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Soluvit novum

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Soluvit novum

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Treatment option:

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Soluvit novum

Property Description
Active Ingredients Nine essential water-soluble vitamins (B-group and C)
Form Lyophilised powder (for reconstitution)
Pharmacological Class Nutritional Supplement / Multivitamin Preparation
Common Use Maintaining nutritional status during parenteral feeding
Origin Synthetic (pharmaceutically manufactured)

What Type of Preparation is Soluvit Novum?

Soluvit novum is a specialized, combination product classified as a Multivitamin Preparation belonging to the pharmacological class of Nutritional Supplements, specifically Water-Soluble Vitamin Supplementation. It is fundamentally a supportive medicine whose general purpose is to ensure the body receives its essential water-soluble vitamins when oral intake or absorption is compromised. This preparation differs from standard oral vitamins by its specific formulation and concentration, making it suitable for direct intravenous administration. The product is recognized for its comprehensive composition, often utilized in clinical scenarios like post-surgical recovery or prolonged illness where adequate nutrient absorption is temporarily impossible.


Composition and Pharmaceutical Form of the Product

The preparation's composition includes a complete blend of nine necessary synthetic water-soluble vitamins, specifically all members of the B-group—such as Thiamine (B1), Riboflavine (B2), Pyridoxine (B6), Cyanocobalamin (B12), and Folic acid—alongside Ascorbic acid (Vitamin C). Soluvit novum is provided in the dosage form of a lyophilised powder, which appears as a sterile, porous cake. This dry concentrate format is designed to provide stability for its active components and must be fully diluted into an appropriate aqueous infusion solution before it can be safely delivered into the vein. The lyophilised form is intended to maintain the stability and bioavailability of the vitamins upon reconstitution.


The General Purpose of Soluvit Novum in Nutritional Support

The primary role of Soluvit novum is to prevent or correct deficiencies of water-soluble vitamins in patients who are critically ill or receiving long-term artificial feeding. Because the body does not store these vitamins in large reserves, continuous supply is essential for metabolic functions like energy production. By providing a source of these essential cofactors directly into the circulation, the preparation acts to maintain metabolic balance and support the constant operation of the body's enzyme systems. In clinical practice, vitamin supplementation is utilized to reduce the risk of deficiency-related complications in patients receiving total parenteral nutrition.

Regulatory References

  1. Soluvit N label (DailyMed)
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What side effects are possible with Soluvit novum?

Possible Side Effects and Safety Information

The safety profile of Soluvit novum, a preparation of water-soluble vitamins, is documented through classification of adverse reactions based on frequency and affected body system, according to regulatory standards.


Officially Documented Adverse Reactions

Adverse reactions are classified into several System-Organ Classes (SOC) in official labeling. These include Immune System Disorders, Skin and Subcutaneous Tissue Disorders, Nervous System Disorders, and Gastrointestinal Disorders.

  • Serious Adverse Reactions: The most critical safety concern documented is the potential for severe allergic reactions, including anaphylaxis. These reactions are classified as having a Not known frequency and can involve sudden symptoms like rash, swelling, or difficulty breathing.

  • Common Reactions: Reactions affecting the skin, such as flushing, itching, and burning, are noted, along with general reactions like headache, dizziness, and tiredness. Gastrointestinal effects, including nausea and vomiting, are typically classified as having an Uncommon frequency (less than 1%).


Safety Constraints and Considerations

The preparation's regulatory profile outlines specific safety constraints.

  • Hypersensitivity: Known hypersensitivity to any component is a contraindication, meaning the medicine should not be used in such individuals.

  • Duration and Population: Safety notes address the risk of reactions following repeated exposure to thiamine-containing preparations. For paediatric patients, official documents emphasize the need for careful calculation of vitamin requirements to avoid overdosage, especially when mixing with other fat-soluble vitamin solutions.

  • Interaction Consequences: The label highlights the potential for the Biotin content to interfere with certain laboratory tests. Furthermore, the formulation's Vitamin B6 and Folic acid can officially reduce the efficacy or serum concentration of certain co-administered medications, such as Levodopa and Phenytoin.

