qanastek/EMEA-V3 huggingface dataset:
If injected otherwise OPTISON bubbles will be destroyed.
Jekk jiġi injettat mod ieħor il- bżieżaq ta 'OPTISON jinqerdu.
- Immediately before injection a careful visual inspection of the syringe is mandatory in order to
- Eżatt qabel l- injezzjoni għandha bil- fors issir spezzjoni viżwali tas- siringa biex ikun aċċertat li
ensure complete suspension of the microspheres.
l- mikrosferi huma sospiżi għal kollox.
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution for injection should be injected at a rate of 1 ml/ s.
Eżatt wara l- injezzjoni ta 'OPTISON, 10 ml ta' sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall - injezzjoni jew glucose 50 mg/ ml (5%) soluzzjoni għall- injezzjoni għandhom jiġu injettati b' rata ta '1 ml/ s.
Alternately, the flushing may be performed by infusion.
Inkella, it- tlaħlieħ jista 'jsir b' infużjoni.
The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a “ to keep open” (TKO) rate.
Mbagħad is- sett ta 'l- infużjoni għandu jitwaħħal ma' vit ta 'bi tlieta u tinbeda infużjoni ġol- vina b' rata "biex jitħalla miftuħ ” (TKO).
Immediately after OPTISON injection, the intravenous infusion should be wide open until contrast begins to fade from the left ventricle.
Eżatt wara l- injezzjoni ta 'OPTISON l- infużjoni ġol- vina trid tkun miftuħa beraħ sakemm il- kuntrast jibda jiċċara mill- ventriklu tax- xellug.
The infusion should then be returned to a TKO rate.
L- infużjoni mbagħad trid terġa 'titpoġġa fuq ir- rata TKO.
7 GE Healthcare AS Nycoveien 1-2 P. O. BOX 4220 Nydalen NO-0401 OSLO, Norway
GE Healthcare AS Nycoveien 1- 2 P. O. BOX 4220 Nydalen NO- 0401 OSLO, Norveġja
18/ 05/ 1998 Date of latest renewal:
18/ 05/ 98
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
L- AWTORIZZAZZJONI
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Box 4220 Nydalen NO-0401 Oslo Norway
Box 4220 Nydalen NO- 0401 Oslo Norveġja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product Characteristics, 4.2)
Karatteristiċi tal- Prodott fil- Qosor, 4. 2)
The Marketing Authorisation Holder will continue to submit yearly Periodic Safety Update Reports (PSURs), unless otherwise specified by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ser ikompli jissottometti Rapporti Perjodiċi dwar l- Aġġornament tas- Sigurtà (PSURs) kull sena, ħlief jekk ikun speċifikat mod ieħor mis- CHMP.
OPTISON 0.19 mg/ ml dispersion for injection Perflutren-containing microspheres
OPTISON 0. 19 mg/ ml dispersjoni għall- injezzjoni Mikrosferi li fihom perflutren
Perflutren-containing microspheres 5 - 8 x 108, with a mean diameter range of 2.5 - 4.5 µm, equivalent to 0.19 mg perflutren gas per ml.
5 - 8 x 108 mikrosferi li fihom perflutren, b 'medja ta' dijametru fil- limiti ta 'bejn 2. 5 u 4. 5 µm, ekwivalenti għal 0. 19 mg gass ta' perflutren f’ kull ml.
Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Sustanzi mhux attivi: soluzzjoni ta 'l- albumina tal- bniedem, sodium chloride, N- acetyltryptophan, caprylic acid, sodium hydroxide u ilma għall- injezzjonijiet.
See the package leaflet for further information.
Ara l- fuljett fil- pakkett għal aktar tagħrif.
Ultrasound contrast medium.
Medjum għall- kuntrast għall- ultrasawnd.
Resuspend before use.
Erġa 'ħallat qabel l- użu.
Read the package leaflet before use.
Tinjettax arja fil- kunjett Aqra l- fuljett ta ’ tagħrif qabel l- użu.
For single use only.
. Għal użu ta 'darba.
Discard any unused portion.
Armi l- porzjonijiet mhux użati.
EXPIRY DATE
JIS [XX/ SSSS]
SPECIAL STORAGE CONDITIONS
13 Aħżen wieqaf fi friġġ.
GE Healthcare AS, Nycoveien 1-2, 0401 Oslo, Norway
GE Healthcare AS, Nycoveien 1- 2, 0401 Oslo, Norveġja
Lot:
< Lott > [numru]
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
please tell your doctor.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
What OPTISON is and what it is used for 2.
X’ inhu OPTISON u għalxiex jintuża 2.
Before you use OPTISON 3.
Qabel ma tuża OPTISON 3.
How to use OPTISON 4.
Kif għandek tuża OPTISON 4.
How to store OPTISON 6.
Kif taħżen OPTISON 6.
WHAT OPTISON IS AND WHAT IT IS USED FOR
X’ INHU OPTISON U GĦALXIEX JINTUŻA
OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during an echocardiography (a procedure where an image of the heart is obtained by using ultrasound).
OPTISON huwa sustanza biex ittejjeb il- kuntrast ultrasoniku li tgħin biex jinkisbu stampi iktar ċari (skan) tal- qalb waqt ekokardjografija (proċedura biex jittieħdu immaġni tal- qalb bl- ultrasound).
OPTISON improves the visualization of the inner cardiac walls in patients where the walls are difficult to see.
OPTISON itejjeb il- viżwalizzazzjoni tal- ħitan kardijaċi interni f’ pazjenti fejn ikun diffiċli li tara l - ħitan.
OPTISON contains microspheres (tiny gas bubbles) that after injection travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualise and asses the function of the heart.
OPTISON fih mikrosferi (bżieżaq tal- gass żgħar ħafna) li, wara l- injezzjoni, jivvjaġġaw minn ġol- vini sal- qalb u jimlew il- kompartimenti tax- xellug tal- qalb, u b’ hekk jippermettu lit- tabib biex jara u jassessja l - funzjoni tal- qalb.
