LymeRix Vaccine Ingredients
Lymerix Lyme Disease Vaccine (Recombinant OspA)
Manufacturer
Microorganism
Licensed
Recommendations
Ingredients
Product Descriptions
Information here: http://www.novaccine.com/specific-vaccines/vaccine.asp?v_id=20
SmithKline Beecham Biologicals
Borrelia burgdorferi
12/21/1998
Three i.m. injections, administered at 0, 1, 12 months for those aged 15 to 70 years.
Aluminum hydroxide, 2 - Phenoxyethanol, Kanamycin (antibiotic), Saline solution, Yeast extract, Lipoprotein OspA, Silicon.
Aluminum hydroxide:Al(OH)3 an Adjuvant
Aluminum adjuvants are used in vaccine manufacturing to "stimulate" the immune system The presence of aluminium adjuvants has been associated with injection-site reactions such as nodules, granulomas and erythema. Aluminum adjuvants may lead to the syndrome macrophagic myofascitis, a histological finding where aluminium-containing macrophages infiltrate muscle tissue, and may be accompanied by a clinical syndrome of myalgia, arthralgia and fatigue. A systematic review of controlled safety studies reported that vaccines containing aluminum produce more erythema and induration than other vaccines in young children (up to 18 months of age), and greater local pain in older children (10–18 years).
EDF Suspected - cardiovascular or blood toxicant, neurotoxicant, respiratory toxicant, respiratory toxicant. Implicated as a cause of brain damage; suspected factor in Alzheimer's Disease, dementia, convulsions and comas. More hazardous than most chemicals in 2 out of 6 ranking systems. On at least 2 federal regulatory lists. EDF Suspected - cardiovascular or blood toxicant neurotoxicant, respiratory toxicant. More hazardous than most chemicals in 3 out of 11 ranking systems. On at least 3 federal regulatory lists.
http://www.novaccine.com/vaccine-ingredients/results.asp?sc=3
Precipitated aluminium hydroxide is included as an adjuvant in some vaccines (e.g. anthrax vaccine). One of the well-known brands of aluminium hydroxide adjuvant is Alhydrogel, made by Brenntag. Since it absorbs protein well, it also functions to stabilize vaccines by preventing the proteins in the vaccine from precipitating or sticking to the walls of the container during storage. Aluminium hydroxide is often mis-called "alum" even by researchers; however, "alum" properly refers to aluminium potassium sulfate (alum).[citation needed] The aluminium hydroxide causes adsorption of antigens made of proteins, which slows the release of the antigen from the injection site (the "depot effect"), as well as causing a nonspecific irritation to the immune system.[13] Vaccine formulations containing aluminium hydroxide stimulates the immune system by inducing the release of uric acid, an immunological danger signal. This strongly attracts certain types ofmonocytes which differentiate into dendritic cells. The DCs pick up the antigen, carry it to lymph nodes, and stimulate T cells and B cells.[14]It appears to contribute to induction of a good Th2 response, so is useful for immunizing against pathogens that are blocked by antibodies. However, it has little capacity to stimulate cellular (Th1) immune responses, important for protection against many pathogens,[15] nor is it useful when the antigen is peptide-based.[13]
The pathological persistence of aluminium hydroxide used in some vaccines has also been associated with macrophagic myofasciitis,[21] a rare muscle disease. http://en.wikipedia.org/wiki/Aluminium_hydroxide
2 - Phenoxyethanol:C8H10O2, a Preservative, Stabilizer
Used as an insect repellent, a topical antiseptic, a solvent for cellulose acetate, dyes, inks and resins, in organic synthesis of plasticizers, in germicides. In vaccines, 2-Phenoxyethanol is an alternative to thiomersal.
Classed as "Very Toxic Material". May lead to kidney, liver, blood and central nervous system (CNS) disorders. Harmful or fatal if swallowed. Effects include behavioural disorders, drowsiness, vomiting, diarrhoea, visual disturbances, thirst, convulsions, cyanosis, and rapid heart rate, CNS stimulation, depression, cardiopulmonary effects, kidney disorders. May also lead to liver and blood disorders. Produces reproductive and developmental effects in experimental animals.
May cause reproductive defects. Severe eye and skin irritant. Harmful if swallowed, inhaled or absorbed through the skin. One report describes generalised eczema occurring after vaccination where 2-phenoxyethanol was found to be the sensitising agent.
http://physchem.ox.ac.uk/MSDS/PH/2-phenoxyethanol.html
Kanamycin (antibiotic):C18H36N4O11, and antibiotic
Common side effects include changes in hearing (either hearing loss or ringing in the ears), toxicity to kidneys, and allergic reactions to the drug.
Kanamycin (also known as kanamycin A) is an aminoglycoside bacteriocidal antibiotic, available in oral, intravenous, and intramuscular forms, and used to treat a wide variety ofinfections. Kanamycin is isolated from the bacterium Streptomyces kanamyceticus[1] and its most commonly used form is kanamycin sulfate.
It is clear that Kanamycin B is generally 4-6 times more toxic to sensitive cells. http://www.kanamycin-evopure.com/Technical.html
Black Box Warning- Kanamycin
Kantrex
(kanamycin) Injection, Solution
WARNING
Patients treated with aminoglycosides by any route should be under close clinical observation because of the potential toxicity associated with their use. As with other aminoglycosides, the major toxic effects of kanamycin sulfate are its action on the auditory and vestibular branches of the eighth nerve and the renal tubules. Neurotoxicity is manifested by bilateral auditory toxicity which often is permanent and, sometimes, by vestibular ototoxicity. Loss of high frequency perception usually occurs before there is noticeable clinical hearing loss and can be detected by audiometric testing. There may not be clinical symptoms to warn of developing cochlear damage. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations and continues to progress after drug withdrawal.
