qanastek/EMEA-V3 huggingface dataset:
73 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Mode of action
74 Il- mod kif jaħdem
74 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
It is longer in patients with severe renal insufficiency.
F’ pazjenti li għandhom insuffiċjenza severa tal- kliewi, dan iż - żmien jitwal.
Shelf life after first use of the vial:
75 Żmien kemm idum tajjeb il- kunjett wara l- ewwel użu:
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25 C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
75 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
10 ml suspension in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
10 ml suspensjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu bi flanġ (aluminju), tapp (lastku tal - chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
Jekk żewġ insulini differenti sejrin jittellgħu f’ siringa waħda għall- injezzjoni, huwa rrakkomandat li l - ewwel titella ’ l- insulina li taħdem fuq perijodu iqsar sabiex tevita l- kontaminazzjoni tal- kunjett tal -
It is advisable to inject immediately after mixing.
Ta ’ min jirrikkmanda li l- injezzjoni ssir immedjatament wara li titħallat.
100 IU per ml and 40 IU per ml) must not be mixed.
100 IU kull ml u 40 IU kull ml) m’ għandhomx jitħalltu.
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Basal 100 IU ’ / ml, Suspensjoni għall- injezzjoni, ġo skartoċċ.
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml fih 100 IU t’ insulina umana (ekwivalenti għal 3. 5 mg).
Each cartridge contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull skartoċċ fih 3 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għal 300 IU t’ insulina.
Suspension for injection in a cartridge.
Suspensjoni għall- injezzjoni ġo skartoċċ.
After re-suspension, milky white suspension.
Wara li s- suspensjoni titħawwad mill- ġdid, tifforma suspensjoni bajda ħalib.
78 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
78 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 Basal in cartridges has been developed for use in the OptiPen series.
Insulin Human Winthrop Basal fi skartoċċi kienet żviluppata għall- użu mas- serje ta ’ l- OptiPen.
Insulin Human Winthrop Basal is administered subcutaneously.
Insulin Human Winthrop Basal tingħata fit- tessut ta ’ taħt il- ġilda.
79 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
79 F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- disturbi fil- glandoli endokrini mhux ikkompensati (e. ż. l- ipotirojdiżmu, l- insuffiċjenza tal- parti
adrenocortical insufficiency),
anterjura tal- pitwitarja u l- insuffiċjenza tas- surrenali),
Intercurrent illness
80 Mard kurrenti
80 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma’ jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Is- sustanzi li jistgħu jżidu l- effett fuq it- tnaqqis tal- livell tal- glucose fid- demm, u jżidu s- suxxettibbiltà għall- ipogliċemja, jinkludu oral antidijabetiċi orali, inibituri ta ’ l- enzima li tikkonverti anġjotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates u l- antibijotiċi sulphonamide.
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Fil- kontrċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline) u l- ormoni tat- tirojde, inibituri tal- protease u l - prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem maġni
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Dawn jikkonstitwixxu riskju
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
81 f’ sitwazzjonijiet fejn dawn l- abbiltajiet huma t’ importanza speċjali (e. ż. sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
81 Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemja, speċjalment meta jirrikorru, jistgħu jwasslu għall- ħsara newroloġika.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
82 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
82 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ sit mnejn jingħata
Pharmacodynamic characteristics
83 Karatteristiċi farmakodinamiċi
83 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Shelf life after first use of the cartridge:
Żmien kemm idum tajjeb l- iskartoċċ wara l- ewwel użu:
The cartridge in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Meta l- iskartoċċ ikun qed jintuża (ġol- pinna ta ’ l- insulina) jew ikun qed jinġarr bħala riżerva, jista ’ jinħażen għal massimu ta ’ 4 ġimgħat, f’ temperatura mhux ‘ il fuq minn 25°C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The pen containing a cartridge must not be stored in the refrigerator.
Il- pinna li fiha skartoċċ m’ għandiex tinżamm fil- friġġ.
The pen cap must be put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, għandek terġa ’ tpoġġi l- kappa tal- pinna fuq il- pinna sabiex tilqa ’ mid- dawl.
Do not put Insulin Human Winthrop Basal next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Basal m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
84 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Each cartridge contains 3 balls (stainless steel).