BEFORE YOU USE OPTISON
QABEL MA TUŻA OPTISON
Do not use OPTISON
Tużax OPTISON:
- if you are allergic (hypersensitive) to perflutren or to any of the ingredients of OPTISON.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal perflutren jew sustanzi oħra ta ’ OPTISON.
- if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg).
- jekk għandek ipertensjoni qawwija fil- pulmun (pressjoni sistolika ta 'l- arterja tal- pulmun > 90 mm
Take special care with OPTISON
Oqgħod attent ħafna b’ OPTISON:
- if you have any known allergies.
- jekk għandek kwalunkwe allerġiji li taf bihom
- if you have a severe heart, lung, kidney or liver disease.
- jekk għandek mard serju tal- qalb, tal- pulmun, tal- kliewi jew tal- fwied.
The experience of OPTISON in severely ill
L- esperjenza dwar
patients is limited.
OPTISON f' pazjenti morda ħafna hi limitata
- if you have an artificial valve in your heart.
- jekk għandek valvola artifiċjali tal- qalb
- if you have acute severe inflammation or sepsis.
- jekk għandek infjammazzjoni qawwija akuta jew infezzjoni
- if you have a known blood clotting problem
- jekk għandek problema tad- demm li jagħqad malajr jew idum biex jagħqad
Your heart activity and rhythm will be monitored when you get OPTISON.
L- attività u r- ritmu ta ’ qalbek ser ikunu mmonitorjati meta tingħata OPTISON.
Efficacy and safety in patients below 18 years has not been studied.
Ma ġewx studjati l- effikaċja u s- sigurta` ta 'pazjenti ta ’ eta ’ iżgħar minn 18- il sena.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk
17 Pregnancy and breast-feeding The safety of OPTISON for use during human pregnancy has not been fully established.
17 mingħajr riċetta.
Therefore, the medicine should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the doctor.
Tqala u treddigħ Is- sigurtà ta ’ OPTISON għall- użu waqt it- tqala fil- bniedem ma ġietx stabbilita b’ mod sħiħ.
However, because OPTISON is based on human albumin (the main protein in our blood), it is highly unlikely that it will have any harmful effects in pregnancy.
Madankollu, minħabba li OPTISON hu bbażat fuq l- albumina umana (il- proteina ewlenija fid- demm tagħna), diffiċli ħafna li ser ikollu xi effetti li jagħmlu l- ħsara waqt it- tqala.
It is not known whether OPTISON passes into human milk.
Mhux magħruf jekk OPTISON jgħaddix fil- ħalib tal- omm.
Therefore, caution should be exercised when OPTISON is administered to nursing women.
Għalhekk, għandha tittieħed attenzjoni meta OPTISON jingħata lin- nisa li qed ireddgħu.
Driving and using machines No effects are known.
Sewqan u tħaddim ta ’ magni L- ebda effett mhu magħruf.
Important information about some of the ingredients of OPTISON This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ OPTISON Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodium (23 mg) f’ kull doża, i. e. hu essenzjalment ‘ sodium- free ’.
HOW TO USE OPTISON
KIF GĦANDEK TUŻA OPTISON
OPTISON should only be administered by doctors experienced in the field of diagnostic ultrasound imaging.
OPTISON għandu jingħata biss minn tobba b' esperjenza fil- qasam tal- viżjoni bl- ultrasawnd.
OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber.
OPTISON jingħata b' injezzjoni minn ġol- vina biex il- mikrosferi jkunu jistgħu jidħlu fil- kompartiment tal- qalb u jimlew kompartiment tal- qalb tax- xellug.
OPTISON is injected during the ultrasound examination in order to allow the doctor to assess the function of your heart.
OPTISON jiġi njettat waqt eżami bl- ultrasawnd biex it- tabib ikun jista ’ jevalwa l- funzjoni ta ’ qalbek.
The recommended dose is 0.5 ml - 3.0 ml per patient.
Id- doża rrakkomandata hija 0. 5 ml - 3. 0 ml għal kull pazjent.
This dose might be repeated if needed.
Ġeneralment, doża ta '3. 0 ml tkun biżżejjed, imma xi pazjenti jista` jkollhom bżonn doża ogħla jew tiġi ripetuta..
The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Doża ta '0. 5 - 3. 0 ml isservi għal bejn 2. 5 u 4. 5 minuti
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ ml solution for injection or glucose 50 mg/ ml solution for injection should be injected at a rate of 1 ml/ s to optimise the effect of the contrast agent.
Eżatt wara l- injezzjoni ta 'OPTISON, 10 ml ta' sodium chloride 0. 9 mg/ ml soluzzjoni għall- injezzjoni jew glucose 50 mg/ ml soluzzjoni għall- injezzjoni għandhom ikunu injettati b’ rata ta ’ 1 ml/ s biex ittejjeb l - effett tas- sustanza tal- kuntrast.
If you are given more OPTISON than you should Effects suspected to be due to overdose have not been reported.
Jekk tingħata aktar OPTISON milli suppost Ma ġewx irrapurtati effetti li jistgħu jkunu minħabba doża eċċessiva.
Like all medicines, OPTISON can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, OPTISON jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects to OPTISON are rare and usually not serious.
L- effetti sekondarji għal OPTISON huma rari u s- soltu ma jkunux serji.
In general the administration of human albumin has been associated with transient (non lasting)altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.
Ġeneralment, l- għoti ta 'l - albumina tal- bniedem ġie assoċjat ma' bidla fit- togħma li ma tibqax, dardir, fwawar, raxx, uġigħ ta 'ras, remettar, tkexkix ta ’ bard u deni.
Rare severe allergic reactions (anaphylaxis) have been associated with the administration of human albumin products.
F’ każijiet rari, reazzjonijiet allerġiċi severi (anafilassi) ġew assoċjati ma 'l- għoti ta' prodotti ta 'l- albumina tal- bniedem.
Reported side effects following the use of OPTISON:
Effetti sekondarji li ġew irrappurati wara l - użu ta 'OPTISON:
Common side effects (affects 1 to 10 users in 100): • Dysgeusia (altered taste) • Headache • Flushing (redness) • Warm sensation
Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100: • Dysgeusia (tibdil fis- sens tat- togħma) • Uġigħ ta ’ ras • Fwawar (ħmura) • Sensazzjoni ta ’ sħana
18 Uncommon side effects (affects 1 to 10 users in 1,000): • Eosinophilia (increased number of a type of white blood cells in the blood) • Dyspnoea (difficulty in breathing) • Chest pain
18 • Eosinofilja (żieda fin- numru ta ’ tip ta ’ ċelluli bojod tad- demm) • Dispnea (diffikultà biex tieħu n- nifs) • Uġigħ fis- sider
Rare side effects (affects 1 to 10 users in 10,000): • Tinnitus (noises in the ear) • Dizziness • Paraesthesia (tingling sensations)
Effetti sekondarji rari (jaffettwaw minn 1 sa 10 utenti minn kull 10, 000: • Tinnitus (żanżin fil- widnejn) • Sturdament • Parestesija (sensazzjoni ta ’ tnemnim)
Unknown frequency (side effects where frequency cannot be estimated from the available data): • Allergic type symptoms, for example, a severe allergic reaction or – shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria). • Visual disturbances
Frekwenza mhux magħrufa (effetti sekondarji fejn ma tistax tiġi stmata l- frekwenza mid- dejta disponibbli) • Sintomi ta ’ l- allerġija, per eżempju, reazzjoni allerġika severa jew xokk (anafilassi), nefħa tal - wiċċ (edema tal- wiċċ), fawra fuq il- ġilda bil- ħakk (urtikarja). • Disturbi tal- vista
HOW TO STORE OPTISON
KIF TAĦŻEN OPTISON
Do not use OPTISON after the expiry date which is stated on the label, after EXP.
Tużax OPTISON wara d- data ta ’ skadenza li tidher fuq it- tikketta wara JIS.
Store upright in a refrigerator (2°C -8°C).
Aħżen f’ pożizzjoni vertikali fi friġġ (2°C - 8°C).
Storage at room temperature (up to 25°C) for 1 day is acceptable.
Il- ħażna fit- temperatura tal- kamra (sa 25°C) għal jum wieħed hija aċċettabbli.
The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been penetrated.
Il- kontenut tal- kunjett ta 'OPTISON għandu jintuża fi żmien 30 minuta minn meta jittaqqab it- tapp tal - gomma.
What OPTISON contains
X’ fih OPTISON
- The active substance is perflutren-containing microspheres of heat treated human albumin 5-
- Is- sustanza attiva tikkonsisti f’ mikrosferi li fihom perflutren ta ’ albumina umana ttrattata bis -
8 x 108/ ml, suspended in human albumin solution 1%.
sħana 5- 8 x 108/ ml, bħala sospensjoni f’ soluzzjoni ta ’ albumina umana 1%.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg
Bejn wieħed u ieħor l- ammont ta ’ gass ta ’ perflutren f’ kull ml ta ’ OPTISON hu ta ’ 0. 19 mg
- The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid,
- Is- sustanzi l- oħra huma albumina umana, sodium chloride, N- acetyltryptophan, caprylic acid,
sodium hydroxide and water for injections.
sodium hydroxide u ilma għall- injezzjonijiet.
It is a clear solution with white microsphere layer on top.
Id- dehra ta ’ OPTISON u l- kontenuti tal- pakkett OPTISON hu dispersjoni għall- injezzjoni. bħala soluzzjoni ċara b’ saff ta ’ mikrosferi bojod fin- naħa ta ’ fuq.
The product is supplied as 1 vial of 3 ml and 5 vials of 3 ml.
Il- prodott hu fornut bħala kunjett 1 ta ’ 3 ml, u 5 kunjetti ta ’ 3 ml.
19 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
GE Healthcare AS Nycoveien 1-2, P. O. BOX 4220 Nydalen NO-0401 Oslo, Norway
GE Healthcare AS Nycoveien 1- 2, P. O. BOX 4220 Nydalen NO- 0401 Oslo, in- Norveġja
Č eská republika GE Healthcare SCE Handels GmbH Branch Office Czech Republic Vyskoč ilova 1422/ 1a CZ-140 28 Praha 4 Tel: + 420 224 446 179
Malta Česká republika GE Healthcare SCE Handels GmbH Branch Office Czech Republic Vyskočilova 1422/ 1a CZ- 140 28 Praha 4 Tel: + 420 224 446 179
Malta Pharma-Cos Ltd Triq C.
Pharma- Cos Ltd Triq C.
Danmark GE Healthcare A/ S Huginsvej 8 DK-3400 Hillerød Tlf: + 45 70 22 22 03
20 Danmark GE Healthcare A/ S Huginsvej 8 DK- 3400 Hillerød Tlf: + 45 70 22 22 03
GE Healthcare Handels GmbH Europlaza, Gebäude E Technologiestrasse 10 A-1120 Wien Tel: + 43 1 972 72-0
Österreich GE Healthcare Handels GmbH Europlaza, Gebäude E Technologiestrasse 10 A- 1120 Wien Tel: + 43 1 972 72- 0
Avda. de Europa, 22 – 2o Planta Parque Empresarial ” La Moraleja” E-28108 Alcobendas Madrid Tel: + 34 91 663 25 00
Avda. de Europa, 22 – 2o Planta Parque Empresarial ” La Moraleja ” E- 28108 Alcobendas Madrid Tel: + 34 91 663 25 00
Italia GE Healthcare Srl Via Galeno 36 I-20126 Milano Tel: + 39 02 26001 111
Via Galeno 36 I- 20126 Milano Tel: + 39 02 26001 111
Suomi/ Finland Oy GE Healthcare Bio-Sciences Ab Kuortaneenkatu 2 FIN-00510 Helsinki Puh/ Tel: + 35 810 394 11
Kuortaneenkatu 2 FIN- 00510 Helsinki Puh/ Tel: + 35 810 394 11
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss huwa maħsub għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa:
The recommended dose is 0.5 ml - 3.0 ml per patient.
