qanastek/EMEA-V3 huggingface dataset:
Insuman Infusat is specially prepared ready to be used in infusion pumps.
Insuman Infusat huwa speċjalment imħejji sabiex jintuża f’ pompi ta ’ infużjoni.
How does Insuman work?
Kif jaħdem Insuman?
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Id- dijabete hi marda li biha l- ġisem ma jipproduċix biżżejjed insulina biex jikkontrolla l- livell ta ’ zokkor fid- demm.
Insuman is a replacement insulin that is identical to the insulin made by the body.
Insuman jintuża bħala sostitut u huwa identiku għall- insulina prodotta mill- ġisem.
The active substance in Insuman, insulin human, 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.
Is- sustanza attiva f’ Insuman, insulina umana (insulin human) tiġi prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’. hija magħmula minn batterju li rċieva ġene (DNA), li jagħmlu kapaċi jipproduċi l- insulina.
Insuman contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystalline-protamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action.
Insuman fih insulina f’ żewġ forom: fil- forma solubbli li taġixxi malajr (fi żmien 30 minuta mill- injezzjoni) u fil- forma isofana u dik kristallina bil- protamina, li jiġu assorbiti b’ mod iktar bil- mod matul il- jum u b’ hekk jaġixxu iktar fit- tul.
The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
L- insulina ta ’ sostituzzjoni taġixxi bl- istess mod bħall- insulina prodotta b’ mod naturali u tgħin lill - glukożju jidħol fiċ- ċelloli mid- demm.
By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Billi jiġi kkontrollat il- glukożju fid- demm, is- sintomi u l - komplikazzjonijiet tad- dijabete jitnaqqsu.
How has Insuman been studied?
Kif ġie studjat Insuman?
Insuman has been studied in two trials in 611 patients with either type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Insuman ġie studjat f’ żewġ provi fuq total ta ’ 611 - il pazjent li għandhom jew dijabete tat- tip1 (fejn il - frixa ma tistax tipproduċi insulina) jew dijabete tat- tip 2 (meta l- ġisem ma jkunx kapaċi juża l- insulina b’ mod effikaċi).
In one of the studies, Insuman was used in an insulin pump.
F’ wieħed mill- situdji, Insuman intuża bħala pompa ta ’ l- insulina.
In the other study, Insuman Comb 25 was compared with semi-synthetic human insulin.
Fi studju ieħor, Insuman Comb 25 tqabbel ma ’ insulina umana semisintetika.
The studies measured the ‘ fasting’ blood glucose levels (measured when the patient had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the 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.
The studies also looked at the number of patients who developed hypoglycaemia (low blood glucose levels).
L- istudji eżaminaw ukoll in- numru ta ’ pazjenti li żviluppaw ipogliċemija (livelli baxxi ta ’ glukożju fid- demm).
What benefit has Insuman shown during the studies?
X' benefiċċju wera Insuman matul l- istudji?
Insuman 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 semi-synthetic human insulin.
Insuman 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 umana semisintetika.
Insuman was effective for both type 1 and type 2 diabetes.
Insuman kien effikaċi kemm għad- dijabete tat- tip 1 kif ukoll tat- tip 2.
What is the risk associated with Insuman?
X’ inhu r- riskju assoċjat ma ’ Insuman?
Insuman may cause hypoglycaemia.
Insuman jista ’ jikkawża ipogliċemija.
For the full list of all side effects reported with Insuman, see the Package Leaflet.
Għal- lista sħiħ ta ’ l- effetti sekondarji kollha rrappurtati b' Insuman, ara l- Fuljett ta 'Tagħrif.
Insuman should not be used in people who may be hypersensitive (allergic) to insulin human or any of the other ingredients.
Insuman m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għall- insulina umana jew għal kwalunkwe wieħed mis- sustanzi l- oħra.
Insuman doses might also need to be adjusted when it is given with other medicines that may have an effect on blood glucose levels.
Dożi ta 'Insuman 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 Insuman been approved?
Għaliex ġie approvat Insuman?
The Committee for Medicinal Products for Human Use (CHMP) decided that Insuman’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Insuman għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete mellitu.
The Committee recommended that Insuman be given marketing authorisation.