3 ml soluzzjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) u għatu bi flanġ (aluminju), b’ tapp (lastku tal- bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Insulin pen The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insulin Human Winthrop cartridges and as recommended in the information provided by the device manufacturer.
Pinna ta ’ l- insulina L- skartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra oħrajn li jaqblu ma ’ l- skartoċċi ta ’ Insulin Human Winthrop u skond kif inhu rrakkomandat fit- tagħrif pprovduta mill- manifattur tal- pinna.
If the pen malfunctions (see instructions for using the pen), the suspension may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
Jekk il- pinna ma taħdimx sew (ara l- istruzzjonijiet dwar l- użu tal- pinna), is- soluzzjoni tista ’ titella ’ f’ siringa ta ’ l- injezzjoni (adatta għal insulina ta 100 IU/ ml) u tiġi injettata.
Cartridges Before insertion into the pen, Insulin Human Winthrop Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
SkartoċċiQabel ma jiddaħħal fil- pinna, Insulin Human Winthrop Basal għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
This is best done by gently tilting the cartridge back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil l- istoċċ bil- mod ’ il quddiem u lura (għal mhux anqas minn għaxar darbiet).
Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents.
Kull stoċċ fih tliet boċċi żgħar tal- metall biex jiffaċilitaw it- taħlit malajr u sew tal - kontenut.
Later on, when the cartridge has been inserted into the pen, the insulin must be resuspended again prior to each injection.
Aktar tard, meta l- istoċċ jiddaħħal fil- pinna, l- insulina trid terġa ’ titħallat mill- ġdid qabel kull injezzjoni.
This is best done by gently tilting the pen back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil bil- mod il- pinna ’ il quddiem u lura (għall għal mhux anqas minn għaxar darbiet).
After resuspension, the fluid must have a uniformly milky appearance.
Wara r- ridistribuzzjoni tal- partiċelli, il- likwidu għandu jkollu dehera uniformi tixbaħ lil dik tal- ħalib.
Insulin Human Winthrop Basal 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- istoċċ, Insulin Human Winthrop Basal ma tistax tintuża.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- bidliet xi mindaqqiet jagħtu lill- istoċċ dehera mtappna.
In such cases, a new cartridge yielding a uniform suspension must be used.
F’ każijiet bħal dawn, stoċċ ġdid li juri l- partiċelli żgħar mqassmin b’ mod uniformi jrid jintuża.
It is also necessary to change to a new cartridge if the insulin requirement changes substantially.
Huwa neċessarju wkoll li jinbidel l- istoċċ għal wieħed ġdid jekk il- ħtieġa għall- insulina tinbidel b’ mod sostanzjali.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel issir l- injezzjoni (ara l- istruzzjonijiet dwar l- użu tal- pinna).
Empty cartridges must not be refilled.
L- skartoċċi vojta m’ għandhomx jerġgħu jimtlew.
As with all insulin preparations, Insulin Human Winthrop Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha Insuman Basal m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Mixing of insulins
85 Taħlit ta ’ l- insulini
Insulin Human Winthrop Basal cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insulin Human Winthrop Basal m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċċ.
85 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Basal 100 IU/ ml, suspensjoni għall- injezzjoni, ġo pinna mimlija għal- lest.
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml fih 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5mg).
Each pen contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull pinna fiha 3 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għal 300 IU t’ insulina.
Suspension for injection in a pre-filled pen.
Suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest,.
OptiSet delivers insulin in increments of 2 IU up to a maximum single dose of 40 IU.
Insulin Human WinthropOptiSet tagħti insulina f’ ammonti ta ’ 2 IU kull żieda sa massimu ta ’ doża waħda ta ’ 40 IU.
87 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
87 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 Basal is administered subcutaneously.
Insulin Human Winthrop Basal għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Basal must never be injected intravenously.
Insulin Human Winthrop Basal qatt m’ għandu jingħata ġol- vina.
Insulin absorption and hence the blood glucose lowering effect of a dose may vary from one injection area to another (e. g. the abdominal wall compared with the thigh).
L- assorbiment ta ’ l- insulina u, għalhekk, l- effett fit- tnaqqis tal- livell tal- glucose fid- demm minn doża jista ’ jvarja minn żona ta ’ injezzjoni għal oħra (per eżempju, ż- żaqq meta mqabbla mal- koxxa).
Injection sites within an injection area must be rotated from one injection to the next.
Il - postijiet ta ’ l- injezzjoni f’ zona partikolari għandhom jinbiddlu minn injezzjoni għall- oħra.
For further details on handling, see section 6.6.
Għal aktar informazzjoni dwar l- immaniġġar, ara sezzjoni 6. 6.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
88 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
88 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.
89 Handling of the pen
89
OptiSet has to be used as recommended in these Instructions for Use (see section 6.6).
OptiSet għandu jintuża skond kif inhu irrikkmandat fl- Istruzzjonijiet għall- Użu (ara sezzjoni 6. 6).
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. fil - kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine)
Lactation
90 Treddigħ
90 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
91 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.
91 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Mode of action
92 Il- mod kif jaħdem
92 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The pen in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
93 Żmien kemm iddum tajba l- pinna wara wara l- ewwel użu; Il- pinna fl- użu jew li qed tinġarr bħala riżerva tista ’ tinħażen għall- massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Pens in-use must not be stored in the refrigerator.
Il- pinen fl- użu m’ għandhomx jinżammu fi friġġ.
Do not freeze.
Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ - 8°Ċ) Tagħmilhomx fil- friża.
For storage precautions, see section 6.3.
Pinen fl- użu Għall- kundizzjonijiet ta ’ ħażna,, ara sezzjoni 6. 3.
93 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml soluzzjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) u għatubi flanġ (aluminju), b’ tapp (lastku tal- bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Each cartridge contains 3 balls (stainless steel).
Kull skartoċċ fih 3 boċċi (ta ’ l- azzar li ma jissaddadx).
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor Qabel l- ewwel użu, Insulin Human Winthrop Basal għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
This is best done by gently tilting the pen back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil l- pinna bil- mod ’ l hinn u ’ l hawn (għal mhux anqas minn għaxar darbiet).
Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents.
Kull skartoċċ fih tliet boċci żgħar tal- metall biex jiżguraw li l- kontenut jitħallat malajr u sew.
Later on, the insulin must be resuspended again prior to each injection.
Aktar tard, l- insulina trid tiġi sospiża mill- ġdid qabel kull injezzjoni.
After resuspension, the fluid must have a uniformly milky appearance.
Wara li tissospendi l- kontenut mill- ġdid, il- likwidu għandu jkollu dehra uniformi qisha ħalib.
Insulin Human Winthrop Basal 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 Basal 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.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- kambjamenti x’ imdaqqiet jagħtu dehra lill- iskartoċċ li qisu miksi bil- ġlata.
In such cases, a new pen yielding a uniform suspension must be used.
F’ każijiet bħal dawn, pinna ġdida li tagħti suspensjoni uniformi għandha tintuża.
It is also necessary to change to a new pen if the insulin requirement changes substantially.
Huwa wkoll meħtieġ li tinbidel il- pinna jekk il- bżonn għall- insulina jinbidel sostanzjalment.
It must also be remembered that insulin protamine crystals dissolve in an acid pH range.
Wieħed għandu wkoll jiftakar li l- kristalli ta ’ l- insulina protamine jiddissolvu f’ firxa ta ’ pH aċiduża.
Mixing of insulins
94 Taħlit ta ’ l- insulini
Insulin Human Winthrop Basal must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Basal m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi.
Any unused product or waste material should be disposed of in accordance with local requirements.
L- immaniġġar tal- pinna
94 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.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out. • This pen is only for the patients use.
Uża biss labar li huma kompatibbli ma ’ l - użu ta ’ OptiSet. • Dejjem agħmel it- test ta ’ sigurtà qabel kull injezzjoni. • Jekk ser tintuża OptiSet ġdida, it- test inizjali ta ’ sigurtà għandu jsir bit- 8 Unità issettjati minn qabel mill- manifattur. • Il- mekkaniżmu għas- selezzjoni tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar dan il- mekkaniżmu (tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni ikun inġibed ’ il barra. • Din il- pinna hija intiża għall- użu mill- pazjent biss.
It must not be shared with anyone else. • If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
• Qatt tuża OptiSet jekk tkun bil- ħsara jew m’ intix ċert li qed taħdem sew. • Dejjem żomm miegħek OptiSet żejda f’ każ li OptiSet tiegħek tintilef jew jiġrilha l- ħsara.
