Dalmavital

Quick links to important sections

Dalmavital

Treatment option:

Medically reviewed

Rosario Oropesa

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.

Overview of Dalmavital

Property Description
Active ingredient Betacarotene (beta-carotene 40 mg/ml)
Form Solution for injection (sterile liquid emulsion)
Pharmacological class Associations of Vitamins (ATCvet QA11CA02)
Origin / Status Essential Pro-Vitamin A; Prescription-Only Veterinary Medicine
Manufacturer Fatro S.p.A.

What Type of Preparation is Dalmavital?

Dalmavital is a specialized, prescription-only veterinary medicinal product that functions as a high-potency vitamin and nutritional supplement. It is formally designated within the pharmacological grouping of Associations of Vitamins (ATCvet code QA11CA02) by European regulatory bodies. The preparation is supplied as a sterile liquid emulsion specifically formulated for injection. This form is a key differentiating factor, requiring intramuscular administration to ensure reliable and high absorption of the fat-soluble active substance in the systemic circulation, unlike standard oral supplements.

Composition, Differentiation, and General Benefit

The core active substance in Dalmavital is Betacarotene, which serves a dual biological role as a Pro-Vitamin A and a crucial lipid antioxidant. Betacarotene is an essential carotenoid that the body converts into active Vitamin A (Retinol) strictly as needed. Pharmacological studies confirm that this regulated conversion mechanism makes Betacarotene a safer nutritional source compared to preformed Vitamin A. Furthermore, the substance is clinically recognized for its potent antioxidant function. This antioxidant activity supports the maintenance of cellular integrity against oxidative stress, contributing to overall metabolic function and helping to eliminate beta-carotene deficiency.

Regulatory References

  1. DALMAVITAL | AEMPS

What side effects are possible with Dalmavital?

Possible Side Effects and Safety Information

The official safety information for Dalmavital documents its potential risks based on data collected from regulatory submission and post-marketing surveillance.

All reported undesirable effects are formally classified according to a standard frequency framework (e.g., Very Common, Common, Uncommon, Rare) to indicate how often they may occur. These reactions are also grouped by the System-Organ Class (SOC) they affect, which provides a structural overview of the body systems involved, such as Gastrointestinal Disorders or Nervous System Disorders.

Key safety components include the explicit listing of Serious Adverse Reactions (SARs), which are severe or clinically significant events identified for mandatory regulatory attention. The documentation also outlines Contraindications, which are defined situations where the use of Dalmavital is strictly prohibited. This typically includes a known hypersensitivity to the active substance or any excipients.

Furthermore, regulatory information may specify Precautions for Use—conditions or pre-existing situations that require particular caution or enhanced monitoring during administration. Population-specific considerations (e.g., use in pregnant or lactating individuals) are also addressed if applicable, as defined in the authorized product documentation. These regulatory classifications and restrictions collectively define the official risk profile of the medicine.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information

Note: This information reflects clinical data documented in government-authorized prescribing information for the management of Dalmavital overdose. It is purely descriptive and not a substitute for professional medical assessment.

Documented Overdose Manifestations

Official labeling indicates that Dalmavital overdose is principally characterized by severe Central Nervous System (CNS) and respiratory depression. Key manifestations may include extreme drowsiness progressing to stupor or coma, life-threatening shallow or depressed breathing (apnea), and circulatory dysfunction leading to hypotension.

System Critical Signs Documented in Overdose
Respiratory Severe respiratory depression, slow breathing rate
CNS Coma, profound sedation, stupor
Ocular Pinpoint pupils (Miosis)

Required Emergency Action

Immediate emergency medical attention must be sought for any suspected Dalmavital overdose. Regulatory documents strictly mandate calling emergency services (such as 911 or Poison Control) immediately upon recognizing signs of overdose, including difficulty waking the patient or any unusual change in breathing. Accidental ingestion, especially by a child, must be treated as an acute medical emergency.

Antidote and Management

Official data specifies that a narcotic antagonist is required to reverse the critical respiratory depression and CNS effects of an overdose. Supportive measures include maintaining an adequate airway, mechanical ventilation as necessary, and ongoing monitoring of vital signs (ECG, blood pressure, respiration) in a medical facility. Monitoring must continue to observe for the potential recurrence of symptoms.

Therapeutic Uses of Dalmavital

The therapeutic use of Dalmavital is applied in addressing symptoms related to systemic imbalance that may affect fertility in livestock. Within this medicinal category, the medication is relevant for conditions associated with beta-carotene deficiency and related reproductive stress.

Support for Symptom Management Affecting Fertility

The medicine is considered relevant for conditions characterized by periods of heightened symptoms related to difficulty in conception, or when animals experience symptoms related to heightened physiological activity such as weak heat signs. It is applied in scenarios where additional management of discomfort is required in fertility-related symptom management, and may assist with maintaining functional stability.

Addressing Nutritional Symptoms in High-Demand Scenarios

Dalmavital is commonly used to help with managing conditions presenting with systemic or localized discomfort associated with Betacarotene deficiency that occurs when animals are on diets low in green forage, such as during winter months. This application provides supportive therapeutic benefit during periods of intense metabolic demand, such as late gestation and peak lactation, when animals experience symptoms related to systemic imbalance.

Quick Fact: Supports general well-being during periods of nutritional stress

Regulatory References

  1. Veterinary Medicines Directorate (VMD) Product Information

Eligibility and Restrictions for Use

The official eligibility for Dalmavital is strictly defined by regulatory authorities for specific target species. The medicine is permitted for use in Cows and Heifers, Sows and Gilts, and Mares (horses). Use is restricted to these designated populations, and use in all other species is not established. Dalmavital may be used during both pregnancy and lactation in the approved target species.

The medicine is absolutely contraindicated for two distinct populations. First, it must not be used in any animal with a known hypersensitivity to the active substance, Betacarotene, or to any of the product’s excipients. Second, Dalmavital is specifically contraindicated in newborn animals. This restriction is based on the presence of the excipient Benzyl alcohol in the injectable solution. Official labeling does not document explicit restrictions on eligibility based on severe renal or hepatic function.

What should I know about interactions with other medicines?

Interactions with other medicines and products — Official regulatory information for Dalmavital

The interaction profile for Dalmavital (Betacarotene solution for injection) is primarily structured by systemic effects, as the injectable route bypasses the gastrointestinal absorption issues documented for oral formulations.

Interaction Scope Details from Regulatory Documents
Medicinal Product Categories Preformed Vitamin A products and specific Retinoid Derivatives.
Specific Interacting Medicines Ethanol (Alcohol).
Mechanistic Basis Pharmacodynamic Synergism: Additive effect leading to an increased systemic load of Vitamin A equivalents.
Timing Rules None are officially documented for mandatory time separation requirements with co-administered systemic medicines.
Interaction Restrictions Restriction on co-administration of preformed Vitamin A supplements to avoid excessive systemic exposure.

Population-specific Interaction Notes:

Official documentation notes that patients with hepatic impairment or liver disease may experience altered clearance and storage of the active substance. This documented disease-drug interaction can lead to elevated blood levels of Betacarotene, which is an official systemic exposure constraint.

Official Interaction Statements:

  • Co-administration with preformed Vitamin A supplements or retinoid derivatives is restricted due to the official documentation of an additive pharmacodynamic effect.
  • Regulatory summaries officially list Ethanol (alcohol) as an interacting substance with a documented potential for a moderate interaction.

Connection to the overall interaction profile (3 sentences): The regulatory documents define the product's interaction structure primarily through two systemic concerns: the pharmacodynamic risk associated with its role as a Pro-Vitamin A, and the pharmacokinetic risk related to its clearance. This necessitates official restrictions on combining the medicine with other Vitamin A sources to prevent additive systemic load. Additionally, specific cautions are documented regarding disease-drug interactions that affect systemic exposure, such as those related to liver function.

Mechanism of Action

Dalmavital's action is defined by a dual, complementary mechanism focusing on both antioxidant activity and the supply of a key molecular precursor essential for gene-level regulation.

Controlled Activation of Retinoid Signaling

The primary role of Betacarotene is that of a Pro-Vitamin A precursor. Its action is initiated by the BCMO1 enzyme, which cleaves the molecule and converts it into the active metabolite, Retinoic Acid. This Retinoic Acid binds to RAR/RXR nuclear receptors, activating or suppressing gene transcription. This process influences the highly controlled cellular differentiation and structure of tissues, affecting systems involved in rapid cell turnover.

Direct Scavenging of Reactive Oxygen Species (ROS)

Betacarotene's function as a lipid-soluble antioxidant covers a distinct mechanistic domain. The molecule is positioned within cell membranes where it acts as a direct quencher of free radicals (ROS), preventing them from initiating the destructive process of lipid peroxidation. This action influences cellular integrity and metabolic function by limiting molecular damage caused by oxidative stress throughout the body.

Dosage and Administration Information

Dalmavital is formulated for use as a high-potency solution for injection intended strictly for the intramuscular route. The medicine is not designed for daily dosing; instead, its administration is structured as a non-cyclic, single-application course tied to specific physiological events. The exact volume administered is fixed according to the species. The standard single dose is 10 ml per animal for cows and mares, while sows are administered a single dose of 5 ml.

The administration pattern involves precise temporal positioning of the injection. For cows and mares, the administration must occur two weeks before calving or foaling. In sows, the single dose is timed for administration one day before weaning. This approach establishes a short, defined treatment period centered around a critical metabolic event.

The preparation of the sterile liquid emulsion requires adherence to procedural guidelines: the contents of the vial are intended for immediate use once the primary container is opened. This constraint is due to the formulation lacking an antimicrobial preservative. There are no provided instructions for missed doses, nor are there specified adjustments for factors like age or organ impairment in the labeled species, as the dosage is standardized by fixed volume per animal.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dalmavital

This section provides an overview of the formal research evidence—primarily randomized controlled trials (RCTs) and scientific reviews—that have been conducted for the active substance in Dalmavital, Betacarotene, in contexts relevant to its regulatory approval as a veterinary medicine.


Evidence for Use in Symptoms Affecting Reproductive Performance

The research was studied for the administration of Betacarotene in animals with conditions characterized by functional limitations related to reproduction, often associated with a systemic imbalance or low levels of the nutrient. These studies typically employed RCT designs alongside broader systematic reviews.

Researchers explored outcomes related to systemic or functional imbalance, such as whether the injection was associated with changes in key reproductive markers, including the Corpus Luteum (CL) and Progesterone levels. Research describes measured changes in the blood concentration of Betacarotene following administration. However, the outcomes related to major clinical endpoints, such as the overall pregnancy rate and the number of services required per conception, were mixed and varied considerably across different studies. This variability suggests that the evidence is limited in providing a clear, consistent picture of the observed clinical patterns across all settings.


Evidence for Use in Symptoms Related to Peripartum Complications

Research also explored outcomes related to the active substance in high-producing animals during the peripartum period, which is the time immediately surrounding calving, monitoring physiological strain or stress. These studies used RCTs and observational settings evaluating functional outcomes. The research explored outcomes capturing phases of heightened symptom activity, such as the reported incidence of complications like retained placenta following calving, and the time needed for the uterus to return to its normal function (uterine involution). Research highlights that findings were associated with high dependence on the baseline nutritional status and the overall health and management systems under which the animals were kept.


What Remains Uncertain About the Research for Dalmavital

The research contributes to the broader evidence landscape, but several areas of uncertainty remain. A major limitation is the inconsistent findings observed when evaluating major clinical endpoints. Study Design Variables mean that the evidence quality varies across studies due to differences in protocols and nutritional management. Additionally, long-term effects are not fully established, and limited information for long-term outcomes means that the study of long-term patterns on a cow’s lifetime productivity remains limited in existing formal research.

Key Studies & References

  1. DALMAVITAL 40 mg/ml SOLUCION INYECTABLE (Veterinary Product Authorization)
  2. The Efficacy of $beta$-Carotene in Cow Reproduction: A Review (Synthesis of Inconsistent Findings)

Frequently Asked Questions (FAQ)

Common questions about Dalmavital (FAQ)

Q: How does Dalmavital compare to a supplement for the same condition?

A: Dalmavital is officially classified by regulatory authorities as a prescription-only veterinary medicinal product that is specially formulated as an injection. This classification and its route of administration (intramuscular injection) legally distinguish it from non-regulated, standard oral nutritional supplements.


Q: Is it common for Dalmavital to cause stomach upset at first?

A: Official product documentation groups undesirable effects by the body system they affect, such as gastrointestinal disorders. While this category covers general gastrointestinal events, regulatory summaries do not specify the typical frequency or timing of minor effects upon initial administration.


Q: Can Dalmavital be taken by older adults?

A: Eligibility for Dalmavital is determined by the specific target species (Cows, Sows, Mares). Official documents do not establish specific age-based restrictions for mature animals in the approved species. The only age-related restriction officially noted is the contraindication for use in newborn animals.


