qanastek/EMEA-V3 huggingface dataset:
• The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
• Il- qoxra tal- kapsula fiha: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).
Flimkien ma ’ dan, il- qoxra tal- kapsula ta ’ 100 mg fiha sunset yellow FCF (E110) u allura red (E129).
See Section 2 for important information about the ingredient, sunset yellow FCF (E110).
Ara Sezzjoni 2 għal informazzjoni importanti dwar l- ingredjent, sunset yellow FCF (E110).
What Zonegran looks like and contents of the pack
Id- dehra ta ’ Zonegran u l- kontenuti tal- pakkett
- Zonegran 25 mg hard capsules have a white opaque body and a white opaque cap and are
- Zonegran 25 mg kapsuli iebsin għandhom korp opak abjad u għatu opak abjad u fuqhom hemm
printed with a logo and “ ZONEGRAN 25” in black.
stampat bl- iswed il- logo u “ ZONEGRAN 25 ”.
- Zonegran 50 mg hard capsules have a white opaque body and a grey opaque cap and are printed
- Zonegran 50 mg kapsuli iebsin għandhom korp opak abjad u għatu opak griż u fuqhom hemm
with a logo and “ ZONEGRAN 50” in black.
stampat bl- iswed il- logo u “ ZONEGRAN 50 ”.
- Zonegran 100 mg hard capsules have a white opaque body and a red opaque cap and are printed
- Zonegran 100 mg kapsuli iebsin għandhom korp opak abjad u għatu opak aħmar u fuqhom
with a logo and “ ZONEGRAN 100” in black.
hemm stampat bl- iswed il- logo u “ ZONEGRAN 100 ”.
Zonegran capsules are packaged in blister packs supplied in boxes containing:
Il- kapsuli Zonegran huma ppakkjati f’ pakketti bil- folji u huma fornuti f’ kaxxi li fihom:
14, 28, 56 and 84 capsules
14, 28, 56 u 84 kapsuli
28, 56, 84, 98 and 196 capsules.
28, 56, 84, 98 u 196 kapsuli.
Not all pack sizes may be available.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu disponibbli.
Marketing Authorisation Holder Eisai Ltd., 3 Shortlands, London W6 8EE, United Kingdom.
53 Eisai Ltd., 3 Shortlands, London W6 8EE, ir- Ir- Renju Unit.
Manufacturer Eisai Manufacturing Ltd, Titan Court, 3 Bishop Square, Hatfield, Hertfordshire AL10 9NE, United Kingdom.
l- Manifattur Eisai Manufacturing Ltd, Titan Court, 3 Bishop Square, Hatfield, Hertfordshire AL10 9NE, ir- Ir- Renju Unit.
51 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Tel: + 44 208 600 1400 (Ir-Renju Unit)
Tel: + 44 208 600 1400 (Ir- Ir- Renju Unit)
Tel: +44 208 600 1400
Tel: +44 0208 600 1400
> 19,400 PFU of varicella-zoster virus (Live)
> 19, 400 PFU tal- virus tal - variċella- zoster (Ħaj)
Powder and solvent for suspension for injection in a pre-filled syringe
Trab u solvent għal sospensjoni għal injezzjoni f’ siringa mimlija għal- lest
10 vials + 10 pre-filled syringes with attached needle
10 kunjetti + 10 siringi mimlija għal- lest b’ labra mwaħħla
10 vials + 10 pre-filled syringes without needle
10 kunjetti + 10 siringi mimlijin għal- lest mingħajr labra
1 vial + 1 pre-filled syringe + 1 separate needle
1 kunjett + 1 siringa mimlija għal- lest + 1 labra separata
10 vials + 10 pre-filled syringes + 10 separate needles
10 kunjetti + 10 siringi mimlijin għal- lest + 10 labar separati
20 vials + 20 pre-filled syringes + 20 separate needles
20 kunjett + 20 siringa mimlija għal- lest + 20 labra separata
1 vial + 1 pre-filled syringe + 2 separate needles
1 kunjett + 1 siringa mimlija għal- lest + 2 labar separati
10 vials + 10 pre-filled syringes + 20 separate needles
10 kunjetti + 10 siringi mimlija għal- lest + 20 labra separata
20 vials + 20 pre-filled syringes + 40 separate needles
20 kunjett + 20 siringa mimlija għal- lest + 40 labra separata
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINAL
ZOSTAVAX powder and solvent for suspension for injection
ZOSTAVAX trab u solvent għal sospensjoni għal injezzjoni
zoster vaccine (live)
vaċċin zoster (ħaj)
After reconstitution, 1 dose (0.65 ml) contains:
Wara r- rikostituzzjoni, doża 1 (0. 65 ml) fiha:
Varicella-zoster virus1, Oka/ Merck strain, (live, attenuated) not less than 19400 PFU2 1 produced in human diploid (MRC-5) cells 2 PFU = Plaque-forming units
Virus tal- Varicella- zoster1, razza Oka/ Merck, (ħaj, attenwat) mhux inqas minn 19400 PFU2 1 prodott f' ċelloli diploid umani (MRC- 5) 2 PFU = Unitajiet li jiffurmaw plakka
Powder and solvent for suspension for injection.
Trab u solvent għal sospensjoni għal injezzjoni.
Before reconstitution, the powder is a white to off-white compact crystalline plug, and the solvent is a clear, colourless fluid.
Qabel ir- rikonstituzzjoni, it- trab huwa plug kristallin kumpatt bajdani għal abjad fl- isfar, u s- solvent huwa fluwidu ċar u bla kulur.