If OptiSet is in cool storage, it should be taken out 1 to 2 hours before injection to allow it to warm up.
Jekk OptiSet qiegħeda maħżuna fil- kesħa, trid tinħareġ biex tisħon, minn siegħa sa sagħtejn qabel l - injezzjoni.
Check and mix the Insulin
Iċċekkja u ħallat l- insulina
The insulin should be mixed by turning OptiSet slowly up and down at least 10 times.
L- insulina għandha titħallat billi iddawwar l- Optiset bilmod ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
The appearance of the insulin should be checked: the insulin suspension must have an evenly milky white appearance.
Id- dehra ta ’ l- insulina trid tkun iċċekkjata wkoll: is- suspensjoni ta ’ l- insulina għandha tkun uniformement bajda qisha ħalib.
95 Step 2.
2
Pull out the injection button completely in order to load the dose.
Iġbed kompletament ’ il barra l- buttun ta ’ l- injezzjoni sabiex ittella ’ d- doża.
Never turn the dosage selector after injection button has been pulled out.
Qatt m’ għandek iddawwar il- mekkaniżmu li jagħżel d- dożaġġ wara li tkun ġbidt il- buttun ta ’ l- injezzjoni ’ il barra.
If no insulin appears at the needle tip, step 3 should be repeated two more times until insulin appears at the needle tip.
Jekk ebda insulina ma titfaċċa fil- ponta tal- labra, l- pass numru 3 għandu jiġi repetut darbtejn oħra sakemm l- insulina titfaċċa fil- ponta tal- labra.
The dosage selector should be turned forward until the dose arrow points to the required dose.
96 Dawwar il- mekkaniżmu għas- selezzjoni tad- dożaġġ ’ il quddiem sakemm il- vleġġa qed tipponta lejn id- doża meħtieġa.
Note that the injection button only goes out as far as the amount of insulin that is left in the reservoir.
Kun af li l- buttun ta ’ l- injezzjoni joħroġ biss ’ il barra sa l- ammont ta ’ insulina li fadal fir- riżervwar.
The injection button allows checking the actual loaded dose.
Il- buttun ta ’ l- injezzjoni jippermetti li tkun iċċekkjata d- doża attwali mtella ’.
96 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.
This helps prevent contamination and/ or infection as well as entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Dan jgħin biex tevita l- kontaminazzjoni u/ jew l - infezzjoni kif ukoll id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u t- tqattir ta ’ l- insulina, li tista ’ twassal għal doża ineżatta.
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Basal 100 IU/ ml, suspensjoni għall- injezzjoni, ġo skartoċċ.
Each cartridge contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull skartoċċ fih 3 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għal 300 IU ta ’ insulina.
Suspension for injection in a cartridge for OptiClik.
Suspensjoni għall- injezzjoni ġo skartoċċ għal OptiClik.
98 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
98 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 Basal in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Basal fi skartoċċi għal OptiClik kienet żviluppata għall- użu f’ OptiClik biss.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
99 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Fl- anzjani, l- aggravament progressiv tal- funzjoni tal– kliewi jista ’ jwassal għat- tnaqqis sostanzjali fil- bżonn ta ’ l- insulina.
99 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
100 Intercurrent illness
100
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. fil- kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
Insulin Human Winthrop Basal can be used during breastfeeding.
Insulin Human Winthrop Basal jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
101 L- abbiltà tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jkunu mdgħajfa mħabba l- ipogliċemja jew l- ipergliċemija jew, per eżempju, bħala riżultat tat- tnaqqis fil- vista.
101 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
102 Kambjament sostanzjali tal- kontroll gliċemiku jista ’ jikkawża tnaqqis tamporanju tal- vista, dovut għal bidla temporanja fl- ebbusija u l- indiċi tar- rifrazzjoni tal- lenti ta ’ l- għajn.
102 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
The pen cap must be put back on the pen after each injection in order to protect from light.
104 Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed fuq il- pinna sabiex tilqa ’ mid- dawl.
104 6.5 Nature and contents of container
6. 5 In- natura tal- materjal 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 bi flanġ (aluminju), b’ tapp (lastku tal- bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Insulin pen The cartridges for OptiClik are to be used in conjunction OptiClik only and as recommended in the information provided by the device manufacturer.
Pinna ta ’ l- insulina L- skartoċċi għal OptiClik għandhom jintużaw flimkien ma ’ OptiClik biss u skond kif inhu irrakkomandat fit- tagħrif ipprovdut mill- manifattur tal- pinna.
If the pen malfunctions (see instructions for using the pen), the suspension may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
Jekk il- pinna ma taħdimx sew (ara l- istruzzjonijiet dwar l- użu tal- pinna), is - suspensjoni tista ’ titella ’ f’ siringa ta ’ l- injezzjoni (adatta għal insulina ta 100 Unita ’ / ml) u tiġi injettata.
Cartridges Before insertion into the pen, Insulin Human Winthrop Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Skartoċċi Qabel ma jiddaħħal fil- pinna, Insulin Human Winthrop Basal għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents.
Kull stoċċ fih tliet boċċi żgħar tal- metall biex jiffaċilitaw it- taħlit malajr u sew tal- kontenut.
Later on, when the cartridge has been inserted into the pen, the insulin must be resuspended again prior to each injection.
Aktar tard, meta l- iskartoċċ jiddaħħal fil- pinna, l- insulina trid terġa ’ titħallat mill- ġdid qabel kull injezzjoni.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
105 Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel issir l- injezzjoni (ara l- istruzzjonijiet dwar l- użu tal- pinna).
As with all insulin preparations, Insulin Human Winthrop Basal 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 Basal m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bħal thioles u sulphites.
Insulin Human Winthrop Basal 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 Basal għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċċ għal OptiClik.
105 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Basal 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Each pen contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull pinna fiha 3 ml ta’ suspensjoni għall- injezzjoni, ekwivalenti għal 300 IU insulina.
107 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
107 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 Basal is administered subcutaneously.
Insulin Human Winthrop Basal għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Patients hypersensitive to Insulin Human Winthrop Basal 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 Basal, 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 renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
108 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
108 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.
109 Handling of the pen
L- immaniġġar tal- pinna
Lactation
110 Treddigħ
110 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Metabolism and nutrition disorders
111 Disturbi fil- metaboliżmu u n- nutrizzjoni
111 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Insulins and analogues, intermediate-acting, ATC Code:
L- insulini u l- analogi tagħhom,, li jaħdmu intermedju.
Insulin Human Winthrop Basal (an isophane insulin suspension) is an insulin with gradual onset and long duration of action.
Insulin Human Winthrop Basal (suspensjoni ta ’ insulina isophane) huwa insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
112 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Studji fuq l- effetti farmakodinamiċi wara l- għoti fit- tessut ta ’ taħt il- ġilda fil - fniek u l- klieb urew reazzjonijiet ipogliċemiċi mistennija.
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- agġustament tal- pH) ilma għall- injezzjonijiet
6.2 Incompatibilities
6. 4 Inkompatibilitajiet
Concerning mixing or incompatibility with other insulins see section 6.6.
113 Rigward it- taħlit jew l- inkompatibilità ma ’ insulini oħrajn ara sezzjoni 6. 6.
Care must be taken to ensure that no alcohol or other disinfectants enter the insulin suspension.
Il- kawtela trid titttieħed biex tiżgura li ebda alkoħol jew disinfettanti oħra ma jidħlu fis- suspensjoni ta ’ l- insulina.
113 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 Basal 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 Basal għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
This is best done by gently tilting the pen back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil il- pinna bil- mod ’ il quddiem u lura (għal mhux anqas minn għaxar darbiet).
Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents.
Kull skartoċċ fih tliet boċċi żgħar tal- metall biex jiffaċilitaw it- taħlit malajr u sew tal- kontenut.
Later on, the insulin must be resuspended again prior to each injection.
Aktar tard, meta l- iskartoċċ jiddaħħal fil- pinna, l- insulina trid terġa ’ titħallat mill- ġdid qabel kull injezzjoni.
After resuspension, the fluid must have a uniformly milky appearance.
Wara r- ridistribuzzjoni tal- partiċelli, il- likwidu għandu jkollu dehra uniformi tixbaħ lil dik tal- ħalib.
Insulin Human Winthrop Basal 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 Basal ma tistax tintuża.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- bidliet xi mindaqqiet jagħtu lill - istkartoċċ dehra mtappna.
