Apis Mellifera 4D. Other Ingredients: Lactose, Sucrose.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Apis Mellifica Granules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Apis Mellifica Granules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when FDA-approved purified bee venom is given by subcutaneous injection by a trained medical professional (2619,6070,96572).
POSSIBLY SAFE ...when applied using stings from live bees. Live bee stings have been safely administered under medical supervision in doses up to 20 bee stings three times weekly for up to 24 weeks (13222). There is insufficient reliable information available about the safety of bee venom when used topically or injected in combination with acupuncture.
PREGNANCY AND LACTATION: POSSIBLY SAFE
when used by subcutaneous injection by a trained medical professional.
Significant adverse effects to fetus or mother have not been reported. However, some clinicians decrease maintenance dose by half during pregnancy (2619).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used by subcutaneous injection in high doses.
High doses of bee venom can increase release of histamine, which can cause uterine contraction (2619); avoid using in high doses.
Below is general information about the interactions of the known ingredients contained in the product Apis Mellifica Granules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Bee venom might stimulate immune system activity (6044,6071).Theoretically, bee venom might interfere with immunosuppressant therapy. Immunosuppressant drugs include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), corticosteroids (glucocorticoids), and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Apis Mellifica Granules. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Purified bee venom given subcutaneously by a trained medical professional is generally well tolerated when used for diagnosis or immunotherapy of bee sting allergy.
Most Common Adverse Effects:
Parenterally: Dizziness, injection site erythema, itching, nausea and vomiting, swelling, tenderness, urticaria.
Serious Adverse Effects (Rare):
Parenterally: Anaphylaxis, asthma, chest pain or tightness, coagulation abnormalities, confusion, edema, hypotension, laryngeal edema, malaise, palpitations, respiratory distress, somnolence.
Cardiovascular ...Case reports have described stroke, and bradycardia associated with bee venom therapy (96576). Other reported adverse cardiovascular effects include cardiac dysfunction, palpitations, hypotension, and chest pain or tightness (1343,2619,6070,6078,111472,111474).
Dermatologic ...Local adverse effects of parenteral bee venom include erythema, swelling, numbness, pain, and tenderness at the injection site, itching, urticaria, and edema (1343,13222,102531). Bee stings have been associated with eosinophilic foreign body granuloma (111482), and bee venom acupuncture can cause dermatitis, contact urticaria, skin infection with Mycobacterium chelonae (11483), giant dermatofibroma, or chronic folliculitis (96576). A case report describes panniculitis associated with bee venom immunotherapy (96576).
Hematologic ...Bee venom therapy has been associated with coagulation abnormalities including intravascular hemolysis and thrombocytopenia (6046,96576,111474). Bee venom given with acupuncture can cause disseminated intravascular coagulation (6046,96576).
Hepatic ...Two case reports describe hepatotoxicity, including acute icteric hepatitis associated with bee venom acupuncture (96576). Another case report describes hepatitis B reactivation complicated by nephritic syndrome during bee venom immunotherapy (96576).
Immunologic
...Immune-mediated reactions associated with bee venom include rash, itching, generalized hypersensitivity reaction, anaphylaxis, serum sickness reaction, and immune thrombocytopenia
6077,95899,96576,11470). Estimates of the rate of immunologic reactions to various forms of bee venom range from 0.025% to 29% (96576,105770,11470,111475). They occur most frequently when doses are increased rapidly. Females and people with a c-KIT mutation may have more severe and frequent adverse effects (1343,6077,102533,11470). Doses of bee venom associated with adverse effects vary from 0.1 to 2 mL, and anaphylaxis has occurred after 1-24 doses (11470).
Bee venom is also associated with autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barre syndrome, and pemphigus vulgaris (96574,111473). In a case report, a 68-year-old female developed Guillain-Barré syndrome with progressive quadriplegia ten days after receiving acupuncture with honeybee venom for pain (96573). In another case, a 64-year-old female developed pemphigus foliaceus, involving pruritic, erythematous, erosive skin lesions with crusting and plaques, after bee venom acupuncture twice weekly for 2 months. Immunoglobulin G was detected in the intercellular spaces between keratinocytes. Partial resolution occurred after 2 months of treatment with oral corticosteroids and azathioprine (111473).
Musculoskeletal ...Bee venom can cause rhabdomyolysis (111474). A 63-year-old female who received an accidental injection into the psoas muscle of 2 mL of normal saline containing bee venom diluted in a 1:2000 ratio, experienced severe burning pain at the injection site which persisted for 1 month, with imaging showing inflammation of the muscle. The pain gradually resolved over the following 5 months (11475).
Neurologic/CNS ...Bee venom can cause pain, headache, somnolence, and confusion (1343,2619,6070,6078,96576,111472). It has also been associated with a case of neuralgic amyotrophy (96576).
Pulmonary/Respiratory ...Bee venom has been associated with asthma, hyperventilation, respiratory distress, paralysis of respiratory muscles, and pulmonary or laryngeal edema (1343,2619,6070,6078,96576,111474).
Renal ...Bee venom immunotherapy has been associated with nephrotic syndrome, acute interstitial nephritis, and acute tubular necrosis (96576,111474). A case report describes a 50-year-old male with type 2 diabetes and normal renal function who developed acute kidney injury with combined features of interstitial nephritis and tubular necrosis after being stung by more than 1000 bees. He made a full recovery over several weeks with intermittent hemodialysis (111474).
