Besivance Eye Drops

BESIVANCE is indicated for treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria in patients of at least one year of age:

• Aerococcus viridans*
• CDC coryneform group G
• Corynebacterium pseudodiphtheriticum*
• Corynebacterium striatum*
• Haemophilus influenzae
• Moraxella catarrhalis*
• Moraxella lacunata*
• Pseudomonas aeruginosa*
• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus hominis*
• Staphylococcus lugdunensis*
• Staphylococcus warneri*
• Streptococcus mitis group
• Streptococcus oralis
• Streptococcus pneumoniae
• Streptococcus salivarius*

*Efficacy for this organism was studied in fewer than 10 infections.

Invert closed bottle and shake once before use.

Adults and children aged one year and older:

Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days.

Handling the container:

To avoid contamination, do not let the applicator tip touch the surface of the eye, fingers, or any other surface.

Paediatric population

The safety and efficacy of BESIVANCE in infants below one year of age have not been established. No data are available. The efficacy of BESIVANCE in treating bacterial conjunctivitis in paediatric patients one year or older, at the same dose as for adults, has been demonstrated in controlled clinical trials.

Elderly population

No overall differences in effectiveness have been observed between elderly and younger patients.

Hypersensitivity to besifloxacin or any other ingredients (see 6.1 List of excipients).

Not for injection into the eye or other tissue.

Growth of resistant organisms with prolonged use:

Prolonged use of BESIVANCE may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

Avoidance of contact lenses:

Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. BESIVANCE should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

BESIVANCE is administered locally to the eye at low dose levels, and the resulting systemic exposure to besifloxacin is minimal. Therefore, no specific medicine interaction studies were performed.

Pregnancy

There are no available human data for the use of BESIVANCE during pregnancy to inform any medicine-associated risks; however, systemic exposure to besifloxacin from ocular administration is low (see section 5.2).

Breastfeeding

There are no data on the presence of BESIVANCE in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to besifloxacin following topical ocular administration is low (see section 5.2) and it is not known whether measurable levels of besifloxacin would be present in maternal milk following topical ocular administration.

Developmental and health benefits of breastfeeding should be considered, along with the motheru2019s clinical need for BESIVANCE, and any potential adverse effects on the breastfed infant from BESIVANCE.

Caution should be exercised when BESIVANCE is administered to a nursing mother.

Fertility

In a fertility and early embryonic development study in rats, besifloxacin did not impair the fertility of male or female rats at oral doses of up to 500 mg/kg/day. This dose is approximately 26 500 times higher than the mean plasma concentration measured in humans at the recommended ophthalmic use.

Patients may experience temporary blurred vision or irritation, pain or itching of the treated eye(s). If blurred vision occurs at instillation, patients should wait until their vision clears before driving or using machinery.

a. Summary of the safety profile

The data described below reflect exposure to BESIVANCE in approximately 1 000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2 % of patients. Other adverse reactions reported in patients receiving BESIVANCE occurring in approximately 1-2 % of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

b. Tabulated list of adverse reactions

Common (u22651/100 to <1/10):

• Conjunctivitis
• Blurred vision
• Eye irritation
• Eye pain
• Eye pruritus
• Headache

Uncommon (u22651/1000 to <1/100):

• Conjunctival haemorrhage
• Eye discharge
• Eyelid oedema
• Conjunctival hyperaemia
• Punctate keratitis
• Ocular hyperaemia
• Viral conjunctivitis
• Dry eye
• Limbal hyperaemia
• Increased lacrimation

d. Paediatric population

The safety of BESIVANCE in infants below one year of age have not been established.

e. Other special populations

Elderly use: No overall differences in safety have been observed between elderly and younger patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit-risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 Suspected adverse reactions may also be reported directly to the Holder of the Certificate of registration using the following e-mail address: [email protected]

Overdosage of this medicine is unlikely to occur via the ophthalmic route.