synthetic absorbalbe braided Polyglactin 910 4 0# sutures

ABSORBABLE SURGICAL SUTURE U.S.P
(SYNTHETIC, BRAIDED POLYGLACTIN 910 SUTURE,
COATED WITH POLYCARPOLACTONE AND CALCIUM STEARATE )
DEscriptION
POLYGLACTIN 910 is an absorbable, sterile, surgical suture, composed of a Polyglactin 910. POLYGLACTIN 910 is colored violet with D & C Violet No.2, conforming to U.S. Code of Federal regulations. For added lubrication and smoothness, POLYGLACTIN 910 is coated with unique combination of Polycarpolactone and Calcium Stearate. POLYGLACTIN 910 meets all the requirements, established by the United States Pharmacopeia for Absorbable Surgical Suture (Synthetic)
INDICATIONS:
POLYGLACTIN 910 is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures but not for use in cardio vascular and neurological tissues.
ACTIONS
POLYGLACTIN 910 sutures get absorbed in the site of implantation, owing to the hydrolysis, where the polymer degrades to Glycolic acid and lactic acid. It is slowly absorbed and metabolized in the body. Absorption begins with loss of tensile strength followed by loss of mass. 80% of the original tensile strength is retained up to 14 days after surgery. 90% of the initial tensile strength is lost at the end of the fourth week post implantation. Absorption of POLYGLACTIN 910 suture is minimal up to 10% in two weeks, 25% of the mass gets absorbed in four weeks, up to 75% in two months and absorption is essentially complete between 75 and 90 days.
CONTRAINDICATIONS
POLYGLACTIN 910 suture being absorbable should not be used where extended approximation of tissue is required.
WARNINGS
Do not re-sterilize. Discard open, unused sutures. Prolonged contact of this suture or any other suture with salt solutions such as those found in urinary and billiary tracts, may result in calculus formation. As an absorbable suture, it may act transiently as a foreign body. As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable surgical practice, must be followed with respect to drainage and closure of infected or contaminated wounds. The use of this suture may be inappropriate in patients suffering from conditions which may delay wound healing.
PRECAUTIONS
As this is an absorbable suture, the surgeon in the closure of sites undergoing expansion, stretching or distention, which may require additional support, should consider the use of supplemental nonabsorbable suture. Under some circumstances, notably orthopaedic procedure, immobilisation by external support may be employed at the discretion of the surgeon. Skin suture, which remain in place for more than 7 days may cause localized irritation and should be snipped off or removed. In handling POLYGLACTIN 910 suture or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. As with any suture material, adequate knot security requires the accepted surgical techniques of flat and square ties, with additional throws as warranted by surgical circumstances and the experience of the surgeon.
ADVERSE REACTIONS
Adverse effects associated with the use of POLYGLACTIN 910 include allergic response in certain patients, transient local irritation at the wound site, transient inflammatory foreign body response, erythema and induration during the absorption process of subcuticular sutures.
SUPPLY
POLYGLACTIN 910 suture is available in U.S.P: sizes 5-0, 4-0, 3-0, 2-0, 0, 1 and 2 (1 metric to 7 metric). The suture is supplied sterile in pre-cut lengths, both non-needled and attached to various needle type, shape and length. 12 unit packs are packed in a printed box.
STORAGE
Recommended Storage conditions: Below 25 Deg. Centigrade away from moisture and direct heat. Do not use after expiry
Symbols used on label:
....................... for single use only
....................... expiry date
....................... Sterile unless the package is damaged or opened.
Method of Sterilization- Ethylene oxide
...................... Batch Number