qanastek/EMEA-V3 huggingface dataset:
Insuman Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.
Insuman Comb 25 huwa injettat fit- tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insuman Comb 25
Il- bidla għal Insuman Comb 25
175 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
Insuman Comb 25 contains 100 IU of insulin per ml suspension.
Insuman Comb 25 fih 100 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Insuman Comb 25 is administered subcutaneously.
Insuman Comb 25 għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Comb 25 must never be injected intravenously.
Insuman Comb 25 qatt m’ għandu jkun injettat ġol- vina.
Insuman Comb 25 must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insuman Comb 25 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 Insuman 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 li juru sensittività eċċessiva għal Insuman Comb 25 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 Insuman Comb 25, 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 Insuman Comb 25, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
176 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
177 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
177 Intercurrent illness
178 Mard kurrenti
Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women.
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
Insuman Comb 25 can be used during breastfeeding.
Insuman Comb 25 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).
179 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
178 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
180 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
179 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Insuman Comb 25 (a biphasic isophane insulin suspension with 25% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insuman Comb 25 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 25% ta ’ insulina maħlula) hija insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
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.
180 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
6.4 Special precautions for storage
182 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insuman Comb 25 next to the freezer compartment or a freezer pack.
Insuman Comb 25 m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
181 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
5 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
5 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).
Insuman 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.
Insuman 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, Insuman Comb 25 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Comb 25 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Comb 25 may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insuman 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.
Insuman Comb 25 must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insuman Comb 25 ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
Insuman Comb 25 40 IU/ ml suspension for injection in a vial
Insuman Comb 25 40 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
184 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
185 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insuman Comb 25 contains 40 IU of insulin per ml suspension.
Insuman Comb 25 fih 40 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
185 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
186 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
186 Intercurrent illness
187 Mard kurrenti
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
188 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
187 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
189 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
188 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.
189 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
6.4 Special precautions for storage
191 6. 4 Prekawzjonijiet speċjali għall- ħażna
190 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Insuman Comb 25 100 IU/ ml suspension for injection in a cartridge
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni ġo skartoċċ
Suspension for injection in a cartridge.
Suspensjoni għall- injezzjoni f’ skartoċċ.
193 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
Insuman Comb 25 in cartridges has been developed for use in the OptiPen series.
Insuman 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 Insuman 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 Insuman Comb 25, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
194 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
195 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.
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.
196 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.
195 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
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
197 Għandu jkun ikkunsidrat jekk is- sewqan jew it- tħaddim ta ’ magni hux ta ’ min jirrikkmandhom f ’ dawn iċ- ċirkustanzi.
196 Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemija, speċjalment jekk huma rikurrenti, jistgħu jwasslu għall- ħsara newroloġika.
Skin and subcutaneous tissue disorders
198 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
197 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
Pharmacodynamic characteristics
199 Karatteristiċi farmakodinamiċi
Do not freeze.
200 Tagħmilhomx fil- friża.
Do not put Insuman Comb 25 next to the freezer compartment or a freezer pack.
Insuman Comb 25 m’ għandux jitqiegħed viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
199 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Insulin pen The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman 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 adatti għall- skartoċċi ta ’ Insuman u skond kif inhu irrakkomandat fl- informazzjoni ipprovduta mill - manifattur tal- pinna.
Cartridges Before insertion into the pen, Insuman 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, Insuman Comb 25 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
Insuman 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.
Insuman 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.
Insuman Comb 25 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insuman Comb 25 m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc.
NAME OF THE MEDICINAL PRODUCT
202 ISEM TAL- PRODOTT MEDIĊINALI
Insuman Comb 25 100 IU/ ml suspension for injection in a pre-filled pen.
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Insuman Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.
Insuman 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.
OptiSet tagħti insulina f’ ammonti ta ’ 2 IU kull żieda sa massimu ta ’ 40 IU li tista ’ tingħata f’ doża waħda.
202 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
203 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 hyperglycaemia
- jiġġru ċirkustanzi oħra li jżidu s- suxxettibbiltà għall- ipo - jew għall- iper- gliċemija (ara sezzjoni
Insuman Comb 25 must never be injected intravenously.
Insuman Comb 25 qatt m’ għandu jingħata ġol- vina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
204 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.
203 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
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.
205 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.
204 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).
206 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
205 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
207 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
206 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.
the liver, and improves pyruvate utilisation.
fwied, u ittejjeb l- utilizzazzjoni tal- piruvat.
207 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Pens in-use must not be stored in the refrigerator.
Il- pinen li qegħdin jintużaw m’ għandhomx jinżammu fi friġġ.
The pen cap must be put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed g fuq il- pinna sabiex tilqa ’ mid - dawl.
6.4 Special precautions for storage
209 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insuman Comb 25 next to the freezer compartment or a freezer pack.
