Powder for supersaturated calcium phosphate rinse
Ingredients: (Active) Dibasic Sodium Phosphate 0.010, Monobasic Sodium Phosphate 0.010, Calcium Chloride 0.050, Sodium Chloride 0.450, Sodium Bicarbonate 0.016, (lnactive) Silicon Dioxide 0.002
Pharmaceutical form: Neutrasal® is a powder containing 538 mg of ingredients in a foil sachet intended to be dissolved or dispersed in water (tap water, distilled or purified water) before administration to form a solution supersaturated with respect to both calcium and phosphate ions.
Actions: Neutrasal®, when dissolved or dispersed in water before use, forms an electrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate and clean the oral cavity including the mucosa of the mouth, tongue and throat. Neutrasal® facilitates chewing and speaking; loosens tough mucus and prevents mucous membranes from sticking together.
Indications for use: Neutrasal® is indicated for dryness of the mouth or throat (hyposalivation, xerostomia); regardless of the cause and regardless of whether the conditions are temporary or permanent. Neutrasal® is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Special precautions for use: Avoid eating or drinking for at least 15 minutes after use.
Neutrasal® should not be swallowed and the solution should be spit out. NeutraSal® must be dissolved in water before being taken.
Do not use if the foil sachet is ripped or torn or shows sign of leakage or damage.
Contains sodium. (Approximately 50 mg per 30 ml dose). Patients restricted to a low sodium diet should consult their physician before use. Store at room temperature, avoid excessive heat or moisture.
KEEP OUT OF REACH OF CHILDREN.
Interaction with other medicinal products and other forms of interaction:
There are no known interactions with medicinal or other products.
If NeutraSal® is swallowed accidentally, no adverse effects are anticipated.
Stop Use and Consult Your Doctor or Dentist if:
NeutraSal® is supplied in individual foil-lined sachets containing 538 mg of ingredients.
Directions for use:
Fore use during high dose chemotherapy or radiation treatment:
4 doses per day from the onset of the cancer treatment or as needed. Up to 10 Doses per day may be used if pain from mucositis is experienced. Use for the duration of the treatment or as instructed by physician.
Relief of dry mouth: 2 - 10 times per day or as instructed by physician or as needed.
Advanced Pharmaceutical Technology, Inc.
132 South Central Avenue
Elmsford, NY 10532
Distributed in Germany by:
Ingrid Goergen Medical Imports e.K.
NeutraSal® is a prescription free medical device in Germany