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Parkinson's Movement
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B1 vials contain ALUMINUM!

Just finished talking to my CVS pharmacist who contacted McGuff Compounding Pharmacy in California and was told that they (McGuff) do not compound B1 vials but they order them from the pharmaceutical company which compounds B1 vials. These vials contain traces of ALUMINUM as a preservative. The question is: safer to pop pills than having B1 vials with aluminum?

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I thought aluminium is used as a stabiliser in every injection? Isn't that why parents of autistic children think it is triggered from inoculations? I read somewhere that the amount is minuscule and if my husband gets relief from this shitty disease but ends up with a little more aluminium in his body than he needs, then so be it.

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I tried B1 injections about 3 years ago and felt worse after each one. Headache. Fatigue and very irritable. I stopped at 3 injections. Later it dawned on me there was probably some kind of preservative I was reacting to. Now I know.

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Surely the aluminium could not accumulate in just 3 injections enough to cause problems? My husband has had 2 per week since June and has had no side effects. Maybe something else caused the symptoms? I hope it is not aluminium....

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nellie58- it may only be a small amount, but heavy metals accumulate over time, so if you have heavy metals from other sources, like other vaccines or amalgam fillings, it is definitely possible that another small dose of aluminum could cause ill effects. i would stay away from the injectable thiamine, since the oral form works well, anyhow.

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The injections work for us and they are what Dr C wanted my hubby to have. He is 66 and someone has noted on this forum that B1 is better absorbed by injection after age 60. Hubby is doing great and so I am doubly happy to hear that the vials have no aluminium 😀 In any case hubby does not want to stop the B1 injections.

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I read, in a study, that the injections to contain aluminum. I pay attention to this because if you download a list of aluminum rich foods it's rather long and just like my previous diet.

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dailymed.nlm.nih.gov/dailym...

"WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. Deaths have resulted from IV or IM administration of thiamine (see package insert for ADVERSE REACTIONS). "

I searched and did not find an indication of how much aluminum is in a thiamine injection. The safety limit of 5 mcg/kg/day is pretty low - it would not take much aluminum to exceed that - .35 mg for an average adult.

Based on this I would say the oral route is safer. Vitacost is a good source. Personally I encapsulate my own from pure thiamine HCl but it is extra work, even with a jig made for the purpose.

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Thank you park bear. I still need to buy the jig you posted for encapsulating please post again.

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capsulcn.com/manual-capsule...

It helps but it is still a laborious task.

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Thank you

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Thank you all for your insight. Hopefully, Art will give us his opinion, but most importantly Dr. C. As I wrote before, after the first injection, there are some improvements but nothing significant. My husband had to stop the injections three times for dose adjustments. He is on B1 break again and will restart on 3 December. I will email Dr. C. to ask him about the safety of the vials.

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My husband is stable on half a vial twice a week. He still has days where he is below par, but most days he feels great. I hope you find that sweet spot soon.

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'Aluminium becomes dangerous if the kidneys are impaired'.

Yikes, I am sure Dr Costantini with all his knowledge and expertise would not recommend B1 by injection if there was such a high chance of complications. That is probably why he asked so much information about hubby's general health.

My husband is doing really well now, after we sorted the dose. We would hate to go back to pre B1🤔 and Dr C did not suggest he took it by tablet form.

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In Italy B1 injection have no aluminum. Someone posted on this site about a compounding pharmacy in California it is McGuff compounding pharmacy. She is getting her injectable from there. I think a safe alternative is using Vitacost thiamine HCL 500mg capsules. Mary

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Thank you, Mary. Yes, I purchased the vials at McGuff Compounding, CA, but they didn't compound the vials. Their supplier is Mylan Pharmaceuticals and according to both, middle man (McGuff) and supplier they do contain aluminum.

