Minims Povidone Iodine 5% w/v eye drops, solution

Section 2 Qualitative and Quantitative Composition- Addition of quantity in each drop of excipient with known effect. 

Section 4.1 Therapeutic Indication - Addition of surgical procedure "intravitreal injection"

Section 4.2 Posology - Editorial updates to text, removal of "neonates" from the Paediatric Population section. 

Section 4.3 Contraindications: Addition of pre-term infants

Section 4.4 Special warnings and precautions for use: extensive updates with the addition of the following text: 

The use of Minims Povidone Iodine 5% w/v eye drops, solution is restricted to cutaneous-conjunctival surface antisepsis ONLY.

Repeated applications of povidone-iodine to ocular surface related to long term ophthalmic therapy with intravitreal injections may result in tear film abnormalities or aggravate existing tear film abnormalities. Patients with dry eye syndrome should be monitored for any exacerbation of their condition and treated appropriately.

Precautions for use

After the medicinal product has been left in contact with the conjunctiva and conjunctival sacs for two minutes, flush thoroughly with sterile 0.9 % NaCL solution.

Concomitant use with topical ophthalmic formulations containing mercury-based preservatives is to be avoided.

Minims Povidone Iodine should be used with caution in patients suffering from thyroid dysfunction and in elderly patients, who are at increased risk of thyroid dysfunction development. Monitoring of thyroid function should be considered, particularly during regular repeated use of the medicinal product.

Cross-reactions with iodinated contrast agents have not been reported. Hypersensitivity (anaphylactoid reactions) to iodinated contrast agents or anaphylactic reaction to shellfish are not contraindications for Minims Povidone Iodine 5% w/v eye drops administration.

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Section 4.5 Interaction with other medicinal products and other forms of interaction: Information added on avoidance or special caution for concomitant use with other antiseptic agents or mercury based preservatives. 

Section 4.6 Fertility, pregnancy and lactation: Update of animal and clinical data.

Section 4.8 Undesirable effects: Update of some categories. Update of Endocrine Disorders discussing the effect of toxic levels of iodine, and some exceptional cases of hypothyroidism. New sections Eye disorders and Skin and subcutaneous tissue disorders have been added. 

Section 5.1 Pharmacodynamic Properties: a description of the spectrum of activity of iodine has been added. 

Section 5.3 Preclinical safety data: Added text to describe preclinical studies do not provide evidence of a particular risk to humans. Added descriptions of animal studies. 

Section 10: Revision date of text updated.