FrancophonIA/ELRC3.0 huggingface dataset:
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Maltese: Is-sustanzi li jistgħu jżidu l-effett fuq it-tnaqqis tal-livell tal-glucose fid-demm, u jżidu s-suxxettibbiltà għall-ipogliċemja, jinkludu prodotti mediċinali antidijabetiċi orali , inibituri ta' l-enzima li tikkonverti anġiotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta' monoamine oxidase (MAO),
English: Insuman Comb 30 100 IU/ml in a cartridge
Maltese: Insuman Comb 30 100 UI/ml f'skartoċċ
English: BRAILLE
Maltese: Labra
English: 3 ml solution 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)).
Maltese: 3 ml suspensjoni f'skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) għatu bi flanġ (aluminju), b'tapp (lastku bromobutyl jew laminat ta' polyisoprene u bromobutyl (tip 1)).
English: HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Maltese: hydrochloric acid, ilma għall-injezzjonijiet
English: Insulin deposits can cause blockage of the pump.
Maltese: Depożiti ta' insulina jistgħu jimblokkaw il-pompa.
English: Insuman Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Maltese: Insuman Comb 15 huwa injettat taħt il-ġilda minn 30 sa 45 minuta qabel ikla.
English: The pump reservoir stores about 6,000 units of insulin and requires a refill procedure every 40 to 45 days for insulin in-use stability reasons in the pump or earlier based on the insulin needs of the patients.
Maltese: Il-parti fejn jitqiegħed il-likwidu jaħżen madwar 6,000 unità ta' insulina u teħtieġ li ssir proċedura ta' mili mill-ġdid kull 40 sa 45 jum għal raġunijiet ta' stabbilita tal-insulina fil-pompa waqt l-użu jew isir mili mill-ġdid qabel imsejjes fuq il-ħtiġijiet tal-insulina tal-pazjenti.
English: Insuman Basal 40 IU/ml suspension for injection in a vial Insuman Basal 100 IU/ml suspension for injection in a vial Insuman Basal 100 IU/ml suspension for injection in a cartridge Insuman Basal SoloStar 100 IU/ml suspension for injection in a pre-filled pen
Maltese: Insuman Basal 40 IU/ml, suspensjoni għall-injezzjoni, ġo kunjett Insuman Basal 100 UI/ml, suspensjoni għall-injezzjoni, ġo kunjett.
English: These include:
Maltese: Attent:
English: • Stomach ache • Pain due to the catheter positioning
Maltese: • Uġigħ minħabba l-pożizzjoni tal-kateter Rappurtar tal-effetti sekondarji
English: - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat the thyroid gland disorders), - protease inhibitors (used to treat HIV), - atypical antipsychotic medicines (such as olanzapine and clozapine).
Maltese: (eż. epinephrine [adrenaline], salbutamol, terbutaline), l-ormoni tat-tirojde, inibituri tal-protease u prodotti mediċinali antipsikotiċi atipiċi (eż olanzapine u clozapine).
English: Insuman Comb 30 SoloStar 100 IU/ml in a pre-filled pen Insuman Comb 30 SoloStar 100 IU/ml in a pre-filled pen must also not be mixed with insulins of animal origin or with insulin analogues (see section 4.2, 4.4 and 6.6).
Maltese: Insuman Comb 30 100 UI/ml f'skartoċċ Insuman Comb 30 100 UI/ml fl-iskrataċ m'għandux jitħallat ukoll ma' insulini li ġejjin mill-annimali jew ma' analogi tal-insulina (ara sezzjonijiet 4.2,4.4 u 4.6).
English: Insuman Basal 40 IU/ml suspension for injection
Maltese: Insuman Basal 40 UI/ml f'kunjett
English: Insuman Rapid is injected under the skin 15 to 20 minutes before a meal.
Maltese: Insuman Rapid hija injettata fittessut ta' taħt il-ġilda minn 15 sa 20 minuta qabel ikla.
English: Insuman Rapid may be mixed with all insulin human preparations, EXCEPT those specially designed for use in insulin pumps.
Maltese: Insuman Rapid jista' jitħallat mal-preparazzjonijiet tal-insulini umani kollha, iżda mhux ma' dawk magħmulin speċifikament għall-użu fil-pompi ta' l-insulini.
