Halocarbon - FAQs: Anesthetics

By: Halocarbon  06-Dec-2011
Keywords: Anesthetics, Halocarbon,

How can I contact you?

Where can I get your anesthetics if I am a researcher?

You can order directly from Halocarbon.

Does your company produce both human label and veterinary label Isoflurane?

Yes.

Where can a veterinarian order your veterinary label Isoflurane, USP?

It is stocked and sold by most veterinary distributors.

In what size bottles do you sell your Isoflurane, USP?

It is available in 100ml and 250ml bottles packed 6 bottles per case.

Why did Halocarbon decide to stop producing Halothane?

Worldwide usage of Halothane has been declining for years and continued production no longer made economic sense.

What is the recommended way to dispose of Halothane or Isoflurane?

Can I get my Halothane Vaporizer converted to an Isoflurane Vaporizer?

Yes. Contact us for a list of companies that perform this service.

Where can I purchase a Key Fill Adaptor?

Call G.A.S. at 1-800-717-5955 (U.S. only) or Southmedic at 1-800-463-7146 (U.S. and Canada).

What are some of the things that you are working on for the future?

We are working on next generation anesthetics.

Does Halocarbon manufacture its own sevoflurane?

Yes, Halocarbon manufactures its sevoflurane in its plant in South Carolina, USA. In addition, unlike other sevoflurane suppliers, Halocarbon is one of the world's largest manufacturers of the key precursor to sevoflurane, hexafluoroisopropanol (HFIP).

Is Halocarbon® Sevoflurane FDA approved as a therapeutic equivalent to the branded drug and is it listed in the "Orange Book"?

Yes, the US FDA has approved Halocarbon's sevoflurane as a therapeutic equivalent to Ultane® and lists Halocarbon's sevoflurane in their "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book").

How is Halocarbon's sevoflurane packaged?

Halocarbon's sevoflurane is packaged in 250 ml USP Type III amber glass containers with a water content of not more than 70 parts per million (ppm). In order to receive FDA approval, a drug's manufacturer must demonstrate its product's stability in the sale container. Data submitted to the FDA showed Halocarbon's sevoflurane in glass bottles was stable under standard accelerated conditions (bottles stored at 40ºC and 75% relative humidity for 3 months). Halocarbon also submitted data that showed its sevoflurane in glass bottles was stable under even more stressful hotter and drier conditions (60ºC and less than 5% relative humidity for 3 months). Halocarbon's stability testing and other research has produced no evidence that storing sevoflurane in type III glass results in Lewis Acid formation or otherwise contributes to decomposition of sevoflurane, or that the addition of water is necessary to promote stability.

What is the shelf life of Halocarbon Sevoflurane?

24 months.

Why are there different types of containers for sevoflurane?

Packaging is a matter of patents and/or marketing preference and each container type has its advantages and disadvantages. If a company has a compatible plastic container patented, obviously other manufacturers cannot use that type of packaging. While a glass bottle can break and an aluminum bottle can't, the sevoflurane level in the glass bottle is visible. Sevoflurane in plastic bottles has been recalled due to pinhole leaks in the plastic. As previously noted, in order to receive FDA approval, a drug must be shown to be stable in whatever container it is supplied.

Are there any labeling differences between the branded drug and Halocarbon Sevoflurane?

No, other than company names.

Can Halocarbon Sevoflurane be used the same as t he branded drug?

Yes, Halocarbon's sevoflurane is listed by the FDA as a therapeutic equivalent to Ultane®.

What information do I need prior to using Halocarbon Sevoflurane?

As with all inhalation anesthetics, product handling, storage and administration information must be thoroughly reviewed prior to any use of drug. Please consult both the product insert and the MSDS.

Ultane® is a registered trademark of Abbott Laboratories, N. Chicago, IL.

Keywords: Anesthetics, Halocarbon,

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