qanastek/EMEA-V3 huggingface dataset:
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).
Sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f‘ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u il - prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
L- imblokkaturi tar- riċetturi beta, clonidine, lithium salts, jew l- alkoħol jistgħu jżiedu jew inaqqsu l - effett ta ’ l- insulina fuq it- tnaqqis fil- livell tal- glucose fid- demm.
Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Pentamidine jista ’ jikkawża l - ipogliċemja, li xi mdaqqiet 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.
Hekk wkoll, is- sinjali adrenerġiċi ta ’ kontra l- kontroll jistgħu jitnaqqsu jew ikunu assenti taħt l- effett ta ’ sustanzi mediċinali simpatolitiċi bħall- imblokkaturi tar- riċetturi beta, clonidine, guanethidine u reserpine.
For insulin human, no clinical data on exposed pregnancies are available.
Għall- insulina umana, m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Insulin does not cross the placental barrier.
L- insulina ma taqsamx għal ġol- plaċenta.
5 It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
5 Huwa essenzjali, li l- pazjenti li kellhom id- dijabete qabel, jew għandhom id- dijabete waqt it- tqala, jżommu kontroll metaboliku tajjeb tul it- tqala kollha.
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Il- ħtieġa għall- insulina tonqos fl- ewwel tliet xhur u normalment tiżdied waqt it- tieni u t- tielet perijodi ta ’ tliet xhur- il wieħed.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Immedjatament wara t- twelid, il- ħtieġa għall- insulina tonqos malajr (b’ riskju miżjud t’ ipogliċemja).
Careful monitoring of glucose control is essential.
L- immoniterjar bir - reqqa tal- livell tal- glucose huwa essenzjali.
No effects on the suckling child are anticipated.
M’ humiex mistennija ebda effetti fuq it- tarbija waqt it- treddigħ.
Insulin Human Winthrop Rapid can be used during breastfeeding.
Insulin Human Winthrop 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.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
L- abbiltà tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jkunu mdgħajfa mħabba l- ipogliċemja jew l- ipergliċemija jew, per eżempju, bħala riżultat tat- tnaqqis fil- vista.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dawn jikkonstitwixxu riskju f’ sitwazzjonijiet fejn dawn l- abbiltajiet huma t’ importanza speċjali (e. ż. sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
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.
This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan huwa partikolarment importanti f’ dawk li għandhom sintomi mnaqqsa ta ’ ipogliċemja, jew li ma jistgħux jgħarrfu s- sintomi ta ’ twissija tal- bidu, jew li għandhom episodji spissi ta ’ ipogliċemja.
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
Għandu jkun ikkunsidrat jekk ikunx għaqli s- sewqan jew it- tħaddim tal- makkinarju f’ ċirkostanzi bħal dawn.
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemja, li ġeneralment hija l- aktar effett komuni u mhux mixtieq tat- terapija bl- insulina, tista ’ tiġri meta d- doża ta ’ l- insulina tkun għolja wisq relatata mal- bżonn tagħha.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Fi provi kliniċi u meta l - prodott kien fuq is- suq u ntuża, l- frekwenza tvarja minn grupp ta ’ pazjenti għal ieħor u skond s- sistemi ta ’ dożi użati.
Therefore, no specific frequency can be presented.
Għalhekk, ebda frekwenza speċifika ma tista ’ tingħata.
Prolonged or severe hypoglycaemic episodes may be life-threatening.
Attakki severi ta ’ ipogliċemja, speċjalment meta jirrikorru, jistgħu jwasslu għall- ħsara newroloġika.
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.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Ġeneralment dan il- fenomenu tat- tnaqqis fil- kontroll, u s- sintomi tiegħu, huma aktar immarkati meta t - tnaqqis fil- livell tal- glucose fid- demm ikun akbar u aktar mgħaġġel.
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
L- effetti avversi relatati u imniżżlin hawn taħt, miġbura minn studji kliniċi, huma elenkati skond is - sistema tal- klassifika ta ’ l- organi u f’ ordni fejn l- inċidenza dejjem tonqos: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
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
Immediate type allergic reactions to insulin or to the excipients may be life-threatening.
Reazzjonijiet allergici immedjati ghall- insulina jew għas- sustanzi mhux attivi jistgħu jkunu fatali.
6 Metabolism and nutrition disorders
6 L- għoti ta ’ l- insulina jista ’ jwassal għall- produzzjoni ta ’ l- antikorpi kontra l- insulina.
Common: oedema Not known: sodium retention
Komuni: edema Mhux magħrufin: iż- zamma tas- sodju
Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
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.
Eyes disorders
Disturbi fl- għajnejn
Not known: proliferative retinopathy, diabetic retinopathy, visual impairment
Mhux magħrufin: retinopatija proliferattiva, retinopatija dijabetika, tnaqqis fil- vista
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.
Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Madankollu, żieda fit- terapija bl- insulina b’ ċaqlieq imtejjeb, iżda goff, tal- kontroll gliċemiku, jista ’ jkun assoċjat ma ’ deterjorament temporanju tar- retinopatija dijabetika.
Not known: lipodystrophy
Mhux magħrufin: lipodistrofija
As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Bdil kontinwu fis- sit ta ’ l- injezzjoni, f’ żona ta ’ injezzjoni partikolari, jista ’ jgħin biex inaqqas jew jevita dawn ir- reazzjonijiet.
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Komuni: reazzjonijiet fis- sit ta ’ l- injezzjonijiet Mhux komuni: urtikarja fis- sit ta ’ l- injezzjoni Mhux magħrufin: infjammazzjoni fis- sit ta ’ l- injezzjoni, nefħa fis- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l - injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Il- biċċa l- kbira tar- reazzjonijiet żgħar għall- insulini fis- sit ta ’ l- injezzjoni is- soltu jgħaddu fi żmien ftit jiem sa ftit ġimgħat.
Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Doża eċċessiva t’ insulina tista ’ twassal għall- ipogliċemja severa, u xi kull tant fit- tul, u tista ’ tpoġġi l - pazjent f’ periklu tal- mewt.
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
ManiġġarEpisodji ħfief ta ’ ipogliċemja jistgħu normalment ikunu ittrattati bil- karboidrati oralment.
Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.
Tibdili fid- dożaġġ tal- prodott mediċinali, fl- ikliet u fl- attività fiżika jistgħu jkunu jridu jsiru.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Episodji aktar severi b’ koma, l- aċċessjoni, jew disturb newroloġiku jistgħu jiġu ittrattati b’ glucagon intramuskolari jew fit- tessut ta ’ taħt il- ġilda, jew bl- għoti tal- glucose ikkonċentrat fil- vina.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Jista ’ jkun meħtieġ li t- teħid tal- karboidrati jitkompla, u l- moniteraġġ jista ’ jkun neċessarju għaliex l- ipogliċemja li tkun hemm tista ’ terġa ’ titfaċċa, wara li jkun reġistrat fejqan kliniku apparenti.
Pharmacotherapeutic group:
Kategorija farmakoterapewtiku:
Antidiabetic agent.
Sustanza antidijabetika.
Insulins and analogues, fast-acting, ATC Code:
L- insulini u l- analogi tagħhom, li jaħdmu malajr.
Mode of action
Il- mod kif jaħdem
Insulin
L- insulina
- lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,
- tnaqqas il- livell tal- glucose fid- demm u tinkoraġixxi l- effetti anaboliċi, kif ukoll tnaqqas l -
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles
- iżżid it- trasport tal- glucose glujosju ġewwa ċ- ċelluli, kif ukoll il- produzzjoni ta’ glycogen fil -
and the liver, and improves pyruvate utilisation.
muskoli u l- fwied u timmiljora l- użu ta’ pyruvate.
