INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BioLone Sterile solution for injection

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

BioLone Sterile solution for injection

COMPOSITION
Each mL contains 10 mg
sodium hyaluronate in a physiological buffer.

PHARMACOLOGICAL CLASSIFICATION
A.3 Connective Tissue Medicine

PHARMACOLOGICAL ACTION
Sodium hyaluronate is a naturally occurring polysaccharide found in structural matrix as well as in synovial fluids, the vitreous humour of the eye and in healthy skin and connective tissue. Sodium hyaluronate is pharmacologically inert and protects the eye by virtue of its physiocochemical/rheological properties. Its role in BioLone is to produce a viscoelastic solution which serves as an ophthalmological surgical aid by supporting and maintaining eye tissue during surgery.

INDICATIONS
Eye surgery, including intraocular lens insertion, intracapsular and extracapsular lens extraction, glaucoma surgery, corneal graft surgery for accidental trauma, retinal detachment and vitreal replacement procedures.

CONTRA-INDICATIONS
Sensitivity to any of the ingredients.

WARNINGS:
None.

DOSAGE AND DIRECTIONS FOR USE:
Dosage varies with type of surgery. Usually a dose of 0,2 to 0,6 mL is injected into the anterior segment of the eye. Greater amounts are used in the posterior segment.

EXAMPLES OF SURGICAL APPLICATIONS
Cataract Surgery
Before lens extraction, BioLone is introduced into anterior chamber to protect the corneal endothelium and to maintain a deep anterior chamber. Additional amounts may also be introduced before implantation of an intraocular lens, and to coat the artificial lens and the surgical instruments.
Glaucoma Surgery
BioLone is instilled before the trabeculectomy in order to reconstitute the anterior chamber. At the close of surgery, further instillation of BioLone may be required to achieve good sub-conjuctival filtration and to prevent tissue adherences.
Corneal Transplant Surgery
In trepanation of the cornea, the anterior chamber is filled with BioLone. The donor graft should be placed on the surface of the solution and sutured into position. Additional amounts of BioLone may be injected to maintain a deep anterior chamber. BioLone may also be used in the anterior chamber of the donor eye to protect the corneal endothelial cells of the graft prior to trepanation, and to protect the exposed endothelial layer of the donor button during preparation of the recipient eye.
Retinal and Vitreous Surgery
BioLone should be introduced slowly into the vitreous cavity. By carefully directing the injection, BioLone can be used to separate membranes from the retina for safe excision and release of traction. BioLone also helps in moving tissues into desired positions. For example, it is helpful in gently pushing back a detached retina, in unrolling a retinal flap, or in holding the retina against the sclera during reattachment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Adverse Reactions
Transient rises of post-operative intraocular pressure have been reported in some cases. A causal relationship has not been established between BioLone use and postoperative inflammatory reactions (iritis), corneal oedema and corneal decompensation.
Precautions
Precautions are limited to those normally associated with the surgical procedures being performed.
Instilling excessive amounts of BioLone into the anterior or posterior segments of the eye may increase intraocular pressure. Increased postoperative intraocular pressure may also be cuased by a pre-existing glaucoma condition or by compromised outflow and by operative procedures and sequelae thereto, including enzymatic zonulysis, absence of an iridectomy, trauma to filtration structures, and by blood and lenticular remnants in the anterior chamber. Because these factors vary from case to case and are difficult to predict, the following precautions are recommended:
Do not overfill the eye with BioLone. Avoid using large amounts of BioLone for posterior segment procedures in aphakic diabetic patients.
At the end of surgery, all remaining BioLone should be removed by irrigation or aspiration. Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If a significant increase in pressure is observed, treat appropriately.
Avoid the trapping of air bubbles behind BioLone.
BioLone is a very highly purified substance extracted from bacterial cells. Since the presence of minute quantities of impurities (proteins, etc.) cannot be totally excluded, the physician should be aware of immunological, allergic and other potential risks associated with the injection of biological substances.
On rare occasions, viscoelastic products containing sodium hyaluronate have been observed to become slightlt opaque or to form a slight precipitate upon instillation into the eye. The physician should, however, be aware of this possibility, and, should it be observed, the cloudy or precipitated material should be removed by irrigation and/or aspiration.
Avoid re-use of the cannula. If re-use is necessary, rinse the cannula thoroughly to remove all traces of residual material.
Incompatibilities
Mixing of quaternary ammonium salts such as benzalkonium chloride with sodium hyaluronate solutions results if formation of a precipitate. BioLone should not be administered through a cannula previously used with medical solutions containing benzalkonium chloride.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
None currently known.

IDENTIFICATION
A sterile (2,25 mL nomina capacity) clear type I borosilicate glass syringe containing 0,5 mL or 1,0 mL of a colourless, viscous solution.

PRESENTATION
BioLone is supplied in a box containing a single blister pack containing a sterile, clear, type 1, borosilicate glass disposable syringe containing 0,5 mL or 1,0 mL of clear solution and a separate sterile cannula.

STORAGE INSTRUCTIONS
Store between 2-8ºC, protect from light. May be stored at 25ºC for up to one month.
Keep out of reach of children.

REGISTRATION NUMBER (OR REFERENCE NUMBER)
30/3/0194

NAME AND BUSINESS ADDRESS OF APPLICANT
PHARMAFRICA (PTY) LTD
33 Hulbert Road
New Centre
Johannesburg
2001

DATE OF PUBLICATION OF THIS PACKAGE INSERT
UNDER LICENCE TO:
Bio-Technology General
Israel

Updated on this site: May 2014
Source: Pharmaceutical Industry

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