In such cases, a new pen yielding a uniform suspension must be used.
F’ każijiet bħal dawn, skartoċċ ġdid li juri l- partiċelli żgħar mqassmin b’ mod uniformi jrid jintuża.
It is also necessary to change to a new pen if the insulin requirement changes substantially.
Huwa neċessarju wkoll li tinbidel il- pinna għal waħda ġdida jekk il - ħtieġa għall- insulina tinbidel b’ mod sostanzjali.
As with all insulin preparations, Insulin Human Winthrop Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
114 Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Basal m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insulin Human Winthrop Basal must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Basal m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
114 Handling of the pen
L- immaniġġar tal- pinna
Schematic diagram of the pen
Riżervwar ta ’ l- Insulina
Important information for use of SoloStar:
Dijagramma skematika tal- pinna
• Before each use, a new needle must always be carefully attached and a safety test must be performed.
Tagħrif importanti għall- użu ta ’ SoloStar: • Dejjem waħħal labra ġdida u għandu jsir it- test ta ’ sigurtà qabel kull darba li tużaha.
SoloStar is designed to work accurately and safely.
115 Is- SoloStar hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
Insulin Human Winthrop SoloStar is white with a colour on the injection button.
Iċċekkja t- tikketti tal- pinna biex tiżgura li għandha t- tip korrett t’ insulina. L- Insulin Human Winthrop SoloStar hija ta ’ kulur abjad b’ kulur fuq il- buttun ta ’ l- injezzjoni.
The injection button colour will vary based on the formulation of Insulin Human Winthrop insulin used.
Il- kulur tal- buttun ta ’ l- injezzjoni jista ’ jvarja skond il- formulazzjoni tal- insulina Insulin Human Winthrop.
After removing the pen cap, the appearance of the insulin should also be checked: • The insulin solution (Insulin Human Winthrop Rapid) must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Wara li tneħħi l- kappa tal- pinna, iċċekkja wkoll id- dehra ta ’ l- insulina: • Is- soluzzjoni ta ’ l- insulina (Insulin Human Winthrop Rapid) għandha tkun ċara, mingħajr kulur, b’ ebda partikuli solidi u viżibbli u għandu jkollha konsistenza bħal dik ta ’ l- ilma.
115 Step 2.
2
The dose can be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Id- doża tista ’ tiġi ssettjata f’ qabżiet ta ’ Unità il- waħda, minn minimu ta ’ Unità waħda (1) għall - massimu ta ’ 80 Unità.
The needle should be inserted into the skin.
116 Il- labra trid tiddaħħal fil- ġilda.
Special caution must be taken when removing and disposing of the needle.
Il- kawtela speċjali trid tiġi eżerċitata meta titneħħa u tintrema l- labra.
EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX
EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368 / XXX EU/ 1/ 06/ 368 / XXX EU/ 1/ 06/ 368 / XXX EU/ 1/ 06/ 368 / XXX EU/ 1/ 06/ 368 / XXX
Insulin Human Winthrop Comb 15 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 15 100 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Each vial contains 5 ml of suspension for injection, equivalent to 500 IU insulin.
Kull kunjett fih 5 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għall- 500 IU ta ’ insulina.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
IU waħda (Unità Internazzjonali) tikkorrispondi għal 0. 035 mg ta ’ insulina umana anidru.
Insulin Human Winthrop Comb 15 is a biphasic isophane insulin suspension consisting of 15% dissolved insulin and 85% crystalline protamine insulin.
Insulin Human Winthrop Comb 15 hija suspensjoni ta ’ insulina isophane f’ żewġ fażijiet li tikkonsisti f’ 15% ta ’ insulina maħlula u 85% ta ’ insulina protamine taħt għamla ta ’ kristalli.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Insulina umana hija magħmula bit- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
Diabetes mellitus where treatment with insulin is required.
Id- dijabete mellitus, meta t- trattament bl- insulina huwa meħtieġ.
The desired blood glucose levels, the insulin preparations to be used and the insulin dosage (doses and timings) must be determined individually and adjusted to suit the patient ’ s diet, physical activity and life-style.
Il- livelli meħtieġa tal- glucose fid- demm, it- tipi ta ’ l- insulina użati u d- dożaġġ ta ’ l- insulina (id- dożi u l- ħinijiet meta jingħataw) 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.
