qanastek/EMEA-V3 huggingface dataset:
156 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
157 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Dose adjustment may also be required, for example, if
L- aġġustament tad- doża tista ’ wkoll tkun meħtieġa jekk, per eżempju, -
- the patient's weight changes,
- il- piż tal- pazjent jinbidel,
Insulin Human Winthrop Comb 15 in cartridges for OptiClik has been developed for use with OptiClik only.
Insulin Human Winthrop Comb 15 fi skartoċċi għal OptiClik kien żviluppat għall- użu f ’ OptiClik biss.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
158 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
157 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
F’ pazjenti b’ indeboliment sever tal- fwied, il- ħtiega ghall- insulina tista ’ tonqos dovut għan- nuqqas ta ’ produzzjoni tal- glucose u t- tnaqqis fil- metaboliżmu ta ’ l- insulina.
158 Intercurrent illness
159 Mard kurrenti
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f ’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline), l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
160 L- abbiltà tal- pazjent biex jikkonċentra u jirreaġixxi jistgħu jkunu mdgħajfa mħabba l- ipogliċemija jew l- ipergliċemija jew, per eżempju, bħala riżultat ta ’ indeboliment tal- vista.
159 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.
161 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.
160 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Bdil kontinwu fis- sitta ’ l- injezzjoni, f’ żona ta ’ injezzjoni partikolari, jista ’ jgħin biex inaqqas jew jevita dawn ir- reazzjonijiet.
It inhibits glycogenolysis and gluconeogenesis,
Tinibixxi l- glykoġenoliżilu l- glukoneoġenesi
161 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
The pen containing a cartridge must not be stored in the refrigerator.
163 Il- pinna li fiha skartoċċ m’ għandiex tinżamm fil- friġġ.
Do not put Insulin Human Winthrop Comb 15 next to the freezer compartment or a freezer pack.
Insulin Human Winthrop Comb 15 m’ għandux jitqiegħed viċin il- kompartament tal- friża jew viċin xi pakkett tal- friża.
162 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
3 ml suspensjoni f’ skartoċċ (ħġieġ tip 1 mingħajr kulur) bi planġer (lastku bromobutyl (tip 1)) għatu taħt għamla ta ’ flanġ (ta ’ l - aluminju), b’ tapp (lastku bromobutyl jew laminat ta ’ polyisoprene u bromobutyl (tip 1)).
Packs of 3, 4, 5, 6, 9 or 10 cartridges for OptiClik are available.
Pakketti ta ’ 3, 4, 5, 6, 9 jew 10 skartoċċi għal OptiClik huma disponibbli.
If the pen malfunctions (see instructions for using the pen), the suspension may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
Jekk il- pinna ma taħdimx sew (ara l- istruzzjonijiet dwar l- użu tal- pinna), is- suspensjoni tista ’ titella ’ mill- iskartoċċ f’ siringa ta ’ l- injezzjoni (adatta għal insulina ta 100 IU/ ml) u tiġi injettata.
Cartridges Before insertion into the pen, Insulin Human Winthrop 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, Insulin Human Winthrop Comb 15 għandu jinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u wara jiġi sospiż mill- ġdid biex jiġi iċċekkjat il - kontenut.
Insulin Human Winthrop Comb 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.
Insulin Human Winthrop Comb 15 m’ għandux jintuża jekk dan ma jintlaħaqx, iġifieri, jekk is- suspensjoni tibqa ’ ċara, jew per eżempju, jitfaċċaw ċapep, partikuli jew biċċiet li jixbħu t- trofof tas- suf fl- insulina,
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l - użu tal- pinna).
163 Insulin Human Winthrop Comb 15 cartridges for OptiClik are not designed to allow any other insulin to be mixed in the cartridge for OptiClik.
L- skartoċċi ta ’ Insulin Human Winthrop Comb 15 għal OptiClik m’ humiex magħmulin biex jippermettu li titħallat ebda insulina oħra fl- iskartoċcgħal OptiClik.
