qanastek/EMEA-V3 huggingface dataset:
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
255 jikkonsmaw ta ’ l- anqas ammont żghir ta ’ karboidrati fuq bażi regolari, anki jekk jistgħu jieklu ftit jew ebda ikel, jew qed jirremettu eċċ. u qatt m’ għandhom iħallu barra l- insulina għal kollox.
255 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom ikunu mwissija biex jieħdu l- prekawzjonijiet ħalli jevitaw l- iżvilupp ta ’ l - ipogliċemija waqt is- sewqan.
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
256 Għandu jkun ikkunsidrat jekk is- sewqan jew it- tħaddim ta ’ magni hux ta ’ min jirrikkmandhom f ’ dawn iċ- ċirkustanzi.
256 Skin and subcutaneous tissue disorders
257 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi l- glykoġenoliżi u glukoġenesi
Insulin Human Winthrop Comb 50 (a biphasic isophane insulin suspension with 50% dissolved insulin) is an insulin with rapid onset and moderately long duration of action.
258 Insulin Human Winthrop Comb 50 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 50% ta ’ insulina maħlula) hija insulina li tibda taħdem malajr u ddum taħdem għal żmien moderatament twil.
257 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The pen cap must be put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed lura fuq il- pinna sabiex tilqa ’ mid - dawl.
Do not freeze.
259 Tagħmilhomx fil- friża.
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 50 m’ għanduxjitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
258 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Cartridges Before insertion into the pen, Insulin Human Winthrop Comb 50 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Skartoċċi Qabel jiddaħħal fil- pinna, Insulin Human Winthrop Comb 50 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il - kontenut.
Insulin Human Winthrop Comb 50 must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
Insulin Human Winthrop Comb 50 m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal- ġenb jew il- qiegħ ta ’ l- iskartoċċ.
Empty cartridges must not be refilled.
Skartoċċi vojta m’ għandhomx jerġgħu jimtlew.
As with all insulin preparations, Insulin Human Winthrop Comb 50 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
260 Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Comb 50 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insulin Human Winthrop Comb 50 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insulin Human Winthrop Comb 50 m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc.
259 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.
17 January 2007
17 ta ’ jannar 2007
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest,
OptiSet.
Suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest OptiSet.
Insulin Human Winthrop Comb 50 is injected subcutaneously 20 to 30 minutes before a meal.
Insulin Human Winthrop Comb 50 hija injettata fit- tessut ta ’ taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
OptiSet delivers insulin in increments of 2 IU up to a maximum single dose of 40 IU.
OptiSet tagħti insulina f’ ammonti ta ’ 2 IU kull żieda sal massimu ta ’ doża waħda ta ’ 40 IU.
261 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
262 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Comb 50 must never be injected intravenously.
Insulin Human Winthrop Comb 50 qatt m’ għandu jingħata ġol- vina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
263 F’ pazjenti b’ indeboliment sever tal- fwied, il- ħtiega ghall- insulina tista ’ tonqos dovut għan- nuqqas ta ’ produzzjoni tal- glucose u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
262 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ li l- kontroll tal- glucose mhux tajjeb jew hemm tendenza għall- iżvilupp ta ’ grajjiet ta ’ iper - jew ipo- glicemija, għandhom jiġu investigati jekk il- pazjent huwiex qed iżomm mad- dieta preskritta, s- siti ta ’ l- injezzjoni, t- teknika korretta ta ’ l- injezzjoni u l- fatturi rilevanti l- ohrajn kollha qabel ma l - aġġustament fid- doża tkun ikkunsidrata
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kumpensati (e. g. f’ kas ta’ ipotirojdiżmu u
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
264 jikkonsmaw ta ’ l- anqas ammont żghir ta ’ karboidrati fuq bażi regolari, anki jekk jistgħu jieklu ftit jew ebda ikel, jew qed jirremettu eċċ. u qatt m’ għandhom iħallu barra l- insulina għal kollox.
263 Handling of the pen
L- immaniġġar tal- pinna
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
265 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
264 Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemija, ġeneralment, hija l- aktar effett spiss li mhux mixtieq, tat- terapija bl- insulina; din tista ’ tiġri jekk id- doża ta ’ l- insulina hija għolja wisq relatata mal- bżonnijiet tal- persuna għall- insulina.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl - aktar serji jitniżżlu l- ewwel.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
266 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
265 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ sit mnejn jingħata
266 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
The pen in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Żmien kemm iddum tajba l- pinna wara; l- ewwel użu Il- pinna li qed tintuża jew li qed tinġarr bħala riżerva tista ’ tinħażen għall- massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Pens in-use must not be stored in the refrigerator.
