qanastek/EMEA-V3 huggingface dataset:
87 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.
Intercurrent illness
89 Mard kurrenti
88 Handling of the pen
L- immaniġġar tal- pinna
OptiSet has to be used as recommended in these Instructions for Use (see section 6.6).
OptiSet għandu jintuża skond kif inhu irrikkmandat fl- Istruzzjonijiet dwar l- Użu (ara sezzjoni 6. 6).
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. 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)
4.7 Effects on ability to drive and use machines
90 4. 7 Effetti fuq il- ħila biex issuq u tħaddem maġni
89 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Eyes disorders
91 Disturbi fl- għajnejn
90 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.
91 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The pen in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
93 Żmien kemm iddum tajba l- pinna wara l- ewwel użu; Il- pinna fl- użu jew li qed tinġarr bħala riżerva tista ’ tinħażen għall- massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
92 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Before first use, Insuman Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel l- ewwel użu, Insuman Basal għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
This is best done by gently tilting the pen back and forth (at least ten times).
Dan l- aħjar li jsir billi tmil l - pinna bil- mod ’ l hinn u ’ l hawn (għal mhux anqas minn għaxar darbiet).
Insuman Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
Insuman Basal m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina, jew jekk dawn jeħlu mal- ġenb jew il- qiegħ ta ’ l- iskartoċċ.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- kambjamenti x’ imdaqqiet jagħtu dehra lill - iskartoċċ li qisu miksi bil- ġlata.
Insuman Basal must not be mixed with any other insulin or with insulin analogues.
Insuman Basal m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi.
Important information for use of OptiSet: • Always attach a new needle before each use.
Tagħrif importanti dwar l- Użu ta ’ OptiSet: • Dejjem waħħal labra ġdida qabel kull darba li tużaha.
Only use needles that are compatible for use with OptiSet. • Always perform the safety test before each injection. • If a new OptiSet is used the initial safety test must be done with the 8 units preset by the manufacturer. • The dosage selector can only be turned in one direction. • Never turn the dosage selector (change the dose) after injection button has been pulled out.
Uża biss labar li huma kompatibbli ma ’ l - użu ta ’ OptiSet. • Dejjem agħmel it- test ta ’ sigurtà qabel kull injezzjoni. • Jekk ser tintuża OptiSet ġdida, it- test inizjali ta ’ sigurtà għandu jsir bit- 8 Unità issettjati minn qabel mill- manifattur. • Il- mekkaniżmu għas- selezzjoni tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar dan il- mekkaniżmu (tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni ikun inġibed ’ il barra. • Din il- pinna hija intiża għall- użu mill- pazjent biss.
It must not be shared with anyone else. • If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
• Qatt tuża OptiSet jekk tkun bil- ħsara jew m’ intix ċert li qed taħdem sew. • Dejjem żomm miegħek OptiSet żejda f’ każ li tintilef jew jiġrilha l- ħsara.
OptiSet is designed to work accurately and safely.
95 OptiSet hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
The needle should be carefully attached straight onto the pen.
Il- labra għandha titwaħħal
Prior to each injection a safety test has to be performed.
Qabel kull injezzjoni jrid
94 Then the injection button should be pressed all the way in.
Imbagħad agħfas il- buttun ta ’ l- injezzjoni sa ġewwa.
Step 4.
Pass Nru.
Select the dose
4Tagħżel id- doża
If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
96 Jekk il- planġer iswed qiegħed fit- tarf ta ’ l- indikatur ikkulurita, allura hemm madwar 20 Unità t’ insulina disponibbli.
Load the dose
5 Ttella ’ d- doża
Inject the dose
6 Tinjetta d- doża
Remove and discard the needle
7 Tneħħi u tarmi l- labra
Insuman Basal 100 IU/ ml suspension for injection in a cartridge
Insuman Basal 100 IU/ ml, suspensjoni għall- injezzjoni, ġo skartoċċ.
Suspension for injection in a cartridge for OptiClik.
Suspensjoni għall- injezzjoni f’ skartoċċ għal OptiClik.
97 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 Basal in cartridges for OptiClik has been developed for use with OptiClik only.