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Overdose and Emergency Response

Overdose and when to seek help

Overdose of Soluvit novum is considered unlikely when the product is administered within standard dosing guidelines, as confirmed by regulatory documentation. No adverse effects or clinically significant manifestations are anticipated under normal use. Regulatory reports of adverse effects are limited to cases involving the use of extremely high parenteral doses of water-soluble vitamins.

Immediate Actions Required by Regulators

If overdosage is suspected, the patient must inform a doctor or nurse immediately for professional assessment and management. The regulatory procedure mandates that further administration of the product be discontinued. Management for overexposure primarily involves the institution of symptomatic and supportive therapy as appropriate. The official labeling confirms that no specific treatment or antidote is required.

Specific Monitoring Consideration

A critical consideration in managing potential overexposure is the vitamin Biotin content, which may interfere with laboratory tests that rely on the biotin/streptavidin interaction. This interference can potentially yield falsely increased or decreased results. Regulatory labeling identifies this risk as higher in children and patients with renal impairment, indicating that any treatment or management protocol must address these specific population and testing constraints.

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Therapeutic Uses of Soluvit novum

The therapeutic category of intravenous multivitamin supplementation is generally applied in clinical settings to assist in meeting the required daily intake of water-soluble vitamins in patients of all ages. This core use is relevant for nutritional maintenance when oral intake is compromised.


Supporting Nutritional Status During Intravenous Feeding

This preparation is primarily used to support the delivery of essential water-soluble vitamins (B-group and Vitamin C) to assist with meeting the body's requirements when a patient is receiving Total Parenteral Nutrition (TPN) or cannot absorb nutrients orally. The main benefit contributes to the maintenance of nutritional balance and helps reduce the risks associated with deficiency states during prolonged periods of artificial feeding. Common clinical indications include use in Total Parenteral Nutrition (TPN) regimens, during post-surgical recovery, and in patients with gastrointestinal failure.

“The provision of essential intravenous vitamins is considered relevant for supporting a patient's recovery and metabolic stability.”


Managing Risks of Systemic Imbalance and Fatigue

Soluvit novum supports systemic function essential for energy levels and recovery. By addressing this need, it helps manage the risk of deficiency-related symptoms, including profound fatigue, generalized muscle weakness, and systemic imbalance, which may interfere with the recovery process and overall comfort in critically ill patients.


Assisting Recovery in High-Demand Clinical Scenarios

The supplement is commonly used in clinical settings such as major trauma or in patients with conditions where metabolic demand for vitamins is significantly heightened. The benefit is relevant for providing essential nutrients for processes like wound healing and red blood cell formation, thereby assisting with maintaining functional stability essential for the recovery process.

Quick Fact: Relief for Fatigue and Weakness

The preparation assists in managing symptoms related to metabolic insufficiency, such as profound fatigue and muscle weakness, and helps address the symptoms related to systemic imbalance that often accompany vitamin depletion.

Regulatory References

  1. U.S. National Library of Medicine DailyMed
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Soluvit novum — official regulatory information


Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • All Age Groups: Permitted for use in adults, adolescents, children, infants, and neonates requiring intravenous nutritional support.
  • Pregnancy and Lactation: Use is permitted during both pregnancy and breastfeeding.

Populations for whom use is contraindicated:

  • Patients with known hypersensitivity to any of the components of the product, including active vitamin substances (e.g., folic acid, thiamine) or excipients (e.g., methyl parahydroxybenzoate).

Eligibility Classifications (High-Level)

Eligibility severity classification (as defined in official documents):

  • Absolute Contraindication: Hypersensitivity to ingredients.
  • Conditional Use/Caution: Severe deficiency states, latent pernicious anemia, and patients with renal impairment.
  • Not Established (Insufficient Data): Geriatric patients, hepatic impairment, and renal impairment (due to lack of dedicated studies).

Official eligibility statements:

  • The product is not intended to correct established severe vitamin deficiency states; its role is for nutritional maintenance.
  • Use requires caution in patients with renal impairment and in children, due to the component Biotin potentially interfering with certain laboratory test results.
  • Folic acid within the product requires caution as it may obscure the symptoms of latent pernicious anemia.