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I had no idea, good to know. Because of the aluminum I decided against injections. I have gotten good results with thiamine HCL. I'm one of the very few that thiamine and other B vitamins raise my blood pressure very high I do check my blood pressure and stop thiamine HCL when it starts to rise. I did get

Up to 3000 milligrams per day but high blood pressure skyrocketed. I stopped it for a while and now I am just taking 500 milligrams per day, not every single day at that. I am taking my sinemet also however thiamine HCL made a great difference in my well being. Mary

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I am happy for you Mary.

everyone has his body and the b1 needs some education and practical use. For someone it is very simple for others not. You were really very good at persisting despite the difficulty of your case. I am very happy for you..

Gio

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Thank you Mary

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I have email the company where I bought our B1 vials for comment. homoempatia.eu and will let you know what they have to say!

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Did you get the ones manufactured by Pascoe? If so, the only added ingredients are Sodium Phosphate and water.

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I purchase my injections from this company and would be pleased to hear how they respond to your enquiry.

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No aluminium, just water 😀

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Great..:). Thank you

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They also sell ones made by 2 other companies - Hevert, the only other ingredients are Sodium Hydroxide and water. Ratiopharm, the only other ingredient is water.

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I was trying to read the pamphlet that came with the b1 vials but it is in German! I couldn't see any other ingredient except water but I messaged the company but have not had a reply yet. Thank you sdolly for confirming this! Ratiopharm are the manufacturer of our vials. I had already discussed with my husband that he might be getting a bit of aluminium with his B1 but he said he didn't care anyway. I will tell him he is actually just getting a little more hydration instead 😉

Another bit of stress gone.

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Here's the info, it should translate if you have a translate programme on your computer. Click on 6 under information for patients. ratiopharm.de/produkte/prae...

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My husband uses the Pascoe injections and the only added ingredients are Sodium Phosphate and water. We get them from Germany.

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What is vit b1 do for you.

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Hi Despe,

Just as I was messaging sdolly to thank her for her research, I had a reply from where I bought our b1 vials.

The vitamin B1 ampoules do not contain aluminium.

Yours sincerely

Homoempatia Team

Sdolly has posted a few labs you can get b1 vials from without aluminium.

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Hi Nellie, I had ordered B1 vials from this company, but US customs would not allow entry of these vials into the country as they are prescribed meds in the US. So sorry I couldn't get them from Europe.

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Oh sorry, just read this. That is crazy, it is a vitamin supplement. I got 12 months supply within a week of ordering and with no problem.

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So, I just got off the phone with a pharmacist at McGuff and he said they do not buy their product from another compounding pharmacy, that they make it themselves. He was certain of that. I will send them an email I get an answer in writing.

We talked at some length about aluminum and he said they do not put aluminum in it but that virtually all products (not just thiamine) have trace amounts of aluminum. I asked him to get out and look at the Certificate of Analysis for me and he said aluminum is not listed. (He did say nickel and zinc was listed.) He did not know if that's because the trace amounts is too small to show up or because it wasn't tested for.

There's millions of people all over the world who will take injections all their life. So, is it possible that healthcare industries in numerous countries would allow such a risk?

I posted a picture of the label on the box of injectable thiamine in a previous thiamine injection discussion which said how much aluminum is in the stuff, so if I'm lucky, I can find that.

This presents us with a conundrum (requiring more research,) because, I for one, have been hoping and expecting to take intramuscular injections indefinitely and I don't think we know how much is absorbed when it goes thru the stomach. I recall reading one abstract that said in people over 65, only 2.5 mg is absorbed.

Marc

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Marc, I got a reply from Mylan Pharmaceuticals who provide B1 vials to McGuff. Their B1 vials DO CONTAIN aluminum no more than 400mcg/liter. I contacted them after my CVS pharmacist told me that she had talked to the pharmacist at McGuff and McGuff pharmacist told my CVS pharmacist that they get their B1 vials from Mylan Pharmaceuticals and that they (McGuff) do not compound their B1.

I emailed Dr. C. asking him about the safety of these vials with aluminum but he hasn't replied yet.

