qanastek/EMEA-V3 huggingface dataset:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8oC.
Stabilità kimika u fiżika waqt l- użu ġiet murija għal 24 siegħa f’ temperatura ta ’ 2 - 8oC.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25oC.
Stabilità kimika u fiżika waqt l- użu ġiet murija għal 24 siegħa f’ temperatura ta ’ 25oC.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8 oC, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax mill- ewwel, iż- żminijiet tal- ħażna u l- kundizzjonijiet effettivi qabel l- użu huma fir- responsabilità ta ’ min jużah u normalment ma jkunux itwal minn 24 siegħa f’ temperatura ta ’ 2 – 8 oC, sakemm ir - rikostituzzjoni/ dilwizzjoni ma tkunx saret f’ kundizzjonijiet asettiċi kkontrollati u validati.
Lyophilised powder:
Trab lajofilizzat:
Store in a refrigerator (2 – 8oC).
Aħżen fi friġġ (2 – 8oC).
16 Diluted solution:
Soluzzjoni dilwita:
Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl rubber stopper and sealed with a crimped aluminum seal.
Angiox huwa fornut bħala trab lajofilizzat f’ kunjetti tal- ħġieġ (Tip I) ta ’ 10 ml li jintużaw darba biss magħluqin b’ tapp tal- lastku butyl u ssiġillati b’ siġill ta ’ l- aluminju.
Angiox is available in packs of 2 and 10 vials.
Angiox huwa disponibbli f’ pakketti ta ’ 2 u 10 kunjetti.
6.6 Special precautions for disposal and other handling
16 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Instructions for administration
Struzzjonijiet dwar kif jingħata
Aseptic procedures should be used for the preparation and administration of Angiox.
Għandhom jintużaw proċeduri asettiċi għall- preparazzjoni u l- għoti ta ’ Angiox.
Add 5ml sterile water for injections to one vial of Angiox and swirl gently until completely dissolved and the solution is clear.
Żid 5ml ta ’ ilma sterili għall- injezzjonijiet ma ’ kunjett wieħed ta ’ Angiox u dawwar b’ mod ġentili sakemm jinħall għalkollox u s- soluzzjoni tkun ċara.
Withdraw 5ml from the vial, and further dilute in a total volume of 50ml of glucose solution for injection 5%, or sodium chloride 9mg/ ml (0.9%) solution for injection to give a final bivalirudin concentration of 5mg/ ml.
Iġbed 5ml mill- kunjett, u kompli ddilwa f’ volum totali ta ’ 50 ml ta ’ soluzzjoni għal injezzjoni ta ’ glucose 5%, jew soluzzjoni għal injezzjoni ta ’ sodium chloride 9mg/ ml (0. 9%) biex tagħti konċentrazzjoni finali ta ’ bivalirudin ta ’ 5mg/ ml.
The reconstituted/ diluted solution should be inspected visually for particulate matter and discolouration.
Is- soluzzjoni rikostitwita/ dilwita għandha tiġi eżaminata viżwalment għal frak u telf tal- kulur.
Solutions containing particulate matter should not be used.
Soluzzjonijiet li jkun fihom il- frak m’ għandhomx jintużaw.
The reconstituted/ diluted solution will be a clear to slightly opalescent, colourless to slightly yellow solution.
Is- soluzzjoni rikostitwita/ dilwita tkun soluzzjoni ċara għal daqsxejn opalexxenti, bla kulur għal daqsxejn fl- isfar.
The Medicines Company UK Ltd 115L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM
The Medicines Company UK Ltd 115L Milton Park Abingdon Oxfordshire OX14 4SA IR- RENJU UNIT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
18 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Hälsa Pharma GmbH, Immermannstraße 9, 33619 Bielefeld, GERMANY
Hälsa Pharma GmbH, Immermannstraße 9, 33619 Bielefeld, Germanja
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Ġestjoni tar- Riskji Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqhom fil- verżjoni 4 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP li jkun sar qbil fuqu mill- CHMP.
In addition, an updated RMP should be submitted;
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat;
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone reached
Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, fuq il- Pjan tal- Farmakoviġilanza jew fuq l- attivitajiet ta ’ minimizzazzjoni tar- riskji Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) Fuq talba ta ’ l- EMEA
Outer carton (pack of 2 vials).
Kartuna ta ’ barra (pakkett ta ’ 2 kunjetti).
Angiox 250 mg powder for concentrate for solution for injection or infusion. bivalirudin
Angiox 250 mg trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni. bivalirudin
1 vial contains 250 mg bivalirudin.
Kunjett wieħed fih 250 mg bivalirudin.
After dilution 1ml contains 5 mg bivalirudin.
Wara dilwizzjoni 1 ml ikun fih 5 mg bivalirudin.
Mannitol, sodium hydroxide 2%.
Mannitol, sodium hydroxide 2%.
Powder for concentrate for solution for injection or infusion.
Trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni.
2 vials.
2 kunjetti.
Outer carton (pack of 10 vials).
Kartuna ta ’ barra (pakkett ta ’ 10 kunjetti)
10 vials.
10 kunjetti.
Angiox 250 mg powder for concentrate for solution for injection or infusion Intravenous use bivalirudin
Angiox 250 mg trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni Użu għal ġol- vini bivalirudin
INFORMATION FOR THE USER Angiox 250 mg powder for concentrate for solution for injection and infusion bivalirudin
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Angiox 250 mg trab għal konċentrat għal soluzzjoni għal injezzjoni u infużjoni bivalirudin
- If you have further questions, ask your doctor.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Tista ’ tagħmlilhom
please tell your doctor.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Angiox is and what it is used for 2.
X’ inhu Angiox u għalxiex jintuża 2.
Before you are given Angiox 3.
Qabel ma tuża Angiox 3.
How Angiox is used 4.
Kif għandek tuża Angiox 4.
How to store Angiox 6.
Kif taħżen Angiox 6.
