Quest for the right Drug
טוג'או TOUJEO (INSULIN GLARGINE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תת-עורי : S.C
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
Pharmaceutical particulars : מידע רוקחי
6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Zinc chloride Metacresol Glycerol Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections. 6.2 Incompatibilities Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Mixing or diluting Toujeo changes its time/action profile and mixing causes precipitation. 6.3 Shelf life The expiry date of the product is indicated on the packaging materials. Shelf life after first use of the pen The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light. Pens in use must not be stored in the refrigerator. The pen cap must be put back on the pen after each injection in order to protect from light. 6.4 Special precautions for storage Before first use Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light. After first use or if carried as a spare For storage conditions after first opening of this medicinal product, see section 6.3. 6.5 Nature and contents of container SoloStar pen Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber). The cartridge is sealed in a disposable pen injector. Each cartridge contains 1.5 ml solution. Packs of 1, 3 and 5 pens are available. Not all pack sizes may be marketed. Needles are not included in the pack. DoubleStar pen Cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber). The cartridge is sealed in a disposable pen injector. Each cartridge contains 3 ml solution. Packs of 3 pens are available. Not all pack sizes may be marketed. Needles are not included in the pack. 6.6 Special precautions for disposal and other handling Before first use, the pen must be stored at room temperature at least 1 hour before use. Before using Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen, the Instructions for Use included in the package leaflet must be read carefully. Toujeo SoloStar pre-filled pen have to be used as recommended in these Instructions for Use (see section 4.2). Instruct patients to perform a safety test as described in Step 3 of the Instructions for Use. If they don’t, the full dose might not be delivered. If this occurs, patients should increase the frequency of checking their blood glucose levels and might need to administer additional insulin. The cartridge should be inspected before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Toujeo is a solution, it does not require resuspension before use. Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins. The strength“300” is highlighted in honey gold on the label (see section 4.4). Patients should be informed that the dose counter of Toujeo SoloStar or Toujeo DoubleStar pre-filled pen shows the number of units of Toujeo to be injected. No dose re-calculation is required. • The Toujeo SoloStar pen contains 450 units of Toujeo. It delivers doses of 1-80 units per injection, in steps of 1 unit. • The Toujeo DoubleStar pen contains 900 units of Toujeo. It delivers doses of 2-160 units per injection, in steps of 2 units. o Tow reduce potential underdose, Toujeo DoubleStar is recommended for patients requiring at least 20 units per day. • If safety tests are not performed before the first use of a new pen, insulin underdose can occur. A syringe must never be used to withdraw Toujeo from the cartridge of the pre-filled pen or severe overdose can result (see section 4.2, 4.4 and 4.9). A new sterile needle must be attached before each injection. Needles must be discarded immediately after use. Needles must not be re-used. Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing. Using a new sterile needle for each injection also minimizes the risk of contamination and infection. In the event of blocked needle, the patients must follow the instructions described in Step 3 of the Instructions for Use accompanying the package leaflet (see section 4.2 and 4.4). Used needles should be thrown away in a puncture resistant container or disposed of in accordance with local requirements. Empty pens must never be reused and must be properly discarded. To prevent possible transmission of disease, insulin pen should never be used by for more than one person, even when the needle is changed (see section 4.2). 7. MARKETING AUTHORISATION HOLDER Sanofi israel ltd, Greenwork Park P.O. box 47, Yakum
פרטי מסגרת הכללה בסל
התרופה תינתן לחולי סוכרת
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
| התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
|---|---|---|---|---|
| INSULIN GLARGINE | ||||
| INSULIN DETEMIR | ||||
| סכרת |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
15/04/2005
הגבלות
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