dm+d

7561000

Articles

Providing patient information leaflets following COVID-19 treatment

31 March 2021Following treatment for COVID-19 with tocilizumab, sarilumab, or steroids, clinicians should provide suitable patient information leaflets at discharge

Safety in Lactation: Corticosteroids

9 November 2020There is very limited information on the use of corticosteroids during breastfeeding, although they are likely to be present in milk. Avoid prolonged high dose…

What injections can be given orally or via enteral feeding tubes?

6 November 2020This updated Medicines Q&A is a quick reference summary to different types of enteral feeding tubes, in relation to medication issues. Not all enteral feeding…

Dexamethasone

4 February 2016A fixed dose combination of dexamethasone (cortiocosteroid) and netilmicin (aminoglycoside antibiotic)
Search Articles

New Medicines

NetildexOcular inflammation, including post-operative, where bacterial infection or a risk of bacterial infection exists

Information

Netildex
New formulation
SIFI
SIFI

Development and Regulatory status

Licensed but not launched
Launched
None
Jun 20Communication from New Line Pharma: netilmicin products are to be transferred to new MAA, SIFI, who are planning to launch by end of 2021 [6].
Apr 20Approved by the MHRA for treatment of inflammatory ocular conditions of the anterior segment of the eye, including post-operative cases, where bacterial infection or a risk of bacterial infection with netilmicin-susceptible microorganisms exists. SPCs and PILs (generic, no brand name) listed on MHRA website, marketing authorisation holder is NewLine Pharma, Spain; manufacturer is SIFI, Italy [5].
Oct 19Approved by Health Canada for treatment of inflammatory ocular conditions of the anterior segment of the eye following cataract surgery where adjunct topical therapy to reduce the risk of bacterial infection is appropriate. Netildex is available as multi-dose and single-use drops and a single-dose ophthalmic gel. Company states "Filing for regulatory approval in additional countries is ongoing" [3,4]
Jan 19Netildex is launched in Italy, Romania, Turkey, Mexico and Lebanon, and is awaiting regulatory approval in Canada [2].

Category

A fixed dose combination of dexamethasone (cortiocosteroid) and netilmicin (aminoglycoside antibiotic)
Globally, cataracts are the leading cause of blindness, responsible for 51% of world blindness, representing 20 million people in 2010. Cataracts are a global health priority for the WHO. The prevalence increases with age. In the UK, cataracts are thought to affect around half of those aged >65 years to some degree, rising to 70% in those aged >85yrs. Surgical removal of the cataract is the only effective treatment to restore or maintain vision. Pain and inflammation are common post surgery [1].
Ocular inflammation, including post-operative, where bacterial infection or a risk of bacterial infection exists
Topical

Trial or other data

Dec 18PIII trial to evaluate the efficacy and safety of dexamethasone/netilmicin ophthalmic gel versus dexamethasone/netilmicin eye drop solution in the prevention of post-surgery inflammation after cataract extraction by means of phaco-emulsification completes (NCT02973880; 044-SI). The randomised, multi-center, active-controlled, double-blind trial enrolled 180 patients in Italy [2].

Evidence based evaluations