Renal impairment may be characterized by decreased creatinine clearance, the presence of cells or casts, oliguria, proteinuria, decreased urine specific gravity, or evidence of increasing nitrogen retention (increasing BUN, NPN, or serum creatinine).
The risks of severe ototoxic and nephrotoxic reactions are sharply increased in patients with impaired renal function and in those with normal renal function who receive high doses or prolonged therapy.
Renal and eighth nerve function should be closely monitored, especially in patients with known or suspected reduced renal function at the onset of therapy, and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Serum concentrations of parenterally administered aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Urine should be examined for decreased specific gravity, increased excretion of protein and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained when feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug. Neuromuscular blockade with respiratory paralysis may occur when kanamycin sulfate is instilled intraperitoneally concomitantly with anesthesia and muscle-relaxing drugs.
Neuromuscular blockade has been reported following parenteral injection and the oral use of aminoglycosides. The possibility of the occurrence of neuromuscular blockade and respiratory paralysis should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular-blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate-anticoagulated blood. If blockage occurs, calcium salts may reduce these phenomena but mechanical respiratory assistance may be necessary.
The concurrent and/or sequential systemic, oral, or topical use of kanamycin and other potentially nephrotoxic, and/or neurotoxic drugs, particularly polymyxin B, bacitracin, colistin, amphotericin B, cisplatin, vancomycin, and all other aminoglycosides (including paromomycin) should be avoided because the toxicity may be additive. Other factors which may increase patient risk of toxicity are advanced age and dehydration.
Kanamycin sulfate should not be given concurrently with potent diuretics (ethacrynic acid, furosemide, meralluride sodium, sodium mercaptomerin, or mannitol). Some diuretics themselves cause ototoxicity, and intravenously administered diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using kanamycin and call your doctor at once if you have any of these serious side effects:
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. http://www.rxlist.com/kantrex-side-effects-drug-center.htm
Kanamycin has the potential to induce auditory and sometimes vestibular toxicity, renal toxicity, and neuromuscular blockade. The risks are higher for patients with a present or past history of renal impairment (especially ifhemodialysis is required): for those receiving concomitant or sequential treatment with other ototoxic or nephrotoxic drugs or rapid acting diuretic agents given intravenously (ethacrynic acid, furosemide, and mannitol), and for patients treated for longer periods and/or with higher doses than recommended.
Ototoxicity
Toxic effects of kanamycin on the eighth cranial nerve can result in partially reversible or irreversible bilateral loss of hearing, loss of balance, or both. Tinnitus or vertigo may or may not be experienced. Cochlear damage is usually manifested initially by small changes in audiometric test results at the high frequencies and may not be associated with subjective hearing loss. Vestibular dysfunction is usually manifested by nystagmus, vertigo,nausea, vomiting, or acute Meniere's syndrome.
Nephrotoxicity
Albuminuria, presence of red and white cells, and granular casts; azotemiaand oliguria have been reported. Renal function changes are usually reversible when the drug is discontinued. Renal impairment may be characterized by a rise in serum creatinine and may be accompanied by oliguria, presence of casts, cells, and protein in the urine, by rising levels of BUN or by decrease in creatinine clearance.
Neuromuscular Blockade
Acute muscular paralysis and apnea can occur following treatment with aminoglycoside antibiotics. Neurotoxicity can occur after intrapleural and interperitoneal instillation of large doses of an aminoglycoside; however, the reaction has followed intravenous, intramuscular, and even the oral administration of these agents.
Other
Some local irritation or pain may follow the intramuscular injection of kanamycin. Other adverse reactions of the drug reported on rare occasions are skin rash, drug fever, headache, paresthesia, nausea, vomiting, and diarrhea. The "malabsorption syndrome" characterized by an increase in fecal fat, decrease in serum carotene, and fall in xylose absorption, reportedly has occurred with prolonged therapy.
Read the entire FDA prescribing information for Kantrex (Kanamycin) »
http://www.rxlist.com/kantrex-drug/patient-images-side-effects.htm
Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
You should not use this medication if you are allergic to kanamycin or any other type of aminoglycoside, including amikacin (Amikin), gentamicin (Garamycin), neomycin (Mycifradin, Neo-Fradin, (Neo-Tab), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).
Before using kanamycin, tell your doctor if you are allergic to any drugs, or if you have kidney disease, asthma or sulfite allergy, or a muscle disorder such as myasthenia gravis.
To be sure this medication is not causing harmful effects, your kidney function will need to be tested on a regular basis. Your hearing may also need to be checked. Do not miss any scheduled appointments.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Kanamycin will not treat a viral infection such as the common cold or flu.
Stop using this medicine if you have a serious side effect such as hearing loss, ringing in your ears, spinning sensation, problems with balance, numbness or tingling, muscle twitching, seizure (convulsions), or urinating less than usual or not at all. http://www.rxlist.com/kantrex-drug/patient-images-side-effects.htm
Lipoprotein OspA
*** E. coli was one of the first organisms to have its genome sequenced; the complete genome of E. coli K12 was published by Science in 1997. The Lyme vaccine was licensed in 1998.