For those in Europe, YOU ARE LUCKY to get your vials aluminum free.

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I seem to remember that 400 mcg/L figure. So, aren't there 1,000,000 µg per gram? And, 1000 mL per liter? 1 mg/L equals one part per million. We need Park bear to do the math on this, but it seems like such an infinitesimal amount that I will long be dead before the accumulation is a threat.

Well, it certainly is curious that we are being told 2 different things about who makes the stuff.

Marc

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I think 400 mcg/L is .4 ppm.

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Guess if Dr. C. won't reply to my inquiry, I will have my husband continue the injections although Dr. C. needs to adjust his dose again. He is supposed to start the new dose on Monday, 3 December.

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You can buy them from Europe. Anyone can.

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Yes, Nellie, but the problem is US customs! They won't allow delivery of the vials from Europe.

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I'll shop a dozen compounding pharmacies regarding price and aluminum and believe we will turn up something we like.

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:) :) If you find one let me know, Marc!!

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Me too please as like you I plan to start using IM in time

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Gio, you posted a comment but doesn't appear here.

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Despe Thank you for this research. 🤗

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You're welcome!

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THIAMINE HYDROCHLORIDE- thiamine hydrochloride injection, s olution

Mylan Ins titutional LLC

----------

DESCRIPTION

Thiamine hydrochloride injection, USP is a sterile solution of thiamine hydrochloride in Water for

Injection for intramuscular (IM) or slow intravenous (IV) administration.

Each mL contains: Thiamine hydrochloride 100 mg; monothioglycerol 0.5%; Water for Injection q.s.

Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5).

Thiamine hydrochloride, or vitamin B , occurs as white crystals or crystalline powder that usually has a

slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol;

insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is

stable in the dry state. It is reasonably stable to heat in acid solution.

The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-

pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following

structural formula:

C H ClN OS • HCl M.W. 337.27

CLINICAL PHARMACOLOGY

The water soluble vitamins are widely distributed in both plants and animals. They are absorbed in man

by both diffusion and active transport mechanisms. These vitamins are structurally diverse (derivatives

of sugar, pyridine, purines, pyrimidine, organic acid complexes and nucleotide complex) and act as

coenzymes, as oxidation-reduction agents, possibly as mitochondrial agents. Metabolism is rapid, and

the excess is excreted in the urine.

Thiamine is distributed in all tissues. The highest concentrations occur in liver, brain, kidney and heart.

When thiamine intake is greatly in excess of need, tissue stores increase 2 to 3 times. If intake is

insufficient, tissues become depleted of their vitamin content. Absorption of thiamine following IM

administration is rapid and complete.

Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also known as

cocarboxylase, a coenzyme. Its role in carbohydrate metabolism is the decarboxylation of pyruvic acid

in the blood and α-ketoacids to acetaldehyde and carbon dioxide. Increased levels of pyruvic acid in the

blood indicate vitamin B deficiency.

The requirement for thiamine is greater when the carbohydrate content of the diet is raised. Body

depletion of vitamin B can occur after approximately 3 weeks of total absence of thiamine in the diet.

INDICATIONS AND USAGE

Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi

whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to

the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid

restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute

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collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is

severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid

precipitation of heart failure.

Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who

cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption.

Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or

decreased gastrointestinal absorption, because multiple vitamins should usually be given.

CONTRAINDICATIONS

A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See

WARNINGS for further information.)

WARNINGS

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with

prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at

risk because their kidneys are immature, and they require large amounts of calcium and phosphate

solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who

receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels

associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates

of administration.

Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration.

Deaths have resulted from IV or IM administration of thiamine (see ADVERSE REACTIONS).

Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless, a skin

test should be performed on patients who are suspected of drug allergies or previous reactions to

thiamine, and any positive responders should not receive thiamine by injection.

