat ma' ħruq ta 'Sant' Antnin eżistenti.
Using other medicines and other vaccines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jgħoġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
ZOSTAVAX can be administered at the same time as inactivated influenza vaccine.
ZOSTAVAX jista 'jingħata fl- istess ħin li jingħata l- vaċċin inattivat kontra l- influwenza.
The two vaccines should be given as separate injections at different body sites.
Iż- żewġ vaċċini għandhom jingħataw b' żewġ injezzjonijiet separati f' partijiet differenti tal- ġisem.
Pregnancy and breast-feeding ZOSTAVAX should not be given to pregnant women.
Tqala u Treddigħ ZOSTAVAX ma għandux jingħata lil nisa tqal.
Women of child-bearing potential should take the necessary precautions to avoid pregnancy for 3 months following vaccination.
Nisa li jista 'jkollhom it- tfal għandhom jieħdu l - prekawzjonijiet meħtieġa sabiex jevitaw tqala għat- tliet xhur ta' wara li jieħdu t- tilqima.
Inform your doctor if you are breast-feeding or intending to breast-feed.
Avża lit- tabib tiegħek jekk qed tredda 'jew għandek il- ħsieb li tredda'.
Your doctor will decide if ZOSTAVAX should be given.
It- tabib tiegħek jiddeċiedi jekk għandekx tingħata ZOSTAVAX.
Driving and using machines There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.
Sewqan u tħaddim ta 'magni M' hemm ebda tagħrif li jissuġġerixxi li ZOSTAVAX jaffettwa l- ħila biex issuq jew tħaddem magni.
Important information about the ingredients of ZOSTAVAX Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin or any of the ingredients listed under “ the other ingredients are” - see section 6.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'ZOSTAVAX Avża lit- tabib tiegħek jekk qatt kellek reazzjoni allerġika għal xi wieħed mis- sustanzi (inkluż neomycin jew xi sustanzi mniżżla taħt “ is- sustanzi l- oħra huma ” - ara sezzjoni 6.
Further information- what ZOSTAVAX contains) before you receive this vaccine.
Aktar tagħrif - x' fih ZOSTAVAX) qabel tirċievi din it- tilqima.
HOW TO USE ZOSTAVAX
KIF GĦANDEK TUŻA ZOSTAVAX
ZOSTAVAX should be injected under the skin, preferably in the upper arm.
ZOSTAVAX għandu jiġi injettat taħt il- ġilda, preferibbilment fil- parti ta 'fuq tad- dirgħajn.
ZOSTAVAX is given as a single dose by injection.
ZOSTAVAX jingħata bħala doża waħda b' injezzjoni.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet.
L- istruzzjonijiet dwar ir- rikonstituzzjoni maħsubin għal professjonisti mediċi u tal- kura tas - saħħa huma nklużi fil- parti ta 'l- aħħar tal- fuljett.
Like all medicines, ZOSTAVAX can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ZOSTAVAX jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In studies, the most commonly reported side effects (occurring in at least 1 in 10 individuals) were at the injection site.
Fl- istudji, l- aktar effetti sekondarji komuni rrapportati (li jseħħu f' għallinqas individwu 1 minn kull 10) seħħew fil- post fejn ingħatat l- injezzjoni.
These side effects included redness, pain, swelling, itching, warmth, and bruising at the injection site.
Dawn l- effetti sekondarji nkludew ħmura, uġigħ, nefħa, ħakk, sħana, u tbenġil fil- post ta 'l- injezzjoni.
Headache was also commonly reported (occurring in at least 1 of 100 and less than 1 of 10 individuals).
Uġigħ ta 'ras ġie rrapportat ukoll b' mod komuni (li jseħħ f' għallinqas 1 minn 100 u inqas minn individwu 1 minn kull 10).
The following additional side effects have been reported in general use with ZOSTAVAX: fever; rash; allergic reactions, which may be serious and may include difficulty in breathing or swallowing.
L- effetti sekondarji addizzjonali li ġejjin ġew irrapportati f’ użu ġenerali b’ ZOSTAVAX: deni; raxx; reazzjonijiet allerġiċi, li jistgħu jkunu serji u jistgħu jinkludu diffikultà fit- teħid tan- nifs jew biex tibla ’.
If you have an allergic reaction, call your doctor right away.
Jekk għandek reazzjoni allerġika, kellem lit- tabib tiegħek minnufih.