Insuman Comb 25 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
208 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 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 skartoċċ fih 3 boċċi (ta ’ l- azzar, li ma jsaddadx).
Before first use, Insuman Comb 25 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel l- ewwel użu, Insuman Comb 25 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
Insuman Comb 25 must not be mixed with any other insulin or with insulin analogues.
Insuman Comb 25 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi.
209 Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
L- Istruzzjonijiet dwar l- Użu li jinsabu fil- Fuljett ta ’ Tagħrif fil- pakkett għandhom jinqraw bir - reqqa qabel tintuża l- OptiSet.
The appearance of the insulin should be checked: the insulin suspension must have an evenly milky white appearance.
211 Id- dehra ta ’ l- insulina trid tkun iċċekkjata wkoll: is- suspensjoni ta ’ l- insulina għandha tkun uniformement bajda qisha ħalib.
210 Step 3.
Pass Nru.
Load the dose
5 Tgħabbi d- doża
Check if the selected dose is fully loaded.
212 Iċċekkja jekk id- doża magħżula telgħetx kollha.
211 The injection button should be pressed all the way in.
Il- buttun ta ’ l- injezzjoni għandu jingħafas sa ġewwa.
213 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
Insuman Comb 25 in cartridges for OptiClik has been developed for use with OptiClik only.
Insuman Comb 25 fi skartoċċi għal OptiClik kien żviluppat għall- użu f’ OptiClik biss.
214 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
215 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.
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.
216 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.
215 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
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
217 Għandu jkun ikkunsidrat jekk is- sewqan jew it- tħaddim ta ’ magni hux ta ’ min jirrikkmandhom f ’ dawn iċ- ċirkustanzi.
216 Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemija, speċjalment jekk huma rikurrenti, jistgħu jwasslu għall- ħsara newroloġika.
Uncommon: shock Not known: immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions), anti-insulin antibodies
Mhux magħrufin: reazzjonijiet allerġiċi immedjati (pressjoni baxxa tad- demm, angioneurotic- edema, djuq ostruttiv u akut tal- bronki, reazzjonijiet ġeneraliżżati tal- ġilda), antikorpi kontra l- insulina
Skin and subcutaneous tissue disorders
218 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
217 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
Pharmacodynamic characteristics
219 Karatteristiċi farmakodinamiċi
The pen cap must be put back on the pen after each injection in order to protect from light.
Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed lura g fuq il- pinna sabiex tilqa ’ mid - dawl.
6.4 Special precautions for storage
220 6. 4 Prekawzjonijiet speċjali għall- ħażna
219 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.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
221 Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l - użu tal- pinna).
Insuman Comb 25 cartridges for OptiClik are not designed to allow any other insulin to be mixed in the cartridge for OptiClik.
L- skartoċċi ta ’ Insuman Comb 25 għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc għal OptiClik.
Insuman Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.
Insuman Comb 25 hija injettata fit- tessut ta ’ taħt il - ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insuman Comb 25
Kif taqleb għal Insuman Comb 25
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
223 Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
222 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
Insuman Comb 25 is administered subcutaneously.
Insuman Comb 25 għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Comb 25 must never be injected intravenously.
Insuman Comb 25 qatt m’ għandha tingħata fil- vina.
Patients hypersensitive to Insuman 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 Insuman 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 Insuman 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 Insuman 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.
224 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
223 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.
224 Handling of the pen
L- immaniġġar tal- pinna
Lactation
226 Treddigħ
225 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Metabolism and nutrition disorders
227 Disturbi fil- metaboliżmu u n- nutrizzjoni
226 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.
Insuman Comb 25 (a biphasic isophane insulin suspension with 25% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insuman 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.
227 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Concerning mixing or incompatibility with other insulins see section 6.6.
229 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.
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 ligh.
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.
228 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 mlsuspension 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)).
Before first use, Insuman 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, Insuman Comb 25 għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
Insuman 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, Insuman Comb 25 ma tistax tintuża.
As with all insulin preparations, Insuman Comb 25 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
230 Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Comb 25 m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Comb 25 must not be mixed with any other insulin or with insulin analogues.
Insuman Comb 25 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
229 Handling of the pen
L- immaniġġar tal- pinna
SoloStar is designed to work accurately and safely.
231 Is- SoloStar hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
Do not use this SoloStar if insulin is cloudy, coloured or has particles. • The insulin suspensions (Insuman Basal or Insuman 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 (Insuman Basal jew taħlit ta ’ Insuman) għandhom jitħalltu billi iddawwar is- SoloStar ’ il fuq u ’ l isfel għal mhux anqas minn 10 darbiet.
230 Only needles that are compatible for use with SoloStar should be used.
Labar li huma kompatibbli biss mas- SoloStar għandhom jintużaw.
Insuman Comb 50 100 IU/ ml suspension for injection in a vial
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Insuman Comb 50 is a biphasic isophane insulin suspension consisting of 50% dissolved insulin and 50% crystalline protamine insulin.
