Quest for the right Drug
ליומג'ב 100 יחידות/מ"ל LYUMJEV 100 UNITS/ML (INSULIN LISPRO, INSULIN LISPRO AS ZINC CRYSTALS)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תת-עורי, תוך-ורידי : S.C, I.V
צורת מינון:
תמיסה להזרקה : SOLUTION FOR INJECTION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Summary of safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia (very common) (see sections 4.2, 4.4 and 4.9). The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000) and not known (cannot be estimated from the available data). Table 1. Adverse reactions MedDRA System Very common Common Uncommon Not known Organ Class Metabolism and Hypoglycaemia nutrition disorders Skin and Lipodystrophy Cutaneous subcutaneous tissue Rash amyloidosis disorders Pruritus General disorders and Infusion site Injection site Oedema administration site reactionsa reactions b conditions Allergic reactions c a Reported in PRONTO-Pump-2 b Reported in PRONTO-T1D, PRONTO-T2D and PRONTO-Peds c See section 4.8 Description of selected adverse events Description of selected adverse reactions Hypoglycaemia Hypoglycaemia is the most commonly observed adverse reaction in patients using insulin. The incidence of severe hypoglycaemia in the 26 week Phase 3 adult clinical studies was 5.5% in patients with type 1 diabetes mellitus and 0.9% in patients with type 2 diabetes (see tables 2 and 3). In Study PRONTO-Peds, severe hypoglycaemia was reported in 0.7 % of paediatric patients treated with Lyumjev. The symptoms of hypoglycaemia usually occur suddenly. They may include listlessness, confusion, palpitations, sweating, vomiting, and headache. There were no clinically significant differences in the frequency of hypoglycaemia with administration of Lyumjev or the comparator (another medicinal product containing insulin lispro) across all studies. In studies where Lyumjev and the comparator were administered at different times relative to meals, there were no clinically relevant differences in the frequency of hypoglycaemia. Hypoglycaemia may occur earlier after an injection/infusion of Lyumjev compared to other mealtime insulins due to the earlier onset of action. Allergic reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Lyumjev. Injection / Infusion site reactions Lyumjev contains treprostinil sodium and sodium citrate dihydrate as inactive ingredients which have been associated with infusion and injection site reactions with other non-insulin products. As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or itching at the site of Lyumjev injection or infusion. In Studies PRONTO-T1D and PRONTO-T2D (multiple-dose injection [MDI] administration), injection site reactions occurred in 2.7% of adult patients treated with Lyumjev. These reactions were usually mild and normally disappeared during continued treatment. Of the 1,116 patients who received Lyumjev, 1 discontinued treatment due to injection site reactions (< 0.1%). In Study PRONTO-Peds, injection site reactions occurred in 6.2% of paediatric patients treated with Lyumjev. These events were mild or moderate. Of the 418 patients treated with Lyumjev, 2 discontinued treatment due to injection site reactions (< 0.5%). In Study PRONTO-Pump-2, infusion site reactions were reported in 38% of patients treated with Lyumjev, compared to 12.5% of patients treated with Humalog. Of the 215 patients treated with Lyumjev, 7 discontinued treatment due to infusion site reactions (3.3%). The majority of these events were mild. Immunogenicity Administration of insulin can cause formation of insulin antibodies. The presence of anti-drug antibodies did not have a clinically meaningful effect on the pharmacokinetics, efficacy, or safety of Lyumjev. Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4). Oedema Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy. Paediatric population Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes aged 3 to <18 years. In the trial, 418 patients were treated with Lyumjev. The frequency, type and severity of adverse reactions observed in the paediatric population is consistent with the safety profile in adult patients. Other special populations Based on results from clinical trials with insulin lispro in general, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population. The safety information in very elderly patients (≥ 75 years) or patients with moderate to severe renal impairment or hepatic impairment is limited (see section 5.1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/
פרטי מסגרת הכללה בסל
התרופה האמורה תינתן לטיפול בחולי סוכרת.
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
התרופה האמורה תינתן לטיפול בחולי סוכרת. | 09/03/1999 | מחלות מטבוליות | INSULIN ASPART, INSULIN GLULISINE, INSULIN LISPRO |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
09/03/1999
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
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ליומג'ב 100 יחידות/מ"ל