The regulatory documents establish that Soluvit Novum is broadly eligible for all age groups requiring intravenous nutritional support, based on its classification as a supplemental vitamin preparation. The only absolute prohibition stated in the label is for individuals with a known hypersensitivity to the ingredients. Specific caution is mandated for patients with conditions such as latent pernicious anemia or renal impairment, where use is not prohibited but must be managed under regulatory guidance.

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What should I know about interactions with other medicines?

The interaction profile for Soluvit novum is defined by documented effects on the efficacy and exposure of co-administered medicines, specific physical mixing constraints, and potential interference with diagnostic procedures. All interactions listed are based strictly on official government regulatory documents.

Interaction Type Interacting Substance/Condition Regulatory Statement
Pharmacodynamic & Exposure Levodopa Pyridoxine (Vitamin B6) is officially documented to reduce the therapeutic effect of levodopa.
Phenytoin & Antiepileptics The Folic acid component may lower the serum concentration of phenytoin, as well as certain other antiepileptic medicines and barbiturates.
Physical Incompatibility Fat Emulsions (e.g., Intralipid, SMOFlipid) The product must not be added to specific fat emulsions due to the documented risk of physical incompatibilities. Mixing is restricted unless official compatibility is documented.
Diagnostic Interference Biotin-Sensitive Lab Tests Biotin may interfere with laboratory tests based on the biotin/streptavidin assay, potentially yielding false results. This risk is noted as higher in children and those with renal impairment.
Pernicious Anaemia The Folic acid component may obscure the diagnosis of pernicious anaemia.

These officially documented interactions establish procedural requirements and co-administration awareness. The regulatory documents define constraints on concurrent use with certain pharmacological agents and mandate strict adherence to technical mixing rules when preparing the final intravenous solution.

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Mechanism of Action

How Soluvit Novum Works

Soluvit Novum provides water-soluble vitamins that function as co-factors for numerous biological reactions. The systemic availability of these co-factors facilitates diverse enzymatic reactions throughout the organism. Its primary action is focused on enzyme function rather than regulatory signaling.

Supporting Core Energy Production and Metabolism

The B-vitamins in the formulation act as co-factors to enable apoenzymes to process carbohydrates, fats, and proteins. This activity engages the Krebs cycle and other key metabolic pathways, resulting in the generation of ATP, the cell's energy source.

Facilitating Cellular Repair and Renewal

The components, such as folic acid and Vitamin B12, are required for DNA and RNA synthesis and the conversion of homocysteine. These molecular steps contribute to the synthesis of cells in rapidly renewing tissues, including hematopoietic cells and components of the nervous system.

Systemic Support and Protection

This relates to the widespread influence of co-factor activity across multiple physiological regulatory systems. Components like Vitamin C also function as antioxidants, contributing to the neutralization of reactive oxygen species. The widespread cofactor activity facilitates diverse enzyme-driven processes across all organ systems.

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Dosage and Administration Information

Administration Guidelines

Property Instruction
Route of Administration Strictly intravenous infusion only, delivered into a vein as part of a parenteral nutrition regimen.
Dosing Schedule The standard daily dose for adults and children weighing 10 kg or more is the content of one vial. Children weighing less than 10 kg should receive a weight-adjusted dose of 1/10 of the vial content per kilogram of body weight daily.
Frequency Pattern The preparation is administered once daily. The dose should be administered over a number of hours as a continuous infusion to prevent rapid excretion of water-soluble vitamins.

Preparation and Procedural Rules

The lyophilised powder must not be given undiluted. Proper preparation requires the powder to be reconstituted by adding 10 mL of an approved diluent, such as Water for Injections or Glucose solution.

The reconstituted solution is then added to the final parenteral nutrition admixture, provided the compatibility of all components has been confirmed. This final mixing must occur aseptically and immediately before the start of the infusion, with the mixture used within 24 hours of preparation.