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi glykoġenoliżi u glukoneoġenesi
- increases lipogenesis in the liver and adipose tissue and inhibits lipolysis,
- iżżid il- lipoġenesi fil - fwied u t- tessut xaħmi fil- waqt li tinibixxi il- lipolisi,
- promotes the uptake of amino acids into cells and promotes protein synthesis,
- tippromwovi id- dħul ta ’ l- aċidi amminiċi fiċ- ċelluli u tippromwovi l- produzzjoni tal- proteini,
- enhances the uptake of potassium into cells.
- iżżid id- dħul ta ’ potassium gewwa ċ- ċelluli.
Pharmacodynamic characteristics
Karatteristiċi farmakodinamiċi
Insulin Human Winthrop Rapid is an insulin with rapid onset and short duration of action.
Insulin Human Winthrop 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.
In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
F’ pazjenti b’ saħħithom, il- half- life fis- serum tad- demm huwa bejn wieħed u ieħor minn 4 sa 6 minuti.
However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
F’ pazjenti li għandhom insuffiċjenza severa renali, dan iż- żmien jitwal. kliewi Madankollu, ta ’ min jinnota li l- farmakokinetiċi ta ’ l- insulina ma jirriflettix l- effett metaboliku tagħha.
The acute toxicity was studied following subcutaneous administration in rats.
It- tossiċita akuta kienet studjata fil- firien wara injezzjoni fit- tessut ta ’ taħt il- ġilda.
No evidence of toxic effects was found.
Ma nstabet ebda evidenza t’ effetti tossiċi.
Local tolerability studies following subcutaneous and intramuscular administration in rabbits gave no remarkable findings.
Studji dwar it- tollerabbiltà lokali wara t- teħid fit- tessut ta ’ taħt il- ġilda u intramuskulari fil- fniek ma tawx riżultati mhux mistennijaurew.
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Studji fuq l- effetti farmakodinamiċi wara l- għoti fit- tessut ta ’ taħt il- ġilda fil- fniek u l- klieb urew reazzjonijiet ipogliċemiċi mistennija.
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
Concerning mixing or incompatibility with other insulins see section 6.6.
Rigward it- taħlit jew l- inkompatibilità ma ’ insulini oħrajn ara sezzjoni 6. 6.
Care must be taken to ensure that no alcohol or other disinfectants enter the insulin solution.
Il- kawtela trid titttieħed biex tiżgura li ebda alkoħol jew disinfettanti oħra ma jidħlu fis- soluzzjoni ta ’ l- insulina.
8 6.3 Shelf life
8 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Shelf life after first use of the vial:
Żmien kemm idum tajjeb il- kunjett wara l- ewwel użu:
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
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.
It is recommended that the date of the first use be noted on the label.
Huwa rakkomandat li d- data ta ’ l- ewwel użu tkun mniżżla fuq it- tikketta..
Do not put Insulin Human Winthrop Rapid next to the freezer compartment or a freezer pack.
Insulin Human WinthropInsulin Human Winthrop Rapid m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
Opened vials:
Kunjetti miftuħa:
For storage precautions, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna, ara sezzjoni 6. 3.
5 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).
5 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.
Packs of 1 and 5 vials are available.
Pakketti ta ’ 1 u 5 kunjetti huma disponibbli.
Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.
Qabel ma tiġbed l- insulina mill- kunjett għall- ewwel darba, neħħi l- għatu protettiv tal- plastik.
Do not shake the vial vigorously as this may cause frothing.
Tħawwadx il- kunjett bil- qawwa għax dan jagħmel ir- ragħwa.
Froth may interfere with the correct measurement of the dose.
Ir- ragħwa tista ’ tinterferixxi fil- kejl korrett tad- doża.
Insulin Human Winthrop 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.
Insulin Human Winthrop 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, Insulin Human Winthrop Rapid must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Rapid m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
It must also be remembered that neutral regular insulin precipitates out at a pH of approximately 4.5 to 6.5.
Wieħed għandu wkoll jiftakar li l- insulina newtrali u regolari tippreċipita f’ pH ta ’ madwar 4. 5 sa 6. 5.
Insulin Human Winthrop Rapid may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Meta tħallat l- insulini Insulin Human Winthrop Rapid jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insulin Human Winthrop rapid must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insulin Human Winthrop Rapid ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
Jekk hemm il- ħtieġa li jinġibdu żewġ insulini diversi fl- istess siringa għall- injezzjoni, huwa irrakkomandat li l- insulina li ddum taħdem għal żmien qasir tinġibed l- ewwel biex tevita l - kontaminazzjoni tal- kunjett bil- preparat li jdum jaħdem għal zmien itwal.
It is advisable to inject immediately after mixing.
Huwa rrakkomandat li tinjetta immedjatament wara li titħallat.
Insulins of different concentration (e. g.
Insulini li għandhom konċentrazzjonijiet differenti (e. ż.
100 IU per ml and 40 IU per ml) must not be mixed.
100 IU/ ml u 40 IU/ ml) m’ għandhomx jitħalltu flimkien.
Any unused product or waste material should be disposed of in accordance with local requirements.
9 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Il- Ġermanja.
17 January 2007
17 ta ’ Jannar 2007
Insulin Human Winthrop Rapid 40 IU/ ml solution for injection in a vial
Insulin Human Winthrop Rapid 40 IU/ ml soluzzjoni għall- injezzjoni ġo kunjett.
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Kull ml fih 40 IU insulina umana (ekwivalenti għal 1. 4 mg).
Each vial contains 10 ml of solution for injection, equivalent to 400 IU insulin.
Kull kunjett fih 10 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 400 IU insulina.
Insulin Human Winthrop Rapid is a neutral insulin solution (regular insulin).
Insulin Human WinthropRapid hija soluzzjoni newtrali ta ’ insulina (insulina regolari).
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Insulina umana Insulin Human Winthrophija magħmula permezz tat- teknoloġija rikombinanti tad - DNA ġo Escherichia coli.
11 Transfer to Insulin Human Winthrop Rapid
11 Kif taqleb għal Insulin Human Winthrop Rapid
Insulin Human Winthrop Rapid contains 40 IU of insulin per ml solution.
Insulin Human Winthrop 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.
12 4.3 Contraindications
12 4. 3 Kontra- indikazzjonijiet
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
13 Jekk ikun hemm livelli normali jew imnaqqsa ta’ emoglobina glikata, il- possibbiltà t’ attakki ta ’ ipogliċemja rikurrenti, u dawk fejn il- pazjent ma jintebaħx bihom (speċjalment matul il- lejl), trid tkun ikkunsidrata.
13 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.
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.
Intercurrent illness
Mard kurrenti
Intercurrent illness requires intensified metabolic monitoring.
Il- mard kurrenti jirrikjedi l- moniteraġġ metaboliku aktar intensiv.
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 anġiotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates u l- antibijotiċi sulphonamide.
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (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).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline) l- ormoni tat- tirojde, inibituri tal- protease u il - prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
4.6 Pregnancy and lactation
14 4. 6 Tqala u Treddigħ
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Huwa essenzjali, li l- pazjenti li kellhom id- dijabete qabel, jew għandhom id- dijabete waqt it- tqala, jżommu kontroll metaboliku tajjeb tul it- tqala kollha.
14 Lactation
Treddigħ
Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemja, speċjalment meta jirrikorru, jistgħu jwasslu għall- ħsara newroloġika.
Prolonged or severe hypoglycaemic episodes may be life-threatening.
Episodji twal jew severi t’ ipogliċemja jistgħu jpoġġu l- ħajja fil- periklu.
