qanastek/EMEA-V3 huggingface dataset:
Insuman Infusat 100 IU/ml solution for injection in a vial Insulin human
Insuman Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett Insulina umana
What Insuman Infusat is and what it is used for 2.
X’ inhu Insuman Infusat u għalxiex jintuża 2.
Before you use Insuman Infusat 3.
Qabel ma tuża Insuman Infusat 3.
How to use Insuman Infusat 4.
Kif għandek tuża Insuman Infusat 4.
How to store Insuman Infusat 6.
Kif taħżen Insuman Infusat 6.
WHAT INSUMAN INFUSAT IS AND WHAT IT IS USED FOR
X’ INHU INSUMAN INFUSAT U GĦALXIEX JINTUŻA
Insuman Infusat is a solution to be given under the skin.
Insuman Infusat huwa soluzzjoni biex tingħata fit- tessut ta ’ taħt il- ġilda.
The insulin contained in Insuman Infusat is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Infusat hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu.
Insuman Infusat is an insulin preparation with a rapid onset and short duration of action.
Insuman Infusat huwa preparat ta ’ l- insulina li jibda jaħdem malajr u jdum jaħdem għal żmien qasir.
Insuman Infusat must only be used in insulin pumps suitable for this insulin.
Insuman Infusat għandu jintuża biss f’ pompi ta ’ l- insulina adattati għal din l- insulina.
Insuman Infusat is used to reduce high blood sugar in patients with diabetes mellitus.
Insuman Infusat huwa użat biex inaqqas il- livell għoli taz- zokkor fid- demm fil- pazjenti bid- dijabete mellitus.
BEFORE YOU USE INSUMAN INFUSAT
QABEL MA TUŻA INSUMAN INFUSAT
Do not use Insuman Infusat
Tużax Insuman Infusat
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Infusat.
Jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insuman Infusat.
Do not use Insuman Infusat in peristaltic pumps with silicone tubing.
Tużax Insuman Infusat f’ pompi peristaltiċi b’ tubi tas- silikown.
Take special care with Insuman Infusat
Oqgħod attent ħafna b’ Insuman Infusat
777 Special patient groups
Gruppi speċjali ta ’ pazjenti
Travel
792 Safar
778
793
Using Insuman Infusat with food and drink
Meta tuża Insuman Infusat ma ’ l- ikel u max- xorb
However, there is no experience with the use of Insuman Infusat in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Insuman Infusat waqt it- tqala.
HOW TO USE INSUMAN INFUSAT
KIF GĦANDEK TUŻA INSUMAN INFUSAT
- determine how much Insuman Infusat per day you will need, how much of this is infused
- kemm għandek bżonn tieħu Insuman Infusat kuljum, kemm minnu jingħata bħala infuzzjoni
continuously ("basal rate") and how much and when you need additional insulin as an "insulin boost" ("bolus dose"),
kontinwa (“ rata bażika ”), u kemm u meta tinħtieġ insulina addizzjonali bħala “ boost t’ insulina ” (“ doża bolus ”)
- tell you when you may need to use a higher or lower dose of Insuman Infusat,
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Infusat,
Insuman Infusat has been developed for use in Hoechst Infusor and H-Tron.
Insuman Infusat kien żviluppat għall- użu ma ’ Hoechst Infusor u H- Tron.
Insuman Infusat must only be used if the solution is clear, colourless, with no solid particles visible, and has a water-like consistency.
Insuman Infusat għandu jintuża biss jekk is- soluzzjoni hija cara, mingħajr kulur, u bla ebda partikuli solidi u viżibbli, u jekk tixbaħ id- dehra ta ’ l- ilma.
Insuman Infusat must NOT be mixed with any other insulin preparations.
Insuman Infusat M’ GĦANDUX jitħallat ma ’ ebda preparazzjonijiet oħra ta ’ l- insulina.
If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe.
Jekk il- pompa mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ ġewwa siringa ta ’ l- injezzjoni.
Mistakes in dosage
795 Żbalji fid- dożaġġ
780 If you use more Insuman Infusat than you should
Jekk tuża Insuman Infusat aktar milli suppost
- If you have injected too much Insuman Infusat, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Infusat milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm
If you forget to use Insuman Infusat
Jekk tinsa tuża Insuman Infusat
- If you have missed a dose of Insuman Infusat or if you have not injected enough insulin, your
- Jekk qbiżt doża ta ’ Insuman Infusat jew jekk ma injettajtx biżżejjed insulina, il- livell
If you stop using Insuman Infusat This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insuman Infusat Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Insuman Infusat without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Insuman Infusat mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
Like all medicines, Insuman Infusat can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Insuman Infusat jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
796 Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
Changing the injection site with each injection may help to prevent such skin changes.
Bidla l fis- sit tal - injezzjoni ma ’ kull injezzjoni jgħin biex dawn il- bidliet fil- ġilda ma jiġrux. • Reazzjonijiet tal- ġilda u dawk allerġiċi.
781 • Skin and allergic reactions Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Reazzjonijiet oħrajn ħfief fis- sit ta ’ l- injezzjoni (bħal ħmura fis- sit ta ’ l- injezzjoni, uġigħ qawwi mhux tas- soltu fis- sit ta ’ l- injezzjoni wara li din tingħata, ħakk, nefħa jew infjammazzjoni post ta ’ l - injezzjoni), jistgħu jiġru..
HOW TO STORE INSUMAN INFUSAT
KIF TAĦŻEN INSUMAN INFUSAT
Do not use Insuman Infusat after the expiry date which is stated on the carton and on the label of the vial.
Tużax Insuman Infusat wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
Do not put Insuman Infusat next to the freezer compartment or a freezer pack.
Insuman Comb 50 m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża..
Once in the pump, Insuman Infusat may be kept for up to 2 weeks.
Ġaladarba fil- pompa, Insuman Infusat jista ’ jinżamm sa ġimgħatejn.
What Insuman Infusat contains
X’ fih Insuman Infusat
One ml of Insuman Infusat contains 100 IU (International
Millilitru wieħed ta ’ Insuman Infusat fih 100 IU (Unita
- The other ingredients are: phenol, zinc chloride, trometamol, poloxamer 171, glycerol, hydrochloric
- Is- sustanzi l- oħra huma: phenol, zinc chloride, trometamol, poloxamer 171, glycerol,
acid (for pH adjustment) and water for injections.
hydrochloric acid (għall- aġġustament tal- pH), u ilma għall- injezzjonijiet.
What Insuman Infusat looks like and contents of the pack Insuman Infusat is a clear, colourless solution for injection, with no solid particles visible, and of water-like consistency.
Id- Dehra ta ’ Insuman Infusat u l- kontenuti tal- pakkett Insuman Infusat huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
Insuman Infusat is supplied in vials contains 10 ml solution (1000 IU).
Insuman Infusat huwa fornut f’ kunjetti ta ’ 10 ml ta ’ soluzzjoni (1000 IU).
782 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ireland sanofi-aventis Ireland Ltd.
798 Ireland sanofi- aventis Ireland Ltd.
- your insulin pump does not work properly,
- int qiegħed tagħmel anqas eżerċizzju fiżiku mis- soltu, jew int qiegħed taħt stress (inkwiet,
Warning symptoms of hyperglycaemia
799 Sintomi ta ’ twissija ta ’ ipergliċemija
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
800 L- ewwel sintomi li jagħtuk indikazzjoni li ser tiżviluppa l- ipogliċemija (“ sintomi ta ’ twissija ”) jistgħu jinbidlu, jiddgħajfu jew ikunu nieqsin għal kollox, jekk:
786 PACKAGE LEAFLET:
801 FULJETT TA ’ TAGĦRIF:
Insuman Infusat 100 IU/ml solution for injection in a cartridge Insulin human
Insuman Infusat 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ Insulina umana
The insulin contained in Insuman Infusat is made by a biotechnology process and is identical with the body's own insulin.
L- insulina li hemm f’ Insuman Infusat hija magħmula bi proċess bijoteknoloġiku u hija identika għall- insulina li jagħmel il- ġisem innifsu (“ insulina umana ”).
If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Infusat.
Jekk int allerġiku/ a( tbati minn sensittività eċċessiva) għal- insulina jew għal xi waħda mis- sustanzi l - oħra ta ’ Insuman Infusat.
Special patient groups
802 Gruppi speċjali ta ’ pazjenti
787 Before travelling, consult your doctor.
Qabel tivvjaġġa kellem lit- tabib tiegħek.
3.
804 3.
- determine how much Insuman Infusat per day you will need, how much of this is infused
- jikkalkula kemm għandek bżonn tieħu Insuman Infusat kuljum, kemm minnu jingħata bħala
continuously ("basal rate") and how much and when you need additional insulin as an "insulin boost" ("bolus dose"),
infuzzjoni kontinwa (“ rata bażika ”), u kemm u meta tinħtieġ insulina addizzjonali bħala “ boost t’ insulina ” (“ doża bolus ”)
- tell you when you may need to use a higher or lower dose of Insuman Infusat.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Insuman Infusat,
789 Method of administration
Mod ta ’ kif jingħata
Insuman Infusat comes in cartridges designed for use in Hoechst Infusor and H-Tron.
Insuman Infusat huwa fornut f’ skartoċċi magħmulin għall- użu ma ’ Hoechst Infusor u H- Tron.
Special care before infusion
Attenzjoni speċjali qabel l- infużjoni
If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe.
805 Jekk il- pompa mhix taħdem sew, tista ’ tiġbed l- insulina mill- iskartoċċ ġewwa siringa ta ’ l- injezzjoni.
If you use more Insuman Infusat than you should
Jekk tuża Insuman Infusat aktar milli suppost
- If you have injected too much Insuman Infusat, your blood sugar level may become too low
- Jekk injettajt aktar Insuman Infusat, milli meħtieġ il- livell taz- zokkor tiegħek fid- demm
790 If you stop using Insuman Infusat This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Jekk tieqaf tuża Insuman Infusat Dan jista ’ jwassal għall- ipergliċemija severa (zokkor għoli ħafna fid- demm) u l- ketoaċidożi (jakkumula livell għoli t’ aċidu fid- demm għax il- ġisem qiegħed jutiliżża x- xaħam minflok iz- zokkor bħala sors t’ enerġija).
Do not stop Insuman Infusat without speaking to a doctor, who will tell you what needs to be done.
Twaqqafx Insuman Infusat mingħajr ma tkellem tabib, li mbagħad jgħidlek x’ għandu jsir.
