Pharmaceutical particulars : מידע רוקחי

6.     Pharmaceutical Particulars
6.1.   List of Excipients

Sodium bisulphite (E222)
Hydrochloric acid for pH adjustment
Water for injection

6.2.   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3.   Special Precautions for Storage

Store below 25°C.
Keep the container in the outer carton to protect from light.

The product should be stored at the same conditions after opening and between withdrawals.
Store for 48 hours after first opening.
6.4.   Nature and Contents of Container

Cartridge.

APO-go PEN 10 mg/ml is a disposable multiple-dose PEN injector system incorporating a clear glass (type I) cartridge containing a clear solution for injection. The glass cartridge is sealed at one end with a bromobutyl rubber piston, and at the other end with a bromobutyl rubber/aluminium membrane.
Each PEN contains 3ml of solution for injection.

Packs containing 1, 5, or 10 x 3 ml PENs in a moulded plastic tray in an outer cardboard carton.

Not all pack sizes may be marketed.

6.5.   Special Precautions for Disposal
APO-go PEN

Do not use if solution has turned green.
Discard each PEN no later than 48 hours from first use.
(See attached diagram).





1) Dosage dial

7) Arrow showing the dosage selected

8) Numbers indicating the dose per injection (1-10 mg)


9) Graduations (in mg) on the cartridge showing total amount of apomorphine in the PEN.

4) Membrane

10) Needle*
6) Needle protector*



3) Outer sleeve of PEN



2) Needle in sealed unit* containing
10) needle
6) needle protector
5) protective cone


* This pack does NOT contain needles for use with your PEN.
Use PEN needles not more than 12.7 mm (½”) in length and not finer than 30G. PEN needles recommended for use with insulin PENS are compatible with APO-go® PEN.

IMPORTANT: Do not pull the red capped dial (see 1) before you have set the dosage (see “selecting the correct dose”).


Attaching the needle
(a) Before using APO-go PEN you will need some surgical wipes and one needle in its protective cone (see 2).

(b) Take the PEN out of its box and remove the outer sleeve (see 3).



(c ) Wipe the membrane of the PEN (see 4) with a surgical wipe.


(d) Peel off the paper from the needle cone (see 2).



(e) It is important to bring the needle to the PEN in a straight line, as shown below. If the needle is presented at an angle, it may cause the PEN to leak.






(f) screw the cone (see 2) clockwise onto the membrane until it is tight. This securely attaches the needle.

(g) Remove the protective cone (see 5), but do not throw it away. Do not remove the needle protector(see 6) at this stage.



(h) Replace the PEN’s outer sleeve (see 3).

Selecting the correct dose
(i) Press the red capped dosage dial (see 1) and whilst holding it down, turn the dial clockwise until the arrow points to the dose your doctor chose for you (see 7 & 8). Release the downward pressure on the red capped dial. The dose is now set and you do not need to redial for subsequent injections.






Important: If you pass your prescribed dose while turning the dial, just continue pressing and turning in the same direction until the arrow points to the dose your doctor chose for you.
Never pull and turn the red capped dosage dial at the same time.

If your dose is 1 mg, start by emptying a 1 mg dose onto a paper tissue and discarding it. This is called ‘priming’ and is important because it ensures you get a full dose the first time you use your PEN. Then, set the dose you require for injection and inject it in the usual way (see “Injecting”). If the first dose required is more than 1 mg, you do not need to prime the PEN.


Injecting
(j) Once you have set the dose, gently pull out the red capped dosage dial as far as it will go.
Check the red scale on the plunger (see 9) and inject only if the line that is just visible matches the intended dose.



(k) Using a surgical wipe, clean the area of skin where you plan to inject the medicine and around it.

(l) Remove the PEN’s outer sleeve (see 3).

(m) Remove the needle protector (see 6).


(n) Insert the needle (see 10) into the skin as shown by your doctor.


(o) To inject, press the red capped dosage dial (see 1) down as far as it will go, using your thumb if possible. Once the red capped dosage dial is fully depressed, count to three before withdrawing the needle.



(p) Replace the protective cone (see 5) onto the used needle, and push gently into place. Once secure, turn the needle anti-clockwise to unscrew it.

Keep the needle in its protective cone and discard it in a safe place, such as a “sharps” bin or an empty coffee jar.






Preparing for the next injection

(q) Remove the outer sleeve of the PEN and check there is enough apomorphine left in the cartridge for your next injection. If there is, put a new needle in place in the same way as before.


(r) If there is not enough apomorphine left for another injection, prepare another PEN.
(s) Finally, replace the outer sleeve of your PEN.



7.     Registration Number

136.82.31425.00.