qanastek/EMEA-V3 huggingface dataset:
România Roche România S.R.L.
România France Roche România S. R. L.
United Kingdom Roche Products Ltd.
279 United Kingdom Latvija Roche Products Ltd.
The MIRCERA pre-filled syringe is ready for use and can be self-injected by yourself either under the skin or if you are on haemodialysis, through the haemodialysis line according to your doctor’s advice.
MIRCERA siringa mimlija għal- lest hija lesta għall- użu u tista ’ tiġi injettat minnek nnifsek jew taħt il - ġilda jew jekk inti fuq emodijalisi, minn ġol- linja tal- emodijalisi skond il- parir tat- tabib tiegħek.
The pre-filled syringe does not contain any preservative and is to be used for one single injection only.
Kull siringa mimlija għal- lest ma fiha l- ebda preservattiv u għandha tintuża għall- injezzjoni waħda biss.
More than one dose must not be administered per pre-filled syringe.
M’ għandiex tingħata aktar minn doża waħda kull siringa mimlija għal- lest.
Store the pre-filled syringe in the outer carton box.
Aħżen is- siringa mimlija għal- lest fil- kartuna ta ’ barra.
Safety tips ● Make sure that the pre-filled syringe has not been removed from the fridge for more than a single period not extending 1 month. ● Do not use a pre-filled syringe that has been frozen and do not expose it to temperatures above 25°C. ● Do not use a pre-filled syringe after the expiry date stated on the label. ● Only use the pre-filled syringe if the solution is clear, colourless (slightly yellow in colour is acceptable) and is free of visible particles. ● Do not shake the pre-filled syringe, if the solution has been shaken and appears foamy, do not use it (shaking MIRCERA or exposing it to light may damage the medicine). ● When handling the syringe, do not touch the needle. ● Do not use a syringe more than once
Pariri ta ’ sigurtà • Kun żgur li s- siringa mimlija għal- lest ma nħariġitx mill- friġġ għall- aktar minn perijodu wieħed li ma jaqbisx xahar. • Tużax siringa mimlija għal- lest li kienet iffriżata u tesponihiex għal temperatura ta ’ ’ l fuq minn 25°C. • Tużax siringa mimlija għal- lest wara d- data ta ’ skadenza li tidher fuq it- tikketta. • Uża s- siringa mimlija għal- lest biss jekk is- soluzzjoni hija ċara, bla kulur (kulur kemmxejn safrani huwa aċċettabbli) u m’ għandhiex frak viżibbli. • Tħawwadx is- siringa mimlija għal- lest, jekk is- soluzzjoni kienet imħawwda u tidher bir- rawa, tużahiex (li tħawwad MIRCERA jew l- espożizzjoni għad- dawl jista ’ jagħmel ħsara lill - mediċina). • Meta qed tuża siringi, tmissx il- labar. • Tużax siringa aktar minn darba.
Setting up for an injection Assemble all of the supplies you will need for an injection on a clean surface:
Preparazzjoni għall- injezzjoni Iġbor l- affarijiet kollha li se jkollok bżonn għall- injezzjoni fuq wiċċ nadif:
Included in the pack: ● A pre-filled syringe of MIRCERA and a separate injection needle Not included in the pack: ● Cleansing alcohol swabs ● Sterile gauze ● A container for the waste material
Inkluż fil- pakkett: • Siringa mimlija għal- lest ta ’ MIRCERA u labra għall- injezzjoni separata Mhux inkluż fil- pakkett: • Msielaħ tal- alkoħol biex tnaddaf • Garża sterili • Kontenitur għall- materjal ta ’ skart
The following instructions explain how to use MIRCERA pre-filled syringes to inject yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif tuża siringi mimlija għal- lest ta ’ MIRCERA biex tinjetta lilek innifsek.
Remove the box containing MIRCERA from the refrigerator.
Neħħi l- kaxxa li fiha MIRCERA mill- friġġ.
Keep the medicine in the box to protect it from light and allow it to reach room temperature for at least 30 minutes
Żomm il- mediċina fil- kaxxa sabiex tipproteġiha mid- dawl u ħalliha tilħaq temperatura tal- kamra għal ta ’ l- inqas 30 minuta.
Remove the plastic tray of MIRCERA from the box without peeling back the protective film.
280 Neħħi t- trej tal- plastik ta ’ MIRCERA mill- kaxxa mingħajr ma tqaxxar il- kisja ta ’ protezzjoni.
Wash your hands well with soap and warm water.