Il- doża rrakkomandata hija 0. 5 ml - 3. 0 ml għal kull pazjent.
A dose of 3.0 ml is usually sufficient, but some patients may need higher doses.
Ġeneralment doża ta '3. 0 ml tkun biżżejjed, imma xi pazjenti jista' jkollhom bżonn dożi ogħla.
The total dose should not exceed 8.7 ml per patient.
Id- doża totali m' għandhiex tkun iktar minn 8. 7 ml għal kull pazjent.
The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
It- tul ta 'żmien li jkun hemm bżonn għal- viżjoni huwa 2. 5 - 4. 5 minuti għal doża ta' 0. 5 - 3. 0 ml.
Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking effects with the possibility of obscuring important information.
Uża l- iżgħar doża biex jiċċajpru l- kavitajiet billi dożi ikbar jipproduċu effetti li jimblukkaw l - immaġini bil- possibilita` li tinħeba informazzjoni importanti.
Vials are intended for single use only.
Il- kunjetti huma intenzjonati għal użu ta ’ darba.
Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded.
Ladarba it- tapp tal- gomma jittaqqab, il- prodott għandu jintuża fi żmien 30 sekonda u kull fdal tal- prodott li ma jiġix użat għandu jintrema.
Homogenous white suspension after resuspension.
OPTISAN, meta mhux imħallat mill- ġdid, għandu saff abjad ta 'mikrosferi fil- wiċċ tal- fażi likwida li għandha bżonn terġa' titħallat qabel tintuża. li jsir suspensjoni bajda omoġenja wara s- suspensjoni mill - ġdid.
- Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or
Ħalli l- kunjett jilħaq it- temperatura tal- kamra u spezzjona l- fażi likwida biex tara jekk hemmx xi
Attach a three-
- Daħħal kannula tal- plastik 20 G f' vina kbira antekubitali, preferibbilment fid- driegħ tal- lemin.
way stopcock to the cannula.
Waħħal vit ta 'bi tlieta mal- kannula.
material on stopper and vial surfaces.
ma jkunx hemm traċċi mat- tapp u l- ġnub tal- kunjett.
- OPTISON should be withdrawn with care into the syringe within 1 minute after resuspension.
- OPTISON għandu jinġibed bil- mod b' siringa fi żmien minuta mit- taħlit mill- ġdid.
- Resuspend the microspheres in the syringe immediately before injection by holding the syringe
Erġa 'ħallat il- mikrosferi fis- siringa eżatt qabel l- injezzjoni billi żżomm is- siringa minduda bejn
- Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate
- Injetta s- suspensjoni permezz tal- kannula tal- plastik, li ma tkunx iżgħar minn 20 G b' rata
of 1.0 ml/ s.
massima ta 'injezzjoni ta' 1. 0 ml/ s.
- Immediately before injection a careful visual inspection of the syringe is mandatory in order to
- Eżatt qabel l- injezzjoni għandha bil- fors issir ispezzjoni viżwali tas- siringa bein ikun aċċertat li
ensure complete resuspension of the microspheres.
l- mikrosferi huma sospiżi għal kollox.
Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution for injection should be injected at a rate of 1 ml/ s.
Eżatt wara l- injezzjoni ta 'OPTISON, 10 ml ta' sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall - injezzjoni jew glucose 50 mg/ ml (5%) soluzzjoni għall- injezzjoni għandhom jiġu injettati b' rata ta '1 ml/ s
Alternatively the flushing may be performed by infusion.
Inkella, it- tlaħlieħ jista 'jsir b' infużjoni.
The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a ” to keep open” (TKO) rate.
Mbagħad is- sett ta 'l- infużjoni għandu jitwaħħal ma' vit ta 'bi tlieta u tinbeda infużjoni ġol- vina b' rata "biex jitħalla miftuħ ” (TKO).
Immediately after OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the left ventricle.
Eżatt wara l- injezzjoni ta 'OPTISON l- infużjoni ġol- vina trid tkun miftuħa beraħ sakemm il- kuntrast jibda jiċċara mill- ventriklu tax- xellug.
What is Optisulin?
X' inhu Optisulin?
Optisulin is a clear solution for injection containing the active substance insulin glargine.
Optisulin huwa soluzzjoni ċara għal injezzjoni li fiha s- sustanza attiva insulina glargine.
It is supplied in vials or as cartridges.
Huwa disponibbli bħala kunjetti jew skrataċ.
What is Optisulin used for?
Għal xiex jintuża Optisulin?
Optisulin is used to treat adults, adolescents and children aged six years or older with diabetes mellitus, when they need insulin.
Optisulin jintuża biex għat- trattament ta 'adulti, adolexxenti u tfal minn sitt snin jew akbar li jabtu mid- dijabete mellitu, meta jkollhom bżonn l- insulina.
How is Optisulin used?
Kif jintuża Optisulin?
Optisulin is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder).
Optisulin jingħata permezz ta 'injezzjoni taħt il- ġilda addominali (żaqq), il- koxxa, jew fir- reġjun deltojde (spalla).
The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Il- punt ta 'l- injezzjoni għandu jinbidel ma' kull injezzjoni biex ikun evitat tibdil fil - ġilda (bħal tħaxxin) li jista 'jġiegħel lill- insulina ma taħdimx tajjeb daqs kemm mistenni.
The patient ’ s blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Il- glukożju fid- demm tal- pazjent (zokkor) għandu jkun ittestjat regolarment biex tinsab l- aktar doża baxxa effettiva.
Optisulin is given once daily at any time during the day provided that it is the same time each day.