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.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Ġeneralment dan il- fenomenu tat- tnaqqis fil- kontroll, u s- sintomi tiegħu, huma aktar immarkati meta t- tnaqqis fil- livell tal- glucose fid- demm ikun akbar u aktar mgħaġġel.
Immune system disorders
15 Disturbi fis- sistema immuni
Insulin administration may cause anti-insulin antibodies to form.
L- għoti ta ’ l- insulina jista ’ jwassal għall- produzzjoni ta ’ l- 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.
15 Eyes disorders
Disturbi fl- għajnejn
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ sit mnejn jingħata
Management
16 Maniġġar
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Episodji ħfief ta ’ ipogliċemja jistgħu normalment ikunu ittrattati bil- karboidrati oralment.
Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.
Tibdili fid - dożaġġ tal- prodott mediċinali, fl- ikliet u fl- attività fiżika jistgħu jkunu jridu jsiru.
16 Mode of action
Il- mod kif jaħdem
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi glykoġenoliżi u glukoneoġenesi,
Metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Metacresol, sodium dihydrogen phosphate dihydrate glycerol sodium hydroxide
17 Shelf life after first use of the vial:
Żmien kemm idum tajjeb il- kunjett wara l- ewwel użu:
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
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.
It is recommended that the date of the first use be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu tkun mniżżla fuq it- tikketta..
Do not put Insulin Human Winthrop Rapid next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Insulin Human Winthrop Rapid m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
10 mlsolution 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.
Mixing of insulins
18 Meta tħallat l- insulini
Insulin Human Winthrop Rapid may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Human Winthrop Rapid jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insulin Human Winthrop Rapid must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insulin Human Winthrop Rapid ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a cartridge
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo skartoċċ.
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml fih 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5 mg.
Each cartridge contains 3 ml of solution for injection, equivalent to 300 IU insulin.
Kull skartoċċ fih 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 300 UI insulina.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
UI (Unita Internazzjonali) waħda hija ekwivalenti għal 0. 035 mg insulina umana anidru.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Insulina umana Insulin Human Winthrop hija magħmula permezz tat- teknoloġija rikombinanti tad - DNA ġo Escherichia coli.
Solution for injection in a cartridge.
Soluzzjoni għall- injezzjoni ġo skartoċċ.
The basal metabolic requirement is 40% to 60% of the total daily requirement.
Il- bżonn għall- metaboliżmu bażiku huwa ta ’ minn 40 sa 60% tal- ħtieġa sħiħa ta ’ jum wieħed.
20 Transfer to Insulin Human Winthrop Rapid
20 Kif taqleb għal Insulin Human Winthrop Rapid
Insulin Human Winthrop Rapid in cartridges has been developed for use in the OptiPen series.
Insulin Human Winthrop Rapid fi skartoċċi ġie żviluppat għall- użu fis- serje ta ’ l- OptiPen.
Insulin Human Winthrop Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.
21 Insulin Human Winthrop 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.
21 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Jekk ikun hemm livelli normali jew imnaqqsa ta’ emoglobina glikata, il- possibbiltà t’ attakki ta ’ ipogliċemja rikurrenti, u dawk fejn il- pazjent ma jintebaħx bihom (speċjalment matul il- lejl), trid tkun ikkunsidrata.
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.
22 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.
For insulin human, no clinical data on exposed pregnancies are available.
Għall- insulina umana, m’ hemmx tagħrif kliniku dwar l’ użu waqt it- tqala.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Immedjatament wara
23 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Metabolism and nutrition disorders
24 Disturbi fil- metaboliżmu u n- nutrizzjoni
24 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.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Madankollu, żieda fit- terapija bl- insulina b’ ċaqlieq imtejjeb, iżda goff, fil- kontroll gliċemiku, jista ’ jkun assoċjat ma ’ deterjorament temporanju tar- retinopatija dijabetika.
Management
Maniġġar
25 Mode of action
Il- mod kif jaħdem
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi l- glykoġenoliżi u glukoneoġenesi,
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
26 Shelf life after first use of the cartridge:
Żmien kemm idum tajjeb l- iskartoċċ wara l- ewwel użu:
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.
