erformed.
In a fertility and early embryonic development study at systemic exposures below those observed clinically there was no evidence of effect on pregnancy or in utero survival in rats. Length of the estrous cycle was increased and a delay in fertility was seen in female rats. Reproduction was unaffected in male rats.
Tetrabenazine was not embryotoxic or teratogenic in the rabbit; however, the observed systemic exposure was lower than that observed clinically. The potential embryotoxic and teratogenic effects were also insufficiently studied in the rat. In a peri/postnatal study in the rat, increased neonatal mortality was observed, the cause of which is unknown.
6. Pharmaceutical particulars
6.1 List of excipients
Pregelatinised maize starch
Lactose monohydrate
Talc
Ferric oxide yellow E172
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Keep the container in the outer carton in order to protect from light.
This medicinal product does not require any special temperature storage conditions.
6.5 Nature and contents of container
White round high-density polyethylene (HDPE) tablet container with a child-resistant, tamper-evident polypropylene (PP) screw cap with mounted desiccant containing 112 tablets.
6.6 Special precautions for disposal and other handling
No special requirements
7. Marketing authorisation holder
AOP Orphan Pharmaceuticals AG
1160 Vienna, Austria
8. Marketing authorisation number(s)
PL 21344/0015
9. Date of first authorisation/renewal of the authorisation
20/07/2010 |
