CYTOSOL OPHTHALMICS - BALANCED SALT SOLUTION
-
calcium chloride,
magnesium chloride,
potassium chloride,
sodium acetate,
sodium chloride and
trisodium citrate dihydrate solution
Biomet Biologics
----------
Cytosol Ophthalmics - Balanced Salt SolutionDESCRIPTION: Balanced Salt Solution is a sterile physiologic solution which is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1.0 ml of Balanced Salt Solution contains Calcium Chloride (Ca.2Cl.2H2O) 0.48 mg, Magnesium Chloride (2Cl.Mg.6H2O) 0.30 mg, Potassium Chloride (Cl.K) 0.75 mg, Sodium Acetate (C2H3O2.Na.3H2O) 3.90 mg, Sodium Chloride (Cl.Na) 6.40 mg, Sodium Citrate (C6H5O7.3Na.2H2O) 1.70 mg, Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
PHARMACOLOGY: A physiological irrigating solution.
INDICATIONS: For irrigation of the eyes,ears, nose and/or throat during a variety of surgical procedures.
PRECAUTIONS: This solution does not contain a preservative and should be discarded after a single use. Do not use this solution unless it is clear and vacuum is present. Do not use if seal assembly or bottle is damaged. The addition of any medication to Balanced Salt Solution may result in damage to Intraocular tissue. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been abserved. There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution was used as an irrigating fluid. As in all surgical procedures appropiate measures should be taken to minimize trauma to the cornea and other ocular tissues.
CONTRAINDICATIONS: There are no known contraindications.
INTERACTIONS: The product should not be mixed with any other solution or therapeutic agent as ocular tissue damage may result.
USE IN PREGNANCY AND LACTATION: As Balanced Salt Solution contains no therapeutically or pharmacologically actice ingredient and is not intended to be absorbed it poses no special threat to pregnancy or lactation.
ADVERSE REACTIONS: Bullous keratopathy may result when abnormal corneal endothelium is irrigated or subjected to any other trauma. There have been reports of corneal clouding and corneal edema following ocular surgery in which a balanced salt solution was used for irrigation. The frequency of such events has not been established adequately.
Should any adverse reaction occur, discontinue use of this product, institute appropriate care, and save the remaining fluid for analysis.
DOSAGE AND ADMINISTRATION: Balanced Salt Solution should be used in conjunction with established practices for each surgical procedure. An administration set equipped with a vented spike should be used since the container does not have an airway tube. Flip off plastic cap from the aluminum seal assembly. Using aseptic technique, insert the spike through the larger, circular, indented area of the rubber slopper. Prior to irrigation, invert the bottle and allow solution to flow entire length of tubing so air is purge air from the tubing or fluid path.
STOREAGE: Store below 25 degree Centigrade. Do not freeze.
Store under normal room conditions at temperature ranges from 46 degree F to 75 degree F (8 degree centigrade - 24 degree centigrade). Avoid exposure to excessive heat and do not allow to freeze.
NAME AND ADDRESS OF SPONSOR: Sole Health Care Products Pty Ltd
(ACN 068274626), 119 Abbey Street Forestdale QLD (4118)
Ph. 617-3806-7866 Fax 617-3800-5989
APPROVED: By The Therapeutic Goods Administration 26 September 1997.
Manufactured for: Cytosol Ophthaimics, Inc., 55 Messina Drive, Braintree, MA 02184 USA
Manufactured by: Cytosol Laboratories, Inc., Braintres, MA 02184 USA
PATIENT INFORMATION
IDENTIFICATION: Cytosol Ophthalmics Balanced Salt Solution. Each 1.0 ml of contains Calcium Chloride 0.48 mg, Magnesium Chloride 0.30 mg, Potassium Chloride 0.75 mg, Sodium Acetate 3.90 mg, Sodium Chloride 6.40 mg, and Sodium Citrate 1.70 mg, Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
WHAT THE PRODUCT IS USED FOR AND HOW IT WORKS: Balanced Salt Solution is used to irrigate the eye during surgery. It is a sterile solution which contains the salts necessary for normal cell function.