If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse

reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe

for 30 minutes. If no reaction occurs, full dose can be given; the patient should be observed for at least

30 minutes after injection. Be prepared to treat anaphylactic reactions regardless of the precautions

taken.

Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine,

oxygen, vasopressors, steroids and antihistamines.

PRECAUTIONS

General

Simple vitamin B deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of

dietary inadequacy.

Information for Patients

The patient should be advised as to proper dietary habits during treatment so that relapses will be less

likely to occur with reduction in dosage or cessation of injection therapy.

Us age in Pregnancy

Pregnancy Category A

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Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal

abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of

fetal harm appears remote. Because studies cannot rule out the possibility of harm however, thiamine

hydrochloride should be used during pregnancy only if clearly needed.

Nurs ing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother.

ADVERSE REACTIONS

An occasional individual may develop a hypersensitivity or life threatening anaphylactic reaction to

thiamine, especially after repeated injection. Collapse and death have been reported. A feeling of

warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat,

angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have

also been reported. Some tenderness and induration may follow IM use (see WARNINGS).

OVERDOSAGE

Parenteral doses of 100 mg to 500 mg singly have been administered without toxic effects. However,

dosages exceeding 30 mg 3 times a day are not utilized effectively.

When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. As the intake

of thiamine is further increased, it appears unchanged in the urine.

DOSAGE AND ADMINISTRATION

"Wet" beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine

must be administered slowly by the IV route in this situation (see WARNINGS).

In the treatment of beriberi, 10 mg to 20 mg of thiamine hydrochloride are given IM 3 times daily for as

long as 2 weeks. (See WARNINGS regarding repeated injection of thiamine.) An oral therapeutic

multivitamin preparation containing 5 mg to 10 mg thiamine, administered daily for one month, is

recommended to achieve body tissue saturation.

Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may

cautiously be given IV.

Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.

Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral

therapy should receive 5 mg to 10 mg of thiamine hydrochloride IM daily.

In the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in

an initial dose of 100 mg, followed by IM doses of 50 mg to 100 mg daily until the patient is consuming

a regular, balanced diet. (See WARNINGS regarding repeated injections of thiamine.)

Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg

thiamine hydrochloride in each of the first few liters of IV fluid to avoid precipitating heart failure.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

HOW SUPPLIED

Thiamine Hydrochloride Injection, USP, 200 mg/2 mL (100 mg/mL), is available in:

NDC 67457-196-02

2 mL (200 mg) multiple dose vial, packaged 25 vials per carton.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Use only if solution is clear and seal intact.

Pres ervative Free.

Manufactured for:

Mylan Ins titutional LLC

Rockford, IL 61103 U.S.A.

Manufactured by:

Mylan Ins titutional

Galway, Ireland

0941L100

Revised: 1/2017

MI:THIAIJ:R3

PRINCIPAL DISPLAY PANEL - 200 mg/2 mL

NDC 67457-196-02

Thiamine

Hydrochloride

Injection, USP

200 mg/2 mL

(100 mg/mL)

For Intramus cular or

Intravenous Us e Only

Rx only 25 x 2 mL Multi-Dos e Vials

Pres ervative Free

Sterile. Non-pyrogenic.

Each mL contains : Thiamine HCl, 100 mg; monothioglycerol 0.5% v/v; water

for injection, q.s. Sodium Hydroxide may have been added for pH adjustment.

Contains no more than 400 mcg/L of aluminum.

Us ual Dos age: See accompanying prescribing information.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Use only if solution is clear and seal intact.

Manufactured for:

Mylan Ins titutional LLC

Rockford, IL

THIS IS THE REPLY TO MY EMAIL FROM MYLAN!

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Thank you for all of the information. All of you people are a wonderful group. I am so glad that I belong to this forum, I get more information from you guys than I do from the Parkinson Org. I think we all help each other better than an org. it is more personal, we all have problems with this horrible disease, some more than others. THANKS AGAIN for taking the time.

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My pleasure to help.

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