Registered Rwanda · Rwanda FDA

SMOFKABIVEN PERIPHERAL

AMINO ACID SOLUTION WITH ELECTROLYTES, GLUCOSE 13%& LIPID EMULSION (1000 ml contains: Glucose71g, Alanine4.4g, Arginine3.8g, Glycine3.5g, Histidine0.93g, Isoleucine1.6g, Leucine2.3g, Lysine2.1g, Methionine1.3g, Phenylalanine1.6g, Proline3.5g, Serine2.1g, Taurine0.32g, Threonine1.4 g, Tryptophan0.63 g, Tyrosine 0.12 g, Valine2.0 g, Calcium chloride0.18 g, Sodium glycerophosphate1.3 g, Magnesium sulphate0.38 g, Potassium chloride1.4 g, Sodium acetate1.1 g, Zinc sulphate0.004 g, Soya-bean oil, refined8.5 g, Medium-chain triglycerides 8.5 g, Olive oil, refined7.0 g, Fish oil, rich in omega-3-acids4.2 g per 1000ml)

Rwanda FDA-HMP-MA-2073 EMULSION FOR INFUSION 71g, 4.4g, 3.8g, 3.5g, 0.93g, 1.6g, 2.3g, 2.1g, 1.3g, 1.6g, 3.5g, 2.1g, 0.32g, 1.4 g, 0.63 g, 0.12 g, 2.0 g, 0.18 g, 1.3 g, 0.38 g, 1.4 g, 1.1 g, 0.004 g, 8.5 g, 8.5 g, 7.0 g, 4.2 g blood and blood forming organs INN generic

What it does

Amino is a medication that may be used to support various health conditions. It works in the body to help improve certain functions.

Commonly used for: nutritional support, amino acid deficiency

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.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2073
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
AMINO ACID SOLUTION WITH ELECTROLYTES, GLUCOSE 13%& LIPID EMULSION (1000 ml contains: Glucose71g, Alanine4.4g, Arginine3.8g, Glycine3.5g, Histidine0.93g, Isoleucine1.6g, Leucine2.3g, Lysine2.1g, Methionine1.3g, Phenylalanine1.6g, Proline3.5g, Serine2.1g, Taurine0.32g, Threonine1.4 g, Tryptophan0.63 g, Tyrosine 0.12 g, Valine2.0 g, Calcium chloride0.18 g, Sodium glycerophosphate1.3 g, Magnesium sulphate0.38 g, Potassium chloride1.4 g, Sodium acetate1.1 g, Zinc sulphate0.004 g, Soya-bean oil, refined8.5 g, Medium-chain triglycerides 8.5 g, Olive oil, refined7.0 g, Fish oil, rich in omega-3-acids4.2 g per 1000ml)
Dosage form
EMULSION FOR INFUSION
Strength
71g, 4.4g, 3.8g, 3.5g, 0.93g, 1.6g, 2.3g, 2.1g, 1.3g, 1.6g, 3.5g, 2.1g, 0.32g, 1.4 g, 0.63 g, 0.12 g, 2.0 g, 0.18 g, 1.3 g, 0.38 g, 1.4 g, 1.1 g, 0.004 g, 8.5 g, 8.5 g, 7.0 g, 4.2 g
Pack size
1206 ml, 1448 ml, 1904 ml , 4x1206 ml
Therapeutic class
-
ATC class (WHO)
B05CX - Other irrigating solutions
RxNorm RxCUI
4850
Manufacturer / MAH
Fresenius Kabi
Country of origin
Sweden
Manufacturer location
Estermannstraße 17, 4020 Linz, Austria

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:06 · updated 2026-09-17 02:30:43

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

About amino

Amino is a medication that may be used to support various health conditions. It works in the body to help improve certain functions.

What it treats

  • nutritional support
  • amino acid deficiency

How it works

Amino helps provide essential building blocks for proteins in the body, supporting overall health and well-being.

Who it's for

Amino is suitable for individuals needing extra nutritional support or those who have low levels of amino acids.

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

About electrolytes

Electrolytes are essential minerals in the body that help maintain fluid balance and support various bodily functions.

What it treats

  • dehydration
  • electrolyte imbalance

How it works

Electrolytes help regulate nerve and muscle function and maintain hydration.

Who it's for

People who are dehydrated or have an imbalance of minerals in their body.

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

About emulsion

Emulsion is a mixture used to deliver medicine effectively, often in a liquid form.

What it treats

  • skin conditions
  • hydration of the skin
  • medication delivery

How it works

Emulsions help mix oil and water, making it easier for the body to absorb the medication.

Who it's for

Suitable for individuals needing topical treatment for skin issues or hydration.

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

About glucose

Glucose is a simple sugar that provides energy to the body.

What it treats

  • low blood sugar (hypoglycemia)
  • energy supplement

How it works

Glucose quickly raises blood sugar levels, providing immediate energy.

Who it's for

People who need quick energy, especially those with low blood sugar.

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

About lipid

Lipids are fats that are important for energy storage and overall health.

