Expiration date: 01/2025

The composition and form of issue

The restasis eye drops

1 ml contains cyclosporine 500 mg, pack of 30 vials. 0.4 ml.

Pharmacological action:

The restasis is an immunosuppressive agent, a cyclic polypeptide consisting of 11 amino acids. Inhibits the development of reactions of cellular type, including immunity in respect of allograft, skin hypersensitivity of the delayed type, allergic encephalomyelitis, arthritis caused by Freund adjuvant disease "transplant against the owner", as well as dependent T-lymphocytes formation of antibodies. At the cellular level blocks resting lymphocytes in the G0 or G1 phases of the cell cycle and inhibits antigen-triggered the production and secretion of cytokines (including interleukin 2, the growth factor of T cells) activated T-lymphocytes. Effect on lymphocytes is reversible. Does not suppress haematopoiesis and has no effect on the functioning of phagocytic cells.

Indications:

Reduction of lesoproduktsii because of dry keratoconjunctivitis.

Contraindications

• acute infectious diseases of the eye,
  
• pregnancy
  
• lactation,
  
• the age of 18,
  
• hypersensitivity to components of drug.
  
• With caution: in patients with herpetic keratitis in history.
  

Application of pregnancy and breastfeeding

Adequate and well-controlled studies of the drug Restasis in pregnant women have not been conducted. The restasis used during pregnancy is not recommended. With systemic administration of cyclosporine passes into breast milk, excretion in breast milk when applied topically has not been studied. In the appointment during lactation breastfeeding should be discontinued.

Method of application and doses

Local. Before use, invert the vial several times until a homogeneous emulsion is opaque white. One drop instilled into the conjunctival SAC of 2 times/day. with an interval of 12 h

Side effects:

In applying the drug Restasis most often (in 17% of cases) noted a burning sensation in the eye.

The incidence of side effects: very frequent (>10 per cent), frequent (>,1%,0.1%,0.01%,

Very common: burning sensation in the eye.

Common: eye irritation, conjunctival hyperemia eyes, foreign body sensation in the eye, pain and itching in the eye, discharge from eye, blurred vision, dry eye syndrome, photophobia, headache.

Infrequent: keratitis with ulceration, swelling and redness of the eyelids, increased lacrimation, dizziness, nausea, rash.

Frequency unknown: swelling of the conjunctiva of the eye and eyelid, hypersensitivity reactions, urticaria.

Special instructions:

The emulsion contained in one bottle for individual use, should be used immediately after opening the bottle — the remaining amount of the drug after backfilling shall be disposed of immediately after use.

Avoid touching the tip of the bottle to the eyes and any surface to eliminate the possibility of contamination of its contents.

Do not use Restasis while wearing contact lenses. Patients with reduced production of tears is generally not recommended the use of contact lenses. If the lens is used, it must be removed before application of the drug and can be re-installed after 15 minutes after applying the drug Restasis.

Effects on ability to drive vehicles and management mechanisms

The restasis has a negligible influence on the ability to drive vehicles and mechanisms.

If the patient after administration of the drug reduced visual acuity, to restore it is not recommended to drive and engage in activities, require increased attention.

Storage conditions

Keep out of reach of children at temperature not exceeding 25°C.

Shelf life - 2 years.