Optisulin jingħata darba kuljum fi kwalunkwe ħin matul il- jum bil- kundizzjoni li dan isir dejjem fl - istess ħin tal- jum.
This should be in the evening when used in children.
Fit- tfal dan għandu jkun filgħaxija.
Optisulin can also be given together with anti-diabetes medicines taken by mouth in patients who have non-insulin-dependent diabetes (type 2 diabetes).
Optisulin jista 'jingħata wkoll flimkien ma' mediċini kontra d- dijabete mogħtijin mill- ħalq f' pazjenti li għandhom id- dijabete u li mhumiex dipendenti fuq l- insulina (dijabete tat- tip 2).
How does Optisulin work?
Kif jaħdem Optisulin?
Optisulin is a replacement insulin that is very similar to the insulin made by the pancreas.
Optisulin huwa insulina ta 'sostituzzjoni li hija simili għall- insulina magħmula mill- frixa (pankreas).
The active substance in Optisulin, insulin glargine, is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glargine.
Is- sustanza attiva f' Optisulin, insulina glargine, hija magħmula permezz ta 'metodu magħruf bħala' teknoloġija tad- DNA rikombinanti ': hija magħmula minn batterju li rċieva ġene (DNA), li jagħmlu kapaċi jipproduċi insulina glargine.
The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Il- bidla tfisser li hija assorbita aktar bil- mod u regolari mill- ġisem wara injezzjoni, u li għandha tul ta 'żmien ta' azzjoni itwal.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
L - insulina ta 'sostituzzjoni taġixxi bl- istess mod bħal insulina magħmula naturalment u tgħin il- glukożju jidħol fiċ- ċelluli mid- demm.
By controlling blood glucose levels, the symptoms and complications of diabetes are reduced.
Billi tikkontrolla l- livelli ta 'glukożju fid- demm, is- sintomi u l - kumplikazzjonijiet tad- dijabete jonqsu.
How has Optisulin been studied?
Kif ġie studjat Optisulin?
Optisulin was originally studied in 10 studies, in both type 1 and type 2 diabetes.
Optisulin kien oriġinarjament studjat f' 10 studji, kemm f' dijabete tat- tip 1 kif ukoll tat- tip 2.
A total of 2,106 patients received Optisulin in all trials combined.
Total ta '2, 106 pazjenti rċevew Optisulin fil- provi kollha kkombinati.
The main studies compared Optisulin given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day.
L- istudji ewlenin qabblu Optisulin mogħti darba kuljum fil- ħin ta 'qabel l- irqad ma' insulina tal- bniedem NPH (insulina b' azzjoni intermedja) mogħti darba jew darbtejn kuljum.
Injections of fast-acting insulin were also used at mealtimes.
L- injezzjonijiet ta 'l- insulina b' azzjoni immedjata ntużaw ukoll fil- ħinijiet ta' l- ikel.
In one study, patients with type 2 diabetes also received anti-diabetes medicines by mouth.
Fi studju wieħed, pazjenti b' dijabete tat- tip 2 irċevew oralment ukoll mediċini kontra d- dijabete.
Further studies were carried out to compare Optisulin and human insulin NPH in children and adolescents aged between five and 18 years, 200 of whom received Optisulin.
Saru aktar studji biex iqabblu Optisulin u insulina tal- bniedem NPH fi tfal u adolexxenti ta 'etajiet bejn ħamsa u 18- il sena, 200 minnhom irċevew Optisulin.
Studies were also carried out in nearly 1,400 adult patients with type 1 or type 2 diabetes to measure the effectiveness of Optisulin injected at any time during the day, compared with an evening injection.
Saru wkoll studji fi kważi 1, 400 pazjent b' dijabete tat- tip 1 u tat- tip 2 biex ikejlu l- effikaċja ta 'Optisulin injettat fi kwalunkwe ħin tal- jum, imqabbla ma' injezzjoni filgħaxija.
All of the studies measured the level of ‘ fasting’ blood glucose (measured after not eating for at least eight hours) or of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
L- istudji kollha kejlu l- livell ta 'glukożju fid- demm' fi stat ta 'sawm' (imkejjel wara li ma jittiħidx ikel għal ta 'l- inqas tmien sigħat) jew ta' sustanza fid- demm magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni fuq kemm ikun qiegħed jiġi kkontrollat tajjeb il- glukożju fid- demm.
What benefit has Optisulin shown during the studies?
X' benefiċċju wera Optisulin matul l- istudji mwettqa?
Optisulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin.
Optisulin wassal għal tnaqqis fil- livell ta 'HbA1c, u dan jindika li l- livelli tal- glukożju fid- demm kienu ġew ikkontrollati għal livell simili għal dak li jidher b' insulina tal- bniedem.
Optisulin was effective for both type 1 and type 2 diabetes.
Optisulin kien effikaċi kemm għad- dijabete tat- tip 1 kif ukoll għas- dijabete tat- tip 2.
However, there were too few children aged below six years to determine the medicine ’ s effectiveness in this group.
Madankollu, kien hemm ftit wisq tfal taħt l- età ta 'sitt snin biex tkun stabbilita l- effikaċja tal- mediċina f' dan il- grupp.
The effectiveness of Optisulin was seen regardless of the time of the injection.
L- effikaċja ta 'Optisulin dehret indipendentement mill- ħin ta' l- injezzjoni.
What is the risk associated with Optisulin?
X' inhu r- riskju assoċjat ma 'Optisulin?
The most common side effect seen with Optisulin (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
L- aktar effett sekondarju komuni b' Optisulin (li deher f' aktar minn pazjent 1 minn kull 10) huwa ipogliċemija (livelli baxxi ta 'glukożju fid- demm).
Reactions at the site of the injection (redness, pain, itching and swelling) have been seen more often in children than in adults.
Reazzjonijiet fil- punt ta 'l- injezzjoni (ħmura, uġigħ, ħakk u nefħa) dehru aktar ta' spiss fit- tfal milli fl- adulti.
