qanastek/EMEA-V3 huggingface dataset:
It is not necessary to shake the vaccine before use.
M’ hemmx bżonn iċċaqlaq il- vaċċin qabel l- użu.
14 The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro- needle (1.5 mm) and a needle shielding system.
Is- Sistema ta ’ Mikro- Injezzjoni għal injezzjoni minn ġol- ġilda tikkonsisti f’ siringa mimlija għall- lest b’ labra mikro (1. 5 mm) u sistema tal- protezzjoni tal- labra.
15 INSTRUCTIONS FOR USE
15 STRUZZJONIJIET GĦALL- UŻU
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
F’ każ tal- preżenza ta ’ likwidu fil- post fejn tingħata l- injezzjoni wara l- għoti tal- vaċċin, il- vaċċin mhuwiex meħtieġ mill ġdid.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F- 69007 Lyon, Franza.
17 ANNEX II
17 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Sanofi Pasteur Parc Industriel d’ Incarville 27100 Val-de-Reuil France
Sanofi Pasteur Parc Industriel d’ Incarville 27100 Val- de- Reuil Franza
Sanofi Pasteur Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l’ Etoile France
Sanofi Pasteur Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l’ Etoile Franza
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq irid jiżgura li jkun hemm sistema ta ’ farmakoviġilanza, kif inhu deskritt fil- verzjoni 8. 0 ippresentat fi Module 1. 8. 1 tal- Awtorizzazzjoni għat- tqegħid fis- Suq, li tkun taħdem qabel u waqt ma l- prodott jitpoġġa fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jwiegħed li jkun obbligat li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fil- pjan tal- Farmakoviġilanza, kif inhu maqbul fil- verzjoni 1. 0 tal- Pjan dwar l- Immaniġġar tar- Riskju (RMP) ippresentat fi Module 1. 8. 2 ta ’ l - applikazzjoni għal l- Awtorizzazzjoni għat- tqegħid fis- suq u kwalunkwe informazzjoni ġdid tal- RMP maqbul minn CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
19 Bħalma hemm fil - linji gwida tal- CHMP għas- Sistemi fuq l- Immaniġġar tar- Riskju għal mediċinali għal l- użu uman, l- RMP aġġornat irid ikun mogħti fl- istess ħin bħal Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) li jmiss.
19 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Iktar minn hekk, l- RMP aġġornat irid jkun mogħti • Meta hemm informazzjoni ġdida li jista jkollha effett fuq l- Ispeċifikazzjoni tas- Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60- il ġurnata ta xi grajja importanti (farmacoviġilanza jew tnaqqis tar- riskju) li tkun intlaħqet • Fuq talba tal- EMEA
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta ’ l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
20 ANNEX III
20 ANNESS III
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA:
Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
Pakkett ta ’ 1 jew 10 jew 20 siringa( i) mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni
IDflu 9 microgram/ strain, suspension for injection Influenza vaccine (split virion, inactivated).
IDflu 9 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
Strains 2006/ 2007
Razez 2006/ 2007
A/ New Caledonia/ 20/ 99 (H1N1) like strain (IVR-116) 9 micrograms HA**
Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (IVR- 116) 9 mikrogrammi HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (NYMC X-161) 9 micrograms HA**
Razza li tixbaħ lil A/ Wisconsin/ 67/ 2005 (H3N2) (NYMC X- 161) 9 mikrogrammi HA **
B/ Malaysia/ 2506/ 2004 like strain 9 micrograms HA**
Razza li tixbaħ lil B/ Malaysia/ 2506/ 2004 9 mikrogrammi HA **
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għal injezzjonijiet
Suspension for injection Pre-filled syringe with a Micro-Injection System (0.1 ml) - pack of 1 Pre-filled syringe with a Micro-Injection System (0.1 ml) - pack of 10 Pre-filled syringe with a Micro-Injection System (0.1 ml) - pack of 20
Suspensjoni għall- injezzjoni Siringa mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni (0. 1 ml) - pakkett ta ’ 1 Siringa mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni (0. 1 ml) - pakkett ta ’ 10 Siringa mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni (0. 1 ml) - pakkett ta ’ 20
Intradermal use.
Użu minn ġol- ġilda.
Sanofi Pasteur SA, 2, avenue Pont Pasteur F-69007 Lyon France
Sanofi Pasteur SA 2, avenue Pont Pasteur F- 69007 Lyon Franza
EU/ 0/ 00/ 000/ 000 - pack of 1 pre-filled syringe with a Micro-Injection System EU/ 0/ 00/ 000/ 000 - pack of 10 pre-filled syringes with a Micro-Injection System EU/ 0/ 00/ 000/ 000 - pack of 20 pre-filled syringes with a Micro-Injection System
EU/ 0/ 00/ 000/ 000 - pakkett ta ’ siringa mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni EU/ 0/ 00/ 000/ 000 - pakkett ta ’ 10 siringi mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni EU/ 0/ 00/ 000/ 000 - pakkett ta ’ 20 siringa mimlija għall- lest b’ Sistema ta ’ Mikro- Injezzjoni
Justification for not including Braille is accepted.
Il- ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata.