What it treats

  • providing energy to the body
  • supporting cell function
  • aiding in the absorption of vitamins

How it works

Lipids store energy and help in the structure of cell membranes, as well as playing a role in hormone production.

Who it's for

Lipids are essential for everyone, as they are a vital part of a balanced diet.

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

Clinical monograph: Glucose

BNF-referenced

Glucose is a simple sugar and a vital carbohydrate that serves as the primary energy source for human cells. It is essential for various metabolic processes, providing energy through glycolysis and subsequent pathways. Glucose is utilized by nearly all tissues and plays a crucial role in maintaining energy homeostasis in the body. It can be administered orally or intravenously and is commonly used in clinical settings for fluid and electrolyte management.

Indications

  • Fluid and electrolyte imbalances
  • Hypoglycemia
  • Nutritional supplementation
  • Diabetic emergencies

Dosage

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

Adults: The dosage varies based on the clinical condition and specific formulation used. For intravenous administration, consult product literature for precise dosing.

Mechanism of action

Glucose supplies energy to tissues by undergoing glycolysis, which begins with its phosphorylation by hexokinase to form glucose 6-phosphate. This activates glucose for breakdown, ultimately generating ATP and NADH. The aerobic metabolism of glucose can yield up to 36 ATP molecules. Glucose also serves as a precursor for other biomolecules and regulates various physiological processes including gene transcription and hormone secretion.

Pharmacodynamics

Glucose is an obligatory energy source for cellular activities and plays a significant role in metabolic signaling. It is oxidized to yield energy through glycolysis, the citric acid cycle, and oxidative phosphorylation. Glucose can be converted into fat for energy storage and is stored as glycogen in the liver and muscles. Its administration increases blood glucose levels and stimulates insulin secretion, particularly through oral routes that activate gut incretin hormones.

Pharmacokinetics

Glucose is rapidly absorbed from the gastrointestinal tract or directly into the bloodstream when administered intravenously. It is distributed widely throughout the body and metabolized primarily in tissues requiring energy. The body maintains glucose homeostasis through regulatory mechanisms involving insulin and glucagon. Excess glucose can be stored as glycogen or converted to triglycerides for long-term energy storage.

Adverse effects

  • Hyperglycemia
  • Increased osmolarity
  • Fluid overload
  • Electrolyte imbalances

Interactions

  • Insulin - may require dose adjustments

Precautions

  • Use with caution in patients with diabetes mellitus
  • Monitor blood glucose levels in patients receiving parenteral glucose
  • Adjust dosage in renal impairment

Pregnancy

Glucose is generally considered safe in pregnancy; however, monitoring is advised, especially in diabetic patients.

Breast-feeding

Glucose is considered safe during breastfeeding, as it is a natural sugar found in breast milk.

Storage

Store at room temperature, away from light. Avoid freezing.

Formulations

  • Glucose 5% solution for infusion
  • Glucose 10% solution for infusion
  • Glucose 0.9% solution for injection
  • Glucose sodium chloride combination solutions
BNF 85 (British National Formulary) p.1173 BNF for Children 2019-2020 p.633 PubChem / pathway

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: amino

Aminophylline is a compound that consists of theophylline and ethylenediamine, primarily used as a bronchodilator in the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other conditions associated with reversible airway obstruction. It acts by relaxing the smooth muscles of the airways, thereby improving airflow and reducing the work of breathing.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Bronchospasm associated with respiratory conditions

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing guidelines.

Adults: Refer to the BNF for specific adult dosing guidelines.

Mechanism of action

Aminophylline works as a phosphodiesterase inhibitor, leading to an increase in intracellular cyclic AMP (cAMP). This action results in the relaxation of bronchial smooth muscle, bronchodilation, and reduced airway resistance. It may also exert anti-inflammatory effects by inhibiting the release of inflammatory mediators from mast cells.

Pharmacodynamics

The pharmacodynamics of aminophylline involve its ability to enhance respiratory function by decreasing airway resistance, improving mucociliary clearance, and increasing respiratory muscle strength. Its therapeutic effects typically begin within 30 minutes of administration, with a peak effect occurring within 2 hours.

Pharmacokinetics

Aminophylline is rapidly absorbed following intravenous administration, with a bioavailability of approximately 100%. Its volume of distribution is large, indicating extensive tissue binding. The drug is metabolized primarily in the liver via cytochrome P450 enzymes, with a half-life ranging from 3 to 10 hours depending on patient factors, including age, liver function, and concurrent medications.

Interactions

  • aminoglycosides+agalsidasealfa: Severe (decreases effects)
  • aminoglycosides+agalsidasebeta: Severe (decreases effects)
  • betablockers,selective+aminophylline: Severe (increases risk of bronchospasm)
  • aminophylline+phosphodiesterasetype-: Severe (increases exposure)
  • stiripentol+aminophylline: Severe (increases exposure)
  • deferasirox+aminophylline: Severe (increases exposure)
  • aminophylline+roflumilast: Severe (increases exposure)
  • aciclovir+aminophylline: Moderate (increases exposure)
  • aminophylline+macrolides: Moderate (decreases exposure)
  • aminophylline+erythromycin: Moderate (decreases exposure)

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: electrolytes

Electrolytes are essential ions in the body that play critical roles in maintaining fluid balance, nerve conduction, muscle contraction, and acid-base homeostasis. Common electrolytes include sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate. Imbalances in these electrolytes can lead to various clinical conditions requiring supplementation or correction.