WHAT ANGIOX IS AND WHAT IT IS USED FOR
X’ INHU ANGIOX U GĦALXIEX JINTUŻA
Angiox is an antithrombotic medicine.
Angiox huwa mediċina anti- trombotika.
Antithrombotics are medicines which prevent the formation of blood clots (thrombosis).
L- anti- trombotiċi huma mediċina li jimpedixxu l- formazzjoni ta ’ għoqod tad- demm (trombożi).
Angiox is used to treat patients:
Angiox jintuża biex jittratta pazjenti:
• with chest pain due to heart disease (acute coronary syndromes - ACS) • who are having surgery to treat blockages in their blood vessels (angioplasty and/or percutaneous coronary intervention - PCI).
li għandhom uġigħ fis- sider minħabba mard tal- qalb (sindromi koronarji akuti - ACS) • li jkunu qed jagħmlu kirurġija sabiex jittrattaw imblokku fil- vażi tad- demm (anġjoplastija u/ jew • intervent koronarju perkutanju – PCI).
BEFORE YOU ARE GIVEN ANGIOX
QABEL MA TUŻA ANGIOX
Do not use Angiox:
Tużax Angiox
(See
- Jekk inti sensittiv/ a żżejjed (allerġiku/ a) għal bivalirudin jew sustanzi oħra ta ’ Angiox
- if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other
- Jekk għandek, jew riċentement kellek fsada mill- istonku tiegħek, l- imsaren, il- bużżieqa ta ’ l -
organs, for example, if you have noticed abnormal blood in your stools or urine, (except from menstrual bleeding).
awrina jew organi oħra, ngħidu aħna jekk rajt demm mhux normali fl- ippurgar jew l- awrina tiegħek (għajr minn fsada mestrwali).
- if you have, or have had, difficulty with your blood clotting (a low platelet count).
- Jekk kellek diffikultà bit- tagħqid tad- demm tiegħek jew għadd baxx ta ’ plejtlits fid- demm.
- if you have, or have had, severe high blood pressure.
- Jekk għandek, jew kellek ipertensjoni (pressjoni għolja tad- demm) severa mhux ikkontrollata.
- if you have, or have had, an infection of the heart tissue.
- Jekk għandek, jew kellek infezzjoni tat- tessut tal- qalb.
- if you have severe kidney problems or if you need kidney dialysis.
- Jekk għandek problemi serji fil- kliewi jew jekk teħtieġ dijalisi.
Check with the doctor if you are unsure.
Ara mat- tabib tiegħek jekk m’ intix ċert.
28 Taking other medicines
Meta tieħu mediċini oħra
Please tell your doctor
Jekk jogħġbok għid lit- tabib tiegħek
• if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. • If you are taking blood thinners (anticoagulants e.g. warfarin) or medicines to prevent blood clots (antithrombotics) • if you have been treated before with medicines similar to Angiox (e.g. lepirudin)
• jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta. • jekk qiegħed tieħu mediċini li jraqqu d- demm (antikoagulanti eż. warfarin) jew mediċini li jimpedixxu l- għoqiedi tad- demm (antitrombotiċi) • jekk ġejt ittrattat qabel b’ mediċini simili għal Angiox (eż. lepirudin) 28 billi dawn il- mediċini jistgħu jżidu r- riskju ta ’ effetti sekondarji bħal fsada meta jingħataw fl- istess żmien ma ’ Angiox.
You must tell the doctor if:
Trid tgħid lit- tabib tiegħek jekk:.
• you are pregnant or think you may be pregnant • you are planning to become pregnant • you are breast-feeding.
jekk inti tqila jew taħseb li tista ’ tkun tqila • jekk qed tippjana li tinqabad tqila • jekk qegħda tredda ’. •
Angiox should not be used during pregnancy, unless clearly necessary.
Angiox m’ għandux jintuża fit- tqala, sakemm huwa verament neċessarju.
Your doctor will decide whether or not this treatment is appropriate for you.
It- tabib tiegħek se jqis jekk din il- kura hiex adattata jew le għalik.
If you are breast-feeding, the doctor will decide whether Angiox should be used.
Jekk qiegħda tredda ’, it- tabib tiegħek se jqis jekk Angiox għandux jintuża.
Driving and using machines
Tħaddim u użu ta ’ magni
No studies of the effects on the ability to drive and use machines have been performed, but the effects of this medicine are known to be short-term.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni, iżda l- effetti ta ’ din il - mediċina huma magħrufin li huma għal perijodu qasir.
Angiox is only given when a patient is in hospital.
Angiox jingħata biss meta pazjent ikun l- isptar.
It is, therefore, unlikely to affect your ability to drive or to use machines.
Għalhekk mhux probabbli li dan jaffettwa l- ħila tiegħek li ssuq jew tħaddem magni.
HOW ANGIOX IS USED
KIF GĦANDEK TUŻA ANGIOX
Your treatment with Angiox will be supervised by a doctor.
Il- kura tiegħek b’ Angiox se tkun sorveljata minn tabib.
The doctor will decide how much Angiox you receive, and will prepare the medicine.
It- tabib jiddeċiedi kemm se tirċievi Angiox, u se jipprepara l- mediċina.
Angiox is for injection, followed by infusion (drip), into a vein (never into a muscle).
Angiox huwa għal injezzjoni, segwit minn infużjoni (drip), ġol- vina (qatt ġo muskolu).
This is administered and supervised by a doctor experienced in caring for patients with heart disease.
Din hija mogħtija u sorveljata minn tabib esperjenzat fil- kura ta ’ pazjenti b’ mard tal- qalb.
• Throughout your treatment, the doctor will check you for any signs of bleeding.
• It- tabib jiċċekkjak għal kwalunkwe sinjali ta ’ fsada, matul il- kura tiegħek.
If bleeding occurs, treatment with Angiox will be stopped. • Before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction.
Il- kura b’ Angiox titwaqqaf, jekk isseħħ fsada. • Qabel tinbeda l- injezzjoni jew l- infużjoni, it- tabib se jgħidlek dwar is- sinjali ta ’ reazzjoni allerġika.
Such a reaction is rare (occurring in fewer than 1 in every 1,000 patients treated). • Extra care will be taken if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy). • The dose given depends on your weight and on the kind of treatment you are being given.
Reazzjoni bħal din hija rari (isseħħ f’ anqas minn 1 f’ kull 1, 000 pazjent ikkurat). • Tittieħed aktar attenzjoni jekk qed tieħu kura b’ radjazzjoni fil- vażi li jfornu demm lill- qalb (kura msejħa brakiterapija beta jew gamma). • Id- doża tiddependi fuq il- piż tiegħek u fuq il- kwalità tal- kura li qed tingħata.
29 Dosage
Dożaġġ
For patients with acute coronary syndromes (ACS) the recommended starting dose is:
Għal pazjenti b’ sindromi koronarji akuti (ACS) id- doża tal- bidu irrikmandata hija:
• 0.1mg/kg body weight as an injection, followed by an infusion (drip) of 0.25mg/kg body weight per hour.
0. 1mg/ kg piż korporali bħala injezzjoni, segwita minn infużjoni (drip) ta ’ 0. 25mg/ kg piż • korporali kull siegħa.
(0.1 mg/kg body weight means one tenth of a milligram of the medicine for each kilogram you weigh; 0.25 mg/kg body weight per hour means a quarter of a milligram for each kilogram you weigh, per hour).
(0. 1 mg/ kg piż korporali tfisser parti minn għaxra ta ’ milligram tal - mediċina għal kull kilogramm li tiżen; 0. 25 mg/ kg piż korporali kull siegħa jfisser kwart ta ’ milligram għal kull kilogramm li tiżen, kull siegħa).
If, after this, you then need percutaneous coronary intervention (PCI) treatment, the dosage will be increased to:
Jekk, wara dan, tkun teħtieġ kura ta ’ intervent koronarju perkutaneju (PCI), id- dożaġġ se jiżdied għal:
• 0.5mg/kg body weight for the injection, followed by an infusion of 1.75mg/kg body weight, per hour.
0. 5mg/ kg piż korporali għall- injezzjoni, segwit minn infużjoni ta ’ 1. 75mg/ kg piż korporali, kull • siegħa.
• When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight, per hour.
Meta l- kura tispiċċa, l- infużjoni tista ’ tmur lura għal 0. 25 mg/ kg piż korporali, kull siegħa. •
For patients starting with percutaneous coronary intervention (PCI) the recommended dose is:
29 Għal pazjenti li jibdew b’ intervent koronarju perkutaneju (PCI), id- dożaġġ irrikmandat huwa:
• 0.75mg/kg body weight as an injection, followed immediately by an infusion of 1.75mg/kg body weight, per hour.
0. 75mg/ kg piż korporali bħala injezzjoni, segwita minnufih minn infużjoni ta ’ 1. 75mg/ kg piż • korporali, kull siegħa.
(The infusion may continue for up to 4 hours).
(L- infużjoni tista ’ tkompli sa 4 sigħat).
If you have mild kidney problems, the dose of Angiox may need to be reduced.
Jekk għandek problemi tal- kliewi ħfief, jista ’ jkun hemm bżonn li d- doża ta ’ Angiox titnaqqas.
The doctor will decide for how long you should be treated.
It- tabib se jiddeċiedi kemm għandek iddum tiġi ikkurat/ a.
If you have more of this medicine than you should
Jekk tieħu Angiox aktar milli suppost
These doses are carefully checked by the doctor, so an overdose is very unlikely.
Dawn id- dożi huma iċċekkjati bir- reqqa mit- tabib, għalhekk dożaġġ eċċessiv mhuwiex tabilħaqq probabbli.
If you forget to have Angiox
Jekk tinsa tieħu Angiox
Because treatment with Angiox is administered and supervised by a doctor, this is very unlikely.
Jekk kura b’ Angiox tingħata u tkun sorveljata minn tabib, dan mhuwiex probabbli.
If you have any further questions on the use of this product, ask the doctor.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib.
Like all medicines, Angiox can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Angiox jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If side effects occur, they may need medical attention.
Jekk isseħħu effetti sekondarji, jafu jeħtieġu attenzjoni medika.
The most common, important side effect of treatment with anticoagulants, including Angiox, is bleeding.
L- aktar effett sekondarju komuni importanti ta ’ kura bl- antikoagulanti, inkluż Angiox, hija fsada.
This can become serious, and may, very rarely, be fatal, (fewer than 1 in every 10,000 patients treated).
Din tista ’ ssir serja, u tista ’, f’ każijiet rari ħafna, tkun fatali (inqas minn 1 f’ kull 1, 000 pazjent ikkurat).
Bleeding is more likely to occur when Angiox is used in combination with other anticoagulant or antithrombotic medicines (see section 2 ‘Taking other medicines’).
Hemm iżjed probabbiltà li sseħħ fsada meta Angiox jintuża f’ kombinazzjoni ma ’ mediċini antikoagulanti jew antitrombotiċi oħrajn (ara sezzjoni 2 ‘ Meta tieħu mediċini oħra ’
If y ou get any of the following, potentially serious, side effects:
Jekk ikollok kwalunkwe effett sekondarju, potenzjalment serju, minn dawn li ġejjin:
o while you are in hospital: tell the doctor or nurse immediately – o after you’ve left hospital: go immediately to the Emergency Department of your nearest hospital -
waqt li qiegħed l- isptar: għid lit- tabib jew lill- infermiera minnufih – o wara li tkun tlaqt mill- isptar: mur minnufih fid- Dipartiment ta ’ l- Emerġenza ta ’ l- eqreb o sptar tiegħek -
• Bleeding – a common side effect (fewer than 1 in every 10 patients treated).
• Fsada – effett sekondarju komuni (inqas minn pazjent 1 minn kull 10 ikkurati).
30 • Allergic reactions, such as hives (nettle rash), itching all over your body, tightness of the chest.
Din tista ’ tirriżulta f’ kumplikazzjonijiet bħal ma huma anemija (għadd taċ- ċelloli tad- demm baxx) jew ematoma (tbenġil). • Reazzjonijiet allerġiċi, bħal urtikarja (ħorriqija), ħakk ma ’ ġismek kollu, għafis fis- sider.
These are uncommon reactions (fewer than 1 in every 100 patients treated). • Thrombosis (blood clots) which may result in serious complications such as heart attack.
Dawn huma reazzjonijiet mhux komuni (inqas minn pazjent 1 minn kull 100 ikkurati). • Trombożi (emboli tad- demm) li jistgħu jirriżultaw f’ kumplikazzjonijiet serji bħal attakk tal - qalb.
This is an uncommon side effect (fewer than 1 patient in every 100 patients treated). • Pain, bleeding and bruising at the puncture site (after PCI treatment).
Dan huwa effett sekondarju mhux komuni (inqas minn pazjent 1 minn kull 100 ikkurati). • Uġigħ, fsada u tbenġil fis- sit tat- titqiba (wara kura PCI).
These side effects are rare (fewer than 1 in every 1,000 patients treated).
Dawn l- effetti sekondarji huma rari (inqas minn pazjent 1 minn kull 1, 000 ikkurati).
If y ou get any of the following, (potentially less serious), side effects:
Jekk ikollok kwalunkwe effett sekondarju, (potenzjalment inqas serju), minn dawn li ġejjin:
o while you are in hospital: tell the doctor or nurse - o after you’ve left hospital: go immediately to the Emergency Department of your nearest hospital -
waqt li tkun qiegħed l- isptar: għid lit- tabib jew infermiera minnufih – o wara li tkun tlaqt mill- isptar: mur minnufih fid- Dipartiment ta ’ l- Emerġenza ta ’ l- eqreb o sptar tiegħek -
- severe bruising (which may be due to a reduction in the number of platelets in your blood.
- tbenġil sever (li jista ’ jkun minħabba tnaqqis fin- numru ta ’ plejtlits fid- demm tiegħek.
This
Dan
may prevent your blood from clotting as well as it should)
jista ’ jimpedixxi lil demmek milli jagħqad sewwa kif suppost)
- changes in blood pressure
- tibdil fil- pressjoni tad- demm
- changes in the rate of your heart beat
- tibdil fir- rata tat- taħbit ta ’ qalbek
- nausea (feeling sick) and/or vomiting (being sick)
- nawżeja (dardir) u/ jew remettar (tħossok ma tiflaħx)
- chest pain
- uġigħ fis- sider
- shortness of breath
- qtugħ ta ’ nifs
These side effects are uncommon (fewer than 1 in every 100 patients treated).
Dawn l- effetti sekondarji mhumiex komuni (inqas minn pazjent 1 minn kull 100 ikkurati).
HOW TO STORE ANGIOX
KIF TAĦŻEN ANGIOX
The expiry date refers to the last day of that month.
Tużax Angiox wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna wara ‘ JIS ’. Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
Lyophilised (freeze-dried) powder:
Trab liofilizzat (imnixxef bil- friża):
Store in a refrigerator (2 – 8oC)..
Aħżen fi friġġ (2 – 8oC).
Do not store above 25ºC.
Taħżinx f’ temperatura ogħla minn 25°C.
The doctor will check the solution and will discard it, if it contains particles or is discoloured.
It- tabib jiċċekkja s- soluzzjoni u jekk ikun fiha partikoli jew ikollha kulur imdennes, jarmiha.
FURTHER INFORMATION
X’ fih Angiox
What Angiox contains The active substance is bivalirudin.
Is- sustanza attiva hija bivalirudin.
After reconstitution, 1ml contains 50 mg bivalirudin.
Wara rikostituzzjoni, 1ml fih 50 mg bivalirudin.
After further dilution, 1ml contains 5 mg bivalirudin.
Wara aktar dilwizzjoni, 1ml fih 5 mg bivalirudin.
The other ingredients are mannitol and sodium hydroxide.
Is- sustanzi l- oħra huma mannitol u sodium hydroxide.
31 What Angiox looks like and contents of the pack
Id- dehra ta ’ Angiox
Angiox is a white to off-white powder in a glass vial.
Angiox huwa trab abjad għal kważi abjad f’ kunjett tal- ħġieġ.
Angiox is available in cartons containing 2 and 10 vials.
Angiox jiġi f’ kartuniet li fihom 2 u 10 kunjetti.
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq huwa:
The Medicines Company UK Limited 115L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM
The Medicines Company UK Limited 115L Milton Park Abingdon Oxfordshire OX14 4SA IR- RENJU UNIT
Manufacturer:
31 Il- Manifattur huwa:
Hälsa Pharma GmbH Immermannstraße 9 33619 Bielefeld GERMANY
Hälsa Pharma GmbH Immermannstraße 9 33619 Bielefeld Germanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
What is Apidra?
X' inhu Apidra?
Apidra is a solution for injection.
Apidra hu soluzzjoni għall- injezzjoni.
It is available in a vial, in cartridges (standard or OptiClick) or in a pre-filled pen (OptiSet or SoloStar).
Jinsab disponibbli f’ kunjetti, fi stoċċijiet (standard jew OptiClick) jew f’ kontenituri diġà mimlija f’ forma ta ’ pinna (OptiSet jew SoloStar).
Apidra contains the active substance insulin glulisine.
Apidra fih is - sustanza attiva insulina glulisina.
What is Apidra used for?
Għal xiex jintuża Apidra?
Apidra is used to treat adults, adolescents and children aged six years or over who have diabetes and need insulin treatment.
Apidra jintuża fit- trattament ta 'adulti, adolexxenti u tfal minn sitt snin jew akbar li jkollhom id - dijabete u jkollhom bżonn l- insulina.
How is Apidra used?
Kif jintuża Apidra?
Apidra is given subcutaneously (under the skin) by injection in the abdominal wall (tummy), the thigh, or the upper arm, or by continuous infusion using an insulin pump.
Apidra jingħata minn taħt il- ġilda permezz ta ’ injezzjoni fil- parti addominali (iż- żaqq), fil- koxxa jew fil- parti ta ’ fuq tad- dirgħajn, jew inkella permezz ta ’ infużjoni kontinwa bl- użu ta ’ pompa ta ’ l- insulina.
The patient ’ s blood glucose (sugar) levels should be regularly tested to find the lowest effective dose.
Il- glukożju (zokkor) fid- demm tal- pazjent għandu jkun ittestjat regolarment biex tinsab l- aktar doża baxxa effettiva.
Apidra should be given up to 15 minutes before or just after a meal.
Apidra għandu jingħata sa 15– il minuta qabel jew eżatt wara l- ikel.
Apidra is a short-acting insulin that is used in combination with intermediate- or long-acting insulins or insulin analogues (modified forms of insulin).
Apidra huwa insulina li taġixxi għal żmien qasir li tintuża flimkien ma ’ insulina intermedja jew li tkun taġixxi fuq żmien twil jew tip ta ’ insulina analoga (forom modifikati ta ’ insulina).
It may also be used in combination with antidiabetic medicines that are taken by mouth.
Tista ’ tintuża wkoll ma ’ mediċini orali għal kontra d- dijabete.
How does Apidra work?
Kif jaħdem Apidra?
Apidra is a replacement insulin that is very similar to the insulin made by the body.
Apidra huwa insulina simili ħafna ta ’ dik li jagħmel il- ġisem u tintuża għalhekk biex tpatti għan- nuqqas tagħha fil - ġisem.
The active substance in Apidra, insulin glulisine, 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 glulisine.
Is- sustanza attiva f’ Apidra, insulina glulisina tiġi prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: hija magħmula minn batterju li jkun irċieva ġene (DNA), li jwasslu sabiex ikun kapaċi li jipproduċi l- insulina glulisina.
Insulin glulisine is very slightly different from human insulin.
L- insulina glulisina hija ftit biss differenti mill- insulina tal- bniedem.
The difference means that insulin glulisine acts more rapidly, and has a shorter duration of action than a short-acting human insulin.
Id- differenza tfisser li l- insulina glulisina taġixxi b’ iktar ħeffa, u t- tul ta ’ żmien ta ’ azzjoni jkun iqsar minn insulina tal- bniedem li taġixxi għal żmien qasir.
The replacement insulin acts in same way as naturally produced insulin and helps glucose to enter cells from the blood.
L- insulina ta ’ sostituzzjoni taġixxi bl- istess mod bħall- insulina prodotta naturalment u tgħin lill- glukożju jidħol fiċ- ċelloli mid- demm.
This helps to control the level of blood glucose, reducing the symptoms and complications of diabetes.
Dan jgħin fil- kontroll tal- livell tal - glukożju fid- demm, billi jnaqqas is- sintomi u l- komplikazzjonijiet tad- dijabete.
How has Apidra been studied?
Kif ġie studjat Apidra?
Apidra, used in combination with a long-acting insulin, has been studied in patients with type 1 diabetes (when the body cannot produce insulin) in two studies involving a total of 1,549 adults and in one study involving 572 children aged between four and 17 years.
Apidra użat ma ’ insulina li taġixxi għal żmien twil, ġie studjat f’ pazjenti b’ dijabete tat- tip 1 (meta l - ġisem ma jkunx jista ’ jipproduċi l- insulina) f’ żewġ studji li kienu jinvolvi 1, 549 adult u fi studju wieħed li kien jinvolvi 572 tifel ta ’ l- età bejn erba ’ snin u 17- il sena.
In type 2 diabetes (when the body is unable to use insulin effectively), Apidra has been studied in one study involving 878 adults.
Fid- dijabete tat- tip 2 (meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effikaċi), Apidra ġie studjat fi studju wieħed li kien jinvolvi 878 adult.
In this study, Apidra was used in combination with an intermediate-acting insulin and antidiabetic medicines taken by mouth.
F’ dan l- istudju, Apidra intuża ma ’ l- insulina b’ azzjoni intermedja u mediċini orali li jaħdmu kontra d- dijabete.
In all four studies, Apidra was compared with other insulins or insulin analogues (regular human insulin or insulin lispro).
Fl- erba ’ studji, Apidra tqabbel ma ’ insulini oħra jew analogy ta ’ l- insulina (insulina regolari tal - bniedem jew insulina lispro).
The main measure of effectiveness was the change in the blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Il- kejl ewlieni ta ’ l- effikaċja kien il- bidla fil- livelli tad- demm ta ’ sustanza msejħa emoglobina glikosilata (HbA1c - glycosylated haemoglobin), li tagħti indikazzjoni ta ’ kemm il- glukożju fid- demm huwa kkontrollat tajjeb.
What benefit has Apidra shown during the studies?
X' benefiċċju wera Apidra matul l- istudji?
Blood glucose control with Apidra was at least as effective as that with the comparator insulins.
Il- kontroll tal- glukożju fid- demm b’ Apidra kien għall- inqas daqshekk effikaċi daqs l- insulini ta ’ tqabbil.
In all studies, the change in the level of HbA1c observed with Apidra was similar to that seen with the comparator insulins.
Fl- istudji kollha, it- tnaqqis fil- livell ta ’ HbA1c osservat ma ’ Apidra kien simili għal dak li deher b’ insulini oħra ta ’ tqabbil.
In the first study of adults with type 1 diabetes, there was a decrease of 0.14% (from 7.60% to 7.46%) after six months, compared with a decrease of 0.14% for insulin lispro.
Fl- ewwel studju ta ’ adulti bid- dijabete tat- tip 1, kien hemm tnaqqis b’ 0. 14% (minn 7. 60% għal 7. 46%) wara sitt xhur, meta mqabbel ma ’ tnaqqis ta ’ 0. 14% għall- insulina lispro.
Similar reductions were seen in the second study in adults, which compared Apidra with regular human insulin.
Tnaqqis simili deher fit- tieni studju ta ’ adulti, li qabbel Apidra ma ’ insulina normali tal- bniedem.
In the study in children, Apidra and insulin lispro produced similar changes in HbA1c after six months.
Fl- istudji fit- tfal, Apidra u insulina lispro kellhom l- istess bidliet f’ HbA1c wara sitt xhur.
However, there was not enough information to show whether Apidra was effective in children aged below six years.
Madankollu, ma kienx hemm biżżejjed informazzjoni biex juri li Apidra kien effikaċi fit- tfal ta’ età ta ’ inqas minn sitt snin.
In adults with type 2 diabetes, there was a decrease in HbA1c of 0.46% after six months of Apidra, compared with 0.30% for regular human insulin.
F’ adulti bid- dijabete tat- tip 2, kien hemm tnaqqis f’ HbA1c ta ’ 0. 46% wara sitt xhur ta ’ Apidra, meta mqabbel ma ’ 0. 30% għall- insulina normali tal- bniedem.
What is the risk associated with Apidra?
X' inhu r- riskju assoċjat ma 'Apidra?
The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
L- iktar effett sekondarju komuni b’ Apidra (li deher f' iktar minn pazjent 1 minn kull 10) hija l - ipogliċemija (livelli baxxi ta ’ glukożju fid- demm).
For the full list of all side effects reported with Apidra, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Apidra, ara l- Fuljett ta ’ Tagħrif.
Apidra should not be used in people who may be hypersensitive (allergic) to insulin glulisine or any of the other ingredients, or in patients who already have hypoglycaemia.
Apidra ma għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal insulina glulisina jew għal kwalunkwe wieħed mill- ingredjenti l- oħra, jew f’ pazjenti li diġà jkollhom l- ipogliċemija.
Apidra doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Dożi ta 'Apidra jistgħu wkoll jeħtieġu li jiġu aġġustati meta jingħataw ma' xi mediċini oħrajn li jista 'jkollhom effett fuq il- livelli ta' glukożju fid- demm.
The full list of these medicines is available in the Package Leaflet.
Il- lista sħiħa ta ’ dawn il- mediċini tinsab fil- Fuljett ta ’ Tagħrif.
Why has Apidra been approved?
Għaliex ġie approvat Apidra?
The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra’ s benefits are greater than its risks for the treatment of adults, adolescents and children six years or older with diabetes mellitus, where treatment with insulin is required.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Apidra huma akbar mir- riskji tiegħu għat- trattament ta' adulti, adolexxenti u tfal ta 'sitt snin jew aktar li jbatu mid- dijabete mellitu, fejn huwa meħtieġ trattament bl- insulina.
The Committee recommended that Apidra be given marketing authorisation.
Il- Kumitat irrakkomanda li Apidra jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Apidra:
Tagħrif ieħor dwar Apidra:
The European Commission granted a marketing authorisation valid throughout the European Union for Apidra to Sanofi-Aventis Deutschland GmbH on 27 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l- Unjoni Ewropea kollha għal Apidra lil Sanofi Aventis Deutschland GmbH fis- 27 ta ’ Settembru 2004.
The full EPAR for Apidra can be found here.
L- EPAR sħiħ għal Apidra jista ’ jiġi kkonsultat hawn.
Route of Administration
Mnejn jing ata
100 Units/ ml
100 Unita ’ / ml
Solution for injection
Soluzzjoni g all- injezzjoni
vial (glass)
ie)
cartridge (glass)
ie)
1 cartridge
1 skarto
3 cartridges
3 skarto i
4 cartridges
4 skarto i
5 cartridges
5 skarto i
6 cartridges
6 skarto i
8 cartridges
8 skarto i
9 cartridges
9 skarto i
10 cartridges
10 skarto i
pre-filled pen (glass) (OptiSet)
pinna mimlija g al- lest (ie) (Optiset)
1 pre-filled pen
1 pinna mimlija g al- lest
3 pre-filled pens
3 pinnen mimlija g al- lest
4 pre-filled pens
4 pinnen mimlija g al- lest
5 pre-filled pens
5 pinnen mimlija g al- lest
6 pre-filled pens
6 pinnen mimlija g al- lest
8 pre-filled pens
8 pinnen mimlija g al- lest
9 pre-filled pens
9 pinnen mimlija g al- lest
10 pre-filled pens
10 pinnen mimlija g al- lest
cartridge (glass) for OptiClik
skarto (ie) g al OptiClik
pre-filled pen (glass) (SoloStar)
pinna mimlija g al- lest (ie) (SoloStar)
Apidra 100 Units/ ml, solution for injection in a vial
Apidra 100 Unità/ ml, soluzzjoni għall- injezzjoni f’ kunjett
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Kull ml fih 100 Unità ta ’ insulina glulisine (ekwivalenti għal 3. 49 mg).
Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
Kull kunjett fih 10 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 1000 Unità.
Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
L- insulina glulisine hija magħmula bit- teknoloġija rikombinanti tad- DNA f’ Escherichia coli.
Treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required.
Trattament tad- dijabete mellitus f’ pazjenti adulti, adoloxxenti u tfal ta ’ 6 snin jew akbar, meta jkun meħtieġ it- trattament bl- insulina.
The potency of this preparation is stated in units.
Il- qawwa ta ’ dan il- prodott huwa stmat f’ unitajiet.
These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues.
Dawn l- unitajiet huma esklussivament għal Apidra u m’ humiex l- istess bħal IU jew dawk l- unitajiet użati biex tkun stmata l- qawwa ta ’ analogi oħra ta ’ l - insulina.
See section 5.1 (Pharmacodynamics).
Ara sezzjoni 5. 1 (Farmakodinamika).
Apidra should be given shortly (0-15 min) before or soon after meals.
Apidra għandu jingħata ftit ħin (0- 15- il minuta) qabel jew malajr wara l- ikel.
Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.
Apidra għandu jintuża f’ korsijiet ta ’ trattamenti li jinkludu insulini li jaħdmu fuq tul ta ’ ħin intermedju jew twil jew analogu ta ’ insulina basal, u tista ’ tintuża flimkien ma ’ sustanzi orali ipogliċemiċi.
The dosage of Apidra should be individually adjusted.
Id- dożaġġ ta ’ Apidra għandu jkun aġġustat individwalment.
Apidra should be given by subcutaneous injection or by continuous subcutaneous pump infusion.
Apidra għandu jingħata b’ injezzjoni taħt il- ġilda jew permezz ta ’ pompa għall- infużjoni kontinwa taħt il- ġilda.
Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall.
Apidra għandu jingħata taħt il- ġilda taż- żaqq, tal- koxxa jew fil- parti tad- deltoid tad- driegħ, jew permezz ta ’ infużjoni kontinwa taħt il- ġilda taż- żaqq.
Injection sites and infusion sites within an-injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next.
Il- postijiet ta ’ l- injezzjoni u l- infużjoni, f’ parti partikolari (iż- żaqq, il- koxxa jew id- deltoid), għandhom jinbidlu minn injezzjoni għall- oħra.
The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables.
Ir- rata ta ’ assorbiment, u konsegwentement it- tul ta ’ ħin biex is- sustanza tibda taħdem u kemm iddum taħdem, jistgħu jiġu effetwati mis- sit ta ’ l- injezzjoni, l- eżerċizzju u fatturi oħra li jistgħu jinbidlu.
Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
L- injezzjoni taħt il- ġilda taż- żaqq tassigura assorbiment ftit aktar mgħaġġel minn postijiet oħrajn ta ’ injezzjoni (ara sezzjoni 5. 2).
Care should be taken to ensure that a blood vessel has not been entered.
2 Wieħed irid joqgħod attent li l- injezzjoni ma ssirx ġo vina jew arterja.
After injection, the site of injection should not be massaged.
Wara li ssir l- injezzjoni, il- post ta ’ l- injezzjoni m’ għandux jiġi mmassaġjat.
Patients must be educated to use proper injection techniques.
Il- pazjenti għandhom jiġu mgħallma dwar il- mod korrett ta ’ kif tingħata l- injezzjoni.
2 Mixing with insulins
It- taħlit ma ’ l- insulini
In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
Fin- nuqqas ta ’ studji dwar il- kompatibiltà, l- insulina glulisine m’ għandhiex titħallat ma ’ sustanzi mediċinali oħra, ħlief għall- insulina umana NPH.
Continuous subcutaneous infusion pump
Il- pompa għall- infuzjoni kontinwa taħt il- ġilda
When used with an insulin infusion pump, Apidra must not be mixed with diluents or any other insulin.
Meta jintuża b’ pompa għall- infuzjoni ta ’ l- insulina, Apidra m’ għandux jitħallat ma ’ sustanzi miżjuda biex jiddilwuh jew ma ’ kwalunkwe insulina oħra.
For further details on handling, see section 6.6.
Għal aktar dettalji dwar l- immaniġġar, ara sezzjoni 6. 6.
Renal impairment The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment.
Indeboliment renali Il- karateristiċi farmakokinetiċi ta ’ l- insulina glulisine ġeneralment dehru f’ pazjenti b’ indeboliment renali.
However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Madankollu, l- ħtieġa għall- insulina tista ’ tonqos meta jkun hemm l- indeboliment renali (ara sezzjoni 5. 2).
Hepatic impairment The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function.
Indeboliment Epatiku Il- karatieristiċi farmakokinetiċi ta ’ l- insulina glulisine ma kienux studjati f’ pazjenti bi tnaqqis fil - funzjoni tal- fwied.
In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti b’ indeboliment epatiku, il- ħtieġa għall- insulina tista ’ tonqos dovuta għat- tnaqqis fl- abbiltà għal glukoġenesi u għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
Elderly Limited pharmacokinetic data are available in elderly patients with diabetes mellitus.
Anzjani Id- data farmakokinetika disponibbli hija limitata f’ pazjenti anzjani bid- dijabete mellitus.
Deterioration of renal function may lead to a decrease in insulin requirements.
Id - deterjorament fil- funzjoni renali jista ’ jwassal għat- tnaqqis fil- ħtieġa ta ’ l- insulina.
Children and adolescents There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Tfal u adoloxxenti M’ hemmx biżżejjed informazzjoni klinika adegwata dwar l- użu ta ’ Apidra fit- tfal taħt 6 snin...
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Meta pazjent ser jinqaleb fuq tip ġdid jew marka ġdida ta ’ insulina, dan irid isir taħt sorveljanza medika stretta.
Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal) and/ or method of manufacturing may result in a change in dosage.
Bidliet fil- qawwa, il- marka (manifattur), it- tip (regolari, NPH, lente, eċċ), l- ispeċi (ta ’ l- annimal) u/ jew il- metodu tal- manifattura jistgħu jwasslu għall- bidla fid- dożaġġ.
Concomitant oral antidiabetic treatment may need to be adjusted.
It- trattament orali tad- dijabete li jkun qed jingħata fl- istess ħin għandu mnejn jeħtieġ l- aġġustament.
The use of inadequate dosages or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
L- użu ta ’ dożaġġi inadegwati jew il- waqfien tal- kura, speċjalment fid- dijabetiċi li huma dipendenti fuq l- insulina, jista ’ jwassal għall- ipergliċemija u l- kitoaċidożi dijabetika, li huma potenzjalment fatali.
Switching a patient to another type or brand of insulin should be done under strict medical supervision and may require change in dose.
Meta pazjent jinqaleb għal tip ieħor jew marka oħra ta ’ insulina, dan irid isir taħt sorveljanza medika stretta u jista ’ jeħtieġ bidla fid- doża.
Hypoglycaemia The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
3 Ipogliċemija Il- ħin meta tiġri l- ipogliċemija jiddependi fuq il- profil ta ’ kif jaħdmu l- insulini użati u, għalhekk, jista ’ jinbidel meta jinbidel il- kors tat- trattament.
3 Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.
Il- kundizzjonijiet li jistgħu jibdlu s- sintomi bikrija ta ’ twissija ta ’ l- ipogliċemija jew jagħmluhom anqas prominenti, jinkludu ż- żmien twil ta ’ dijabete, terapija qawwija bl- insulina, marda fin- nervituri minħabba d- dijabete, l- użu ta ’ sustanzi mediċinali bħal imblokkaturi tar- riċetturi beta, jew wara l- bidla ta ’ insulina derivata mill- annimali għal waħda li ġejja mill- bniedem.
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
L- aġġustament tad- dożaġġ jista ’ jkun meħtieġ ukoll f’ dawk il- pazjenti li jżidu l- attività fiżika jew jibdlu l- ħin tas- soltu meta jieklu.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
L- eżerċizzju magħmul immedjatament wara l- ikel jista ’ jżid ir- riskju ta ’ l- ipogliċemija.
When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
Meta mqabbla ma ’ l- insulina solubbli umana, jekk l- ipogliċemija tiġri wara injezzjoni ta ’ analogi ta ’ l - insulina li jaħdmu malajr, din tista ’ titfaċċa aktar kmieni.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Reazzjonijiet ta ’ ipogliċemija u ipergliċemija li ma jiġux ikkoreġuti jistgħu jikkaġunaw it- telf mis - sensi, koma jew mewt.
Insulin requirements may be altered during illness or emotional disturbances.
Il- ħtieġa għall- insulina tista ’ tinbidel waqt il- mard jew disturbi emozzjonali.
Studies on pharmacokinetic interactions have not been performed.
Studji fuq interazzjonijiet farmakokinetiċi ma sarux.
Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
Mit- tagħrif empiriku dwar prodotti mediċinali simili, interazzjonijiet farmakokinetiċi klinikament rilevanti mhux probabbli li jiġru.
A number of substances affect glucose metabolism and may require dose adjustment of insulin glulisine and particularly close monitoring.
Hemm diversi sustanzi li jeffettwaw il- metaboliżmu tal- glukosju u dawn jistgħu jeħtieġu aġġustament fid- doża ta ’ l- insulina glulisine u speċjalment l- immoniteraġġ mill- qrib.
Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamide oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Sustanzi li jistgħu jżidu l- attività biex jonqos il- livell tal- glukosju fid- demm u jżidu s- suxxettibilità għall- ipogliċemija jinkludu s- sustanzi orali anti- dijabetiċi, inibituri ta ’ l- enzima li tikkonverti angiotensin( ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monamine oxidase (MAOIs), pentoxifylline, propoxyphene, salicylates and l- antibijotiċi sulfonamides.
Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, estrogens, progestins (e. g. in oral contraceptives), protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Sustanzi li jistgħu jnaqqsu l- attività biex jonqos il- livell tal- glukosju fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, id- derivattivi tal- phenothiazine, somatropin, is- sustanzi simpatomimetiċi (e. ż. epinephrine [adrenaline], salbutamol, terbutaline), l - ormoni tat- tirojde, l- estroġeni, il- proġesteni (e. ż. il- kontraċettivi orali), l- inibituri ta ’ l- enżima protease u prodotti mediċinali anti- psikotiċi u atipiċi (e. ż. olanzapine u clozapine).
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering activity of insulin.
L- imblokkaturi tar- riċetturi beta, clonidine, is- sustanzi tal- lithium jew l- alkoħol jistgħu jsaħħu jew idgħajjfu l- effett ta ’ l- insulina biex tbaxxi l- livell tal- glukosju fid- demm.
Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
Pentamidine jista ’ jikkawża l- ipogliċemija, li xi kultant tista ’ tkun segwita mill- 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.
Addizzjonalment, is- sinjali ta ’ kontroregulazzjoni adrenerġika jistgħu jitnaqqsu jew jintilfu taħt l - effetti ta ’ prodotti mediċinali simpatolitiċi bħall- imblokkaturi tar- riċetturi beta, clonidine, guanethidine u reserpine.
There are no adequate data on the use of insulin glulisine in pregnant women.
M’ hemmx biżżejjed tagħrif dwar l- użu ta ’ l- insulina glulisine waqt it- tqala.
Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- proċess tar- riproduzzjoni fl- annimali ma urew ebda differenzi fl- effetti bejn l- insulina glulisine u l- insulina umana fuq it- tqala, l- iżvilupp ta ’ l- embriju jew il- fetu, il- proċess tat- twelid u l - iżvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
Caution should be exercised when prescribing to pregnant women.
4 Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal..
Careful monitoring of glucose control is essential.
L- immoniteraġġ bil- ħsieb tal- kontroll tal- livelli tal- glukosju huwa essenzjali.
Insulin requirements may decrease during the first trimester and generally
Huwa essenzjali li jinżamm kontroll metaboliku tajjeb tul it- tqala kollha fil- pazjenti li żviluppaw id - dijabete qabel jew waqt it- tqala innifisha.
4 increase during the second and third trimesters.
L- ammonti ta ’ insulina meħtieġa jistgħu jonqsu waqt l - ewwel trimestru tat- tqala u ġeneralment jiżdiedu waqt it- tieni u t- tielet trimestri.
Immediately after delivery, insulin requirements decline rapidly.
Immedjatament wara l- ħlas, il- ħtieġa għall- insulina tonqos malajr.
It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Mhux magħruf jekk l- insulina glulisine toħroġx fil- ħalib tas- sider fil- bniedem, iżda normalment l - insulina ma tgħaddix fil- ħalib tas- sider u m’ hix assorbita wara li tingħata oralment.
Breast-feeding mothers may require adjustments in insulin dose and diet.
Ommijiet li qed ireddgħu jistgħu jeħtieġu aġġustamenti fid- doża ta ’ l- insulina u tad- dieta.