ratogenicity, and had no effect on weight or structure of the placenta, although, based on its pharmacological effect ranibizumab should be regarded as potentially teratogenic and embryo-/foetotoxic.
The absence of ranibizumab-mediated effects on embryo-foetal development is plausibly related mainly to the inability of the Fab fragment to cross the placenta. Nevertheless, a case was described with high maternal ranibizumab serum levels and presence of ranibizumab in foetal serum, suggesting that the anti-ranibizumab antibody acted as (Fc region containing) carrier protein for ranibizumab, thereby decreasing its maternal serum clearance and enabling its placental transfer. As the embryo-foetal development investigations were performed in healthy pregnant animals and disease (such as diabetes) may modify the permeability of the placenta towards a Fab fragment, the study should be interpreted with caution.
6. Pharmaceutical particulars
6.1 List of excipients
α,α-trehalose dihydrate
Histidine hydrochloride, monohydrate
Histidine
Polysorbate 20
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
3 years
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.
6.5 Nature and contents of container
0.23 ml sterile solution in a vial (type I glass) with a stopper (chlorobutyl rubber), 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm), 1 injection needle (30G x ½″, 0.3 mm x 13 mm) and 1 syringe (polypropylene) (1 ml). Pack containing 1 vial.
6.6 Special precautions for disposal and other handling
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, the outer part of the rubber stopper of the vial should be disinfected.
2. Assemble the 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided) onto the 1 ml syringe (provided) 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 the injection needle (30G x ½″, 0.3 mm x 13 mm, provided) onto the syringe.
7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe.
Note: Grip at the yellow hub of the injection needle while removing the cap.
8. Caref |