ZOSTAVAX is indicated for prevention of herpes zoster (“ zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
ZOSTAVAX huwa indikat għall- prevenzjoni ta 'herpes zoster (“ zoster ” jew ħruq ta' Sant' Antnin) u post- herpetic neuralgia relatata ma 'herpes zoster (PHN).
ZOSTAVAX is indicated for immunization of individuals 50 years of age or older.
ZOSTAVAX huwa indikat għall- immunizzazzjoni ta 'individwi ta' 50 sena jew aktar.
Individuals should receive a single dose administered subcutaneously.
Individwi għandhom jirċievu doża waħda amministrata taħt il- ġilda.
The need for a second dose is currently unknown.
Fil- preżent, il- ħtieġa għal tieni doża għadha mhux magħrufa.
The vaccine is to be injected SUBCUTANEOUSLY, preferably in the deltoid region.
Din it- tilqima għandha tiġi injettata TAĦT IL- ĠILDA, preferibbilment fil- muskolu tad- deltoid.
• Hypersensitivity to the active substance, to any of the excipients or trace residuals (e. g., neomycin) (see sections 4.4 and 6.1).
• Sensittività eċċessiva għas- sustanza( i) attiva( i), jew għal xi sustanza mhux attivi jew residwi ta 'traċċa (eż. neomycin) (ara sezzjonijiet 4. 4 u 6. 1). • Stati ta' immunodefiċjenza primarja u akkwistata minħabba kundizzjonijiet bħal: lewkimja akuta u kronika; lymphoma; kundizzjonijiet oħra li jaffettwaw il- mudullun jew is- sistema limfatika; immunosuppressjoni dovuta għal HIV/ AIDS; defiċjenzi ta 'immunità taċ- ċelloli.
2 • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/ AIDS; cellular immune deficiencies. • Immunosuppressive therapy (including high-dose corticosteroids); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/ inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e. g., for adrenal insufficiency. • Active untreated tuberculosis. • Pregnancy (see sections 4.4 and 4.6).
2 • Terapija immunosuppressiva (inkluż corticosteroids f 'doża kbira); madankollu, m' hemmx kontra- indikazzjonijiet għall- użu ta' ZOSTAVAX f' individwi li qegħdin jieħdu corticosteroids f' parti mill- ġisem/ b’ inalatur jew corticosteroids sistemiċi ta 'doża żgħira jew f' pazjenti li qegħdin jirċievu corticosteroids bħala terapija ta' sostituzzjoni, eż., għal insuffiċjenza adrenali. • Tuberkolożi attiva mhux trattata. • Tqala (ara sezzjonijiet 4. 4 u 4. 6).
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/ anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e. g., neomycin) present in the vaccine (see sections 4.3 and 6.1).
Trattament approprjat u sorveljanza medika xierqa għandhom ikunu dejjem disponibbli minnufih fil - każ ta 'reazzjonijiet anafilattiċic/ anafilattiċi rari wara l- għoti tat- tilqima, minħabba li hemm il - possibbiltà ta' reazzjonijiet ta 'sensittività eċċessiva, mhux biss għas- sustanzi attivi, iżda wkoll għas - sustanzi mhux attivi u residwi ta' traċċa (eż., neomycin) preżenti fit- tilqima (ara sezzjonijiet 4. 3 and 6. 1).
Neomycin allergy generally manifests as a contact dermatitis.
Ġeneralment, allerġija għal neomycin timmanifesta ruħha bħala contact dermatitis.
However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
Madankollu, storja ta 'contact dermatitis dovuta għal neomycin mhix kontra- indikazzjoni għal tilqim b' virus ħaj.
Before vaccination of women of child-bearing potential, pregnancy must be excluded and effective contraception must be used for 3 months following vaccination (see sections 4.3 and 4.6).
Qabel it- tilqim ta 'nisa fl- età li fiha jistgħu jwelldu t- tfal, għandu l- ewwel jiġi żgurat li l- mara mhijiex tqila u għandha tintuża kontraċezzjoni effettiva għal 3 xhur wara t- tilqima (ara sezzjonijiet 4. 3 u 4. 6).
ZOSTAVAX is not indicated for treatment of zoster or PHN.
ZOSTAVAX mhuwiex indikat għal trattament ta 'zoster jew PHN.
Deferral of vaccination should be considered in the presence of fever.
Fil- preżenza ta 'deni, il- posponiment ta' l- għoti tat- tilqima għandu jiġi kkunsidrat.
Vaccination with ZOSTAVAX may not result in protection in all vaccine recipients.
It- tilqim b' ZOSTAVAX jista 'ma jirriżultax fi protezzjoni fir- riċevituri kollha tal- vaċċin.
The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see section 4.3).
Is- sigurtà u l- effikaċja ta 'ZOSTAVAX ma ġewx stabbiliti f' adulti li huma magħrufin li huma infettati b' HIV bi jew mingħajr evidenza ta' immunosuppressjoni (ara sezzjoni 4. 3).
Transmission In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Trasmissjoni Fi provi kliniċi b' ZOSTAVAX, it- trasmissjoni tal- virus tal- vaċċin ma ġietx irrapportata.
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- kummercjalizzazzjoni 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).
Transmission of vaccine virus from varicella vaccine recipients without a varicella-zoster virus (VZV)-like rash has been reported but has not been confirmed.
It- trasmissjoni tal- virus tat- tilqima minn riċevituri tat- tilqima kontra l- ġidri r- riħ mingħajr raxx li jixbah lill- virus ta 'varicella- zoster (VZV) ġiet irrapportata iżda għadha ma ġietx ikkonfermata.
This is a theoretical risk for vaccination with ZOSTAVAX.
Dan huwa riskju teoretiku għal tilqima b' ZOSTAVAX.
The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighed against the risk of developing natural herpes zoster that could be transmitted to a susceptible individual.