Aħsel idejk sew bis- sapun u l- ilma fietel.
● Peel back plastic foil from plastic tray and remove syringe and needle
Qaxxar il- folja tal- plastik mit- trej tal- plastik u neħħi s- siringa u l- labra. ●
Preparing the MIRCERA pre-filled syringe and the needle for injection
Preparazzjoni tas- siringa mimlija għal- lest ta ’ MIRCERA u l- labra għall- injezzjoni
Picture 1.
Stampa 1.
Grasp the needle firmly in both hands.
Aqbad il- labra sew f’ idejk it - tnejn.
Break seal of the needle, using a twisting motion and remove the cap.
Ikser is- siġill tal- labra, billi ddawwar u neħħi l- għatu.
Do not remove the needle shield.
Tneħħix l- għatu ta ’ protezzjoni tal- labra.
254 Picture 2.
Stampa 2.
Remove the rubber tip cap from the syringe (bend and pull)
Neħħi l- għatu tat- tarf tal- lasktu minn mas- siringa (ilwi u iġbed).
Picture 3.
Stampa 3.
Attach the needle to the syringe by pushing firmly together.
Waħħal il- labra mas- siringa billi timbotta sew flimkien.
Picture 4.
Stampa 4.
Choose one of the recommended injection sites, arm abdomen or thigh (exept the navel or waistline).
Għażel waħda mill- postijiet għall - injezzjoni rrakkomandati, dirgħajn, addome jew koxxa (minbarra ż- żokra jew il- qadd).
Do not inject MIRCERA into an area that is tender or healing
Tinjettax MIRCERA f’ post li juġgħa jew li qed ifieq.
Picture 5.
Stampa 5.
Clean the site with a new alcohol swab and wait for the area to dry.
Naddaf il- post b’ imselħa ta ’ l - alkoħol ġdida u stenna sakemm il- post jinxef.
Grab syringe and needle shield and pull firmly to remove shield.
Aqbad is- siringa u l- għatu ta ’ protezzjoni tal - labra u iġbed biex tneħħi l- għatu ta ’ protezzjoni.
To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Biex tneħħi l- bżieżaq ta ’ l- arja mis- siringa, żomm is- siringa bil- labra tħares ’ l fuq.
Tap the syringe gently to bring any bubbles to the top.
Tektek is- siringa bil- mod biex il- bżieżaq ta ’ l- arja jitilgħu ’ l fuq.
Push the plunger up slowly to the correct dose, as shown to you by a health care professional.
Imbotta l - planġer ’ l fuq bil- mod sad- doża t- tajba, kif ġejt muri minn professjonist fil- qasam tas - saħħa.
Injecting the solution If your doctor has advised you to inject MIRCERA through the haemodialysis line or into a vein, please administer your dose as shown by your health care professional.
Injezzjoni tas- soluzzjoni Jekk it- tabib tiegħek irrakkomandalek biex tinjetta MIRCERA minn ġol- linja tal- emodijalisi jew fil - vina, jekk jogħġbok amministra d- doża tiegħek kif urik il- professjonist fil- qasam tas- saħħa tiegħek.
If you are advised to inject MIRCERA under your skin please administer your dose as described below.
281 Jekk ġejt irrakkomandat biex tinjetta MIRCERA taħt il- ġilda jekk jogħġbok amministra d- doża tiegħek kif deskritt hawn taħt.
Picture 6.
Stampa 6.
Pinch a fold of skin at the site and insert the needle.
Oqros parti mill- ġilda fil- post u daħħal il- labra.
Insert the needle in a quick, “dart-like” motion.
Daħħal il- labra b’ moviment ħafif “ qisek qed titfa ’ vleġġa ”.
255 Picture 7.
Stampa 7.
Slowly push the plunger all the way down until all the medicine is injected.
Imbotta l- planġer bil- mod s’ isfel nett sakemm il- mediċina tkun injettata kollha.
Do not release plunger.
Terħix il- planġer.
Removing the needle
Tneħħija tal- labra
Picture 8 Take the needle out of the skin without releasing the plunger.
Neħħi l- labra minn ġol- ġilda mingħajr ma terħi l- planġer.
Picture 9.
Stampa 9.
Release the plunger allowing the needle guard to protect the needle.
Erħi l- planġer biex b’ hekk tħalli l - għatu ta ’ protezzjoni tal- labra jipproteġi lill - labra.
