Ozurdeq - instructions for use, doses, side effects, contraindications

Composition:One implant for intravitreal administration contains
Active substance: dexamethasone, micronized 0.700 mg.
Excipients: lactic and glycolic acid copolymer (50: 50 SMGC acid) 0.350 mg, lactic and glycolic acid copolymer (50:50 smGC ether) 0.116 mg.

Description:white or almost white implant in the form of a rod.

Pharmacotherapeutic group:glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.02 Dexamethasone

S.01.B.A.01 Dexamethasone

H.02.A.B Glucocorticoids

S.01.B.A Corticosteroids

Pharmacodynamics:DexamethasoneBeing potent glucocorticosteroid, inhibits inflammation, reducing the severity of edema, fibrin deposition, capillary permeability and migration of phagocytes to the site of inflammation.
Glucocorticosteroids suppress the expression of vascular endothelial growth factor, and also prevent the release of prostaglandins, some of which are mediators of cystoid macular edema.

Pharmacokinetics:The plasma concentration of dexamethasone was below the quantification limit (0.05 ng / ml) in 95% of the patients who received dexamethasone in a dose of 350 μg, and in 86% of patients who received dexamethasone in a dose of 700 mcg. The maximum value of the concentration of dexamethasone in the plasma, which was 0.094 ng / ml, was noted in one patient who received 700 μg of dexamethasone.
In studies in animals, it was noted that dexamethasone in the vitreous body is determined for 6 months from the time of administration of the drug. Quantitatively dexamethasone was distributed as follows: retina> iris> ciliary body> vital fluid> aqueous humor> plasma. The half-life (T1 / 2) of the vitreous body is about 3 hours. The rate of removal from the vitreous humor in humans is approximately 12 ml / day. Dexamethasone is metabolized to the final fat and water-soluble metabolites secreted with bile and urine.

Indications:Macular edema due to occlusion of the central vein of the retina or its branches.

Contraindications:- Active or suspected ocular or periocular infection, including active herpes simplex epithelial keratitis (dendritic keratitis), vaccinia, chicken pox, mycobacterial infections and fungal diseases.
- The advanced stage of glaucoma (the disease is not controlled with the help of only medicamental therapy).
- Hypersensitivity to the active or any other component of the drug.
- Age to 18 years.

Carefully:- Herpetic infections of the eye (herpes simplex) in the anamnesis.
- Pregnancy and lactation.
- Afakia.
- In patients taking anticoagulants or antiplatelet agents.

Pregnancy and lactation:Experience with Ozardex in pregnancy is not available, the possible risks are unknown. Ozardex can be used in pregnancy in cases where the intended benefit to the mother exceeds the potential risk to the fetus.
With systemic application dexamethasone excreted in breast milk. With topical application, due to low systemic absorption of dexamethasone, the effect of the drug on children who are breastfed is not expected. However, due to the lack of data on the excretion of the drug with breast milk, the risk can not be ruled out completely, therefore, when prescribing Ozurdex during lactation, breastfeeding should be stopped for the duration of treatment.

Dosing and Administration:Ozurdex is an implant in the applicator, intended strictly for single intravitreal administration.
The preparation should be administered by a qualified ophthalmologist with experience of intravitreal injections.
The recommended dose is one Ozurdex implant that is administered intravitreally into the affected eye.
Repeated prescription of the drug is possible if, following the response to treatment, a decrease in visual acuity is observed, and if, according to the attending physician, the benefit from re-appointment exceeds the potential risk to the patient's health. If the patient retains the improvement in visual acuity achieved during treatment, reassignment is not required.
Also, Ozirdex should not be re-administered to patients with visual impairment that has not slowed down after use. Data on repeated use of the drug with an interval of less than 6 months from the date of the first injection are limited. The experience of re-appointment of more than 2 implants with macular edema due to occlusion of the central vein of the retina or its branches is absent.
The effect of treatment after a single injection is observed already from the 30th day, reaches a maximum on the 60th day and remains statistically significant until the 90th day from the date of injection.It is shown that the effect of Ozurdex on the prevention of loss of vision is numerically superior to the placebo effect within 6 months from the date of injection.
Requirements for the procedure of injection
Intravitreal injection should be carried out under controlled aseptic conditions using sterile gloves, a sterile surgical drape, and a sterile eyelid expander.
When using Ozurdex, follow the instructions below.
1) Before the injection, it is necessary to provide an adequate degree of anesthesia, apply a local antiseptic and local broad-spectrum antimicrobial agent to the conjunctiva.
2) Remove the package with the applicator from the box and inspect it for possible damage. Then in a sterile field, open the package and gently place the applicator in a sterile tray. Carefully remove the protective cap of the applicator. 3) Holding the applicator in one hand, with the other hand, carefully pull out the safety tab, avoiding bending or twisting it.
4) Approaching the cut of the applicator needle directly to the sclera, slide the needle about 1 mm into it,then direct the applicator to the center of the eye and push the needle into the vitreous cavity until the needle contacts the silicone muffle of the needle with the conjunctiva surface.
5) Slowly click the button on the applicator, pushing the implant through the needle. Before removing the applicator from the eye, make sure that the button on the applicator is fully depressed, that is, fixed level with the surface of the applicator body.
6) Remove the needle in the reverse order.
7) After removing the needle, perform standard postinjection procedures.
Each applicator can only be used once for one eye.