164 1.
165 1.
Insulin Human Winthrop Comb 15 is injected subcutaneously 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 15 hija injettata fit - tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insulin Human Winthrop Comb 15
Kif taqleb għal Insulin Human Winthrop Comb 15
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
166 Il- ħtieġa ta ’ l- tibdil (e. ż. tnaqqis) tad- doża tista ’ tidher immedjatament wara l- bidla.
165 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Wara l- bidla minn insulina ġejja mill- annimali għal waħda umana, it- tnaqqis fid- dożaġġ jista ’ jkun meħtieġ speċjalment f’ pazjenti li
Insulin Human Winthrop Comb 15 is administered subcutaneously.
Insulin Human Winthrop Comb 15 għandha tingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Comb 15 must never be injected intravenously.
Insulin Human Winthrop Comb 15 qatt m’ għandha tingħata fil- vina.
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Qabel tintuża SoloStar, l- Istruzzjonijiet ghall- Użu li jinsabu fil- Fuljett ta ’ Taghrif għandhom jinqraw bir- reqqa.
Patients hypersensitive to Insulin Human Winthrop 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 Insulin Human Winthrop 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 Insulin Human Winthrop 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 Insulin Human Winthrop 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.
167 F’ pazjenti b’ indeboliment renali, il- ħtieġa ta ’ l- insulina tista ’ tonqos dovut għat- tnaqqis fil- livell metaboliku ta ’ l- insulina.
166 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.
167 Handling of the pen
L- immaniġġar tal- pinna
Lactation
169 Treddigħ
168 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.
170 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.
169 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
171 Il- mod kif jaħdem
Insulin Human Winthrop Comb 15 (a biphasic isophane insulin suspension with 15% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insulin Human Winthrop 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 sa 60 minuta, tilħaq ħidma massima ta ’ bejn 2 u 4 sigħat mill- injezzjoni, u ddum taħdem minn 11 sa 20 sigħat.
170 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
6.2 Incompatibilities
6. 5 Inkompatibilitajiet
6.3 Shelf life
172 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
171 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Before first use, Insulin Human Winthrop Comb 15 must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
Qabel ma jiddaħħal fil- pinna, Insulin Human Winthrop Comb 15 għandha tinżamm f’ temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn u mbagħad erġa ’ issospendi l- kontenut biex tiċċekjah.
Insulin Human Winthrop 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, Insulin Human Winthrop Comb 15 ma tistax tintuża.
These changes sometimes give the cartridge a frosted appearance.
Dawn il- bidliet xi mindaqqiet jagħtu lill- iskartoċċ dehra mtappna.
As with all insulin preparations, Insulin Human Winthrop Comb 15 must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Kif jiġri bil- preparazzjonijiet ta ’ l- insulini kollha, Insulin Human Winthrop Comb 15 m’ għandux jitħallat ma ’ soluzzjonijiet li għandhom sustanzi kimiċi riduttivi bhal thioles u sulphites.
- insulin protamine crystals dissolve in an acid pH range,
- l- kristalli ta ’ l- insulina protamine jiddisolvu f’ firxa ta ’ pH aciduża.
Insulin Human Winthrop Comb 15 must not be mixed with any other insulin or with insulin analogues.
Insulin Human Winthrop Comb 15 m’ għandhiex titħallat ma ’ ebda insulina oħra jew insulini analogi
172 Handling of the pen
L- immaniġġar tal- pinna
SoloStar is designed to work accurately and safely.
174 Is- SoloStar hija magħmula biex taħdem b’ mod preċiż u mingħajr periklu.
173 Step 2.
2
The needle should be inserted into the skin.
175 Il- labra trid tiddaħħal fil- ġilda.
Insulin Human Winthrop Comb 25 100 IU/ ml suspension for injection in a vial
Insulin Human Winthrop Comb 25 100 IU/ ml suspensjoni għall- injezzjoni ġo kunjett
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Kull ml fih 100 IUI ta ’ insulina umana (ekwivalenti għal 3. 5 mg).