Place a cotton ball over the injection site.
Poġġi biċċa tajjar fuq il- post ta ’ l- injezzjoni.
Disposal The syringe is intended for single use and must be thrown away after the injection.
Rimi Is- siringa hija maħsuba għall- użu ta ’ darba u għandha tintrema wara l- injezzjoni.
Dispose of the syringe in a puncture-proof disposal container..
Armi s- siringa f’ kontenitur għar- rimi li ma jittaqqabx.
256
282
What is Mixtard?
X’ inhu Mixtard?
Mixtard is a range of insulin suspensions for injection.
Mixtard hija varjetà ta ’ sospensjonijiet ta ’ l- insulina għall- injezzjoni.
Mixtard is supplied in vials, cartridges (PenFill) or pre-filled pens (NovoLet, FlexPen or InnoLet).
Mixtard hija fornuta f’ kunjetti, stoċċijiet (PenFill) jew kontenituri mimlija (NovoLet, FlexPen jew InnoLet).
Mixtard contains the active substance insulin human (rDNA).
Mixtard fih is- sustanza attiva insulina umana (rDNA).
Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin: • Mixtard 10: soluble insulin 10% and isophane insulin 90%, • Mixtard 20: soluble insulin 20% and isophane insulin 80%, • Mixtard 30: soluble insulin 30% and isophane insulin 70%, • Mixtard 40: soluble insulin 40% and isophane insulin 60%, • Mixtard 50: soluble insulin 50% and isophane insulin 50%.
Mixtard fiha kemm l- insulina li taħdem malajr (li tinħall) u kemm dik li taħdem għal żmien twil (isophane): • Mixtard 10: insulina li tinħall 10% u insulina isophane 90%, • Mixtard 20: insulina li tinħall 20% u insulina isophane 80%, • Mixtard 30: insulina li tinħall 30% u insulina isophane 70%, • Mixtard 40: insulina li tinħall 40% u insulina isophane 60%, • Mixtard 50: insulina li tinħall 50% u insulina isophane 50%,
What is Mixtard used for?
Għal x' hiex jintuża Mixtard?
Mixtard is used in patients with diabetes.
Mixtard jintuża f’ pazjenti bid- dijabete.
How is Mixtard used?
Kif jintuża Mixtard?
Mixtard is given subcutaneously (under the skin) by injection, usually in the abdominal wall (tummy).
Mixtard tingħata b’ mod subkutanju (taħt il- ġilda) permezz ta ’ injezzjoni, normalment f’ parti addominali (fiż- żaqq).
If convenient it may also be given in the gluteal region (buttocks) or the deltoid region (shoulder).
Jekk ikun konvenjenti tingħata wkoll f’ reġjun gluteali (fil- warrani) jew fir - reġjun deltojdu (fl- ispalla).
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Il- livell tal- glukożju fid- demm tal- pazjent (zokkor) għandu jiġi ttestjat b’ mod regolari sabiex tinsab l- aktar doża baxxa effettiva.
The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Id- doża normali hija bejn 0. 3 u 1. 0 f’ unitajiet internazzjonali (IU) għal kull kilogramm ta ’ piż tal- ġisem kuljum.
Mixtard is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.
Mixtard jingħata normalement darba jew darbtejn kuljum meta effett inizjali rapidu u effett li jdum fuq aktar żmien huwa meħtieġ.
How does Mixtard work?
Kif jaħdem Mixtard?
Mixtard is a replacement insulin which is identical to the insulin made by the pancreas.
Id- dijabete hija marda fejn il- ġisem ma jipproduċix insulina biżżejjed sabiex jikkontrolla l- ġlukożju fid- demm.
Mixtard contains insulin in two forms: the soluble form, which acts quickly (within 30 minutes of injection) and the ‘ isophane’ form which is absorbed much more slowly during the day.
Mixtard jintuża minflok insulina li huwa identiku għall- insulina magħmula mill- frixa.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is - sustanza attiva f’ Mixtard, insulina umana (rDNA) hija manifatturata b’ metodu magħruf bħala ‘ teknoloġija ta ’ rikombinar ’. l- insulina hija magħmula minn ħmira li tkun irciviet ġene (DNA), li 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged This gives Mixtard a longer duration of action.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged jagħmilha kapaċi tipproduċi l- insulina.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
L- insulina ta ’ tibdil taġixxi bl- istess mod bħall- insulina naturali u tgħin sabiex il- glukożju jidħol fiċ- ċelloli tad- demm.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Billi jiġi kkontrollat il- glukożju fid- demm, is- sintomi u l- komplikazzjonijiet tad- dijabete jiġu mnaqqsa.