Ir- riskju ta 'trasmissjoni tal- virus attenwat tat- tilqima fuq individwu suxxettibbli għandu jitqies kontra r- riskju ta' l- iżvilupp ta 'herpes zoster naturali li jista' jiġi trasmess lil individwu suxxettibbli.
ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
ZOSTAVAX jista 'jingħata fl- istess ħin ma' vaċċin kontra l- influwenza mhux attivat bħala tilqim separat u f' postijiet differenti tal- ġisem (ara sezzjoni 5. 1).
No data are currently available regarding concomitant use with other vaccines.
Fil- preżent m' hemm ebda informazzjoni disponibbli dwar l- użu konkomitanti ma 'tilqim ieħor.
Concurrent administration of ZOSTAVAX and anti-viral medications known to be effective against VZV has not been evaluated.
L- għoti fl- istess ħin ta 'ZOSTAVAX ma' mediċini anti- virali magħrufin li huma effettivi kontra VZV ma ġiex evalwat.
There are no studies in pregnant women.
Ma saru ebda studji fuq nisa tqal.
It is also not known whether ZOSTAVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
M' huwiex magħruf ukoll jekk ZOSTAVAX jistax jikkawża ħsara għall- fetu meta mogħti lil mara tqila jew jistax jaffettwa l- kapaċità riproduttiva.
However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm.
Madankollu huwa magħruf li infezzjoni bil- virus tal- varicella- zoster li sseħħ b' mod naturali tista 'tikkawża ħsara lill- fetu.
As ZOSTAVAX is not indicated in individuals less than 50 years of age, ZOSTAVAX is not intended to be administered to pregnant women.
Minħabba li ZOSTAVAX mhuwiex indikat f' individwi ta 'inqas minn 50 sena, ZOSTAVAX m' huwiex maħsub sabiex jingħata lil mara tqila.
In any case, pregnancy should be avoided for three months following vaccination (see sections 4.3 and 4.4).
Fi kwalunkwe każ, it- tqala għandha tiġi evitata għal tliet xhur wara t- tilqima (ara sezzjonijiet 4. 3 u 4. 4).
It is not known whether VZV is secreted in human milk.
M' huwiex magħruf jekk VZV jaqsamx fil- ħalib tal- bniedem.
Therefore, because some viruses are secreted in human milk, caution should be exercised if ZOSTAVAX is administered to a breast-feeding woman.
Għalhekk, minħabba li xi virusijiet jaqsamx fil- ħalib tal- bniedem, għandha tingħata attenzjoni jekk ZOSTAVAX jingħata lil mara li qegħda tredda '.
In clinical trials, ZOSTAVAX has been evaluated for safety in more than 20000 adults.
Fi provi kliniċi, ZOSTAVAX ġie evalwat għas- sigurtà f' aktar minn 20000 adult.
In the largest of these trials, the Shingles Prevention Study (SPS), 38546 subjects received a single dose of either the frozen formulation of ZOSTAVAX (n=19270) or placebo (n=19276) and were monitored for safety throughout the study.
Fl- ikbar prova minn dawn, l- Istudju fuq il- Prevenzjoni tal- Ħruq ta 'Sant' Antnin (SPS), 38546 suġġett irċevew doża waħda ta' jew il- formulazzjoni ffriżata ta 'ZOSTAVAX (n=19270) jew placebo (n=19276) u dawn ġew immonitorjati għas- sigurtà matul l- istudju.
During the study, vaccine-related serious adverse reactions were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture’ s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
Matul l- istudju, ġew irrapportati reazzjonijiet avversi serji relatati mat- tilqima għal 2 suġġetti imlaqqmin b' ZOSTAVAX (taħrix ta 'l - ażżma u polymyalgia rheumatica) u 3 suġġetti li rċevew placebo (sindrome ta' Goodpasture, reazzjoni anafilattika, u polymyalgia rheumatica).
In the Adverse Event Monitoring Substudy, a subgroup of individuals from the SPS (n=3345 received ZOSTAVAX and n=3271 received placebo) were provided vaccination report cards to record adverse reactions occurring from Days 0 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
Fis- Substudju tal- Monitoraġġ tal- Każijiet Avversi, subgrupp ta 'individwi mill- SPS (n=3345 irċevew ZOSTAVAX u n=3271 irċevew placebo) ingħata kards tar- rapporti tat- tilqim sabiex fihom jirreġistraw reazzjonijiet avversi li jseħħu minn Jiem 0 sa 42 wara t- tilqima barra milli għaddew minn monitoraġġ ta' sigurtà ta 'rutina tul l- istudju kollu.
The following vaccine-related injection-site and systemic adverse reactions were reported at a significantly greater incidence in the vaccine group versus the placebo group in the Adverse Event Monitoring Substudy.
Ir- reazzjonijiet avversi fis- sit ta 'injezzjoni relatati mat- tilqima u r- reazzjonijiet avversi sistematiċi ġew irrapportati f' inċidenza ferm ikbar fil- grupp tal- tilqima meta mqabbel mal- grupp tal- placebo fis - Substudju ta' Monitoraġġ ta 'Każijiet Avversi.
Most of these adverse reactions were reported as mild in intensity.
Il- parti l- kbira ta 'dawn ir- reazzjonijiet avversi ġew irrapportati bħala t' intensità ħafifa.
Several adverse reactions were solicited (Days 0-4 postvaccination) and are designated with the * symbol.
Ġew solleċitati bosta reazzjonijiet avversi (Jiem 0- 4 ta 'wara t - tilqima) u dawn huma mmarkati bis- simbolu *.
[Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000); Very rare (< 1/ 10,000) including isolated cases]
Komuni ħafna (≥1/ 10), Komuni (≥1/ 100, < 1/ 10), Mhux komuni (≥1/ 1000,, < 1/ 100), Rari (≥1/ 10, 000, < 1/ 1, 000), Rari ħafna (< 1/ 10, 000) inkluż każijiet iżolati].
Nervous system disorder Common: headache
Mard tas- sistema nervuża Komuni: uġigħ ta 'ras
General disorders and administration site conditions Very common: erythema, * pain/ tenderness, * swelling* Common: haematoma, pruritus, warmth
Mard ġenerali u kundizzjonijiet ta 'mnejn jittieħed Komuni ħafna: erythema, * uġigħ/ sensibilità, * nefħa * Komuni: ematoma, prurite, sħana
The overall incidence of vaccine-related injection-site adverse reactions was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (48% for ZOSTAVAX and 17% for placebo).
L- inċidenza globali ta 'reazzjonijiet avversi f' postijiet fejn tingħata l- injezzjoni relatati mal- vaċċin kienet ferm akbar għal suġġetti mlaqqmin b' ZOSTAVAX meta mqabbla ma' suġġetti li rċevew placebo (48% għal ZOSTAVAX u 17% għal placebo).
4 The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards.
4 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 rrappurtati f' dawn il- pazjenti kienu ġeneralment simili għal dawk irrappurtati mis- subgrupp ta' pazjenti fis- Substudju tal- Monitoraġġ tal- Każ Avvers.
Within the 42-day postvaccination reporting period in the SPS, the number of reported zosteriform rashes among all subjects was small (17 for ZOSTAVAX, 36 for placebo; p=0.009).
Fi żmien 42 jum wara l- perjodu ta 'rapportar tat- tilqima fl- SPS, in- numru ta' raxxijiet zosteriform irrapportati fost is- suġġetti kollha kien żgħir (17 għal ZOSTAVAX, 36 għal placebo; p=0. 009).
Of these 53 zosteriform rashes, 41 had specimens that were available and adequate for PCR testing.
Minn dawn it- 53 raxx zosteriform, 41 kellhom kampjuni li kienu disponibbli u adegwati għal PCR testing.
Wild-type VZV was detected in 25 (5 for ZOSTAVAX, 20 for placebo) of these specimens.
Wild- type VZV instab f' 25 (5 għal ZOSTAVAX, 20 għal placebo) ta 'dawn il- kampjuni.
The Oka/ Merck strain of VZV was not detected from any of these specimens.
Ir- razza Oka/ Merck ta 'VZV ma ġiet relevata f' ebda minn dawn il- kampjuni.
Within the same 42-day postvaccination reporting period in the SPS, the number (n=59) of reported varicella-like rashes was also small.
Matul l- istess perjodu ta 'rapportar ta' 42 jum ta 'wara t- tilqima fl- SPS, in- numru (n=59) ta' raxxijiet simili għall- ġidri r- riħ kien żgħir ukoll.
Of these varicella-like rashes, 10 had specimens that were available and adequate for PCR testing.
Minn dawn ir- raxxijiet simili għall- ġidri r- riħ, 10 kellhom kampjuni li kienu disponibbli u adegwati għal PCR testing.
VZV was not detected in any of these specimens.
VZV ma ġie relevat f' ebda minn dawn il - kampjuni.
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 li jappoġġjaw il- liċenzjar inizjali tal- formulazzjoni 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 raxx 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- kampjun tal- leżjoni ta 'żewġ suġġetti biss, li rrapportaw raxxijiet simili għall- ġidri r- riħ (bidu f' Jum 8 u 17).
In other clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
Fi provi kliniċi oħra li jevalwaw ZOSTAVAX f' suġġetti ta '50 sena jew akbar, inkluż studju ta' għoti fl- istess ħin ta 'vaċċin inattivat kontra l- influwenza, il- profil tas- sigurtà kien ġeneralment simili għal dak li jidher fis- Substudju ta' Monitoraġġ tal- Każ Avvers tal- SPS.
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 section 5.1).
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- formoluzzjoni ffriżata.
In a double-blind, placebo-controlled, randomized clinical trial, in which ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
Fi prova klinika randomizzata, ikkontrollata bi plaċebo, double- blind, li fiha ZOSTAVAX ingħata lil 100 suġġett ta ’ 50 sena jew aktar bi storja ta ’ ħerpes zoster (HZ) qabel it- tilqima, il- profil tas- sigurtà kien ġeneralment simili għal dak muri fis- Substudju tal- Monitoraġġ ta ’ l- Episodji Avversi ta ’ l- SPS.
Based on limited data from 2 clinical trials that enrolled VZV-seronegative or low seropositive subjects (27 subjects 30 years of age or older received live attenuated zoster vaccine), injection site and systemic adverse experiences were generally similar to those reported by other subjects who received ZOSTAVAX in clinical trials, with 2 of the 27 subjects reporting fever.
Dejta limitata minn 2 provi kliniċi li fihom ġew reġistrati suġġetti VZV- seronegattivi jew suġġetti ftit seropożittivi (27 suġġett ta ’ 30 sena jew aktar irċevew vaċċin żoster attenwat ħaj), uriet li s- sit tal - injezzjoni u l- esperjenzi avversi sistemiċi kienu ġeneralment simili għal dawk irrapportati minn suġġetti oħrajn li rċevew ZOSTAVAX fi provi kliniċi, bi 2 mis- 27 suġġett jirrapportaw deni.
No subjects reported varicella-like or herpes zoster-like rashes.
Ebda suġġett ma rrapporta raxx simili għall- variċella jew raxx simili għall- ħerpes żoster.
No serious vaccine-related adverse experiences were reported.