A critical procedural condition is the protection of the admixture from light during infusion, particularly when the medicine is diluted in clear, water-based solutions. This specific handling requirement is essential for preserving the stability of the vitamins.

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Recent Clinical Evidence

Soluvit novum: Overview of Clinical Evidence

The Role of Soluvit novum in Intravenous Nutritional Support Research

This section summarizes the clinical evaluation of the multivitamin preparation, focusing on studies that examine the product as a component of intravenous feeding regimens, which is its primary context of use. The preparation was observed in research contexts where patients could not receive or absorb nutrients orally. Because providing essential vitamins is an established requirement for maintaining health during artificial feeding, research explored the preparation’s inclusion as a component of Total Parenteral Nutrition (TPN). The research examined vitamin status and general clinical courses in patient groups facing acute illness or prolonged nutritional challenges.

Research Evidence for Preventing Vitamin Deficiency During Intravenous Feeding

Studies evaluating the necessity of vitamin supplementation in TPN often use observational settings and nutritional status monitoring in patient cohorts. This research describes the patterns observed in how vitamin levels evolve when the preparation is provided directly into the circulation. Studies report patterns related to plasma levels of B-group vitamins and Vitamin C measured during study intervals. Regulatory and clinical guidelines describe the provision of micronutrients as a standard requirement for nutritional balance in these settings.

Outcomes Examined in Clinical Research

Studies explored outcomes related to systemic or functional imbalance and measures of clinical resource use. Researchers examined measures such as the length of hospital stay, duration of mechanical ventilation, and the duration until patients met criteria for oral feeding. These outcomes were measured in the context of the entire nutritional support regimen, of which Soluvit novum was observed in as a necessary component.

Evidence in Specific Patient Groups

The preparation was observed in diverse populations, including adults, older adults, and critically ill children (including infants and neonates) requiring intravenous nutrition. Research describes patterns in how the children's nutritional status evolved during the study interval. Additionally, evidence suggests the preparation was observed in research contexts examining nutritional balance in patients undergoing Chronic Intermittent Haemodialysis, a setting where water-soluble vitamins are often lost. Data show patterns related to the observed changes in nutrient status due to these increased losses.

Understanding Long-Term Studies and Follow-up Data

The follow-up durations were limited in many key trials, often focusing on the acute phase of illness. Research exploring short-term changes typically assesses outcomes within a few weeks. For patients who receive this intravenous preparation for prolonged or chronic nutritional maintenance, the available data largely comes from observational settings and clinical consensus rather than large, long-running placebo-controlled trials. Therefore, long-term data are not fully established.

What is Still Uncertain About Soluvit novum

Evidence quality varies across studies, and some comparative evidence is lacking. Because providing essential vitamins in TPN is standard practice, limited direct, high-quality RCTs have been conducted comparing the standard-dose multivitamin mixture component alone against a placebo. This means the specific contribution of the vitamin component to overall clinical outcomes is not yet clear. Certainty remains low regarding whether the doses provided can actively correct severe, pre-existing deficiency states. Finally, studies reported that the biotin component may be associated with interference in certain common laboratory tests.

Key Studies & References

  1. SOLUVIT N - Thiamine Mononitrate, Riboflavin 5-Phosphate Sodium Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Sodium Pantothenate, Biotin, Sodium Ascorbate Powder, for Solution (US Labeling/DailyMed)
  2. Soluvit N (Injection, powder) - Medsafe (New Zealand Product Datasheet)
  3. ESPEN practical guideline: Home parenteral nutrition (Used to contextualize TPN necessity and long-term data gaps)
  4. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Vitamins (Used for context on pediatric/infant use and vitamin monitoring)
  5. SOLUVIT N Product Information (Fresenius Kabi Datasheet - Used for general product data, indication, and biotin interference warning)
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Frequently Asked Questions (FAQ)

Common questions about Soluvit novum (FAQ)

Q: Does Soluvit novum require a prescription?

A: Yes, Soluvit novum is classified as a prescription drug in jurisdictions such as the United States, and its use is intended for administration under the supervision and order of a qualified healthcare professional. Its highly specialized use in intravenous nutrition dictates this classification. According to official product information, it is not available for general purchase.

