qanastek/EMEA-V3 huggingface dataset:
Following subcutaneous injection, onset of action is within 30 to 60 minutes, the phase of maximum action is between 2 and 4 hours after injection and the duration of action is 12 to 19 hours.
Wara injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 30 sa 60 minuta, l- fażi ta ’ l- azzjoni massima hija bejn sagħtejn u 4 sigħat wara l- injezzjoni u ż- żmien kemm iddum tahdem huwa minn 12 sa 19- il siegħa.
181 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Concerning mixing or incompatibility with other insulins see section 6.6.
Rigward it- taħlit jew l- inkompatibilità ma ’ insulini oħrajn ara sezzjoni 4. 2.
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ‘ il fuq minn 25 C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
6.4 Special precautions for storage
183 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insulin Human Winthrop Comb 25 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 25 m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
182 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Insulin Human Winthrop Comb 25 must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the vial.
Insulin Human Winthrop Comb 15 m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal- ġenb jew il- qiegħ tal- kunjett.
As with all insulin preparations, Insulin Human Winthrop Comb 25 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 25 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insulin Human Winthrop Comb 25 may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Human Winthrop Comb 25 jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insulin Human Winthrop Comb 25 must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insulin Human Winthrop Comb 25 ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
Any unused product or waste material should be disposed of in accordance with local requirements.
184 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Comb 25 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 25 40 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Kull ml fih 40 IU ta ’ insulina umana (ekwivalenti għal 1. 4 mg).
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Insulina umana Insulin Human Winthrop hija magħmula bit- teknoloġija rikombinanti tad- DNA ġo Escherichia coli.
185 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
186 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 25 contains 40 IU of insulin per ml suspension.
Insulin Human Winthrop Comb 25 fih 40 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Only injection syringes designed for this strength of insulin (40 IU per ml) are to be used.
Is- siringi għall - injezzjoni magħmulin għal din il- qawwa biss ta ’ insulina (40 IU kull ml) għandhom jintużaw.
186 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
187 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
187 Intercurrent illness
188 Mard kurrenti
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż clozapine u olanzapine).
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
189 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
188 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
190 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
189 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Komuni: reazzjonijiet fis- sit ta ’ l- injezzjonijiet Mhux komuni: urtikarja fis- sit ta ’ l- injezzjoni Mhux magħrufin: infjammazzjoni tas- sit ta ’ l- injezzjoni, nefħa fis- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l - injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
190 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25 °C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
6.4 Special precautions for storage
192 6. 4 Prekawzjonijiet speċjali għall- ħażna
191 6.5 Nature and contents of container
6. 5 In- natura 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 taħt għamla ta ’ flanġ (aluminju), tapp (lastku tal- chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
Any unused product or waste material should be disposed of in accordance with local requirements.
193 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni ġo skartoċċ
194 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
195 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 25 in cartridges has been developed for use in the OptiPen series.
Insulin Human Winthrop Comb 25 fi skartoċċi kien żviluppat għall- użu mas- serje ta ’ l- OptiPen.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Comb 25, 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 Comb 25, 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.
196 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
195 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.
196 Intercurrent illness
197 Mard kurrenti
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
L- imblokkaturi tar- riċetturi beta, clonidine, is sustanzi tal- lithium jew l- alcohol jistgħu jsaħħu jew idgħajjfu l- effett li għandha l- insulina li tbaxxi l- livell tal- glucose fid- demm.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
198 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
197 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.
199 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
198 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Komuni: reazzjonijiet fis- siti ta ’ l- injezzjonijiet Mhux komuni: urtikarja fis- sit ta ’ l- injezzjoni Mhux magħrufin: infjammazzjoni tas- sit ta ’ l- injezzjoni, nefħa tas- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l- injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi l- glykoġenoliżi u glukoneogenesi
199 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.