Il- Kumitat irrakkomanda li Insuman jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Insuman:
Tagħrif ieħor dwar Insuman:
The European Commission granted a marketing authorisation valid throughout the European Union for Insuman to Sanofi-Aventis Deutschland GmbH on 21 February 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Insuman lil Sanofi- Aventis Deutschland GmbH fil- 21 ta 'Frar 1997.
The marketing authorisation was renewed on 21 February 2002 and on 21 February 2007.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fil- 21 ta 'Frar 2002 u fil- 21 ta ’ Frar 2007.
The full EPAR for Insuman is available here.
L- EPAR sħiħ għal Insuman jista ’ jiġi kkonsultat hawn.
Subcutaneous or intravenous use
Użu għal taħt il- ġilda jew ġol - vina
vials (glass)
kunjett (ħġieġ)
1/ 9 EU Number
1/ 11 Numru ta ’ l- EU
100IU/ ml 100 IU/ ml 100 IU/ ml
100IU/ ml
Solution for injection Solution for injection Solution for injection
Soluzzjoni għall - injezzjoni
Subcutaneous use Subcutaneous use Subcutaneous or intravenous use
Użu għal taħt il- ġilda
vial (glass) cartridge (glass) cartridge (glass)
kunjett (ħġieġ)
3 vials 5 cartridges 4 cartridges
4 skartoċċi
OptiSet, solution for injection
OptiSet, soluzzjoni għall - injezzjoni
cartridge (glass) in disposable pens
skartoċċ (ħġieġ) f’ pinen għall- injezzjoni, li jintremew wara li jinħlew
EU/ 1/ 97/ 030/ 087
EU/ 1/ 97/ 030 // 087
EU/ 1/ 97/ 030/ 092
EU/ 1/ 97/ 030 // 092
EU/ 1/ 97/ 030/ 097
EU/ 1/ 97/ 030 // 097
6 pens
6 pinen
EU/ 1/ 97/ 030/ 102
EU/ 1/ 97/ 030 // 102
cartridge (glass) in disposable pens
skartoċċ (ħġieġ) f’ pinna għall- injezzjoni, li tintrema wara li tinħela
OptiSet, solution for injection
OptiSet, soluzzjoni għall - injezzjoni i
9 pens
9 pinen
EU/ 1/ 97/ 030/ 107
EU/ 1/ 97/ 030 // 107
OptiSet, suspension for injection
OptiSet, suspensjoni għall - injezzjoni i
cartridge (glass) for OptiClik
skartoċċ (ħġieġ) għal OptiClik
cartridge (glass) in pre- filled pen (SoloStar)
skartoċċ (ħġieġ) f’ pinna mimlija għal- lest (SoloStar)
SUMMARYOF PRODUCT CHARACTERISTICS
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Insuman Rapid 100 IU/ ml solution for injection in a vial
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo kunjett.
Insuman Rapid is a neutral insulin solution (regular insulin).
Insuman Rapid hija soluzzjoni newtrali ta ’ insulina (insulina regolari).
Human insulin is produced by recombinant DNA technology in Escherichia coli.
L- insulina umana hija magħmula permezz tat- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus.
Insuman Rapid hija wkoll adatta għall- kura tal- koma ipergliċemija u l- ketoaċidożi, kif ukoll għall- kontroll stabbli f’ pazjenti b’ diabetes mellitus qabel, waqt u wara interventi kirurġiċi.
The desired blood glucose levels, the insulin preparations to be used and the insulin dosage (doses and timings) must be determined individually and adjusted to suit the patient’ s diet, physical activity and life- style.
Il- livelli mixtieqa tal- glucose fid- demm, il- preparazzjonijiet t’ insulina li ser jintużaw, u d- dożaġġ ta ’ l - insulina (dożaġġi u l- ħinijiet) għandhom ikunu stabbiliti għal kull pazjent u aġġustati skond id- dieta tal- pazjent, l- attività fiżika u l- istil ta ’ ħajja.
Insuman Rapid is injected subcutaneously 15 to 20 minutes before a meal.
Insuman Rapid hija injettata fit- tessut ta ’ taħt il - ġilda minn 15 sa 20 minuta qabel ikla.
2 Transfer to Insuman Rapid
Kif taqleb għal Insuman Rapid
- other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia
- jokkorru ċikostanzi oħra li jwasslu għal suxxettibbiltà miżjuda għal ipogliċemja jew
(see section 4.4).
ipergliċemija (ara sezzjoni 4. 4).
Insuman Rapid contains 100 IU of insulin per ml solution.
Insuman Rapid fiħ 100 IU t’ insulina kull ml f ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (100 IU per ml) are to be used.
Dawk is- siringi ta ’ l- injezzjoni biss li huma magħmulin għal din il- konċentrazzjoni t’ insulina (100 IU kull ml) għandhom jintużaw.
The injection syringes must not contain any other medicinal product or residue (e. g. traces of heparin).
Is- siringi ta ’ l - injezzjoni m’ għandhomx ikollhom ebda prodott mediċinali ieħor jew xi residwi (e. ż. traċċi ta ’ ħeparina).
Insuman Rapid is administered subcutaneously.
Insuman Rapid għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Rapid may also be administered intravenously.
Insuman Rapid tista ’ tingħata fil- vina.
Insuman Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.
Insuman Rapid m’ għandhux jintuża f’ pompi ta ’ l- insulina, kemm dawk esterni kif ukoll dawk imdaħħla fil- ġisem, jew f’ pompi peristaltiċi b’ tubi ta’ silikon.
Patients hypersensitive to Insuman Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti- allergic treatment.
Pazjenti b’ sensittivita ’ eċċessiva għal Insuman Rapid, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u - fejn hemm bżonn - flimkien ma ’ trattament kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Rapid, since they may experience immunological cross-reactions.
F’ pazjenti li huma allerġiċi għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir analiżi għar- reazzjonijiet allerġiċi b’ injezzoni żgħira fil- ġilda, qabel ma ssir il- bidla għal Insuman Rapid, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
4 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
4 Biex jitnaqqas ir- riskju ta ’ l- ipogliċemja huwa essenzjali li l- pazjent iżomm mad- dożaġġ u l- kura bid - dieta, it- teħid korrett ta ’ l- insulina, u li l- pazjent ikun konxju tas- sintomi ta ’ l- ipogliċemja.
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 sulphonamide antibiotics.
Is- sustanzi li jistgħu jżidu l- effett fuq it- tnaqqis tal- livell tal- glucose fid- demm, u jżidu s - suxxettibbiltà għall- ipogliċemja, jinkludu sustanzi antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monoamine 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 (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
F’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l - prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
5 xhur u normalment tiżdied waqt it- tieni u t- tielet perijodi ta ’ tliet xhur- il wieħed.
5 Lactation
Treddigħ
Insuman Rapid can be used during breastfeeding.
Insuman Rapid jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
Lactating women may require adjustments in insulin dose and diet.
In- nisa li qed ireddgħu jistgħu jeħtieġu aġġustamenti fid- doża ta ’ l - insulina u d- dieta.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter- regulation.
Episodji twal jew severi t’ ipogliċemja jistgħu jpoġġu l- ħajja fil- periklu. F’ ħafna pazjenti, is- sinjali u s - sintomi ta’ newroglukopenija huma preċeduti minn sinjali adrenerġiċi ta ’ tnaqqis fil- kontroll.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqahuma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Uncommon: shock Not known: immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions), anti-insulin antibodies
Xokk mediku, Mhux magħrufin: reazzjonijiet allerġiċi immedjati (pressjoni baxxa tad- demm, angioneurotic- edema, djuq ostruttiv u akut tal- bronki, reazzjonijiet ġeneraliżżati tal- ġilda), antikorpi kontra l- insulina
In rare cases, the presence of such anti- 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 tista ’ tinħtieġ aġġustament fid- doża ta ’ l- insulina biex tikkoreġi t - tendenza għall- iper - jew l- ipo- gliċemija.
Metabolism and nutrition disorders
6 Disturbi fil- metaboliżmu u n- nutrizzjoni
6 Eyes disorders
Disturbi fl- għajnejn
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles and
- iżżid it- trasport tal- glucose glujosju ġewwa ċ- ċelluli, kif ukoll il- produzzjoni ta’ glycogen fil -
the liver, and improves pyruvate utilisation.
muskoli u l- fwied u timmiljora l- użu ta’ pyruvate.
Insuman Rapid is an insulin with rapid onset and short duration of action.
Insuman Rapid huwa insulina li tibda taħdem malajr u ddum taħdem għal żmien qasir.
Following subcutaneous injection, onset of action is within 30 minutes, the phase of maximum action is between 1 and 4 hours after injection and the duration of action is 7 to 9 hours.
Wara l - injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 30 minuta, tilħaq ħidma massima ta ’ bejn siegħa u 4 sigħat mill- injezzjoni, u ddum taħdem minn 7 sa 9 sigħat.
6.3 Shelf life
8 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
8 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insuman Rapid next to the freezer compartment or a freezer pack.
Insuman Rapid m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Insuman Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.
Insuman Rapid għandu jintuża biss jekk is- soluzzjoni hija ċara, bla kulur, mingħajr partikoli viżibbli u għandu l- konsistenza tixbaħ dik ta ’ l- ilma.
As with all insulin preparations, Insuman Rapid must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Rapid m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Rapid may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insuman Rapid jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insuman Rapid must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insuman Rapid ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
21 February 1997 Date of latest renewal:
21 ta ’ Frar 1997 Data ta ’ l- aħħar tiġdid:
21 February 2007
21 ta ’ Frar 2007
Insuman Rapid 40 IU/ ml solution for injection in a vial
Insuman Rapid 40 IU/ ml soluzzjoni għall- injezzjoni ġo kunjett.
11 Transfer to Insuman Rapid
11 Kif taqleb għal Insuman Rapid
Insuman Rapid contains 40 IU of insulin per ml solution.
Insuman Rapid fiħ 40 IU t’ insulina kull ml f ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (40 IU per ml) are to be used.
Dawk is- siringi ta ’ l- injezzjoni biss li huma magħmulin għal din il- konċentrazzjoni t’ insulina (40 IU kull ml) għandhom jintużaw.
Patients hypersensitive to Insuman Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti- allergic treatment.
Pazjenti b’ sensittivita ’ eċċessiva għal Insuman Rapid, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter- regulation.
F’ ħafna pazjenti, is- sinjali u s- sintomi ta’ newroglukopenija huma preċeduti minn sinjali adrenerġiċi ta ’ tnaqqis fil- kontroll.
Uncommon: shock Not known: immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions), anti-insulin antibodies
Xokk medikuMhux magħrufin: reazzjonijiet allerġiċi immedjati (pressjoni baxxa tad - demm, angioneurotic- edema, djuq ostruttiv u akut tal- bronki, reazzjonijiet ġeneraliżżati tal- ġilda), antikorpi kontra l- insulina
17 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
10 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
10 ml soluzzjoni f’ kunjett (ħġieġ tip I, bla kulur) b’ tapp (aluminju) bil- ħanek, u b’ tapp tal- lasktu (chlorobutyl) (tip I), u għatu (polypropylene) li jista ’ jinġibed.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Il- Ġermanja
Insuman Rapid 100 IU/ ml solution for injection in a cartridge
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo skartoċċ.
Insuman Rapid is injected subcutaneously 15 to 20 minutes before a meal.
Insuman Rapid hija injettata fit- tessut ta ’ taħt il- ġilda minn 15 sa 20 minuta qabel ikla.
Insuman Rapid in cartridges has been developed for use in the OptiPen series.
Insuman Rapid fi skartoċċi ġie żviluppat għall- użu fis- serje ta ’ l- OptiPen.
Patients hypersensitive to Insuman Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti- allergic treatment.
21 Pazjenti b’ sensittivita ’ eċċessiva għal Insuman Rapid, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
Lactation
23 Treddigħ
24 Eyes disorders
24 L- insulina tista ’ tikkawża ż- żamma tas- sodju u l- edema, speċjalment jekk il- kontroll metaboliku fqir preċedenti jkun imtejjeb b’ terapija intensifikata bl- insulina.
25 Mode of action
25 Il- mod kif jaħdem
26 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
The cartridge in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
26 Meta l- iskartoċċ ikun qed jintuża (ġo pinna ta ’ l- insulina) jew ikun qed jinġarr bħala riżerva jista ’ jinħażen għal massimu ta ’ 4 ġimgħat, f’ temperatura mhux ‘ il fuq minn 25°C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The pen containing a cartridge must not be stored in the refrigerator.
Il- pinna li fiha skartoċċ m’ għandhiex tinħażen fi friġġ.
Do not put Insuman Rapid next to the freezer compartment or a freezer pack.
Insuman Rapid m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
Insulin pen The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman cartridges and as recommended in the information provided by the device manufacturer.
Pinna ta ’ l- insulina L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adatti għall- skartoċċi ta ’ Insuman u skond kif inhu rrakkomandat fl- informazzjoni pprovduta mill- manifattur tal- pinna.
Cartridges Before insertion into the pen, Insuman Rapid must be kept at room temperature for 1 to 2 hours.
Skartoċċi Qabel jiddaħħal fil- pinna, Insuman Rapid għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn.
Insuman Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.
Insuman Rapid għandu jintuża biss jekk is - soluzzjoni hija ċara, mingħajr kulur, u bla partikuli solidi u viżibbli, u jekk hija ta ’ konsistenza li tixbah dik ta ’ l- ilma.
As with all insulin preparations, Insuman Rapid must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha Insuman Rapid m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
27 Mixing of insulins
27 Taħlit ta ’ l- insulini
Insuman Rapid cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insuman Rapid m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl - iskartoċċ.
Insuman Rapid 100 IU/ ml solution for injection in a pre-filled pen.
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
Transfer to Insuman Rapid
Kif taqleb għal Insuman Rapid
29 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
29 Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully
Qabel jintuża OptiSet, l- Istruzzjonijiet ghall- Użu li jinsabu fil- Fuljett ta ’ Taghrif għandhom jinqraw bir- reqqa.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
30 F’ pazjenti li għandhom mard sever tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil- kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
Intercurrent illness
31 Mard kurrenti
4.7 Effects on ability to drive and use machines
32 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Eyes disorders
33 Disturbi fl- għajnejn
Mode of action
34 Il- mod kif jaħdem
34 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Pens in-use must not be stored in the refrigerator.
35 Il- pinen fl- użu m’ għandhomx jinżammu fil- friġġ.
Insuman Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.
Insuman Rapid għandu jintuża biss jekk is- soluzzjoni hija ċara, bla kulur, mingħajr ebda partikuli solidi u viżibbli, u jekk għandha konsistenza li tixbah dik ta ’ l- ilma.
Insuman Rapid must not be mixed with any other insulin or with insulin analogues.
Insuman Rapid m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
L- Istruzzjonijiet dwar l- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir - reqqa qabel tintuża l- OptiSet.
Schematic diagram of the pen
36 Dijagramma skematika tal- pinna
36 Storage Instructions
Tagħrif kif għandek taħżen
Check the Insulin
1 Iċċekkja l- insulina
Attach the needle
2 Waħħal il- labra
The needle should be carefully attached straight onto the pen.
Il- labra għandha titwaħħal b’ kawtela u dritta fuq il- pinna.
Perform a safety test
3 Agħmel test ta ’ sigurtà
Prior to each injection a safety test has to be performed.
Qabel kull injezzjoni jrid isir test ta ’ sigurtà.
In-use OptiSet, select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
37 Għal OptiSet fl- użu, agħżel doża ta ’ 2 unitajiet billi ddawwar ’ il quddiem il- mekkaniżmu li jisselezzjona d- dożaġġ, sakemm il- vleġġa li tindika d- doża tipponta lejn “ 2 ”.
37 Step 4.
Pass Nru.
The injection button should be pressed all the way in.
38 Il- buttun ta ’ l- injezzjoni għandu jingħafas sa ġewwa.
Solution for injection in a cartridge for OptiClik.
Soluzzjoni għall- injezzjoni f’ skartoċċ għal OptiClik.
Insuman Rapid in cartridges for OptiClik has been developed for use with OptiClik only.
Insuman Rapid fi skartoċċi għal OptiClik. ġie żviluppat għall- użu f’ OptiClik biss.
41 4.4 Special warnings and precautions for use
41 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
42 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Il- fatturi li
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
42 jżidu s- suxxettibbiltà għas- sintomu tal- ipogliċemja jeħtieġu partikolarment l- moniteraġġ mill- qrib u jistgħu jirrikjedu tibdil tad- l- aġġustament fid- doża.
43 Lactation
43 t- twelid, il- ħtieġa għall- insulina tonqos malajr (b’ riskju miżjud t’ ipogliċemja).
Metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Metacresol, sodium dihydrogen phosphate dihydrate glycerol sodium hydroxide hydrochloric acid (għall- agġustament tal- pH) ilma għall- injezzjonijiet.
Packs of 3, 4, 5, 6, 9 or 10 cartridges for OptiClik are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi għal OptiClik huma disponibbli.
As with all insulin preparations, Insuman Rapid must not be mixed with solutions containing reducing agents such as thioles and sulphites.
47 Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha Insuman Rapid m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Rapid cartridges for OptiClik are not designed to allow any other insulin to be mixed in the cartridge for OptiClik.
L- skartoċċi ta ’ Insuman Rapid għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċċ għal OptiClik.
Insuman Rapid 100 IU/ ml solution for injection in a pre-filled pen.
Insuman Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest
53 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Handling of the pen
56 L- immaniġġar tal- pinna
Important information for use of SoloStar:
French (France)
56 Storage Instructions
Tagħrif kif għandek taħżen
The label on the pen should be checked to make sure it contains the correct insulin.
Iċċekkja t- tikketti tal- pinna biex tiżgura li għandha t- tip korrett t’ insulina. L- Insuman SoloStar hija ta ’ kulur abjad b’ kulur fuq il- buttun ta ’ l- injezzjoni.
Insuman SoloStar is white with a colour on the injection button.
Il- kulur tal- buttun ta ’ l- injezzjoni jista ’ jvarja skond il- formulazzjoni tal- insulina Insuman.
The injection button colour will vary based on the formulation of Insuman insulin used.
Wara li tneħħi l- kappa tal- pinna, iċċekkja wkoll id- dehra ta ’ l- insulina:
After removing the pen cap, the appearance of the insulin should also be checked: • The insulin solution (Insuman Rapid) must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
57 • Is- soluzzjoni ta ’ l- insulina (Insuman Rapid) għandha tkun ċara, mingħajr kulur, b’ ebda partikuli solidi u viżibbli u għandha jkollha konsistenza bħal dik ta ’ l- ilma.
Do not use this SoloStar if insulin is cloudy, coloured or has particles. • The insulin suspensions (Insuman Basal or Insuman mixtures) should be mixed by turning SoloStar up and down at least 10 times to resuspend the insulin.
Tużax din s- SoloStar jekk l - insulina hija mdardra, ikkulurita jew għandha l- partikuli. • Is- suspensjonijiet ta ’ l- insulina (Insuman Basal jew taħlit ta ’ Insuman) għandhom jitħalltu billi iddawwar is- SoloStar ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
57 Step 4.
4
The dose window must show “ 0” following the safety test.
It- tieqa li turi d- dożaġġ trid taqra ‘ 0 ’ wara li jsir it- test ta ’ sigurtà.
Follow recommended safety measures for removal and disposal of needles (e. g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri ta ’ sigurtà għat - tneħħija u r- rimi tal- labar (e. g. tikkappja l- labra permezz ta ’ teknika li tinvolvi l- użu t’ id waħda), biex b’ hekk jonqos ir- riskju li tweġġa ’ aċċidentalment bil- labra u tittrasmetti l- mard infettiv.
Insuman Basal 100 IU/ ml suspension for injection in a vial
Insuman Basal 100 IU/ ml, suspensjoni għall- injezzjoni, ġo kunjett.
Insuman Basal is an isophane insulin suspension.
Insuman Basal hija suspensjoni ta ’ insulina isophane.
Insuman Basal is injected subcutaneously 45 to 60 minutes before a meal.
Insuman Basal hija injettata fit- tessut ta ’ taħt il- ġilda minn 45 sa 60 minuta qabel ikla.
Transfer to Insuman Basal
Kif taqleb għal Insuman Basal
59 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insuman Basal contains 100 IU of insulin per ml suspension.
Insuman Basal fih 100 IU ta ’ insulina f’ kull millilitru ta ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (100 IU per ml) are to be used.
Is- siringi ta ’ l- injezzjoni magħmulin għal din is- saħħa ta ’ preparat ta ’ l- insulina (100 IU kull ml) għandhom jintużaw.
Insuman Basal is administered subcutaneously.
Insuman Basal tingħata fit- tessut taħt il- ġilda.
Insuman Basal must never be injected intravenously.
Insuman Basal qatt m’ għandha tingħata fil- vina.
Insuman Basal must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insuman Basal m’ għandha qatt tingħata intravenuża u m’ għandhiex tintuża f’ pompi għall- infużjoni, jew pompi ta ’ l- insulina, kemm dawk esterni kif ukoll dawk imdaħħla fil- ġisem.
Patients hypersensitive to Insuman Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti- allergic treatment.
Pazjenti b’ sensittivita ’ eċċesiva għal Insuman Basal, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Basal, since they may experience immunological cross-reactions.
F’ pazjenti li huma allerġiċi għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir analiżi għar- reazzjonijiet allerġiċi b’ injezzoni żgħira fil- ġilda, qabel ma ssir il- bidla għal Insuman Basal, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
60 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
61 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
61 Intercurrent illness
Mard kurrenti
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
F’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
Insuman Basal can be used during breastfeeding.
Insuman Rapid jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
62 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom jingħataw parir biex jieħdu l- prekawzjonijiet biex jevitaw l- ipogliċemja waqt is - sewqan.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter- regulation.
F’ ħafna pazjenti, is- sinjali u s- sintomi ta ’ newroglukopenja huma preċeduti minn sinjali adrenerġiċi ta ’ tnaqqis fil- kontroll.
63 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles and
- iżżid it- trasport tal- glucose ġewwa ċ- ċelluli, kif ukoll il- produzzjoni ta’ glycogen fil- muskoli u l -
the liver, and improves pyruvate utilisation.
fwied u timmiljora l- użu ta’ pyruvate.
Insuman Basal (an isophane insulin suspension) is an insulin with gradual onset and long duration of action.
Insuman Basal (insulin isophane, likwidu b’ ħafna partiċelli żgħar) hija insulina li ddum biex taħdem u li l- effett tagħha hu wieħed fit- tul.
64 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Protamine sulphate, metacresol, phenol zinc chloride sodium dihydrogen phosphate dihydrate glycerol sodium hydroxide hydrochloric acid (għall- agġustament tal- pH), ilma għall- injezzjonijiet.
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
66 Il- prodott jista ’ jinħażen għal massimu ta’ 4 ġimgħat f’ temperatura mhux ‘ il fuq minn 25 °C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Do not put Insuman Basal next to the freezer compartment or a freezer pack.
Insuman Basal m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Immediately before withdrawal from the vial into the injection syringe, the insulin must be re-suspended.
Immedjatament qabel titella ’ is- sustanza mediċinali mill- kunjett fis- siringa għall- injezzjoni, l- insulina għandha tkun sospiża mill- ġdid.
Insuman Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the vial.
Insuman Basal m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal - ġenb jew il- qiegħ tal- kunjett.
These changes sometimes give the vial a frosted appearance.
Dawn il- kambjamenti x’ imdaqqiet jagħtu dehra lill- kunjett li qisu miksi bil- ġlata.
As with all insulin preparations, Insuman Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Basal m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Basal may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insuman Basal jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insuman Basal must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insuman Basal ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
It is advisable to inject immediately after mixing.
Jekk żewġ insulini differenti sejrin jittellgħu f’ siringa waħda għall- injezzjoni, huwa rrakkomandat li l - ewwel titella ’ l- insulina li taħdem fuq perijodu iqsar sabiex tevita l- kontaminazzjoni tal- kunjett tal - preparat li jaħdem fuq tul ta ’ ħin itwal. Ta ’ min jirrikkmanda li l- injezzjoni ssir immedjatament wara li titħallat.
Any unused product or waste material should be disposed of in accordance with local requirements.
67 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insuman Basal 40 IU/ ml suspension for injection in a vial
Insuman Basal 40 IU/ ml, suspensjoni għall- injezzjoni, ġo kunjett.
68 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insuman Basal contains 40 IU of insulin per ml suspension.
Insuman Basal fih 40 IU ta ’ insulina f’ kull millilitru ta ’ soluzzjoni.
Only injection syringes designed for this strength of insulin (40 IU per ml) are to be used.
Is- siringi ta ’ l- injezzjoni magħmulin għal din is- saħħa ta ’ preparat ta ’ l- insulina (40 IU kull ml) għandhom jintużaw.
69 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
70 F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
70 Intercurrent illness
71 Mard kurrenti
71 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem maġni
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
72 f’ sitwazzjonijiet fejn dawn l- abbiltajiet huma t’ importanza speċjali (e. ż. sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
72 A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Kambjament sostanzjali tal- kontroll gliċemiku jista ’ jikkawża tnaqqis tamporanju tal- vista, dovut għal bidla temporanja fl- ebbusija u l- indiċi tar- rifrazzjoni tal- lenti ta ’ l- għajn.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
73 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
73 Pharmacodynamic characteristics
Karatteristiċi farmakodinamiċi
74 6.4 Special precautions for storage
75 6. 4 Prekawzjonijiet speċjali għall- ħażna
Insuman Basal 100 IU/ ml suspension for injection in a cartridge
Insuman Basal 100 IU/ ml, Suspensjoni għall- injezzjoni, ġo skartoċċ.
77 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insuman Basal in cartridges has been developed for use in the OptiPen series.
Insuman Basal fi skartoċċi kienet żviluppata għall- użu mas- serje ta ’ l- OptiPen.
Insuman Basal is administered subcutaneously.
Insuman Basal tingħata fit- tessut ta ’ taħt il- ġilda.
78 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
79 F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
79 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma’ jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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 sulphonamide antibiotics.
Is- sustanzi li jistgħu jżidu l- effett fuq it- tnaqqis tal- livell tal- glucose fid- demm, u jżidu s- suxxettibbiltà għall- ipogliċemja, jinkludu oral antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti anġiotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monoamine oxidase (MAO) inhibitors, 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 (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
F’ kontrċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline) u l- ormoni tat- tirojde, inibituri tal- protease u l - prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
80 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
81 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
82 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Unopened cartridges:
84 Skartoċċi mhux miftuħa:
Do not put Insuman Basal next to the freezer compartment or a freezer pack.
Insuman Basal m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
83 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Insulin pen The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman cartridges and as recommended in the information provided by the device manufacturer.
Pinna ta ’ l- insulina L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra oħrajn li jaqblu ma ’ l- skartoċċi ta ’ Insuman u skond kif inhu rrakkomandat fit- tagħrif pprovduta mill - manifattur tal- pinna.
Cartridges Before insertion into the pen, Insuman Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Skartoċċi Qabel ma jiddaħħal fil- pinna, Insuman Basal għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
This is best done by gently tilting the cartridge back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil l- iskartoċċ bil- mod ’ il quddiem u lura (għal mhux anqas minn għaxar darbiet).
Insuman Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
Jekk din l- apparenza ma tintlaħaqx, iġifieri jekk il- preparat per eżempju jibqa ’ ċar, jew jitfaċċaw xi ċapep, partikoli jew biċċiet bħal trofof tas- suf fl- insulina, jew jeħlu mal- ġenb jew il- qiegħ ta ’ l - iskartoċċ, Insuman Basal ma tistax tintuża.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- bidliet xi mindaqqiet jagħtu lill- iskartoċċ dehera mtappna.
In such cases, a new cartridge yielding a uniform suspension must be used.
F’ każijiet bħal dawn, skartoċċ ġdid li juri l- partiċelli żgħar mqassmin b’ mod uniformi jrid jintuża.
It is also necessary to change to a new cartridge if the insulin requirement changes substantially.
Huwa neċessarju wkoll li jinbidel l- iskartoċċ għal wieħed ġdid jekk il- ħtieġa għall- insulina tinbidel b’ mod sostanzjali.
As with all insulin preparations, Insuman Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha Insuman Basal m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Basal cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insuman Basal m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl - iskartoċċ.
Insuman Basal 100 IU/ ml suspension for injection in a pre-filled pen.
Insuman Basal 100 IU/ ml, suspensjoni għall- injezzjoni, ġo pinna mimlija għal- lest.
Suspension for injection in a pre-filled pen.
Suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest,.
86 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insuman Basal is administered subcutaneously.
Insuman Basal għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Basal must never be injected intravenously.
Insuman Basal qatt m’ għandu jingħata ġol - vina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
88 F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.