There are no fixed rules for insulin dosage.
M’ hemmx regoli fissi fid- dożaġġ ta ’ l- insulina.
However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day.
Madankollu, l- bżonn medju ta ’ l- insulina huwa spiss ta ’ 0. 5 sa 1. 0Unita ’ għal kull kg piż, kuljum.
The basal metabolic requirement is 40% to 60% of the total daily requirement.
Il- ħtieġa bażika metabolika hija minn 40% sa 60% tal - bżonn sħiħ kuljum.
Insulin Human Winthrop Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 15 huwa injettat fit- tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insulin Human Winthrop Comb 15
Il- bidla għal Insulin Human Winthrop Comb 15
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another.
L- aġġustament fid- dożaġġ jista ’ jkun neċessarju meta pazjenti jinqalbu minn tip ta ’ insulina għal oħra.
This applies, for example, when transferring from:
Dan japplika meta, per eżempju, l- bidla tkun minn:
- an animal insulin (especially a bovine insulin) to human insulin,
- insulina derivata mill- annimali (speċjalment l- insulina mill- ifrat) għall- insulina umana,
- one human insulin preparation to another,
- tip ta ’ insulina umana għal tip oħra,
- 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 fit- tul aktar.
Alternatively, it may emerge gradually over a period of several weeks.
Il- ħtieġa għall- aġġustament (per eżempju t- tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla, jew inkella tista ’ tiżviluppa fuq perijodu ta ’ diversi ġimgħat.
118 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
118 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
- have a tendency to hypoglycaemia,
- għandhom tendenza ghall- ipogliċemija,
- previously required high insulin doses due to the presence of insulin antibodies.
- kienu jinħtieġu qabel dożi għoljin ta ’ insulina dovut għall- preżenza ta ’ l- antikorpi kontra l -
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
L- immoniterjar bir- reqqa huwa irrakkomandat waqt il- bidla u fl- ewwel ftit ġimghat ta ’ wara.
In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.
Fil - pazjenti li jinħtieġu dożi għoljin ta ’ insulina dovut għall- preżenza ta ’ l- antikorpi kontra l- insulina, l - bidla li għandha issir taħt sorveljanza medika fi sptar, jew xi post bħalu, trid tiġi ikkunsidrata.
Secondary dose adjustment
L- aġġustament sekondarju tad- doża
Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement.
Il- kontroll metaboliku imtejjeb jista ’ jikkawża sensittività miżjuda ghall- insulina, li twassal għall - ħtiega mnaqqsa għall- insulina.
Dose adjustment may also be required, for example, if
L- aġġustament tad- doża tista ’ wkoll tkun meħtieġa jekk, per eżempju, - il- piż tal- pazjent jinbidel,
- the patient's life-style changes,
- l- istil ta ’ ħajja tal- pazjent tinbidel,
- other circumstances arise that may promote an increased susceptibility to hypo- or
- jiġru ċirkustanzi oħra li jżidu s- suxxettibbiltà għall- ipo - jew għall- iper- gliċemija (ara sezzjoni
In patients with hepatic or renal impairment as well as in the elderly, insulin requirements may be diminished (see section 4.4).
F’ pazjenti b’ indeboliment tal- fwied jew renali, kif ukoll fl- anzjani, il- ħtieġa għall- insulina tista ’ tonqos (ara sezzjoni 4. 4).
Insulin Human Winthrop Comb 15 contains 100 IU of insulin per ml suspension.
Insulin Human Winthrop Comb 15 fih 100 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Only injection syringes designed for this strength of insulin (100 IU per ml) are to be used.
Is- siringi għall- injezzjoni magħmulin għal din il- qawwa biss ta ’ insulina (100 IU kull ml) għandhom jintużaw.
The injection syringes must not contain any other medicinal product or residue (e. g. traces of heparin).
Is- siringi ta ’ l- injezzjoni m’ għandhomx ikollhom kwalunkwe sustanza mediċinali oħra jew xi residwu tagħhom (eż. traċċi tal- ħeparina).
Insulin Human Winthrop Comb 15 is administered subcutaneously.
Insulin Human Winthrop Comb 15 għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Comb 15 must never be injected intravenously.
Insulin Human Winthrop Comb 15 qatt m’ għandu jkun injettat ġol- vina.