qanastek/EMEA-V3 huggingface dataset:
Insulin Human Winthrop Comb 15 must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insulin Human Winthrop Comb 15 m’ ghandux jinghata ġol- vina u anqas m’ għandu jintuża f’ pompi ta ’ l- infuzzjoni jew f’ pompi ta ’ l- insulina, kemm esterni kif ukoll dawk interni.
Patients hypersensitive to Insulin Human Winthrop Comb 15 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 li juru sensittività eċċessiva għal Insulin Human Winthrop Comb 15 u li m’ hemmx preparat aħjar disponibbli għalihom għandhom ikomplu biss it- trattament taħt supervizzjoni medika u, fejn huwa meħtieġ, flimkien mal- kura kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Comb 15, since they may experience immunological cross-reactions.
F’ pazjenti li jbatu minn allergija għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir test ta ’ l- allerġija fil- ġilda qabel ma ssir il- bidla għal Insulin Human Winthrop Comb 15, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
119 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
119 F’ pazjenti b’ indeboliment renali,, il- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Fl- anzjani, d- deterjorament progressiv fil- funzjoni renali jista ’ jwassal għal tnaqqis miżmum fil- bżonn ghall- insulina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti b’ indeboliment sever tal- fwied, il- ħtiega ghall- insulina tista ’ tonqos dovut għan- nuqqas ta ’ produzzjoni tal- glucose u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ li l- kontroll tal- glucose mhux tajjeb jew hemm tendenza għall- iżvilupp ta ’ grajjiet ta ’ iper - jew ipo- glicemija, għandhom jiġu investigati jekk il- pazjent huwiex qed iżomm mad- dieta preskritta, s- siti ta ’ l- injezzjoni, t- teknika korretta ta ’ l- injezzjoni u l- fatturi rilevanti l- ohrajn kollha qabel ma l - aġġustament fid- doża tkun ikkunsidrata
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipoglicemija tista ’ tiġri jekk id- doża ta ’ l- insulina hija għolja wisq meta tkun relatata mal- bżonn ta ’ l- insulina.
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Il- kawtela speċjali trid tiġi eżerċitata, u ta ’ min jirrikkmanda l- itensifikar fl- immoniterjar tal- livell tal - glucose fid- demm, f’ dawk il- pazjenti meta l- ġrajjiet ipogliċemiċi jkunu ta ’ rilevanza klinika speċjali, bħal dawk il- pazjenti bi djuq sinifikanti ta ’ l- arterji koronarji jew ta ’ l- arterji li jissupplixxu l- moħħ (riskju ta ’ komplikazzjonijiet tal- qalb u tal- moħħ mill- ipogliċemija), kif ukoll il- pazjenti li jbatu minn retinopatija proliferattiva, speċjalment jekk mhux qed ikunu ittrattati bil- fotokoagulazzjoni (riskju t’ għama temporanja wara l- ipoglicemija).
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Il- pazjenti għandhom ikunu konxji taċ- ċirkustanzi meta s- sintomi ta ’ twissija ta ’ l- ipogliċemija huma imnaqqsin.
The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.
Is- sintomi ta ’ twissija ta ’ l- ipogliċemija jistgħu jinbiddlu, jsiru anqas immarkati jew jintilfu f’ ċerti gruppi ta ’ riskju.
- in whom glycaemic control is markedly improved,
- fejn il- kontroll taz- zokkor fid- demm tjieb ħafna,
- in whom hypoglycaemia develops gradually,
- fejn l- ipogliċemija tiżviluppa bilmod,
- after transfer from animal insulin to human insulin,
- wara li jinqalbu minn insulina derivata mill- annimali għal waħda umana,
- with a long history of diabetes,
- li għandhom storja twila tad- dijabete,
- suffering from a psychiatric illness,
- li qed ibatu minn mard psikjatriku,
- receiving concurrent treatment with certain other medicinal products (see section 4.5).
- li qed jieħdu fl- istess ħin trattament bi prodotti mediċinali oħrajn (ara sezzjoni 4. 5).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Sitwazzjonijiet bħal dawn jistgħu jirriżultaw f’ ipogliċemija severa (u possibbilment in- nuqqas mis - sensi) qabel ma l- pazjent jintebaħ bl- ipogliċemija.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Jekk il- livelli ta ’ l- emoglobina glycated huma normali jew imnaqqsin, il- possibbiltà ta ’ ġrajjiet tal - ipogliċemija rikurrenti u mhux magħrufin (speċjalment billejl) għandha tiġi ikkunsidrata.
Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Il- fatturi li jżidu s- suxxettibbiltà għas- sintomu tal- ipogliċemja jeħtieġu partikolarment l- moniteraġġ mill- qrib u jistgħu jirrikjedu tibdil tad- l- aġġustament fid- doża..
- change in the injection area,
- bidla fiż- żona ta ’ l- injezzjoni,
- improved insulin sensitivity (by, e. g., removal of stress factors),
- sensittività ogħla għall- insulina (per eżempju, bit- tneħħija ta ’ fatturi li jikkaġunaw l- istress),
- unaccustomed, increased or prolonged physical activity,
- attività fiżika mhux tas- soltu, miżjuda jew fuq tul aktar ta ’ żmien,
- intercurrent illness (e. g. vomiting, diarrhoea),
- mard ieħor fl- istess waqt (e. g. rimettar, dijarea),
- inadequate food intake,
- tnaqqis fil- konsum ta ’ l- ikel,
- missed meals,
- ikliet maqbużin,
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kompensati (e. g. f’ kas ta’ ipotirojdiżmu u
adrenocortical insufficiency),
insuffiċjenza tal- pitwitarja anterjuri jew ta’ l- adrenokortikali),
- concomitant treatment with certain other medicinal products.
- trattament konkomittanti bi prodotti mediċinali oħrajn.
120 Intercurrent illness
120 Mard kurrenti
Intercurrent illness requires intensified metabolic monitoring.
Il- mard kurrenti jeħtieġ l- immoniterjar metaboliku intensifikat.
In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet, it- testijiet għall - preżenza tal- ketoni fl- awrina huma meħtieġa, u ħafna drabi huwa neċessarju li tiġi aġġustata d- doża ta ’ l- insulina.
The insulin requirement is often increased.
Il- ħtieġa għall- insulina spiss tiżdied.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Il- pazjenti bid- dijabete tip 1 għandhom jibqgħu jikkonsmaw ta ’ l- anqas ammont żghir ta ’ karboidrati fuq bażi regolari, anki jekk jistgħu jieklu ftit jew ebda ikel, jew qed jirremettu eċċ. u qatt m’ għandhom iħallu barra l- insulina għal kollox.
A number of substances affect glucose metabolism and may require dose adjustment of human insulin.
Hemm numru ta ’ sustanzi li jeffettwaw il- metaboliżmu tal- glucose u dan għandu mnejn jeħtieġ aġġustament fid- doża ta ’ l- insulina umana.
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), 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) u l- ormoni tat- tirojde, inibituri tal- protease u l - 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, is sustanzi tal- lithium jew l- alcoħol jistgħu jsaħħu jew idgħajjfu l- effett li għandha l- insulina li tbaxxi l- livell tal- glucose fid- demm.
Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Il- pentamidine jista ’ jikkawża l- ipogliċemija, li xi mdaqqiet 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.
Addizjonalment is- sinjali adrenerġiċi ta ’ counter- regulation jistgħu jkunu mnaqqsin jew assenti, taħt l - effetti tas- sustanzi mediċinali simpatolitiċi bħall- imblokkaturi tar- riċetturi beta, clonidine, guanethidine u reserpine.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Huwa essenzjali għall- pazjenti, li jbatu mid- dijabete li tfaċċat qabel jew waqt it- tqala, li jżommu kontroll metaboliku tajjeb mill- bidu sa l- aħħar tat- tqala.
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Il- ħtieġa għall- insulina tista ’ tonqos waqt l - ewwel trimestru u ġeneralment tiżdied waqt it- tieni u t- tielet trimestri.
Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia).
Immedjatament wara l- ħlas, il - bżonn għall- insulina jonqos malajr (riskju miżjud ta ’ ipogliċemija).
Careful monitoring of glucose control is essential.
Huwa essenzjali li l- kontroll tal - livell tal- glucose għandu jkun immoniterjat bir- reqqa.
Insulin Human Winthrop Comb 15 can be used during breastfeeding.
Insulin Human Winthrop Comb 15 jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
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.
Dan jista ’ jkun ta ’ riskju
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
121 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom ikunu mwissija biex jieħdu l- prekawzjonijiet ħalli jevitaw l- iżvilupp ta ’ l - ipogliċemija 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 speċjalment importanti f’ dawk li għandhom is- sintomi ta ’ twissija ta ’ l- ipogliċemija imnaqqsin jew assenti, jew ibatu minn ġrajjiet spissi ta ’ ipogliċemija.
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
Għandu jkun ikkunsidrat jekk is- sewqan jew it- tħaddim ta ’ magni hux ta ’ min jirrikkmandhom f ’ dawn iċ- ċirkustanzi.
121 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
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- ipogliċemija, ġeneralment, hija l- aktar effett spiss li mhux mixtieq, tat- terapija bl- insulina; din tista ’ tiġri jekk id- doża ta ’ l- insulina hija għolja wisq relatata mal- bżonnijiet tal- persuna għall- insulina.
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.
Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemija, speċjalment jekk huma rikurrenti, jistgħu jwasslu għall- ħsara newroloġika.
Prolonged or severe hypoglycaemic episodes may be life-threatening.
Ġrajjiet ta ’ ipogliċemija fit- tul jew severi jistgħu jkunu fatali.
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 ippreċeduti minn sinjali adrenerġiċi ta ’ counter- regulation.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Ġeneralment, aktar ma tkun qawwija u mgħaġġla l- waqgħa fil- livell tal - glukusju fid- demm, aktar ikun immarkat dan il- fenomenu u s- sintomi tiegħu.
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).
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
122 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
122 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.
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, nefħafis- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l - injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Doża eċċessiva ta ’ insulina tista ’ twassal għall- ipogliċemija severa li x’ imdaqqiet tittawwal u tkun fatali.
Management
Trattament
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Ġrajjiet ħfief ta ’ ipogliċemija jistgħu jiġu ikkurati b’ karboidrati orali.
Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.
Jista ’ jkun meħtieġ xi aġġustamenti fid- dożaġġ tal- prodott mediċinali, il- ħin ta ’ l- ikliet, jew l- attività fiżika.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Ġrajjiet aktar severi b’ koma, aċċessjoni jew indeboliment newroloġiku jistgħu jkunu ittrattati b’ injezzjoni ta ’ glucagon fil- muskolu/ fit- tessut ta ’ taħt il- ġilda, jew b’ injezzjoni ġol vina ta ’ soluzzjoni ikkonċentrata tal- glucose.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Il- konsum tal- karboidrati għandu mnejn jeħtieġ li jkun sostnut u l - osservazzjoni tista ’ tkun neċessarja għax l- ipogliċemija tista ’ terġa ’ titfaċċa wara il- fejqan kliniku apparenti.
Antidiabetic agent.
Sustanza medicinali antidijabetika.
Insulins and analogues, intermediate-acting combined with fast-acting, ATC Code:
Kodiċi ATC:
Mode of action
Il- mod kif taħdem
- lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,
- tbaxxi l- livell tal- glucose fid- demm u tippromwovi l- effetti anaboliċi kif ukoll tnaqqas l- effetti
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles
- iżżid it- trasport tal- glucose ġewwa ċ- ċelluli kif ukoll l- produzzjoni tal- glikoġen fil- muskoli u l -
and the liver, and improves pyruvate utilisation.
fwied, u ittejjeb l- utilizzazzjoni tal- pyruvate.
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi t- tkissir tal- glikoġen u l- formazzjoni tal - glucose,
- increases lipogenesis in the liver and adipose tissue and inhibits lipolysis,
- iżżid il- formazzjoni tax- xaħam fil- fwied u fit- tessut xaħmi ta ’ taħt il- ġilda u tinibixxi l- lipolisi,
- promotes the uptake of amino acids into cells and promotes protein synthesis,
- tippromwovi d- dħul ta ’ l- aċidi amminiċi ġewwa ċ- ċelluli u tippromwovi s- sintesi tal- proteini,
- enhances the uptake of potassium into cells.
- tippromwovi d- daħla tal- potassju ġewwa ċ- ċelluli.
Insulin Human Winthrop Comb 15 (a biphasic isophane insulin suspension with 15% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insulin Human Winthrop Comb 15 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 15% ta ’ insulina maħlula) hija insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
Following subcutaneous injection, onset of action is within 30 to 60 minutes, the phase of maximum action is between 2 and 4 hours after injection and the duration of action is 11 to 20 hours.
Wara injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 30 sa 60 minuta, l- fażi ta ’ l- azzjoni massima hija bejn sagħtejn u 4 sigħat wara l- injezzjoni u ż- żmien kemm iddum tahdem huwa minn 11 sa 20 siegħa.
123 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
F’ suġġetti b’ saħħithom, il- half- life ta ’ l- insulina fis- serum huwa ta ’ madwar 4 sa 6 minuti.
It is longer in patients with severe renal insufficiency.
Hija itwal f’ pazjenti b’ insuffiċjenza severa renali.
However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
Madankollu, ta ’ min jinnota li l- komportament farmakokinetiku ta ’ l- insulina ma jirriflettix l- azzjoni metabolika tagħha.
The acute toxicity was studied following subcutaneous administration in rats.
It- tossiċità akuta kienet studjata fil- firien wara li ngħatat fit- tessut ta ’ taħt l- ġilda.
No evidence of toxic effects was found.
Ma nstabitx evidenza ta ’ tossiċità akuta.
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Studji fuq l- effetti farmakodinamiċi wara li ngħatat fit- tessut ta ’ taħt il - ġilda fil- fniek u l- klieb wrew r- reazzjonijiet ipogliċemiċi mistennija.
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.
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.
6.4 Special precautions for storage
124 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insulin Human Winthrop Comb 15 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 15 m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
124 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
5 ml suspension 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 suspensjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu bi flanġ (aluminju), tapp (lastku tal - chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
Insulin Human Winthrop Comb 15 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.
Insulin Human Winthrop Comb 15 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.
As with all insulin preparations, Insulin Human Winthrop Comb 15 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 Comb 15 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
It must also be remembered that
Wieħed għandu wkoll jiftakar li
- insulin protamine crystals dissolve in an acid pH range,
- il- kristalli ta ’ l- insulina protamine jiddisolvu f’ firxa ta ’ pH aciduża,
- the soluble insulin part precipitates out at a pH of approximately 4.5 to 6.5.
6. 5.
Insulin Human Winthrop Comb 15 may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Human Winthrop Comb 15 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 Comb 15 must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insulin Human Winthrop Comb 15 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 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.
Any unused product or waste material should be disposed of in accordance with local requirements.
125 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZJONI
Insulin Human Winthrop Comb 15 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 15 40 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Kull mlfih 40 IU ta ’ insulina umana (ekwivalenti għal 1. 4 mg).
Each vial contains 10 ml of suspension for injection, equivalent to 400 IU insulin.
Kull kunjett fih 10 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għall- 400 IU ta ’ insulina.
However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day.
Madankollu, l- bżonn medju ta ’ l- insulina huwa spiss ta ’ 0. 5 sa 1. 0 UI għal kull kg piż, kuljum.
The basal metabolic requirement is 40% to 60% of the total daily requirement.
Il- ħtieġa bażika metabolika hija minn 40% sa 60% tal- bżonn sħiħ kuljum.
127 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
127 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Comb 15 contains 40 IU of insulin per ml suspension.
Insulin Human Winthrop Comb 15 fih 40 UI ta ’ insulina kull millilitru ta ’ suspensjoni.
Only injection syringes designed for this strength of insulin (40 IU per ml) are to be used.
Is- siringi għall - injezzjoni magħmulin għal din il- qawwa biss ta ’ insulina (40 UI 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 kwalunkwe sustanza mediċinali oħra jew xi residwu tagħhom (eż. traċċi tal- ħeparina).
128 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
128 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
- intercurrent illness (e. g. vomiting, diarrhoea),
- mard ieħor fl- istess waqt (eż. rimettar, dijarea),
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kompensati (eż. f’ kas ta ’ ipotirojdiżmu u
adrenocortical insufficiency),
insuffiċjenza tal- pitwitarja anterjuri jew ta ’ l- adrenokortikali),
129 Intercurrent illness
129 Mard kurrenti
In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
F’ ħafna każijiet it- testijiet għall - preżenza tal- ketoni fl- awrina huma meħtieġa, u ħafna drabi huwa neċessarju li tiġi aġġustata d- doża ta ’ l- insulina.
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) u l- ormoni tat- tirojde, inibituri tal- protease u il - prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
For insulin human, no clinical data on exposed pregnancies are available.
Għall- insulina umana, m’ hemmx tagħrif kliniku disponibbli dwar l- użu waqt it- tqala.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
130 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
130 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
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).
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
131 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
131 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.
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta’ sit mnejn jingħata
132 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, ilma għall- injezzjonijiet.
6.4 Special precautions for storage
133 6. 4 Prekawzjonijiet speċjali għall- ħażna
133 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Insulins of different concentration (e. g.
Insulini ta ’ konċentrazzjoni differenti (eż.
Any unused product or waste material should be disposed of in accordance with local requirements.
134 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni ġo skartoċċ
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml15 fih 100 IUI ta ’ insulina umana (ekwivalenti għal 3. 5 mg).
Each cartridge contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull skartoċċ fih 3 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għall- 300 IU ta ’ insulina.
Suspension for injectionin a cartridge.
Suspensjoni għall- injezzjoni ġo skartoċċ.
However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day.
Madankollu, l- bżonn medju ta ’ l- insulina huwa spiss ta ’ 0. 5 sa 1. 0 IU għal kull kg piż, kuljum.
136 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
136 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Comb 15 in cartridges has been developed for use in the OptiPen series.
Insulin Human Winthrop Comb 15 fi skartoċċi kien żviluppat għall- użu mas- serje ta ’ l- OptiPen.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
137 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
137 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti b’ indeboliment sever tal- fwied, il- ħtiega ghall- insulina tista ’ tonqos dovut għan- nuqqas ta ’ produzzjoni tal- glucose u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
These include:
Il- fatturi li jżidu s- suxxettibbiltà għas- sintomu tal- ipogliċemja jeħtieġu partikolarment l- moniteraġġ mill- qrib u jistgħu jirrikjedu tibdil tad- l- aġġustament fid- doża Dawn jinkludu:
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kompensati (e. g. f’ kas ta ’ ipotirojdiżmu u
138 Intercurrent illness
138 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).
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 l- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
139 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
139 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
140 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
140 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.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Ġrajjiet aktar severi b’ koma, aċċessjoni jew indeboliment newroloġiku jistgħu jkunu ittrattati b’ injezzjoni ta ’ glucagon fil- muskolu/ fit- tessut ta ’ taħt il- ġilda, jew b’ injezzjoni ġol- vina ta ’ soluzzjoni ikkonċentrata tal- glucose.
141 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
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 (ġol- 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 cap must be put back on the pen after each injection in order to protect from light.
142 Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed fuq il- pinna sabiex tilqa ’ mid- dawl.
Do not put Insulin Human Winthrop Comb 15 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 15 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
142 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension 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 suspensjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) għatu bi flanġ (aluminju), b’ tapp (lastku bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Each cartridge contains 3 balls (stainless steel).
Kull skartoċċ fih 3 boċċi (ta ’ l- azzar li ma jissaddadx)
Packs of 3, 4, 5, 6, 9 or 10 cartridges are available.
Pakketti ta ’ 3, 4, 5, 6, 9 jew 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 irrakkomandat fl- informazzjoni ipprovduta mill- manifattur tal- pinna.
If the pen malfunctions (see instructions for using the pen), the suspension 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 ’ mill- iskartoċċ f’ siringa ta ’ l- injezzjoni (adatta għal insulina ta 100 IU/ ml) u tiġi injettata.
Cartridges Before insertion into the pen, Insulin Human Winthrop Comb 15 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
SkartoċċiQabel jiddaħħal fil- pinna, Insulin Human Winthrop Comb 15 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il - kontenut.
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 ’ l hinn u ’ l hawn (għal mhux anqas minn għaxar darbiet).
Later on, when the cartridge has been inserted into the pen, the insulin must be resuspended again prior to each injection.
Aktar tard, meta l- iskartoċċ ikun iddaħħal fil- pinna, l- insulina trid tiġi sospiża mill- ġdid qabel kull injezzjoni.
This is best done by gently tilting the pen back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil il- pinna ’ l hinn u ’ l hawn (għal mhux anqas minn għaxar darbiet).
Insulin Human Winthrop Comb 15 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.
Insulin Human Winthrop Comb 15 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 ta ’ l- iskartoċċ.
In such cases, a new cartridge yielding a uniform suspension must be used.
F’ każijiet bħal dawn, skartoċċ ġdid li jagħti suspensjoni uniformi għandu jintuża.
It is also necessary to change to a new cartridge if the insulin requirement changes substantially.
Huwa wkoll meħtieġ li jinbidel l- iskartoċċ jekk il- bżonn għall- insulina jinbidel sostanzjalment.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
143 Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l - użu tal- pinna).
Insulin Human Winthrop Comb 15 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insulin Human Winthrop Comb 15 m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc.
143 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Each pen contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull pinna fiha 3 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għal 300 IU insulina.
Insulin Human Winthrop Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 15 hija injettata fit- tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
145 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
145 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Comb 15 must never be injected intravenously.
Insulin Human Winthrop Comb 15 qatt m’ għandu jingħata ġol- vina.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
146 F’ pazjenti b’ indeboliment sever tal- fwied, il- ħtiega ghall- insulina tista ’ tonqos dovut għan- nuqqas ta ’ produzzjoni tal- glucose u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
146 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 li l- kontroll tal- glucose mhux tajjeb jew hemm tendenza għall- iżvilupp ta ’ grajjiet ta ’ iper - jew ipo- glicemija, għandhom jiġu investigati jekk il- pazjent huwiex qed iżomm mad- dieta preskritta, s- siti ta ’ l- injezzjoni, t- teknika korretta ta ’ l- injezzjoni u l- fatturi rilevanti l- ohrajn kollha qabel ma l - aġġustament fid- doża tkun ikkunsidrata
The insulin requirement is often increased.
F’ ħafna każijiet, it- testijiet għall - preżenza tal- ketoni fl- awrina huma meħtieġa, u ħafna drabi huwa neċessarju li tiġi aġġustata d- doża
147 Handling of the pen
147 ta ’ l- insulina.
4.7 Effects on ability to drive and use machines
148 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
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- ipogliċemija jew l- ipergliċemija jew, per eżempju, bħala riżultat ta ’ indeboliment tal- vista.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista ’ jkun ta ’ riskju f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
148 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Eyes disorders
149 Disturbi fl- għajnejn
149 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.
Mode of action
150 Il- mod kif taħdem
150 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
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.
151 Żmien kemm iddum tajba 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’ għandhom jinżammu fi friġġ.
Do not put Insulin Human Winthrop Comb 15 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 15 m’ għanduxjitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
151 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension 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)).
Before first use, Insulin Human Winthrop Comb 15 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel l- ewwel użu, Insulin Human Winthrop Comb 15 OptiSet għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il - kontenut.
Insulin Human Winthrop Comb 15 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.
Insulin Human Winthrop Comb 15 OptiSet 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 ta ’ l- iskartoċċ.
As with all insulin preparations, Insulin Human Winthrop Comb 15 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 Comb 15 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insulin Human Winthrop Comb 15 must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Comb 15 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi.
152 Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir - reqqa qabel tintuża l- OptiSet.
OptiSet is designed to work accurately and safely.
153 OptiSet hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
153 Step 2.
2
If no insulin comes out after changing the needle, the OptiSet may be damaged.
Jekk ebda insulina ma toħroġ mill- labra, wara li tkun bdilt il - labra, jista ’ jagħti l- każ li l- OptiSet hija bil- ħsara.
If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
154 Jekk il- planġer iswed qiegħed fil- bidu ta ’ l - istrixxa ikkulurita, allura hemm madwar 40 Unità t’ insulina disponibbli.
154 Step 6.
6
A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
JJinstama ’ ħoss, li jieqaf meta l- buttun ta ’ l - injezzjoni jingħafas kompletament ’ il ġewwa.
155 1.
156 1.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Insulina umana Insulin Human Winthrophija magħmula bit- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
Suspension for injectionin a cartridge for OptiClik.
Suspensjoni għall- injezzjoni ġo skartoċċ għal OptiClik.