Panzytrat 25000

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Pancreatin 314.65mg - 350.175mg ((25000U Lipase, 22500U Amylase, 1250U Protease))

Prieinama:

Pharmaco (NZ) Ltd

INN (Tarptautinis Pavadinimas):

Pancreatin (314.650-350.175mg(25,000ULipase,22,500UAmylase,1.250UProteas)

Vaisto forma:

Modified release capsule

Sudėtis:

Active: Pancreatin 314.65mg - 350.175mg ((25000U Lipase, 22500U Amylase, 1250U Protease)) Excipient: Colloidal silicon dioxide Crospovidone Gelatin   Glycol montanate Iron oxide black Iron oxide red Magnesium stearate Methacrylic acid - ethyl acrylate copolymer Microcrystalline cellulose Purified talc Simeticone Titanium dioxide Triethyl citrate Erythrosine Gelatin   Patent blue V

Vienetai pakuotėje:

Bottle, glass, 100 capsules

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Nordmark Arzneimittel GmbH & Co. KG

Terapinės indikacijos:

PANZYTRAT is indicated for patients with exocrine pancreatic enzyme deficiency such as (but not restricted to): · Cystic fibrosis · Chronic pancreatitis · Post-pancreatectomy · Post-gastrointestinal bypass surgery e.g. Billroth II gastroenterostomy · Ductal obstructions from neoplasm e.g. of the pancreas or common bile duct

Produkto santrauka:

Package - Contents - Shelf Life: Bottle, glass, - 100 capsules - 36 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C

Leidimo data:

1990-07-12

Prekės savybės

NEW ZEALAND DATA SHEET
PANZYTRAT – PANZ004
Nov 2017
Page 1 of 7
PANZYTRAT 25,000 MODIFIED RELEASE CAPSULE
Pancrelipase
1 PRODUCT NAME
PANZYTRAT 25,000
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PANZYTRAT 25,000 capsule contains pancreatin from porcine
pancreas with the following
enzyme activities:
Lipase
25,000 Ph Eur Units
Amylase
22,000 Ph Eur Units
Protease
1,250 Ph Eur Units
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
PANZYTRAT capsules contain white-grey enteric-coated microtablets with
a characteristic odour.
PANZYTRAT 25,000 capsules are of size “0” elongated with a
chestnut-coloured opaque cap and
natural transparent body.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PANZYTRAT is indicated for patients with exocrine pancreatic enzyme
deficiency such as (but not
restricted to):
•
Cystic fibrosis
•
Chronic pancreatitis
•
Post-pancreatectomy
•
Post-gastrointestinal bypass surgery e.g. Billroth II
gastroenterostomy
•
Ductal obstructions from neoplasm e.g. of the pancreas or common bile
duct
4.2
DOSE AND METHOD OF ADMINISTRATION
_ _
The dosage should be adjusted to suit the individual severity of the
pancreatic insufficiency.
Unless otherwise prescribed by the physician the following dose levels
apply for PANZYTRAT 25,000:
in infants up to 18 months
- 2 capsules daily (corresp. to 50,000 lipase units)
in children
- 4 capsules daily (corresp. to 100,000 lipase units)
in adults
- 6 capsules daily (corresp. to 150,000 lipase units)
NEW ZEALAND DATA SHEET
PANZYTRAT – PANZ004
Nov 2017
Page 2 of 7
Some patients may require much higher doses than those shown here.
Where there is total
pancreatic insufficiency the entire daily requirement for lipase must
be substituted, generally up to
400,000 lipase units daily.
Particular care should be taken in the case of cystic fibrosis
patients to ensure that the dose does not
exceed the enzyme dose required for adequate fat absorption, taking
into account the size and
composition of meals. Any increases in the dose should be c