For the full list of all side effects reported with Optisulin, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Optisulin, ara l- Fuljett ta' Tagħrif.
Optisulin should not be used in people who may be hypersensitive (allergic) to insulin glargine or to any of the other ingredients.
Optisulin m' għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal insulina glargine jew għal kwalunkwe mis- sustanzi attivi l- oħrajn.
Optisulin doses might also need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Dożi ta 'Optisulin jistgħu wkoll jeħtieġu li jiġu aġġustati meta mogħtijin ma' xi mediċini oħrajn li jista 'jkollhom effett fuq il- livelli ta' glukożju fid - demm.
The full list is available in the Package Leaflet.
Il- lista sħiħa tinsab fil- Fuljett ta 'Tagħrif.
Why has Optisulin been approved?
Għaliex ġie approvat Optisulin?
The Committee for Medicinal Products for Human Use (CHMP) decided that Optisulin’ s benefits are greater than its risks for the treatment of adults, adolescents and children of six years or above with diabetes mellitus, where treatment with insulin is required.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Optisulin huma akbar mir- riskji tiegħu għat- trattament ta' adulti, adolexxenti u tfal ta 'sitt snin jew aktar li jbatu mid- dijabete mellitu, fejn hija meħtieġa kura bl- insulina.
The Committee recommended that Optisulin be given marketing authorisation.
Il- Kumitat irrakkomanda li Optisulin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Optisulin:
Tagħrif ieħor dwar Optisulin:
The European Commission granted a marketing authorisation valid throughout the European Union for Optisulin to Sanofi-Aventis Deutschland GmbH on 27 June 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Optisulin lil Sanofi- Aventis Deutschland GmbH fis- 27 ta 'Ġunju 2000.
The marketing authorisation was renewed on 27 June 2005.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 27 ta 'Ġunju 2005.
The full EPAR for Optisulin is available here.
L- EPAR sħiħ għal Optisulin jiġi kkonsultat hawn.
EU Number EU/ 1/ 00/ 133/ 001 EU/ 1/ 00/ 133/ 002 EU/ 1/ 00/ 133/ 003 EU/ 1/ 00/ 133/ 004 EU/ 1/ 00/ 133/ 005
Numru ta ’ l- EU EU/ 1/ 00/ 133/ 001
Invented name Optisulin Optisulin Optisulin Optisulin Optisulin
Isem inventat Optisulin
Strength 100 Units/ ml 100 Units/ ml 100 Units/ ml 100 Units/ ml 100 Units/ ml
Qawwa 100 Unità / ml
Pharmaceutical Form Solution for injection in a vial Solution for injection in a vial Solution for injection in a vial Solution for injection in a vial Solution for injection in a cartridge
Għamla farmaċewtika Soluzzjoni għall- injezzjoni f ’ kunjett
Route of Administration Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
Mnejn jingħata Użu għal taħt il- ġilda
Packaging vial (glass) vial (glass) vial (glass) vial (glass) cartridge (glass)
Il- pakkett kunjett (ħġieġ)
Content 5 ml 5 ml 5 ml 5 ml 3 ml
Kontenut 5 ml
Package size 1 vial 2 vials 5 vials 10 vials 4 cartridges
Daqs tal- pakkett 1 kunjett
EU/ 1/ 00/ 133/ 006
EU/ 1/ 00/ 133/ 002
Solution for injection in a cartridge
Soluzzjoni għall- injezzjoni f ’ kunjett
Subcutaneous use
EU/ 1/ 00/ 133/ 003
cartridge (glass)
kunjett (ħġieġ)
3 ml
5 ml
5 cartridges
5 kunjetti
EU/ 1/ 00/ 133/ 007
EU/ 1/ 00/ 133/ 004
Optisulin 100 Units/ ml solution for injection in a vial
Optisulin 100 Unità / ml ta ’ soluzzjoni għall- injezzjoni fikunjett.
Each ml contains 100 Units insulin glargine (equivalent to 3.64 mg).
Kull ml fiha 100 Unità insulin glargine (ekwivalenti għal 3. 64 mg).
For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required.
Għat- trattament ta ’ diabetes mellitus fl- adulti, l- adoloxxenti u t- tfal ta ’ 6 snin u akbar, meta jkun meħtieġ it- trattament bl- insulina.
These units are exclusive to Optisulin and are not the same as IU or the units used to express the potency of other insulin analogues.
Dawn l- unitajiet huma esklussivi għal Optisulin u m’ humiex xorta bħal IU jew l- unitajiet użati biex ikunu espressi l- qawwa ta ’ insulini analogi oħra.
Optisulin contains insulin glargine an insulin analogue with a prolonged duration of action.
Optisulin fih insulin glargine, analogu ta ’ l- insulina li jaħdem fit- tul.
The dosage and timing of dose of Optisulin should be individually adjusted.
Id- dożaġġ u l- ħin meta tingħata d- doża ta ’ Optisulin għandu jkun imfassal skond l- individwu partikolari.
In patients with type 2 diabetes mellitus, Optisulin can also be given together with orally active antidiabetic medicinal products.
F’ pazjenti li għandhom id- diabetes mellitus tip 2, Optisulin jista ’ jingħata wkoll flimkien ma ’ prodotti mediċinali attivi mill- ħalq kontra d- dijabete.
In children efficacy and safety of Optisulin have only been demonstrated when given in the evening.
L- effikaċja u s- sigurtà ta ’ Optisulin fit- tfal intweriet biss meta ngħata filgħaxija.
Due to limited experience the efficacy and safety of Optisulin have not been demonstrated in children below the age of 6 years.
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Optisulin ma ntwerewx fi tfal taħt is- 6 snin.
Transition from other insulins to Optisulin
Il- bidla minn tipi oħrajn ta ’ insulina għal Optisulin
When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Optisulin, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast- acting insulin analogues or the dose of oral antidiabetic agents).
Meta ssir il- bidla minn reġimen ta ’ trattament b’ insulina li għandha effett intermedju jew twil, għal wieħed b’ Optisulin, bidla fid- doża bażi ta ’ l- insulina tista ’ tkun meħtieġa, u t- trattament fl- istess waqt kontra d- dijabete għandu mnejn ikollu bżonn ikun aġġustat (id- doża u l- ħin ta ’ insulini regolari u addizzjonali jew l- analogi ta ’ l- insulina li jaħdmu malajr, jew id- doża ta ’ sustanzi orali kontra d - dijabete).
2 To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Optisulin should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
2 Biex jitnaqqas ir- riskju ta ’ l- ipogliċemija matul il- lejl u filgħodu kmieni, il- pazjenti li qed jaqilbu s - sistema bażi tal- kura tagħhom b’ NPH insulin minn darbtejn kuljum, għall- sistema ta ’ kura b ’ Optisulin ta ’ darba kuljum, għandhom inaqqsu d- doża bażi ta ’ kuljum b’ 20% sa 30%, waqt l- ewwel ftit ġimgħat tat- trattament.
During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
F’ dawn l- ewwel ftit ġimgħat, it- tnaqqis irid ikun, almenu parzjalment, ikkumpensat b’ żieda fid- doża ta ’ l- insulina fil- ħin ta ’ l- ikel, u wara dan il- perijodu, is- sistema ta ’ kura trid tkun imfassla skond l- individwu.
As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Optisulin.
Kif jiġri b’ analogi oħra ta ’ insulina, il- pazjenti li qegħdin jieħdu dożi għoljin ta ’ insulina minħabba l - antikorpi kontra l- insulina umana, jista` jkollhom rispons aħjar għall- insulina b ’ Optisulin.
With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dosage regimen may become necessary.
Meta l- kontroll metaboliku jitjieb u tiżdied is- sensittività għall- insulina, aktar tibdil fis- sistema tad - dożaġġ jista ’ jkun meħtieġ.
Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo-or hyperglycaemia (see section 4.4).
Tibdil fid- doża jista ’ jkun meħtieġ, per eżempju, meta ssir bidla fil- piż tal - pazjent, jew fl- istil tal- ħajja tiegħu, jew bidla fil- ħin meta d- doża ta ’ insulina tittieħed, jew meta jseħħu xi ċirkostanzi oħra li jżidu s- suxxettibbiltà għall- ipogliċemija jew għall- ipergliċemija (ara sezzjoni 4. 4).
Optisulin is administered subcutaneously.
Optisulin jingħata b’ mod subkutanju.
Optisulin should not be administered intravenously.
Optisulin m’ għandhux jingħata fil- vina.
The prolonged duration of action of Optisulin is dependent on its injection into subcutaneous tissue.
L- effett fit- tul ta ’ Optisulin jiddependi fuq it- teħid b’ injezzjoni fit- tessut subkutanju.
Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
L- użu intravenuż tad- doża subkutanja tas- soltu tista ’ twassal għall - ipogliċemija severa.
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Optisulin.
M’ hemmx differenzi klinikament rilevanti fil- livelli ta ’ l- insulina jew dak tal- glukożju fis- seru tad - demm wara li jingħata Optisulin fit- tessut taż- żaqq, il- parti laterali ta ’ fuq tad- driegħ, jew fil- koxxa.
Injection sites must be rotated within a given injection area from one injection to the next.
Is- siti fejn isiru l- injezzjonijiet iridu jinbidlu, b’ sistema ta ’ tidwir, fiż- żona partikolari magħżula għalihom, minn titqiba waħda għall- oħra.
Optisulin must not be mixed with any other insulin or diluted.
Optisulin m’ għandux jitħallat ma ’ ebda insulina oħra u anqas jiġi dilwit.
Mixing or diluting can change its time/ action profile and mixing can cause precipitation.
Meta jitħallat jew jiġi dilwit jista ’ jinbidel il- profil tal- ħin jew l- effett, u t- taħlit jista ’ jikkawża l- formazzjoni ta ’ trab fin fis - sustanza likwida.
Due to limited experience the efficacy and safety of Optisulin could not be assessed in the following groups of patients: patients with impaired liver function or patients with moderate/ severe renal impairment (see section 4.4).
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Optisulin ma setgħux ikunu mistħarrġa f’ dawn il- gruppi ta ’ pazjenti: dawk li għandhom indeboliment fil- funzjoni epatika jew dawk il- pazjenti b’ indeboliment ta ’ grad moderat / sever fil- funzjoni renali (ara sezzjoni 4. 4).
Optisulin is not the insulin of choice for the treatment of diabetic ketoacidosis.
Optisulin mhux l- insulina adatta għat- trattament ta ’ ketoaċidożi tad- dijabete.
Safety and efficacy of Optisulin have been established in adolescents and children of 6 years and above.
Is- sigurtà u l- effikaċja ta ’ Optisulin intwerew fl- adoloxxenti u t- tfal ta ’ sitt snin u ’ l fuq.
Due to limited experience the efficacy and safety of Optisulin could not be assessed in children below 6 years of age, in patients with impaired liver function or in patients with moderate/ severe renal impairment (see section 4.2).
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Optisulin ma setgħux ikunu mistħarrġa fit- tfal, taħt is- 6 snin, f’ pazjenti li għandhom indeboliment fil- funzjoni epatika, u f’ pazjenti li għandhom indeboliment moderat / sever fil- funzjoni renali (ara sezzjoni 4. 2).
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
3 F’ pazjenti li għandhom indeboliment fil- funzjoni renali, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat- tnaqqis tal- metaboliżmu ta ’ l- insulina.