English: Other medicines and Insuman Comb 30
Maltese: Mediċini oħra u Insuman Comb 30
English: The presence of antibodies has been reported in patients after treatment using the Medtronic MiniMed Implantable Pump.
Maltese: Il-preżenza ta' antikorpi kienet irrappurtata f'pazjenti wara kura bl-użu ta' Medtronic MiniMed Implantable Pump.
English: you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Implantable").
Maltese: - int qed tieħu jew ħadt ċerti mediċini oħrajn (ara sezzjoni 2, “Mediċini oħra u Insuman Implantable”).
English: Other medicines and Insuman Comb 50
Maltese: Mediċini oħra u Insuman Comb 50
English: Insuman Infusat is an insulin preparation with a rapid onset and short duration of action.
Maltese: Insuman Rapid jista' jintuża fin-nisa waqt il-perijodu li qed ireddgħu.
English: The Insuman Rapid cartridges should only be used with the following pens: - JuniorSTAR which delivers Insuman Rapid in 0.5 unit dose increments - ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Insuman Rapid in 1 unit dose increments.
Maltese: - JuniorSTAR li tagħti Insuman Rapid f'żidiet fid-doża ta' 0.5 unitajiet - ClikSTAR, Tactipen, Autopen 24, AllStar u AllStar PRO li kollha jagħtu Insuman Rapid f'żidiet fiddoża ta' unità 1.
English: Insuman Comb 25 100 IU/ml in cartridges must also not be mixed with insulins of animal origin or with insulin analogues (see section 4.2, 4.4 and 6.6).
Maltese: Insuman Comb 25 100 UI/ml f'skartoċċ Insuman Comb 25 m'għandux jitħallat ukoll ma' insulini li ġejjin mill-annimali jew ma' analogi tal insulina (ara sezzjonijiet 4.2,4.4 u 6.6).
English: Do NOT inject Insuman Comb 30 into a vein (blood vessel).
Maltese: Insuman Comb 30 ġewwa vina (sistema vaskulari).
English: Insuman Rapid 100 IU/ml solution for injection in a cartridge
Maltese: Insuman Rapid 100 IU/ml soluzzjoni għall-injezzjoni f'skartoċċ
English: EU/1/97/030/038 EU/1/97/030/039 EU/1/97/030/040 EU/1/97/030/059 EU/1/97/030/060 EU/1/97/030/087 EU/1/97/030/092 EU/1/97/030/097 EU/1/97/030/152 EU/1/97/030/153 EU/1/97/030/154 EU/1/97/030/155 EU/1/97/030/156 EU/1/97/030/157
Maltese: EU/1/97/030/087 EU/1/97/030/092 EU/1/97/030/097 EU/1/97/030/152 EU/1/97/030/153 EU/1/97/030/154
English: - enhances the uptake of potassium into cells.
Maltese: - iżżid id-dħul ta' potassium gewwa ċ-ċelluli.
English: Insuman Rapid contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin.
Maltese: Insuman Rapid, fiha s-sustanza attiva ta' l-insulina umana magħmula bi proċess bijoteknoloġiku.
English: In case of severe hypoglycaemia, the pump should be investigated by the treating physician for possible catheter occlusion leading to accumulation of insulin with subsequent release of this accumulated insulin (see sections 4.4 and 6.6).
Maltese: F'każ ta' ipogliċemija qawwija, il-pompa għandha tiġi investigata mit-tabib li qed jikkura għallpossibbiltà ta' sadda tal-kateter li twassal għal akkumulazzjoni tal-insulina b'rilaxx sussegwenti ta' din l-insulina akkumulata (ara sezzjonijiet 4.4 u 6.6).
English: Insuman Comb 50 100 IU/ml in a vial
Maltese: Insuman Comb 50 100 UI/ml f'kunjett
English: EU/1/97/030/043 (1 vial of 5 ml) EU/1/97/030/044 (5 vials of 5 ml)
Maltese: EU/1/97/030/043 (Kunjett 1 ta' 5 ml) EU/1/97/030/044
English: • A refill accuracy of less than 85% is calculated during a refill procedure.
Maltese: • Tiġi kkalkulata preċiżjoni ta' inqas minn 85% għal mili mill-ġdid waqt proċedura ta' mili mill-ġdid.