Insulin Human Winthrop Comb 25 is a biphasic isophane insulin suspension consisting of 25% dissolved insulin and 75% crystalline protamine insulin.
Insulin Human Winthrop 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.
The basal metabolic requirement is 40% to 60% of the total daily requirement.
Il- ħtiega bażika metabolika hija minn 40% sa 60% tal- bżonn sħiħ kuljum.
Insulin Human Winthrop Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.
Insulin Human Winthrop Comb 25 huwa injettat fit- tessut ta ’ taħt il- ġilda minn 30 sa 45 minuta qabel ikla.
Transfer to Insulin Human Winthrop Comb 25
Il- bidla għal Insulin Human Winthrop Comb 25
176 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
177 Wara l- bidla minn insulina derivata mill- annimali għal insulina umana, t- tnaqqis fid- dożaġg jista ’ jkun meħtieġ partikolarment f’ pazjenti li
Insulin Human Winthrop Comb 25 contains 100 IU of insulin per ml suspension.
Insulin Human Winthrop Comb 25 fih 100 IU ta ’ insulina kull millilitru ta ’ suspensjoni.
Insulin Human Winthrop Comb 25 is administered subcutaneously.
Insulin Human Winthrop Comb 25 għandu jingħata fit- tessut ta ’ taħt il- ġilda.
Insulin Human Winthrop Comb 25 must never be injected intravenously.
Insulin Human Winthrop Comb 25 qatt m’ għandu jkun injettat ġol- vina.
Insulin Human Winthrop Comb 25 must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Insulin Human Winthrop 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 Insulin Human Winthrop Comb 25 for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
Pazjenti li juru sensittività eċċessiva għal Insulin Human Winthrop 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 Insulin Human Winthrop 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 Insulin Human Winthrop Comb 25, għaliex jista ’ jkollhom reazzjonijiet allerġiċi għaż- żewġ tipi ta ’ prodotti.
177 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
178 F’ pazjenti b’ indeboliment renali, l- ħtieġa għall- insulina tista ’ tonqos dovut għall- metaboliżmu imnaqqas ta ’ l- insulina.
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
- ċertu disturbi fis- sistema endokrinarja mhux kompensati (e. g. f’ kas ta ’ ipotiojdiżmu u
178 Intercurrent illness
179 Mard kurrenti
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Is- sustanzi li jistgħu jnaqqsu l- effett fuq it- tnaqqis fil- livell tal- glucose fid- demm jinkludu l - kortikosterojdi, danazol, diazoxide, id- dijuretiċi, glucagon, isoniazid, oestrogens u progestrogens (eż. f’ kontraċettivi orali), derivattivi ta’ phenothiazine, somatropin, sustanzi simpatomimetiċi (e. ż. epinephrine[ adrenalin], salbutamol u terbutaline) l- ormoni tat- tirojde, inibituri tal- protease u l- prodotti mediċinali antipsikotiċi atipiċi (e. ż. clozapine u olanzapine).
Insulin Human Winthrop Comb 25 can be used during breastfeeding.
Insulin Human Winthrop 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).
180 f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (per eżempju fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni).
179 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Ġeneralment, aktar ma tkun qawwija u mgħaġġla l- waqgħa fil- livell tal - glucose fid- demm, aktar ikun immarkat dan il- fenomenu u s- sintomi tiegħu.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
181 Kontroll tajjeb gliċemiku, miżmum fuq tul ta ’ żmien, inaqqas ir- riskju ta ’ l- iżvilupp tar- retinopatija dijabetika.
180 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.
Insulin Human Winthrop Comb 25 (a biphasic isophane insulin suspension with 25% dissolved insulin) is an insulin with gradual onset and long duration of action.
Insulin Human Winthrop Comb 25 (suspensjoni ta ’ l- insulina isophane f’ żewġ fażijiet bi 25% ta ’ insulina maħlula) hija insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.