ADVICE BEFORE USING CYTOSOL OPHTHALMICS TM BALANCED SALT SOLUTION:DO NOT TAKE CYTOSOLOPHTHALMICS TM BALANCED SALT SOLUTION INTRAVENOUSLY, NOT FOR INJECTION. Do not use the solution unless it is dear and a vacuum is present in the bottle. Notify the physician if you are diabetic due to possible complications during surgery.
HOW TO USE CYTOSOL OPHTHALMICS TM BALANCED SALT SOLUTION
PROPERLY: Balanced Salt Solution should be used by a physician in conjunction with established practices for each surgical procedure. The volume of solution used will be determined by the physician.
FURTHER INFORMATION: Single dose container. This solution does not contain a preservative and should be discarded after a single use.
UNWANTED EFFECTS: Report any vision cloudiness or eye pain to the physician immediately.
IN CASE OF OVERDOSE: The physician will seek appropriate treatment.
STORAGE CONDITION: Store below 25 degree centigrade. Do not freeze.
WHERE TO GO FOR FURTHER INFORMATION: Contact your physician or pharmacist.
SPONSOR: Sole Health Care Products Pty Ltd., (ACN 068274626), 119 Abbey Street Forestdale QLD (4118). Ph. 617-3806-7866 Fax 617-3800-5989.
DATE OF INFORMATION: 26th September 1997
MANUFACTURED FOR: Cytosol Ophthalmics, Inc. 55 Messina Drive, Braintree, MA 02184 USA.
MANUFACTURED BY: Cytosol Laboratories, Inc. Braintree, MA 02184 USA
WARNINGS:DO NOT ADMINISTER BALANCED SALT SOLUTIONS INTRAVENOUSLY. NOT FOR INJECTION.
PRESENTATION: PN8100 500ml bottle NDC 61534-8100-5 (box of 12).
PN8120 200ml bottle NDC 61534-8100-2 (box of 12).
REFERENCES:
1. Faulborn, J., Conway, B.P., Machemer, R., Surgical Complications of Pars Plana Vitreous Surgery. Ophthalmology 85: 116-125, 1978.
2. Haimann, M.H. and Abrams, G.W., Prevention of Lens Opacification During Diabetic Vitrectomy. Ophthalmology 91: 116-121, 1984.
Manufactured for: Cytosol Ophthalmics, Inc., PO BOX 1408, 1325 William White Place, Lenoir, NC 28645 USA.
1-800-234-5186 - 828-758-2343 - Fax 828-758-2345
Manufactured by: Cytosol Laboratories, Inc. Braintree, MA 02184 USA
Authorized European Representative: MDSS GmbH, Burckhardistr, 1, D-30163 Hannover, Germany.
CYTOSOL OPHTHALMICS NOT FOR INTRAVENOUS USE
Balanced Salt Solution REF 8100
(Sterile Irrigating Solution) NDC 61534-8100-5
- Rx Only
- Do not use unless solution is clear and vaccum is present.
- Store at 46 degree F to 75 degree F (8 degree centigrade-24 degree centigrade)- Avoid excessive heat.
- Do not freeze.
- See package information before use.
- Do not use if seal assembly or bottle is damaged.
Single Dose Container Sterile 500mL
Calcium Chloride Dihydrate, USP 0.48mg
Magnesium Chloride Hexahydrate, USP 0.30mg
Potassium Chloride, USP 0.75mg
Sodium Acetate Trihydrate, USP 3.90mg
Sodium Chloride, USP 6.40mg
Sodium Citrate Dihydrate, USP 1.70mg
Water for Injection, USP q.s.
Balanced Salt Solution
(Sterile Irrigating Solution)
Manufactured for: Cytosol Ophthalmics, Inc.,
PO BOX 1408 - 1325 William White Place - Lenoir, NC 28645 - USA.
1-800-234-5186 - 828-758-2343 - Fax 828-758-2345
Manufactured by: Cytosol Laboratories, Inc.
Braintree, MA 02184 - USA
EXP DATE
LOT
| CYTOSOL OPHTHALMICS - BALANCED SALT SOLUTION
calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, trisodium citrate dihydrate solution |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/01/2010 | 09/04/2010 | |
| Labeler - Biomet Biologics (066629064) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Biomet Biologics | 066629064 | manufacture | |