Il- pinen fl- użu m’ għandhomxjinżammu fil- friġġ.
6.4 Special precautions for storage
268 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 50 m’ għandux jitqiegħed viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
267 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml suspensjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) u għatu taħt għamla ta ’ flanġ (aluminju), b’ tapp (lastku tal- bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Before first use, Insulin Human Winthrop Comb 50must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel l- ewwel użu, Insulin Human Winthrop Comb 50 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
Insulin Human Winthrop Comb 50 must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Comb 50 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi.
268 Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir - reqqa qabel tintuża l- OptiSet.
The appearance of the insulin should be checked: the insulin suspension must have an evenly milky white appearance.
270 Id- dehra ta ’ l- insulina trid tkun iċċekkjata wkoll: is- suspensjoni ta ’ l- insulina għandha tkun uniformement bajda qisha ħalib.
269 Step 2.
2
Load the dose
Ttella’ d- doża
Check if the selected dose is fully loaded.
271 Iċċekkja jekk id- doża magħżula telgħetx kollha.
270 The patient should be informed on the injection technique by his health care professional.
Il- pazjent għandu jkun mgħallem fuq it- teknika ta ’ l- injezzjoni mill- professjonist tiegħu fil- qasam tas - saħħa.
272 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
273 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Comb 50 in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Comb 50 fi skartoċċi għal OptiClik kien żviluppat għall- użu f’ OptiClik biss.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
274 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
273 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti b’ indeboliment sever tal- fwied, il- ħtiega ghall- insulina tista ’ tonqos dovut għan- nuqqas ta ’ produzzjoni tal- glucose u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
274 Intercurrent illness
275 Mard kurrenti
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
276 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
275 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom ikunu mwissija biex jieħdu l- prekawzjonijiet ħalli jevitaw l- iżvilupp ta ’ l - ipogliċemija waqt is- sewqan.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
277 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
276 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
277 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The acute toxicity was studied following subcutaneous administration in rats.
It- tossiċità akuta kienet studjata fil- firien war li ngħatat fit- tessut ta ’ taħt l- ġilda.
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Studji fuq l- effetti farmakodinamiċi wara li ngħatat fit- tessut ta ’ taħt il- ġilda fil - fniek u l- klieb wrew r- reazzjonijiet ipogliċemiċi mistennija.
The pen cap must be put back on the pen after each injection in order to protect from light.
279 Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed fuq il- pinna sabiex tilqa ’ mid- dawl.
278 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
279 Insulin Human Winthrop Comb 50 cartridges for OptiClik are not designed to allow any other insulin to be mixed in the cartridge for OptiClik.
L- skartoċċi ta ’ Insulin Human Winthrop Comb 50 għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc għal OptiClik.
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Insulin Human Winthrop Comb 50 is injected subcutaneously 20 to 30 minutes before a meal.
Insulin Human Winthrop Comb 50 hija injettata fit - tessut ta ’ taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
Transfer to Insulin Human Winthrop Comb 50
Kif taqleb għal Insulin Human Winthrop Comb 50
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
282 Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
281 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insulin Human Winthrop Comb 50 is administered subcutaneously.
Insulin Human Winthrop Comb 50 għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Comb 50 must never be injected intravenously.
Insulin Human Winthrop Comb 50 qatt m’ għandha tingħata fil- vina.
Patients hypersensitive to Insulin Human Winthrop Comb 50 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
Pazjenti b’ sensittivita ’ eċċessiva għal Insulin Human Winthrop Comb 50, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Comb 50, since they may experience immunological cross-reactions.
F’ pazjenti li huma allerġiċi għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir analiżi għar- reazzjonijiet allerġiċi b’ injezzoni żgħira fil- ġilda, qabel ma ssir il- bidla għal Insulin Human Winthrop Comb 50, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
283 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
282 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
F’ każ ta ’ nuqqas adegwat tal- kontroll tal- livell tal- glucose, jew f’ każ ta ’ tendenza biex jokkorru attakki ta ’ l- ipergliċemija jew l- ipogliċemja, għandha ssir rievalwazzjoni ta ’ kemm il- pazjent qiegħed jieħu t- trattament preskritt, is- siti ta ’ l- injezzjoni, it- teknika korretta ta ’ kif qed issir l- injezzjoni u kull fattur ieħor rilevanti, qabel ma tkun ikkunsidrata l- tibdil tad- doża.
283 Handling of the pen
L- immaniġġar tal- pinna
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Qabel tuża SoloStar, aqra bir- reqqa l- Istruzzjonijiet dwar l- Użu li jinsabu fil- Fuljett ta ’ Tagħrif.
Lactation
285 Treddigħ
284 Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemja, li ġeneralment hija l- aktar effett komuni u mhux mixtieq tat- terapija bl- insulina, tista ’ tiġri meta d- doża ta ’ l- insulina tkun għolja wisq relatata mal- bżonn tagħha.
Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
286 L- insulina tista ’ tikkawża ż- żamma tas- sodju u l- edema, speċjalment jekk il- kontroll metaboliku fqir preċedenti jkun imtejjeb b’ terapija intensifikata bl- insulina.
285 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Mode of action
287 Il- mod kif jaħdem
Insulin Human Winthrop Comb 50 (a biphasic isophane insulin suspension with 50% dissolved insulin) is an insulin with rapid onset and moderately long duration of action.
Insulin Human Winthrop Comb 50 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 50% ta ’ insulina maħlula) huwa insulina li tibda taħdem malajr u ddum taħdem għal żmien qasir.
Following subcutaneous injection, onset of action is within 30 minutes, the phase of maximum action is between 1.5 and 4 hours after injection and the duration of action is 12 to 16 hours.
Wara l - injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 30 minuta, tilħaq ħidma massima ta ’ bejn 1. 5 u 4 sigħat mill- injezzjoni, u ddum taħdem minn 12 sa 16 sigħat.
286 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
6.3 Shelf life
288 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 50 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
287 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Before first use, Insulin Human Winthrop Comb 50 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel ma jiddaħħal fil- pinna, Insulin Human Winthrop Comb 50 għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
Insulin Human Winthrop Comb 50 must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
Jekk din l- apparenza ma tintlaħaqx, iġifieri jekk il- preparat per eżempju jibqa ’ ċar, jew jitfaċċaw xi ċapep, partikoli jew biċċiet bħal trofof tas- suf fl- insulina, jew jeħlu mal- ġenb jew il- qiegħ ta ’ l - iskartoċċ, Insulin Human Winthrop Comb 50 ma tistax tintuża.
As with all insulin preparations, Insulin Human Winthrop Comb 50 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Comb 50 m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insulin Human Winthrop Comb 50 must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Comb 50 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
288 Handling of the pen
L- immaniġġar tal- pinna
SoloStar is designed to work accurately and safely.
290 Is- SoloStar hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
289 Step 2.
2
The needle should be inserted into the skin.
291 Il- labra trid tiddaħħal fil- ġilda.
Insulin Human Winthrop Infusat 100 IU/ ml solution for injection in a vial
Insulin Human Winthrop Infusat 100 IU/ ml soluzzjoni għall- injezzjoni ġo kunjett
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml pfih 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5 mg).
Each vial contains 10 ml of solution for injection, equivalent to 1000 IU insulin.
Kull kunjett fih 10 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 1000 IU insulina.
Insulin Human Winthrop Infusat is a neutral insulin solution (regular insulin).
Insulin Human Winthrop Infusat hija soluzzjoni newtrali ta ’ insulina (insulina regolari).
Insulin Human Winthrop Infusat has been specially designed for use in external portable insulin pumps.
Insulin Human Winthrop Infusat huwa magħmul speċjalment għall- użu ma ’ pompi esterni ta ’ l - insulina, li jistgħu jinġarru.
It is specially stabilised to minimise loss of efficacy which may result from mechanical and thermal stress in such pumps.
Huwa partikolarment stabiliżżat biex jimminimiżża n- nuqqas ta ’ effikaċja, li jista jirriżulta minn stress mekkaniku jew dak dovut għas- sħana, f’ pompi bħal dawn.
Insulin Human Winthrop Infusat is therefore also suitable for continuous insulin infusion with other, conventional injection syringe pumps.
Insulin Human Winthrop Infusat huwa, għalhekk, addattat ukoll għall- infuzzjoni kontinwa b’ pompi ohrajn konvenzjonali taħt għamla ta ’ siringi għall- injezzjoni.
The desired blood glucose levels and the insulin dosage must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.
Il- livelli meħtieġa tal- glucose fid- demm u d- dożaġġ ta ’ l- insulina għandhom ikunu maħdumin fuq bażi individwali u jkunu aġġustati skond il- bżonnijiet tal- pazjent fejn jidħlu d- dieta, l- attività fiżika u l- istil ta ’ ħajja.