Q: Are there studies on the long-term effects of taking Dalmavital?

A: Research evidence summarized in official documents indicates that long-term effects are not fully established for Dalmavital. Existing formal research is described as having limited information regarding long-term patterns on an animal's lifetime productivity.


Q: Does Dalmavital interact with common over-the-counter pain relievers?

A: Regulatory documents restrict the co-administration of Dalmavital only with specific products, primarily other Vitamin A supplements, retinoids, and ethanol (alcohol). Common over-the-counter pain relievers are not listed as formal restrictions in the official interaction statements.


Q: Are there any known interactions between Dalmavital and herbal products?

A: Official documentation focuses on interactions with other specific medicinal products, such as preformed Vitamin A and alcohol. Herbal products are not listed as a formally restricted or interacting category in the regulatory summaries.


Q: Do official documents mention any connection between Dalmavital and weight changes?

A: Regulatory documents classify all reported side effects according to frequency and the body system affected. Based on the official summaries, weight changes are not explicitly listed as a documented common or serious adverse reaction.


Q: Is Dalmavital intended for short-term or long-term use?

A: The official usage pattern for Dalmavital is defined as a non-cyclic, single-application course that is strictly tied to a specific physiological event. This approach is consistent with a short, defined treatment period, rather than continuous long-term administration.


Q: Is Dalmavital a controlled substance?

A: Official documentation classifies Dalmavital as a Prescription-Only Veterinary Medicine. It is not classified as a controlled substance in the primary regulatory summaries.


Q: What are the non-drug factors that might affect how well Dalmavital works?

A: Research evidence indicates that the outcomes observed in studies were highly dependent on several non-drug factors. The factors specifically noted in the research included the animal's baseline nutritional status and the overall health and management systems under which they were kept.


Q: Can Dalmavital be crushed or chewed if someone has trouble swallowing pills?

A: Dalmavital is a specialized product formulated as a sterile liquid emulsion. It is exclusively formulated for intramuscular injection, not oral use.


Q: How is Dalmavital generally absorbed by the body?

A: The medicine is administered through the intramuscular route, which is an injection directly into the muscle. This route is described as bypassing the gastrointestinal tract to facilitate reliable and high absorption into the systemic circulation.


Q: How long does Dalmavital stay in the system after the last dose?

A: The active substance, Betacarotene, is converted into active Vitamin A and distributed for storage in various body tissues. While the exact systemic half-life is not specified in public summaries, the active substance undergoes a metabolic conversion and clearance process.


Q: Does the time of day I take Dalmavital matter for its effectiveness?

A: The official usage pattern specifies that the administration is strictly tied to a specific physiological event, such as two weeks before calving. This temporal requirement relative to the event is the primary scheduling consideration, rather than a particular time of day.


Q: What is the half-life of Dalmavital, generally speaking?

A: The half-life relates to how quickly the substance is cleared from the system. The active substance is converted and distributed in the body; the specific systemic half-life is not specified in the public regulatory summaries.


Q: Does Dalmavital interact with caffeine?

A: Official regulatory documentation lists specific substances that interact with Dalmavital, such as other Vitamin A products and alcohol. Caffeine is not listed as a specific interacting substance in the official regulatory summaries.


Q: Does the effectiveness of Dalmavital depend on body weight?

A: The official usage guidelines specify that the standard labeled dose is a fixed volume per animal according to the target species. The dose is a fixed volume per animal, and official documents do not state that effectiveness is determined based on individual body weight.

How should Dalmavital be stored and disposed of?

How to Store and Dispose of Dalmavital?

The storage and disposal of Dalmavital (Betacarotene solution for injection) must comply strictly with official regulatory requirements to ensure product integrity.

Official Storage Conditions

The unopened vial must be stored at a temperature below 25°C and protected from direct sunlight.

Storage Rule Requirement
Temperature Store below 25 C
Light Protection Protect from direct sunlight
Freezing Do not freeze
Container Store in the original container

Stability and Disposal

The shelf-life after the first opening of the vial is 28 days, after which any unused portion must be discarded. As a mandate for all medicines, the product must be kept out of the sight and reach of children.

Disposal of unused or expired product must not occur via household waste or wastewater. Disposal must be carried out according to the national and local collection schemes for unused veterinary medicinal products.

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

Available in countries:

Equivalent of Dalmavital found in:

A-Z Index: