Granulox®: Frequently asked questions (FAQ)

Where is the haemoglobin sourced from?

The haemoglobin is sourced from porcine blood, which goes through a rigorous filtering process to extract only the haemoglobin.

Why is porcine haemoglobin used in Granulox®?

Porcine haemoglobin is an abundant and safe source of haemoglobin. The haemoglobin solution in Granulox® does not require blood type matching as it is purified without any other red blood cell components, and is available in potentially unlimited amounts. The manufacturing of the haemoglobin solution comprises all relevant steps to ensure virus and microbial safety.

What is the process for extracting the haemoglobin?

Haemoglobin is separated from red blood cells and the extracted haemoglobin solution then goes through a purification process where it is filtered, sterilised and packaged for use.

What happens to the animals after the haemoglobin has been extracted?

The origin of the haemoglobin is from porcine blood from the regular food supply chain. The animals' health is monitored to meet the highest veterinary standards. The animals are not specifically bred for medical purposes.

How do you ensure the product is not contaminated with bacteria or viruses?

The product goes through a complex process of filtration and testing for bacteria and viruses to make sure that only haemoglobin is extracted. Additionally the haemoglobin solution goes through a sterilisation process to ensure that the finished product can be guaranteed free from infectious agents. Finally the haemoglobin solution is formulated with preservatives to further ensure it remains bacteria and virus free even after multiple uses. Sterility of Granulox® is one of the main release criteria for each batch.

Where is the product manufactured?

The haemoglobin extraction takes place in Germany and the packaging takes place in a factory in Sweden with bag-on-valve technology. The bag-on-valve technology allows the Granulox® solution to be protected from the aerosol propellant - and it also means that Granulox® can be sprayed at any angle, even upside down, for difficult to reach wound areas.

What is the process for informing patients about the animal origin of the haemoglobin?

It is the responsibility of the healthcare professional to inform the patient about any medical product they are administering.

Is the product suitable/acceptable for vegetarians/all religious groups?

The product is not ingested; however patients are encouraged to seek advice from religious leaders if concerned about the product's origins.

What other ingredients does Granulox® have?

10% carbonylated haemoglobin; 0.9% sodium chloride; 0.7% phenoxyethanol; 0.05% N-acetylcysteine; and water to 100%.

How many pigs are slaughtered to create this product (per year)?

No pigs are especially slaughtered for the making of Granulox®

Where are the pigs from?

Germany

What is the supply chain for the haemoglobin?

The animals meet the highest quality veterinary standards. The haemoglobin then goes through a certified purification process before it is packaged for use as Granulox®. reDermis® transports Granulox® under a cold-chain transportation protocol from the manufacturer, who works only with trusted and approved partners worldwide.

What sort of shelf life does a Granulox® can have?

Granulox® has a shelf life of at least 36 months from the date of manufacture if refrigerated. Opening the can will not shorten this time period since no air from the surroundings can enter the can through the nozzle. Each can is labelled with a use by date. The shelf-life is reduced if the can is exposed to high temperatures and if stored outside of refrigerated conditions the can should be discarded after 6 weeks. Storing the can in a refrigerator overnight correspondingly extends the 6 weeks. Each can has approximately 30 applications. If used on a single patient at the lowest recommended dosing frequency of every three days, a can is expected to last no more than 10 weeks. With daily application a can is correspondingly expected to last for 4 weeks. If used on multiple patients or on very large wounds a can may last only a few days.

Can I apply it myself, or do I need a qualified clinician?

Granulox® should be used as part of a holistic treatment regimen under the supervision of a healthcare professional.

Are there any side effects?

Granulox® contains pure haemoglobin, a natural oxygen transporter, existing in the body's red blood cells. No negative side-effects have been reported.

Are porcine materials used in any other medically approved products?

Yes, porcine origin materials are used in several other wound care products, in some gelatine coated capsules for a variety of medicines, as well as for several hormone treatments, notably some of the older insulin products.

SATiBA SAMED Ambledown First Health Finance