International reference: 6 US FDA recalls for this ingredient
Lack of Assurance of Sterility: Media fill with bacterial contamination (bacterial)
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. (bacterial)
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. (bacterial)
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured. (bacterial)
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. (bacterial)
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory. (bacterial)
US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.
What it does
Bacterial treatments are used to fight infections caused by bacteria.
Commonly used for: bacterial infections, infections caused by germs
Read more in plain English ↓Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.
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Sourcing - Kenya onlyRegistration & product details
Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:38:56 · updated 2026-09-17 03:00:43
About bacterial
Bacterial treatments are used to fight infections caused by bacteria.
What it treats
- bacterial infections
- infections caused by germs
How it works
These treatments kill bacteria or stop them from growing, helping the body recover from infections.
Who it's for
These treatments are for anyone suffering from bacterial infections.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
About proteinase
Proteinase is an enzyme that helps break down proteins in the body.
What it treats
- pancreatic insufficiency
- digestive disorders
How it works
It aids in the digestion of proteins into smaller parts for better absorption.
Who it's for
People with conditions that affect their ability to digest proteins properly.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: bacterial
Bacterial refers to a class of microorganisms that are unicellular and prokaryotic in nature. They are found in various environments, including soil, water, and the human body. Some bacteria are pathogenic and can cause diseases, while others are beneficial and play essential roles in processes such as digestion and nutrient cycling. Treatment of bacterial infections typically involves the use of antibiotics, which target specific bacterial functions or structures.
Indications
- Bacterial pneumonia
- Urinary tract infections
- Skin and soft tissue infections
- Sepsis
- Bacterial meningitis
- Gastroenteritis caused by bacteria
Dosage
Children: Refer to BNF for Children for appropriate dosing guidelines based on age, weight, and specific infection.
Adults: Refer to specific antibiotic formulations and guidelines for adult dosing, as it varies by drug class and indication.
Mechanism of action
Antibiotics act by various mechanisms depending on their class. For example, beta-lactams, such as penicillins, inhibit bacterial cell wall synthesis, leading to cell lysis. Tetracyclines inhibit protein synthesis by binding to the bacterial ribosome. Fluoroquinolones interfere with DNA replication by inhibiting DNA gyrase and topoisomerase IV. Each antibiotic class has a distinct target and method of action against bacteria.
Pharmacodynamics
Antibiotics exhibit bactericidal or bacteriostatic activity. Bactericidal antibiotics kill bacteria, while bacteriostatic antibiotics inhibit bacterial growth. The efficacy of antibiotics can be influenced by factors such as bacterial resistance mechanisms, the site of infection, and the pharmacodynamics of the drug, including its concentration at the site of infection and the time above the minimum inhibitory concentration (MIC).
Pharmacokinetics
Pharmacokinetics of antibiotics varies widely among different classes. Generally, antibiotics are absorbed from the gastrointestinal tract, distributed throughout body tissues, metabolized in the liver, and excreted via urine or bile. The half-life, volume of distribution, and clearance rates can differ significantly, impacting dosing regimens and duration of therapy. Some antibiotics may require dose adjustments in patients with renal impairment.
Pregnancy
Safety in pregnancy has not been established for all bacterial agents. Some may be contraindicated due to potential teratogenic effects.
Breast-feeding
Many bacterial agents are excreted in breast milk, and caution is advised when administering these drugs to breastfeeding mothers.
Storage
Store in a cool, dry place away from direct light. Follow specific storage instructions for individual agents.
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
Clinical monograph: proteinase
Proteinases, also known as proteases or peptidases, are a class of enzymes that catalyze the hydrolysis of peptide bonds in proteins, leading to their breakdown into smaller peptides or amino acids. These enzymes play crucial roles in various biological processes, including protein digestion, cell signaling, immune response, and the regulation of metabolic pathways. Proteinases are widely distributed in organisms and are classified into several categories based on their catalytic mechanisms, including serine, cysteine, aspartic, and metalloproteinases.
Indications
- Digestive disorders due to protein malabsorption
- Pancreatic insufficiency
- Inflammatory conditions where proteolytic activity is beneficial
- Certain types of cancer where proteases are involved in tumor progression
Dosage
Children: Refer to specific clinical guidelines or product information for appropriate dosing as it may vary based on indication and formulation.
Adults: Refer to specific clinical guidelines or product information for appropriate dosing as it may vary based on indication and formulation.
Mechanism of action
Proteinases function by cleaving peptide bonds in proteins, which can lead to the activation or inactivation of certain proteins involved in biological pathways. The mechanism typically involves the formation of a tetrahedral intermediate during the hydrolysis process, which is stabilized by specific amino acid residues at the active site of the enzyme. This enzymatic activity is essential for a variety of physiological processes, such as digestion, cell division, and apoptosis.
Pharmacodynamics
The pharmacodynamics of proteinases involve their interaction with substrates to produce specific physiological effects. The activity of proteinases can influence numerous biological processes, including inflammation, immune responses, and tissue remodeling. Inhibition or dysregulation of proteinase activity can lead to pathological conditions, such as chronic inflammatory diseases, cancer, and cardiovascular disorders.
Pharmacokinetics
The pharmacokinetics of proteinases vary depending on their source and formulation. Generally, proteinases can be administered systemically or locally, where their absorption, distribution, metabolism, and excretion are influenced by factors such as molecular weight, stability, and the presence of inhibitors. Enzymatic activity may be affected by pH levels, temperature, and the presence of cofactors. For therapeutic applications, the route of administration can also impact the bioavailability and efficacy of proteinase treatments.
Pregnancy
Consult a healthcare provider before use; safety during pregnancy not established.
Breast-feeding
Consult a healthcare provider before use; safety during breastfeeding not established.
Storage
Store in a cool, dry place away from direct sunlight. Ensure the container is tightly closed.
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
This drug in other countries
The same active ingredient registered across other registries we cover - including different brands.