INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PORTAGEN® POWDER

SCHEDULING STATUS
Non scheduled

PROPRIETARY NAME
(and dosage form)

PORTAGEN® POWDER

COMPOSITION
Maize syrup solids, medium chain triglycerides (fractionated coconut oil), sodium caseinate, sugar (sucrose), maize oil, calcium citrate, potassium chloride, dibasic magnesium phosphate, dibasic calcium phosphate, potassium citrate, lecithin, vitamins (vitamin A palmitate, ergocalciferol, de-alphatocopheryl acetate, sodium ascorbate, folic acid, thiamine hydrochloride, riboflavine, nicotinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, phytonadione and choline chloride) and trace minerals (ferrous sulphate, cupric sulphate, zinc sulphate, manganese sulphate, and sodium iodide).

APPROXIMATE ANALYSIS:
PORTAGEN powder contains (%M/M) 16,5% protein, 22,5% fat, 54,3% carbohydrate, 3% moisture, and 3,7% ash. The fat blend of PORTAGEN contains 87% Medium Chain Triglycerides, which are glycerol esters of Octanoic (C8) and Decanoic (C10) acids along with maize oil which provides linoleic acid and essential fatty acid.

1 Litre of PORTAGEN formula (at 70 kJ/25 mL) supplies approximately:
Vitamin A.I.U. 5 000
Vitamin D I.U. 500
Vitamin E I.U. 20
Vitamin C (Ascorbic acid), mg 50
Folic acid (Folacin) µg 100
Thiamine (Vitamin B1), mg 1
Riboflavine (Vitamin B2) mg 1,2
Nicotinic acid, mg 13
Vitamin B6 mg 1,3
Vitamin B12 µg 4
Biotin, mg 0,05
Panthothenic acid, mg 6,7
Vitamin K1 µg 100
Choline, mg 85
Calcium, g 0,6
Phosphorus, g 0,45
Iodine, µg 45
Iron, mg 12
Magnesium, mg 130
Copper, mg 1
Zinc, mg 6
Manganese, mg 2
Chloride, mg 550 (15,5 m. equiv.)
Potassium, mg 800 (20,5 m. equiv.)
Sodium, mg 300 (13,0 m. equiv.)
Protein, g 22,4
Fat, g 30,5
Carbohydrate, g 73,6
Lactose, g (not more than) 0,2
Kilojoules 2 816
The nutrient levels of PORTAGEN formula in the 70 kJ/25 mL dilution meet or exceed United States Food and Drug Administration requirements for infant formulae.

PHARMACOLOGICAL CLASSIFICATION:
A25 –Special Foods

PHARMACOLOGICAL ACTION:
PORTAGEN powder is nutritionally complete and may, therefore, be used as the major or sole constituent of the diet or as a beverage to be consumed with each meal in accordance with recommendations of the physician.

Medium chain triglycerides (MCT) are specially processed triglycerides containing medium chain length fatty acids. They are more readily hydrolyzed and absorbed than long chain fatty acids present in conventional food fat. Medium chain triglycerides contain glycerol esterified to saturated medium chain length fatty acids. They require much less pancreatic lipase and bile salts for effective digestion and do not require formation of micelle with conversion to chylomicron for digestion or absorption. Medium chain triglycerides are transported in unesterified form directly from the intestinal tract into the portal circulation rather than via the lymphatic system.

INDICATIONS
PORTAGEN is indicated in the nutritional management of infants, children and adults who do not efficiently digest conventional food fat or absorb the resulting long chain fatty acids.

Impaired fat absorption may be a nutritional problem in the following conditions:

Intraluminal defect in hydrolysis of fat, decreased pancreatic lipase (pancreatic insufficiency and cystic fibrosis of the pancreas) or decreased bile salts (chronic liver disease, biliary atresia and biliary obstruction):

Mucosal defect in absorption of fat, decreased permeability (sprue and idiopathic steatorrhoea) or decreased surface (intestinal resection and blind loop syndrome) or defective lipoprotein lipase system (hyperchylomicronaemia): and

Lymphatic defect in transport of fat with intestinal lymphatic obstruction (lymphangiectasia. chylothorax, chyluria, chylous ascites and exudative enterophathy).

CONTRA-INDICATIONS:
Nil (See precautions)

DOSAGE AND DIRECTIONS FOR USE:
To prepare 1 litre as an Infant Formula in normal dilution of 70 kJ per 25 mL.
1. Pour 750 mL of previously boiled water into a sterilized measuring jug.
2. Add 143 grams of PORTAGEN powder and mix with egg beater or fork until smooth.
3. Stir in enough previously boiled water to make 1 litre.
4. Pour into sterilized bottles and put on sterile teats and caps.
5. Store bottled formula in refrigerator and use same day or next.
TO PREPARE AS A BEVERAGE:
Prepare as directed under points 1 to 3 above using 214 grams. The beverage obtained supplies 105 kJ per 25 mL.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The usual intake of water should be maintained when PORTAGEN beverage is used as the sole article or major part of the diet. Patients should begin by consuming slowly smaller amounts of PORTAGEN beverage since abdominal discomfort and/or diarrhoea may occur due to high osmolarity. Should these symptoms appear, it may be advisable to reduce the daily intake of PORTAGEN beverage or use it in 70 kJ/25 mL dilution.

Diets containing high levels of medium chain triglyceride fat should be used with caution in persons with hepatic cirrhosis and complications thereof, such as portacaval shunts or tendency to encephalopathy.

IDENTIFICATION
White to ivory coloured powder.

PRESENTATION
454 g tins.

STORAGE INSTRUCTIONS
Store at room temperature not exceeding 25 °C. After opening, keep well covered with plastic lid provided and store in a cool dry place.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
H2719 (Act 101 of 1965)

NAME AND BUSINESS ADDRESS OF APPLICANT
BRISTOL-MYERS SQUIBB (PTY) LTD*
AMR Park, 1 Concorde Road East,
Bedfordview. 2008.

DATE OF PUBLICATION OF THIS PACKAGE INSERT
Jan 1982

® Regd. TM.
*Authorised User
29-0153        09/91

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