Insuman Basal fi skartoċċi għal OptiClik kienet żviluppata għall- użu f’ OptiClik biss.
98 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
99 F’ pazjenti li għandhom mard tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil - kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
Intercurrent illness
100 Mard kurrenti
99 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
Insuman Basal can be used during breastfeeding.
Insuman Basal 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).
101 f’ sitwazzjonijiet fejn dawn l- abbiltajiet huma t’ importanza speċjali (e. ż. sewqan ta ’ karozza jew tħaddim ta ’ makkinarju).
100 Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
Attakki severi ta ’ ipogliċemja, speċjalment meta jirrikorru, jistgħu jwasslu għall- ħsara newroloġika.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
102 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
101 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 fil - ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni
6.4 Special precautions for storage
104 6. 4 Prekawzjonijiet speċjali għall- ħażna
103 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
As with all insulin preparations, Insuman Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
105 Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Basal m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bħal thioles u sulphites.
Insuman Basal cartridges for Opticlik are not designed to allow any other insulin to be mixed in the cartridge for Opticlik.
L- skartoċċi ta ’ Insuman Basal għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċċ għal OptiClik.
Insuman Basal 100 IU/ ml suspension for injection in a pre-filled pen.
Insuman Basal 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
106 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
107 Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insuman Basal is administered subcutaneously.
Insuman Basal għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Basal must never be injected intravenously.
Insuman Basal qatt m’ għandha tingħata fil - vina.
Patients hypersensitive to Insuman Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti- allergic treatment.
Pazjenti b’ sensittivita ’ eċċessiva għal Insuman Basal, fejn m’ hemmx preparat disponibbli u tollerat aktar, għandhom ikomplu bit- trattament taħt sorveljanza medika mill- qrib u, fejn hemm bżonn, flimkien ma ’ trattament kontra l- allerġija.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
108 F’ pazjenti li għandhom mard sever tal- fwied, il- bżonn ta ’ l- insulina jista ’ jonqos, dovut għat- tnaqqis fil- kapaċità tal- formazzjoni tal- glucose minn molekuli li fihom nfushom mhumiex karboidrati, kif ukoll għat- tnaqqis fil- metaboliżmu ta ’ l- insulina.
107 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.
Intercurrent illness
109 Mard kurrenti
108 Handling of the pen
L- immaniġġar tal- pinna
4.7 Effects on ability to drive and use machines
110 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
109 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Eyes disorders
111 Disturbi fl- għajnejn
110 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Insulins and analogues, intermediate-acting, ATC Code:
L- insulini u l- analogi tagħhom, li jaħdmu intermedju.
Insuman Basal (an isophane insulin suspension) is an insulin with gradual onset and long duration of action.
Insuman Basal (suspensjoni ta ’ insulina isophane) huwa insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
111 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.
The pen cap must be put back on the pen after each injection in order to protect from light.
113 Wara kull injezzjoni, il- kappa tal- pinna għandha terġa ’ titqiegħed fuq il- pinna sabiex tilqa ’ mid- dawl.
112 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Before first use, Insuman Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel ma jiddaħħal fil- pinna, Insuman Basal għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
It is also necessary to change to a new pen if the insulin requirement changes substantially.
Huwa neċessarju wkoll li tinbidel il- pinna għal waħda ġdida jekk il- ħtieġa għall- insulina tinbidel b’ mod sostanzjali.
As with all insulin preparations, Insuman Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Basal m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Basal must not be mixed with any other insulin or with insulin analogues.
Insuman Basal m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
113 Handling of the pen
114 L- immaniġġar tal- pinna
Check the insulin
1 Iċċekkja l- insulina
After removing the pen cap, the appearance of the insulin should also be checked: • The insulin solution (Insuman Rapid) must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
115 • Is- soluzzjoni ta ’ l- insulina (Insuman Rapid) għandha tkun ċara, mingħajr kulur, b’ ebda partikuli solidi u viżibbli u għandu jkollha konsistenza bħal dik ta ’ l- ilma.
114 Step 2.
Pass Nru.