English: Insuman Comb 50 40 IU/ml in a vial
Maltese: Insuman Comb 50 40 UI/ml f'kunjett
English: Infection of the pump pocket
Maltese: Infezzjoni fil-borża tal-pompa
English: Insuman Comb 50 100 IU/ml in a cartridge
Maltese: Insuman Comb 50 100 UI/ml f'skartoċċ
English: Insulin treatment by continuous infusion in the body is likely to cause your body to produce antibodies to insulin (substances that act against insulin).
Maltese: L-għoti ta' l-insulina jista' jwassal għall-produzzjoni ta' l-antikorpi kontra l-insulina.
English: The Insuman Com 15 cartridges should only be used with the following pens: - JuniorSTAR which delivers Insuman Comb 15 in 0.5 unit dose increments - ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Insuman Comb 15 in 1 unit dose increments.
Maltese: - JuniorSTAR li tagħti Insuman Comb 15 f'żidiet fid-doża ta' 0.5 unitajiet - ClikSTAR, Tactipen, Autopen 24, AllStar u AllStar PRO li kollha jagħtu Insuman Comb 15 f'żidiet fid-doża ta' unità 1.
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone),
Maltese: - danazol (mediċina li taħdem fuq l-ovulazzjoni), - diazoxide (użat għall-kura ta' pressjoni għolja fid-demm), - id-dijuretiċi (użati għall-kura ta' pressjoni għolja fid-demm jew iż-żamma eċċessiva ta' fluwidi), - glukagon (ormon tal-frixa użat għall-kura ta' ipogliċemija severa), - isoniazid (użat għall-kura tat-tuberkulożi), - l-estroġeni u l-proġesteni (bħal fil-pillola kontraċettiva, użata għall-kontroll tat-twelid), - id-derivattivi ta' phenothiazine (użati għall-kura ta' disturbi psikjatriċi),
English: Insuman Comb 50 is supplied in vials containing 10 ml suspension (400 IU).
Maltese: Insuman Comb 50 huwa fornut f'kunjetti ta' 10 ml ta' suspensjoni (400
English: 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.
Maltese: Wara injezzjoni fit-tessut ta' taħt ilġilda, 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 siegħa.
English: In addition, use of Insuman Implantable in continuous intraperitoneal infusion resulted in stable glycaemic control in patients with type 1 diabetes mellitus (per protocol population: mean reduction: -0.25 ± 0.67; [95% CI: -0.36; 0.11]) without increasing the risk of severe hypoglycaemia compared to semi-synthetic human insulin (14.3% versus 13.1%).
Maltese: [95% CI: -0.36; 0.11]) mingħajr ma żied ir-riskju ta' ipogliċemija qawwija meta mqabbel ma' insulina semisintetika umana (14.3% versus 13.1%).
English: Insuman Basal is injected subcutaneously 45 to 60 minutes before a meal.
Maltese: Insuman Basal huwa injettat taħt il-ġilda 45 sa 60 minuta qabel ikla.
English: Proliferative retinopathy; Diabetic retinopathy;
Maltese: Retinopatija dijabetika,
English: Insuman Comb 15 with alcohol
Maltese: Insuman Comb 15 ma' alkoħol
English: Other medicines and Insuman Basal
Maltese: Mediċini oħra u Insuman Basal
English: Insuman Infusat with alcohol
Maltese: Insuman Infusat ma' alkoħol
English: However, only very rarely, this will require a change to your insulin dose.
Maltese: Ma nstabet l-ebda xhieda ta' effetti tossiċi.
English: EU/1/97/030/164 (3 pens of 3 ml) EU/1/97/030/165 (4 pens of 3 ml) EU/1/97/030/166 (5 pens of 3 ml) EU/1/97/030/167(6 pens of 3 ml) EU/1/97/030/168 (9 pens of 3 ml) EU/1/97/030/169(10 pens of 3 ml)
Maltese: (3 skartoċċi ta' 3 ml) EU/1/97/030/165 (4 skartoċċi ta' 3 ml) EU/1/97/030/166 (5 skartoċċi ta' 3 ml) EU/1/97/030/167 (6 skartoċċi ta' 3 ml) EU/1/97/030/168 (9 skartoċċi ta' 3 ml) EU/1/97/030/169 (10 skartoċċi ta' 3 ml)
English: EU/1/97/030/090 EU/1/97/030/095 EU/1/97/030/140 EU/1/97/030/141 EU/1/97/030/142 EU/1/97/030/143 EU/1/97/030/144 EU/1/97/030/145
Maltese: EU/1/97/030/141 EU/1/97/030/142 EU/1/97/030/143 EU/1/97/030/144
English: Pack size
Maltese: kulħadd.
