DAPIRING Vaginal delivery system (2022)
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Περιεχόμενα
1. Name of the medicinal product
DapiRing vaginal delivery system.
2. Qualitative and quantitative composition
Each dapivirine vaginal ring contains 25 mg of dapivirine and releases approximately 4 mg of dapivirine over a period of one month. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Vaginal delivery system. The dapivirine vaginal ring is a flexible, off-white vaginal ring with an outer diameter of 56 mm and a cross-sectional diameter of 7,7 mm.
4.1. Therapeutic indications
Reducing the risk of HIV-1 infection via vaginal intercourse in HIV-uninfected women 18 years and older in combination with safer sex practices when oral PrEP is not/cannot be used or is not available. ...
4.2. Posology and method of administration
Posology One DapiRing is inserted into the vagina and kept in until replaced every 28 days with a new ring. To maintain efficacy, a new DapiRing should be inserted immediately after the previous ring is ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use in women with unknown or positive HIV status.
4.4. Special warnings and precautions for use
Overall HIV-1 infection prevention strategy The DapiRing is not always effective in preventing HIV-1 infection. The time to onset of risk reduction after initial insertion or following reinsertion after ...
4.5. Interaction with other medicinal products and other forms of interaction
Due to the low systemic exposure to dapivirine in women using the DapiRing, which does not exceed 2 ng/mL (see section 5.2), the risk of systemic medicine interactions is considered low and medicine interaction ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of the DapiRing in pregnant women. Animal studies do not indicate direct or indirect harmful effects with ...
4.7. Effects on ability to drive and use machines
The DapiRing has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions (i.e. reported by ≥5% of participants in the DapiRing group) were: Urinary tract infection (15,2%) Vaginal discharge (7,1%) Vulvovaginal ...
4.9. Overdose
The potential for overdose using the DapiRing is considered highly unlikely. No case of overdose has been reported in clinical trials. If an overdose occurs, standard supportive treatment should be applied ...
5.1. Pharmacodynamic properties
Category and class: A 20.2.8 Antiviral agents <b>Pharmacotherapeutic group:</b> Gynaecological anti-infectives and antiseptics <b>ATC code:</b> G01AX17 Mechanism of action Dapivirine is an NNRTI with potent ...
5.2. Pharmacokinetic properties
Absorption Dapivirine is released from the ring in a sustained manner, distributed into vaginal fluid and absorbed into surrounding tissues and plasma. Measurable dapivirine concentrations were detected ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for women relevant to use of the DapiRing based on conventional studies of safety pharmacology, repeated dose toxicity, irritancy, genotoxicity, carcinogenic ...
6.1. List of excipients
Dimeticone, 1,000 centistokes (cSt) Silicone Elastomer (DDU-4870): Siloxanes and silicones, dimethyl, vinyl group-terminated Platinum(0)-1,3-divinyl-1,1,3,3-tetramethyldisiloxane Silica, amorphous, fumed, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
60 months. Store at or below 30°C.
6.4. Special precautions for storage
Store in the original package in order to protect from light.
6.5. Nature and contents of container
Each DapiRing is packaged into a laminated (PET-Alu/Adhesive/PP), square, heat-sealed pouch. A carton contains either one pouch (1 ring) or three pouches (3 rings).
6.6. Special precautions for disposal and other handling
Do not use if the seal on the pouch is broken. Do not flush used or unused product. Do not throw away the DapiRing in the toilet or water drains. The used DapiRing should either be placed in an empty pouch ...
7. Marketing authorization holder
LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551
8. Marketing authorization number(s)
55/20.2.8/0786
9. Date of first authorization / renewal of the authorization
8 March 2022
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