qanastek/EMEA-V3 huggingface dataset:
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Il- ħtieġa ta ’ l- insulina ta ’ kuljum tista ’ tkun ogħla f’ pazjenti b’ reżistenza għall- insulina (eż. waqt il- pubertà jew minħabba obeżità), u aktar baxxa f’ pazjenti bi produzzjoni residwa ta ’ insulina endoġenika.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
F’ pazjenti bid- dijabete mellitus, l- aħjar kontroll possibbli tal- livell tal- glukosju fid- demm jittardja l - bidu ta ’ komplikazzjonijiet dijabetiċi li jitfaċċaw tard fil- marda.
Close blood glucose monitoring is therefore recommended.
Għalhekk, il- monitoraġġ mill- qrib ta ’ glukosju hu rakkomandat.
An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.
L- injezzjoni għandha tkun segwita minn ikla jew ikla ħafifa li jkun fiha l- karboidrati, fi żmien 30 minuta.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta ’ deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
L- aġġustament fid- dożaġġ jista ’ jkun neċessarju wkoll jekk il- pazjenti jibdlu l- attività fiżika jew id - dieta normali tagħhom.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
2 L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta ’ insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
2 Administration For subcutaneous or intravenous use.
Kif jingħata Għall- użu minn taħt il- ġilda jew minn ġol- vini.
Actrapid may also be administered intravenously, which should only be carried out by health care professionals.
Actrapid jista ’ jingħata wkoll minn ġol- vini, iżda għandu jsir biss minn professjonisti fil- kura tas- saħħa.
Actrapid is administered subcutaneously in the abdominal wall.
Actrapid jingħata minn taħt il- ġilda fiż- żaqq.
The thigh, the gluteal region or the deltoid region may also be used.
Il- koxxa, iż- żona gluteali jew iż- żona tad- deltojd jistgħu jintużaw ukoll.
Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.
L- injezzjoni minn taħt il- ġilda fiż- żaqq tiżgura assorbiment aktar mgħaġġel milli meta tingħata injezzjoni f’ postijiet oħrajn.
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Jekk it- titqiba issir fil- ġilda merfugħa ’ l fuq, jonqos ir- riskju li bi żball wieħed jinjetta fil- muskolu.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Il- labra għandha tinżamm taħt il- ġilda għal mill- anqas 6 sekondi biex tiżgura li d- doża kollha tkun injettata.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Ġo l- istess żona anatomika l- postijiet fejn tingħata l- injezzjoni għandhom jinbidlu biex tiġi evitata l - lipodistrofija.
The vials are for use with insulin syringes with a corresponding unit scale.
Il- kunjetti huma għall- użu ma ’ siringi ta ’ l- insulina bi skala ta ’ unità korrispondenti.
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Meta żewġ tipi ta ’ insulina jitħalltu, l- ewwel iġbed l- ammont ta ’ insulina li taħdem malajr, imbagħad iġbed l- insulina li taħdem fit- tul.
Actrapid is accompanied by a package leaflet with detailed instruction for use to be followed.
Actrapid jiġi b’ fuljett ta ’ tagħrif miegħu, bi struzzjonijiet dettaljati għall- użu li għandhom jiġu segwiti.
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia.
Dożaġġ inadegwat jew it- twaqqif tal- kura, speċjalment f’ pazjenti b’ dijabete ta ’ tip 1, jista ’ jwassal għall- ipergliċemija.
Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Normalment, l- ewwel sintomi ta ’ ipergliċemija jibdew bil- mod, fuq perijodu ta ’ sigħat jew jiem.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
F’ pazjenti b’ dijabete ta ’ tip 1, avvenimenti ipergliċemiċi li ma jkunux ikkurati, eventwalment iwasslu għal ketoaċidosi dijabetika, li hi potenzjalment fatali.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).
Tista ’ sseħħ l- ipogliċemija jekk id- doża ta ’ l- insulina tkun għolja wisq meta mqabbla mal- ħtieġa ta ’ l - insulina (ara sezzjonijiet 4. 8 u 4. 9).
Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
Dawk il- pazjenti li l- kontroll ta ’ glukosju fid- demm tagħhom jitjieb bil- kbir, eż. permezz ta ’ terapija intensifikata bl- insulina, jista ’ jkollhom bidla fis- sintomi normali ta ’ twissija tagħhom ta ’ l - ipogliċemija, u għandhom jingħataw parir kif jixraq.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, il- marka (manifattur), it- tip (insulina li taħdem malajr, li għandha azzjoni doppja, li taħdem fit- tul, eċċ), l- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew il- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
If an adjustment is needed when switching the patients to Actrapid, it may occur with the first dose or during the first several weeks or months.
Jekk ikun hemm bżonn ta ’ aġġustament meta l- pazjenti jaqilbu għal Actrapid, dan jista ’ jsir ma ’ l- ewwel doża jew matul l- ewwel diversi ġimgħat jew xhur.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
3 Bħal kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
On rare occasions, injection site reactions may require discontinuation of Actrapid
F’ okkażjonijiet rari, minħabba ir - reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm bżonn li Actrapid jitwaqqaf.
3 Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
Qabel ma jivvjaġġa bejn żoni tal- ħin differenti, il- pazjent għandu jingħata parir biex jikkonsulta lit - tabib, għax dan jista ’ jfisser li l- pazjent irid jieħu l- insulina u l- ikel f’ ħinijiet differenti.
Due to the risk of precipitation in pump catheters, Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion.
Minħabba r- riskju ta ’ preċipitazzjoni fil- kateter tal- pompi, Actrapid m’ għandux jintuża fil- pompi ta ’ l - insulina għall- infużjoni kontinwa ta ’ l- insulina taħt il- ġilda.
Actrapid contains metacresol, which may cause allergic reactions.
Actrapid fih metacresol, li jista ’ jikkawża reazzjonijiet allerġiċi.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Sustanzi ipogliċemiċi li jittieħdu mill- ħalq (OHA), inibituri ta ’ monoamine oxidase (MAOI), sustanzi li jimblukkaw ir- riċetturi beta mhux selettivi, inibituri ta ’ l- enzima li tikkonverti l- anġjotensin (ACE), salicylates, alkoħol, sterojdi anaboliċi u sulphonamides.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Kontraċettivi orali, thiazides, glukokortikojdi, ormoni tat- tirojde u beta- simpatomimetiċi, ormon tat - tikbir u danazol.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Sustanzi li jimblukkaw ir- riċetturi beta jistgħu jaħbu s- sintomi ta ’ l- ipogliċemija u jdewmu l- irkupru mill- ipogliċemija.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Kemm l- ipogliċemija kif ukoll l- ipergliċemija, li jistgħu jseħħu f’ terapija fejn id- dijabete ma tkunx ikkontrollata b’ mod adegwat, iżidu r- riskju ta ’ malformazzjonijiet u mewt in utero.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
Għalhekk hu rakkomandat li jkun hemm kontroll intensifikat fil- kura ta ’ nisa bid- dijabete waqt l- ippjanar tat- tqala u matul l- istess tqala.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
Il- ħtiġijiet ta ’ l- insulina normalment jonqsu fl- ewwel trimestru u jiżdiedu sussegwentement matul it - tieni u t- tielet trimestri.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
Wara l- ħlas, il- ħtiġijiet ta ’ l- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Insulin treatment of the nursing mother presents no risk to the baby.
Il- kura bl- insulina fl- omm li tkun qed tredda ’ ma toħloq l- ebda riskju għat- tarbija.
However, the Actrapid dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm il- bżonn li d- dożaġġ ta ’ Actrapid, jiġi aġġustat.
4.7 Effects on ability to drive and use machines
4 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan hu partikularment importanti f’ dawk li għandhom nuqqas ta ’ għarfien jew l- ebda għarfien tas- sinjali ta ’ twissija ta ’ l- ipogliċemija, jew li għandhom episodji frekwenti ta ’ ipogliċemija.
The advisability of driving should be considered in these circumstances.
Wieħed għandu jikkunsidra jekk isuqx jew le f’ dawn iċ- ċirkustanzi.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
Kif jiġri bl- użu ta ’ prodotti oħrajn ta ’ l- insulina, ġeneralment, l- ipogliċemija, hi l- effett mhux mixtieq l- aktar komuni li jkun hemm.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Din tista ’ sseħħ jekk id- doża ta ’ l- insulina tkun għolja wisq fir- rigward tal- ħtieġa ta ’ l- insulina.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Fi studji kliniċi u waqt l- użu meta l- prodott tqiegħed fis- suq, il- frekwenza tvarja skond il- popolazzjoni tal- pazjenti u skond l- iskeda tad- dożaġġ.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Ipogliċemija serja tista ’ twassal għal telf mis- sensi u/ jew għal konvulżjonijiet u tista ’ tirriżulta f’ indeboliment temporanju jew permanenti fil- funzjoni tal- moħħ jew anki f’ mewt.
Frequencies of adverse drug reactions from clinical trials that are considered related to Actrapid, are listed below.
Minn studji kliniċi l- frekwenzi tar- reazzjonijiet avversi tal- mediċina, li huma kkunsidrati li huma konnessi ma ’ Actrapid, huma mniżżlin hawn taħt.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Il- frekwenzi huma definiti kif ġej: mhux komuni (≥1/ 1, 000 sa < 1/ 100).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Każijiet spontanji iżolati li jinkludu rapporti iżolati huma ppreżentati bħala rari ħafna u definiti bħala < 1/ 10, 000 F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla f’ ordni li tibda b’ dak l- iżjed serju u tkompli sa dak l- inqas serju.
Nervous system disorders Uncommon - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
Disturbi fis- sistema nervuża Mhux komuni - Newropatija periferali Titjib ta ’ malajr fil- kontroll tal- glukosju fid- demm jista ’ jkun assoċjat ma ’ kundizzjoni msejħa “ newropatija akuta bl- uġigħ ”, li normalment tkun riversibbli.
Eye disorders Uncommon - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
Disturbi fl- għajnejn Mhux komuni - Disturbi fir- rifrazzjoni Anomaliji fir- rifrazzjoni jistgħu jseħħu mal- bidu tat- terapija bl- insulina.
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Rari ħafna - Retinopatija dijabetika Titjib fil- kontroll gliċemiku fit- tul inaqqas ir- riskju tal- progressjoni tar- retinopatija dijabetika.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Madankollu, l- intensifikazzjoni tat- terapija bl- insulina b’ titjib f’ daqqa tal- kontroll gliċemiku, tista ’ tkun assoċjata ma ’ retinopatija dijabetika li temporanjament tmur għall- agħar.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni - Lipodistrofija Il- lipodistrofija tista ’ sseħħ fil- post ta ’ l- injezzjoni bħala konsegwenza li f’ dik iż- żona wieħed ma jibdilx il- post minn fejn tingħata l- injezzjoni.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Mhux komuni - Reazzjonijiet fis- sit ta ’ l- injezzjoni Reazzjonijiet fis- sit ta ’ l- injezzjoni (ħmura, nefħa, ħakk, uġigħ u ematoma fis- sit ta ’ l- injezzjoni) jistgħu jseħħu waqt il- kura bl- insulina.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
5 Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
Generalised hypersensitivity reactions are potentially life- threatening.
Reazzjonijiet ta ’ sensittività eċċessiva ġeneralizzata huma potenzjalment ta ’ periklu għall- ħajja.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Madankollu, l- ipogliċemija tista ’ tiżviluppa fi stadji sekwenzjali: • Episodji ipogliċemiċi ħfief jistgħu jkunu kkurati bl- għoti mill- ħalq ta ’ glukosju jew ta ’ prodotti li fihom iz- zokkor.
5 • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Huwa għalhekk rakkomandat li pazjenti dijabetiċi jżommu fuqhom xi kubi taz- zokkor, ħelu, gallettini jew meraq tal- frott biz- zokkor. • Episodji ta ’ ipogliċemija severa, fejn il- pazjent jintilef minn sensih, jistgħu jiġu kkurati bi glucagon (0. 5 sa 1 mg) mogħti minn ġol- muskoli jew minn taħt il- ġilda minn persuna li tkun irċeviet struzzjonijiet xierqa, jew bi glukosju mogħti minn ġol- vini minn professjonist mediku.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Glukosju għandu wkoll jingħata minn ġol- vini jekk il- pazjent ma jirrispondix għal glucagon fi żmien 10 sa 15- il minuta.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Meta jerġa ’ jiġi f’ sensih, l- għoti ta ’ karboidrati mill- ħalq lill- pazjent hu rakkomandat, biex tkun evitata rikaduta.
Pharmacotherapeutic group: insulins and analogues for injection, fast-acting, insulin (human).
Kategorija farmakoterapewtika: insulini u analogi għall- injezzjoni, insulina (umana) li taħdem malajr.
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
L- effett ta ’ l- insulina li tbaxxi l- livell ta ’ glukosju fid- demm iseħħ minħabba li l- insulina tingħaqad mar- riċetturi fuq iċ- ċelluli tal- muskolu u tax- xaħam u b’ hekk tiġi ffaċilitata d- dħul ta ’ glukosju f’ dawn iċ- ċelluli u minħabba l- inibizzjoni fl- istess ħin tal- produzzjoni ta ’ glukosju mill- fwied.
A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/ l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 – 6.1 mmol/ l) induced by intravenous Actrapid reduced mortality by 42% (8% versus 4.6%).
Studju kliniku magħmul f’ unità ta ’ kura intensiva waħda fejn kienet qed tiġi kkurata l- ipergliċemija (livell ta ’ glukosju fid- demm ogħla minn 10 mmol/ l) wera li n- normogliċemija (livell ta ’ glukosju fid - demm ta ’ 4. 4 – 6. 1 mmol/ l), li nkisbet permezz ta ’ Actrapid mogħti minn ġol- vini, naqqset il - mortalita ’ bi 42% (8% kontra 4. 6%) f’ 204 pazjent dijabetiku u f’ 1344 pazjent mhux dijabetiku li kellhom operazzjoni maġġura.
Actrapid is a fast-acting insulin.
Actrapid hu insulina li taħdem malajr.
Onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours.
Jibda jaħdem fi żmien nofs siegħa, jilħaq l- effett massimu fi żmien 1. 5- 3. 5 sigħat, u l- ħin totali ta ’ kemm idum jaħdem hu ta ’ madwar 7- 8 sigħat.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
Konsegwentement, il- profil taż- żmien ta ’ azzjoni ta ’ preparazzjoni insulinika jiddependi biss mill- karatteristiċi ta ’ l- assorbiment tagħha.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xaħam taħt il- ġilda, it- tip tad- dijabete).
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
Għalhekk, il- proprjetajiet farmakokinetiċi tal- prodotti ta ’ l- insulina huma influwenzati minn varjazzjonijiet sinifikanti kemm fl - individwu stess u kemm bejn individwu u ieħor.
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
6 Assorbiment Il- konċentrazzjoni massima fil- plażma tintlaħaq fi żmien 1. 5- 2. 5 sigħat wara l- għoti minn taħt il- ġilda.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma ġietx osservata ebda rabta qawwija mal- proteini tal- plażma, ħlief ma ’ l- antikorpi ta ’ l- insulina (jekk kienu preżenti) li jkunu qegħdin jiċċirkolaw.
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metaboliżmu Hu rrappurtat li l- insulina umana tiġi degradata mill- protease insulinika jew mill- enzimi degradanti ta ’ l- insulina u possibbilment mill- proteina disulfide isomerase.
Trials have indicated a t½ of about 2-5 hours.
Għalhekk il - half- life terminali (t½) hi kejl ta ’ l- assorbiment u mhux ta ’ l- eliminazzjoni ta ’ l- insulina mill- plażma per se (l- insulina fiċ- ċirkolazzjoni tad- demm għandha t½ ta ’ ftit minuti). L- istudji indikaw t½ ta ’ madwar 2- 5 sigħat.
6 Children and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Tfal u adolexxenti Il- profil farmakokinetiku ta ’ Actrapid kien studjat f’ numru żgħir (n=18) ta ’ tfal dijabetiċi (6- 12- il sena) u adolexxenti (13- 17- il sena).
The data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
L- informazzjoni hi limitata iżda tissuġġerixxi li l- profil farmakokinetiku fit- tfal u fl- adolexxenti jista ’ jkun simili għal dak fl- adulti.
However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Madankollu, kien hemm differenzi f’ Cmax bejn il- gruppi ta ’ l- età, u dan jenfasizza l- importanza ta ’ dożaġġ individwali.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhix klinika magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
Zinc chloride Glycerol Metacresol Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Zinc chloride Glycerol Metacresol Sodium hydroxide (għall- aġġustament tal- pH) Hydrochloric acid (għall- aġġustament tal- pH) Ilma għall- injezzjonijiet
Insulin products should only be added to compounds with which it is known to be compatible.
Il- prodotti ta ’ l- insulina għandhom jiżdiedu biss ma ’ dawk is- sustanzi li hu magħruf li magħhom huma kompatibbli.
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
Prodotti mediċinali li jiżdiedu mas- soluzzjoni ta ’ l- insulina jistgħu jikkawżaw id - degradazzjoni ta ’ l- insulina, eż. jekk il- prodotti mediċinali jkun fihom thiols jew sulphites.
4 weeks when used or stored at room temperature (below 25°C).
4 ġimgħat meta jintużaw jew jinħażnu fit- temperatura tal- kamra (taħt 25°C).
6.4 Special precautions for storage
7 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store them in or too near the freezer section or cooling element.
Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta ’ l- element li jkessaħ.
Do not store above 25°C.
Taħżinx f’ temperaturi ’ l fuq minn 25°C.
Protect from excessive heat and sunlight.
Ipproteġi minn sħana eċċessiva u mid- dawl tax- xemx.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
Kunjett tal- ħġieġ (tip 1) ta ’ 10 ml magħluq b’ tapp tal- gomma ta ’ bromobutyl/ polyisoprene u b’ għatu protettiv tal- plastik li ma jistax isir tbagħbis fih.
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 u 5 kunjetti x 10 ml u pakkett multiplu ta ’ 5 x (1 x 10 ml) kunjetti.
7 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
For intravenous use, infusion systems with Actrapid at concentrations 0.05 IU/ ml - 1.0 IU/ ml insulin human in the following infusion fluids; 0.9% sodium chloride, 5% dextrose and 10% dextrose inclusive 40 mmol/ l potassium chloride, using polypropylene infusion bags, are stable at room temperature for 24 hours.
Għall- użu minn ġol- vini, sistemi ta ’ l- infużjoni b’ Actrapid f’ konċentrazzjonijiet ta ’ 0. 05 UI/ ml - 1. 0 UI/ ml ta ’ insulina umana fil- fluwidi ta ’ l- infużjoni li ġejjin; 0. 9% sodium chloride, 5% dextrose u 10% dextrose li jinkludi 40 mmol/ l ta ’ potassium chloride, bl- użu ta ’ boroż ta ’ l- infużjoni ta ’ polypropylene, huma stabbli fit- temperatura tal- kamra għal 24 siegħa.
Although stable over time, a certain amount of insulin will initially be absorbed to the material of the infusion bag.
Għalkemm stabbli fuq perjodu ta ’ żmien, inizjalment ċertu ammont ta ’ insulina se tiġi assorbita mill- materjal tal- borża ta ’ l- infużjoni.
Monitoring of blood glucose is necessary during the infusion.
Il- monitoraġġ tal- glukosju fid- demm hu meħtieġ waqt l- infużjoni.
Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta ’ l- insulina li kienu ffriżati m’ għandhomx jintużaw.
Insulin solutions should not be used if they do not appear water clear and colourless.
Is- soluzzjonijiet ta ’ l- insulina m’ għandhomx jintużaw jekk ma jidhrux ċari daqs l- ilma u bla kulur.
Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion.
Actrapid m’ għandux jintuża f’ pompi ta ’ l- insulina għall- infużjoni kontinwa ta ’ l- insulina minn taħt il - ġilda.
Actrapid 100 IU/ ml solution for injection in a vial
Actrapid 100 UI/ ml soluzzjoni għall- injezzjoni f’ kunjett
1 vial contains 10 ml equivalent to 1000 IU.
Kunjett fih 10 ml ekwivalenti għal 400 UI.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
9 L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta ’ insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
9 Administration For subcutaneous or intravenous use.
Kif jingħata Għall- użu minn taħt il- ġilda jew minn ġol- vini.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Li fl- istess żona partikulari jkun hemm tibdil kontinwu
Reactions usually resolve in a few days to a few weeks.
10 tal- post ta ’ l- injezzjoni jista ’ jgħin biex inaqqas jew jimpedixxi dawn ir- reazzjonijiet. Normalment dawn ir- reazzjonijiet imorru wara xi ftit ġranet jew ġimgħat.
10 Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
Qabel ma jivvjaġġa bejn żoni tal- ħin differenti, il- pazjent għandu jingħata parir biex jikkonsulta lit - tabib, għax dan jista ’ jfisser li l- pazjent irid jieħu l- insulina u l- ikel f’ ħinijiet differenti.
4.7 Effects on ability to drive and use machines
11 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
11 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
12 Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
12 • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Huwa għalhekk rakkomandat li pazjenti dijabetiċi jżommu fuqhom xi kubi taz- zokkor, ħelu, gallettini jew meraq tal- frott biz- zokkor. • Episodji ta ’ ipogliċemija severa, fejn il- pazjent jintilef minn sensih, jistgħu jiġu kkurati bi glucagon (0. 5 sa 1 mg) mogħti minn ġol- muskoli jew minn taħt il- ġilda minn persuna li tkun irċeviet struzzjonijiet xierqa, jew bi glukosju mogħti minn ġol- vini minn professjonist mediku.
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
13 Assorbiment Il- konċentrazzjoni massima fil- plażma tintlaħaq fi żmien 1. 5- 2. 5 sigħat wara l- għoti minn taħt il- ġilda.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma ġiet osservata ebda rabta qawwija mal- proteini tal- plażma, ħlief ma ’ l- antikorpi ta ’ l- insulina (jekk kienu preżenti) li jkunu qegħdin jiċċirkolaw.
13 Children and adolscents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Tfalu u adolexxenti Il- profil farmakokinetiku ta ’ Actrapid kien studjat f’ numru żgħir (n=18) ta ’ tfal dijabetiċi (6- 12- il sena) u adolexxenti (13- 17- il sena).
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
Prodotti mediċinali li jiżdiedu mas- soluzzjoni ta ’ l- insulina jistgħu jikkawżaw id - degradazzjoni ta ’ l- insulina, eż. jekk il- prodotti mediċinali jkun fihom thiols jew sulphites..
6 weeks when used or stored at room temperature (below 25°C)
6 ġimgħat meta jintużaw jew jinħażnu fit- temperatura tal- kamra (taħt 25°C).
6.4 Special precautions for storage
14 6. 4 Prekawzjonijiet speċjali għall- ħażna
14 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Actrapid Penfill 100 IU/ ml solution for injection in a cartridge
Actrapid Penfill 100 UI/ ml soluzzjoni għal injezzjoni fi skartoċċ
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Insulina umana, rDNA (magħmula permezz tat- teknoloġija tad- DNA rikombinanti f’ Saccharomyces cerevisiae.
1 cartridge contains 3 ml equivalent to 300 IU.
Skartoċċ fih 3 ml ekwivalenti għal 300 IU.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
UI waħda (Unità Internazzjonali) tikkorrispondi għal 0. 035 mg ta ’ insulina umana anhydrous.
Solution for injection in a cartridge.
Soluzzjoni għal injezzjoni fi skartoċċ.
Treatment of diabetes mellitus.
Għall- kura tad- dijabete mellitus.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Il- ħtieġa individwali ta ’ l - insulina normalment hi ta ’ bejn 0. 3 and 1. 0 IU/ kg/ kuljum.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Il- ħtieġa ta ’ l- insulina ta ’ kuljum tista ’ tkun ogħla f’ pazjenti b’ reżistenza għall- insulina (eż. waqt il- pubertà jew minħabba l- ħxuna żejda), u aktar baxxa f’ pazjenti bi produzzjoni residwa ta ’ insulina endoġenika.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
16 L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta ’ insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
16 Administration For subcutaneous use.
Għall- użu minn taħt il- ġilda.
The intravenous use of Actrapid from any pen or cartridge should be an exception only in situations where vials are not available.
L- għoti minn ġol- vini ta ’ Actrapid permezz ta ’ pinna jew skartoċċ għandha tkun biss eċċezzjoni f’ sitwazzjonijiet fejn il- kunjetti ma jkunux disponibbli.
In this case Actrapid should be drawn into an insulin syringe, provided air is avoided, or infused with an infusion system.
F’ dan il- każ, Actrapid għandu jinġibed ġo siringa ta ’ l- insulina, bil- kundizzjoni li ma ddaħħalx l- arja, jew infuż permezz ta ’ sistema ta ’ l- infużjoni.
This procedure should only be carried out by health care professionals.
Din il- proċedura għandha ssir biss minn professjonisti fil- kura tas - saħħa.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
L- iskartoċċi huma maħsuba biex jintużaw mas- sistemi tal- għoti Novo Nordisk (strumenti li jservu fit - tul għall- użu ripetut) u labar NovoFine.
Detailed instruction accompanying the delivery system must be followed.
L- istruzzjonijiet dettaljati li jakkumpanjaw is- sistema tal- għoti għandhom ikunu segwiti.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, il- marka (manifattur), it- tip (insulina li taħdem malajr, li għandha azzjoni doppja, li taħdem fit- tul, eċċ), l- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew il- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’
Insulin treatment of the nursing mother presents no risk to the baby.
18 Il- kura bl- insulina fl- omm li tkun qed tredda ’ ma toħloq l- ebda riskju għat- tarbija.
This is particularly important in those who have reduced or absent awareness of the warning signs of
Dan hu partikularment importanti f’ dawk li għandhom nuqqas ta ’ għarfien jew l- ebda għarfien tas- sinjali ta ’ twissija ta ’ l- ipogliċemija, jew li għandhom episodji frekwenti ta ’ ipogliċemija.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
19 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Madankollu, l- ipogliċemija tista ’ tiżviluppa fi stadji sekwenzjali: • Episodji ipogliċemiċi ħfief jistgħu jkunu kkurati bl- għoti mill- ħalq ta ’ glukosju jew ta ’ prodotti li fihom iz- zokkor.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Huwa għalhekk rakkomandat li pazjenti dijabetiċi jżommu fuqhom xi kubi taz- zokkor, ħelu, gallettini jew meraq tal- frott biz- zokkor. • Episodji ta ’ ipogliċemija severa, fejn il- pazjent jintilef minn sensih, jistgħu jiġu kkurati bi glucagon (0. 5 sa 1 mg) mogħti minn ġol- muskoli jew minn taħt il- ġilda minn persuna li tkun irċeviet struzzjonijiet xierqa, jew bi glukosju mogħti minn ġol- vini minn professjonist mediku.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Għalhekk, il- proprjetajiet
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
20 farmakokinetiċi tal- prodotti ta ’ l- insulina huma influwenzati minn varjazzjonijiet sinifikanti kemm fl - individwu stess u kemm bejn individwu u ieħor.
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Assorbiment Il- konċentrazzjoni massima fil- plażma tintlaħaq fi żmien 1. 5- 2. 5 sigħat wara l- għoti minn taħt il- ġilda.
Children and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Tfal u adolexxenti Il- profil farmakokinetiku ta ’ Actrapid kien studjat f’ numru żgħir (n=18) ta ’ tfal dijabetiċi (6- 12- il sena) u adolexxenti (13- 17- il sena).
6 weeks when used or carried as a spare (below 30°C).
6 ġimgħat meta jiġi użat jew jinġarr għal li jista ’ jinqala ’ (taħt 30°C).
Protect from excessive heat and sunlight.
Ipproteġih minn sħana eċessiva u mid- dawl tax- xemx.
21 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
1, 5 and 10 cartridges x 3 ml.
1, 5 u 10 skartoċċi x 3 ml.
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
L- iskartoċċi għandhom jintużaw biss ma ’ prodotti li jkunu kompatibbli magħhom u li jippermettu li l - iskartoċċ jaħdem b’ mod sikur u b’ mod effettiv.
Actrapid Penfill is for single person use only.
Actrapid Penfill hu maħsub biex jintuża minn persuna waħda biss.
Actrapid NovoLet 100 IU/ ml solution for injection in a pre-filled pen
Actrapid NovoLet 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Il- ħtieġa individwali ta ’ l - insulina normalment hi ta ’ bejn 0. 3 u 1. 0 IU/ kg/ kuljum.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
24 L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta ’ insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
23 Administration For subcutaneous use.
Kif jingħata Għall- użu taħt il- ġilda.
This procedure should only be carried out by health care professionals
Din il- proċedura għandha ssir biss minn professjonisti fil- kura tas- saħħa.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Il - labra għandha tinżamm taħt il- ġilda għal mill- anqas 6 sekondi biex tiżgura li d- doża kollha tkun injettata.
Actrapid NovoLet is designed to be used with NovoFine needles.
Actrapid NovoLet hi maħsuba biex tintuża mal- labar NovoFine.
NovoLet delivers 2-78 units in increments of 2 units.
NovoLet tipprovdi 2- 78 unitajiet f’ inkrementi ta ’ 2 unitajiet.
The pens should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle top.
Il- pinen għandhom ikunu pprajmati qabel l- injezzjoni biex is- selettur tad- doża jmur lura fuq iż- żero u qatra ta ’ insulina tidher fit- tarf tal- labra.
The dose is set by turning the selector, which returns to zero during the injection..
Id- doża tiġi ssettjata billi ddawwar is- selettur, li jerġa ’ jmur lura fuq iż- żero waqt l- injezzjoni.
If an adjustment is needed when switching the patients to Actrapid, it may occur with the first dose or during the first several weeks or months.
Tibdil fil- qawwa, il- marka (manifattur), it- tip (insulina li taħdem malajr, b’ żewġ funzjonijiet, taħdem fit- tul, eċċ), l- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew il - metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l -
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
25 annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
Continuous rotation of the injection site within a given area may help to
Jekk ikun hemm bżonn ta ’ aġġustament meta l - pazjenti jaqilbu għal Actrapid, dan jista ’ jsir ma ’ l- ewwel doża jew matul l- ewwel diversi ġimgħat jew xhur.
24 reduce or prevent these reactions.
Bħal kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
A number of medicinal products are known to interact with glucose metabolism.
Numru ta ’ prodotti mediċinali huma magħrufa li għandhom effett fuq il - metaboliżmu ta ’ glukosju.
Insulin treatment of the nursing mother presents no risk to the baby.
26 Il- kura bl- insulina fl- omm li tkun qed tredda ’ ma toħloq l- ebda riskju għat- tarbija.
25 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan hu partikularment importanti f’ dawk li għandhom nuqqas ta ’ għarfien jew l- ebda għarfien tas- sinjali ta ’ twissija ta ’ l- ipogliċemija jew li għandhom episodji frekwenti ta ’ ipogliċemija.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
27 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
26 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
28 Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, l- ammont ta ’ xaħam taħt il- ġilda, it- tip tad- dijabete).
27 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Distribuzzjoni Ma ġiet osservata ebda rabta qawwija mal- proteini tal- plażma, ħlief ma ’ l- antikorpi ta ’ l- insulina (jekk kienu preżenti) li jkunu qegħdin jiċċirkolaw.
Chrildren and adolescents The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Tfal u adolexxenti Il- profil farmakokinetiku ta ’ Actrapid kien studjat f’ numru żgħir (n=18) ta ’ tfal dijabetiċi (6- 12- il sena) u adolexxenti (13- 17- il sena).
Do not store them in or too near the freezer section or cooling element.
Qabel l- użu: aħżen fi friġġ (2°C - 8°C), Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta ’ l- element li jkessaħ.
28 During use: do not refrigerate.
Waqt l- użu: tagħmilhomx fil- friġġ.
Protect from excessive heat and sunlight.
Żomm l- għatu fuq il- pinna sabiex tilqa ’ mid- dawl Ipproteġi minn sħana eċċessiva u mid- dawl tax- xemx.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Pinna mimlija għal- lest (pinna b’ ħafna dożi li tintrema wara li tintuża) li tinkludi injettur pinna bi skartoċċ (3 ml).
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Il- pinen għandhom jintużaw biss ma ’ prodotti li jkunu kompatibbli magħhom u li jippermettu li l - pinen jaħdmu b’ mod sikur u b’ mod effettiv.
Actrapid NovoLet is for single person use only.
Actrapid NovoLet hi maħsuba biex tintuża minn persuna waħda biss.
Actrapid InnoLet 100 IU/ ml solution for injection in a pre-filled pen
Actrapid InnoLet 100 UI/ ml soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4 Special warnings and precautions for use).
32 L- aġġustament fid- dożaġġ jista ’ jkun meħtieġ meta l- pazjenti jaqilbu minn tip ta ’ insulina għall- oħra (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
30 Administration For subcutaneous use.
Kif jingħata Għall- użu minn taħt il- ġilda.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Żomm il- labra taħt il- ġilda għal mill- anqas 6 sekondi biex tiżgura li d- doża kollha tkun injettata.
Actrapid InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Actrapid InnoLet hi maħsuba biex tintuża ma ’ labar NovoFine bl- għatu qasir ta ’ 8 mm jew iqsar.
The needle box is marked with an S.
Il - kaxxa tal- labar hi mmarkata b’ S.
InnoLet delivers 1-50 units in increments of 1 unit.
InnoLet tipprovdi 1- 50 unità f’ inkrementi ta ’ unità waħda.
The dose is set by turning the selector, which returns to zero during the injection.
Id- doża tiġi ssettjata billi ddawwar is- selettur, li jerġa ’ jmur lura fuq iż- żero waqt l- injezzjoni.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Tibdil fil- qawwa, il- marka (manifattur), it- tip (insulina li taħdem malajr, b’ żewġ funzjonijiet, taħdem fit- tul, eċċ), l- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew il -
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
33 metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l - annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
31 reduce or prevent these reactions.
Bħal kull terapija bl- insulina, jista ’ jkun hemm xi reazzjonijiet fil- post ta ’ l- injezzjoni u dawn jinkludu uġigħ, ħaqq, urtikarja, nefħa u infjammazzjoni.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Sustanzi ipogliċemiċi li jittieħdu mill- ħalq (OHA), inibituri ta ’ monoamine oxidase (MAOI), sustanzi li jimblukkaw ir- riċetturi beta mhux selettivi, inibituri ta ’ enzimi li jikkonveru l- angjotensin (ACE), salicylates, alkoħol, sterojdi anaboliċi u sulphonamides.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
34 Wara l- ħlas, il- ħtiġijiet ta ’ l- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
32 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
35 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
33 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi Sintomi ta ’ sensittività eċċessiva ġeneralizzata jistgħu jinkludu raxx ġeneralizzat tal- ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ħass ħażin/ tintilef minn sensik.