English: Insuman Basal is supplied in cartridges containing 3 ml suspension (300 IU).
Maltese: Insuman Basal huwa fornut f'skartoċċi li fihom 3 ml ta' soluzzjoni (300 IU).
English: Insuman Rapid 100 IU/ml in a vial
Maltese: Informazzjoni għall-utent Insuman Rapid 100 IU/ml soluzzjoni għall-injezzjoni f'kunjett
English: One ml of Insuman Rapid contains 100 IU (International
Maltese: Millilitru wieħed ta' Insuman Rapid fih 100
English: 10 ml suspension in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
Maltese: 10 ml suspensjoni f'kunjett (ħġieġ tip 1 mingħajr kulur) b'għatu taħt għamla ta' flanġ (aluminju), tapp (lastku tal-chlorobutyl (tip 1)) u għatu li jiċċarrat (polypropylene).
English: Insuman Basal SoloStar 100 IU/ml suspension for injection
Maltese: Insuman Basal SoloStar 100 IU/ml suspensjoni għall-injezzjoni .
English: INSTRUCTIONS ON USE
Maltese: Mhux maghruf
English: Patients must be informed to closely monitor blood glucose levels on refill days (see section 6.6).
Maltese: Il-pazjenti għandhom jiġu infurmati biex jimmonitorjaw mill qrib il-livelli tal-glucose fid-demm fil-jiem ta' mili mill-ġdid (ara sezzjoni 6.6).
English: The Insuman Comb 50 cartridges should only be used with the following pens: - JuniorSTAR which delivers Insuman Comb 50 in 0.5 unit dose increments - ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Insuman Comb 50 in 1 unit dose increments.
Maltese: - JuniorSTAR li tagħti Insuman Comb 50 f'żidiet fid-doża ta' 0.5 unitajiet - ClikSTAR, Tactipen, Autopen 24, AllStar u AllStar PRO li kollha jagħtu Insuman Comb 50 f'żidiet fid-doża ta' unità 1.
English: Insuman Comb 15 100 IU/ml suspension for injection in a vial Insuman Comb 15 100 IU/ml suspension for injection in a cartridge Insuman Comb 15 SoloStar 100 IU/ml suspension for injection in a pre-filled pen
Maltese: Insuman Comb 15 100 UI/ml f'skartoċċ Insuman Comb 15 100 UI/ml fl-iskrataċ m'għandux jitħallat ma' kwalunkwe insulina oħra jew ma'
English: EU/1/97/030/140 (3 pens of 3 ml) EU/1/97/030/141(4 pens of 3 ml) EU/1/97/030/142 (5 pens of 3 ml) EU/1/97/030/143 (6 pens of 3 ml) EU/1/97/030/144(9 pens of 3 ml) EU/1/97/030/145 (10 pens of 3 ml)
Maltese: (3 pinen ta' 3 ml) EU/1/97/030/141(4 pinen ta' 3 ml) EU/1/97/030/142 (5 pinen ta' 3 ml) EU/1/97/030/143 (6 pinen ta' 3 ml) EU/1/97/030/144
English: Other medicines and Insuman Comb 25
Maltese: Mediċini oħra u Insuman Comb 25
English: Insuman Comb 25 may be mixed with all insulin human preparations, EXCEPT those specially designed for use in insulin pumps.
Maltese: Insuman Comb 25 jista' jitħallat ma preparazzjonijiet tal-insulini umani kollha, iżda mhux ma' dawk magħmulin speċifikament għall-użu fil-pompi ta' l-insulini.
English: The Insuman Basal cartridges should only be used with the following pens: - JuniorSTAR which delivers Insuman Basal in 0.5 unit dose increments - ClikSTAR, Tactipen, Autopen 24, and AllStar and AllStar PRO which all deliver Insuman Basal in 1 unit dose increments.
Maltese: - JuniorSTAR li tagħti Insuman Basal f'żidiet fid-doża ta' 0.5 unitajiet - ClikSTAR, Tactipen, Autopen 24, AllStar u AllStar PRO li kollha jagħtu Insuman Basal f'żidiet fid doża ta' unità 1.
English: Insuman Rapid 100 IU/ml in a pre-filled pen Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Maltese: Kull ml fih 100 UI t'insulina umana (ekwivalenti għal 3.5 mg).
English: • other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).
Maltese: - trattament konkomittanti bi prodotti mediċinali oħrajn (ara sezzjoni 4.5).
English: Insuman Comb 25 SoloStar 100 IU/ml in a pre-filled pen
Maltese: Insuman Comb 25 SoloStar 100 UI/ml f'pinna mimlija għal-lest
English: Focal hepatic steatosis
Maltese: Urtikarja fis-sit talinjezzjoni
English: • Insulin antobodies
Maltese: • li għandhom newropatija awtonomika,
English: Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur.
Maltese: Dan huwa partikolarment importanti f'dawk li għandhom sintomi mnaqqsa ta' ipogliċemja, jew li ma jistgħux jgħarrfu s-sintomi ta' twissija tal-bidu, jew li għandhom episodji spissi ta' ipogliċemja.
English: Insuman Implantable contains the active substance insulin human which is made by a biotechnology process and is identical to the body's own insulin.
Maltese: Insuman Implantable fiha s-sustanza attiva ta' l-insulina umana magħmula bi proċess bijoteknoloġiku u hija identika għall-insulina tal-ġisem stess.
English: Surgical and medicinal procedures
Maltese: Proċeduri kirurġiċi u mediċi
English: There was an additional 12-month open-label randomised controlled study (MIP 310) to assess the effect of intraperitoneal insulin administration versus subcutaneous insulin administration on glycaemic control and the frequency of severe hypoglycaemia.
Maltese: Il-kontroll metaboliku aħjar jista' jġib miegħu żieda fis-sensittività għall-insulina, li twassal għal ħtieġa t'anqas insulina.
English: Insuman Comb 30 100 IU/ml suspension for injection in a vial Insuman Comb 30 100 IU/ml suspension for injection in a cartridge Insuman Comb 30 SoloStar 100 IU/ml suspension for injection in a pre-filled pen
Maltese: Insuman Comb 30 100 UI/ml suspensjoni għall-injezzjoni ġo kunjett Insuman Comb 30 100
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting.
Maltese: Mediċini użati fid-dijabete, l-insulini u l-analogi għall-injezzjoni,
English: Time of refill of insulin pump
Maltese: Ħsarat fil-pompa ta' l-insulina
English: In such cases, a new pen yielding a uniform suspension must be used.
Maltese: Wara li s-suspensjoni titħawwad mill-ġdid, tifforma suspensjoni bajda ħalib.
English: Other medicines and Insuman Comb 15
Maltese: Mediċini oħra u Insuman Comb 15
English: Insuman Infusat 100 IU/ml solution for injection in a cartridge
Maltese: Insuman Infusat 100 IU/ml soluzzjoni għall-injezzjoni f'skartoċċ
English: OUTER CARTONS / 3 ML PRE-FILLED PEN SOLOSTAR
Maltese: KARTUNA TA' BARRA /PINNA MIMLIJA GĦAL-LEST TA' 3ML, SOLOSTAR
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
Maltese: Jista' jkun li dawn il-pinen mhux kollha jkunu fis-suq fil-pajjiż tiegħek (ara sezzjonijiet 4.2 u 6.6).
English: Based on the change in HbA1c values from baseline, the glycaemic control in patients treated with Insuman Implantable was similar to that of patients treated with semi-synthetic human insulin.
Maltese: Hemm numru ta' sustanzi li jaffetwaw il-metaboliżmu tal-glucose u jistgħu jeħtieġu tibdil fid-doża talinsulina umana.
English: EU/1/97/030/089 (3 cartridges of 3 ml) EU/1/97/030/063 (4 cartridges of 3 ml) EU/1/97/030/050 (5 cartridges of 3 ml) EU/1/97/030/094 (6 cartridges of 3 ml) EU/1/97/030/099 (9 cartridges of 3 ml) EU/1/97/030/064 (10 cartridges of 3 ml)
Maltese: EU/1/97/030/089 (3 skartoċċi ta' 3 ml) EU/1/97/030/063 (4 skartoċċi ta' 3 ml) EU/1/97/030/050 (5 skartoċċi ta' 3 ml) EU/1/97/030/094
English: All solutions that will enter the pump must be properly degassed prior to filling the pump reservoir to avoid insulin aggregation and under-delivery.The vials of insulin should be withdrawn from the refrigerator and stored at room temperature in the outer carton in order to protect from light for a minimum of 4 hours and no longer than 24 hours before use, to ensure further efficient degassing by following the procedure described in the Physician's manual.
