International reference: 6 US FDA recalls for this ingredient

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL th (administration)

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. (administration)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. (administration)

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. (administration)

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL th (administration)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. (administration)

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

Registered Rwanda · Rwanda FDA

V-IMMUNE

Human Normal Immunoglobulin for Intravenous Administration B.P 5 %

Rwanda FDA-HBP-MA-0141 Injection 5%

What it does

Administration involves providing medication or treatment to a patient.

Commonly used for: medication delivery, treatment administration

Read more in plain English ↓

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

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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.
Rwanda FDA-HBP-MA-0141
Registration date
09/01/2025
Expiry date
08/01/2030
Status
Registered
Active ingredient
Human Normal Immunoglobulin for Intravenous Administration B.P 5 %
Dosage form
Injection
Strength
5%
Pack size
1x100mL
Therapeutic class
-
Manufacturer / MAH
Virchow Biotech
Applicant / LTR
Virchow Healthcare Pvt Ltd
Country of origin
India
Manufacturer location
Survey no, 172 part, Gagillapur, Hyderabad, Sambhupur, Telangana 500043, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-21 02:30:19

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

About administration

Administration involves providing medication or treatment to a patient.

What it treats

  • medication delivery
  • treatment administration

How it works

It ensures that the right medicine reaches the patient in the correct manner.

Who it's for

It is for anyone who requires medication or treatment.

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

About human

Human is a term that generally refers to a member of the species Homo sapiens, and in the context of medicine, it may relate to various human-derived products or treatments. However, there are no specific drug class, interactions, or cautions provided for this entry.

How it works

There is no specific information on how this ingredient works as it may relate to various contexts within human health.

Who it's for

Information regarding specific patients or conditions is not provided.

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

About immunoglobulin

Immunoglobulin is a treatment that helps boost the immune system by providing antibodies. It is often used to help people with weakened immune systems.

What it treats

  • weakened immune system
  • certain autoimmune diseases
  • infections

How it works

Immunoglobulin provides antibodies to the body, which help fight off infections and support the immune response.

Who it's for

This treatment is suitable for individuals with conditions that cause a low level of antibodies or those who have autoimmune disorders.

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

About intravenous

Intravenous (IV) therapy involves delivering medications or fluids directly into the bloodstream through a vein.

What it treats

  • dehydration
  • infections
  • surgery recovery
  • pain management
  • nutrition support

How it works

IV therapy allows quick delivery of fluids and medications, helping to treat various conditions effectively.

Who it's for

IV therapy is suitable for patients who cannot take medications by mouth or need immediate treatment.

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

About normal

Normal is a medication used to treat various health conditions.

How it works

Normal works by balancing certain functions in the body to improve health.

Who it's for

Normal is suitable for individuals with specific health needs as determined by a healthcare provider.

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

Clinical monograph: administration

Administration refers to the process of giving a drug to a patient. This can be done via various routes, including oral, intravenous, intramuscular, subcutaneous, and topical, among others. The route of administration can significantly affect the drug's pharmacokinetics, efficacy, and safety profile. Understanding the appropriate method of administration is essential for achieving optimal therapeutic outcomes.

Dosage

Children: Refer to specific drug guidelines for paediatric dosing.

Adults: Refer to specific drug guidelines for adult dosing.

Mechanism of action

The mechanism of action varies depending on the specific drug being administered. Generally, drugs interact with specific receptors or enzymes in the body to elicit a therapeutic effect. This interaction can result in various downstream effects, including the modulation of physiological processes, alteration of biochemical pathways, or inhibition of pathological conditions.

Pharmacodynamics

Pharmacodynamics involves the study of how a drug affects the body, including the relationship between drug concentration and effect. It includes the drug's therapeutic effects, side effects, and the duration of action. Factors such as receptor affinity, intrinsic activity, and the presence of other substances can influence pharmacodynamic responses.

Pharmacokinetics

Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes a drug. Key parameters include bioavailability, volume of distribution, half-life, and clearance. The route of administration significantly impacts these parameters, influencing the onset, intensity, and duration of the drug's effects.

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Dizziness
  • Fatigue

Precautions

  • Use with caution in patients with gastrointestinal disorders
  • Monitor for dehydration in patients with significant vomiting or diarrhea
  • Assess for potential interactions with other medications

Pregnancy

Use during pregnancy only if clearly needed, as safety has not been established.

Breast-feeding

Consult a healthcare provider before use, as it may be excreted in breast milk.

Storage

Store in a cool, dry place away from direct sunlight.

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: human

Human refers to the species Homo sapiens, which is characterized by advanced cognitive abilities, social structures, and the capability for complex communication. The term may also refer to human-derived biological products, such as blood, tissues, or organs used in medical treatments and research.