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’ għandiex tinħażen fi friġġ.
The pen cap must be put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed fuq il- pinna sabiex tilqa ’ mid- dawl.
Unopened cartridges:
Skartoċċi mhux miftuħa:
Store in a refrigerator (2°C - 8°C).
Aħżen fil- friġġ (2°Ċ - 8°Ċ).
Do not put Insulin Human Winthrop Rapid next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Rapid m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
Keep the cartridge in the outer carton in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
In-use cartridges:
Skartoċċi fl- użu:
3 ml solution in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml soluzzjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) u għatu taħt għamla ta ’ flanġ (ta ’ l - aluminju), b’ tapp (tal- lastku tal- bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Packs of 3, 4, 5, 6, 9 or 10 cartridges are available.
Pakketti ta ’ 3, 4, 5, 6, 9 u 10 skartoċċi huma disponibbli.
Insulin pen The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insulin Human Winthrop 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 ’ Insulin Human Winthrop u skond kif inhu rrakkomandat fl- informazzjoni pprovduta mill- manifattur tal- pinna.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa biex jiddaħħal l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix taħdem sew (dovut għal difetti mekkaniċi) din għandha tintrema, u pinna ġdida oħra ta ’ l- insulina tintuża minflok.
If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
Jekk il- pinna ma taħdimx sew (ara l- istruzzjonijiet dwar l- użu tal- pinna), is- soluzzjoni tista ’ titella ’ f’ siringa ta ’ l- injezzjoni (adatta għal insulina ta 100 IU/ ml) u tiġi injettata.
Cartridges Before insertion into the pen, Insulin Human Winthrop Rapid must be kept at room temperature for 1 to 2 hours.
Skartoċċi Qabel jiddaħħal fil- pinna, Insulin Human Winthrop Rapid għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn.
Inspect the cartridge before use.
Spezzjona l- iskartoċċ qabel tużah.
Insulin Human Winthrop 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.
Insulin Human Winthrop 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.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
27 Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l - użu tal- pinna).
Empty cartridges must not be refilled.
Skartoċċi vojta m’ għandhomx jerġghu jimtlew.
As with all insulin preparations, Insulin Human Winthrop Rapid must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha Insulin Human Winthrop Rapid m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
27 Mixing of insulins
Taħlit ta ’ l- insulini
Insulin Human Winthrop Rapid cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insulin Human Winthrop Rapid m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċċ.
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a pre-filled pen.
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml fih 100 IU insulina umana (ekwivalenti għal 3. 5 mg).
Each pen contains 3 ml of solution for injection, equivalent to 300 IU insulin.
Kull pinna fiha 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 300 IU insulina.
Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest.
OptiSet delivers insulin in increments of 2 IU up to a maximum single dose of 40 IU.
Insulin Human WinthropOptiSet tagħti insulina f’ ammonti ta ’ 2 IU kull żieda sal massimu ta ’ doża waħda ta ’ 40 IU.
Transfer to Insulin Human Winthrop Rapid
Kif taqleb għal Insulin Human Winthrop Rapid
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
29 Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
29 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
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 renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
30 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Fl- anzjani, l- aggravament progressiv tal- funzjoni tal- jista ’ jwassal għat - tnaqqis sostanzjali fil- bżonn ta ’ l- insulina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom 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.
30 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ nuqqas adegwat tal- kontroll tal- livell tal- glucose, jew f’ każ ta ’ tendenza biex jokkorru attakki ta ’ l- ipergliċemija jew l- ipogliċemja, għandha ssir rievalwazzjoni ta ’ kemm il- pazjent qiegħed jieħu t- trattament preskritt, is- siti ta ’ l- injezzjoni, it- teknika korretta ta ’ kif qed issir l- injezzjoni u kull fattur ieħor rilevanti, qabel ma tkun ikkunsidrata l- tibdil tad- doża.