When used in external portable insulin pumps, part of the daily insulin dose is infused continuously ("basal rate"), and the rest is administered in the form of bolus injections before meals.
Meta użat f’ pompi esterni ta ’ l- insulina, li jistgħu jinġarru, parti mid- doża ta ’ kuljum ta ’ l- insulina hija infuża kontinwament (“ rata bażika ”), u l- bqija tingħata taħt forma ta ’ injezzjoni bolus qabel l- ikel.
Refer to the operating instructions for detailed information about the infusion pump, its functions and the necessary safety precautions.
Ara l- istruzzjonijiet dwar l- operat għal informazzjoni dettaljata fuq il- pompa ta ’ l- infuzzjoni, il- funzjonijiet tagħha, u l- prekawzjonijiet neċċessarji ta ’ sigurtà.
Consequently, about 40% to 60% of the daily dose is administered at a basal rate, and the rest is given as bolus injections before meals.
Għaldaqstant, madwar 40% sa 60% tad- doża meħtieġa kuljum tingħata bħala rata bażika, u l- bqija bħala injezzjonijiet bolus qabel l- ikliet.
292 Transfer to Insulin Human Winthrop Infusat
293 Il- bidla għal Insulin Human Winthrop Infusat
- a regimen with only regular insulin to one with a longer-acting insulin.
- sistema ta ’ trattament b’ insulina regolari biss għal waħda li iddum taħdem aktar fit- tul.
Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Infusat may be infused by the subcutaneous route.
Insulin Human Winthrop Infusat jista ’ jiġi nfuz fit- tessuti ta ’ taħt il- ġilda.
It is designed for use in the Hoechst Infusor and H-Tron insulin pumps.
Huwa magħmul għall- użu mal- pompi ta ’ l- insulina, Hoechst Infusor u H- Tron.
It may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin (see pump manual).
Jista ’ jintuża wkoll ma ’ pompi oħra ta ’ l- insulina fejn intwerew li huma adatti għal din it- tip ta ’ insulina (ara l- manwal tal- pompa).
Only tetrafluoroethylene or polyethylene catheters must be used.
Il- kateter maġhmul minn tetrafluoroethylene jew dak tal- polythene biss għandhom jintużaw.
Insulin Human Winthrop Infusat must not be used in peristaltic pumps with silicone tubing.
Insulin Human Winthrop Infusat m’ għandux jintuża f’ pompi peristaltiċi bit- tubi tas- silikown.
Insulin must always be infused under aseptic conditions.
L- insulina għandha dejjem tiġi nfuza taħt kondizzjonijiet asettiċi.
This is facilitated by the special equipment available for the insulin pumps (e. g. catheters, cannulas).
Dan huwa iffaċilitat bl- apparat speċjali disponibbli mal- pompi ta ’ l- insulina (eż. kateter, kannula).
The puncture site within a given injection area must be changed regularly (generally, every 1 to 3 days).
Il - postijiet ta ’ l- injezzjoni f’ zona partikolari għandhom jinbiddlu minn injezzjoni għall- oħra (ġeneralment, minn 1 sa 3 ijiem).
4.3 Contraindications
294 4. 3 Kontra- indikazzjonijiet
Refer to the technical manual for contraindications relating to the use of insulin pumps.
Ara l - manwal tekniku dwar l- użu tal- pompi ta ’ l- insulina.
293 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Patients hypersensitive to Insulin Human Winthrop Infusat for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
Pazjenti li juru sensittività eċċessiva għal Insulin Human Winthrop Infusat, u li m’ hemmx preparat aħjar disponibbli għalihom, għandhom ikomplu biss it- trattament taħt supervizzjoni medika u, fejn huwa meħtieġ, flimkien mal- kura kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Infusat, since they may experience immunological cross-reactions.
F’ pazjenti li jbatu minn allergija għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir test ta ’ l- allerġija fil- ġilda qabel ma ssir il- bidla għal Insulin Human Winthrop Infusat, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
In case of hypoglycaemia, the insulin pump should temporarily be turned off, at least until the patient has recovered complete consciousness.
Fil- każ ta ’ ipogliċemija, l- pompa ta ’ l- insulina għandha tintefa temporanjament, għall- inqas sakemm il- pazjent jerġa ’ jiġi kompletament f’ sensih.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
295 Jekk il- livelli ta ’ l- emoglobina glycated huma normali jew imnaqqsin, il- possibbiltà ta ’ ġrajjiet tal - ipogliċemija rikurrenti u mhux magħrufin (speċjalment billejl) għandha tiġi ikkunsidrata.
