Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Glycerol
Sodium citrate dihydrate
Metacresol
Magnesium chloride hexahydrate
Zinc oxide
Treprostinil sodium
Hydrochloric acid and sodium hydroxide (for pH adjustment)
Water for injections

6.2   Incompatibilities
This medicinal product must not be mixed with any other insulin or any other medicinal product except those mentioned in section 6.6.

6.3   Shelf life

Before use
The expiry date of the products is indicated on the package materials.

After first use

28 days

Lyumjev 100 units/mL solution for injection in vial

When the vial is diluted for intravenous use
Chemical, physical in-use stability has been demonstrated for 14 days at 2–8 °C and 20 hours at 20-25 °C when protected from light. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions (see section 6.6).

6.4   Special precautions for storage

Before use
Store in the refrigerator (2 °C - 8 °C).
Do not freeze.
Store in the original package in order to protect from light

After first use

Do not store above 30 °C.
Do not freeze.
Lyumjev 100 units/mL solution for injection in vial

Store in the original package in order to protect from light.

Lyumjev 100 units/mL solution for injection in cartridge
Do not refrigerate.
Keep the cap on the pen once cartridge inserted, in order to protect from light.

Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen 
Do not refrigerate.
Keep the cap on the pen in order to protect from light.

6.5   Nature and contents of container
Lyumjev 100 units/mL solution for injection in vial

Type I clear glass vials, sealed with halobutyl stoppers and secured with aluminium seals.

10 mL vial: Packs of 1 vial.
Lyumjev 100 units/mL solution for injection in cartridge

Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.

3 mL cartridge: Packs of 2, 5 or 10 cartridges.

Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 

Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.

The 3 mL cartridges are sealed in a disposable pen injector KwikPen .

The medicinal product is packed in a white carton with dark blue bands and an image of the pen. The KwikPen is taupe, the dose knob is blue with raised ridges on side.

3 mL KwikPen: Packs of 1 pre-filled pen, 2 pre-filled pens or 5 pre-filled pens.

Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen 
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.

The 3 mL cartridges are sealed in a disposable pen injector Junior KwikPen.

The medicinal product is packed in a white carton with stripes of peach, light blue and dark blue bands and an image of the pen. The Junior KwikPen is taupe, the dose knob is peach with raised ridges on end and side.

3 mL Junior KwikPen: Packs of 1 pre-filled pen, 2 pre-filled pens or 5 pre-filled pens.

Not all pack sizes may be marketed.
6.6    Special precautions for disposal and other handling

Lyumjev should look clear and colourless. It should not be used if it is cloudy, coloured, or has particles or clumps in it.

Lyumjev should not be used if it has been frozen.

A new needle must always be attached before each use. Needles must not be re-used. Needles are not included.

Lyumjev 100 units/mL solution for injection in vial

Intravenous use
Lyumjev 100 units/mL vial can be diluted to concentrations of 0.1 to 1.0 unit/mL in 5% glucose solution for injection or sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous use.
Compatibility has been demonstrated in ethylene-propylene copolymer and polyolefin with polyvinyl chloride bags.

It is recommended that the system is primed before starting the infusion to the patient.

CSII
Lyumjev 100 units/mL vial can be used to fill a continuous insulin infusion pump for a maximum of 9 days. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    LICENSE HOLDER

Eli Lilly Israel Ltd., 4 HaSheizaf st., POB 4246, Ra’anana 4366411, Israel.