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.
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.
- missed meals,
- ikliet maqbuża,,
31 Handling of the pen
L- immaniġġar tal- pinna
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully.
Qabel tuża OptiSet, aqra bir- reqqa l- Istruzzjonijiet ghall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif.
OptiSet has to be used as recommended in these Instructions for Use (see section 6.6).
OptiSet għandha tintuża skond kif inhu irrakkomandat fl- Istruzzjonijiet ghall- Użu (ara sezzjoni 6. 6).
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 anġjotensin (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).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u il - prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
Lactation
32 Treddigħ
32 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Metabolism and nutrition disorders
33 Disturbi fil- metaboliżmu u n- nutrizzjoni
33 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi l- glykoġenoliżi u glukoneoġenesi
34 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
It is longer in patients with severe renal insufficiency.
F’ pazjenti li għandhom insuffiċjenza severa renali, dan iż- żmien jitwal.
However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
Madankollu, ta ’ min jinnota li l- farmakokinetiċi ta ’ l- insulina ma jirriflettix l- effett metaboliku tagħha.
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
6.3 Shelf life
35 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
The pen in-use 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.
Żmien kemm iddumtajba l- pinna wara l- ewwel użu; Il- pinna li qed tintuża jew li qed tinġarr bħala riżerva tista ’ tinħażen għall- massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Pens in-use must not be stored in the refrigerator.
Il- pinen fl- użu m’ għandhomx jinżammu fil- friġġ.
Not in-use pens:
Pinen mhux fl- użu:
Do not freeze.
Aħżen fi friġġ (2°Ċ - 8°Ċ) Tagħmilhomx fil- friża.
Keep the pre-filled pen in the outer carton in order to protect from light.
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
In-use pens:
Pinen fl- użu:
35 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml solution in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml soluzzjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) u għatu bi flanġ (aluminju), b’ tapp (lastku tal- bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
The cartridges are sealed in a disposable pen injector.
L- skartoċċi huma issiġġillati fil- pinna għall- injezzjoni, li tintrema wara li tinħela.
Injection needles are not included in the pack.
Il- labar għall- injezzjoni mhux inklużi fil- pakkett.
Packs of 3, 4, 5, 6, 9 or 10 pens are available.
Pakketti ta ’ 3, 4, 5, 6, 9 u 10 pinen huma disponibbli.
Insulin Human Winthrop 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.
Insulin Human Winthrop 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.
Empty pens must never be reused and must be properly discarded.
Pinen vojta m’ għandhom qatt jerġgħu jintużaw u għandhom jintremew kif jixraq.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Biex wieħed jilqa ’ kontra l- possibbiltà tat- tixrid tal- mard, kull pinna għandha tintuża minn pazjent wieħed biss.
Mixing of insulins
Meta tħallat l- insulini
Insulin Human Winthrop Rapid must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Rapid m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
36 Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
36 L- immaniġġar tal- pinna
Schematic diagram of the pen
Dijagramma skematika tal- pinna
Important information for use of OptiSet: • Always attach a new needle before each use.
Tagħrif importanti għall- użu ta ’ OptiSet: • Dejjem waħħal labra ġdida qabel kull darba li tużaha.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out. • This pen is only for the patients use.
Uża biss labar li huma kompatibbli ma ’ l - użu ta ’ OptiSet. • Dejjem agħmel it- test ta ’ sigurtà qabel kull injezzjoni. • Jekk OptiSet ġdida ser tintuża, it- test inizjali ta ’ sigurtà għandu jsir bit- 8 Unità issettjati minn qabel mill- manifattur. • Il- mekkaniżmu għas- selezzjoni tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar dan il- mekkaniżmu (tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni ikun inġibed ’ il barra. • Din il- pinna hija intiża għall- użu mill- pazjent biss.