A Medical Food for the dietary management of Phenylketonuria (PKU).

The next step in the dietary management of Phenylketonuria (PKU).

Phenylalanine free, Large Neutral Amino Acid (LNAA) tablets that allow an individual under medical supervision with proven PKU, to follow a more relaxed diet plan.

Clinically Proven:

• To inhibit phenylalanine transport across blood-brain barrier¹

• Supplemented with the essential amino acid  L-Lysine²
• Supplemented with Vitamin B₁₂ and B₆³

Indications:

• For individuals (with PKU only) 8 years of age and older

• PreKUnil can also be used by untreated or late-diagnosed PKU patients

• Not to be used while planning a pregnancy or during pregnancy

Benefits:

• Now formulated with the essential Amino Acid,  L-Lysine
• Contains Vitamins B₁₂ and B₆

• PreKUnil tablets relaxes the diet making it easier to manage.

• Allows greater intake of natural food.

• Reduces the expenses of modified low protein foods.

• PreKUnil tablets are tasteless and odorless unlike the sensory characteristics of established formulas for PKU.

• A PKU diet plan with PreKUnil allows for unlimited fruit and vegetables, more grains and cereals and meat, poultry or fish in small quantities. (PreKUnil does not allow for unlimited use of high protein foods).

Nutritional Information		Per Tablet
Calories, (kJ)		2.2 (9.11)
Protein Equivalent, g		0.4
Amino Acids, g		0.5
Carbohydrate, g		0.1
Fat, g		0.01
Trans, g		0
Vitamin B6, mg		0.05
Vitamin B12, mcg		0.09

Ingredients: L-Tyrosine, dicalcium phosphate, corn starch, L- Tryptophan, L-Methionine, L-Leucine, L-Lysine, potato starch, talcum, L-Isoleucine, L-Valine, L-Threonine, L-Arginine, L-Histidine, hydroxypropyl methylcellulose, titanium dioxide, povidone, colloidal silicon dioxide, magnesium stearate, shellac, glycerol, vitamin B₆, vitamin B₁₂.

Suggested Intake: 0.5 tablet per kg of body weight per day (0.5 tablet/kg/d).
Daily intake to be determined by your healthcare professional specialized in metabolic disorders. The dosage is dependant on the age, body weight, medical condition and individual Phe tolerance. PreKUnil is not suitable as a sole source of nutrition.

Directions for Use: Use as prescribed by your metabolic specialist. Total number of tablets must be taken 3 or more times per day with meals. Always take tablets with food and at least a glass of water.

Example:
Patient with a body weight of 60 kg
60 kg x 0.5 tablet = 30 tablets/day
Take 10 tablets 3 times a day or 7-8 tablets 4 times per day.

The tablets can be divided so that they can be taken at the beginning, middle or end of a meal.

PreKUnil must be supplemented with a moderately restricted PKU diet containing other sources of protein, fat, carbohydrate, vitamins and minerals.
An individualized diet plan must be followed at all times.

 

Ordering PreKUnil - (888) 876-5223
Reimbursement code (NDC)*: 57771-0001-42

Contact Solace Nutrition
(888) 8-SOLACE (876-5223)
Fax: 401 633-6066
www.solacenutrition.com

 

*National Drug Codes (NDC) Format Codes: Products sold by Solace Nutrition are classified as Medical Foods by the US Food and Drug Administration (FDA). NDC format codes are product codes adjusted according to standard industry practice to meet the format requirements of pharmacy and health insurance computer systems.

Patent Pending: US - 10/826112

 

References

1) Rex A. Moats, Kathryn D. Moseley, Richard Koch, Marvin Nelson. Brain Phenylalanine Concentrations in Phenylketonuria: Research and Treatment of Adults. Pediatrics 2003;112:1575–1579

2) Joachim Pietz, Roland Kreis,2André Rupp, Ertan Mayatepek, Dietz Rating, Chris Boesch,2 and Hans Joachim Bremer Large neutral amino acids block phenylalanine transport into brain tissue in patients with phenylketonuria, J Clin Invest. 1999 April 15; 103(8): 1169–1178.
3) Hvas AM, Nexo E, Nielsen JB. Vitamin B12 and vitamin B6 supplementation is needed among adults with phenylketonuria (PKU). J Inherit Metab Dis. 2006 Feb;29(1):47-53.