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA:
IDflu 15 microgram/ strain, suspension for injection Influenza vaccine (split virion, inactivated).
IDflu 15 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
STATEMENT OF ACTIVE SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
A/ New Caledonia/ 20/ 99 (H1N1) like strain (IVR-116) 15 micrograms HA**
Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (IVR- 116) 15 mikrogrammi HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (NYMC X-161) 15 micrograms HA**
Razza li tixbaħ lil A/ Wisconsin/ 67/ 2005 (H3N2) (NYMC X- 161) 15 mikrogrammi HA **
B/ Malaysia/ 2506/ 2004 like strain 15 micrograms HA**
Razza li tixbaħ lil B/ Malaysia/ 2506/ 2004 15 mikrogrammi HA **
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għal injezzjonijiet
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Pre-filled syringe label text
Kliem fuq it- tikketta tas- siringa mimlija għall- lest
IDflu 9 µg/ strain suspension for injection Influenza vaccine Strains 2006/ 2007 Intradermal use
IDflu 9 µg/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza Razez 2006/ 2007 Użu minn ġol- ġilda
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Strains 2006/ 2007 Intradermal use
IDflu 15 µg/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza Razez 2006/ 2007 Użu minn ġol- ġilda
29 PACKAGE LEAFLET:
29 FULJETT TA ’ TAGĦRIF:
IDflu 9 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
IDflu 9 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat)
Read all of this leaflet carefully before you receive this vaccine.
Aqra sew dan il- fuljett kollu qabel ma tirċievi dan il- vaċċin.
What IDflu is and what it is used for 2.
X’ inhu IDflu u għaliex jintuża 2.
Before you use IDflu 3.
Qabel ma tuża IDflu 3.
How to use IDflu 4.
Kif tuża IDflu 4.
How to store IDflu 6.
Kif taħżen IDflu 6.
WHAT IDflu IS AND WHAT IT IS USED FOR
X’ INHU IDflu U GĦALXIEX JINTUŻA
IDflu is a vaccine.
IDflu hu vaċċin.
This vaccine is recommended to help to protect you against flu.
Dan il- vaċċin hu rakkomandat biex jgħinek tipproteġi ruħek kontra l- influwenza.
The vaccine may be administered to adults up to 59 years of age, especially in those who run an increased risk of associated complications.
Il- vaċċin jista ’ jingħata lil adulti sa 59 sena speċjalment dawk li jkollhom żieda fir- riskju ta ’ komplikazzjonijiet assoċjati.
When an injection of IDflu is given, the immune system (body's natural defences) will develop protection against flu infection.
Meta tingħata injezzjoni ta ’ IDflu, is- sistema immuni (id- difiża naturali tal- ġisem) ser tiżviluppa protezzjoni kontra l- infezzjoni mill- influwenza.
IDflu will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
IDflu ser jgħin biex jipproteġik kontra t- tliet razez ta ’ virus li hemm fil- vaċċin, jew razez oħrajn li huma assoċjati mill- qrib magħhom.
Full effect of the vaccine is generally achieved 2-3 weeks after the vaccination.
L- effett sħiħ tat- vaċċin ġeneralment jinkiseb minn ħmistax sa tliet ġimgħat wara l- injezzjoni.
BEFORE YOU USE IDflu
QABEL MA TUŻA IDflu
Do not use IDflu
Tużax IDflu
- If you are allergic (hypersensitive) to:
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għas -:
The active substances, or any of the other ingredients of IDflu listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
Sustanzi attivi, jew kwalunkwe mill- ingredjenti ta ’ IDflu elenkati f’ sezzjoni 6 ta ’ dan il - fuljett fis- sezzjoni "AKTAR TAGĦRIF",
To eggs, chicken proteins, neomycin, formaldehyde and octoxinol 9.
Għall- bajd, proteini tat- tiġieġ, neomycin, formaldehyde u octoxinol 9.
- If you have an illness with fever or acute infection, the vaccination shall be postponed until after
- Jekk ikollok xi marda bid- deni jew infezzjoni akuta, it- tilqim ser jiġi pospost sakemm tkun fiqt.
Take special care with IDflu
Oqgħod attent ħafna b’ IDflu
- You should tell your doctor before vaccination if you have a poor immune response
- Għandek tgħid lit- tabib tiegħek qabel ma tieħu l- vaċċin jekk għandek rispons immuni batut
(immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
(immunosuppressjoni) minħabba mard jew mediċini, għax il- vaċċin jista ’ ma tantx jaħdem tajjeb f’ dan il- każ.
- IDflu should under no circumstances be administered into a vein (intravascularly).
- IDflu m’ għandu taħt l- ebda ċirkustanza jingħata ġol- vini (arterji).
- Children and adolescents:
- Tfal u adolexxenti:
IDflu is not recommended for use in children and adolescents below 18 years.
IDflu mhuwiex rakkomandat għall- użu fit- tfal jew fl- adolexxenti taħt it- 18- il sena.
- Other vaccines:
- Vaċċini oħrajn:
It
IDflu jista ’ jingħata fl- istess ħin ma ’ vaċċini oħrajn billi tagħtih
should be noted that the side effects may be intensified.
