CREON MINIMICROSPHERES 25 25000 UNIT
PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT · DIN 01985205 · BGP PHARMA ULC
Health Canada status: MARKETED
What is CREON MINIMICROSPHERES 25?
CREON MINIMICROSPHERES 25 25000 UNIT contains PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 01985205, held by BGP PHARMA ULC, supplied as CAPSULE (DELAYED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Nov-2015. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is CREON MINIMICROSPHERES 25 used for?
CREON MINIMICROSPHERES® (pancreatin) is indicated in pediatric and adult patients for: • treatment of pancreatic exocrine insufficiency (PEI) attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy including, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrectomy, pancreatic cancer, gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm), Shwachman-Diamond Syndrome, status after an attack of acute pancreatitis and initiation of enteral or oral feeding.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
What else is CREON MINIMICROSPHERES 25 called?
Also recorded in Canada as: amylase 15000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral Capsule [Creon] (US), amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral Tablet [Viokace] (US), amylase 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral Tablet [Viokace] (US), amylase 60500 UNT / lipase 16000 UNT / protease 57500 UNT Delayed Release Oral Capsule [Pertzye] (US), amylase 30250 UNT / lipase 8000 UNT / protease 28750 UNT Delayed Release Oral Capsule [Pertzye] (US), amylase 180000 UNT / lipase 36000 UNT / protease 114000 UNT Delayed Release Oral Capsule [Creon] (US), amylase 64000 UNT / lipase 9000 UNT / protease 57000 UNT Oral Tablet [PanaKare] (US), amylase 164 UNT/MG / lipase 25.5 UNT/MG / protease 139 UNT/MG Oral Powder [PanaKare] (US), amylase 64000 UNT / lipase 9000 UNT / protease 57000 UNT Oral Tablet [PancrePlus] (US), amylase 15125 UNT / lipase 4000 UNT / protease 14375 UNT Delayed Release Oral Capsule [Pertzye] (US), amylase 105000 UNT / lipase 25000 UNT / protease 79000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 14000 UNT / lipase 3000 UNT / protease 10000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 24000 UNT / lipase 5000 UNT / protease 17000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 63000 UNT / lipase 15000 UNT / protease 47000 UNT Delayed Release Oral Capsule [Zenpep] (US).
Product details and regulatory record
| DIN | 01985205 |
|---|---|
| Brand name | CREON MINIMICROSPHERES 25 |
| Generic / active ingredient | PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT |
| Manufacturer | BGP PHARMA ULC |
| Strength | 25000 UNIT |
| Dosage form | CAPSULE (DELAYED RELEASE) |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A09AA02 MULTIENZYMES (LIPASE, PROTEASE ETC) |
| AHFS class | 56:16.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Nov-2015 |
| Original market date | 1992-12-31 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 01985205 |
|---|---|
| DIN (unpadded, as printed on some documents) | 1985205 |
| Brand name | CREON MINIMICROSPHERES 25 |
| Active ingredient / INN | PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT |
| ATC code | A09AA02 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A09 |
| AHFS class | 56:16.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | BGP PHARMA ULC |
How is it administered?
Individualized based on severity of PEI and fat intake. Infants: 2,000-5,000 units/feeding. Adults: 25,000-80,000 units/meal. Take during or immediately after meals. Do not crush or chew.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store CREON MINIMICROSPHERES® at temperatures not exceeding 25 °C in a tightly-closed container to protect from moisture. Once opened, store at temperatures not exceeding 25 °C, keep the container tightly-closed to protect from moisture and use within 6 months.
How is it supplied?
CREON MINIMICROSPHERES® MICRO: glass bottles of 20 grams. CREON MINIMICROSPHERES® 10, 20, 25, 35: HDPE bottles of 100 capsules.
Which pack is which?
| Strength on the label | 25000 UNIT |
|---|---|
| Dosage form | CAPSULE (DELAYED RELEASE) |
| Route | ORAL |
| Packaging as described in the monograph | CREON MINIMICROSPHERES® MICRO: glass bottles of 20 grams. CREON MINIMICROSPHERES® 10, 20, 25, 35: HDPE bottles of 100 capsules. |
| Storage | Store CREON MINIMICROSPHERES® at temperatures not exceeding 25 °C in a tightly-closed container to protect from moisture. Once opened, store at temperatures not exceeding 25 °C, keep the container tightly-closed to protect from moisture and use within 6 months. |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Contraindications
Hypersensitivity to porcine protein, pancreatic enzymes, or any ingredient in the formulation.
Warnings and precautions
Associated with fibrosing colonopathy at high doses in CF patients. Not unit-for-unit substitutable with other products. Ensure adequate hydration. Potential theoretical viral exposure risk.
What can be used instead?
Other Canadian products sharing ATC code A09AA02 MULTIENZYMES (LIPASE, PROTEASE ETC). 14 of 65 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| COTAZYM | 35000 UNIT | CAPSULE (IMMEDIATE RELEASE) | ORGANON CANADA INC. | MARKETED | DIN 00263818 |
| COTAZYM ECS 20 | 25000 UNIT | CAPSULE (DELAYED RELEASE) | ORGANON CANADA INC. | MARKETED | DIN 00821373 |
| COTAZYM ECS 8 | 10800 UNIT | CAPSULE (DELAYED RELEASE) | ORGANON CANADA INC. | MARKETED | DIN 00502790 |
| CREON MINIMICROSPHERES 10 | 10000 UNIT | CAPSULE (DELAYED RELEASE) | BGP PHARMA ULC | MARKETED | DIN 02200104 |
| CREON MINIMICROSPHERES 35 | 35700 UNIT | CAPSULE (DELAYED RELEASE) | BGP PHARMA ULC | MARKETED | DIN 02494639 |
| CREON MINIMICROSPHERES MICRO | 5000 UNIT / 100 MG | GRANULES FOR SUSPENSION, DELAYED RELEASE | BGP PHARMA ULC | MARKETED | DIN 02445158 |
| PANCREASE MT 10 | 43750 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | DIN 00789437 |
| PANCREASE MT 16 | 70000 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | DIN 00789429 |
| PANCREASE MT 2 | 6200 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | DIN 02503433 |
| PANCREASE MT 20 | 37000 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | DIN 02503441 |
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.