Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Benzyl benzoate
Ethanol 96%
Benzyl alcohol
Castor oil

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

Store at 2°C-8°C (in a refrigerator)
Store the pre-filled syringe in the original package in order to protect from light.

6.5 Nature and contents of container

The pre-filled syringe presentation consists of:
Two clear type 1 glass pre-filled syringes with polystyrene plunger rod. Each syringe has a nominal content of 5 ml Faslodex solution and is fitted with a tamper evident closure.
Two safety needles (BD SafetyGlide™) for connection to the barrel are also provided.


6.6 Special precautions for disposal and other handling
Instructions for administration
Administer the injection according to the local guidelines for performing large volume intramuscular injections.


NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Faslodex at the dorsogluteal injection site (see section 4.4).


Warning - Do not autoclave safety needle (BD Safety Glide™ Shielding Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.


For each of the two syringes:
Remove glass syringe barrel from tray and check that it is not damaged.
• Peal open the safety needle (SafetyGlide™) outer packaging.

• Parenteral solutions must be inspected visually for particulate        Figure 1 matter and discolouration prior to administration.
• Hold the syringe upright on the ribbed part (C). With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure
1).


• Remove the cap (A) in a straight upward direction. To maintain sterility do not touch the syringe tip (B) (see Figure 2).

Figure 2
• Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
• Check that the needle is locked to the Luer connector before moving out of the vertical plane.
• Pull shield straight off needle to avoid damaging needle point.
• Transport filled syringe to point of administration.
• Remove needle sheath.
• Expel excess gas from the syringe.
Figure3

• Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area). For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4).

Figure 4

• After injection, immediately apply a single-finger stroke to the     Figure 5 activation assisted lever arm to activate the shielding mechanism
(see Figure 5).
NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.



Disposal
Pre-filled syringes are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    DRUG REGISTRATION NUMBER
132 67 31114-02