dm+d

12236006

Refrigerated Storage

Pancrex VEssential Pharmaceuticals

Essential Pharmaceuticals
Pancrex V
Capsules (125mg and 340mg)

In the event of an inadvertent temperature excursion the following data may be used:
The product is stable when exposed to temperatures up to 25°C for up to 48 hours for one exposure.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No
19 October 2022
London MI Service

Medicine Compliance Aid Stability

Pancrex V tabletsEssential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V tablets
Tablets e/c
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Storage temperature must not exceed 15 degrees C
22 November 2022

Pancrex V 340mg hard capsulesEssential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V 340mg hard capsules
Capsules
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Store in a refrigerator (2°C - 8°C).
22 November 2022

Nutrizym 22Zentiva

Zentiva
Nutrizym 22
Capsules e/c mini-tablets
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Needs to be stored in a tightly closed container due to complex administration instructions.
22 November 2022

Pancrease HLJanssen-Cilag Ltd

Janssen-Cilag Ltd
Pancrease HL
Capsules e/c mini-tablets
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Store in airtight containers. Has complex administration instructions.
17 November 2022

Pancrex V tablets ForteEssential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V tablets Forte
Tablets e/c
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Storage temperature must not exceed 15 degrees C
22 November 2022

Creon 10,000Mylan

Mylan
Creon 10,000
Capsules e/c granules
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Moisture sensitive product.
22 November 2022

Pancrex V capsules 125Essential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V capsules 125
Capsules
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Store in a refrigerator (2°C - 8°C).
22 November 2022

Creon 25,000Mylan

Mylan
Creon 25,000
Capsules (e/c pellets)
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Moisture sensitive product.
22 November 2022

Lactation Safety Information

Yes
-
No published evidence of safety
Not absorbed from the mother’s GI tract
Used in infants >1 month
13 July 2016

New Medicines

EnzepiExocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer) in infants, children, adolescents and adults

Information

Enzepi
New formulation
Aptalis

Development and Regulatory status

Licence withdrawn
Licence withdrawn
None

Jul 17: The marketing authorisation for Enzepi has been withdrawn at the request of the marketing authorisation holder [4] .


Jul 16: Approved in EU [3].


Apr 16: EU positive opinion for use as a pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer). Enzepi is indicated in infants, children, adolescents and adults [1].

Category

Pancreas powder derived from porcine pancreatic glands containing multiple enzymes, including lipases, amylases, and proteases. Available as gastro-resistant hard capsules (5,000; 10,000; 25,000 and 40,000units).
At least 85% of patients with CF have pancreatic insufficiency so will need to take pancreatic enzymes [2].
Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer) in infants, children, adolescents and adults
Oral

Trial or other data

01. Apr 16: In issuing its positive opinion, the EU CHMP notes that the benefits with Enzepi are its ability to control consequences of exocrine pancreatic insufficiency such as maldigestion and malabsorption of fats, proteins and carbohydrates, which result in nutritional deficiencies. The most common side effects are gastrointestinal complaints [abdominal pain (16%); flatulence (12%); abdominal distension (7%); diarrhoea and vomiting (6%); constipation (5%); nausea (3%)], and headache occurring in approximately 6% of patients. In clinical trials, most of the side effects were mild to moderate in severity. The most important serious adverse reactions observed with pancreatic enzyme medicinal products are anaphylactic reactions and fibrosing colonopathy [1].

Evidence based evaluations