qanastek/EMEA-V3 huggingface dataset:
A relationship between active substance exposure at steady state (rivastigmine and metabolite NAP226-90) and bodyweight was observed in Alzheimer’ s dementia patients.
81 Relazzjoni bejn l- esponiment għas- sustanza attiva fi stat fiss (rivastigmine u l- metabolu NAP226- 90) u l- piż tal- ġisem deher f’ pazjenti bid- dimenzja ta ’ Alzheimer.
73 Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
Esponiment (AUC∞) għal rivastigmine (u l- metabolu NAP266- 90) kienet l- ogħla meta l- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda kienet applikata man- naħa ta ’ isfel tad- dahar, sider jew parti ta ’ fuq tad- driegħ u madwar 20- 30% aktar baxxa meta tkun applikata ma ’ l- addome jew koxxa.
After oral administration, the Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
82 60% ogħla u l- AUC ta ’ rivastigmine kien aktar minn darbtejn ogħla f’ individwi li kellhom indeboliment epatiku ħafif għal moderat, meta dawn kienu mqabbla ma ’ individwi b’ saħħithom.
74 Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Id- dużaġġi mogħtija b’ mod orali u topiku fi studji bl- annimali kienu limitati minħabba s- sensittività ta ’ l- annimali użati bħala mudelli.
6.2 Incompatibilities
83 6. 2 Inkompatibilitajiet
76 ANNEX II
85 ANNESS II
78 ANNEX III
87 ANNESS III
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Prometax 1.5 mg hard capsules Rivastigmine
Prometax 1. 5 mg kapsuli ibsin Rivastigmine
Prometax 1.5 mg
Prometax 1. 5 mg
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Prometax 1.5 mg [folding box only]
Prometax 1. 5 mg [kaxxa li tintlewa biss]
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
94 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Prometax 3.0 mg hard capsules Rivastigmine
Prometax 3. 0 mg kapsuli ibsin Rivastigmine
Prometax 3.0 mg
Prometax 3. 0 mg
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
96 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
97 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Prometax 3.0 mg [folding box only]
Prometax 3. 0 mg [kaxxa li tintlewa biss]
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
99 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Prometax 4.5 mg hard capsules Rivastigmine
Prometax 4. 5 mg kapsuli ibsin Rivastigmine
Prometax 4.5 mg
Prometax 4. 5 mg
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
101 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Prometax 4.5 mg [folding box only]
Prometax 4. 5 mg [kaxxa li tintlewa biss]
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Prometax 6.0 mg hard capsules Rivastigmine
Prometax 6. 0 mg kapsuli ibsin Rivastigmine
Prometax 6.0 mg
Prometax 6. 0 mg
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Prometax 6.0 mg [folding box only]
Prometax 6. 0 mg [kaxxa li tintlewa biss]
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
109 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Prometax 2 mg/ ml oral solution Rivastigmine
Prometax 2 mg/ ml soluzzjoni orali Rivastigmine
Use Prometax oral solution within 1 month of opening the bottle.
Prometax bħala soluzzjoni orali għandha tintuża fi żmien xahar minn meta ’ jinfetaħ il- flixkun.
Prometax 2 mg/ ml [folding box only]
Prometax 2 mg/ ml [kaxxa li tintlewa biss]
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Prometax 4.6 mg/ 24 h transdermal patch rivastigmine
Prometax 4. 6 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda rivastigmine
Prometax 4.6 mg/ 24 h
Prometax 4. 6 mg/ 24 h
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
117 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
118 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Prometax 9.5 mg/ 24 h transdermal patch rivastigmine
Prometax 9. 5 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda rivastigmine
Prometax 9.5 mg/ 24 h
Prometax 9. 5 mg/ 24 h
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
122 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
124 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
117 PACKAGE LEAFLET:
126 FULJETT TA ’ TAGĦRIF:
Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules Rivastigmine
Prometax 1. 5 mg kapsuli ibsin Prometax 3. 0 mg kapsuli ibsin Prometax 4. 5 mg kapsuli ibsin Prometax 6. 0 mg kapsuli ibsin Rivastigmine
What Prometax is and what it is used for 2.
X’ inhu Prometax u għalxiex jintuża 2.
Before you take Prometax 3.
Qabel ma tieħu Prometax 3.
How to take Prometax 4.
Kif għandek tieħu Prometax 4.
How to store Prometax 6.
Kif taħżen Prometax 6.
WHAT PROMETAX IS AND WHAT IT IS USED FOR
X’ INHU PROMETAX U GĦALXIEX JINTUŻA
Prometax belongs to a class of substances called cholinesterase inhibitors.
Prometax jagħmel parti minn klassi ta ’ sustanzi li jissejħu impedituri ta ’ cholinesterase.
Prometax is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Prometax jintuża għall- kura ta ’ disturbi tal- memorja f’ pazjenti bil- marda ta ’ Alzheimer.
Prometax is used for the treatment of dementia in patients with Parkinson’ s disease.
Prometax jintuża għall- kura ta ’ dimenzja f’ pazjenti bil- marda ta ’ Parkinson.
BEFORE YOU TAKE PROMETAX
QABEL MA TIEĦU PROMETAX
Before taking Prometax it is important that you read the following section and discuss any questions you might have with your doctor.
Qabel ma tieħu Prometax huwa importanti li taqra s- sezzjoni li jmiss u li tiddiskuti kull mistoqsijiet li jista ’ jkollok mat- tabib tiegħek.
Do not take Prometax
Tieħux Prometax
- if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Prometax.
- jekk int allerġiku (tbati minn sensittività eċċessiva) għal rivastigmine jew sustanzi oħra ta ’
Take special care with Prometax
Oqgħod attent ħafna b’ Prometax
- if you have not taken Prometax for several days, do not take the next dose until you have talked
- jekk ma tkunx ħadt Prometax għal bosta jiem, tieħux id- doża li jkun imiss qabel ma titkellem
to your doctor.
mat- tabib tiegħek.
118 The use of Prometax in children and adolescents (age below 18 years) is not recommended.
127 L- użu ta ’ Prometax fit- tfal u fl- adoloxxenti (età taħt it- 18- il sena) m’ huwiex rakkomandat.
If you have to undergo surgery whilst taking Prometax, you should inform the doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.
Jekk ikollok bżonn ta ’ operazzjoni waqt li tkun qed tieħu Prometax, għandek tgħarraf lit- tabib qabel ma tingħata l- anestetiku, peress li Prometax jista ’ jeżaġera l- effetti ta ’ xi rilassanti tal- muskoli li jingħataw waqt l- anesteżija.
Prometax should not be given at the same time as other medicines with similar effects to Prometax.
Prometax m’ għandux jingħata fl- istess ħin li jkunu qed jittieħdu mediċini oħrajn b’ effetti simili għal Prometax.
Prometax might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’ s disease or to prevent travel sickness).
Prometax jista ’ jtellef mill- ħidma ta ’ mediċini antikolinerġiċi (mediċini użati biex isserraħ uġigħ ta ’ l- istonku jew spażmi, biex jikkuraw il- marda ta ’ Parkinson jew biex jevitaw il- mard ta ’ l - ivvjaġġar).
Pregnancy and breast-feeding It is preferable to avoid the use of Prometax during pregnancy, unless clearly necessary.
Tqala u Treddigħ Ikun aħjar jekk ma tieħux Prometax waqt it- tqala sakemm dan ma jkunx neċċessarju b’ mod ċar.
Tell your doctor if you become pregnant during treatment.
Għid lit- tabib tiegħek jekk toħroġ tqila waqt li tkun qed tieħu l- kura.
Women on Prometax should not breast-feed.
In- nisa li jkunu qed jieħdu Prometax m’ għandhomx ireddgħu.
Prometax may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Prometax jista ’ jikkaġuna sturdament u jraqdek, l- aktar fil- bidu tal- kura jew meta tkun qed iżżid id- doża.
HOW TO TAKE PROMETAX
KIF GĦANDEK TIEĦU PROMETAX
Always take Prometax exactly as your doctor has told you.
Dejjem għandek tieħu Prometax skond il- parir tat- tabib.
You should take Prometax twice a day with food (in the morning and evening).
Għandek tieħu Prometax darbtejn kuljum ma ’ l- ikel (filgħodu u filgħaxija).
Your doctor will tell you what dosage of Prometax to take, starting with a low dose and gradually increasing, depending on how you respond to the treatment.
It- tabib tiegħek igħidlek x’ doża ta ’ Prometax għandek tieħu, u għandek tibda b’ doża baxxa u żżidha bil- mod, skond kif tirrispondi għall- kura.
If you have not taken Prometax for several days, do not take the next dose until you have talked to your doctor.
Jekk ma tkunx ħadt Prometax għal bosta jiem, m’ għandekx tieħu d- doża li jkun imiss qabel ma titkellem mat- tabib tiegħek.
Tell your caregiver that you are taking Prometax.
Għid lil min ikun qed jikkurak li qed tieħu Prometax.
If you take more Prometax than you should Tell your doctor if you find you have accidentally taken more Prometax than you are told to.
Jekk tieħu Prometax aktar milli suppost Għid lit- tabib tiegħek jekk issib li bi żball ħadt aktar Prometax milli kienu qalulek biex tieħu.
Some people who have accidentally taken too much Prometax have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations.
Xi wħud li bi żball ħadu wisq Prometax kellhom dardir, rimettar, dijarea, pressjoni għolja u alluċinazzjonijiet.
If you forget to take Prometax If you find you have forgotten to take your dose of Prometax, wait and take the next dose at the usual time.
128 Jekk tinsa tieħu Prometax Jekk tinsa tieħu d- doża tiegħek ta ’ Prometax, stenna u ħu d- doża li jkun imiss fil- ħin normali.
Like all medicines, Prometax can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Prometax jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Additional side effects which have been reported with Prometax transdermal patches: severe confusion, anxiety, fever (common).
Effetti sekondarji ohra kienu rrapurtati bil- garżi li tipprovdu mediċina li tghaddi minn ġol- ġilda Prometax: konfużjoni severa, ansjeta ’, deni (komuni).
HOW TO STORE PROMETAX
KIF TAĦŻEN PROMETAX
Do not use Prometax after the expiry date which is stated on the carton.
Tużax Prometax wara d- data ta ’ skadenza li tidher fuq il- kartuna.
120 6.
129 6.
What Prometax contains
X’ fih Prometax
Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.
Kull kapsula Prometax ta ’ 1. 5 mg fiha 1. 5 mg rivastigmine.
Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.
Kull kapsula Prometax ta ’ 3. 0 mg fiha 3. 0 mg rivastigmine.
Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.
Kull kapsula Prometax ta ’ 6. 0 mg fiha 6. 0 mg rivastigmine.
What Prometax looks like and contents of the pack Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ ENA 713 1,5 mg” on the body.
Id- Dehra ta ’ Prometax u l- kontenuti tal- pakkett Prometax 1. 5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu isfar u kappa safra, b’ timbru aħmar “ ENA 713 1, 5 mg ” fuq il- kappa.
Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ ENA 713 3 mg” on the body.
Prometax 3. 0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu oranġjo u kappa oranġjo, b’ timbru aħmar “ ENA 713 3 mg ” fuq il- kappa.
Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “ ENA 713 4,5 mg” on the body.
Prometax 4. 5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu aħmar u kappa ħamra, b’ timbru aħmar “ ENA 713 4, 5 mg ” fuq il- kappa.
Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ ENA 713 6 mg” on the body.
Prometax 6. 0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu aħmar u kappa oranġjo, b’ timbru aħmar “ ENA 713 6 mg ” fuq il- kappa.
Malta Novartis Pharma Services Inc.
130 Malta Česká republika Novartis Pharma Services Inc.
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma GmbH Tel: +49 911 273 0
Portugal MediBIAL, Produtos Médicos e Farmacêuticos, S. A.
Portugal MediBIAL, Produtos Medicos e Farmacêuticos, S. A.
This leaflet was last approved in 122 PACKAGE LEAFLET:
131 FULJETT TA ’ TAGĦRIF:
The use of Prometax in children and adolescents (age below 18 years) is not recommended.
L- użu ta ’ Prometax fit- tfal u fl- adoloxxenti (età taħt it- 18- il sena) m’ huwiex rakkomandat.
123 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
132 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Important information about some of the ingredients of Prometax One of the inactive ingredients in Prometax oral solution is sodium benzoate.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Prometax Waħda mis- sustanżi mhux attivi ta ’ Prometax soluzzjoni orali hija sodium benzoate.
Using this syringe, withdraw the prescribed amount of Prometax oral solution from the container.
Iġbed id- doża ta ’ Prometax soluzzjoni orali, ordnata mit- tabib, minn ġol- flixkun, bl- użu tas- siringa.
Each dose of Prometax oral solution may be swallowed directly from the syringe.
Kull doża ta ’ Prometax soluzzjoni orali tista ’ tittieħed direttament minn ġos- siringa.
If you take more Prometax than you should Tell your doctor if you find you have accidentally taken more Prometax than you are told to.
133 Jekk tieħu Prometax aktar milli suppost Għid lit- tabib tiegħek jekk issib li bi żball ħadt aktar Prometax milli kienu qalulek biex tieħu.
Slow heart beat and
Il- qalb tista ’ tibda tħabbat bil- mod u jista ’ wkoll itik ħass ħażin.
If you forget to take Prometax If you find you have forgotten to take your dose of Prometax, wait and take the next dose at the usual time.
Jekk tinsa tieħu Prometax Jekk tinsa tieħu d- doża tiegħek ta ’ Prometax, stenna u ħu d- doża li jkun imiss fil- ħin normali.
125 Use Prometax oral solution within 1 month of opening the bottle.
Prometax bħala soluzzjoni orali għandha tintuża fi żmien xhar minn meta jinfetaħ il- flixkun.
What Prometax looks like and contents of the pack Prometax oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Id- Dehra ta ’ Prometax u l- kontenuti tal- pakkett Prometax soluzzjoni orali jiġi bħala 50 ml jew 120 ml soluzzjoni ċara, safra (bażi ta ’ 2. 0 mg/ ml), fi flixkun magħmul minn ħġieġ kannella, b’ għatu li ma jinfetaħx mit- tfal, b’ kisja tal- fowm, b’ tubu biex tbill, u b’ tapp li jipożizzjona lilu nnifsu.
Malta Novartis Pharma Services Inc.
135 Malta Česká republika Novartis Pharma Services Inc.
127 Instructions for Use:
136 Struzzjonijiet dwar l- użu:
Prometax oral solution
Prometax soluzzjoni orali
Withdraw prescribed amount of Prometax oral solution from bottle.
Iġbed l- ammont ta ’ Prometax soluzzjoni orali li ordna t- tabib minn ġol - flixkun.
Swallow Prometax oral solution directly from the syringe or first mix in a small glass with water.
Ibla ’ Prometax soluzzjoni orali direttament minn ġos- siringa, jew imħallta ġo tazza ilma żgħira.
129 PACKAGE LEAFLET:
138 FULJETT TA ’ TAGĦRIF:
Prometax 4.6 mg/ 24 h transdermal patch Prometax 9.5 mg/ 24 h transdermal patch rivastigmine
Prometax 4. 6 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Prometax 9. 5 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda rivastigmine
Before you use Prometax 3.
Qabel ma tuża Prometax 3.
How to use Prometax 4.
Kif għandek tuża Prometax 4.
The active substance of Prometax is rivastigmine.
Is- sustanza attiva f’ Prometax hija rivastigmine.
Prometax is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Prometax tintuża għall- kura ta ’ disturbi tal- memorja f’ pazjenti bil- marda ta ’ Alzheimer.
BEFORE YOU USE PROMETAX
QABEL MA TUŻA PROMETAX
Do not use Prometax
Tużax Prometax
- if you are allergic (hypersensitive) to rivastigmine (the active substance in Prometax) or to any
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal rivastigmine (is- sustanza attiva
of the other ingredients listed in section 6 of this leaflet.
f’ Prometax) jew sustanzi oħra elenkati f’ sezzjoni 6 ta ’ dan il- fuljett.
If this applies to you, tell your doctor and do not apply Prometax transdermal patches.
Jekk dan jgħodd għalik, għid lit- tabib u tapplikax Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda.
The use of Prometax in children and adolescents (age below 18 years) is not recommended.
L- użu ta ’ Prometax fi tfal u adolexxenti (età taħt it- 18- il sena) mhux rakkomandat.
130 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
139 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Prometax might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’ s disease or to prevent travel sickness).
Prometax jista ’ jinterferixxi ma ’ mediċini antikolinerġiċi (mediċini li jintużaw biex itaffu weġgħat fl - istonku jew spażmi, għal kura tal- marda ta ’ Parkinson jew biex jevitaw it- tqallih ta ’ l- ivjaġġar).
If you have to undergo surgery whilst using Prometax transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
Jekk ikollok bżonn tagħmel operazzjoni meta tkun qed tuża Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda, għid lit- tabib tiegħek li qed tużahom għax jistgħu jeżaġeraw l- effetti ta ’ xi rilassanti tal- muskoli li jintużaw waqt il- loppju.
Using Prometax with food and drink Food or drink do not affect the use of Prometax transdermal patches because rivastigmine enters the bloodstream through the skin.
Meta tuża Prometax ma ’ l- ikel u max- xorb L- ikel u x- xorb m’ għandux effett fuq l- użu tal- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax għax rivastigmine jidħol fiċ- ċirkolazzjoni tad- demm mill- ġilda.
If you are pregnant, the benefits of using Prometax transdermal patches must be assessed against the possible effects on your unborn child.
Jekk ħriġt tqila, il- benefiċċji tal - garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax għandhom jiġu evalwati kontra l- effetti li jista ’ jkun hemm fuq it- tarbija li għada ma twielditx.
You should not breast-feed during treatment with Prometax transdermal patches.
M’ għandekx tredda ’ waqt il- kura b’ garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax.
Prometax transdermal patches may cause fainting or severe confusion.
Garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax jistgħu jikkawżaw ħass ħażin jew konfużjoni severa.
HOW TO USE PROMETAX
KIF GĦANDEK TUŻA PROMETAX
Always use Prometax transdermal patches exactly as your doctor has told you.
Dejjem għandek tuża l- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax skond il- parir tat- tabib.
Only wear one Prometax patch at a time.
Ilbes Prometax garża waħda f’ kull ħin.
How to start treatment Your doctor will tell you which Prometax transdermal patch is most suitable for you. • Treatment usually starts with Prometax 4.6 mg/ 24 h. • The usual daily dose is Prometax 9.5 mg/ 24 h. • Only one transdermal patch should be worn at a time and the transdermal patch should be replaced by a new one after 24 hours.
Kif tibda ’ l- kura It- tabib tiegħek sejjer jgħidlek liema mill- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax l- aktar li tgħodd għalik. • Il- kura s- soltu tibda b’ Prometax 4. 6 mg/ 24 siegħa. • Id- doża ta ’ kuljum is- soltu tkun Prometax 9. 5 mg/ 24 siegħa. • Għandha tintlibes garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda waħda biss f’ kull ħin u l - garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda għandha tinbidel b’ oħra ġdida wara 24 siegħa.
131 Where to apply Prometax transdermal patches
140 Fejn għandek tapplika Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Applika l- garża fuq il- naħa ta ’ fuq jew ta ’ isfel tad- dahar,
How to apply Prometax transdermal patches Prometax patches are thin, opaque, plastic patches that stick to the skin.
Kif tapplika Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda huma garżi rqaq, opaki tal- plastik li jeħlu mal- ġilda.
132 The patch should be worn continuously until it is time to replace it with a new one.
141 Il- garża għandha tintlibes il- ħin kollu sakemm jasal il- ħin biex tinbidel b’ oħra ġdida.
How to remove Prometax transdermal patches Gently pull at one edge of the patch to remove it completely from the skin.
Kif tneħħi l- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax Iġbed bil- mod minn tarf wieħed tal- garża sabiex tneħħiha għal kollox mill- ġilda.
How to dispose of Prometax transdermal patches After removing a patch, fold it in half with the sticky sides on the inside and press them together.
Kif tarmi il- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax Wara li tneħħi l- garża, itwijha fi tnejn bin- naħa li teħel fuq ġewwa u agħfashom flimkien.
Can you wear Prometax transdermal patches when you are bathing, swimming, or in the sun? • Bathing, swimming or showering should not affect the patch.
Tista ’ tilbes il- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax meta tkun qed tinħasel, tgħum, jew fix- xemx? • Il- ħasil, għawm jew xawer m’ għandhomx jeffettwaw il- garża.
When and for how long to apply Prometax transdermal patches To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Meta u għal kemm għandek tapplika il- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Prometax Sabiex tikseb benefiċċju mill- kura għandek tapplika garża ġdida kuljum, l- aħjar fl- istess ħin tal- jum.
If you use more Prometax than you should If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch.
Jekk tuża Prometax aktar milli suppost Jekk bi żball tapplika aktar minn garża waħda, neħħi l- garżi kollha minn mal- ġilda, imbagħad għarraf lit- tabib li bi żball applikajt aktar minn garża waħda.
Some people who have accidentally taken too much Prometax have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Xi nies li ħadu bi żball wisq Prometax ħassewhom imqalla (dardir), ma jifilħux (irrimettew), dijarea, pressjoni għolja tad- demm u alluċinazzjonijiet.
If you forget to use Prometax If you find you have forgotten to apply a patch, apply one immediately.
Jekk tinsa tuża Prometax Jekk tinduna li nsejt tapplika garża, applika waħda ġdida mill- ewwel.
If you stop using Prometax Tell your doctor or pharmacist if you stop using the patch.
Jekk tieqaf tuża Prometax Għid lit- tabib jew spiżjar tiegħek jekk tieqaf tuża l- garża.
If you have not applied an Prometax patch for several days, do not apply the next one until you have talked to your doctor.
Jekk ma applikajtx garża Prometax għal bosta ġranet, tapplikax dik li jmiss sakemm ma tkun kellimt lit- tabib tiegħek.
Like all medicines, Prometax transdermal patches can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Prometax garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda jista ’ jkollhom effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
133 effects (less than 1 in 10 patients but more than 1 in 100 patients).
142 Reazzjonijiet fl- istonku (gastro- intestinali) bħal tħossok marid (dardir) u tkun ma tiflaħx (rimettar) huma effetti sekondarji komuni (anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent).
Additional side effects which have been reported with Prometax capsules or oral solution are:
Effetti sekondarji oħrajn li kienu rrappurtati bil- kapsuli Prometax jew soluzzjoni orali huma:
- Do not use Prometax after the expiry date, which is stated on the box and sachet.
- Tużax Prometax wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- qartas.
date refers to the last day of the month.
tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
Prometax 4.6 mg/ 24 h transdermal patches:
Prometax 4. 6 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda:
Prometax 9.5 mg/ 24 h transdermal patches:
Prometax 9. 5 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda:
What Prometax looks like and contents of the pack Each transdermal patch is a thin patch consisting of three layers.
Id- Dehra ta ’ Prometax u l- kontenuti tal- pakkett Kull garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda hija garża rqieqa li fiha tliet saffi.
- “ Prometax”, “ 4.6 mg/ 24 h” and “ AMCX”,
- “ Prometax ”, “ 4. 6 mg/ 24 h ” u “ AMCX ”,
- “ Prometax”, “ 9.5 mg/ 24 h” and “ BHDI”.
- “ Prometax ”, “ 9. 5 mg/ 24 h ” u “ BHDI ”.
Slovenija Novartis Pharma Services Inc.
144 Slovenija Ireland Novartis Pharma Services Inc.
What is ProQuad?
X’ inhu ProQuad?
ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox).
ProQuad huwa vaċċin kontra l- ħożba, il- gattone, ir- rubella u l- ġidri r- riħ (variċella).
ProQuad is a suspension given by subcutaneous injection (injection under the skin).
ProQuad huwa sospensjoni li jingħata b' injezzjoni subkutanja (taħt il- ġilda).
The active substances are attenuated (weakened) viruses for the diseases.
Is- sustanzi attivi huma vajrusis attenwati (imdgħajfa) għal dawn il- mardiet.
What is ProQuad used for?
Għal xiex jintuża ProQuad?
ProQuad is given to children from 12 months of age to help protect them from the four diseases: measles, mumps, rubella, and varicella (chickenpox).
ProQuad jingħata lil tfal mill- età ta ’ tnax – il xahar sabiex dan jgħin fil- protezzjoni tagħhom minn dawn l- erba ’ mardiet: il- ħożba, il- gattone, ir- rubella u l- ġidri r- riħ (variċella).
How is ProQuad used?
Kif jintuża ProQuad?
ProQuad is provided as two separate components: a powder that must be kept frozen, and a solvent, in a vial or pre-filled syringe, that is kept in a refrigerator or at room temperature.
ProQuad huwa fornut f’ żewġ komponenti separati: trab li għandu jinżamm iffriżat u solvent f’ kunjett jew f’ siringa diġa ’ mimlija li tiġi miżmuma f’ refriġeratur jew f’ temperatura ambjentali normali.
Immediately before administration, the doctor or nurse will need to make up the suspension for injection by dissolving the frozen powder with the solvent.
Immedjatament qabel l- amministrazzjoni it- tabib jew l- infermier jeħtieġ li jipprepara s- sospensjoni għall- injezzjoni billi jħoll it- trab iffriżat flimkien ma ’ solvent.
In order to protect against varicella (chickenpox), two doses of the weakened varicella virus are needed; this can be done either by giving two doses of ProQuad, or by giving a single dose of ProQuad followed by a dose of another vaccine that only protects against varicella.
ProQuad jista ’ jingħata jew f’ żewġ dożi jew f’ doża waħda segwita minn doża ta ’ vaċċin li jipproteġi biss kontra l- ġidri r- riħ (variċella).
The second dose in both cases is given between one and three months after the first one.
It- tieni doża fiż- żewġ każijiet tiġi mogħtija bejn xahar u tliet xhur wara l- ewwel waħda.
How does ProQuad work?
Kif jaħdem ProQuad?
ProQuad is a vaccine.
ProQuad huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi '‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella, and chickenpox.
ProQuad fih forom imdgħajjfa ta ’ vajrusis li jikkawżaw il- ħożba, il- gattone, ir- rubella u l- ġidri r- riħ (variċella).
When a person is given the vaccine, the immune system recognises the weakened viruses as ‘ foreign’ and makes antibodies against them.
Meta persuna tiġi mogħtija l- vaċċin, is- sistema immunitarja tagħraf il- vajrisis imdgħajfa bħala 'barranin' u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to produce antibodies quicker when it is again exposed to the viruses.
Fil- futur, is- sistema immunitarja tkun tista 'tipproduċi antikorpi iktar malajr meta tkun esposta mill - ġdid għal vajrusis.
The antibodies will help to protect against diseases caused by these viruses.
L- antikorpi jgħinu fil- protezzjoni kontra l- mard ikkawwżat minn dawn il- vajrusis.
How has ProQuad been studied?
Kif ġie studjat ProQuad?
ProQuad contains well known weakened viruses, which are already used in other vaccines.
ProQuad fih vajrusis imdgħajjfa magħrufa sew li huma diġa ’ wżati f’ vaċċini oħrajn.
When ProQuad was studied in humans, it was compared to its ‘ component vaccines’, a triple vaccine against mumps, measles and rubella, and a vaccine against varicella.
Meta ProQuad ġie studjat fil- bnedmin ġie mqabbel mal - ‘ vaċċini komponenti ’ tiegħu, vaċċin triplu kontra l- ħożba, il - gattone, ir- rubella u l- ġidri r- riħ.
The vaccine was studied in 5,446 healthy children (aged 12-23 months) who received one dose of ProQuad.
Il- vaċċin ġie studjat f’ 5, 446 tfal b’ saħħithom (ta ’ etajiet bejn it- 12- 23 xahar) li rċevew doża waħda ta ’ ProQuad.
The studies measured the
Studju iffoka wkoll fuq ir - risponsi sena wara li sar il- vaċċin f’ 2, 108 tifel.
A study also looked at the responses one year after vaccination in 2,108 children.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu
What benefit has ProQuad shown during the studies?
Liema benefiċċju wera ProQuad waqt l- istudji li ġew mwettqa?
The response rates (measuring how the immune system had responded to the viruses) were:
Ir- rati ta ’ rispons (kejl ta ’ kif is- sistema immunitarja rrispondiet għal vajrusis) kienu:
97.4% for measles, 95.8% to 98.8% for mumps, 98.5% for rubella and 91.2% for varicella.
97. 4% għall - ħożba, 95. 8% sa 98. 8% għall- gattone, 98. 5% għar- rubella u 91. 2% għall- ġidri r- riħ.
After the second dose, the rates were 99.4% for measles, 99.9% for mumps, 98.3% for rubella, and 99.4% for varicella.
Wara t- tieni doża, ir- rati kienu ta ’ 99. 4% għall- ħożba, 99. 9% għall- gattone, 98. 3% għar- rubella, u 99. 4% għall- ġidri r- riħ.
What is the risk associated with ProQuad?
X’ inhu r- riskju assoċjat ma ’ ProQuad?
The most common side-effect in the studies was fever (more than 1 child in 10).
L- aktar effett sekondarju komuni fl- istudji kien id- deni (aktar minn tifel/ tifla wieħed/ waħda f’ 10).
For the full list of all side effects reported with ProQuad, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati ma ’ ProQuad, ara l- Fuljett ta ’ Tagħrif.
Children should not be vaccinated with ProQuad if they have an allergy to any varicella vaccine or measles, mumps, or rubella vaccine, to any of the excipients, or to neomycin, or if they have any disease that affects their immune system.
Jekk tfal ikollhom allerġija għal vaċċin tal- ġidri r- riħ jew tal- ħożba jew għal vaċċin tar- rubella, għal xi sustanzi mhux attivi jew għal neomiċina jew jekk ikollhom xi marda li taffettwa s- sistema immunitarja tagħhom ma għandhomx jiġu vaċċinati b’ ProQuad.
Why has ProQuad been approved?
Għaliex ġiet approvata ProQuad?
The Committee for Medicinal Products for Human Use (CHMP) decided that ProQuad’ s benefits are greater than its risks in the simultaneous vaccination against measles, mumps, rubella and varicella of individuals from 12 months of age.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ ProQuad huma akbar mir- riskji tiegħu f’ vaċċin simultanju kontra l- ħożba, il- gattone, ir- rubella u l - ġidri r- riħ (variċella) f’ individwi mill- età ta ’ 12 – il xahar.
They recommended that ProQuad be given a marketing authorisation.
Huma rrakkomandaw li ProQuad jingħata awtorizzazzjoni għat- tqegħid fis- suq.
They also recommended that a second dose of vaccination against varicella (chickenpox) should be given to complete protection against the disease.
Huma rrakkomandaw ukoll li t- tieni doża tal- vaċċin kontra l - ġidri r- riħ (variċella) għandha tingħata sabiex il- protezzjoni tkun sħiħa kontra l- marda.
Other information about ProQuad:
Tagħrif ieħor dwar ProQuad:
The European Commission granted a marketing authorisation valid throughout the European Union to Sanofi Pasteur MSD SNC on 6 April 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l- Unjoni Ewropea kollha lil Sanofi Pasteur MSD SNC fl- 10 ta ’ April 2006.
The full EPAR for ProQuad is available here.
L- EPAR sħiħ għal ProQuad jista ’ jiġi kkonsultat hawn.
This summary was last updated in 04-2006
Dan is- sommarju ġie aġġornat l- aħħar f’ 06- 2008.
Strength Pharmaceutical Form §
Għamla farmaċewtika
Content
Daqs tal - pakkett
Package size
Numru ta ’ l- UE
Powder and solvent for suspension for injection
Trab u solvent għal sospensjoni għal injezzjoni
powder: vial (glass); solvent:
trab: kunjett( ħġieġ); solvent:
0.5 ml vial (glass)
0. 5 ml kunjett( ħġieġ)
0.5 ml pre-filled syringe (glass)
0. 5 ml siringa mimlija għal - lest( ħġieġ)
1 vial + 1 pre-filled syringe with attached needle
1 kunjett + 1 siringa mimlija għal- lest b’ labra mwaħħla
10 vials + 10 pre-filled syringes with attached needle
10 kunjetti + 10 siringi mimlijin għal- lest b’ labra mwaħħla
1 vial + 1 pre-filled syringe without needle
1 kunjett + 1 siringa mimlija għal- lest mingħajr labra mwaħħla
10 vials + 10 pre-filled syringes without needle
10 kunjetti + 10 siringi mimlijin għal- lest mingħajr labra mwaħħla
10 vials + 10 pre-filled syringes + 10 needles
10 kunjetti + 10 siringi mimlijin għal- lest + 10 labriet
1 vial + 1 pre-filled syringe + 2 needles
1 kunjett + siringa mimlija għal- lest + 2 labriet
10 vials + 10 pre-filled syringes + 20 needles
10 kunjetti + 10 siringi mimlijin għal- lest + 20 labra
Powder and solvent for suspension for injection
Trab u solvent għal
Subcutaneous use
Użu għal taħt il - 2/ 2
powder: vial (glass); solvent:
0. 5 ml
0.5 ml pre-filled syringe (glass)
sospensjoni għal injezzjoni
20 vials + 20 pre-filled syringes + 20 needles
mimlija għal- lest + 20 labra
Measles virus1 Enders’ Edmonston strain (live, attenuated)............ not less than 3.00 log10 TCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)....... not less than 4.30 log10 TCID50 Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)................... not less than 3.00 log10 TCID50 Varicella virus3 Oka/ Merck strain (live, attenuated)........................ not less than 3.99 log10 PFU**
Virus tal- ħosba1 razza Enders ’ Edmonston (ħaj, imdgħajjef).......... mhux inqas minn 3. 00 log10 TCID50 * Virus tal- gattone1 razza Jeryl Lynn™ (Livell B) (ħaj, imdgħajjef). mhux inqas minn 4. 30 log10 TCID50 Virus tar- Rubella2 razza Wistar RA 27/ 3 (ħaj, imdgħajjef)............. mhux inqas minn 3. 00 log10 TCID50 Virus tal- ġidri r- riħ3 razza Oka/ Merck (ħaj, imdgħajjef)................. mhux inqas minn 3. 99 log10 PFU **
2/ 2 * 50% tissue culture infectious dose ** plaque-forming units
* 50% doża infettuża ta ’ kultura tat- tessut ** unitajiet li jiffurmaw plakek
(1) Produced in chick embryo cells.
(1) Prodott f’ ċelloli ta ’ l- embrijoni tal- flieles.
(2) Produced in human diploid lung (WI-38) fibroblasts.
(2) Prodott f’ fibroblasts (WI- 38) tal- pulmun diplojde uman.
(3) Produced in human diploid (MRC-5) cells.
(3) Prodott f’ ċelloli (MRC- 5) diplojde umani.
ProQuad powder and solvent for suspension for injection.
ProQuad trab u solvent għal sospensjoni għall injezzjoni.
Measles, mumps, rubella and varicella vaccine (live).
Vaċċin (ħaj) tal- ħosba, gattone, rubella u ġidri r- riħ.
Measles virus1 Enders’ Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated).. not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated).............. not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated)................... not less than 3.99 log10 PFU**
Virus tal- gattone1 razza Jeryl Lynn™ (Livell B) (ħaj, attenwat) mhux inqas minn 4. 30 log10 CCID 50 * Virus tar- rubella2 razza Wistar RA 27/ 3, (ħaj, attenwat) mhux inqas minn 3. 00 log10 CCID 50 * Virus tal- ġidri r- riħ3, razza Oka/ Merck, (ħaj, attenwat)
*50% cell culture infectious dose **plaque-forming units
* 50% doża infettuża tal- kultura taċ- ċelloli ** unitajiet li jiffurmaw plakek
(1) Produced in chick embryo cells.
(1) Prodott f' ċelloli ta 'l- embrijoni tal- flieles.
(2) Produced in human diploid lung (WI-38) fibroblasts.
(2) Prodott f' fibroblasti diplojdi tal- pulmun uman (WI- 38).
(3) Produced in human diploid (MRC-5) cells.
(3) Prodott f' ċelloli diplojdi umani (MRC- 5).
Powder and solvent for suspension for injection.
Trab u solvent għal sospensjoni għall- injezzjoni.
Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid.
Qabel rikonstituzzjoni, it- trab huwa kejk kristallin kompatt abjad għal safrani ċar u s- solvent huwa likwidu ċar u bla kulur.
ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.
ProQuad huwa indikat għal tilqim simultanju kontra ħosba, gattone, rubella, u ġidri r- riħ f' individwu minn 12- il xahar 'il fuq.
Posology Individuals from 12 months of age should receive two doses of ProQuad or a single dose of ProQuad followed by a second dose of a monovalent varicella vaccine to ensure optimal protection against varicella (see section 5.1).
Pożoloġija Individwi minn 12- il xahar 'il fuq iridu jieħdu żewġ dożi ta ’ ProQuad, jew doża waħda ta ’ ProQuad segwiti/ a b' tieni doża ta' vaċċin monovalenti tal- ġidri r- riħ, biex tiġi żgurata l- aqwa protezzjoni kontra l- ġidri r- riħ (ara sezzjoni 5. 1).
At least one month must elapse between the first and second dose of any live viral attenuated vaccine.
Irid jgħaddi mill- inqas xahar bejn l- ewwel u t- tieni doża ta ’ xi vaċċin ta ’ virus attenwat ħaj.
It is preferred that the second dose be administered within three months following the first dose.
Preferribbilment, it- tieni doża tingħata fi żmien tlett xhur wara l- ewwel doża.
Note: applicable official recommendations may vary regarding the interval between doses and the need for two or one doses of measles, mumps and rubella and of varicella-containing vaccine.
Nota: ir- rakkommandazzjonijiet uffiċjali applikabli dwar l- intervall bejn id- dożi, u l- bżonn ta żewġ dożi jew inkella doża waħda ta ’ ħosba, gattone u rubella u tal- vaċċin tal- ġidri r- riħ, jistgħu jvarjaw.
ProQuad may be used as the second dose in individuals from 12 months of age who have previously received measles, mumps, and rubella vaccine and varicella vaccine.
ProQuad jista 'jintuża bħala t- tieni doża f’ individwi minn tnax- il xahar' il fuq, li qabel kienu ħadu l - vaċċin tal- ħosba, gattone u rubella u l- vaċċin tal- ġidri r- riħ.
2 Method of administration The vaccine is to be injected by the subcutaneous route in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
2 Metodu ta 'kif għandu jingħata Il- vaċċin għandu jiġi injettat taħt il- ġilda fir- reġjun tal- muskolu deltojd fin- naħa ta ’ fuq ta ’ l- id jew fil - ġenb ta ’ quddiem fil- parti ta ’ fuq tal- koxxa.
See section 6.6 for preparation instructions.
Ara sezzjoni 6. 6 għall- istruzzjonijiet dwar it- tħejjija.
DO NOT INJECT INTRAVASCULARLY.
TINJETTAX B' MOD INTRAVASKULARI.
History of hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine, to any of the excipients, or to neomycin, which may be present as trace residues (see sections 2, 4.4 and 6.1).
Storja ta ’ sensittività eċċessiva għal xi vaċċin tal- ġidri r- riħ jew għall- vaċċin tal- ħosba, gattone jew rubella, jew għal xi sustanzi mhux attivi, jew għall- neomycin, li jistgħu jkunu preżenti bħala traċċi residwi (ara sezzjonijiet 2, 4. 4 u 6. 1).
Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system.
Mard tad- demm, lewkimja, tumur malinn fil- glandoli limfatiċi ta ’ kull tip, jew neoplażmi malinni oħra li għandhom effett fuq is- sistemi ematopojetiċi u limfatiċi.
Current immunosuppressive therapy (including high doses of corticosteroids).
Persuni li qegħdin taħt terapija immunosuppressiva (inkluż dożi għoljin ta ’ kortikosterojdi).
ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e. g. for asthma prophylaxis or replacement therapy).
ProQuad m' huwiex kontra- indikat f’ individwi li qed jieħdu kortikosterojdi topiċi jew dożi baxxi t a ’ kortikosterojdi parenterali (eżempju għall- prevenzjoni ta ’ l- ażżma jew bħala terapija ta ’ sostituzzjoni).
Humoral or cellular (primary or acquired) immunodeficiency, including hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic HIV infection or a CDC Class 2 or higher or an age-specific CD4+ T-lymphocyte percentage < 25% (see section 4.4).
Immunodefiċjenza (primarju jew akkwistata) ta ’ l- umuri jew fiċ- ċelloli, inkluż ukoll hypogammaglobulinemia, dysgammaglobulinemia u AIDS, jew infezzjoni bis- sintomi ta ’ l- HIV jew CDC klassi 2 jew ogħla jew peċentwal ta ’ < 25% ta ’ CD4+ T- limfoċite speċifiku għall- età (ara sezzjoni 4. 4).
In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
F’ individwi li kienu severament immunokompromessi u li mingħajr ma jafu ġew injettati bil- vaċċin li fih il- virus tal- ħosba, ġie rrappurtat li kien hemm enċefalite tal- ġisem inkluża tal - ħosba, pulmonite u ’ riżultati fatali, konsegwenza iretta ta ’ tixrid ta ’ l- infezzjoni bil- virus tal- vaċċin tal- ħosba.
Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Storja familjari ta 'immunodefiċjenza konġenitali jew ereditarja, sakemm ma tintweriex il- kompetenza ta' l- immunità tar- riċevitur potenzjali tal- vaċċin.
Active untreated tuberculosis (see section 4.4).
Tuberkulożi attiva li mhux qed tiġi ttrattata (ara sezzjoni 4. 4).
Vaccination should be postponed during any illness with fever > 38.5°C.
It- tilqim għandu jiġi pospost waqt mard b' deni li jitla '> 38. 5°C.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Trattament mediku u sorveljanza addattata għandhom ikunu dejjem disponibbli, fil- każ rari li sseħħ reazzjoni anafilattika, li tista 'seħħ wara l- għoti tal- vaċċin.
Additionally, live measles vaccine and live mumps vaccine are produced in chick embryo cell culture.
Barra minn hekk, il- vaċċin tal- ħosba tip ħaj u l- vaċċin tal- gattone tip ħaj huma prodotti f' kulturi taċ - ċelloli ta 'l- embriji tal- flieles.
Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e. g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.
Persuni bi storja ta ’ reazzjoni anafilattika, reazzjoni li tixbah waħda anafilattika, jew reazzjonijiet immedjati oħra (eżempju: ħorriqija, nefħa fil- ħalq u l- griżmejn, diffikultà fit- teħid tan- nifs, tnaqqis fil- pressjoni jew xokk) wara t- teħid tal- bajd, jistgħu jkunu f’ riskju ikbar ta sensittività eċċessiva ta ’ tip immedjata.
The potential risk- to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Il- proporzjon bejn ir- riskju potenzjali u l- benifiċċju għandu jiġi evalwat bl- ikbar attenzjoni qabel wieħed jikkunsidra tilqim f’ każijiet bħal dawn.
Due caution should be employed in the administration of ProQuad to persons with individual or family history of convulsions, or a history of cerebral injury.
Għanda tingħata l- attenzjoni neċessarja waqt l- għoti ta ’ ProQuad lil persuni bi problemi ta ’ konvulżjonijiet kemm individwali kif ukoll familjari, jew bi storja ta ’ ħsara ċerebrali.
The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8).
It- tabib irid joqgħod attent għat- temperatura li tista 'togħla wara t- tilqima (ara sezzjoni 4. 8).
This vaccine contains 16 mg of sorbitol as an excipient.
Dan il- vaċċin fih 16 mg ta ’ sorbitol bħala sustanza mhux attiva.
Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- fructose ma jistgħux jieħdu dan il- vaċċin.
3 Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad as Reye's syndrome has been reported following the use of salicylates during wild-type varicella infection.
3 Riċevituri tal- vaċċin għandhom jevitaw l- użu ta ’ salicylates għal 6 ġimgħat wara t- tilqima bi ProQuad, għaliex is- sindromu ta 'Reye ġie rrapportat wara l- użu ta' salicylates waqt infezzjoni tal- ġidri tip mhux attenwat.
As for any vaccine, vaccination with ProQuad may not result in protection in all vaccine recipients.
Bħal b' kull tilqima oħra, it- tilqim b' ProQuad jista 'ma jirriżultax fi protezzjoni fir- riċevituri kollha tat - tilqima.
Pregnancy See sections 4.3 and 4.6.
Tqala Ara sezzjonijiet 4. 3 u 4. 6.
Transmission Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Trasmissjoni Kien hemm tneħħija t' ammonti żgħar tal- virus tar- rubella tat- tip attenwat ħaj mill- imnieħer jew mill - griżmejn fil- maġġoranza ta ’ individwi suxxettibbli, bejn 7 u 28 jum wara li ngħatat it- tilqima.