Your doctor or pharmacist has a more complete list of side effects for ZOSTAVAX.
It- tabib jew l- ispiżjar tiegħek għandu lista aktar wiesgħa ta 'effetti sekondarji għal ZOSTAVAX.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jgħoġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
If the condition persists or worsens, seek medical attention.
Jekk il- kundizzjoni tippersisti jew tiggrava, fittex attenzjoni medika.
HOW TO STORE ZOSTAVAX
KIF TAĦŻEN ZOSTAVAX
Do not use ZOSTAVAX after the expiry date which is stated on the outer carton after EXP.
Tużax ZOSTAVAX wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta 'barra wara JIS.
Store and transport refrigerated (2°C - 8°C).
Aħżen u ttrasporta imkessaħ (2°C - 8°C).
Keep the vial in the outer carton in order to protect from light.
Żommil- kunjett fil- kaxxa tal- kartun biex tipproteġih mid- dawl.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew mal- iskart domestiku.
These measures will help protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta 'l- ambjent.
What ZOSTAVAX contains After reconstitution, 1 dose (0.65 ml) contains:
X' fih ZOSTAVAX Wara rikostituzzjoni, doża 1 (0. 65 ml) fiha:
The active substance is:
Is- sustanza attiva hi:
Varicella-zoster virus1, Oka/ Merck strain, (live, attenuated) not less than 19400 PFU (plaque-forming units).
Virus tal - variċella- zoster1, razza Oka/ Merck, (ħaj, attenwat) mhux inqas minn 19400 PFU (unitajiet li jiffurmaw plakka).
1 Produced in human diploid (MRC-5) cells
1 Prodott f' ċelloli diploid umani (MRC- 5)
Powder Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate, anhydrous disodium phosphate, sodium hydroxide (to adjust pH), and urea.
41 Trab Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L- glutamate, anhydrous disodium phosphate, sodium hydroxide (għall- aġġustament tal - pH), u urea.
41 The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.
Id- Dehra tal- prodott u d- daqs tal- pakkett It- tilqima hija f' għamla ta 'trab għal sospensjoni għal injezzjoni f' kunjett ta' doża waħda, li għandha tiġi rikonstitwita bis- solvent mogħti mal- kunjett tat- trab.
Before mixing with the solvent, the powder is a white to off- white compact crystalline plug.
Qabel jitħallat mas- solvent, it- trab huwa plug kristallin kumpatt abjad għal abjad fl- isfar.
ZOSTAVAX is available in packs of 1 or 10.
ZOSTAVAX huwa disponibbli f' pakketti ta '1 jew 10.
Marketing Authorisation Holder:
Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jgħoġbok ikkuntattja lir- rappreżentant lokali tad - Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Merck Sharp & Dohme, IDEA, Inc. ,org. sl. ,Tel.: +420.233.010.111 Danmark:
Merck Sharp & Dohme, IDEA, Inc. Tel.: +420. 233. 010. 111 Danmark:
Sanofi Pasteur MSD, Tel: +46.8.564.888.60 United Kingdom:
Sanofi Pasteur MSD, Tel: +46. 8. 564. 888. 60 42 United Kingdom:
42 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Reconstitution instructions
Istruzzjonijiet ta 'rikonstituzzjoni
Before mixing with the solvent, the powder is a white to off- white compact crystalline plug.
Qabel tħallat mas- solvent, it- trab huwa plug kristallin kumpatt abjad għal abjad fl- isfar.
When completely reconstituted, the vaccine is a semi-hazy to translucent, off-white to pale yellow liquid.
Meta rikonstitwit għal kollox, il- vaċċin huwa likwidu kemmxejn imdardar għal trasluċenti, bajdani fl- isfar għal safrani.
Withdraw the entire volume of solvent into a syringe.
Iġbed il- volum kollu ta 'solvent f' siringa.
Withdraw the entire content of the reconstituted vaccine vial into a syringe for injection.
Iġbed il- kontenut kollu tal- kunjett tal- vaċċin rikonstitwit f' siringa għal injezzjoni.
It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency.
Huwa rrakomandat li l- vaċċin jingħata minnufih wara r- rikonstituzzjoni, sabiex tnaqqas it- telf tas - saħħa.
ZOSTAVAX Powder and solvent for suspension for injection in a pre-filled syringe zoster vaccine (live)
ZOSTAVAX Trab u solvent għal sospensjoni għal injezzjoni f' siringa mimlija għal- lest vaċċin zoster (ħaj)
tell your doctor or pharmacist.
elenkati f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Disease information on shingles:
Tagħrif tal- mard fuq il- ħruq ta 'Sant' Antnin:
What is shingles?
X' inhu l- ħruq ta 'Sant' Antnin?
Shingles is a painful, blistering rash.
Il- ħruq ta 'Sant' Antnin huwa raxx li jtella' nfafet u jikkawża uġigħ.
Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur.
B' mod inqas komuni, jista 'jkun hemm infezzjonijiet tal- ġilda b' batterji, debbulizza, paraliżi tal- muskolu, telf tas- smigħ jew tal- vista.
After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Wara li tkun ħadt il- ġidri r- riħ, il- vajrus li jkun ikkawżaha jibqa 'f' ġismek fiċ- ċelloli tan - nervituri.
Sometimes, after many years, the virus becomes active again and causes shingles.
Xi kultant, wara ħafna snin, il- virus jerġa 'jsir attiv u jikkawża ħruq ta' Sant' Antnin.
Do not receive ZOSTAVAX • if you are allergic (hypersensitive) to any of the components (for example, neomycin) of ZOSTAVAX (including any of the ingredients listed under “ the other ingredients are” - see section 6.
Tieħux ZOSTAVAX • jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal xi sustanza (per eżempju, neomycin) ta ’ ZOSTAVAX (inkluż xi ingredjent imniżżel taħt “ l- ingredjenti l- oħra huma ” - ara sezzjoni 6.
44 • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicines, or other treatment • if you have active untreated tuberculosis • if you are pregnant (see Pregnancy and breast-feeding)
Aktar tagħrif - x' fih ZOSTAVAX) • jekk tbati minn xi mard tad- demm jew minn xi tip ta 'kanċer jdgħajjef is- sistema tal- immunità tiegħek • jekk it- tabib tiegħek qallek li inti għandek sistema tal- immunità mdgħajjfa minħabba marda, mediċini jew trattament ieħor • jekk għandek tuberkolożi attiva mhux trattata • jekk inti tqila (ara Tqala u Treddigħ)
Women of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months following vaccination.
Nisa li jista 'jkollhom it- tfal għandhom jieħdu l - prekawzjonijiet meħtieġa sabiex jevitaw tqala għat- tliet xhur ta' wara li jieħdu t- tilqima.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex elenkati f’ dan il- fuljett, jekk jgħoġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Do not use ZOSTAVAX after the expiry date which is stated on the outer carton after EXP.
Tużax ZOSTAVAX wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra wara JIS.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew mal- ilma tad- dranaġġ jew mal- iskart domestiku.
What ZOSTAVAX contains After reconstitution, 1 dose (0.65 ml) contains:
X' fih ZOSTAVAX Wara r- rikonstituzzjoni, doża 1 (0. 65 ml) fiha:
Varicella-zoster virus1, Oka/ Merck strain, (live, attenuated) not less than 19400 PFU (plaque-forming units).
Virus Varicella- zoster1, razza Oka/ Merck, (ħaj, attenwat) mhux inqas minn 19400 PFU (unitajiet ta ’ formazzjoni ta ’ plakka).
Powder Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate, anhydrous disodium phosphate, sodium hydroxide (to adjust pH), and urea.
46 Trab Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L- glutamate, anhydrous disodium phosphate, sodium hydroxide (għall- aġġustament tal - pH), u urea.
46 The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.
Id- Dehra tal- prodott u d- daqs tal- pakkett It- tilqima hija f' għamla ta 'trab għal sospensjoni għal injezzjoni f' kunjett ta' doża waħda, li għandha tiġi rikonstitwita bis- solvent mogħti mal- kunjett tat- trab.
One pack of ZOSTAVAX contains a vial and a prefilled syringe with or without attached needles.
Pakkett ta ’ ZOSTAVAX fih kunjett u siringa mimlija għal- lest bi jew mingħajr labar imwaħħlin.
One or 2 separate needles may be available in the secondary packaging of the presentation containing the pre- filled syringe without the attached needle ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles.
ZOSTAVAX huwa disponibbli f' pakketti ta '1, 10 jew 20 bi jew mingħajr labar.
Merck Sharp & Dohme, IDEA, Inc., org. sl. ,Tel.: +420.233.010.111 Danmark:
Merck Sharp & Dohme, IDEA, Inc. Tel.: +420. 233. 010. 111 Danmark:
Tel: + 4021 529 29 00 Slovenija:
Tel: + 4021 529 29 00 47 Slovenija:
47 The following information is intended for medical or healthcare professionals only:
It- tagħrif li ġej qed jingħata biss għall- professjonisti fil- qasam mediku:
Inject the entire content of the pre-filled syringe into the vial containing the powder.
Injetta l- kontenut kollu tas- siringa mimlija għal- lest fil- kunjett li fih it- trab.
The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90°) to secure the connection.
Il- labra għandha tiġi mbuttata fl - estremità tas- siringa u mdawwra kwart ta 'dawra (90°) biex titqabbad tajjeb.
It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency.
Huwa rrakomandat li l- vaċċin jingħata minnufih wara r- rikostituzzjoni, sabiex tnaqqas it- telf tas - saħħa.
What is Zypadhera?
X’ inhu Zypadhera?
Zypadhera is a powder and solvent that are made up into a prolonged-release suspension for injection.
Zypadhera huwa magħmul minn trab u solvent li jitħalltu f’ sospensjoni injettabbli b’ rilaxx fit- tul.
It contains the active substance olanzapine. ‘ Prolonged release ’ means that the active substance is released slowly over a few weeks after being injected.
Fih is- sustanza attiva olanzapina (olanzapine). ‘ Rilaxx fit- tul ’ tfisser li s- sustanza attiva terħi bil- mod fi żmien ftit ġimgħat wara l- injezzjoni.
What is Zypadhera used for?
Għal xiex jintuża Zypadhera?
Zypadhera is used to maintain the improvement in symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth.
Zypadhera jintuża għall- manteniment tat- titjib fis- sintomi fil- pazjenti li jbatu minn skizofrenija diġà stabbilizzati permezz ta ’ trattament inizjali bl- olanzapina meħuda mill- ħalq.
Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
L- iskizofrenija hija marda mentali kkaratterizzata minn għadd ta ’ sintomi, fosthom disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (il- pazjent jisma ’ jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
How is Zypadhera used?
Kif jintuża Zypadhera?
Zypadhera is given by deep injection into the buttock muscle by a doctor or nurse who has been trained in giving this type of injection.
Zypadhera jingħata b’ injezzjoni fonda fil- muskolu tal- gluteu (warrani) minn tabib jew infermier imħarreġ f’ dan it- tip ta ’ injezzjoni.
In rare cases, patients receiving Zypadhera may experience symptoms of olanzapine overdose after injection if the medicine is accidentally injected into a vein.
F’ każijiet rari l- pazjenti ttrattati b’ Zypadhera jistgħu jesperjenzaw sintomi ta ’ dożaġġ eċċessiv ta ’ olanzapina wara l- injezzjoni, jekk il- mediċina tipi injettata aċċidentalment fil- vina.
Symptoms of overdose include sedation (sleepiness) and delirium (confusion).
Fost is- sintomi ta ’ dożaġġ eċċessiv hemm sedazzjoni (ħedla) u delirju (stat ta ’ konfużjoni).
Because patients should be monitored by qualified staff for these symptoms for at least three hours after injection, they should receive Zypadhera at a centre with the appropriate facilities to deal with a potential overdose.
Billi l- pazjenti għandhom ikunu sorveljati għal dawn is- sintomi minn persunal ikkwalifikat għal tal- anqas tliet sigħat wara l- injezzjoni, l- injezzjoni b’ Zypadhera għandha tingħata f’ ċentri mgħammra apposta biex jittrattaw każijiet eventwali ta ’ dożaġġ eċċessiv.
Patients who have symptoms of overdose should continue to be monitored until the symptoms have passed.
Il- pazjenti li jkollhom is- sintomi ta ’ dożaġġ eċċessiv għandhom ikomplu jkunu sorveljati sakemm ma dawn is - sintomi jisparixxu.
Zypadhera must not be injected into a vein or under the skin.
Zypadhera ma għandux jiġi injettat fil- vina jew taħt il- ġilda.
Zypadhera is given at doses of 150, 210 or 300 mg every two weeks, or 300 or 405 mg every four weeks.
Zypadhera jingħata f’ dożi ta ’ 150 jew 210 mg kull ġimagħtejn, jew f’ dożi ta ’ 300 jew 405 mg kull erba ’ ġimgħat.
The dose depends on the dose of olanzapine that the patient was previously taking by mouth.
Id- doża tiddependi mid- doża ta ’ olanzapina li l- pazjent kien ħa qabel minn ħalqu.
Patients should be monitored closely for signs of relapse (a return of symptoms) during the first one to two months of treatment, and the dose adjusted if necessary.
Il - pazjenti għandhom jinżammu taħt kontroll strett għal sinjali ta ’ rikaduta (jerġgħu lura s- sintomi) waqt l- ewwel xahar jew xahrejn ta ’ trattament, u d- doża aġġustata kif meħtieġ.
Zypadhera is not recommended for patients over 65 years of age.
Zypadhera mhuwiex rakkomandat għall- pazjenti ta ’ età ‘ l fuq minn 65 sena.
However, patients aged between 65 and 75 years or patients with kidney or liver problems may use Zypadhera if an effective and well- tolerated dose of oral olanzapine has been found.
Madankollu, il- pazjenti ta ’ età bejn 65 u 75 sena jew il- pazjenti bi problemi fil- kliewi jew fil- fwied jistgħu jużaw Zypadhera jekk tiġi osservata doża effikaċi u tollerata sew ta ’ olanzapina mill- ħalq.
A lower starting dose may be necessary in patients whose bodies may break olanzapine down slowly, such as those with moderate liver problems.
Fil- pazjenti li l - metabolizzazzjoni tagħhom tal- olanzapina aktarx issir bil- mod, pereżempju minħabba li jbatu minn problemi fil- fwied ta ’ entità moderata, jista ’ jkun neċessarju li tintuża doża inizjali mnaqqsa.
How does Zypadhera work?
Kif jaħdem Zypadhera?
The active substance in Zypadhera, olanzapine, is an antipsychotic medicine.
Is- sustanza attiva f’ Zypadhera, olanzapina, hija mediċina antipsikotika.
It is known as an ‘ atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Hija magħrufa bħala antipsikotiku ‘ atipiku ’ minħabba li hija differenti mill- mediċini antipsikotiċi iktar antiki li ilhom disponibbli mill- Ħamsinijiet.
Olanzapine attaches to several different receptors on the surface of nerve cells in the brain.
L- olanzapina teħel ma ’ bosta riċetturi differenti preżenti fuq is- superfiċje taċ- ċelloli nervużi tal- moħħ.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Dan ifixkel is- sinjali trasmessi bejn iċ- ċelloli tal- moħħ permezz ta ’ ‘ newrotrasmettituri ’, sustanzi kimiċi li jħallu liċ- ċelloli tal- moħħ jikkomunikaw ma ’ xulxin.
It is thought that olanzapine’ s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Hu maħsub li l- effett benefiku tal- olanzapina huwa dovut għall- imblokkar tar- riċetturi għan - newrotrasmettituri 5- idrossitripamina (5- hydroxytrypamine, imsejħa wkoll serotonina) u dopamina.
Since these neurotransmitters are involved in schizophrenia, olanzapine helps to normalise the activity of the brain, reducing the symptoms of the disease.
Billi dawn in- newrotrasmettituri għandhom sehem fl- iskizofrenija, l- olanzapina tgħin fin - normalizzazzjoni tal- attività ċelebrali, u b’ hekk tnaqqas is- sintomi ta ’ din il- marda.
It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth) and rapidly acting injections in Zyprexa, Zyprexa Velotab and other medicines.
L- olanzapina ilha awtorizzata fl- Unjoni Ewropea (UE) mill- 1996 u hija disponibbli f’ pilloli, pilloli orodispersibbli (jiġifieri li jinħallu fil- ħalq) u f’ injezzjonijiet b’ azzjoni rapida f’ Zyprexa, Zyprexa Velotab u mediċini oħra.
The olanzapine in Zypadhera is presented as a ‘ pamoate’ salt, which makes the olanzapine less soluble.
L- olanzapina f’ Zypadhera hija ppreżentata f’ forma ta ’ melħ “ pamoat ” li jagħmilha inqas solubbli.
As a result, the active substance is released slowly for more than four weeks after injection of Zypadhera.
B’ konsegwenza ta ’ dan, is- sustanza attiva tiġi rilaxxata bil- mod għal aktar minn erba ’ ġimgħat wara l- injezzjoni ta ’ Zypadhera.
How has Zypadhera been studied?
Kif ġie studjat Zypadhera?