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NPL 100% Micronised Creatine Monohydrate Powder

Monohydrate

FDA/SD.265-030401 Monohydrate 100%

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Registration & product details

Registration no.
FDA/SD.265-030401
Registration date
2026-03-31
Expiry date
2031-04-01
Status
Valid
Active ingredient
Monohydrate
Dosage form
Monohydrate
Strength
100%
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Nutritional Performance Labs
Country of origin
South Africa
Manufacturer location
Building 2, Boundary River Park, Malibongwe Dr, Northriding, Randburg, 2169, South Africa

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:52 · updated 2026-10-20 04:00:10

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

Clinical monograph: mono

Monoclonal antibodies are laboratory-engineered molecules designed to target specific antigens in the body. They are derived from immune cells and can mimic the immune system's ability to fight off harmful pathogens such as viruses. These agents are widely used in various therapeutic applications, including oncology, autoimmune diseases, and infectious diseases.

Indications

  • Cancer (various types)
  • Rheumatoid arthritis
  • Multiple sclerosis
  • Inflammatory bowel disease
  • Psoriasis
  • Hypercholesterolemia
  • Infectious diseases (e.g., COVID-19)

Dosage

Children: Refer to the BNF for Children for paediatric dosing information, as it varies based on the specific monoclonal antibody and the condition being treated.

Adults: Refer to the specific monoclonal antibody product information for adult dosage, as it varies based on indication and specific agent used.

Mechanism of action

Monoclonal antibodies work by binding to specific proteins on the surface of cells. This binding can block the activity of certain proteins, mark cells for destruction by the immune system, or deliver cytotoxic agents directly to target cells. The mechanism of action varies depending on the specific monoclonal antibody but often involves modulation of immune response, inhibition of cell proliferation, and induction of apoptotic pathways.

Pharmacodynamics

The pharmacodynamics of monoclonal antibodies is primarily characterized by their specificity and affinity for targeted antigens. This leads to a variety of effects, including neutralization of pathogens, blockade of receptor-ligand interactions, and antibody-dependent cellular cytotoxicity. The clinical effects depend on the disease being treated and the specific antibody's action, such as inducing tumor regression in cancer or reducing inflammation in autoimmune diseases.

Pharmacokinetics

Monoclonal antibodies typically have a long half-life, allowing for less frequent dosing. They are generally administered intravenously or subcutaneously, with absorption and distribution influenced by the antibody's size and charge. The elimination occurs primarily through proteolytic degradation and intracellular recycling. Factors such as patient-specific variables, including immunogenicity and the presence of antibodies against the monoclonal antibody, can impact pharmacokinetics.

Interactions

  • abatacept+monoclonalantibodies: Severe (increases risk of generalised infection (possibly life-threatening))
  • anakinra+monoclonalantibodies: Severe (increases risk of generalised infection (possibly life-threatening))
  • anthracyclines+monoclonalantibodies: Severe (increases risk of cardiotoxicity)
  • filgotinib+monoclonalantibodies: Severe (increases risk of immunosuppression)
  • monoclonalantibodies+fingolimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • normal immunoglobulin+monoclonalantibodies: Severe (affects effects)
  • monoclonalantibodies+ozanimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • monoclonalantibodies+siponimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • monoclonalantibodies+vemurafenib: Severe (increases risk of hepatotoxicity)
  • monoclonalantibodies+aminophylline: Moderate (decreases exposure)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.