Ma ġiet irrapportata ebda esperjenza avversa serja relatata mal- vaċċin.
Post-marketing Experience
Esperjenza ta ’ wara t- tqegħid fis- suq
During post-marketing experience, the following additional adverse events have been reported spontaneously:
Matul l- esperjenza ta ’ wara t- tqegħid fis- suq, l- episodji avversi addizzjonali li ġejjin ġew irrapportati b’ mod spontanju:
General disorders and administration site conditions: pyrexia Immune system disorders: hypersensitivity reactions including anaphylactic reactions Skin and subcutaneous tissue disorders: rash
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata: pireksja Disturbi fis- sistema immuni: reazzjonijiet ta ’ sensittività eċċessiva inkluż reazzjonijiet anafilattiċi Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: raxx
Mechanism of Action Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing zoster.
Mekkaniżmu t' Azzjoni Kull persuna li ġiet infettata b' VZV, anki jekk ma għandhiex storja klinika ta 'ġidri r- riħ, hija f' riskju li tiżviluppa zoster.
This risk appears to be causally related to a decline in VZV-specific immunity.
Dan ir- riskju jidher li huwa każwalment relatat ma 'tnaqqis fl- immunità speċifika għal VZV.
ZOSTAVAX was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications.
Intwera li ZOSTAVAX isaħħaħ l- immunità speċifika għall- VZV, li hija maħsuba li hija l - mekkaniżmu li bih jipproteġi kontra zoster u l- kumplikazzjonijiet tiegħu.
(See Immunogenicity.)
(Ara Immunoġeniċità.)
Evaluation of Clinical Efficacy Afforded by ZOSTAVAX ZOSTAVAX significantly reduced the risk of developing zoster and PHN compared with placebo.
Evalwazzjoni ta 'l- Effikaċja Klinika Mogħtija minn ZOSTAVAX ZOSTAVAX naqqas b' mod sinifikanti r- riskju ta' żvilupp ta 'zoster u PHN meta mqabbel ma' placebo.
In addition, ZOSTAVAX significantly reduced zoster-associated pain as measured by the HZ pain Burden of Illness (BOI) score (see results and definition in Table 1).
Barra minn hekk, ZOSTAVAX naqqas b' mod sinifikanti l- uġigħ assoċjat ma 'zoster kif imkejjel mill - iskor tal- Burden of Illness (BOI) ta' l- uġigħ HZ (ara r- riżultati u d- definizzjoni f' Tabella 1).
Table 1 Efficacy of ZOSTAVAX Compared with Placebo in the Shingles Prevention Study
Tabella 1 Effikaċja ta 'ZOSTAVAX meta Mqabbla ma' Placebo fl- Istudju ta 'Prevenzjoni tal- Ħruq ta' Sant' Antnin
Vaccine
tilqima *
Endpoint Incidence of Zoster Incidence of PHN** HZ Pain BOI***
Inċidenza ta 'Zoster Inċidenza ta' PHN ** BOI ta 'l- uġigħ b' HZ ***
95% CI 44 to 58% 48 to 79% 51 to 69%
44 sa 58% 48 sa 79% 51 sa 69%
*Vaccine efficacy = relative reduction in the endpoint measurement in the vaccine group compared with the placebo group **Clinically significant zoster-associated pain persisting or appearing at least 90 days after the onset of rash. ***The HZ pain BOI score is a composite score that incorporates the incidence, severity, and duration of acute and chronic zoster-associated pain over a 6-month follow-up period.
* Effikaċja tat- tilqima = tnaqqis relattiv fil- kejl ta 'l- endpoint fil- grupp tat- tilqima meta mqabbel mal - grupp tal- placebo ** Uġigħ klinikament sinifikanti assoċjat ma' zoster persistenti jew li jidher għallinqas 90 jum wara l - feġġa tar- raxx. *** L- iskor tal- BOI ta 'l- uġigħ b' HZ huwa skor kompost li jinkorpora l- inċidenza, il- gravità, u d - dewmien ta' uġigħ akut u kroniku assoċjat ma 'zoster fuq perjodu ta' follow- up ta '6 xhur.
In the Shingles Prevention Study (SPS), a placebo-controlled, double-blind clinical trial of ZOSTAVAX, 38546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19270) or placebo (n=19276).
Fl- Istudju ta 'Prevenzjoni ta' Ħruq ta 'Sant' Antnin (SPS), prova klinika kkontrollata bi placebo, double - blind ta' ZOSTAVAX, 38546 suġġett ta '60 sena jew akbar ittellgħu b' mod każwali sabiex jirċievu doża waħa ta' jew ZOSTAVAX (n=19270) jew placebo (n=19276).
642 cases [11.1/ 1000 person-years], respectively; p < 0.001).
ZOSTAVAX naqqas b' mod sinifikanti l- inċidenza ta 'zoster meta mqabbel ma' placebo (315 [5. 4/ 1000 person- years] meta mqabbel ma '642 każ [11. 1/ 1000 person- years], rispettivament; p < 0. 001).
The protective efficacy of ZOSTAVAX against zoster was 51% (95% CI:
L- effikaċja tal- protezzjoni ta 'ZOSTAVAX kontra zoster kienet ta' 51% (95% CI:
[44 to 58%]).
[44 sa 58%]).
ZOSTAVAX reduced the incidence of zoster by 64% (95% CI:
ZOSTAVAX naqqas l- inċidenza ta 'zoster b' 64% (95% CI:
[56 to 71%]) in individuals 60-69 years of age and by 38% (95% CI:
[56 sa 71%]) f' individwi ta 'bejn 60- 69 sena u bi 38% (95% CI:
[25 to 48%]) in individuals ≥ 70 years of age.
[25 sa 48%]) f' individwi ta '≥70 sena.
In the SPS, the reduction in zoster was seen in almost all dermatomes.
Fl- SPS, it- tnaqqis f' zoster deher fi kważi d- dermatomes kollha.
Ophthalmic zoster occurred in 35 subjects vaccinated with ZOSTAVAX vs.
Zoster oftalmiku seħħ f' 35 suġġett imlaqqma b' ZOSTAVAX vs.
69 subjects who received placebo.
69 suġġett li irċevew placebo..
9 who received placebo.
Żewġ (2) suġġetti mlaqqmin b' ZOSTAVAX esperjenzaw problemi fil- viżta kontra 9 li rċevew placebo.
80 cases [1.4/ 1000 person-years], respectively; p < 0.001).
ZOSTAVAX naqqas l- inċidenza ta 'PHN meta mqabbel ma' placebo [(27 każ [0. 5/ 1000 person- years] kontra 80 każ [1. 4/ 1000 person- years], rispettivament; p < 0. 001).
In this trial, the definition of PHN was clinically significant zoster-associated pain persisting or appearing at least 90 days after the onset of rash.
F' din il- prova, id- definizzjoni ta 'PHN kienet uġigħ klinikament sinifikanti assoċjat ma' zoster persistenti jew li jidher għallinqas 90 jum wara l- feġġa tar- raxx.
The protective efficacy of ZOSTAVAX against PHN was 67% (95% CI:
L- effikaċja tal- protezzjoni ta 'ZOSTAVAX kontra PHN kienet ta' 67% (95% CI:
[48 to 79%]).
[48 sa 79%]).
Referring only to subjects who developed zoster, there was a decrease in the risk of subsequently developing PHN.
B' referenza għas- suġġetti li żviluppaw zoster biss, kien hemm tnaqqis fir- riskju li sussegwentament jiżviluppaw PHN.
In the vaccine group, the risk of developing PHN after zoster was 9% (27/ 315), while in the placebo group it 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.
6 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.
ZOSTAVAX reduced the HZ pain BOI score by approximately 61% (95% CI:
ZOSTAVAX naqqas l- iskor BOI ta 'l- uġigħ b' HZ b' bejn wieħed u ieħor 61% (95% CI:
[51 to 69%]), compared with placebo.
[51 sa 69%]), meta mqabbel mal- 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:
40 cases, respectively).
[46 għal 87%]) meta mqabbel mal- placebo (11 kontra 40 każ, rispettivament).
Reduction of zoster pain severity-by-duration in vaccinated individuals who developed zoster With regard to the acute pain (pain between 0-30 days) there was no statistically significant difference between the vaccine group and the placebo group.
It- tnaqqis tas- severità skond it- tul ta 'żmien ta' l- uġigħ b' zoster f' individwi mlaqqmin li żviluppaw zoster Fir- rigward ta 'uġigħ serju (uġigħ minn 0- 30 jum) ma kien hemm ebda differenza sinifikanti bejn il - grupp tat- tilqima u l- grupp tal- placebo.
The HZ pain severity-by-duration score was 89 (95%CI:
L- iskor tas- severità skond it- tul ta 'żmien ta' l- uġigħ b' HZ kien ta '89 (95% CI:
92 (95% CI:
[82 sa 97%]) għall- grupp tal- vaċċin meta mqabbel ma '92 (95% CI:
[87 to 97%]) for the placebo group.
[87 sa 97%]) għall - grupp tal- placebo.
The overall use of analgesic medication was similar in both study groups.
L- użu globali ta 'medikazzjoni analġeżika kien simili fiż- żewġ gruppi ta' studju.
Among vaccinated individuals who developed PHN, ZOSTAVAX significantly reduced PHN-associated (chronic) pain compared with placebo.
Fost l- individwi mlaqqmin li żviluppaw PHN, ZOSTAVAX naqqas b' mod sinifikanti l- uġigħ (kroniku) assoċjat ma 'PHN meta mqabbel mal- placebo.
In the period from 90 days after rash onset to the end of follow-up, there was a 57% reduction in the severity-by-duration score (average scores of 347 for ZOSTAVAX and 805 for placebo; p=0.016).
Fil- perjodu minn 90 jum wara l- bidu tar- raxx sat- tmiem tal- follow- up, kien hemm tnaqqis ta '57% fl- iskor tas- severità skond it- tul ta' żmien (skor medju ta '347 għal ZOSTAVAX u 805 għal placebo; p=0. 016).
Among vaccinated individuals who developed zoster, ZOSTAVAX significantly reduced overall acute and chronic zoster-associated pain compared with placebo.
Fost l- individwi mlaqqmin li żviluppaw zoster, ZOSTAVAX naqqas b' mod sinifikanti l- uġigħ globali akut u kroniku assoċjat ma 'zoster meta mqabbel mal- placebo.
Over the 6-month (acute and chronic) follow- up period, there was a 22% reduction (p =0.008) in the severity-by-duration score and a 52% (95% CI:
Tul il- perjodu ta '6 xhur ta' follow- up (akut u kroniku), kien hemm tnaqqis ta '22% (p =0. 008) fl- iskor tas- severità skond it- tul ta' żmien u tnaqqis ta '52% (95% CI:
[7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having HZ with severe and long-lasting pain (severity-by-duration score of > 600).
[7 sa 74%]) (minn 6. 2% sa 3. 5%) fir- riskju ta 'HZ b' uġigħ qawwi u fit- tul (skor tas- severità skond it- tul ta' żmien ta '> 600).
Immunogenicity of ZOSTAVAX Within the Shingles Prevention Study (SPS), immune responses to vaccination were evaluated in a subset of the enrolled subjects (N=1395).