Maltese: Tlaħliħ tal-pompa biex jiġi evitat għoti ta' insulina inqas milli suppost Biex jiġi evitat għoti inqas milli suppost li jista' jseħħ meta depożiti tal-insulina jinġabru filmekkaniżmu tal-ippumpjar ġewwa l-pompa, huwa rrakkomandat li wieħed isegwi proċedura ta' tlaħliħ kull 6 xhur.
English: Insuman Rapid SoloStar 100 IU/ml solution for injection
Maltese: Insuman Rapid SoloStar 100 IU/ml soluzzjoni għall-injezzjoni.
English: Insuman Infusat 100 IU/ml in a cartridge
Maltese: Insuman Infusat 100 UI/ml f'kunjett
English: Insuman Basal 100 IU/ml in a cartridge, Insuman Basal SoloStar 100 IU/ml in a pre-filled pen Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Maltese: UI/ml f'skartoċċ, Insuman Basal SoloStar 100 IU/ml f'pinna mimlija għal-lest
English: The reservoir is completely filled (approximately 15 ml or 6,000 units of Insuman Implantable), independently of the patients needs.
Maltese: Il-parti fejn jitpoġġa l-likwidu timtela kompletament (madwar 15-il ml jew 6,000 unità ta' Insuman Implantable), indipendentement mill-ħtiġijiet talpazjent.
English: Only the refill kit (syringe and stopcock), refill needles, port locating template supplied by Medtronic MiniMed and sterile rinse buffer solution manufactured by Sanofi-Aventis Deutschland GmbH should be used with Insuman Implantable to refill the pump reservoir.
Maltese: Il-proċeduri kollha li għandhom x'jaqsmu mal-pompa ( bħall-mili mill-ġdid tal-pompa, tlaħliħ talpompa, investigazzjonijiet tal-pompa biex tara jekk il-pompa mhijiex taħdem sew) għandhom isiru bl użu ta' teknika sterili biex tevita r-riskju ta' infezzjoni.
English: Marketing Authorisation Holder and Manufacturer Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Il-Ġermanja
English: Opened vials, in-use cartridges, in-use pens For storage conditions after first opening of the medicinal product, see section 6.3.
Maltese: Kunjetti miftuħa, skrataċ fl-użu Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: Do NOT inject Insuman Basal into a vein (blood vessel).
Maltese: Insuman Basal fil-vina (sistema vaskulari).
English: Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will determine how much Insuman Infusat per day you will need, how much of this is infused continuously ("basal rate") and how much and when you need additional insulin as an "insulin boost" ("bolus dose"), tell you when to check your blood sugar level, and whether you need to carry out urine tests, tell you when you may need to use a higher or lower dose of Insuman Infusat.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Hemm numru ta' sustanzi li jeffetwaw il-metaboliżmu tal-glucose u b'hekk ikun meħtieġ tibdil tad doża ta' l-insulina umana.
English: Excipients: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Maltese: Eċċipjenti: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide,
English: Insuman Comb 15 may be mixed with all insulin human preparations, EXCEPT those specially designed for use in insulin pumps.
Maltese: Insuman Comb 15 jista' jitħallat ma preparazzjonijiet tal-insulini umani kollha, iżda mhux ma' dawk magħmulin speċifikament għall-użu fil-pompi ta' l-insulini.
English: Insuman Comb 50 40 IU/ml in a vial, Insuman Comb 50 100 IU/ml in a vial Insuman Comb 50 must not be mixed with insulin human formulations designed specifically for use in insulin pumps.
Maltese: Insuman Comb 50 40 UI/ml f'kunjett, Insuman Comb 50 100 UI/ml f'kunjett Insuman Comb 50 m'għandux jitħallat ma preparazzjonijiet tal-insulini umani magħmulin speċifikament għall-użu fil-pompi ta' l-insulini.
English: Insuman Comb 25 is supplied in vials containing 5 ml suspension (500 IU).
Maltese: Insuman Comb 25 huwa fornut f'kunjetti ta' 5 ml ta' suspensjoni (500