Side effects:The incidence of adverse adverse reactions (CPD) is classified as: "very often" (≥1 / 10); "often" (≥1 / 100, <1/10); "not often" (≥1 / 1000, <1/100), "rarely" (≥1 / 10,000, <1/1 000), "very rarely" (<1/10 000).
From the side of the organ of vision
Very often: increased intraocular pressure, conjunctival hemorrhage *.
Often: ocular hypertension, vitreous detachment, cataract, subcapsular cataract, vitreous hemorrhage *, visual disturbances (spot, line or blackout),opacity of the vitreous humor * (including floating opacities of the vitreous body), pain in the eye *, photopsy *, conjunctival edema *, cell infiltration of the anterior chamber of the eye *, conjunctival hyperemia *.
Infrequent: retinal rupture *, opalescence of watery moisture in the anterior chamber of the eye *.
From the nervous system
Often: headache.
Experience of use in the post-registration period
In the post-marketing period of application of Ozurdeks, the following NDP (frequency unknown) was detected:
From the side of the organ of vision
Endophthalmitis * (see also section "Special instructions").
*: NDP associated with the procedure of intravitreal injection, but not with the dexamethasone implant as such.

Overdose:Cases of overdose are unknown.
In case of an overdose, monitor the intraocular pressure. With its increase - treatment is symptomatic.

Interaction:No drug interaction studies were conducted.
Systemic absorption of Ozurdex is minimal, so it is assumed that there is no drug interaction.

Special instructions:Any intravitreal injection may be associated with a risk of endophthalmitis, inflammation of the eye, increased intraocular pressure, and retinal detachment.It is necessary to strictly follow the rules of asepsis during the injection, and also to monitor the condition of patients after the injection.
Patients should be aware of the need to inform the doctor immediately if any of the possible symptoms of endophthalmitis or symptoms related to the adverse reactions listed above.
After intravitreal injection, it is necessary to control the possibility of increasing intraocular pressure and the development of endophthalmitis. To adequately monitor the patient's condition is recommended to estimate the perfusion of the optic nerve immediately after injection, oftalmotonometricheskoe study for 30 minutes after the injection, and biomicroscopy of the eye on a daily basis from the 2nd to the 7th day from the date of injection.
The use of corticosteroids may cause a posterior subcapsular cataract, glaucoma, as well as lead to the development of secondary ocular infections.
Macular edema due to central retinal vein occlusion or branch cataracts more often observed in patients with phakic lenses after repeated injections.
Increased intraocular pressure in macular edema due to occlusion of the central vein of the retina or its branches is more likely in patients younger than 45 years.
There are data on the occurrence of hemorrhagic complications, including conjunctival hemorrhage, when Ozurdex is prescribed to patients receiving anticoagulants and antiaggregants. In this regard, caution should be exercised in prescribing Ozurdex to patients taking anticoagulants or antiplatelet agents.
The safety and efficacy of ozourdexum with simultaneous introduction into both eyes has not been studied. It is assumed that in this case, an increase in the systemic effect of the drug is possible. The use of ozurdex in patients with macular edema secondary to vein occlusion of the retina with severe retinal ischemia has not been studied, therefore, the use of the drug in this group of patients is not recommended.

Effect on the ability to drive transp. cf. and fur:After using Ozurdeks, temporary visual impairment may develop. In this case, patients should refrain from driving the car and working with the mechanisms until the vision is restored.

Form release / dosage:Implant for intravitreal administration, 0.7 mg.

Packaging:For 1 implant in a plastic applicator in the form of a handle, which consists of a body with a protective cap made of polycarbonate,Stainless steel needles for hypodermic injections of caliber 22, actuator and retainer.
For 1 applicator and 1 container with a desiccant in a package of laminated aluminum foil.
For 1 package together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C.
Keep out of the reach of children!

Shelf life:3 years.
Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001913

Date of registration:23.11.2012

Date of cancellation:2017-11-23

The owner of the registration certificate:Allergen Pharmaceuticals AirlandAllergen Pharmaceuticals Airland Ireland

Manufacturer: & nbsp

ALLERGAN PHARMACEUTICALS IRELAND Ireland

Representation: & nbspAllergen of CIS SARL. LtdAllergen of CIS SARL. LtdRussia

Information update date: & nbsp06.01.2016

Illustrated instructions

Instructions

Ozurdeq (Ozurdex)