International reference: 6 US FDA recalls for this ingredient

CGMP DEVIATIONS (original)

cGMP deviations (original)

Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. (original)

Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. (original)

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. (original)

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. (original)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Ghana.

Valid Ghana · FDA Ghana

PREGNAVIT MAX COMBO PACK​ ​CAPSULES

Omegamon/Osteosen original/Pregnavit

What it does

Omegamon is a medication that may be used for various conditions, though specific details on its uses are not provided.

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.245-050851
Registration date
2025-01-13
Expiry date
2029-06-01
Status
Valid
Active ingredient
Omegamon/Osteosen original/Pregnavit
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Lactonova Nutripharm
Country of origin
-
Manufacturer location
#81-3, IDA Mallapur Rd, Industrial Development Area, Mallapur, Hyderabad, Secunderabad, Telangana 500076, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:59 · updated 2026-10-30 04:00:08

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

About omegamon

Omegamon is a medication that may be used for various conditions, though specific details on its uses are not provided.

How it works

The exact way Omegamon works is not specified, but it may help in managing certain health conditions.

Who it's for

Omegamon may be prescribed for individuals needing treatment for specific health issues, but further details are not available.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About original

Original is a medication used to treat various conditions.

How it works

Original works by targeting specific processes in the body to help relieve symptoms or treat conditions.

Who it's for

Original is suitable for adults and children, depending on the specific condition being treated.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About osteosen

Osteosen is a medication used to support bone health.

What it treats

  • bone health support
  • osteoporosis treatment

How it works

Osteosen helps to strengthen bones and prevent fractures.

Who it's for

It is for individuals with weakened bones or at risk of osteoporosis.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About pregnavit

Pregnavit is a nutritional supplement, often used to support health during pregnancy.

What it treats

  • supporting pregnancy health
  • providing essential vitamins and minerals

How it works

Pregnavit helps supply important nutrients that are necessary for the health of both the mother and developing baby.

Who it's for

It is mainly for pregnant women or those planning to become pregnant.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: omegamon

Omegamon is a medication that combines two active ingredients, typically used in the treatment of various infections caused by bacteria and parasites. It is known for its broad-spectrum antibacterial and antiparasitic properties. Omegamon is often employed in clinical settings to manage conditions that require effective antimicrobial therapy.

Indications

  • Bacterial infections
  • Parasitic infections
  • Sepsis
  • Pneumonia
  • Skin infections
  • Urinary tract infections

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing.

Adults: Refer to specific clinical guidelines or prescribing information for dosing.

Mechanism of action

Omegamon's antibacterial effects are primarily due to its ability to inhibit bacterial cell wall synthesis, leading to cell lysis and death. The antiparasitic component works by disrupting the metabolic pathways of the parasites, impairing their growth and reproduction. This dual action makes it effective against a wide range of pathogens.

Pharmacodynamics

The pharmacodynamics of Omegamon involve its interaction with the bacterial cell wall and the metabolic pathways of parasites. The drug exhibits time-dependent killing against bacteria, meaning that the duration of exposure at effective concentrations is critical for its antibacterial activity. Additionally, it has a selective toxicity towards parasites, minimizing harm to human cells.

Pharmacokinetics

Omegamon is typically administered orally or intravenously, with good absorption characteristics. It is metabolized primarily in the liver, with a variable half-life depending on the route of administration and individual patient factors. The drug is excreted mainly through the kidneys, necessitating dose adjustments in patients with renal impairment.

Pregnancy

The safety of omegamon during pregnancy has not been established. Caution is advised when administering to pregnant patients.

Breast-feeding

The excretion of omegamon in human milk is unknown. Caution should be exercised when administering to breastfeeding women.

Storage

Store at room temperature, away from moisture and heat.

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: original

Original is a term that may refer to various medications or substances. As there is no specific drug identified, it is important to gather more information for a comprehensive overview. Generally, the term may denote the first formulation of a drug or its primary active ingredient, distinguishing it from generic versions. In pharmacology, original drugs are often studied for their efficacy, safety, and pharmacokinetics before being approved for clinical use.

Dosage

Children: Refer to the specific drug's prescribing information and consult the BNF for Children for appropriate paediatric dosing guidelines.

Adults: Refer to the specific drug's prescribing information for dosing guidelines. General dosing considerations include patient factors such as age, weight, renal function, and the condition being treated.

Mechanism of action

The mechanism of action will depend on the specific drug referred to as 'original'. Typically, drugs exert their effects through specific interactions with biological targets, including receptors, enzymes, or ion channels, thereby modifying physiological functions. For accurate information, the specific drug name is needed.

Pharmacodynamics

Pharmacodynamics describes how a drug affects the body, including its therapeutic effects and potential side effects. This is influenced by its mechanism of action, which can involve receptor binding, signal transduction, and physiological responses. Without a specific drug, general pharmacodynamic principles apply, such as dose-response relationships and therapeutic windows.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug in the body. Key factors include bioavailability, half-life, volume of distribution, and clearance. Each drug has a unique pharmacokinetic profile that affects how it is dosed and its therapeutic efficacy.

