Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Powder

Trehalose dihydrate
D-Mannitol
Sodium citrate Dihdrate
L-Methionine
Citric acid Monohydrate
Polysorbate 80



Solvent
Sterile water for injection

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

Unopened vials
The expiry date of the product is indicated on the packaging materials.


Reconstituted solution
Chemical and physical stability has been demonstrated for 3 hours at 25°C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the solution should be used immediately.

If not used immediately, Voxzogo must be administered within 3 hours of reconstitution (see section 4.2).

6.4   Special precautions for storage

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

Voxzogo may be stored at room temperature below 30 °C for a single period up to 90 days, but not beyond the expiry date. Do not return Voxzogo to refrigerator after storage at room temperature.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Vosoritide 0.4 mg powder and solvent for solution for injection

Powder
2 mL vial (glass) with rubber stopper (bromobutyl) and white flip cap.

Solvent
Pre-filled syringe (glass) with plunger (bromobutyl) and tip cap with a luer lock and tamper evident seal containing 0.5 mL of water for injections.

Vosoritide 0.56 mg powder and solvent for solution for injection

Powder
2 mL vial (glass) with rubber stopper (bromobutyl) and magenta flip cap.
Solvent
Pre-filled syringe (glass) with plungers (bromobutyl) and tip cap with a luer lock and tamper evident seal containing 0.7 mL of water for injections.

Vosoritide 1.2 mg powder and solvent for solution for injection

Powder
2 mL vial (glass) with rubber stopper (bromobutyl) and grey flip cap.
Solvent
Pre-filled syringe (glass) with plungers (bromobutyl) and tip cap with a luer lock and tamper evident seal containing 0.6 mL of water for injections

Each carton contains:
•     10 vials of Voxzogo
•     10 pre-filled syringes of water for injections
•     10 individual single use needles (23 gauge, for reconstitution)
•     10 individual single use syringes (30 gauge, for administration) 
6.6   Special precautions for disposal and other handling

Preparation of Voxzogo for subcutaneous injection

•     The correct Voxzogo strength and correct pre-filled syringe of solvent (reconstitution volume) should be confirmed based on the patient’s body weight (see Table 1).
•     All necessary ancillary supplies must be in place before starting.
o      Alcohol pads o      Gauze or bandages o      Sharps container
•     The Voxzogo vial and solvent in a pre-filled syringe (water for injections) should be removed from the refrigerator and allowed to reach room temperature before reconstituting Voxzogo.
•     The solvent needle must be attached to the solvent in the pre-filled syringe (water for injections).
•     The entire solvent volume must be injected into the vial.
•     The solvent in the vial should be gently swirled until the white powder is completely dissolved.
The vial should not be shaken.
•     The dosing volume of the reconstituted solution should be slowly withdrawn from the single use vial into a syringe.
•     Once reconstituted this medicinal product is a clear, colourless to yellow liquid. The solution should not be used if discoloured or cloudy, or if particles are present.
•     After reconstitution, Voxzogo can be held in the vial at a room temperature up to 25 °C for a maximum of 3 hours. The medicinal product contains no preservative.
•     For administration, the required dose volume must be extracted from the vial using the supplied administration syringe (see Table 1).
•     Each vial and pre-filled syringe are for single use only.
•     Only the administration syringe provided should be used .


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

All needles and syringes should be disposed of in a sharps disposal container.