Other side effects include • Systemic allergic reactions Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. • Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
806 Effetti sekondarji oħrajn jinkludu • Reazzjonijiet allerġiċi sistemiċi Simtomi assoċjati ma ’ reazzjonijiet tal- ġilda fuq skala kbira (raxx u ħakk mal- ġisem kollu), nefħa severa fil- membrana mukuża (anġioedema), qtugħ ta ’ nifs, tħarħir, taqa ’ l- pressjoni fid- demm, polz mgħaġġel jew tibda tegħreq. • Reazzjonijiet fl- għajnejn Bidla sostanzjali (titjib jew deterjorament) fil- kontroll taz- zokkor fid- demm tiegħek tista ’ tiddisturba il- vista tiegħek temporanjament.
Do not use Insuman Infusat after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Insuman Infusat wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l- iskartoċċ.
Do not put Insuman Infusat next to the freezer compartment or a freezer pack.
Insuman Infusat m’ għandux jitpoġġa viċin il - kompartiment tal- friża jew viċin xi pakkett tal- friża.
What Insuman Infusat looks like and contents of the pack Insuman Infusat is a clear, colourless solution for injection, with no solid particles visible, and of water-like consistency.
807 Id- Dehra ta ’ Insuman Infusat u l- kontenuti tal- pakkett Insuman Infusat huwa soluzzjoni għall- injezzjoni ċara, minghajr kulur, bla ebda partikuli solidi u viżibbli, u tixbaħ l- ilma.
Insuman Infusat is supplied in cartridges containing 3.15 ml solution (315 IU).Pack of 5 cartridges of 3.15 ml is available.
Issibu f’ pakkett ta ’ 5 skartoċċi ta ’ 3. 15 ml.
Ísland Vistor hf.
808 Ísland Vistor hf.
793 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
Why does hyperglycemia occur?
Għaliex isseħħ l- ipergliċemija?
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur.
809 Ittestja l- livell taz- zokkor fid- demm tiegħek u fl- awrina tiegħek għall- ketoni hekk kif iseħħ xi wieħed mis- sintomi t’ hawn fuq.
794
driegħ),
795
811
What is Intanza?
X’ inhu Intanza?
Intanza is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Intanza hu vaċċin li jiġi bħala sospensjoni għall- injezzjoni f' siringa mimlija minn qabel.
Intanza contains three different strains (types) of influenza virus (A/ New Caledonia/ 20/ 99, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
Intanza fih tliet tipi differenti ta ’ vajrus tal - influwenza (A/ New Caledonia/ 20/ 99, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
What is Intanza used for?
Għal xiex jintuża Intanza?
Intanza is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
Intanza jintuża fit- tilqim tal- adulti kontra l- influwenza, speċjalment dawk li jkollhom riskju ikbar li jiżviluppaw komplikazzjonijiet tal- marda.
How is Intanza used?
Kif jintuża Intanza?
Intanza is given as one ‘ intradermal’ injection into the upper layer of the skin, using a special micro-injection system.
Intanza jingħata bħala injezzjoni ‘ intradermali ’ fis- saff ta ’ fuq tal- ġilda bl- użu ta ’ sistema speċjali ta ’ mikroinjezzjoni.
How does Intanza work?
Kif jaħdem Intanza?
Intanza is a vaccine.
Intanza huwa vaċċin.
Intanza contains fragments from three different strains of flu virus.
Intanza fih frammenti minn tliet tipi differenti tal - vajrus tal- influwenza.
When a person is given the vaccine, the immune system recognises the virus fragments as ‘ foreign’ and makes antibodies against them.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf il- frammenti tal - vajrus bħala 'barranin' u tipproduċi antikorpi kontrihom.
These virus strains need to be included in Intanza before the vaccine can be used.
Dawn it- tipi tal- vajrus għandhom jiddaħħlu f’ Intanza qabel ma jista ’ jintuża l- vaċċin.
Intanza currently contains fragments of the virus strains that were expected to cause flu in the 2006/ 2007 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Bħalissa, Intanza fih frammenti tat- tipi tal- vajrus li kienu mistennija jikkawżaw l- influwenza fl- istaġun 2006/ 2007, skont ir - rakkomandazzjonijiet mill- WHO għall- emisfera tat- tramuntana u mill- Unjoni Ewropea (UE).
The virus strains in Intanza will need to be replaced again before the vaccine can be used in subsequent seasons.
Jeħtieġ li t- tipi tal- vajrus f' Intanza jiġu sostitwiti għal darb' oħra qabel ma jkun jista 'jintuża l- vaċċin fl- istaġuni sussegwenti.
How has Intanza been studied?
Kif ġie studjat Intanza?
The effects of Intanza were first tested in experimental models before being studied in humans.
L- effetti ta 'Intanza għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
Four studies involving over 8,000 people were carried out to study the effectiveness of Intanza in protecting against flu.
Twettqu erba ’ studji li kienu jinvolvu 8, 000 persuna sabiex tiġi eżaminata l- effikaċja ta ’ Intanza fil - prevenzjoni tal- influwenza.
The other two studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
Iż- żewġ studji l- oħra eżaminaw persuni minn 60 sena ’ l fuq, li tlaqqmu bil- qawwa ta ’ 15 mikrogramma.
In all of the studies, Intanza was compared with another flu vaccine given by injection into a muscle.
Fl- istudji kollha, Intanza tqabbel ma ’ vaċċin ieħor kontra l- influwenza li jingħata bħala injezzjoni fil - muskolu.
What benefit has Intanza shown during the studies?
X’ benefiċċji wera Intanza matul l- istudji mwettqa?
In all studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Fl- istudji kollha, kemm Intanza kif ukoll il- vaċċin ta ’ tqabbil kisbu livelli xierqa ta ’ antikorpi għall - protezzjoni kontra t- tliet tipi tal- vajrus tal- influwenza.
In adults below 60 years, the 9-microgram strength provided as good a level of protection as the intramuscular vaccine.
Fl- adulti ta ’ taħt is- 60 sena, il- qawwa ta ’ 9 mikrogrammi li tingħata tipprovdi livell ta ’ protezzjoni tajba daqs il- vaċċin intramuskolari.
In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the intramuscular vaccine.
Fil - persuni minn 60 sena u ’ l fuq, il- qawwa ta ’ 15– il mikrogramma li tingħata tipprovdi livell ta ’ protezzjoni tajba daqs il- vaċċin intramuskolari.
What is the risk associated with Intanza?
X’ inhu r- riskju assoċjat ma ’ Intanza?
The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), malaise (feeling unwell) and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
L- effetti sekondarji l- aktar komuni b’ Intanza (li dehru f' aktar minn pazjent 1 minn 10) huma wġigħ ta 'ras, mijalġija (uġigħ fil- muskoli), telqa mingħajr raġuni partikolari u reazzjonijiet fil- punt tal - injezzjoni (ħmura, nefħa, twebbis tal- ġilda, uġigħ u ħakk).
For the full list of all side effects reported with Intanza, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati ma ’ Intanza, ara l- Fuljett ta ’ Tagħrif.
Intanza should not be used in people who may be hypersensitive to the active substances, any of the other ingredients, egg, chicken protein, neomycin (an antibiotic), formaldehyde (a preservative) or octoxinol 9 (a detergent).
Intanza m’ għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi għas- sustanzi attivi, kwalunkwe mis- sustanzi l- oħra, bajd, proteina tat- tiġieġ, neomiċina (neomycin - antibijotiku), formaldehyde (priżervattiv) jew octoxinol 9 (deterġent).
Why has Intanza been approved?
Għaliex ġie approvat Intanza?
The Committee for Medicinal Products for Human Use (CHMP) decided that Intanza’ s benefits are greater than its risks for the prophylaxis of influenza in adults up to 59 years of age and in individuals 60 years of age and over, especially those who run an increased risk of associated complications.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Intanza huma ikbar mir- riskji tiegħu għall- profilassi tal- influwenza fl- adulti sal- età ta ’ 59 sena u individwi minn 60 sena u ’ l fuq, partikolarment dawk li qegħdin f’ riskju ikbar ta ’ komplikazzjonijiet assoċjati.
The Committee recommended that Intanza be given marketing authorisation.
Il- Kumitat irrakkomanda li Intanza jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Intanza:
Tagħrif ieħor dwar Intanza:
The European Commission granted a marketing authorisation valid throughout the EU for Intanza to Sanofi Pasteur MSD SNC on 24 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE, għal Intanza lil Sanofi Pasteur MSD SNC fi 24 ta ’ Frar 2009.
The full EPAR for Intanza can be found here.
L- EPAR sħiħ għal Intanza jista ’ jiġi kkonsultat hawn.
pre-filled syringe (glass)
siringa mimlija lesta għal l- użu (ħġieġ)
INTANZA 9 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
INTANZA 9 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
The use of INTANZA should be based on official recommendations.
L- użu ta ’ INTANZA għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.
INTANZA is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.
INTANZA mhuwiex rakkomandat għall- użu fit- tfal jew f ’ l- adolexxenti taħt it- 18- il minħabba li m’ hemmx data biżżejjed dwar is- sigurta ’ u l- effikaċja.
4.3 Contraindications 2 Hypersensitivity to the active substances, to any of the excipients, to egg, chicken proteins, neomycin, formaldehyde and octoxinol 9.
Sensittività eċċessiva għas- sustanzi attivi, jew għal xi sustanzi mhux attivi, għall- bajd, proteini tat - tiġieg, neomycin, formaldehyde u octoxinol 9.
INTANZA does not contain more than 0.05 microgram ovalbumin per dose.
INTANZA ma fihx aktar minn 0. 05 mikrogrammi ta ’ ovalbumin f’ kull doża.
INTANZA should under no circumstances be administered intravascularly.
INTANZA m’ għandu taħt l- ebda ċirkustanza jingħata ġol - vini / arteri.
INTANZA may be given at the same time as other vaccines.
INTANZA jista ’ jingħata fl- istess ħin ma ’ vaċċini oħrajn.
For INTANZA no clinical data on exposed pregnancies are available.
Għal INTANZA, m’ hemmx tagħrif kliniku dwar l- użu waqt tqala esposta.
One animal study with INTANZA did not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ fetal development, parturition or postnatal development.
Studju dwar INTANZA fuq l- annimali ma indika l- ebda effetti ta ’ ħsara diretti jew indiretti fir- rigward tat- tqala, l- iżvilupp embrijoniku/ fetali, tal- ħlas jew tal- iżvilupp wara t- twelid.
The use of INTANZA may be considered from the second trimester of pregnancy.
L- użu ta ’ INTANZA jista ’ jkun ikkunsidrat mit- tieni trimestru tat- tqala.
For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Għal nisa tqal b’ kundizzjonijiet mediċi li jżidu r- riskju tagħhom ta ’ kumplikazzjonijiet mill- influwenza, l- għoti tal - vaċċin hu rakkomandat, irrispettivament mill- istadju li fih tkun it- tqala tagħhom.
The vaccine INTANZA may be used during breast-feeding.
Il- vaċċin INTANZA jista ’ jintuża waqt it- treddigħ.
Adverse reactions observed from clinical trials
3 Reazzjonijiet avversi osservati mill- provi kliniċi
The safety of INTANZA has been assessed in 2 open-label randomised clinical trials in which 2,384 vaccinees received an injection of INTANZA.
Is- sigurtà ta ’ INTANZA kienet evalwata f’ 2 studji kliniċi open- label u randomised li fihom 2384 pazjent irċivew injezzjoni ta ’ INTANZA.
Systemic safety profile of INTANZA is similar to the comparator vaccine administered intramuscularly.
Il- profil tas- sigirtà sistemika ta ’ INTANZA hu simili għal dak tal- vaċċin komparatur mogħti ġol - muskoli.
After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
Wara injezzjonijiet li ngħataw ripetutament kull sena, il- profil tas- sigurtà ta ’ INTANZA hu simili għal dak ta ’ injezzjonijiet li ngħataw qabel.
There is no safety data from post-marketing experience with INTANZA.
M’ hemm l- ebda dejta dwar is- sigurtà mill- esperjenza ta ’ wara t- tqegħid fis- suq ta ’ INTANZA.
However, based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, systemic reactions, not listed above, may be reported:
4 Madankollu, ibbażat fuq l- esperjenza b’ vaċċini ta ’ kontra l- influwenza inattivati trivalenti mogħtija permezz ta ’ injezzjoni ġol- muskoli jew injezzjoni fonda taħt il- ġilda, reazzjonijiet sistemiċi, mhux elenkati hawn fuq, jistgħu jiġu rrappurtati:
Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema 4 Nervous system disorders Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Disturbi fis- sistema nervuża Newralġija, konvulżjonijiet bid- deni, disturbi newroloġiċi bħal enċefalomajelite, nevrite u s- sindrome ta ’ Guillain Barré
In a randomised comparative phase III trial, 1,796 subjects from 18 to 59 years of age received 0.1 ml of INTANZA by intradermal route and 453 subjects from 18 to 59 years of age received 0.5 ml of trivalent inactivated influenza vaccine administered by intramuscular route.
Fi studju komparattiv randomised ta ’ fażi III, 1796 persuna li kellhom minn 18 sa 59 sena, irċivew 0. 1 ml ta ’ INTANZA minn ġol- ġilda u 453 persuni minn 18 sa 59 sena irċivew 0. 5 ml ta ’ vaċċin ta ’ kontra l- influwenza inattivat trivalenti ġol- muskoli.
antibody
għar- razza Rata ta ’ seroprotezzjoni
A/ New Caledonia/ 20/ 99 N=1,296
A/ New Caledonia / 20/ 99 N=1296 87. 2%
A/ Wisconsin/ 67/ 2005 N=1,297
A/ Wisconsin / 67/ 2005 N=1297 93. 5%
B/ Malaysia/ 2506/ 2004 N=1,294
B/ Malaysia / 2506/ 2004 N=1294 72. 9%
INTANZA is as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 18 to 59 years of age.
INTANZA hu immunoġeniku daqs il- vaċċin komparatur ta ’ kontra l- influwenza inattivat trivalenti li jingħata ġol- muskoli għal kull waħda mit- 3 razez tal- influwenza f’ persuni ta ’ bejn 18 u 59 sena.
INTANZA 15 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
INTANZA 15 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
10 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substances, to any of the excipients, to egg, chicken proteins, neomycin, formaldehyde and octoxinol 9.
10 Sensittività eċċessiva għas- sustanzi attivi, jew għal xi sustanzi mhux attivi, għall- bajd, proteini tat - tiġieg, neomycin, formaldehyde u octoxinol 9.
The safety of INTANZA has been assessed in 2 open-label randomised clinical trials, 2,974 vaccinees received an injection of INTANZA.
Is- sigurtà ta ’ INTANZA kienet evalwata f’ 2 studji kliniċi open- label u randomised li fihom 2974 pazjent irċivew injezzjoni ta ’ INTANZA.
11 Most reactions resolved spontaneously within 1 to 3 days after onset.
Il- biċċa l- kbira tar- reazzjonijiet għaddew waħidhom fi żmien minn jum sa 3 ijiem wara li bdew.
Systemic safety profile of INTANZA is similar to the comparator vaccine administered intramuscularly.
11 Il- profil tas- sigirtà sistemika ta ’ INTANZA hu simili għal dak tal- vaċċin komparatur mogħti ġol - muskoli.
Local reactions: redness*, induration swelling, pruritus, pain
Reazzjonijiet Telqa, Rogħda, lokali: deni, ħmura *, ebusija, Reazzjonijiet nefħa, ħakk, lokali: uġigħ, ekkimożi
There is no safety data from post-marketing experience with INTANZA.
M’ hemm l- ebda dejta dwar is- sigurtà mill- esperjenza ta ’ wara tqegħid fis- suq ta ’ INTANZA.
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Fi studju pivotali randomised komparattiv ta ’ fażi III, 2606 persuna l- fuq minn 60 sena, irċivew 0. 1 ml ta ’ INTANZA minn ġol- ġilda u 1089 persuni l- fuq minn 60 sena irċivew 0. 5 ml ta ’ vaċċin ta ’ kontra l- influwenza inattivat trivalenti ġol- muskoli.
38.7 (36.8; 40.6) 3.97 (3.77; 4.18)
61. 3 (59. 3; 63. 1)
61.3 (59.3; 63.1) 8.19 (7.68; 8.74)
36. 4 (34. 5; 38. 3)
36.4 (34.5; 38.3) 3.61 (3.47; 3.76)
3. 61 (3. 47; 3. 76)
INTANZA is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
INTANZA hu mill- inqas immunoġeniku daqs il- vaċċini komparatur ta ’ kontra l- influwenza inattivat trivalenti li jingħata ġol- muskoli għal kull waħda mit- 3 razez tal- influwenza f’ persuni ta ’ 60 sena jew iżjed.
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/ dil) and 181.0 (1/ dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
13 Fuq il- medda tat- tliet razez kollha tal- influwenza, għall- vaċċin komparatur li jingħata ġol- muskoli, il - GMTs varjaw bejn 34. 8 (1/ dil) u 181. 0 (1/ dil, ir- rati tas- seroprotezzjoni varjaw bejn 48. 9% u 87. 9%, ir- rata tas- serokonverżjoni jew żieda sinifikanti varjaw bejn 30. 0% u 46. 9%, u l- GMTRs varjaw bejn 3. 04 u 5. 35 - darbiet fuq it- tajters HI fil- linja bażi.
The vaccine should be allowed to reach room temperature before use.
14 Il- vaċċin għandu jitħalla jilħaq it- temperatura tal- kamra qabel l- użu.
Please read the instruction before use
Jekk jogħġbok aqra l- istruzzjonijiet 2 / ŻOMM IS- SISTEMA TA 'MIKRO- INJEZZJONI 1 / NEĦĦI L- GĦATU TAL- LABRA
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
Neħħi l- għatu tal - labra mis - Sistema ta 'Mikro - Injezzjoni.
cap from the Micro-Injection System.
BEJN IS- SABA 'L- KBIR U DAK
Hold the system by placing the thumb and middle finger only on the finger pads; the
TAN- NOFS Żomm is- sistema billi tpoġġi s- saba 'l- kbir u s- saba' tan- nofs biss fuq il- pads tas - subgħajn; is- saba 'l -
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 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 1. 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.
INTANZA 9 microgram/ strain, suspension for injection Influenza vaccine (split virion, inactivated).
INTANZA 9 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
23 7.
23 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
INFORMAZZJONI BIL- BRAILLE 24 Il- ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata.
INTANZA 15 microgram/ strain, suspension for injection Influenza vaccine (split virion, inactivated).
INTANZA 15 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat).
Keep out of the reach and sight of children.
26 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
INTANZA 9 µg/ strain suspension for injection Influenza vaccine Strains 2006/ 2007 Intradermal use
INTANZA 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
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Strains 2006/ 2007 Intradermal use
INTANZA 15 µg/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza Razez 2006/ 2007 Użu minn ġol- ġilda
29 PACKAGE LEAFLET:
31 FULJETT TA ’ TAGĦRIF:
INTANZA 9 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
INTANZA 9 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat)
What INTANZA is and what it is used for 2.
X’ inhu INTANZA u għaliex jintuża 2.
Before you use INTANZA 3.
Qabel ma tuża INTANZA 3.
How to use INTANZA 4.
Kif tuża INTANZA 4.
How to store INTANZA 6.
Kif taħżen INTANZA 6.
WHAT INTANZA IS AND WHAT IT IS USED FOR
X’ INHU INTANZA U GĦALXIEX JINTUŻA
INTANZA is a vaccine.
INTANZA 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.
When an injection of INTANZA is given, the immune system (body's natural defences) will develop protection against flu infection.
Meta tingħata injezzjoni ta ’ INTANZA, is- sistema immuni (id- difiża naturali tal- ġisem) ser tiżviluppa protezzjoni kontra l- infezzjoni mill- influwenza.
INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
INTANZA ser jgħin biex jipproteġik kontra t- tliet razez ta ’ virus li hemm fil- vaċċin, jew razez oħrajn li huma assoċjati mill- qrib magħhom.
BEFORE YOU USE INTANZA
QABEL MA TUŻA INTANZA
Do not use INTANZA
Tużax INTANZA
The active substances, or any of the other ingredients of INTANZA listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
Sustanzi attivi, jew kwalunkwe mill- ingredjenti ta ’ INTANZA 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- tilqim ser jiġi pospost sakemm tkun fiqt.
Take special care with INTANZA
Oqgħod attent ħafna b’ INTANZA
- INTANZA should under no circumstances be administered into a vein (intravascularly).
- INTANZA m’ għandu taħt l- ebda ċirkustanza jingħata ġol- vini (arterji).
INTANZA is not recommended for use in children and adolescents below 18 years.
INTANZA mhuwiex rakkomandat għall- użu fit- tfal jew fl- adolexxenti taħt it- 18- il sena.
INTANZA can be given at the same time as other vaccines by using separate
INTANZA jista ’ jingħata fl- istess ħin ma ’ vaċċini oħrajn billi tagħtih
limbs.
f’ dirgħajn/ riġlejn differenti.
It should be noted that the side effects may be intensified.
Wieħed għandu jinnota li l- effetti sekondarji jistgħu jiħraxu.
Your doctor or pharmacist will be able to decide if you should receive INTANZA.
It- tabib jew tal- ispiżjar tiegħek ser jiddeċiedu jekk għandekx tirċievi INTANZA.
HOW TO USE INTANZA
KIF TUŻA INTANZA
INTANZA is administered to you by your doctor or nurse.
INTANZA jingħatalek mit- tabib jew mill- infermiera tiegħek.
INTANZA is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).
INTANZA jingħata bħala njezzjoni fis- saff ta ’ fuq tal- ġilda (preferibbilment ġol- muskolu tal- parti ta ’ fuq tad- driegħ).
Like all medicines, INTANZA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, INTANZA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
During clinical trials, the following side effects were reported with the use of INTANZA.
Matul il- provi kliniċi, l- effetti sekondarji li ġejjin kienu rrappurtati bl- użu ta ’ INTANZA.
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)
- At the injection site: redness, swelling, hardness, itching and pain.
- Fis- sit tal- injezzjoni: ħmura, nefħa, ebusija, ħakk u wġigħ.
- Feeling generally unwell, headache and muscular pain.
- Sensazzjoni ġenerali li ma tħossokx tajjeb, uġigħ ta ’ ras u uġigħ muskolari.
31 Common
Komuni
- Increased sweating.
- Żieda fl- għaraq.
HOW TO STORE INTANZA
KIF TAĦŻEN INTANZA
Do not use INTANZA after the expiry date which is stated on the carton after EXP.
Tużax INTANZA wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara JIS.
What INTANZA contains
X’ fih INTANZA
What INTANZA looks like and contents of the pack
Id- dehra ta ’ INTANZA u l- kontenuti tal- pakkett
INTANZA 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.
INTANZA 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.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France.
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F- 69007 Lyon, Franza.
Manufacturer: 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:
Česká republika Sanofi Pasteur Odd. vakcín Sanofi-aventis, s.r.o.
35 Česká republika Sanofi Pasteur Odd. vakcín Sanofi- aventis, s. r. o.
This leaflet was last approved in {MM/YYYY}.
36 Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
Micro-Injection System
37 Sistema ta ’ Mikro- Injezzjoni
Nedele shield
Tieqa
35 INSTRUCTIONS FOR USE
38 STRUZZJONIJIET GĦALL- UŻU
HOW TO USE INTANZA
KIF GĦANDEK TUŻA INTANZA.
36 PACKAGE LEAFLET:
39 FULJETT TA ’ TAGĦRIF:
INTANZA 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
INTANZA 15 mikrogrammi/ razza suspensjoni għall- injezzjoni Vaċċin ta ’ kontra l- influwenza (virion maqsum, inattivat)
The active substances or any of the other ingredients of INTANZA listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
Sustanzi attivi, jew kwalunkwe mill- ingredjenti ta ’ INTANZA elenkati f’ sezzjoni 6 ta ’ dan il- fuljett fis- sezzjoni "AKTAR TAGĦRIF",
Common
41 Komuni
The active substances are split Influenza virus*, inactivated, containing antigens equivalent to the following strains:
42 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)) 15 micrograms HA**
Razza li tixbaħ lil A/ New Caledonia/ 20/ 99 (H1N1) (A/ New Caledonia/ 20/ 99 (IVR- 116)) 15 mikrogrammi HA **
39 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 **
Česká republika Sanofi Pasteur Odd. vakcín Sanofi-aventis, s.r.o.
43 Česká republika Sanofi Pasteur Odd. vakcín Sanofi- aventis, s. r. o.
This leaflet was last approved in {MM/YYYY}.
44 Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
• 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.
42 INSTRUCTIONS FOR USE
45 STRUZZJONIJIET GĦALL- UŻU
What is INTEGRILIN?
X’ inhu INTEGRILIN?
INTEGRILIN exists as a solution for infusion and a solution for injection.
INTEGRILIN jiġi bħala soluzzjoni għall- infużjoni jew soluzzjoni għall- injezzjoni.
INTEGRILIN contains the active substance eptifibatide.
INTEGRILIN fih is- sustanza attiva eptifibatide.
What is INTEGRILIN used for?
Għal x’ hiex jintuża INTEGRILIN?
INTEGRILIN is used to prevent a myocardial infarction (heart attack) in adult patients who have unstable angina (chest pains due to narrowed arteries to heart) or already have had a non-Q-wave myocardial infarction (a type of heart attack), when the symptoms have been seen in the last 24 hours and they have abnormalities on their ECG or biological changes detected in the blood.
INTEGRILIN jintuża biex jimpedixxi infart mijokardijaku (attakk tal- qalb) f’ pazjenti adulti li għandhom anġina instabbli (uġigħ fis- sider minħabba arterji dojoq sejrin lejn il- qalb) jew li diġà kellhom infart mijokardijaku tat- tip non- Q- wave (tip ta ’ attakk tal- qalb), meta s- sintomi ħarġu fl- aħħar 24 siegħa u juru anormalitajiet fuq l- ECG jew bidliet bijoloġiċi osservati fid- demm.
It is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Huwa jingħata ma ’ l- aspirina u l- eparina mhux frazzjonata (mediċini oħra li jimpedixxu emboli).
The patients more likely to benefit from a treatment with INTEGRILIN are those who have had acute angina and may have a special type of surgery to clear up the arteries to the heart (percutaneous transluminal coronary angiography, or PTCA).
Il- pazjenti li għandhom iktar probabbiltà li jibbenefikaw minn trattament b’ INTEGRILIN huma dawk li għandhom anġina akuta u li jista ’ jkollhom tip ta ’ kirurġija speċjali biex tnaddaf l- arterji sejrin lejn il- qalb (anġjografija koronarja transluminali perkutaneja, jew PTCA).
How is INTEGRILIN used?
Kif jintuża INTEGRILIN?
INTEGRILIN should be given intravenously (into a vein) by a doctor who has experience in the management of heart conditions.
INTEGRILIN għandu jingħata minn ġol- vina minn tabib li għandu esperjenza fil- ġestjoni tal- kura tal - kundizzjonijiet tal- qalb.
The recommended dose is a single injection into a vein (180 microgram/ kg body weight) given as soon as possible after diagnosis.
Id- doża rrakkomandata hija injezzjoni waħda ġol- vina (180 mikrogramma/ kg piż tal- ġisem) mogħtija kemm jista ’ jkun malajr wara d- dijanjożi.
This is followed by a continuous infusion (drip into a vein) of 2.0 microgram/ kg/ min for up to 72 hours, until the start of surgery, or until discharge from the hospital (whichever occurs first).
Din hija segwita permezz ta ’ infużjoni kontinwa (dripp ġol- vina) ta ’ 2. 0 mikrogrammi/ kg/ min sa 72 siegħa, sakemm tibda l - kirurġija, jew sakemm il- pazjent jintbagħat mill- isptar (skond liema minnhom isseħħ l- ewwel).
Patients who have moderate problems with their kidneys should receive a dose of 1.0 microgram/ kg/ min during the continuous infusion.
Pazjenti li jkollhom problemi moderati bil- kliewi tagħhom għandhom jingħataw doża ta ’ 1. 0 mikrogram/ kg/ min waqt infużjoni kontinwa.
The medicine should not be used in patients with severe kidney problems.
Il- mediċina m’ għandhiex tintuża f’ pazjenti bi problemi serji tal- kliewi.
When the patient undergoes a percutaneous coronary intervention, then the treatment can be continued for up to 20-24 hours after surgery, to a maximum of 96 hours.
Meta l- pazjent jagħmel intervent perkutaneju koronarju, imbagħad it- trattament jista ’ jitkompla sa 20- 24 siegħa wara l- kirurġija, sa massimu ta ’ 96 siegħa.
How does INTEGRILIN work?
Kif jaħdem INTEGRILIN?
INTEGRILIN is an inhibitor of platelet aggregation.
INTEGRILIN huwa impeditur ta ’ l- aggregazzjoni tal- pjastrini.
This means that it helps to prevent blood clots from forming.
Dan ifisser li huwa jgħin biex jimpedixxi li jifformaw emboli.
Eptifibatide, the active substance in INTEGRILIN, stops the platelets aggregating by blocking the special protein on their surface that contributes to making them sticky (glycoprotein IIb/ III).
Eptifibatide, is- sustanza attiva f’ INTEGRILIN, twaqqaf lill- pjastrini milli jaggregaw billi timblokka l- proteina speċjali fuq il- wiċċ tagħhom li tikkontiribwixxi sabiex tagħmilhom iwaħħlu (glycoprotein IIb/ III).
INTEGRILIN greatly reduces the risk of a blood clot forming and helps prevent another heart attack.
INTEGRELIN inaqqas bil- bosta r- riskju li jifforma embolu u dan jgħin biex jimpedixxi attakk tal- qalb ieħor.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has INTEGRILIN been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat INTEGRILIN?
The effectiveness of INTEGRILIN was studied in a large clinical trial, PURSUIT (11,000 patients), where INTEGRILIN was compared with placebo (dummy treatment) in hospital patients who had signs that they may soon develop a heart attack, or who already had a small heart attack.
L- effikaċja ta ’ INTEGRELIN ġiet studjata fi prova klinika kbira, PURSUIT (11, 000 pazjent) fejn INTEGRELIN tqabbel ma ’ plaċebo (trattament finta) f’ pazjenti fl- isptar li kellhom sinjali li dalwaqt jistgħu jiżviluppaw attakk tal- qalb, jew li diġà kellhom attakk tal- qalb żgħir.
Another study, ESPRIT, compared INTEGRILIN with a placebo in 2,000 patients who were having PTCA to remove a blood clot from the coronary arteries and insert a stent (a short tube that remains in the artery to stop it closing).
Studju ieħor, ESPRIT, qabbel INTREGRILIN ma ’ plaċebo f’ 2000 pazjent li kien qed ikollhom PTCA biex jitneħħa embolu mill- arterji koronarji u biex jiddaħħlilhom stent (tubu qasir li jibqa ’ fl- arterja biex iwaqqafha milli tingħalaq).
In both studies, patients also received other medicines to prevent blood clotting.
Fiż- żewġ studji, il- pazjenti ngħataw ukoll mediċini oħra li jimpedixxu li d- demm jagħqad.
What benefit has INTEGRILIN shown during the studies?
X’ benefiċċji wera INTEGRILIN minn dawn l- istudji?
In the PURSUIT trial, INTEGRILIN was more effective than placebo in preventing death or further heart attacks during the 30 days after it was given.
Fil- prova PURSUIT, INTEGRILIN kien aktar effettiv mill- plaċebo fil- prevenzjoni ta ’ mewta jew ta ’ aktar attakki tal- qalb waqt it- 30 jum ta ’ wara li jkun ingħata.