294 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Biex jitnaqqas ir- riskju ta ’ l- ipogliċemja huwa essenzjali li l- pazjent iżomm mad- dożaġġ u l- kura bid - dieta, it- teħid korrett ta ’ l- insulina, u li l- pazjent ikun konxju tas- sintomi ta ’ l- ipogliċemja.
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu mard disturbi fis- sistem endokrinarja mhux kumpensati (e. g. f’ kas ta’ ipotirojdiżmu u
Insulin pump faults
Ħsarat tal- pompa ta ’ l- insulina
Hyperglycaemia, ketoacidosis and coma may develop within hours if the pump catheter is obstructed completely.
L- ipergliċemija, l- ketoaċidożi u l- koma jistgħu jiżviluppaw fi żmien ftit sigħat jekk il- kateter tal - pompa jinstadd kompletament.
Whenever the patient notices a rapid increase in blood glucose which does not respond to a bolus dose, a check must be made for possible catheter obstruction.
Kull meta l- pazjent jinnota li l- livell tal- glujosju fid- demm jitla ’ malajr u li ma jirrispondix għal doża bolus, għandu jkun iċċekkjat jekk il- kateter huwiex possibilment miżdud.
For details on safety precautions in the use of insulin pumps, refer to the operator ’ s manual.
F’ każ li l- pompa jiġrilha ħsara, l- pazjenti għandhom dejjem ikollhom metodi alternattivi ta ’ injezzjoni (siringa għall- injezzjoni jew pinna) u l- insulina disponibbli għall- injezzjoni fit- tessut ta ’ taħt il- ġilda.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
296 Addizjonalment is- sinjali adrenerġiċi ta ’ counter- regulation jistgħu jkunu mnaqqsin jew assenti, taħt l - effetti tas- sustanzi mediċinali simpatolitiċi bħall- imblokkaturi tar- riċetturi beta, clonidine, guanethidine u reserpine.
295 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Insulin Human Winthrop Infusat can be used during breastfeeding.
Insulin Human Winthrop Infusat jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
297 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
296 Insulin administration may cause anti-insulin antibodies to form.
L- għoti ta ’ l- insulina jista ’ jwassal għall- produzzjoni ta ’ l- antikorpi kontra l- insulina.
4.9 Overdose
298 4. 9 Doża eċċessiva
Insulins and analogues, fast-acting, ATC Code:
Kodiċi ATC:
Insulin Human Winthrop Infusat is an insulin with rapid onset and short duration of action.
Insulin Human Winthrop Infusat hija insulina li tibda taħdem malajr u ddum taħdem għal żmien qasir.
Local tolerability studies following subcutaneous and intramuscular administration in rabbits gave no remarkable findings.
Studji fil- fniek dwar it- tollerabbilità lokali wara injezzjoni fit- tessut ta ’ taħt il- gilda u fil- muskoli ma wrew xejn partikolari.
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Studji fuq l- effetti farmakodinamiċi wara li ngħatat fit- tessut ta ’ taħt il- ġilda fil- fniek u l- klieb urew r- reazzjonijiet ipogliċemiċi mistennija.
Phenol, zinc chloride, trometamol, poloxamer 171, glycerol, hydrochloric acid (for pH adjustment), water for injections.
Phenol, zinc chloride, trometamol, poloxamer 171, glycerol, hydrochloric acid (għall- agġustament tal- pH), ilma għall- injezzjonijiet.
298 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Do not put Insulin Human Winthrop Infusat next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Infusat m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
10 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
10 ml soluzzjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu bi flanġ (aluminju), tapp (lastku tal - chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
Not all pack sizes may be marketed.
Pakketti ta ’ 3 kunjetti huma disponibbli.
Insulin Human Winthrop Infusat must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.
Insulin Human Winthrop Infusat għandu jintuża biss jekk is- soluzzjoni hija ċara, bla kulur, mingħajr ebda partikuli solidi u viżibbli, u jekk hija ta ’ konsistenza li tixbah dik ta ’ l- ilma.
For use in an infusion pump, Insulin Human Winthrop Infusat is filled into the sterile cartridge of the pump.
Għall- użu f’ pompa ta ’ l- infuzzjoni, Insulin Human Winthrop Infusat jitqiegħed fl- iskartoċċ sterili tal - pompa.
The cartridge must only be used once.
L- iskartoċċ għandu jintuża darba biss.
Before use, the filled cartridge must be kept at room temperature for 1 to 2 hours.
300 Qabel l- użu l- iskartoċċ mimli għandu jinżamm fit- temperatura ambjentali ta ’ ġewwa għal minn siegħa sa sagħtejn.
Air bubbles must be removed before starting the infusion (see the operator ’ s manual for the pump).
Il- bzieżaq ta ’ l- arja għandhom jitneħħew qabel tibda tingħata l- infuzzjoni (ara l- manwal ta ’ kif tħaddem il- pompa).
If the infusion pump malfunctions, the solution may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
Jekk il- pompa ma tahdimx sew, is- soluzzjoni tista ’ titella ’ mill- iskartoċċ b’ siringa ta ’ l- injezzjoni (magħmula għal insulina ta ’ 100 IU/ ml) u tiġi njettata.
As with all insulin preparations, Insulin Human Winthrop Infusat must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Infusat m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
It must also be remembered that neutral regular insulin precipitates out at a pH of approximately 4.5 to 6.5.
Wieħed għandu wkoll jiftakar li l- insulina newtrali u regolari tissepara mill- likwidu li hi miżmum fih, f’ pH ta ’ madwar 4. 5 sa 6. 5.
Insulin Human Winthrop Infusat must NOT be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Infusat M’ GĦANDUX jitħallat ma ’ ebda insulina oħra jew ma ’ insulini analogi.
Insulin Human Winthrop Infusat 100 IU/ ml solution for injection in a cartridge
Insulin Human Winthrop Infusat 100 IU/ ml soluzzjoni għall- injezzjoni ġo skartoċċ
Each cartridge contains 3.15 ml of solution for injection, equivalent to 315 IU insulin.
Kull skartoċċ fih 3. 15 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għal 315 IU insulina.
301 Transfer to Insulin Human Winthrop Infusat
302 Il- bidla għal Insulin Human Winthrop Infusat
Insulin Human Winthrop Infusat in cartridges may be infused by the subcutaneous route.
Insulin Human Winthrop Infusat f’ skartoċċi jista ’ jiġi nfuz fit- tessuti ta ’ taħt il- ġilda.
It may also be used in other insulin pumps for which it has been shown that they are suitable for this insulin and this type of cartridge (see pump manual).
Jista ’ jintuża wkoll ma ’ pompi oħra ta ’ l- insulina fejn intwerew li huma adatti għal din it- tip ta ’ insulina (ara l- manwal tal- pompa).
The puncture site within a given injection area must be changed regularly (generally, every 1 to 3 days).
Is- siti ta ’ l- injezzjoni f’ zona partikolari għandhom jinbiddlu minn injezzjoni għall- oħra (ġeneralment, minn 1 sa 3 ijiem).
4.3 Contraindications
303 4. 3 Kontra- indikazzjonijiet
302 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Infusat, since they may experience immunological cross-reactions.
F’ pazjenti li jbatu minn allergija għall- insulina derivata mill- annimali, huwa rrakkomandat li jsir test ta ’ l- allerġija fil- ġilda qabel ma ssir il- bidla għal Insulin Human Winthrop Infusat, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
F’ pazjenti b’ indeboliment renali, il- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
304 Jekk il- livelli ta ’ l- emoglobina glycated huma normali jew imnaqqsin, il- possibbiltà ta ’ ġrajjiet tal - ipogliċemija rikurrenti u mhux magħrufin (speċjalment billejl) għandha tiġi ikkunsidrata.
303 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Biex jitnaqqas ir- riskju ta ’ l- ipogliċemja huwa essenzjali li l- pazjent iżomm mad- dożaġġ u l- kura bid - dieta, it- teħid korrett ta ’ l- insulina, u li l- pazjent ikun konxju tas- sintomi ta ’ l- ipogliċemja.
These include:
Il- fatturi li jżidu s- suxxettibbiltà għas- sintomu tal- ipogliċemja jeħtieġu partikolarment l- moniteraġġ mill- qrib u jistgħu jirrikjedu tibdil tad- l- aġġustament fid- dożaDawn jinkludu:
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kumpensati (e. g. f’ kas ta ’ ipotirojdiżmu u
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
305 Addizjonalment is- sinjali adrenerġiċi ta ’ counter- regulation jistgħu jkunu mnaqqsin jew assenti, taħt l - effetti tas- sustanzi mediċinali simpatolitiċi bħall- imblokkaturi tar- riċetturi beta, clonidine, guanethidine u reserpine.