Dosage

Children: Dosage for human-derived biological products in pediatrics should be determined based on specific product guidelines and the clinical context.

Adults: Dosage for human-derived biological products varies widely. Refer to specific product information for appropriate dosing.

Mechanism of action

Human physiology is governed by complex biological systems involving various cellular and molecular pathways. The mechanisms of action for human-derived biological products vary widely depending on the specific context, including immune response, hormonal regulation, and metabolic processes.

Pharmacodynamics

Pharmacodynamics in humans involves the interaction of drugs with biological systems, resulting in therapeutic effects. This includes receptor binding, signal transduction, and physiological responses. The effects are influenced by genetic factors, existing health conditions, and concurrent medications.

Pharmacokinetics

Pharmacokinetics in humans involves the absorption, distribution, metabolism, and excretion (ADME) of substances. Factors such as age, sex, body weight, and organ function can significantly influence these processes. Drug absorption may occur via oral, intravenous, or other routes, while distribution depends on blood flow and tissue permeability. Metabolism typically occurs in the liver, and excretion primarily takes place through the kidneys.

Pregnancy

There is no specific information available; consult local guidelines.

Breast-feeding

There is no specific information available; consult local guidelines.

Storage

Store in a cool, dry place away from direct sunlight.

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: immunoglobulin

Immunoglobulin is a preparation of antibodies derived from human plasma, used for passive immunization and to modulate immune responses. It is composed of a mixture of immunoglobulin G (IgG) antibodies and is administered to prevent infections in immunocompromised patients, treat various autoimmune disorders, and manage conditions like chronic inflammatory demyelinating polyneuropathy (CIDP).

Indications

  • Primary immunodeficiency disorders
  • Secondary immunodeficiency (e.g. due to HIV infection)
  • Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Immune thrombocytopenic purpura (ITP)
  • Kawasaki disease
  • Prevention of infections in at-risk populations (e.g. following bone marrow transplant)

Dosage

Children: Refer to the BNF for Children for age-appropriate dosing guidelines; specific doses depend on the clinical condition and patient age.

Adults: Refer to specific guidelines for dosing based on indication; typically varies based on clinical scenario and patient condition.

Mechanism of action

Immunoglobulin exerts its effects primarily through the neutralization of pathogens and toxins, opsonization, and the activation of the complement system. It modulates immune responses by influencing the activity of various immune cells, including B cells, T cells, and macrophages, thereby enhancing antibody production and regulating inflammation.

Pharmacodynamics

The pharmacodynamics of immunoglobulin involve its ability to bind to specific antigens, effectively neutralizing them and facilitating their clearance. It also plays a crucial role in modulating the immune response, providing immediate passive immunity and promoting the establishment of active immunity over time. The diverse mechanisms through which immunoglobulin operates include antibody-dependent cell-mediated cytotoxicity (ADCC) and inhibition of pro-inflammatory cytokines.

Pharmacokinetics

Immunoglobulin is typically administered intravenously or subcutaneously. After administration, it is distributed throughout the extracellular space. The half-life of immunoglobulin varies but is generally in the range of 21 to 30 days, depending on the specific formulation and the patient's individual characteristics. It is primarily eliminated through the reticuloendothelial system, with catabolism occurring in various tissues.

Contra-indications

  • Hypersensitivity to immunoglobulin preparations
  • Selective IgA deficiency with a history of hypersensitivity
  • Severe hyperprolinemia

Adverse effects

  • Headache
  • Nausea
  • Fever
  • Chills
  • Fatigue
  • Rash
  • Anaphylactic reactions
  • Thromboembolic events

Interactions

  • Live attenuated vaccines may be less effective if administered concurrently with immunoglobulin therapy
  • Caution is advised when administering with other blood products

Precautions

  • Monitor for signs of anaphylaxis during and after administration
  • Use with caution in patients with renal impairment
  • Hydrate adequately to prevent renal dysfunction
  • Consider the risk of thrombosis in patients with a history of thromboembolic events

Pregnancy

Immunoglobulin can be used during pregnancy if indicated, as it is considered safe based on available data.

Breast-feeding

Immunoglobulin is excreted in breast milk, but is generally considered safe during breastfeeding.

Storage

Store at 2-8 degrees Celsius. Do not freeze. Protect from light. Use before expiry date.

Formulations

  • Intravenous immunoglobulin (IVIG)
  • Subcutaneous immunoglobulin (SCIG)
  • Intramuscular immunoglobulin (IMIG)

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: intravenous

Intravenous (IV) administration refers to the delivery of substances directly into the bloodstream through a vein. This method is commonly used for the rapid delivery of medications, fluids, and nutrients, allowing for immediate systemic effects. IV administration is vital in emergency situations, surgical procedures, and for patients who cannot take medications orally.