How has Mixtard been studied?
Kif ġie studjat Mixtard?
Mixtard has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Mixtard ġie studjat f’ total ta ’ 294 pazjent bid- dijabete tat- tip1, fejn il- frixa ma tistax tipproduċi l - insulina, u tad- dijabete tat- tip 2, fejn il- ġisem mhuwiex kapaċi juża l- insulina b’ mod effettiv.
About one- third of the patients had type 1 diabetes and the remainder had type 2 diabetes.
Kważi terz tal- pazjenti kellhom id- dijabete tat- tip1 u l- bqija kellhom dijabete tat- tip 2.
The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
L- istudju jqabbel il - Mixtard 30 ma ’ taħlita simili, iżda magħmula permezz ta ’ l- użu ta ’ l- insulina analoga (insulina aspart).
The study measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 12 weeks, which gives an indication of how well the blood glucose is controlled.
L- istudju kejjel il- livell ta ’ sustanza fid- demm magħrufa bħala Emoglobina Glikosilata (HbA1c), wara 12 – il ġimgħa, li tagħti indikazzjoni ta ’ kemm hu kkontrollat tajjeb il- glukożju fid- demm.
What benefit has Mixtard shown during the studies?
Liema benefiċċju wera Mixtard waqt l- istudji li ġew mwettqa?
Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Mixtard wassal għal tnaqqis fil- livell ta ’ HbA1c, u dan jindika li l- livelli tal- glucosju fid- demm ġew ikkontrolati għal livell simili għal dak misjub fl- insulina umana.
Mixtard was effective for both type 1 and type 2 diabetes.
Mixtard kien effettiv kemm għad - dijabete tat- tip 1 u 2.
What is the risk associated with Mixtard?
X’ inhu r- riskju assoċjat ma ’ Mixtard?
As with all insulins, Mixtard may cause hypoglycaemia (low blood glucose).
Bħall- insulini kollha, Mixtard jista ’ jikkawwża l- ipogliċemija (livelli baxxi ta ’ zokkor fid- demm).
For the full list of all side effects reported with Mixtard, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Mistard, ara l- Fuljett ta' Tagħrif.
Mixtard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Mixtard m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allergiċi) ghall- insulina umana (rDNA) jew għal xi ingredjent mill- oħrajn.
Mixtard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Dożi ta ’ Mixtard jista ’ jkun li hemm bżonn li jiġu aġġustati meta jingħataw f’ numru ta ’ mediċini oħrajn li jista ’ jkollhom effett fuq il- glukożju fid- demm.
The full list is available in the Package Leaflet.
Il- lista sħiħa ta ’ dawn il- mediċini tinsab fil- Fuljett ta ’ Tagħrif.
Why has Mixtard been approved?
Għaliex ġie approvat Mixtard?
The Committee for Medicinal products for Human Use (CHMP) decided that Mixtard’ s benefits are greater than its risks for the treatment of diabetes.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Mixtard għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete tat- tieni tip.
The Committee recommended that Mixtard be given marketing authorisation.
Il- Kumitat irrakkomanda li Mixtard jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Mixtard:
Informazzjoni oħra dwar Mixtard:
The European Commission granted a marketing authorisation valid throughout the European Union, for Mixtard to Novo Nordisk A/ S on 7 October 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Mixtard lil Novo Nordisk A/ S fis- 7 ta ’ Ottubru 2002.
The marketing authorisation was renewed on 7 October 2007.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet aġġornata fis- 7 ta ’ Ottubru 2007.
The full EPAR for Mixtard can be found here.
http: // www. emea. europa. eu/ humandocs/ Humans/ EPAR/ mixtard/ mixtard. htmL- EPAR Mixtard jista ’ jinstab hawnhekk
This summary was last updated in 10-2007.
Dan is- sommarju ġie aġġornat l- aħħar fi 10- 2007.
Mixtard 30 40 IU/ ml suspension for injection in a vial.
Mixtard 30 40 UI/ ml suspensjoni għall- injezzjoni f' kunjett
Mixtard is a mixture of dissolved insulin and isophane (NPH) insulin.
Mixtard hu taħlita ta 'insulina maħlula u insulina isophane (NPH).