Prior to each injection, a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Qabel kull injezzjoni jrid isir test ta ’ sigurtà biex tiżgura li l- pinna u l- labra qed jaħdmu sew u biex jitneħħew il- bżieżaq ta ’ l- arja.
Select the dose
4 Tagħżel id- doża
Inject the dose
5 Tinjetta d- doża
Remove and discard the needle
6 Tneħħi u tarmi l- labra
Special caution must be taken when removing and disposing of the needle.
116 Il- kawtela speċjali trid tiġi eżerċitata meta titneħħa u tintrema l- labra.
Insuman Comb 15 100 IU/ ml suspension for injection in a vial
Insuman Comb 15 100 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Insuman Comb 15 is a biphasic isophane insulin suspension consisting of 15% dissolved insulin and 85% crystalline protamine insulin.
Insuman Comb 15 hija suspensjoni ta ’ insulina isophane f’ żewġ fażijiet li tikkonsisti f’ 15% ta ’ insulina maħlula u 85% ta ’ insulina protamine taħt għamla ta ’ kristalli.
The desired blood glucose levels, the insulin preparations to be used and the insulin dosage (doses and timings) must be determined individually and adjusted to suit the patient’ s diet, physical activity and life- style.
Il- livelli meħtieġa tal- glucose fid- demm, it- tipi ta ’ l- insulina użati u d- dożaġġ ta ’ l- insulina (id- dożi u l- ħinijiet meta jingħataw) għandhom ikunu maħdumin fuq bażi individwali u jkunu aġġustati skond il - bżonnijiet tal- pazjent fejn jidħlu d- dieta, l- attività fiżika u l- istil ta ’ ħajja.
Insuman Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Insuman Comb 15 huwa injettat fit- tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insuman Comb 15
Il- bidla għal Insuman Comb 15
117 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
- other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia
- jiġru ċirkustanzi oħra li jżidu s- suxxettibbiltà għall- ipo - jew għall- iper- gliċemija (ara sezzjoni
Insuman Comb 15 contains 100 IU of insulin per ml suspension.
Insuman Comb 15 fih 100 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
The injection syringes must not contain any other medicinal product or residue (e. g. traces of heparin).
Is- siringi ta ’ l - injezzjoni m’ għandhomx ikollhom kwalunkwe sustanza mediċinali oħra jew xi residwu tagħhom (eż. traċċi tal- ħeparina).
Insuman Comb 15 is administered subcutaneously.
Insuman Comb 15 għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Comb 15 must never be injected intravenously.
Insuman Comb 15 qatt m’ għandu jkun injettat ġol- vina.
Insuman Comb 15 must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insuman Comb 15 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 15 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 15 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 15, 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 15, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
118 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
119 F’ pazjenti b’ indeboliment renali,, il- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
119 Intercurrent illness
120 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 15 can be used during breastfeeding.
Insuman Comb 15 jista ’ jintuża fin - nisa waqt il- perijodu li qed ireddgħu.
120 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter- regulation.
F’ ħafna pazjenti, is- sinjali u s- sintomi ta ’ newroglukopenja huma ippreċeduti minn sinjali adrenerġiċi ta ’ counter- regulation.
121 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles and
- iżżid it- trasport tal- glucose ġewwa ċ- ċelluli kif ukoll l- produzzjoni tal- glikoġen fil- muskoli u l -
the liver, and improves pyruvate utilisation.
fwied, u ittejjeb l- utilizzazzjoni tal- pyruvate.
Insuman Comb 15 (a biphasic isophane insulin suspension with 15% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insuman Comb 15 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 15% 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 11 to 20 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 11 sa 20 siegħa.
122 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
Insuman Comb 15 m’ għandux jitpoġġa viċin il- kumpartiment tal- friża jew viċin xi pakkett tal- friża.
123 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Insuman Comb 15 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 15 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha Insuman Comb 15 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Comb 15 may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insuman Comb 15 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 15 must also NOT be mixed with insulins of animal origin or with insulin analogues.
Insuman Comb 15 ukoll M’ GĦANDUX jitħallat ma ’ insulini derivati mill- annimali jew ma ’ insulini analogi.
7.
125 7.
