man clinical exposure based on AUC, respectively. Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity. GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on a 50 kg human), and 11 times the human mg/m2 equivalent dose for a clinical dose of 50 mg.
Liver toxicity associated with liver enzyme induction was observed in rodents following rilpivirine administration. In dogs, cholestasis-like effects were noted.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core
Mannitol (E421)
Magnesium stearate
Microcrystalline cellulose
Povidone (K29/32)
Sodium starch glycolate
Sodium stearyl fumarate
Lactose monohydrate
Croscarmellose sodium
Povidone (K30)
Polysorbate 20
Silicified microcrystalline cellulose
Tablet coating
Polyvinyl alcohol- part hydrolysed
Titanium dioxide (E171)
Macrogol
Talc
Iron oxide yellow (E172)
Iron oxide red (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant.
This medicinal product does not require any special temperature storage conditions.
6.5 Nature and contents of container
White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner. Each pack consists of one bottle containing 30 film-coated tablets and a desiccant.
Multipacks containing 90 (3 packs of 30) film-coated tablets. Each pack of 30 film-coated tablets contains a desiccant.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorisation holder
ViiV Healthcare BV
Huis ter Heideweg 62
3705 LZ Zeist
Netherlands
8. Marketing authorisation number(s)
EU/1/18/1282/001
EU/1/18/1282/002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 16 May 2018
10. Date of revision of the text
23 January 2019
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |
