Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
α,α-trehalose dihydrate
L-histidine HCl monohydrate
L-histidine
Polysorbate 20
Water for injection
Nitrogen – only for the pre-filled syringe

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

Pre-filled syringe
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the pre-filled syringe in its sealed tray in the carton in order to protect from light.
Prior to use, the unopened tray may be kept at room temperature (25°C) for up to 24 hours.

Vial
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature (25°C) for up to 24 hours.
6.5   Nature and contents of container

Pre-filled syringe

0.165 ml sterile solution in a pre-filled syringe (glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter. The pre-filled syringe has a plunger rod and a finger grip, and is packed in a sealed tray.

Pack size of one pre-filled syringe.

Vial-only pack
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.

Vial + filter needle pack

One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution and 1 blunt filter needle (18G, 5 µm).

Vial + injection kit

One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution, 1 blunt filter needle (18G, 5 µm), 1 injection needle (30G) and 1 plastic syringe (1 ml).


Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Pre-filled syringe

The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The sterility of the pre-filled syringe cannot be guaranteed unless the tray remains sealed. Do not use the pre-filled syringe if the solution is discoloured, cloudy or contains particles.

The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume of the pre-filled syringe (0.1 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg ranibizumab).

For the intravitreal injection, a 30G sterile injection needle should be used.

To prepare Lucentis for intravitreal administration, please adhere to the instructions for use: 
Introduction         Read all the instructions carefully before using the pre-filled syringe.
The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The opening of the sealed tray and all subsequent steps should be done under aseptic conditions.
Note: The dose must be set to 0.05 ml.


Pre-filled syringe description              Syringe cap    0.05 ml dose mark          Finger grip 


Luer lock        Rubber stopper           Plunger rod

Figure 1
Prepare         1.   Make sure that the pack contains:
•    a sterile pre-filled syringe in a sealed tray.
2.   Peel the lid off the syringe tray and, using aseptic technique, carefully remove the syringe.
Check syringe   3.   Check that:
•    the syringe cap is not detached from the
Luer lock.
•    the syringe is not damaged.
•    the solution looks clear, colourless to pale brownish-yellow and does not contain any particles.
4.   If any of the above is not true, discard the pre-filled syringe and use a new one.
Remove          5.   Snap off (do not turn or twist) the syringe syringe cap          cap (see Figure 2).
6.   Dispose of the syringe cap (see Figure 3).



Figure 2



Figure 3
Attach needle   7.  Attach a 30G x ½″ sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 4).
8. Carefully remove the needle cap by pulling it straight off (see Figure 5).
Note: Do not wipe the needle at any time.



Figure 4      Figure 5

Dislodge air    9. Hold the syringe upright.
bubbles         10. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 6).


Figure 6

Set dose        11. Hold the syringe at eye level and carefully push the plunger until the edge below the dome of the rubber stopper is aligned with the dose mark (see
Figure 7). This will expel the air and the excess solution and set the dose to
0.05 ml.
Note: The plunger rod is not attached to the rubber stopper – this is to prevent air being drawn into the syringe.

Figure 7


Inject        The injection procedure should be carried out under aseptic conditions.
12. The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
13. Inject slowly until the rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 ml.
14. A different scleral site should be used for subsequent injections.
15. After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.


Vial-only pack
The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the packaging seal remains intact.

For preparation and intravitreal injection the following medical devices for single use are needed: -       a 5 µm filter needle (18G)
-       a 1 ml sterile syringe (including a 0.05 ml mark)
-       an injection needle (30G x ½″).
These medical devices are not included within this pack.

Vial + filter needle pack

The vial and filter needle are for single use only. Re-use may lead to infection or other illness/injury. All components are sterile. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact.

For preparation and intravitreal injection the following medical devices for single use are needed: -       a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided) -       a 1 ml sterile syringe (including a 0.05 ml mark, not included within this pack) -       an injection needle (30G x ½″; not included within this pack) 
Vial + injection kit

The vial, injection needle, filter needle and syringe are for single use only. Re-use may lead to infection or other illness/injury. All components are sterile. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact.

To prepare Lucentis for intravitreal administration, please adhere to the following instructions: 
1. Before withdrawal, remove the vial cap and clean the vial septum (e.g. with 70% alcohol swab).

2. Assemble a 5 µm filter needle (18G x 1½″,
1.2 mm x 40 mm, 5 µm) onto a 1 ml syringe using aseptic technique. Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
3. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.


4. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
5. Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle. The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.



6. Aseptically and firmly assemble an injection needle
(30G x ½″, 0.3 mm x 13 mm) onto the syringe.

7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe.
Note: Grip at the hub of the injection needle while removing the cap.



8. Carefully expel the air along with the excess solution from the syringe and adjust the dose to the appropriate mark on the syringe. The dose for adults is 0.05 ml. The dose for preterm infants is 0.02 ml. The syringe is ready for injection.

Note: Do not wipe the injection needle. Do not pull back on the plunger.


The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.

After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.


7.      REGISTRATION HOLDER AND IMPORTER
Novartis Israel Ltd., P.O.B. 7126, Tel Aviv.