201 Wara kull injezzjoni, għandek terġa ’ tpoġġi l- kappa tal- pinna fuq il- pinna sabiex tilqa ’ mid- dawl.
Do not put Insulin Human Winthrop Comb 25 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 25 m’ għandux jitqiegħed viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
200 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml suspensjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) għatu taħt għamla ta ’ flanġ (aluminju), b’ tapp (lastku bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Packs of 3, 4, 5, 6, 9 or 10 cartridges are available.
Kull skartoċċ fih 3 boċċi (ta ’ l- azzar li ma jissaddadx) Pakketti ta ’ 3, 4, 5, 6, 9 jew 10 skartoċċi huma disponibbli.
Cartridges Before insertion into the pen, Insulin Human Winthrop Comb 25 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 25 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 25 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 25 m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal- ġenb jew il- qiegħ ta ’ l- iskartoċċ.
In such cases, a new cartridge yielding a uniform suspension must be used.
F’ każijiet bħal dawn, skartoċċ ġdid li jagħti suspensjoni
Insulin Human Winthrop Comb 25 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insulin Human Winthrop Comb 25 m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc.
201 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.
EU/ 1/ 06/ 368/ 091 EU/ 1/ 06/ 368/ 040 EU/ 1/ 06/ 368/ 041 EU/ 1/ 06/ 368/ 096 EU/ 1/ 06/ 368/ 101 EU/ 1/ 06/ 368/ 042
EU/ 1/ 06/ 368/ 091 EU/ 1/ 06/ 368/ 040 EU/ 1/ 06/ 368/ 041 EU/ 1/ 06/ 368 / 096 EU/ 1/ 06/ 368/ 101 EU/ 1/ 06/ 368/ 042
NAME OF THE MEDICINAL PRODUCT
203 ISEM TAL- PRODOTT MEDIĊINALI
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a pre-filled pen.
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Insulin Human Winthrop Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 25 hija injettata fit- tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
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 sal massimu ta ’ doża waħda ta ’ 40 IU li tista ’ tingħata f’ doża waħda.
203 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
204 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
- other circumstances arise that may promote an increased susceptibility to hypo- or
- jiġġru ċirkustanzi oħra li jżidu s- suxxettibbiltà għall- ipo - jew għall- iper- gliċemija (ara sezzjoni
Insulin Human Winthrop Comb 25 must never be injected intravenously.
Insulin Human Winthrop Comb 25 qatt m’ għandu jingħata ġol- vina.
For further details on handling, see section 6.6.
Għal aktar informazzjoni, ara sezzjoni 6. 6.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
205 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.
204 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 kumpensat (e. g. meta l- glandola tat- tirojde ma
adrenocortical insufficiency),
tagħmilx biżżejjed ormoni u insuffiċjenza tal- pitwitarja anterjuri jew adrenokortikali),
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.
206 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.
205 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).
207 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
206 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
208 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
207 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.
and the liver, and improves pyruvate utilisation.
fwied, u ittejjeb l- utilizzazzjoni tal- piruvat.
208 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.
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 li qegħdin jintużaw m’ għandhom jinżammu fi friġġ.
The pen cap must be put back on the pen after each injection in order to protect from light.
210 Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed fuq il- pinna sabiex tilqa ’ mid- dawl.
Do not put Insulin Human Winthrop Comb 25 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 25 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
209 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 ta ’ 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)).
Each cartridge contains 3 balls (stainless steel).
Kull stoċċ fih 3 boċċi (ta ’ l- azzar, li ma jsaddadx).
Injection needles are not included in the pack.
Il- labar għall - injezzjoni mhux inklużi fil- pakkett.
Before first use, Insulin Human Winthrop Comb 25 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel l- ewwel użu, Insulin Human Winthrop Comb 25 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 25 must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Comb 25 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.
211 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
210 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.
211 Step 2.
2
Never turn the dosage selector after injection button has been pulled out.
Qatt m’ għandek iddawwar il- mekkaniżmu li jisselezzjona d- dożaġġ wara li tkun ġbidt il- buttun ta ’ l- injezzjoni ’ il barra.