3 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom indeboliment sever fil- funzjoni epatika, il- ħtieġa għall- insulina tista ’ tonqos, dovuta għat- tnaqqis fil- ħila li jifforma l- glukożju minn molekuli li mhumiex karboidrati, u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ kontroll inadegwat taz- zokkor, jew fejn ikun hemm tendenza biex jiżviluppaw episodji ta ’ ipergliċemija jew ipogliċemija, jridu jkunu ikkunsidrati jekk il- pazjent hux isegwi l- iskema tat - trattament li ngħatatlu, is- siti ta ’ l- injezzjonijiet, il- metodu ta ’ kif qed tingħata l- injezzjoni, u l- fatturi rilevanti l- oħra kollha, qabel l- tibdil fid- doża tkun ikkunsidrata.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
F’ każijiet rari, il- preżenza ta ’ antikorpi għall- insulina jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ l- insulina biex tikkoreġi t- tendenza għall- iper - jew l- ipo- gliċemija.
Due to more sustained basal insulin supply with Optisulin, less nocturnal but more early morning hypoglycaemia can be expected.
Peress li Optisulin jipprovdi livell sostnut tal - bżonn bażiku ta ’ l- insulina, huwa mistenni li jkun hemm anqas possibbiltà ta ’ ipogliċemija matul il - lejl iżda aktar filgħodu kmieni.
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Kawtela speċjali trid tittieħed, u għandu jkun hemm ħarsien aktar strett tal- livell taz- zokkor fid- demm, f’ dawk il- pazjenti li għandhom dawn l- episodji ta ’ ipogliċemija li jistgħu jkunu ta ’ rilevanza klinika speċjali, bħal dawk il- pazjenti li għandhom djuq sinifikanti ta ’ l- arterji koronarji, jew dawk ta ’ l- arterji li qegħdin iwasslu d- demm għall- moħħ (ir- riskju ta ’ kumplikazzjonijiet kardijaċi jew ċerebrali dovuti għall- ipogliċemija), kif ukoll f’ dawk il- pazjenti li għandhom retinopatija proliferattiva, speċjalment meta mhix qed tkun ittrattata b’ photocoagulation (hemm ir- riskju t’ amaurosis temporanja wara l - ipogliċemija).
The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.
Is- sintomi ta ’ twissija ta ’ l- ipogliċemija jistgħu jinbidlu, ikunu anqas evidenti, jew neqsin f’ ċerti gruppi ta ’ pazjenti li qegħdin f’ riskju.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Ċirkostanzi bħal dawn jistgħu jirriżultaw f ’ ipogliċemija severa (u possibbilment telf mis- sensi) qabel ma ’ l- pazjent jinduna bl- ipogliċemija
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Il- fatturi li jżidu s- suxxettibbilità għall- ipogliċemija jeħtieġu monitoraġġ speċjali mill- qrib u għandu mnejn ikun meħtieġ tibdil fid- doża.
4 Intercurrent illness
Mard li jitfaċċa minn żmien għall- ieħor
In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet, testijiet ta ’ l- urina għall- preżenza tal- ketones huwa indikat, u ta ’ spiss huwa meħtieġ tibdil fid- doża ta ’ l- insulina.
A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Hemm numru ta ’ sustanzi li jeffettwaw il- metaboliżmu tal- glukożju u għandu mnejn ikun meħtieġ tibdil fid- doża ta ’ Insulin glargine.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Sustanzi li jistgħu jżidu l- effett tat- tnaqqis fil- livell tal- glukożju fid- demm, u jżidu r- riskju għall - iżvilupp ta ’ l- ipogliċemija, jinkludu sustanzi orali kontra d- dijabete, inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE), disopyramide, fibrati, fluoxetine, inibituri ta ’ monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates, u l- antibijotiċi sulphonamide.
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline) thyroid hormones, atypical antipsychotic medicinal products (e. g. clozapine and olanzapine) and protease inhibitors.
Sustanzi li jistgħu jnaqqsu l- effett tat- tnaqqis fil- livell tal- glukożju fid- demm jinkludu l- corticosteroids, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestogens, id- derivattivi ta ’ phenothiazine, somatropin, is- sustanzi simpatomimetiċi (e. ż. epinephrine [adrenaline], salbutamol u terbutaline), l- ormoni tat- tirojde, il- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine) u l- inibituri tal- protease.
Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Pentamidine jista ’ jġib l - ipogliċemija li xi minn daqqiet tista ’ tkun segwita b’ ipergliċemija.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Hekk ukoll, is- sinjali adrenerġiċi kontra l- kontroll jistgħu jitnaqqsu jew ikunu assenti taħt l- effetti ta ’ prodotti mediċinali simpatolitiċi bħall- imblokkaturi tar- reiċetturi beta, clonidine, guanethidine u reserpine.
Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available.
Tqala Għal insulin glargine m’ hemmx tagħrif kliniku minn studji kliniċi ikkontrollati dwar l- użu waqt it - tqala.
A limited number of exposed pregnancies from Post Marketing Surveillance indicate no adverse effects of insulin glargine on pregnancy or on the health of the foetus and newborn child.
Minn informazzjoni miġbura waqt il- perijodu ta ’ Sorveljanza, Wara li l- Prodott Mediċinali Tpoġġa Fuq is- Suq, ma kienx hemm effetti avversi f’ numru żgħir ta ’ nisa li kienu esposti għall - insulina glargine waqt it- tqala, kemm fuq it- tqala nfisha kif ukoll fuq is- saħħa tal- fetu u t- tarbija tat - twelid.
The use of Optisulin may be considered in pregnancy, if necessary.
L- użu ta ’ Optisulin waqt it- tqala jista ’ jkun ikkunsidrat, f’ każ ta ’ bżonn.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
5 Huwa essenzjali li pazjenti li kellhom id- dijabete minn qabel, jew għandhom id- dijabete ta ’ waqt it - tqala, li jżommu kontroll metaboliku tajjeb tul it- tqala.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Immedjatament wara t- twelid, il- ħtieġa għall- insulina tonqos malajr (b’ riskju akbar ta ’ ipogliċemija).
Careful monitoring of glucose control is essential.
Monitoraġġ bir - reqqa tal- livell taz- zokkor huwa essenzjali.
5 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem il- magni