NAME OF THE MEDICINAL PRODUCT
126 ISEM TAL- PRODOTT MEDIĊINALI
Insuman Comb 15 40 IU/ ml suspension for injection in a vial
Insuman Comb 15 40 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
126 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 15 contains 40 IU of insulin per ml suspension.
Insuman Comb 15 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.
127 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
128 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
128 Intercurrent illness
129 Mard kurrenti
129 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
130 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
131 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Unopened vials:
133 Kunjetti mhux miftuħa:
132 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Insuman Comb 15 100 IU/ ml suspension for injection in a cartridge
Insuman Comb 15 100 IU/ ml suspensjoni għall- injezzjoni ġo skartoċċ
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml15 fih 100 IU ta ’ insulina umana (ekwivalenti għal 3. 5 mg).
135 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 15 in cartridges has been developed for use in the OptiPen series.
Insuman Comb 15 fi skartoċċi kien żviluppat għall- użu mas- serje ta ’ l- OptiPen.
136 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
137 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.
138 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.
137 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
This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
139 twissija ta ’ l- ipogliċemija imnaqqsin jew assenti, jew ibatu minn ġrajjiet spissi ta ’ ipogliċemija.
138 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
140 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
139 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
Insuman Comb 15 (a biphasic isophane insulin suspension with 15% dissolved insulin) is an insulin with gradual onset and long duration of action.
141 Insuman Comb 15 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 15% ta ’ insulina maħlula) hija insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
142 Insuman Comb 15 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
141 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 15 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 15 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
Insuman Comb 15 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 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 ta ’ l- iskartoċċ.
Insuman Comb 15 cartridges are not designed to allow any other insulin to be mixed in the cartridge.
L- skartoċċi ta ’ Insuman Comb 15 m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċc.
Insuman Comb 15 100 IU/ ml suspension for injection in a pre-filled pen.
Insuman Comb 15 100 IU/ ml suspensjoni għall- injezzjoni ġo pinna mimlija għal- lest
Insuman Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Insuman Comb 15 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 ’ doża waħda ta ’ 40 IU.
144 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
145 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insuman Comb 15 must never be injected intravenously.
Insuman Comb 15 qatt m’ għandu jingħata ġol- vina.
145 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.
147 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.
146 Handling of the pen
L- immaniġġar tal- pinna
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), 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).
148 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
147 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
149 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
148 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.
149 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Do not freeze.
151 Pinen mhux fl- użu Aħżen fi friġġ (2°Ċ - 8°Ċ) Tagħmilhomx fil- friża.
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
Insuman Comb 15 m’ għanduxjitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
150 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Before first use, Insuman Comb 15 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel l- ewwel użu, Insuman Comb 15 OptiSet għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il- kontenut.
Insuman Comb 15 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 15 OptiSet 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 15 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Comb 15 m’ ghandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Insuman Comb 15 must not be mixed with any other insulin or with insulin analogues.
Insuman Comb 15 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi.
151 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.
Check and mix the Insulin
1 Iċċekkja u ħallat l- insulina
The appearance of the insulin should be checked: the insulin suspension must have an evenly milky white appearance.
153 Id- dehra ta ’ l- insulina trid tkun iċċekkjata wkoll: is- suspensjoni ta ’ l- insulina għandha tkun uniformement bajda qisha ħalib.
152 Step 3.
Pass Nru.
153 The injection button should be pressed all the way in.
Il- buttun ta ’ l- injezzjoni għandu jingħafas sa ġewwa.
155 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 15 in cartridges for OptiClik has been developed for use with OptiClik only.
Insuman Comb 15 fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss.
156 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
157 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.
158 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.
157 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Substances that may 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 is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
159 twissija ta ’ l- ipogliċemija imnaqqsin jew assenti, jew ibatu minn ġrajjiet spissi ta ’ ipogliċemija.
158 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
160 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
159 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
Insuman Comb 15 (a biphasic isophane insulin suspension with 15% dissolved insulin) is an insulin with gradual onset and long duration of action.
161 Insuman Comb 15 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 15% ta ’ insulina maħlula) hija insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
Insuman Comb 15 m’ għandux jitqiegħed viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
Keep the cartridge in the outer carton in order to protect from light.
162 Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
161 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.
Insuman Comb 15 cartridges for OptiClik are not designed to allow any other insulin to be mixed in the cartridge for OptiClik.
L- skartoċċi ta ’ Insuman Comb 15 għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċcgħal OptiClik.
Insuman Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Insuman Comb 15 hija injettata fit- tessut ta ’ taħt il - ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insuman Comb 15
Kif taqleb għal Insuman Comb 15
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
165 Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
164 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 15 is administered subcutaneously.
Insuman Comb 15 għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Insuman Comb 15 must never be injected intravenously.
Insuman Comb 15 qatt m’ għandha tingħata fil- vina.
Patients hypersensitive to Insuman Comb 15 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 15, 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 15, 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 15, għax dawn jistgħu jiżviluppaw kontro- reazzjonijiet immunoloġiċi kontriha.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
166 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
165 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.
166 Handling of the pen
L- immaniġġar tal- pinna
No effects on the suckling child are anticipated.
168 M’ humiex mistennija ebda effetti fuq it- tarbija waqt it- treddigħ.
167 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.
169 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.
168 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Bħal ma jiġri b’ kull tip ta ’ terapija bl- insulina, l- lipodistrofija tista ’ titfaċċa fis- sit ta ’ l- injezzjoni u din tittardja l- assorbiment lokali ta ’ l- insulina.
Mode of action
170 Il- mod kif jaħdem
Insuman Comb 15 (a biphasic isophane insulin suspension with 15% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insuman Comb 15 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 15% ta ’ insulina maħlula) huwa 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 11 to 20 hours.
Wara l- injezzjoni fit- tessut ta ’ taħt il- ġilda, tibda taħdem fi żmien 30 minuta, tilħaq ħidma massima ta ’ bejn 2 u 4 sigħat mill - injezzjoni, u ddum taħdem minn 11 sa 20 sigħat.
169 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
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.
171 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.
Do not put Insuman Comb 15 next to the freezer compartment or a freezer pack.
Insuman Comb 15 m’ għandux jitpoġġa viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
170 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Before first use, Insuman Comb 15 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 15 għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
Insuman Comb 15 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 15 ma tistax tintuża.
As with all insulin preparations, Insuman Comb 15 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insuman Comb 15 m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
Mixing of insulins
172 Meta tħallat l- insulini
Insuman Comb 15 must not be mixed with any other insulin or with insulin analogues.
Insuman Comb 15 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
171 Handling of the pen
L- immaniġġar tal- pinna
Insuman SoloStar is white with a colour on the injection button.
Iċċekkja t- tikketti tal- pinna biex tiżgura li għandha t- tip korrett t’ insulina. L- Insuman SoloStar hija ta ’ kulur abjad b’ kulur fuq il- buttun ta ’ l- injezzjoni.
The injection button colour will vary based on the formulation of Insuman insulin used.
Il- kulur tal- buttun ta ’ l- injezzjoni jista ’ jvarja skond il- formulazzjoni tal- insulina Insuman.
After removing the pen cap, the appearance of the insulin should also be checked: • The insulin solution (Insuman Rapid) must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Wara li tneħħi l- kappa tal- pinna, iċċekkja wkoll id- dehra ta ’ l- insulina: • Is- soluzzjoni ta ’ l- insulina (Insuman Rapid) għandha tkun ċara, mingħajr kulur, b’ ebda partikuli solidi u viżibbli u għandu jkollha konsistenza bħal dik ta ’ l- ilma.
172 Step 2.
Pass Nru.
Insuman Comb 25 100 IU/ ml suspension for injection in a vial
Insuman Comb 25 100 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Insuman Comb 25 is a biphasic isophane insulin suspension consisting of 25% dissolved insulin and 75% crystalline protamine insulin.
Insuman Comb 25 hija suspensjoni ta ’ insulina isophane f’ żewġ fażijiet li tikkonsisti f’ 25% ta ’ insulina maħlula u 75% ta ’ insulina protamine taħt għamla ta ’ kristalli.