If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- istrixxa ikkulurita, allura hemm madwar 20 Unità t’ insulina disponibbli.
The dosage selector should be turned forward until the dose arrow points to the required dose.
213 Dawwar il- mekkaniżmu għas- selezzjoni tad- dożaġġ ’ il quddiem sakemm il- vleġġa qed tipponta lejn id- doża meħtieġa.
Load the dose
Tgħabbi d- doża
The injection button should be pulled out as far as it will go in order to load the pen.
Il- buttun ta ’ l- injezzjoni għandu jinġibed kollu ’ l barra sabiex tgħabbi l- pinna.
212 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.
A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
Jista ’ jinstama ’ ħoss, li jieqaf meta l- buttun ta ’ l - injezzjoni jingħafas kompletament ’ il ġewwa.
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 telimina 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.
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
214 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
215 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 25 in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Comb 25 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.
216 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
215 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.
216 Intercurrent illness
217 Mard kurrenti
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
218 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
217 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.
219 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
218 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
219 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 wara li ngħatat fit- tessut ta ’ taħt il- ġilda.
The cartridge in-use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Meta l- iskartoċċ ikun qed jintuża (ġol- pinna ta ’ l- insulina) jew ikun qed jinġarr bħala riżerva, jista ’ jinħażen għal massimu ta ’ 4 ġimgħat, f’ temperatura mhux’ il fuq minn 25°C, ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The pen cap must be put back on the pen after each injection in order to protect from light.
221 Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed lura g fuq il- pinna sabiex tilqa ’ mid - dawl.
Unopened cartridges:
Skaroċċi mhux miftuħa:
220 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml suspensjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) għatu taħt għamla ta ’ flanġ (ta ’ l - aluminju), b’ tapp (tal- lastku bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Insulin Human Winthrop Comb 25 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.
Dawn il- kambjamenti x’ imdaqqiet jagħtu
These changes sometimes give the cartridge a frosted appearance.
222 dehra lill- iskartoċċ li qisu miksi bil- ġlata.
221 Insulin Human Winthrop Comb 25 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 25 għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc għal OptiClik.
Insulin Human Winthrop Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 25 hija injettata fit - tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insulin Human Winthrop Comb 25
Kif taqleb għal Insulin Human Winthrop Comb 25
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
224 Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
223 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 25 is administered subcutaneously.
Insulin Human Winthrop Comb 25 għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Comb 25 must never be injected intravenously.
Insulin Human Winthrop Comb 25 qatt m’ għandha tingħata fil- vina.
Patients hypersensitive to Insulin Human Winthrop Comb 25 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 25, 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 25, 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 25, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
225 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
224 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.
225 Handling of the pen
L- immaniġġar tal- pinna
4.6 Pregnancy and lactation
4. 7 Tqala u Treddigħ
Lactation
227 Treddigħ
226 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.
228 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.
227 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.
A10AD01.
A10AB01
Mode of action
229 Il- mod kif jaħdem
Insulin Human Winthrop Comb 25 (a biphasic isophane insulin suspension with 25% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insulin Human Winthrop Comb 25 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 25% ta ’ insulina maħlula) huwa insulina li tibda taħdem malajr u ddum taħdem għal żmien qasir.
Following subcutaneous injection, onset of action is within 30 to 60 minutes, the phase of maximum action is between 2 and 4 hours after injection and the duration of action is 12 to 19 hours.
Wara l - injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem minn 30 sa 60 minuta, tilħaq ħidma massima ta ’ bejn 2 u 4 sigħat mill- injezzjoni, u ddum taħdem minn 12 sa 19 sigħat.
228 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.
230 Żmien kemm iddumtajba 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.
229 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 25 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 25 għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
Insulin Human Winthrop Comb 25 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 25 ma tistax tintuża.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- bidliet xi mindaqqiet jagħtu lill- istkartoċċ dehra mtappna.
