Pernicious Anaemia:
Does anyone have documentation for DR (studies preferably), that prove Hydroxocobalamin Acetat to be as good as plain Hydroxocobalamin, please? The German one from Hevert is an acetat, and Dr says it's a problem....
Help, please...
If you go to the MHRA's documents repository you can find the documents below:
G L Pharma GmbH
Hydroxocobalamin 1mg/ml Solution for Injection (Hydroxocobalamin acetate)
Why is Hydroxocobalamin injection approved? It was concluded that, in accordance with EU requirements, Hydroxocobalamin injection has been shown to have comparable quality and to be bioequivalent to Neo-Cytamen 1000 micrograms/ml solution for injection (RPH Pharmaceuticals AB).Therefore, the view was that, as for Neo-Cytamen 1000 micrograms/ml solution for injection (RPH Pharmaceuticals AB), the benefits outweigh the identified risks.
mhraproducts4853.blob.core....
RPH Pharmaceuticals AB
Neo-Cytamen 1000 micrograms/ml solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION Hydroxocobalamin chloride 1.027 mg equivalent to 1.0 mg Hydroxocobalamin
mhraproducts4853.blob.core....
1: The PAR for the Hydroxocobalamin acetate product expressly confirms bioequivalence with another product which is based on Hydroxocobalamin chloride. (Though there is a very small adjustment of the identified masses of the active ingredients to allow for the chemical differences.)
2: If the doctor has evidence that they are not bioequivalent, his clear duty is to inform the MHRA - supplying that evidence - expecting the MHRA to act to revise their documentation and/or authorisations.
3: It is the doctor telling you that they are not bioequivalent in disagreement with the authorised MHRA information so the doctor should provide the information. It is entirely possible that the MHRA has incorrect information. But it is what all UK medical professionals should be basing their practice on. If wrong, it needs to be corrected.
If you go to the MHRA's documents repository you can find the documents below:
G L Pharma GmbH
Hydroxocobalamin 1mg/ml Solution for Injection (Hydroxocobalamin acetate)
Why is Hydroxocobalamin injection approved? It was concluded that, in accordance with EU requirements, Hydroxocobalamin injection has been shown to have comparable quality and to be bioequivalent to Neo-Cytamen 1000 micrograms/ml solution for injection (RPH Pharmaceuticals AB).Therefore, the view was that, as for Neo-Cytamen 1000 micrograms/ml solution for injection (RPH Pharmaceuticals AB), the benefits outweigh the identified risks.
mhraproducts4853.blob.core....
RPH Pharmaceuticals AB
Neo-Cytamen 1000 micrograms/ml solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION Hydroxocobalamin chloride 1.027 mg equivalent to 1.0 mg Hydroxocobalamin
mhraproducts4853.blob.core....
1: The PAR for the Hydroxocobalamin acetate product expressly confirms bioequivalence with another product which is based on Hydroxocobalamin chloride. (Though there is a very small adjustment of the identified masses of the active ingredients to allow for the chemical differences.)
2: If the doctor has evidence that they are not bioequivalent, his clear duty is to inform the MHRA - supplying that evidence - expecting the MHRA to act to revise their documentation and/or authorisations.
3: It is the doctor telling you that they are not bioequivalent in disagreement with the authorised MHRA information so the doctor should provide the information. It is entirely possible that the MHRA has incorrect information. But it is what all UK medical professionals should be basing their practice on. If wrong, it needs to be corrected.
Dr is a moron.
There are no studies because anybody who has done A level chemistry will know that the two are functionally identical.
Here is a post I wrote comparing the acetate and chloride versions of hydroxocobalamin. healthunlocked.com/pasoc/po...
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