304 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Caution should be exercised when prescribing to pregnant women.
IlWieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
Insulin Human Winthrop Insusat can be used during breastfeeding.
Insulin Human Winthrop Infusat jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
L- effetti avversi relatati u imniżżlin hawn taħt, miġbura minn studji kliniċi, huma elenkati skond is - sistema tal- klassifika ta ’ l- organi u f’ ordni fejn l- inċidenza dejjem tonqos: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < / 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
306 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
305 Insulin administration may cause anti-insulin antibodies to form.
L- għoti ta ’ l- insulina jista ’ jwassal għall- produzzjoni ta ’ l- antikorpi kontra l- insulina.
4.9 Overdose
307 4. 9 Doża eċċessiva
In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
F’ suġġetti b’ saħħithom, il- half- life ta ’ l- insulina fis- seru huwa ta ’ madwar 4 sa 6 minuti.
6.
308 6.
307 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Shelf life after first use of the cartridge:
Iż- żmien kemm idum tajjeb l- iskartoċċ wara l- ewwel użu:
The product (cartridges in-use in the pump) may be stored for a maximum of 2 weeks.
Il- prodott (l- skartoċċi li qegħdin jintużaw fil- pompa) jista ’ jinħażen għal massimu ta ’ 2 ġimgħat,
Do not put Insulin Human Winthrop Infusat next to the freezer compartment or a freezer pack.
Insulin Human Winthrop m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal - friża.
3.15 ml solution in a cartridge (type 1 colourless glass) with a plunger (fluoropolymer coated rubber (type 1, mixture of chlorobutyl and natural rubber)), a flanged cap (aluminium) and a stopper with hole (bromobutyl rubber (type 1), a Luer cone attachment (colourless polyethylene) and a Luer cap (colourless polyethylene).
3. 15 ml soluzzjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur), bi planġer (lastku (tip 1, taħlita ta ’ lastku chlorobutyl u dak naturali) miksi b’ fluoropolymer), b’ għatu bi flanġ (aluminju), tapp b’ toqba fih (lastku tal- bromobutyl (tip 1)), b’ kon razza Luer bħala aċċessorju (polyethylene mingħajr kulur) u kappa tat- tip Luer (polyethylene mingħajr kulur).
Packs of 5 cartridges are available.
Pakketti ta ’ 5 skartoċċi huma disponibbli.
Before use, Insulin Human Winthrop Infusat must be kept at room temperature for 1 to 2 hours.
Qabel l- użu, Insulin Human Winthrop Infusat għandu jinżamm fit- temperatura ambjentali ta ’ ġewwa għal minn siegħa sa sagħtejn.
Air bubbles must be removed before starting the infusion (see the operator ’ s manual for the pump).
Il- bzieżaq ta ’ l- arja għandhom jitneħħew qabel tibda tingħata l - infuzzjoni (ara l- manwal ta ’ kif tħaddem il- pompa).
If the infusion pump malfunctions, the solution may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
309 Jekk il- pompa ma tahdimx sew, is- soluzzjoni tista ’ titella ’ mill- iskartoċċ b’ siringa ta ’ l- injezzjoni (magħmula għal insulina ta ’ 100 IU/ ml) u tiġi njettata.
309 ANNEX II
310 ANNESS II
MANUFACTURE OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKAATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50 D-65926 Frankfurt / Main Germany
Sanofi- Aventis Deutschland GmbH Industriepark Höchst, Brüningstraße 50 D- 65926 Frankfurt / Main Il- Ġermanja
Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50 D-65926 Frankfurt / Main Germany
Sanofi- Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50 D- 65926 Frankfurt Il- Ġermanja
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma l- Kummissjoni Ewropea dwar il- pjanijiet għat tqegħid fis- suq ta ’ dan il- prodott mediċinali awtorizzati minn din id- deċizjoni.
The PSUR cycle of Insulin Human Winthrop is aligned with the one of the cross-referred product, Insuman, unless otherwise specified.
Iċ- ċiklu tal- PSUR ta ’ Insulin Human Winthrop huwa allinjat ma ’ l- prodott ta ’ referenza, Insuman, sakemm ma jiġix mitlub xort ’ oħra.
312 A.
312 ANNESS III
313 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTONS / 5 ML VIAL
314 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA / KUNJETT TA ’ 5 ML
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a vial.
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett
1 ml contains 100 IU (3.5 mg) insulin human.
1 ml fih 100 IU (3. 5 mg) insulina umana.
Insulin with a rapid onset and short duration of action.