As with all insulin preparations, Insulin Human Winthrop Comb 25 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 25 m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Mixing of insulins
231 Meta tħallat l- insulini
Insulin Human Winthrop Comb 25 must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Comb 25 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
230 Handling of the pen
L- immaniġġar tal- pinna
Schematic diagram of the pen
Il- Kappa ta ’ Il- Kappa ta ’
Do not use this SoloStar if insulin is cloudy, coloured or has particles. • The insulin suspensions (Insulin Human Winthrop Basal or Insulin Human Winthrop mixtures) should be mixed by turning SoloStar up and down at least 10 times to resuspend the insulin.
Tużax din s - SoloStar jekk l- insulina hija mdardra, ikkulurita jew għandha l- partikuli. • Is- suspensjoni ta ’ l- insulina (Insulin Human Winthrop Basal jew taħlit ta ’ Insulin Human Winthrop) għandhom jitħalltu billi iddawwar is- SoloStar ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
231 Step 2.
2
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
UI waħda (Unità Internazzjonali) tikkorrispondi għal 0. 035 mg ta ’ insulina umana anidru.
Insulin Human Winthrop Comb 50 is a biphasic isophane insulin suspension consisting of 50% dissolved insulin and 50% crystalline protamine insulin.
Insulin Human Winthrop Comb 50 hija suspensjoni ta ’ insulina isophane f’ żewġ fażijiet li tikkonsisti f’ 50% ta ’ insulina maħlula u 50% ta ’ insulina protamine taħt għamla ta ’ kristalli.
Insulin Human Winthrop Comb 50 is injected subcutaneously 20 to 30 minutes before a meal.
Insulin Human Winthrop Comb 50 huwa injettat fit- tessut ta ’ taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
Transfer to Insulin Human Winthrop Comb 50
Il- bidla għal Insulin Human Winthrop Comb 50
234 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 Comb 50 contains 100 IU of insulin per ml suspension.
Insulin Human Winthrop Comb 50 fih 100 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Insulin Human Winthrop Comb 50 is administered subcutaneously.
Insulin Human Winthrop Comb 50 għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Comb 50 must never be injected intravenously.
Insulin Human Winthrop Comb 50 qatt m’ għandu jkun injettat ġol- vina.
Insulin Human Winthrop Comb 50 must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insulin Human Winthrop Comb 50 m’ ghandux jinghata ġol- vina u anqas m’ għandu jintuża f’ pompi ta ’ l- infuzzjoni jew f’ pompi ta ’ l- insulina, kemm esterni kif ukoll dawk interni.
Patients hypersensitive to Insulin Human Winthrop Comb 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 li juru sensittività eċċessiva għal Insulin Human Winthrop Comb 50 u li m’ hemmx preparat aħjar disponibbli għalihom għandhom ikomplu biss it- trattament taħt supervizzjoni medika u, fejn huwa meħtieġ, flimkien mal- kura kontra l- allerġija.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Comb 50, since they may experience immunological cross-reactions.
F’ pazjenti li jbatu minn allergija għall- insulina derivata mill- annimali, huwa irrakkomandat li jsir test ta ’ l- allerġija fil- ġilda qabel ma ssir il- bidla għal Insulin Human Winthrop Comb 50, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
235 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
236 F’ pazjenti b’ indeboliment renalii, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
adrenocortical insufficiency),
insuffiċjenza tal- pitwitarja anterjuri jew ta ’ adrenokortikali),
236 Intercurrent illness
237 Mard kurrenti
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline) u l- ormoni tat- tirojde, inibituri tal- protease u l - prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
Insulin Human Winthrop Comb 50 can be used during breastfeeding.
Insulin Human Winthrop Comb 50 jista ’ jintuża fin- nisa waqt il- perijodu li qed ireddgħu.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
238 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
237 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.
A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
239 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.