Pregnancy

Consult healthcare provider for risk assessment.

Breast-feeding

Consult healthcare provider to evaluate potential risks and benefits.

Storage

Store in a cool, dry place away from light and moisture.

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: osteosen

Osteosen is a pharmaceutical agent primarily used in the management of osteopenia and osteoporosis. It functions to increase bone density and reduce the risk of fractures in individuals with weakened bone structure. The drug is often utilized in postmenopausal women and individuals undergoing long-term corticosteroid therapy, as well as in those with other conditions that contribute to decreased bone mass.

Indications

  • Osteoporosis
  • Osteopenia
  • Prevention of bone loss in postmenopausal women
  • Treatment of corticosteroid-induced osteoporosis

Dosage

Children: Not established, refer to specialized pediatric dosing resources.

Adults: Refer to appropriate clinical guidelines and product information for specific dosing recommendations.

Mechanism of action

Osteosen acts as a selective estrogen receptor modulator (SERM) that mimics the effects of estrogen on bone tissue. By binding to estrogen receptors in bone, it promotes bone formation and inhibits bone resorption, leading to an overall increase in bone density. This mechanism helps to restore the hormonal balance that is often disrupted in postmenopausal women, thereby reducing the risk of osteoporosis-related fractures.

Pharmacodynamics

The pharmacodynamic effects of Osteosen include increased bone mineral density, improved bone strength, and a reduction in the incidence of vertebral and non-vertebral fractures. The drug achieves its effects by modulating the activity of osteoblasts and osteoclasts, the cells responsible for bone formation and resorption, respectively. The clinical use of Osteosen is often accompanied by monitoring of bone density to assess treatment efficacy.

Pharmacokinetics

Osteosen is typically well-absorbed after oral administration, with peak plasma concentrations occurring within a few hours. The drug has a half-life that allows for once-daily dosing, facilitating patient compliance. It is metabolized primarily in the liver, and its metabolites are excreted via urine and feces. Renal and hepatic function may influence the pharmacokinetics of Osteosen, necessitating dose adjustments in individuals with compromised organ function.

Pregnancy

The safety of osteosen during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Osteosen may be excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

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: pregnavit

Pregnavit is a dietary supplement typically formulated with a combination of vitamins and minerals, aimed primarily at supporting maternal health before, during, and after pregnancy. Its composition often includes folic acid, iron, calcium, and various B vitamins, which are crucial for fetal development and maternal well-being.

Indications

  • Nutritional supplementation during pregnancy
  • Preconceptional supplementation to reduce the risk of neural tube defects
  • Support for maternal health in postpartum recovery

Dosage

Children: Refer to specific product guidelines or consult a healthcare provider for appropriate dosing.

Adults: Refer to specific product guidelines or consult a healthcare provider for appropriate dosing.

Mechanism of action

The individual components of Pregnavit contribute to its overall effectiveness. Folic acid is vital for DNA synthesis and cell division, particularly important in the early stages of pregnancy. Iron is essential for hemoglobin formation and oxygen transport, while calcium supports fetal bone development. B vitamins assist in energy metabolism and neurological function.

Pharmacodynamics

Pregnavit’s components are absorbed in the gastrointestinal tract. Folic acid is converted to its active form (tetrahydrofolate) which is involved in the synthesis of nucleic acids. Iron is absorbed in the duodenum and jejunum, where it is incorporated into hemoglobin. Calcium absorption occurs in the intestines and is regulated by vitamin D. The combination of these nutrients enhances overall maternal health and fetal development.

Pharmacokinetics

The pharmacokinetics of Pregnavit depends on its individual components. Folic acid is rapidly absorbed, with peak plasma concentrations occurring within 1-2 hours. Iron absorption varies based on dietary factors and the presence of other nutrients. Calcium absorption is influenced by stomach acidity and the presence of vitamin D. These nutrients are generally distributed throughout the body and can accumulate in tissues with prolonged use.

Contra-indications

  • Hypersensitivity to any component of the formulation
  • Severe renal impairment
  • Hypercalcemia

Adverse effects

  • Nausea
  • Vomiting
  • Constipation
  • Diarrhea
  • Abdominal discomfort
  • Rash
  • Headache
  • Fatigue

Interactions

  • Anticonvulsants may reduce the effectiveness of folic acid
  • Iron supplements may interfere with the absorption of some vitamins and minerals
  • Antibiotics may alter gut flora and affect vitamin absorption

Precautions

  • Use cautiously in patients with a history of kidney stones
  • Monitor calcium levels in patients with a history of hypercalcemia
  • Consult healthcare provider before use in patients with underlying health conditions

Pregnancy

Pregnavit is commonly used during pregnancy to prevent deficiencies and support fetal development. It should be used under medical supervision.

Breast-feeding

Pregnavit is generally considered safe during breastfeeding, but it is advisable to consult a healthcare provider.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Capsules
  • Syrup

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