Pancreatin

Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·
12236006

Medicine Compliance Aid Stability

Pancrex V tablets · Essential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V tablets
Tablets e/c
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Storage temperature must not exceed 15 degrees C
22nd October 2015

Pancrex V capsules · Essential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V capsules
Capsules
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Storage temperature must not exceed 15 degrees C.
22nd October 2015

Creon 40,000 · Abbott Healthcare Products Ltd

Abbott Healthcare Products Ltd
Creon 40,000
Capsules e/c granules
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Moisture sensitive product.
22nd October 2015

Nutrizym 22 · Merck Serono

Merck Serono
Nutrizym 22
Capsules e/c mini-tablets
R2 · Red 2 · Drug 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.
22nd October 2015

Pancrease HL · Janssen-Cilag Ltd

Janssen-Cilag Ltd
Pancrease HL
Capsules e/c mini-tablets
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Store in airtight containers. Has complex administration instructions.
22nd October 2015

Pancrex V tablets Forte · Essential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V tablets Forte
Tablets e/c
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Storage temperature must not exceed 15 degrees C
22nd October 2015

Creon 10,000 · Abbott Healthcare Products Ltd

Abbott Healthcare Products Ltd
Creon 10,000
Capsules e/c granules
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Moisture sensitive product.
22nd October 2015

Pancrex V capsules 125 · Essential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Pancrex V capsules 125
Capsules
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Storage temperature must not exceed 15 degrees C.
22nd October 2015

Creon 25,000 · Abbott Healthcare Products Ltd

Abbott Healthcare Products Ltd
Creon 25,000
Capsules (e/c pellets)
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Moisture sensitive product.
22nd October 2015

Lactation Safety Information

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

New Medicines

Enzepi · 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

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