Mixtard 30 consists of 30% dissolved insulin and 70% isophane insulin.
Mixtard 30 jikkonsisti fi 30% ta 'insulina maħlula u 70% insulina isophane.
Mixtard is a dual-acting insulin.
Mixtard hu insulina li taħdem b' żewġ modi.
It is biphasic formulation containing both fast-acting and long-acting insulin.
Hu formulazzjoni bifażika li fiha kemm insulina li taħdem malajr kif ukoll insulina li taħdem fit- tul.
Mixtard is administered subcutaneously in the thigh or abdominal wall.
Mixtard jingħata taħt il- ġilda fil- koxxa jew fil- membrana addominali.
Mixtard is accompanied by a package leaflet with detailed instruction for use to be followed.
Mixtard jiġi b' fuljett ta ’ tagħrif miegħu, bi struzzjonijiet dettaljati għall- użu li għandhom jiġu 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, fil- marka (manifattur), fit- tip (insulina li taħdem malajr, b’ żewġ funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’
If an adjustment is needed when switching the patients to Mixtard, 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 Mixtard, dan jista ’ jsir ma ’ l- ewwel doża jew matul l- ewwel diversi ġimgħat jew xhur.
On rare occasions, injection site reactions may require discontinuation of Mixtard.
F’ okkażjonijiet rari, minħabba ir - reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm bżonn li Mixtard jitwaqqaf
Mixtard contains metacresol, which may cause allergic reactions.
Mixtard fih metacresol, li jista ’ jikkawża reazzjonijiet allerġiċi.
However, the Mixtard dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm bżonn li d- doża ta ’ Mixtard, tiġi aġġustata.
Frequencies of adverse drug reactions from clinical trials that are considered related to Mixtard are listed below.
Il- frekwenzi tar- reazzjonijiet avversi tal- mediċina minn provi kliniċi li huma kkunsidrati li huma konnessi ma ’ Mixtard, huma elenkati hawn taħt.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
5 L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
However, hypoglycaemia may develop over sequential stages:
Doża eċċessiva speċifika ta ’ l- insulina ma tistax tiġi definita.
5 • 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 ’ prodotti ta ’ glukosju jew prodotti li fihom iz- zokkor.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
6 Distribuzzjoni Ma kien osservat l- ebda tgħaqqid b’ saħħtu mal- proteini tal- plażma, ħlief għall- antikorpi ta ’ l- insulina li kienu qed jiċċirkolaw (jekk kienu preżenti).
6 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Keep the vial in the outer carton in order to protect from light.
7 Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
After removing Mixtard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- kunjett ta 'Mixtard mill- friġġ, hu rakkomandat li tħalli l- kunjett jilħaq it- temperatura tal- kamra (mhux iżjed minn 25°C) qabel ma' tagħmel is- suspensjoni ta 'l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
7 Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
Is- suspensjonijiet ta 'l- insulina m' għandhomx jintużaw jekk ma jkunux jidhru bojod u opaki b' mod uniformi wara s- suspensjoni mill- ġdid.
Mixtard 30 100 IU/ ml suspension for injection in a vial.
Mixtard 30 100 UI/ ml suspensjoni għall- injezzjoni f' kunjett
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
12 L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
12 • 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 ’ prodotti ta ’ glukosju jew prodotti li fihom iz- zokkor.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
13 Distribuzzjoni Ma kien osservat l- ebda tgħaqqid b’ saħħtu mal- proteini tal- plażma, ħlief għall- antikorpi ta ’ l- insulina li kienu qed jiċċirkolaw (jekk kienu preżenti).
13 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Keep the vial in the outer carton in order to protect from light.
14 Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
14 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.
Mixtard 10 Penfill 100 IU/ ml suspension for injection in a cartridge.
Mixtard 10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
Mixtard 10 consists of 10% dissolved insulin and 90% isophane insulin.
Mixtard 10 jikkonsisti f' 10% ta 'insulina maħlula u 90% ta' insulina isophane.
Mixtard is accompanied by a package leaflet with detailed instruction for use to be followed.
Mixtard jiġi b' fuljett ta ’ tagħrif miegħu, bi struzzjonijiet dettaljati għall- użu li għandhom jiġu 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.
17 funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
18 Wara l- ħlas, il- ħtiġijiet għall- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
However, the Mixtard dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm bżonn li d- doża ta ’ Mixtard tiġi aġġustata.
