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  • Creon
    / Abbott


    Active Ingredient *
    Amylase 3,600, 8000, 18,000 Ph.Eur. units
    Lipase 5,000, 10,000, 25,000 Ph.Eur. units
    Protease 200, 600, 1,000 Ph.Eur. units

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    100 X 10,000 Ph.Eur. units

    partial basket chart 8504 3163

    Capsules

    50 X 25,000 Ph.Eur. units

    partial basket chart 12657

    Capsules

    100 X 25,000 Ph.Eur. units

    partial basket chart 26128 3040

    Granules

    20 g X 5000 Ph.Eur. units

    partial basket chart 43976 3163

    Related information


    Dosage

    CREON micro: Initially 100 mg (5000 lipase units) of gastro-resistant granules (one measure) should be taken with each feed or meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The maximum daily dosage should not exceed 10,000 units lipase/kg/day. The required quantity of gastro-resistant granules should be dispensed using the measuring scoop contained in the pack which holds 100 mg. In young infants, granules should be mixed with a small amount of apple juice and given from a spoon directly before the feed. In weaned infants, granules should be taken with acidic liquids or soft foods (e.g. mixed with apple juice or apple puree), but without chewing, directly before the meal. When giving this formulation  to young or weaned infants the apple juice should not be diluted. Alternatively, the granules can be mixed with a small amount of milk and administered to the infant immediately. The granules should not be added to the baby’s bottle.
    CREON 10000: Initially one to two capsules with each meal. Doses increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing.
    CREON 25000: It is recommended to take the enzymes during or immediately after each meal or snack.
    Adults (including the elderly) and children: Initially one capsule with meals. Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology. For infants and children a median lipase intake of 10,000 Ph. Eur. units per kg body weight a day is recommended. A daily lipase intake of 15,000 – 20,000 Ph.Eur. units per kg body weight should not be exceeded.
    See prescribing information for full details.


    Indications

    For the treatment of pancreatic exocrine insufficiency.


    Contra-Indications

    Hypersensitivity to pancreatin of porcine origin or to any of the excipients.


    Special Precautions

    The product is of porcine origin. Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of lipase/kg/day.


    Side Effects

    Abdominal pain nausea, vomiting, constipation, abdominal distention, diarrhea.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed.


    Pregnancy and Lactation

    Pregnancy: For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected. Caution should be exercised when prescribing to pregnant women.
    Lactation: No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breastfeeding.            


    Overdose

    Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia. Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended. 


    Manufacturer
    Abbott Products GmbH, Hans-Bockler-Allee 20, Hannover, Germany
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