Indications

  • Dehydration
  • Electrolyte imbalances
  • Infections requiring immediate antibiotic therapy
  • Pain management in acute settings
  • Nutritional support in patients unable to eat
  • Chemotherapy administration
  • Anesthesia induction and maintenance

Dosage

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

Adults: Refer to the specific drug's prescribing information in the BNF for appropriate dosing guidelines.

Mechanism of action

The mechanism of action for intravenous drugs depends on the specific medication administered. Generally, intravenous administration allows for rapid drug distribution throughout the body, achieving high plasma concentrations quickly. This is particularly beneficial for medications that require immediate therapeutic effects.

Pharmacodynamics

Pharmacodynamics varies based on the specific drug administered intravenously. In general, drugs delivered via IV can achieve peak plasma concentrations faster than those taken orally, leading to quicker onset of action. This route is often utilized for drugs that are poorly absorbed in the gastrointestinal tract or for those that require precise titration to achieve the desired therapeutic effect.

Pharmacokinetics

Pharmacokinetics for intravenous drugs typically includes immediate bioavailability since the drug is delivered directly into circulation. Distribution is rapid, and elimination depends on the drug's specific metabolic pathways. Volume of distribution, clearance rates, and half-life can significantly vary based on the drug's properties and patient factors such as age, body weight, and organ function.

Interactions

  • ataluren + intravenous aminoglycosides: Severe (increases risk of nephrotoxicity)
  • intravenous dantrolene + calcium channel blockers: Severe (increases risk of acute hyperkalaemia and cardiovascular collapse)
  • intravenous dantrolene + diltiazem: Severe (increases risk of acute hyperkalaemia and cardiovascular collapse)
  • intravenous dantrolene + verapamil: Severe (increases risk of acute hyperkalaemia and cardiovascular collapse)
  • intravenous chloramphenicol + antiepileptics: Moderate (increases concentration)
  • intravenous chloramphenicol + fosphenytoin: Moderate (increases concentration)
  • intravenous chloramphenicol + phenytoin: Moderate (increases concentration)
  • miconazole + intravenous benzodiazepines: Moderate (increases exposure)
  • intravenous magnesium + calcium channel blockers: Unknown (increases risk of hypotension)
  • intravenous magnesium + amlodipine: Unknown (increases risk of hypotension)

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: normal

Normal immunoglobulin is a preparation of immunoglobulins derived from human plasma, primarily containing IgG antibodies. It is used to provide passive immunity to individuals at risk of certain infections or those with immune deficiencies. This treatment is essential for patients who lack specific antibodies due to various medical conditions, offering immediate protection against infections.

Indications

  • Primary immunodeficiency syndromes
  • Secondary immunodeficiency
  • Immunomodulation in certain autoimmune disorders
  • Prevention of infections in patients undergoing immunosuppressive therapy

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations in pediatric patients, as it varies based on age, weight, and clinical condition.

Adults: Refer to the BNF for specific dosing recommendations for adults, as it varies based on clinical indications and patient circumstances.

Mechanism of action

Normal immunoglobulin works by providing a broad spectrum of antibodies that neutralize pathogens and enhance the immune response. These antibodies bind to pathogens, facilitating their removal by immune cells and providing immediate passive immunity against infections.

Pharmacodynamics

The pharmacodynamic effects of normal immunoglobulin include the neutralization of toxins and pathogens, opsonization, and enhancement of phagocytosis. It modulates immune responses and provides immediate humoral immunity, particularly in individuals with inadequate antibody production.

Pharmacokinetics

Normal immunoglobulin is administered intravenously or subcutaneously. After administration, it is distributed throughout the body, with a half-life of approximately 21 to 30 days. It is metabolized by the reticuloendothelial system, and the rate of clearance can vary based on individual patient factors and the presence of underlying conditions.

Interactions

  • normal immunoglobulin + monoclonal antibodies: Severe (affects effects)
  • normal immunoglobulin + dinutuximab: Severe (affects effects)
  • normal immunoglobulin + live vaccines, measles, mumps and rubella vaccine, live, rotavirus vaccine, typhoid vaccine, oral, varicella-zoster vaccine: Unknown (decreases efficacy)
  • normal immunoglobulin + bacillus Calmette-Guérin vaccine: Unknown (decreases efficacy)
  • normal immunoglobulin + herpes-zoster vaccine: Unknown (decreases efficacy)
  • normal immunoglobulin + live: Unknown (decreases efficacy)
  • normal immunoglobulin + influenza vaccine, live: Unknown (decreases efficacy)

Pregnancy

Consult relevant guidelines for use in pregnancy.

Breast-feeding

Consult relevant guidelines for use during breastfeeding.

Storage

Store at 2-8°C. Do not freeze.

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.