Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Lactose monohydrate
Crospovidone type A
Sodium stearyl fumarate
Saccharin sodium dihydrate
Colloidal Silicone Dioxide

6.2   Incompatibilities

Not applicable.


6.3   Shelf life

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

Reconstituted suspension

The suspension must be administered within 30 minutes after preparation.
Residual suspension must be discarded according to local regulations.
6.4     Special precautions for storage

Store in the original package, in order to protect from light and moisture.
Store in a refrigerator (2°C - 8°C).

For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

One LDPE /Alu/LDPE/ paper sachet containing 1,817 mg granules placed in cardboard box.

Each cardboard box contains 1 sachet.
6.6   Special precautions for disposal and other handling

The suspension must be prepared and administered by a healthcare professional.

Items needed: MACRILEN sachet, tap water in decanter, graduated glass or transparent plastic container, stirring device, 50 mL graduated syringe without needle, drinking glass

Step 1
Weigh the patient.

Step 2
Determine the number of test sachets needed based on body weight: one sachet will be required for a patient weighing up to 120 kg, two sachets will be required if the patient weighs more than 120 kg.

Step 3
Add required volume of water in a graduated glass or transparent plastic container. Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable.

Stir the suspension gently for 2 minutes (a small amount of undissolved particles will remain giving a slightly turbid suspension). The suspension should be stirred until it is slightly turbid without particles at the bottom of the container. The suspension should be stirred again, when some particles settle at the bottom of the container for example after the suspension is left standing for some time.

Step 4
Determine the volume of suspension needed for the recommended macimorelin dose of 0.5 mg/kg. The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.

Measure the required volume using a 50 mL graduated syringe without a needle.

Transfer the measured amount to a drinking glass.
Step 5
Have the patient drink the entire content of the drinking glass within 30 seconds.

The suspension must be used within 30 minutes after preparation. Any suspension that remains must not be stored and must be discarded.

Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Step 6
Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.

Step 7
Prepare plasma or serum samples and send to a laboratory for growth hormone determination.

7.    MANUFACTURER:
Aeterna Zentaris GmbH
Weismuellerstrasse 50, 60314 Frankfurt am Main, Germany