Immunoġeniċità ta ’ ZOSTAVAX Fl- Istudju tal- Prevenzjoni tal- Ħruq ta 'Sant' Antnin (SPS), ir- rispons ta' immunità għat- tilqima ġie evalwat f' subsett tas- suġġetti rreġistrati (N=1395).
ZOSTAVAX elicited higher VZV-specific immune responses at 6 weeks postvaccination compared with placebo.
ZOSTAVAX kiseb aktar rispons ta 'immunità speċifiku għal VZV sitt ġimgħat wara t- tilqima meta mqabbel mal- placebo.
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 żidiet 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.
288 gpELISA units/ ml, p < 0.001), and T-cell activity, measured by VZV interferon- gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay (2.2-fold difference, geometric mean count [GMC] of 70 vs.
288 gpELISA unità/ ml, p < 0. 001), u attività T- cell, imkejla b' VZV interferon- gamma enzyme- linked immunospot (IFN- γ ELISPOT) assay (differenza ta '2. 2- drabi, geometric mean count [GMC] ta' 70 vs.
32 spot-forming cells per million peripheral blood mononuclear cells [SFC/ 106 PBMCs], p < 0.001) were demonstrated.
32 ċellola li jiffurmaw tikek għal kull miljun ċellola mononukleari tad- demm periferali [SFC/ 106 PBMCs], p < 0. 001).
When evaluated at 4 weeks postvaccination, the immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier frozen formulation of ZOSTAVAX.
Meta evalwata 4 ġimgħat wara t- tilqima, l- immunoġeniċità tal- formulazzjoni kurrenti li hi stabbli fil- friġġ ntweriet li kienet simili għall- immunoġeniċità tal- formulazzjoni preċedenti ta 'ZOSTAVAX li kienet iffriżata.
In an integrated analysis of two clinical trials evaluating immune response to ZOSTAVAX at 4 weeks postvaccination, responses were generally similar in subjects 50 to 59 (N=389) compared to subjects ≥ 60 years of age (N=731) (GMT of 668 vs.
F’ analiżi integrata ta ’ żewġ provi kliniċi li evalwaw ir- rispons immuni ta ’ ZOSTAVAX 4 ġimgħat wara t- tilqima, ir- rispons kien ġeneralment simili fis- suġġetti 50 u 59 (N=389) meta mqabbla ma ’ suġġetti ≥60 sena (N=731) (GMT ta ’ 668 vs.
614 gpELISA units/ ml, respectively).
614 gpELISA unità/ ml, rispettivament).
The geometric mean fold- rise of immune response following vaccination as measured by gpELISA was 2.6-fold (95% CI:
Iż- żieda ġeometrika medja tar- rispons ta ’ l- immunità wara tilqima kif imkejjel b’ gpELISA kien 2. 6- darba (95% CI:
[2.4 to 2.9]) in subjects 50 to 59 years of age and 2.3-fold (95% CI:
[2. 4 sa 2. 9]) f’ suġġetti ta ’ 50 sa 59 sena u 2. 3- drabi (95% CI:
[2.1 to 2.4]) in subjects ≥ 60 years age.
[2. 1 sa 2. 4]) f’ suġġetti ≥60 sena.
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 konkomitanti 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 tal- influwenza.
The antibody responses to both vaccines at 4 weeks postvaccination were similar, whether administered concomitantly or nonconcomitantly.
Ir- rispons tal- antikorpi għaż- żewġ tilqimiet 4 ġimgħat wara t- tilqima kien wieħed simili, kemm meta mogħtija flimkien jew le.
7 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.
7 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.
ZOSTAVAX induced a significantly higher VZV-specific immune response measured by gpELISA at 4 weeks postvaccination, compared with placebo (2.1-fold difference (95% CI:
ZOSTAVAX wassal għal rispons immuni VZV- speċifiku ferm ogħla imkejjel b’ gpELISA fir- 4 ġimgħa wara t- tilqima, meta mqabbel ma ’ plaċebo (differenza ta ’ 2. 1 drabi (95% CI:
[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).
VZV antibody responses were generally similar in subjects 50 to 59 compared to subjects ≥ 60 years of age.
Ir- risponsi ta ’ antikorpi VZV kienu ġeneralment simili f’ suġġetti ta ’ 50 sa 59 sena meta mqabbla ma ’ suġġetti ta ’ ≥60 sena.
Revaccination The need for, or timing of, revaccination with ZOSTAVAX has not yet been determined.
Tilqim mill- ġdid Il- ħtieġa għal, jew iż- żmien meta għandha tingħata tilqima mill- ġdid ta 'ZOSTAVAX għadhom ma ġewx stabbiliti.
In a placebo-controlled, double-blind, study, 98 adults 60 years of age or older received a second dose of ZOSTAVAX 42 days following the initial dose; the vaccine was generally well tolerated.
Fi studju kkontrollat bi placebo, double- blind, 98 adult ta '60 sena u aktar irċevew tieni doża ta' ZOSTAVAX 42 jum wara l- ewwel doża; b' mod ġenerali, t- tilqima ġiet ittollerata sewwa.
The frequency of vaccine-related adverse experiences after the second dose of ZOSTAVAX was generally similar to that seen with the first dose.
Il- frekwenza ta 'esperjenzi avversi relatati mat- tilqima wara t- tieni doża ta' ZOSTAVAX kienet simili b' mod ġenerali għal dik li ntweriet fl- ewwel doża.
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.
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni tat- tagħrif farmakokinetiku m' hiex meħtieġa għat- tilqim.
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.
