Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Sodium phosphate dibasic dihydrate
Sodium phosphate monobasic dihydrate


Water for injection
Phosphoric acid (for pH adjustment).
Sodium hydroxide (for pH adjustment)

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

Do not store above 30 °C. Do not freeze.

6.5   Nature and contents of container
Pre-filled syringe (Type I glass) with stainless steel 29-gauge needle with a needle shield.

Amvuttra is available in packs containing one single-use pre-filled syringe.

6.6   Special precautions for disposal and other handling
Amvuttra is for subcutaneous use only and should be administered by a healthcare professional.


Instructions for use
Prior to administration, if stored cold, allow Amvuttra to warm by leaving carton at room temperature for about 30 minutes.
•     Administer subcutaneous injection into one of the following sites: the abdomen, thighs, or upper arms. Do not inject into scar tissue or areas that are reddened, inflamed, or swollen.
•     If injecting into the abdomen, avoid the area around the navel.
•     Each 25 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for singleuse only.



How the syringe looks before and after use:
Before Use                                       After Use

Needle cap

Needle


Drug
Syringe              solution body                                            Needle shield
(Locked)
Syringe label

Finger flange

Plunger
Thumb pad                     rod



1.    Prepare syringe
If stored cold, allow the syringe to warm to room temperature for 30 minutes prior to use.

Remove the syringe from the packaging by gripping the syringe body.



Do not touch plunger rod until ready to inject.
Amvuttra is a sterile, preservative-free, clear, colourless-to-yellow solution. Visually inspect the solution. Do not use if it contains particulate matter or if it is cloudy or discoloured.

Check:

•      Syringe is not damaged, such as cracked or leaking
•      Needle cap is attached to the syringe

•      Expiry date on syringe label.

Do not use the syringe if any issues are found while checking the syringe.
2.    Choose injection site

Choose an injection site from the following areas: the abdomen,
thighs, or upper arms.

Avoid:


•      Area around the navel
•      Scar tissue or areas that are reddened, inflamed, or swollen.

Clean the chosen injection site.

3.    Prepare for injection
Hold the syringe body with one hand. Pull the needle cap straight off with other hand and dispose of needle cap immediately. It is normal to see a drop of liquid at the tip of the needle.

Do not touch the needle or let it touch any surface.

Do not recap the syringe.
Do not use the syringe if it is dropped.

4.    Perform Injection

Pinch the cleaned skin.
Fully insert the needle into the pinched skin at a 45-90° angle.

Inject all of the medicine

Push the plunger rod as far as it will go to administer the dose and activate the needle shield.


Release the plunger rod to allow the needle shield to cover the needle.

Do not block plunger rod movement.



5.    Dispose of syringe
Immediately dispose of the used syringe into a sharps container.



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