Insulina li tibda taħdem malajr u ddum taħdem għall- perijodu qasir
Excipients: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid, ilma għall- injezzjonijiet
1 vial of 5 ml 5 vials of 5 ml
Soluzzjoni għall- injezzjoni f’ kunjett Kunjett 1 ta ’ 5 ml 5 kunjetti ta ’ 5 ml
Use only clear and colourless solutions.
Uża biss soluzzjonijiet li huma ċari u bla kulur.
Once in-use, vials may be kept for up to 4 weeks.
Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
Do not store above 25°C and protect from direct heat and light.
Taħżinx ’ il fuq minn 25°Ċ u żommu ’ l bogħod mis- sħana diretta u d- dawl dirett.
314 9.
315 9.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, Il- Ġermanja.
EU/ 1/ 06/ 368/ 011 (1 vial of 5 ml) EU/ 1/ 06/ 368/ 012 (5 vials of 5 ml)
EU/ 1/ 06/ 368/ 011( kunjett 1 ta ’ 5 ml) EU/ 1/ 06/ 368/ 012 (5 kunjetti ta ’ 5 ml)
Medicinal product subject to medical prescription.
Prodott mediċinali li jingħata bir- riċetta tat- tabib
BRAILLE
INFORMAZZJONI BIL- BRAILLE
315 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
316 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
316 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
317 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTONS / 10 ML VIAL
KARTUNA TA ’ BARRA / KUNJETT TA ’ 10 ML
Insulin Human Winthrop Rapid 40 IU/ ml solution for injection in a vial.
Insulin Human Winthrop Rapid 40 IU/ ml soluzzjoni għall- injezzjoni f’ kunjett
1 ml contains 40 IU (1.4 mg) insulin human.
1 ml fih 40 IU (1. 4 mg) insulina umana.
Insulin with a rapid onset and short duration of action.
Insulina li tibda taħdem malajr u ddum taħdem għall- perijodu qasir.
Excipients: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet
1 vial of 10 ml 5 vials of 10 ml
Soluzzjoni għall- injezzjoni f’ kunjett Kunjett 1 ta ’ 10 ml 5 kunjetti ta ’ 10 ml
Subcutaneous or intravenous use.
Użu għal taħt il- ġilda jew ġol- vina.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ JIET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Use only clear and colourless solutions.
Uża biss soluzzjonijiet ċari u mingħajr kulur.
Once in-use, vials may be kept for up to 4 weeks.
318 Ġaladarba fl- użu, l- kunjetti jistgħu jinżammu sa 4 ġimgħat.
Do not freeze.
Tagħmlux fil- friza.
Keep the vial in the outer carton in order to protect from light.
Żomm fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI JEKK HEMM BŻONN
EU/ 1/ 06/ 368/ 001 (1 vial of 10 ml) EU/ 1/ 06/ 368/ 002 (5 vials of 10 ml)
EU/ 1/ 06/ 368/ 001 (kunjett 1 ta ’ 10 ml) EU/ 1/ 06/ 368/ 002 (5 kunjetti 1 ta ’ 10 ml)
318 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
319 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
VIAL LABEL
TIKKETTA TAL_ KUNJETT
METHOD OF ADMINISTRATION
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Il- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
10 ml
10ml
OUTER CARTONS / 3 ML CARTRIDGES
320 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA / SKARTOĊĊI TA ’ 3 ML
Insulin Human Winthrop Rapid 100 IU/ ml solution for injection in a cartridge.
Insulin Human Winthrop Rapid 100 IU/ ml soluzzjoni għall- injezzjoni f’ skartoċċ
1 ml contains 100 IU (3.5 mg) insulin human.
1 ml fih 100 Unità (3. 5 mg) insulina umana.
3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Soluzzjoni għall- injezzjoni, f’ skartoċċ 3skartoċċi ta ’ 3ml 4 skartoċċi ta ’ 3 ml 5 skartoċċi ta ’ 3 ml 6 skartoċċi ta ’ 3 ml 9 skartoċċi ta ’ 3 ml 10 skartoċċi ta ’ 3 ml
Read the package leaflet before use.
L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- skartoċċi ta ’ Insulin Human Winthrop Aqra l- fuljett ta ’ tagħrif qabel l- użu.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Jekk il- pinna ta ’ l- insulina hija bil- ħsara jew mhix qed taħdem sew (dovut għal difetti mekkaniċi) għandha tintrema, u pinna ġdida ta ’ l- insulina tintuża minflok.
320 8.
321 8.