DOSAGE AND ADMINISTRATION
Directions For Use
To prepare for use, immerse
absorbable gelatin film in sterile saline solution and allow it to soak until
it becomes quite pliable; it may then be cut to desired size and shape without
difficulty and applied as follows:
For covering dural defects, GELFILM Sterile Film
is placed over the surface of the brain, the edges of the implant tucked
beneath the dura and the wound then closed in the usual manner. If desired, the
GELFILM can be sutured loosely to the dura. Care must be exercised, however,
because moist film tears easily. For covering pleural defects, GELFILM Sterile
Film is placed over the defect and anchored in place by small interrupted
sutures.
For use as a seton in
iridencleisis, a small piece of GELFILM Sterile Ophthalmic Film
(approximately 4 x 10 mm) is placed over the prolapsed iris pillar parallel to
the limbus; Tenon's capsule and the conjunctiva are then closed with continuous
absorbable sutures spaced to insure tight closure.
In diathermy or scleral
“buckling” operations, GELFILM Sterile Ophthalmic Film may be placed over the
sclera, the muscle and the conjunctiva then sutured over the underlying
GELFILM.
In extraocular muscle
surgery, GELFILM Sterile Ophthalmic Film may be placed over and
beneath the muscle before Tenon's capsule and the conjunctiva are closed in layers.
HOW SUPPLIED
GELFILM Sterile Film and
GELFILM Sterile Ophthalmic Film are supplied in the following packages:
GELFILM Sterile Film, for use
in neurosurgery and thoracic surgery, sterile envelopes, one per carton, GTIN 00300090283018 (0009-0283-01).
GELFILM Sterile Ophthalmic
Film, for use in ocular surgery, sterile envelopes, six per carton, GTIN 00300090297039 (0009-0297-03).
Storage And Handling
GELFILM Sterile Film and
GELFILM Sterile Ophthalmic Film should be stored at 25°C (77°F); excursions
permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Once the envelopes have been opened, contents are subject to contamination. To
insure sterility, it is recommended that absorbable gelatin film be used
immediately after withdrawal from the envelope.
This product is prepackaged
sterile and intended only for single use. Reuse can result in transmission of
bloodborne pathogens (including HIV and hepatitis), potentially endangering
patients and health care providers. Adherence to the principles of aseptic
technique when using this product is essential.
Warning: To prevent
contamination, employ aseptic procedure in opening envelope and withdrawing
GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film. If the envelope is torn
or punctured, the contained GELFILM Sterile Film and GELFILM Sterile Ophthalmic
Film should not be used.
Caution
Federal law restricts this
device to sale by or on the order of a physician.
Manufactured by: Pharmacia and
Upjohn Company, 7000 Portage Road, Kalamazoo, Michigan 49001, USA, 1-800-253-8600,
Revised: December 2014. Distributed by: Pharmacia &
Upjohn Co., Division of Pfizer Inc., New York, NY 10017