19 • 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 ’ prodotti ta ’ glukosju jew prodotti li fihom iz- zokkor.
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
20 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
20 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Do not store them in or too near the freezer section or cooling element.
21 Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
6.6 Special precaustions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Mixtard Penfill is for single person use only.
Mixtard Penfill hu maħsub biex jintuża minn persuna waħda biss.
21 After removing Mixtard Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard Penfill mill- friġġ, hu rakkomandat li tħalli l- Penfill jilħaq it- temperatura tal - kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl - istruzzjonijiet għall- ewwel użu.
Mixtard 20 Penfill 100 IU/ ml suspension for injection in a cartridge.
Mixtard 20 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
Mixtard 20 consists of 20% dissolved insulin and 80% isophane insulin.
Mixtard 20 jikkonsisti f' 20% ta 'insulina maħlula u 80% ta' insulina isophane.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
23 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
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.
24 funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
25 Wara l- ħlas, il- ħtiġijiet għall- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
26 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
26 • 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 ’ prodotti ta ’ glukosju jew prodotti li fihom iz- zokkor.
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
27 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
27 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Do not freeze.
28 Tagħmilhomx fil- friża.
28 After removing Mixtard Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard Penfill mill- friġġ, hu rakkomandat li tħalli l- Penfill jilħaq it- temperatura tal - kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl - istruzzjonijiet għall- ewwel użu.
07 October 2002
07 Ottubru 2002 Data ta ’ l- aħħar tiġdid:
Mixtard 30 Penfill 100 IU/ ml suspension for injection in a cartridge.
Mixtard 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
30 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
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.
31 funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
32 Wara l- ħlas, il- ħtiġijiet għall- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
33 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
34 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
Do not freeze.
35 Tagħmilhomx fil- friża.
35 Insulin preparations which have been frozen must not be used.
Preparazzjonijiet ta 'l- insulina li kienu ffriżati m’ għandhomx jintużaw.
After removing Mixtard Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard Penfill mill- friġġ, hu rakkomandat li tħalli l- Penfill jilħaq it- temperatura tal - kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl - istruzzjonijiet għall- ewwel użu.
Mixtard 40 Penfill 100 IU/ ml suspension for injection in a cartridge.
Mixtard 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ.
Mixtard 40 consists of 40% dissolved insulin and 60% isophane insulin.
Mixtard 40 jikkonsisti f' 40% ta 'insulina maħlula u 60% ta' insulina isophane.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
37 Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
38 u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- 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 Mixtard, dan jista ’ jsir ma ’ l- ewwel doża jew matul l- ewwel diversi ġimgħat jew xhur.
Insulin treatment of the nursing mother presents no risk to the baby.
39 Il- kura bl- insulina fl- omm li tkun qed tredda 'ma toħloq l- ebda riskju għat- tarbija.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
40 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
41 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
Do not freeze.
42 Tagħmilhomx fil- friża.
Mixtard 50 Penfill 100 IU/ ml suspension for injection in a cartridge.
Mixtard 50 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ
Mixtard 50 consists of 50% dissolved insulin and 50% isophane insulin.
Mixtard 50 jikkonsisti f' 50% ta 'insulina maħlula u 50% ta' insulina isophane.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
44 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
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.
45 funzjonijiet, li taħdem fit- tul, eċċ.), fl- oriġini (insulina li ġejja mill- annimali, umana jew analoga) u/ jew fil- metodu tal- manifattura (insulina tad- DNA rikombinanti, kontra insulina li ġejja minn sors ta ’ l- annimali), jista ’ jirriżulta fi ħtieġa għal tibdil fid- doża.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
46 Wara l- ħlas, il- ħtiġijiet għall- insulina jerġgħu lura malajr għal- livelli ta ’ qabel it- tqala.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
47 Mhux komuni - Edima L- edima tista ’ sseħħ fil- bidu tat- terapija bl- insulina.
47 • 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 ’ prodotti ta ’ glukosju jew prodotti li fihom iz- zokkor.
Absorption The absorption profile is due to the product being a mixture of insulin products with fast and protracted absorption respectively.
48 Assorbiment Il- profil ta 'l- assorbiment huwa minħabba li l- prodott hu taħlita ta' prodotti ta ’ l- insulini li għandhom rispettivament assorbiment mgħaġġel u assorbiment li jieħu fit- tul.
48 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Do not store them in or too near the freezer section or cooling element.