Insuman 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.
Insuman Comb 50 is injected subcutaneously 20 to 30 minutes before a meal.
Insuman Comb 50 huwa injettat fit- tessut ta ’ taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
Transfer to Insuman Comb 50
Il- bidla għal Insuman Comb 50
233 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
Insuman Comb 50 contains 100 IU of insulin per ml suspension.
Insuman Comb 50 fih 100 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Insuman Comb 50 is administered subcutaneously.
Insuman Comb 50 għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Comb 50 must never be injected intravenously.
Insuman Comb 50 qatt m’ għandu jkun injettat ġol- vina.
Insuman Comb 50 must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insuman 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 Insuman 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 Insuman 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 Insuman 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 Insuman Comb 50, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
234 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
235 F’ pazjenti b’ indeboliment renalii, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
235 Intercurrent illness
236 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).
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).
Insuman Comb 50 can be used during breastfeeding.
Insuman 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).
237 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
236 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.
238 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.
237 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Insuman Comb 50 (a biphasic isophane insulin suspension with 50% dissolved insulin) is an insulin with rapid onset and moderately long duration of action.
Insuman 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.
238 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
It is recommended that the date of the first use be noted on the label.
Huwa rrakkomandat li d- data ta ’ l- ewwel użu tkun mniżżla fuq it- tikketta.
6.4 Special precautions for storage
240 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insuman Comb 50 next to the freezer compartment or a freezer pack.
Insuman Comb 50 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
239 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).
Insuman 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.
Insuman 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, Insuman Comb 50 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Comb 50 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Comb 50 may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insuman 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.
Insuman Comb 50 must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insuman Comb 50 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.
241 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Insuman Comb 50 40 IU/ ml suspension for injection in a vial
Insuman Comb 50 40 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
241 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
Insuman Comb 50 contains 40 IU of insulin per ml suspension.
Insuman Comb 50 fih 40 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
242 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
244 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
243 Intercurrent illness
245 Mard kurrenti
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
246 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
244 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.
247 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
245 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
246 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
6.4 Special precautions for storage
249 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insuman Comb 50 next to the freezer compartment or a freezer pack.
Insuman Comb 50 m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
247 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Insuman Comb 50 100 IU/ ml suspension for injection in a cartridge
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo skartoċċ
Each ml contains 100 IU insulin human (equivalent to 3,5 mg).
Kull ml fih 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5 mg).
250 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
Insuman Comb 50 in cartridges has been developed for use in the OptiPen series.
Insuman Comb 50 fi skartoċċi kien żviluppat għas- serje ta ’ l- OptiPen.
251 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
253 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.
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.
254 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.
252 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
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
255 Għandu jkun ikkunsidrat jekk is- sewqan jew it- tħaddim ta ’ magni hux ta ’ min jirrikkmandhom f ’ dawn iċ- ċirkustanzi.
253 Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemija, speċjalment jekk huma rikurrenti, jistgħu jwasslu għall- ħsara newroloġika.
Skin and subcutaneous tissue disorders
256 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
254 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- 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
Pharmacodynamic characteristics
257 Karatteristiċi farmakodinamiċi
6.4 Special precautions for storage
258 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not put Insuman Comb 50 next to the freezer compartment or a freezer pack.
Insuman Comb 50 m’ għanduxjitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
256 The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Insuman 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 adatti għall- skartoċċi ta ’ Insuman u skond kif inhu irrakkomandat fl- informazzjoni ipprovduta mill - manifattur tal- pinna.
Cartridges Before insertion into the pen, Insuman Comb 50 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Skartoċċi Qabel jiddaħħal fil- pinna, Insuman Comb 50 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
Insuman Comb 50 must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
Insuman Comb 50 m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal- ġenb jew il- qiegħ ta ’ l- iskartoċċ.
As with all insulin preparations, Insuman Comb 50 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
259 Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Comb 50 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Comb 50 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insuman Comb 50 m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc.
Insuman Comb 50 100 IU/ ml suspension for injection in a pre-filled pen.
Insuman Comb 50 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Insuman Comb 50 is injected subcutaneously 20 to 30 minutes before a meal.
Insuman Comb 50 hija injettata fit- tessut ta ’ taħt il- ġilda minn 20 sa 30 minuta qabel ikla.
259 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
261 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insuman Comb 50 must never be injected intravenously.
Insuman Comb 50 qatt m’ għandu jingħata ġol- vina.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
262 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.
260 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
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.
263 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.
261 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).
264 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
262 Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemija, ġeneralment, hija l- aktar effett spiss li mhux mixtieq, tat- terapija bl- insulina; din tista ’ tiġri jekk id- doża ta ’ l- insulina hija għolja wisq relatata mal- bżonnijiet tal- persuna għall- insulina.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
265 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
263 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ sit mnejn jingħata