Sucrose Hydrolysed gelatin Sodium chloride Potassium dihydrogen phosphate Potassium chloride Monosodium L-glutamate Anhydrous disodium phosphate Sodium hydroxide (to adjust pH) Urea
Sucrose Hydrolysed gelatin Sodium chloride Potassium dihydrogen phosphate Potassium chloride Monosodium L- glutamate Anhydrous disodium phosphate Sodium hydroxide (għall- aġġustament tal- pH) Urea
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 l- prodotti li ma jaqblux miegħu, dan il- prodott medċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
8 6.3 Shelf life
8 6. 3 Żmien ta 'kemm idum tajjeb il- prodott mediċinali
After reconstitution, the vaccine should be used immediately.
Wara rikonstituzzjoni, it- tilqima għandha tintuża minnufih.
However, the in-use stability has been demonstrated for 30 minutes when stored at 20oC - 25oC.
Madankollu, l- istabbilità waqt l- użu ntweriet għal 30 minuta meta maħżun bejn l- 20oC - 25oC.
Store and transport refrigerated (2°C - 8°C).
Aħżen u ttrasporta mkessaħ (2°C - 8°C).
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (Type I glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) 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' kunjett (ħġieġ ta' Tip I) b' tapp (chlorobutyl rubber) u kappa tat- tip flip off (aluminju) f' pakkett ta 'daqs 1 jew 10.
Avoid contact with disinfectants.
Evita kuntatt ma 'diżinfettanti.
To reconstitute the vaccine, use the solvent provided.
Biex tirrikonstitwixxi l- vaċċin, uża s- solvent provdut.
When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.
Meta rikonstitwit, ZOSTAVAX huwa likwidu kemmxejn imdardar għal trasluċidu, abjad fl- isfar għal safrani ċar.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
Huwa importanti li tintuża siringa u labra sterilizzata separata għal kull pazjent sabiex tiġi evitata t - trasmissjoni ta 'aġenti ta' infezzjoni minn individwu għal ieħor.
Reconstitution instructions To reconstitute the vaccine, first withdraw the entire contents of the solvent vial into a syringe.
Istruzzjonijiet ta 'rikostituzzjoni Biex tirrikonstitwixxi l- vaċċin, l- ewwel iġbed il- kontenut kollu tal- kunjett tas- solvent f' siringa.
Inject all the solvent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
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 għal injezzjoni.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
HUWA IRRAKOMANDAT LI L- VAĊĊIN JINGĦATA MINNUFIH WARA IR - RIKOSTITUZZJONI, SABIEX JITNAQQAS IT- TELF TAS- SAĦĦA.
DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
ARMI T- TILQIMA RIKONSTITWITA JEKK MA TINTUŻAX FI ŻMIEN 30 MINUTA.
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.
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.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu il- liġijiet lokali.
SANOFI PASTEUR MSD, SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD, SNC 8, rue Jonas Salk F- 69007 Lyon Franza
May 19, 2006
19 ta 'Mejju 2006
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe
ZOSTAVAX trab u solvent għal sospensjoni għal injezzjoni f' siringa mimlija għal- lest
Varicella-zoster virus1, Oka/ Merck strain, (live, attenuated) not less than 19400 PFU2 1 produced in human diploid (MRC-5) cells 2 PFU = Plaque-forming units
Virus tal- Varicella- zoster1, razza Oka/ Merck, (ħaj, attenwat) mhux inqas minn 19400 PFU2 1 prodott f' ċelloli diploid umani (MRC- 5) 2 PFU = Unitajiet li jiffurmaw plakek
Powder and solvent for suspension for injection in a pre-filled syringe.
Trab u solvent għal sospensjoni għal injezzjoni f' siringa mimlija għal- lest.
Before reconstitution, the powder is a white to off-white compact crystalline plug, and the solvent is a clear, colourless fluid.
Qabel ir- rikonstituzzjoni, it- trab huwa plug kristallin kumpatt bajdani għal bajdani fl- isfar, u s- solvent huwa fluwidu ċar u bla kulur.
11 • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/ AIDS; cellular immune deficiencies. • Immunosuppressive therapy (including high-dose corticosteroids); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/ inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e. g., for adrenal insufficiency. • Active untreated tuberculosis. • Pregnancy (see sections 4.4 and 4.6).
11 • Terapija immunosuppressiva (inkluż corticosteroids f 'doża kbira); madankollu, m' hemmx kontra- indikazzjonijiet għall- użu ta' ZOSTAVAX f' individwi li qegħdin jieħdu corticosteroids f' parti mill- ġisem/ b’ inalatur jew corticosteroids sistematiċi ta 'doża żgħira jew f' pazjenti li qegħdin jirċievu corticosteroids bħala terapija ta' sostituzzjoni, eż., għal insuffiċjenza adrenali. • Tuberkolożi attiva mhux trattata. • Tqala (ara sezzjonijiet 4. 4 u 4. 6).
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/ anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e. g., neomycin) present in the vaccine (see sections 4.3 and 6.1).
Trattament approprjat u sorveljanza medika xierqa għandhom ikunu dejjem disponibbli minnufih fil - każ ta 'reazzjonijiet anafilattiċi/ anafilattojdi rari wara l- għoti tat- tilqima, minħabba li hemm il - possibbiltà ta' reazzjonijiet ta 'sensittività eċċessiva, mhux biss għas- sustanzi attivi, iżda wkoll għas - sustanzi mhux attivi u residwi ta' traċċa (eż., neomycin) preżenti fit- tilqima (ara sezzjonijiet 4. 3 and 6. 1).
Vaccination with ZOSTAVAX may not result in protection in all vaccine recipients.
It- tilqim b' ZOSTAVAX jista 'ma jirriżultax fi protezzjoni fir- riċeviturikollha tal- vaċċin.