Wieħed għandu jinnota li l- effetti sekondarji jistgħu jiħraxu.
- Tell your doctor if you have been treated with medicines that may reduce your immune
- Għid it- tabib tiegħek jekk kont ikkurat b’ mediċini li jistgħu jnaqqsu r- rispons immuni tiegħek
response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
bħal kortikosterojdi (per eżempju cortisone), mediċini kontra l- kanċer (kimoterapija), radjuterapija jew mediċini oħrajn li jaffettwaw is- sistema immuni.
In this case, the vaccine may not work very well.
F’ dan il- każ, il- vaċċin jista ’ ma tantx jaħdem tajjeb.
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk inti tqila jew jekk taħseb li tista ’ tkun tqila.
Your doctor or pharmacist will be able to decide if you should receive IDflu.
It- tabib jew tal- ispiżjar tiegħek ser jiddeċiedu jekk għandekx tirċievi IDflu.
Ask your doctor or pharmacist for advice before taking any medicines.
Itlob il- parir tat- tabib jew tal- ispiżjar tiegħek qabel tieħu xi mediċina.
Driving and using machines
Sewqan u l- użu tal- magni
The vaccine is unlikely to affect your ability to drive or use machines.
X’ aktarx li l- vaċċin mhux ser jaffettwa l- ħila tiegħek li ssuq jew tħaddem il- magni.
HOW TO USE IDflu
KIF TUŻA IDflu
IDflu is administered to you by your doctor or nurse.
IDflu jingħatalek mit- tabib jew mill- infermiera tiegħek.
Adults from 18 to 59 of age receive one 0.1 ml dose.
Adulti minn 18 sa 59 sena jirċievu doża ta ’ 0. 1 ml dose.
IDflu is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).
IDflu jingħata bħala njezzjoni fis- saff ta ’ fuq tal- ġilda (preferibbilment ġol- muskolu tal- parti ta ’ fuq tad- driegħ).
Like all medicines, IDflu can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, IDflu jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
During clinical trials, the following side effects were reported with the use of IDflu.
Matul il- provi kliniċi, l- effetti sekondarji li ġejjin kienu rrappurtati bl- użu ta ’ IDflu.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza ta ’ effetti sekondarji li jista ’ jkun hemm, huwa deskritt hawn taħt, bdin il- konvenzjoni: komuni ħafna (li jaffettwaw iktar minn utent 1 minn kull 10) komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100) mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1000) rari (jaffettwaw minn 1 sa 10 utenti minn kull 10000) rari ħafna (jaffettwaw anqas minn utent kull 10000) mhux magħruf (ma tistax tittieħed stima tal- frekwenza mid- data disponibbli)
Common 31
31 Komuni ħafna
- Bruising at the injection site
- Fis- sit tal- injezzjoni: ħmura, nefħa, ebusija, ħakk u wġigħ.
- Shivering and fever (38.0°C or higher).
- Rogħda u deni (temperatura ta ’ 38. 0°C jew ogħla).
- Tiredness, swelling of the glands in the neck, armpit or groin, tingling or numbness, joint pain,
- Għeja, nefħa tal- glandoli tal- għonq, taħt id- dirgħajn jew l- irqiq ta ’ bejn il- koxxa u ż- żaqq,
itching and rash.
tnemnim jew tmewwit, uġigħ fil- ġogi, ħakk u raxx.
Rare • Increased sweating.
- Żieda fl- għaraq.
The following side effects have been reported with other influenza vaccines: • temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding • allergic reactions which can lead in rare cases:
L- effetti sekondarji li ġejjin kienu rrappurtati b’ vaċċini oħra ta ’ kontra l- influwenza: • tnaqqis temporanju fin- numru ta ’ partikuli tad- demm li jissejħu plejtlits li jista ’ jirriżulta fi tbenġil jew fsada • reazzjonijiet allerġiċi li jistgħu jwasslu f’ każijiet rari:
- to a failure of the circulatory system (shock) leading to medical emergency
- għal kollass tas- sistema ċirkolatorja (xokk) li jwassal għal emerġenza medika
- to swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe
- għal nefħa fil- wiċċ, ilsien jew farinġi, diffikultà biex tibla ’, urtikarja u diffikultajiet biex tieħu
(angioedema) • pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord, inflammation of nerves, or Guillain-Barré syndrome which causes extreme weakness and paralysis • vessel inflammation which may result in very rare cases in temporary kidney problems • skin reactions that may spread throughout the body including hives.
n- nifs (anġjodema) • uġigħ lokalizzat fir- rotta tan- nervaturi, konvulżjonijiet assoċjati ma ’ deni, disturbi tas- sistema nervuża li jinkludu infjammazzjoni tal- moħħ jew tas- sinsla, infjammazzjoni tan- nervaturi, jew is- sindrome ta ’ Guillain- Barré li jikkawża dgħjufija u paralisi estremi • infjammazzjoni tal- vini/ arterji li tista ’ tirriżulta f’ każijiet rari ħafna ta ’ problemi temporanji tal - kliewi. • reazzjonijiet tal- ġilda li jistgħu jinfirxu mal- ġisem kollu, li jinkludu l- urtikarja.
You should see your doctor immediately if you experience symptoms of angioedema, such as:
Għandek tara lit- tabib tiegħek immedjatament jekk ikollok sintomi ta ’ anġjoedema bħal: • wiċċ, xufftejn jew farinġi minfuħin • diffikultà biex tibla ’ • urtikarja u diffikultajiet biex tieħu n- nifs.
HOW TO STORE IDflu
KIF TAĦŻEN IDflu
Do not use IDflu after the expiry date which is stated on the carton after EXP.
Tużax IDflu wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara JIS.
Keep the syringe in the outer carton in order to protect from light.
Żomm is- siringa fil- kartuna ta ’ barra sabiex tilqa ’ mid - dawl.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni tal- ambjent.
What IDflu contains
X’ fih IDflu
The active substances are split Influenza virus*, inactivated, containing antigens equivalent to the following strains:
Is- sustanzi attivi huma virus * tal- influwenza maqsum *, inattivat, li fih antiġeni ekwivalenti għar- razez li ġejjin:
A/New Caledonia/20/99 (H1N1) like strain (A/New Caledonia/20/99 (IVR-116)) 9 micrograms HA**
Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (A/ New Caledonia/ 20/ 99 (IVR- 116)) 9 mikrogrammi HA **
32 A/Wisconsin/67/2005 (H3N2) like strain (A/Wisconsin/67/2005 (NYMC X-161)) 9 micrograms HA**
Razza li tixbaħ lil A/ Wisconsin/ 67/ 2005 (H3N2) (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 9 mikrogrammi HA **
B/ Malaysia/2506/2004 like strain (B/Malaysia/2506/2004) 9 micrograms HA**
Razza li tixbaħ lil B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004) 9 mikrogrammi HA **
Per 0.1 ml dose
Kull doża ta ’ 0. 1
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2006/2007 season.
Dan il- vaċċin hu konformi mar- rakkomandazzjonijiet tal- WHO (Emisferu tat- Tramuntana) u d - deċiżjoni tal- UE għall- istaġun 2006/ 2007.
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate potassium dihydrogen phosphate and water for injections.
Is- sustanzi l- oħra huma: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għal injezzjonijiet.
What IDflu looks like and contents of the pack
Id- dehra ta ’ IDflu u l- kontenuti tal- pakkett
The vaccine is a colourless and opalescent suspension.
Il- vaċċin hu suspensjoni bla kulur u opalexxenti.
IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in packs of 1, 10 or 20.
IDflu hu suspensjoni għall- injezzjoni f’ siringa mimlija għall- lest ta ’ 0. 1 ml b’ Sistema ta ’ Mikro - Injezzjoni f’ pakketti ta ’ 1, 10 jew 20.
Not all pack sizes may be marketed
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder and Manufacturer
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder:
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F - 69007 Lyon, Franza.
Sanofi Pasteur – Parc Industriel d’Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’Etoile – France
Sanofi Pasteur - Parc Industriel d’ Incarville - 27100 Val- de- Reuil - Franza Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’ Etoile - Franza
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 tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
This leaflet was last approved in {MM/YYYY}.
34 Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ ---------------------------------------------------------------------------------------------------------------------------
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website tal- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu / --------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine. • The vaccine should be allowed to reach room temperature before use. • The vaccine should not be used if foreign particles are present in the suspension. • It is not necessary to shake the vaccine before use. • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro- needle (1.5 mm) and a needle shielding system.
• Bħal vaċċini kollha li jistgħu jiġu injettati, il- kura u s- superviżjoni medika adattata għandhom dejjem ikunu disponibbli fil- pront f’ każ ta ’ avveniment anafilattiku wara l- għoti tal- vaċċin. • Il- vaċċin għandu jitħalla jilħaq it- temperatura tal- kamra qabel l- użu. • Il- vaċċin m’ għandux jintuża jekk ikun hemm il- frak fis- suspensjoni. • M’ hemmx bżonn iċċaqlaq il- vaċċin qabel l- użu. • Is- Sistema ta ’ Mikro- Injezzjoni għal injezzjoni minn ġol- ġilda tikkonsisti f’ siringa mimlija għall- lest b’ labra mikro (1. 5 mm) u sistema tal- protezzjoni tal- labra.
Micro-Injection System
35 Sistema ta ’ Mikro- Injezzjoni
Micro-needle
Pads tas -
Finger pads
Labra mikro
Plunger
subgħajn
Window
Planġer
Needle shield
Tieqa
Needle cap
Protezzjoni tal - labra Għatu tal - labra
35 INSTRUCTIONS FOR USE
36 STRUZZJONIJIET GĦALL- UŻU
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
Jekk jogħġbok aqra l- istruzzjonijiet 2 / ŻOMM IS- SISTEMA TA 'MIKRO- INJEZZJONI 1 / NEĦĦI L- GĦATU TAL- LABRA BEJN IS- SABA' L- KBIR U DAK TAN- NOFS
Hold the system by placing the thumb and middle finger only on the finger pads; the
Żomm is- sistema billi tpoġġi s- saba 'l- kbir u s- saba' tan- nofs biss fuq il- pads tas - subgħajn; is- saba 'l -
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER Remove the needle from the skin.
5 / ATTIVA L- PROTEZZJONI TAL- LABRA BILLI TAGĦFAS BIS- SAĦĦA FUQ IL- PLANĠER Neħħi l- labra minn ġol- ġilda.
Orient the needle away from you and others.
Dawwar il- labra lilhemm minnek u minn persuni oħrajn.
With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.
Bl- istess id, agħfas bis- saħħa ħafna bis- saba 'l- kbir fuq il- planġer biex tattiva l- protezzjoni tal- labra.
You hear a click and a shield comes out to cover the needle.
Ser tisma 'klikk u l- protezzjoni toħroġ biex tiksi l- labra.
Activated needle shield
L- injezzjoni tkun ikkunsidrata li rnexxiet kemm jekk il- preżenza ta 'ħakk sever tkun osservata jew le.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Attiva l- protezzjoni tal- labra F’ każ tal- preżenza ta ’ likwidu fil- post fejn tingħata l- injezzjoni wara l- għoti tal- vaċċin, il- vaċċin mhuwiex meħtieġ mill- ġdid.
See also section 3.
Ara wkoll sezzjoni 3.
HOW TO USE IDflu
KIF GĦANDEK TUŻA IDflu.
36 PACKAGE LEAFLET:
37 FULJETT TA ’ TAGĦRIF:
IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
IDflu 15 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat)
The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications.
Il- vaċċin jista ’ jingħata lil adulti l- fuq minn 60 sena speċjalment dawk li jkollhom żieda fir- riskju ta ’ komplikazzjonijiet assoċjati.
The active substances or any of the other ingredients of IDflu listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
Sustanzi attivi, jew kwalunkwe mill- ingredjenti ta ’ IDflu elenkati f’ sezzjoni 6 ta ’ dan il - fuljett fis- sezzjoni "AKTAR TAGĦRIF",
have an illness with fever or acute infection, the vaccination shall be postponed until after
- Jekk ikollok xi marda bid- deni jew infezzjoni akuta, it- tilquim ser jiġi pospost sakemm tkun
you have recovered.
fiqt.
- If, for any reason, you have a blood test within a few days following an influenza vaccination,
- Jekk, għal kwalunkwe raġuni, ikollok test tad- demm ftit jiem wara l- vaċċin kontra influwenza,
please tell your doctor.
jekk jogħġbok għid lit- tabib tiegħek.
Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.
Testijiet għall- HIV- 1, il- virus ta ’ l- epatite Ċ u HTLV- 1 jistgħu jkunu affettwati.
37 Using other medicines
Meta tuża mediċini oħra
This vaccine is intended for individuals 60 years of age and over.
Dan il- vaċċin huwa indikat għal adulti l- fuq minn 60 sena.
Therefore, this information is not applicable.
Għalhekk, din l- infomormazzjoni ma taplikax.
Individuals 60 years of age and over receive one 0.1 ml dose.
Adulti l- fuq minn 60 sena jirċievu doża ta ’ 0. 1 ml dose.
- At the injection site: redness, hardness, swelling, itching and pain.
- Fis- sit tal- injezzjoni: ħmura, ebusija, nefħa, ħakk u wġigħ.
- Headache and muscular pain.
- Uġigħ ta ’ ras u uġigħ muskolari.
Common
39 Komuni
- Bruising at the injection site
- Tbenġil fis- sit tal- injezzjoni
- Feeling generally unwell, fever (38.0°C or higher) and shivering.
- Sensazzjoni ġenerali li ma tħossokx tajjeb (temperatura ta ’ 38. 0°C jew ogħla) u rogħda.
38 Uncommon
Mhux komuni
- Tiredness, joint pain and increased sweating.
- Għeja, uġigħ fil- ġogi, żieda fl- għaraq.
- tingling or numbness, pain, loss of reflexes, paralysis on a nerve route, itching and rash.
- Tnemnim jew tmewwit, uġigħ, telf ta ’ riflessi, paralisi fuq rotta tan- nervaturi, ħakk u raxx.
The following side effects have been reported with other influenza vaccines: • temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin • allergic reactions which can lead in rare cases:
L- effetti sekondarji li ġejjin kienu rrappurtati b’ vaċċini oħra ta ’ kontra l- influwenza: • tnaqqis temporanju fin- numru ta ’ partikuli tad- demm li jissejħu plejtlits li jista ’ jirriżulta fi tbenġil jew fsada, nefħa temporanja tal- glandoli tal- għonq, taħt id- dirgħajn jew l- irqiq ta ’ bejn il- koxxa u ż- żaqq • reazzjonijiet allerġiċi li jistgħu jwasslu f’ każijiet rari:
A/New Caledonia/20/99 (H1N1) like strain (A/New Caledonia/20/99 (IVR-116)) 15 micrograms HA**
40 Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (A/ New Caledonia/ 20/ 99 (IVR- 116)) 15 mikrogrammi HA **
A/Wisconsin/67/2005 (H3N2) like strain (A/Wisconsin/67/2005 (NYMC X-161)) 15 micrograms HA**
Razza li tixbaħ lil A/ Wisconsin/ 67/ 2005 (H3N2) (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 15 mikrogrammi HA **
B/ Malaysia/2506/2004 like strain (B/Malaysia/2506/2004) 15 micrograms HA **
Razza li tixbaħ lil B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004) 15 mikrogrammi HA **
39 Per 0.1 ml dose
Kull doża ta ’ 0. 1
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Is- sustanzi l- oħra huma: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għal injezzjonijiet.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F -69007 Lyon, France.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F - 69007 Lyon, Franza.
Sanofi Pasteur - Parc Industriel d’Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’Etoile - France
Sanofi Pasteur - Parc Industriel d’ Incarville - 27100 Val- de- Reuil - Franza Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’ Etoile - Franza
Danmark Sanofi Pasteur MSD Tlf: +45 23 32 69 29
41 Danmark Sanofi Pasteur MSD Tlf: +45 23 32 69 29
This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ --------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website tal- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu / --------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine. • The vaccine should be allowed to reach room temperature before use. • The vaccine should not be used if foreign particles are present in the suspension. • It is not necessary to shake the vaccine before use. • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
42 • Bħal vaċċini kollha li jistgħu jiġu injettati, il- kura u s- superviżjoni medika adattata għandhom dejjem ikunu disponibbli fil- pront f’ każ ta ’ avveniment anafilattiku wara l- għoti tal- vaċċin. • Il- vaċċin għandu jitħalla jilħaq it- temperatura tal- kamra qabel l- użu. • Il- vaċċin m’ għandux jintuża jekk ikun hemm il- frak fis- suspensjoni. • M’ hemmx bżonn iċċaqlaq il- vaċċin qabel l- użu. • Is- Sistema ta ’ Mikro- Injezzjoni għal injezzjoni minn ġol- ġilda tikkonsisti f’ siringa mimlija għall- lest b’ labra mikro (1. 5 mm) u sistema tal- protezzjoni tal- labra.
41 Micro-Injection System
Sistema ta ’ Mikro- Injezzjoni
42 INSTRUCTIONS FOR USE
43 STRUZZJONIJIET GĦALL- UŻU
What is Imprida?
X' inhu Imprida?
Imprida is a medicine containing two active substances, amlodipine and valsartan.
Imprida huwa mediċina li fiha żewġ sustanzi attivi, amlodipina u valsartan.
What is Imprida used for?
Għal xiex jintuża Imprida?
Imprida is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
'Essenzjali' tfisser li l - pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
Imprida is not recommended for use in patients below 18 years of age.
Imprida mhuwiex rakomandat għall - użu f' pazjenti taħt l- età tat- 18- il sena.
How is Imprida used?
Kif jintuża Imprida?
Imprida is taken by mouth as one tablet once a day with some water, with or without food.
Imprida jittieħed mill- ħalq fi kwantità ta 'pillola waħda darba kuljum bi ftit ilma, fuq stonku vojt jew le.
The dose of Imprida to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Id- doża ta 'Imprida li għandha tintuża tiddependi mid- doża ta' amlodipina jew valsartan li l- pazjent kien qiegħed jieħu qabel.
Imprida should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).
Imprida għandu jintuża b' kawtela fil- pazjenti bi problemi fil- fwied jew disturbi minn ostruzzjoni biljari (problemi biex jeliminaw il- bili).
How does Imprida work?
Kif jaħdem Imprida?
Imprida contains two active substances, amlodipine and valsartan.
Imprida fih żewġ sustanzi attivi, amlodipina u valsartan.
How has Imprida been studied?
Kif ġie studjat Imprida?
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Imprida and people taking the separate medicines.
Barra minn dan il- kumpanija ppreżentat tagħrif li juri li l- livelli ta 'amlodipina u valsartan fid- demm kienu l- istess fil- pazjenti ttrattati b' Imprida u fil- pazjenti trattati biż- żewġ mediċini separatament.
What benefit has Imprida shown during the studies?
Liema benefiċċju wera Imprida waqt l- istudji li ġew imwettqa?
What is the risk associated with Imprida?
X' inhu r- riskju assoċjat ma 'Imprida?
The most common side effects with Imprida (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
L- effetti sekondarji l- aktar komuni b' Imprida (li dehru f' bejn pazjent 1 u 100 minn 100) huma wġigħ ta 'ras, nasofarinġite (infjammazzjoni ta' l- imnieħer u tal- gerżuma), influwenza, tipi varji ta 'edema (nefħa), għeja kbira, ħmura, astenija (debbolizza) u fwawar.
Imprida should not be used in patients who may be hypersensitive (allergic) to amlodipine or other medicines in the ‘ dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients.
Imprida ma għandux jintuża f' pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għall- amlodipina jew mediċini oħra tal- klassi tad - 'derivati diidropiridiniċi' (dihydropyridine derivatives), għal valsartan, jew għal kwalunkwe ingredjent ieħor.
Imprida should not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Imprida ma għandux jintuża wkoll fil- pazjenti bi problemi gravi fil- fwied, fil- kliewi jew biljari, jew fil- pazjenti li għaddejjin minn dijaliżi (teknika tat- tisfija tad- demm).
Why has Imprida been approved?
Għaliex ġie approvat Imprida?
The Committee for Medicinal Products for Human Use (CHMP) decided that Imprida’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Imprida huma ogħla mir- riskji tiegħu fit- trattament ta' l- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata adegwatament b' monoterapija abbażi ta 'amlodipina jew valsartan.
The Committee recommended that Imprida be given marketing authorisation.
Il- Kumitat irrakkomanda li Imprida jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Imprida:
Aktar tagħrif dwar Imprida:
The European Commission granted a marketing authorisation valid throughout the EU for Imprida to Novartis Europharm Limited on 17 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Imprida lil Novartis Europharm Limited fis- 17 ta 'Jannar 2007.
The full EPAR for Imprida can be found here.
L- EPAR sħiħ għal Imprida jista 'jiġi kkonsultat hawn.
Imprida 5 mg/ 80 mg film-coated tablets
Imprida 5 mg/ 80 mg pilloli miksija b’ rita
Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Imprida huwa indikat f’ pazjenti li jkollhom pressjoni għolja li ma tkunx kontrollata b’ terapija ta ’ amlodipine jew valsartan mogħtija waħidhom.
The recommended dose of Imprida is one tablet per day.
Id- doża ta ’ Imprida rakkomandata hija pillola waħda kuljum.
Imprida 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Imprida 5 mg/ 80 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 80 mg waħidhom.
Imprida can be used with or without food.
Imprida jista ’ jintuża ma ’ l- ikel jew mingħajr ikel.
It is recommended to take Imprida with some water.
Huwa rakkomandat li Imprida jittieħed ma ’ ftit ilma.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Imprida containing the same component doses.
Għall- konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/ kapsuli separati jistgħu jinqalbu għal Imprida li fihom l- istess dożi tal- komponenti.
Hepatic impairment Caution should be exercised when administering Imprida to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Indeboliment tal- fwied Għandha tintuża kawtela meta jingħata Imprida lill- pazjenti li jsofru minn indeboliment tal- fwied jew mard ta ’ imblokkar tal- marrara (ara sezzjoni 4. 4).
2 Children and adolescents Imprida is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Tfal u adolexxenti Imprida mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Imprida in placebo-controlled studies.
Pazjenti nieqsa mis- sodium u/ jew volum Pressjoni baxxa eċċessiva dehret f’ 0. 4% tal- pazjenti b’ pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b’ Imprida fi studji kontrollati bi plaċebo.
Correction of this condition prior to administration of Imprida or close medical supervision at the start of treatment is recommended.
Qabel tibda l- kura b’ Imprida huwa rakkomandat li din tiġi korretta jew inkella jkun hemm sorveljanza medika mill- qrib meta tibda l- kura.
If hypotension occurs with Imprida, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Jekk taqa ’ l- pressjoni b’ Imprida, il- pazjent għandu jitqiegħed mindud wiċċu ‘ l fuq u jekk ikun meħtieġ, jingħata infużjoni fil- vina b’ ilma bil- melħ.
Renal artery stenosis No data are available on the use of Imprida in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Imprida f’ pazjenti b’ stenożi bilaterali ta ’ l- arterji renali jew stenożi ta ’ kilwa waħda.
Kidney transplantation To date there is no experience of the safe use of Imprida in patients who have had a recent kidney transplantation.
Trapjant tal- kliewi Sa ’ llum għad m’ hemmx esperjenza bl- użu ta ’ Imprida f’ pazjenti li riċentement ħadu trapjant tal - kliewi.
Particular caution should be exercised when administering Imprida to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Għandha ssir attenzjoni partikolari meta Imprida jingħata lill - pazjenti li jsofru minn indeboliment ħafif jew moderat jew mard ta ’ imblokkar tal- marrara.
Renal impairment No dosage adjustment of Imprida is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
Imprida has not been studied in any patient population other than hypertension.
Imprida ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti oħrajn apparti dawk li jsofru minn pressjoni għolja.
Interactions common to the combination No drug interaction studies were performed with Imprida and other medicinal products.
Interazzjonijiet komuni għall- kombinazzjoni Ma sarux studji dwar nuqqas ta ’ qbil b’ Imprida u prodotti mediċinali oħrajn.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm kura b’ AIIRA kontinwata hija ikkunsidrata essenzjali, pazjenti li qed jippjanaw għal tqala għandhom jinqalbu għal kura alternattiva kontra l- pressjoni għolja li għandha profil ta ’
There is no experience on the use of Imprida in pregnant women.
M’ hemmx esperjenza bl- użu ta ’ Imprida waqt it- tqala.
The safety of Imprida has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Is- sigurtà ta ’ Imprida ġiet meqjusa f’ ħames studji kliniċi kontrollati b’ 5, 175 pazjent, li 2, 613 minnhom irċevew valsartan kombinat ma ’ amlodipine.
Cardiac disorders
6 Disturbi tal- qalb
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/ valsartan combination.
7 Il- medja ta ’ l- edima periferali li seħħet, meqjusa b’ mod ugwali fil- medda tad- dożi kollha kienet 5. 1% bil- kombinazzjoni amlodipine/ valsartan.
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Imprida as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- mediċina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Imprida ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqegħid fis- suq.
Symptoms There is no experience of overdose with Imprida.
Sintomi M’ hemmx esperjenza ta ’ doża eċċessiva b’ Imprida.
Clinically significant hypotension due to Imprida overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Meta taqa l- pressjoni b’ Imprida b’ mod li jkun hemm sintomi kliniċi, għandu jkun hemm support għall- qalb, inklużi monitoraġġ frekwenti tal- funzjoni tal- qalb u tas- sistema respiratorja, jittellgħu d- driegħ, u għandha ssir attenzjoni għall- volum ta ’ fluwidi li jiċċirkolaw u l- volum ta ’ awrina.
Imprida combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Imprida jikkombina żewġ sustanzi kontra l- pressjoni għolja ma ’ mekkaniżmi kumplimentari sabiex tkun kontrollata l- pressjoni tad- demm f’ pazjenti b’ pressjoni għolja naturali: amlodipine huwa membru ta ’ klassi li huma antagonisti ta ’ calcium u valsartan ta ’ klassi ta ’ mediċini li huma antagonisti ta angiotensin II.
Amlodipine The amlodipine component of Imprida inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipine Il- komponent amlodipine f’ Imprida jinibixxi id- dħul mill- membrana ta ’ joni ta ’ calcium fil- muskoli tal- qalb u tal- muskoli lixxi tal- vini.
As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/ dt or on
Hekk kif jiġri b’ mediċini oħra li jinblukkaw il- kanali tal- calcium, il- kejl emodinamiku tal- funzjoni tal - qalb waqt is- serħan u waqt l- eżerċizzju (jew mixi) f’ pazjenti b’ funzjoni ventrikulari normali kurati b’ amlodipine wrew b’ mod ġenerali żieda żgħira fl- indiċi kardijaku mingħajr influwenza sinifikanti fid- dP/ dt jew fil- pressjoni jew volum fil- ventrikolu tax- xellug fi tmiem id- dijastoli.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
9 Valsartan ma jaħdimx bħala impeditur ta ’ ACE, magħruf ukoll bħala kininase II, li jaqleb angiotensin I f’ angiotensin II u jkisser bradykinin.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Imprida once daily in two placebo-controlled trials.
Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Imprida darba kuljum f’ żewġ provi kontrollati bi plaċebo.
Imprida was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Imprida kien studjat ukoll fi studju active- controlled ta ’ 130 pazjent bi pressjoni għolja bil- pressjoni dijastolika ≥110 mmHg u < 120 mmHg.
In this study (baseline blood pressure 171/ 113 mmHg), an Imprida regimen of 5 mg/ 160 mg titrated to 10 mg/ 160 mg reduced sitting blood pressure by 36/ 29 mmHg as compared to 32/ 28 mmHg with a regimen of lisinopril/ hydrochlorothiazide 10 mg/ 12.5 mg titrated to 20 mg/ 12.5 mg.
F’ dan l- istudju (il- linja bażi tal- pressjoni tad- demm kienet 171/ 113 mmHg), b’ reġimen ta ’ Imprida ta ’ 5 mg/ 160 mg miżjuda għal 10 mg/ 160 mg naqqset il - pressjoni tad- demm ta ’ bilqiegħeda b’ 36/ 29 mmHg meta imqabbla ma ’ 32/ 28 mmHg b’ reġimen ta ’ lisinopril/ hydrochlorthiazide 10 mg/ 12. 5 mg miżjuda għal 20 mg/ 12. 5 mg.
In two long-term follow-up studies the effect of Imprida was maintained for over one year.
F’ żewġ studji follow- up fit- tul, l- effett ta ’ Imprida inżamm għal aktar minn sena waħda.
Abrupt withdrawal of Imprida has not been associated with a rapid increase in blood pressure.
Meta Imprida twaqqaf f’ daqqa, ma kienx hemm żieda f’ daqqa tal- pressjoni tad- demm.
In patients not adequately controlled on amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg may achieve blood pressure control similar to amlodipine 10 mg with less oedema.
10 F’ pazjenti li mhumiex kontrollati sew fuq amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg jista ’ jwassal għal kontroll tal- pressjoni tad- demm simili għal amlodipine 10 mg b’ anqas edima.
Age, gender and race did not influence the response to Imprida.
L- età, sess u r- razza ma kellhomx effett fuq ir- rispons għal Imprida.
Imprida has not been studied in any patient population other than hypertension.
Imprida ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti apparti dawk li jbatu minn pressjoni għolja.
Excretion:
11 Eskrezzjoni:
Amlodipine/ Valsartan Following oral administration of Imprida, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Amlodipine/ Valsartan Wara li Imprida jittieħed mill- ħalq, il- quċċata tal- konċentrazzjonijiet fil- plażma ta ’ valsartan u amlodipine jintlaħqu fi 3 u 6- 8 sigħat, rispettivament.
The rate and extent of absorption of Imprida are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Ir- rata u l- grad ta’ assorbiment ta ’ Imprida huma ekwivalenti għal bijodisponibilità ta ’ valsartan u amlodipine meta jingħataw bħala pilloli waħidhom.