49 Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
49 After removing Mixtard Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard Penfill mill- friġġ, hu rakkomandat li tħalli l- Penfill jilħaq it- temperatura tal - kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl - istruzzjonijiet għall- ewwel użu.
Mixtard 10 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 10 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
51 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Mixtard NovoLet is designed to be used with NovoFine needles.
Mixtard NovoLet hi maħsuba biex tintuża mal- labar NovoFine.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
52 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
53 rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
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.
54 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.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
55 Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, il- ħxuna tax- xaħam ta 'taħt il- ġilda, it- tip tad- dijabete).
6.4 Special precautions for storage
56 6. 4 Prekawzjonijiet speċjali għall- ħażna
Mixtard NovoLet is for single person use only.
Mixtard NovoLet hi maħsuba biex tintuża minn persuna waħda biss.
After removing Mixtard NovoLet from the refrigerator it is recommended to allow the NovoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard NovoLet mill- friġġ, hu rakkomandat li tħalli n- NovoLet tilħaq it- temperatura tal- kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
Date of first authorisation:
57 Data ta ’ l- ewwel awtorizzazzjoni:
Mixtard 20 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 20 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
59 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Usual warning symptoms may disappear in patients with longstanding diabetes.
60 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
61 rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
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.
62 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.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
63 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
6.4 Special precautions for storage
64 6. 4 Prekawzjonijiet speċjali għall- ħażna
Mixtard 30 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 30 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
66 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Usual warning symptoms may disappear in patients with longstanding diabetes.
67 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
68 rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
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.
69 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.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
70 Dan il- proċess hu influwenzat minn diversi fatturi (eż. id- dożaġġ ta ’ l- insulina, il- mod u s- sit ta ’ l - injezzjoni, il- ħxuna tax- xaħam ta 'taħt il- ġilda, it- tip tad- dijabete).
6.4 Special precautions for storage
71 6. 4 Prekawzjonijiet speċjali għall- ħażna
70 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.
Mixtard 40 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 40 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
73 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
74 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
75 rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
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.
76 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.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
77 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
6.4 Special precautions for storage
78 6. 4 Prekawzjonijiet speċjali għall- ħażna
Mixtard 50 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 50 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
80 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
81 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
82 rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
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.
83 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.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
84 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
6.4 Special precautions for storage
85 6. 4 Prekawzjonijiet speċjali għall- ħażna
84 Mixtard NovoLet is for single person use only.
Mixtard NovoLet hi maħsuba biex tintuża minn persuna waħda biss.
Mixtard 30 InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 30 InnoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Mixtard InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Mixtard NovoLet hi maħsuba biex tintuża mal- labar NovoFine.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
88 It- trasferiment ta ’ pazjent għal tip ieħor jew marka oħra ta ’ insulina għandu jsir taħt sorveljanza medika stretta.
Mixtard InnoLet is for single person use only.
Mixtard InnoLet hu maħsub biex jintuża minn persuna waħda biss.
After removing Mixtard InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard InnoLet mill- friġġ, hu rakkomandat li tħalli l- InnoLet tilħaq it- temperatura tal- kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
Mixtard 30 FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Mixtard 30 FlexPen 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
94 Aġġustament fid- dożaġġ Mard fl- istess żmien, speċjalment infezzjonijiet u kundizzjonijiet ta 'deni, normalment iżidu l- ħtieġa tal- pazjent għall- insulina.
Mixtard FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Mixtard FlexPen hi maħsuba biex tintuża ma 'labar NovoFine bl- għatu qasir ta' 8 mm jew iqsar.
Usual warning symptoms may disappear in patients with longstanding diabetes.
95 Is- sintomi normali ta ’ twissija jistgħu jisparixxu f’ pazjenti li ilhom żmien twil bid- dijabete.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
96 rakkomandat li jsir kontroll intensifikat fil- kura ta ’ nisa tqal li għandhom id- dijabete matul it- tqala kollha, u meta mara tkun qed tippjana li toħroġ tqila.
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.
97 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.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
98 prodotti ta ’ l- insulini hija affettwata minn varjazzjonijiet sinifikanti kemm fl- individwu stess u kemm bejn l- individwu u ieħor..
6.4 Special precautions for storage
99 6. 4 Prekawzjonijiet speċjali għall- ħażna
Mixtard FlexPen is for single person use only.
Mixtard FlexPen hi maħsuba biex tintuża minn persuna waħda biss.