238 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Komuni: reazzjonijiet fis- sit ta ’ l- injezzjonijiet Mhux komuni: urtikarja fis- sit ta ’ l- injezzjoni Mhux magħrufin: infjammazzjoni fis- sitt ta ’ l- injezzjoni, nefħa fis- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l- injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
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) hija insulina li tibda taħdem malajr u ddum taħdem għal żmien moderatament twil.
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 injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 30 minuta, l- fażi ta ’ l- azzjoni massima hija bejn 1. 5 u 4 sigħat wara l- injezzjoni u ż- żmien kemm iddum tahdem huwa minn 12 sa 16- il siegħa.
239 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
It is recommended that the date of the first use be noted on the label.
241 Huwa rrakkomandat li d- data ta ’ l- ewwel użu tkun mniżżla fuq it- tikketta..
Do not put Insulin Human Winthrop Comb 50 next to the freezer compartment or a freezer pack.
M’ għandekx tpoġġi Insulin Human Winthrop Comb 50 viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
240 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
5 ml suspension in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
5 ml suspensjoni f’ kunjett (ħġieġ tip 1 mingħajr kulur) b’ għatu taħt għamla ta ’ flanġ (aluminju), tapp (lastku tal- chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
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 vial.
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 tal- kunjett.
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’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insulin Human Winthrop Comb 50 may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Human Winthrop Comb 50 jista ’ jitħallat ma ’ l- insulini umani kollha ta ’ Sanofi- Aventis, iżda MHUX ma ’ dawk magħmulin speċifikament għall- użu fil- pompi ta ’ l- insulini.
Insulin Human Winthrop Comb 50 must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insulin Human Winthrop Comb 50 ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
It is advisable to inject immediately after mixing.
Ta ’ min jirrikkmanda li l- injezzjoni ssir immedjatament wara li
Insulin Human Winthrop Comb 50 40 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 50 40 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Each ml contains 40 IU insulin human (equivalent to 1.4 mg) of the active substance.
Kull ml fih 40 IU ta ’ insulina umana (ekwivalenti għal 1. 4 mg).
243 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 Comb 50 contains 40 IU of insulin per ml suspension.
Insulin Human Winthrop Comb 50 fih 40 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Injection sites within an injection area must be rotated from one injection to the next.
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). il - postijiet ta ’ l- injezzjoni f’ zona partikolari għandhom jinbiddlu minn injezzjoni għall- oħra.
244 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
245 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kumpensata (e. g. f’ kas ta ’ ipotirojdiżmu u
245 Intercurrent illness
246 Mard kurrenti
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
247 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
246 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.
248 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
247 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Komuni: reazzjonijiet fis- sitta ’ l- injezzjonijiet Mhux komuni: urtikarja fis- sit ta ’ l- injezzjoni Mhux magħrufin: infjammazzjoni fis- sit ta ’ l- injezzjoni, nefħa fis- sit ta ’ l- injezzjoni, uġigħ fis- sit ta ’ l - injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
248 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Protamine sulphate Metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- agġustament tal- pH), ilma għall- injezzjonijiet.
6.4 Special precautions for storage
250 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 jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
249 6.5 Nature and contents of container
6. 5 In- natura 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 taħt għamla ta ’ flanġ (ta ’ l - aluminju), tapp (tal- lastku tal- chlorobutyl (tip 1)) u għatu li jiċċarrat (tal- polypropylene).
Any unused product or waste material should be disposed of in accordance with local requirements.
251 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insulin Human Winthrop Comb 50 100 IU/ ml suspension for injection in a cartridge
Insulin Human Winthrop Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo skartoċċ
Each cartridge contains 3 ml of suspension for injection, equivalent to 300 IU insulin.
Kull kunjett fih 3 ml ta ’ suspensjoni għall- injezzjoni, ekwivalenti għall- 300 IU ta ’ insulina.
252 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 Comb 50 in cartridges has been developed for use in the OptiPen series.
Insulin Human Winthrop Comb 50 fi skartoċċi kien żviluppat għas- serje ta ’ l- OptiPen.
253 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
254 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.
254 Intercurrent illness
Mard kurrenti