Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
α,α-trehalose dihydrate
Histidine hydrochloride monohydrate
Histidine
Polysorbate 20
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   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4 Special precautions for storage
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.
After transfer to syringe the solution can be kept at room temperature (25°C) for up to 8 hours.

6.5   Nature and contents of container



One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Pack size of one vial.

6.6     Special precautions for disposal and other handling

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.

To prepare Ranivisio for intravitreal administration to adults, 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) 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 and adjust the dose to the 0.05 ml mark on the syringe. 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.