VITREAL S is indicated for the vitreous humour staining during vitrectomy.

Posology
The product is intended to be administered exclusively by specialized ophthalmologists on patients undergoing vitrectomy. in intravitreal injections in aseptic conditions.
Before the surgical procedure, it is generally administered an adequate antiseptic and a broad-spectrum microbicide.
The ophthalmologist will adjust the dose based on the procedure progress.
VITREAL S is removed during the surgical procedure. At the end of the procedure, any residues of VITREAL S must be removed by aspiration or prolonged irrigation.
Method of administration
Single application during vitrectomy.

The product is for intravitreal use only during vitrectomy procedure.
Do not use intravenously or intramuscularly.
The product is for single use.
The volume contained in the vial is usable for a single administration during a single surgical procedure, at the end of whixh the residual content of the vial should be discarded.
The re-use of the residual content may cause ophthalmic infection and / or damage to the patient.
Before using Vitreal S check for the presence of any interaction between triamcinolone acetonide and other drugs administered to the patient.

Do not use the product if the vial is damaged.
Do not use the product if agglomerates are present in the vial after vigorous shaking.
The patient should be informed that after surgery and until visual acuity returns to the norm, it is forbidden to drive vehicles or to carry out an activity on dangerous machines.
Keep the preparation out of sight and reach of children.

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After the surgery and until visual acuity returns to normal, it is forbidden to drive vehicles or carry out an activity on dangerous machines.

The following side effects can occur after application of the product:
Increased pressure in the eye (Increased intraocular pressure).
Inflammation and pain with or without infection in the eye (Endophthalmitis, non-infectious endophthalmitis, hypopyon)
Reduced vision (reduced visual acuity).

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5. PHARMACOLOGICAL PROPERTIES
A colouring used to stain connective tissue in the eye during ophthalmic surgery to enhance the visibility of specific structures and therefore aid the performance of the procedure.
It is supplied as a sterile solution in single-use quantities.

5.1 Preclinical safety data & 5.2 Pharmacokinetic properties should be inserted
From the results of the biocompatibility studies examined in the Biological Evaluation Report (BER) of VITREAL S, the following conclusions can be drawn:
- Implant in the vitreous chamber test, Direct contact cytotoxicity test, Eye irritation test, Delayed hypersensitivity maximization assay, Salmonella Typhimurium reverse mutation assay did not report any risk related to the use of VITREAL S;
- all tests were performed according to the relevant guidelines and following correct methods; the doses and animal species used in the tests were suitable for the biological evaluation of VITREAL S;
- the documentation is to be considered adequate to demonstrate the biocompatibility of VITREAL S and justify the human use of the product.
The results of the studies are consistent with the characteristics of the components of the product and are in favour of the safety of the product when utilized in the preconized conditions of use (ocular instillation). Preclinical data are reported in detail in the BER of VITREAL S.
Studies found in literature confirm the safety of TAA injection in the vitreous.

5.1 Preclinical safety data & 5.2 Pharmacokinetic properties should be inserted
From the results of the biocompatibility studies examined in the Biological Evaluation Report (BER) of VITREAL S, the following conclusions can be drawn:
- Implant in the vitreous chamber test, Direct contact cytotoxicity test, Eye irritation test, Delayed hypersensitivity maximization assay, Salmonella Typhimurium reverse mutation assay did not report any risk related to the use of VITREAL S;
- all tests were performed according to the relevant guidelines and following correct methods; the doses and animal species used in the tests were suitable for the biological evaluation of VITREAL S;
- the documentation is to be considered adequate to demonstrate the biocompatibility of VITREAL S and justify the human use of the product.
The results of the studies are consistent with the characteristics of the components of the product and are in favour of the safety of the product when utilized in the preconized conditions of use (ocular instillation). Preclinical data are reported in detail in the BER of VITREAL S.
Studies found in literature confirm the safety of TAA injection in the vitreous.

5.1 Preclinical safety data & 5.2 Pharmacokinetic properties should be inserted
From the results of the biocompatibility studies examined in the Biological Evaluation Report (BER) of VITREAL S, the following conclusions can be drawn:
- Implant in the vitreous chamber test, Direct contact cytotoxicity test, Eye irritation test, Delayed hypersensitivity maximization assay, Salmonella Typhimurium reverse mutation assay did not report any risk related to the use of VITREAL S;
- all tests were performed according to the relevant guidelines and following correct methods; the doses and animal species used in the tests were suitable for the biological evaluation of VITREAL S;
- the documentation is to be considered adequate to demonstrate the biocompatibility of VITREAL S and justify the human use of the product.
The results of the studies are consistent with the characteristics of the components of the product and are in favour of the safety of the product when utilized in the preconized conditions of use (ocular instillation). Preclinical data are reported in detail in the BER of VITREAL S.
Studies found in literature confirm the safety of TAA injection in the vitreous.

Monobasic Dihydrate Sodium Phosphate 0,22%, Bibasic Dihydrate Sodium Phosphate 0,95%, Sodium Chloride 0,45%, Water for Injection (q.b. to 100 ml).

Not applicable

Do not store above 25°C.
Do not freeze.
Keep the product away from light and sources of heat.
Do not use the product after the expiry date indicated on the packaging.
Do not disperse in the environment.

Box containing one glass vial, 2 ml packed in peel-off pouch
A product information

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