Q: Is Soluvit novum the same as other vitamin injections I've heard of?

A: Soluvit novum is a preparation specifically designed to provide nine essential water-soluble vitamins for individuals receiving intravenous (IV) nutrition. It is intended as a supplement to help meet the body’s daily metabolic requirements when oral intake is compromised. Official documents define its specific components and the context of its intended use in clinical settings.

Q: What is the typical duration of treatment with Soluvit novum?

A: The duration of treatment is not fixed and is determined by a healthcare professional based on a patient’s specific nutritional requirements. The product is used in various clinical contexts, ranging from short-term use during an acute illness to longer-term use as a component of Total Parenteral Nutrition (TPN).

Q: What are the most common side effects reported for Soluvit novum?

A: The most serious safety concern documented is the potential for severe allergic reactions, including anaphylaxis, though the frequency of this reaction is unknown. Other less common reactions (occurring in less than 1% of people) include symptoms like shivering, chills, nausea, and vomiting. A complete list of documented effects is available in the official product information.

Q: Does Soluvit novum contain any preservatives or artificial colors?

A: According to the excipients list in the official label, Soluvit novum contains methyl parahydroxybenzoate, which is a type of preservative. The official documents do not list or reference the inclusion of any artificial colors in the preparation.

Q: Is there a risk of overdose with Soluvit novum?

A: The risk of an overdose is considered rare because the medicine is strictly administered by trained healthcare professionals in a controlled environment. Regulatory information states that no adverse effects of overdose have been reported, except in isolated cases involving extremely high parenteral doses (doses administered directly into the vein).

Q: Does Soluvit novum contain Vitamin K?

A: No, Soluvit novum is a mixture of nine water-soluble vitamins (B-group and Vitamin C). Vitamin K is a fat-soluble vitamin and is not included in this product. When Vitamin K is required for a patient receiving intravenous nutrition, it is typically provided through a separate preparation.

Q: Is the use of Soluvit novum documented in major medical guidelines?

A: Official product information indicates that the preparation is formulated in accordance with established nutritional recommendations for intravenous use. Specifically, the composition aligns with the guidelines set forth by the American Medical Association for the composition of parenteral vitamin solutions given to adults.

Q: Does Soluvit novum contain biotin?

A: Yes, Biotin (also known as Vitamin B7) is included as one of the nine water-soluble vitamins that make up the active ingredients of Soluvit novum. The presence of Biotin has been noted in the official documentation due to its potential for interfering with certain laboratory tests.

Q: What happens if a dose of Soluvit novum is missed?

A: Since Soluvit novum is administered in a clinical setting, patients do not need to manage the dosing schedule themselves. A team of healthcare professionals oversees the care and will ensure that the correct amount is administered at the appropriate time as part of the total parenteral nutrition regimen.

Q: What are the official restrictions on who can administer Soluvit novum?

A: The official product labeling states that administration of Soluvit novum must be carried out by a person who is qualified to do so. This means the administration process requires a qualified healthcare professional.

Q: How does the concentration of vitamins in Soluvit novum compare to daily requirements?

A: The preparation is specifically formulated to serve as a supplement that meets the daily requirements of water-soluble vitamins for patients receiving intravenous nutrition. The composition is based on authoritative clinical recommendations for this specialized type of nutritional support.

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How should Soluvit novum be stored and disposed of?

How to Store and Dispose of Soluvit Novum

Soluvit Novum must be stored in its original container and protected from light. The unopened powder vial should be stored at a temperature not exceeding 25 C and must not freeze.

Stability and Child Safety

The reconstituted solution is for single use only. Chemically, it is stable for 24 hours at 25 C, but should be used immediately. If immediate use is not possible, the solution should be stored at 2 C to 8 C (refrigerated) for no longer than 24 hours. Always keep Soluvit Novum out of the sight and reach of children.

Disposal

Disposal of unused product or waste material must comply with local requirements. Medicines should not be disposed of in drains or household rubbish.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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