Indications

  • Dehydration
  • Hyponatremia
  • Hypernatremia
  • Hypokalemia
  • Hyperkalemia
  • Hypocalcemia
  • Hypercalcemia
  • Hypomagnesemia
  • Hypermagnesemia
  • Acid-base imbalances

Dosage

Children: Electrolyte dosing in children varies depending on the specific electrolyte and the child's condition. Refer to pa

Adults: Electrolyte dosing varies based on the specific electrolyte and the clinical situation. Refer to specific guidelines or consult with a healthcare professional for appropriate dosing.

Mechanism of action

Electrolytes exert their effects by dissociating into ions in solution, which then participate in various physiological processes. For instance, sodium and potassium ions are crucial for generating action potentials in neurons and muscle cells, while calcium ions are vital for muscle contraction and neurotransmitter release. The movement of these ions across cell membranes is regulated by transporters and channels, influencing cellular excitability and overall homeostasis.

Pharmacodynamics

Electrolytes function mainly through their roles in fluid balance and neuromuscular activity. Sodium is primarily involved in maintaining osmotic pressure and is vital for the conduction of electrical impulses in nerves and muscles. Potassium is critical for cardiac rhythm and muscle function. Calcium is essential for muscle contractions, neurotransmitter release, and blood coagulation. Magnesium serves as a cofactor for numerous enzymatic reactions and helps regulate calcium levels.

Pharmacokinetics

Electrolytes are absorbed in the gastrointestinal tract and distributed throughout the body fluids. Their levels are regulated by the kidneys, which filter excess electrolytes to maintain homeostasis. Electrolytes can be lost through sweat, urine, and feces, and their replacement may be necessary in cases of dehydration, diarrhea, or other conditions causing imbalances. The half-lives of various electrolytes can vary, but they are typically rapidly equilibrated within the body's compartments.

Contra-indications

  • Severe renal impairment
  • Hyperkalemia
  • Hypercalcemia
  • Hypermagnesemia
  • Severe dehydration

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Hypernatremia
  • Hypokalemia
  • Hyperkalemia
  • Arrhythmias
  • Muscle weakness

Interactions

  • Diuretics (especially potassium-sparing diuretics may increase serum potassium levels)
  • ACE inhibitors (may increase potassium levels)
  • Lithium (sodium fluctuations can affect lithium levels)
  • Digoxin (potassium levels can influence digoxin toxicity)

Precautions

  • Monitor serum electrolyte levels regularly
  • Use with caution in patients with renal impairment
  • Monitor patients with cardiac conditions closely
  • Assess fluid status and hydration before administration

Pregnancy

Electrolyte supplementation should be managed carefully during pregnancy, considering the specific needs of the mother and fetus.

Breast-feeding

Electrolytes are generally safe during breastfeeding, but specific needs should be evaluated.

Storage

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

Formulations

  • Oral electrolyte solutions
  • Intravenous electrolyte solutions
  • Electrolyte tablets or powders

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: emulsion

Emulsions are mixtures of two immiscible liquids, typically oil and water, stabilized by emulsifying agents. They are commonly used in pharmaceuticals to improve the solubility of lipophilic drugs, enhance drug absorption, and facilitate the delivery of nutrients. Emulsions can be administered orally, parenterally, or topically, depending on their formulation.

Indications

  • Nutritional support in patients unable to consume food orally
  • Parenteral nutrition
  • Drug delivery for lipophilic medications
  • Topical applications for skin conditions

Dosage

Children: Refer to specific product guidelines and clinical protocols for paediatric dosing.

Adults: Refer to specific product guidelines and clinical protocols for adult dosing.

Mechanism of action

Emulsions work by reducing the surface tension between the oil and water phases, allowing for the formation of stable droplets. This process is mediated by emulsifying agents, which can be surfactants or natural polymers that stabilize the emulsion and prevent phase separation. The absorption and bioavailability of drugs within the emulsion can be enhanced due to the increased surface area for absorption.

Pharmacodynamics

The pharmacodynamics of emulsions vary based on their composition and formulation. The presence of emulsifying agents can influence the release profile of the active ingredients, allowing for controlled or sustained release. Emulsions can also enhance the solubility of poorly water-soluble drugs, improving their therapeutic effects and minimizing side effects related to high concentrations of active ingredients.

Pharmacokinetics

The pharmacokinetics of emulsions depend on their route of administration and the specific properties of the drug contained within the emulsion. After administration, emulsions can be rapidly absorbed due to their small droplet size, leading to quicker onset of action. The distribution, metabolism, and excretion of the drug will follow the pharmacokinetic principles applicable to the active ingredients, influenced by their solubility and the emulsion's formulation.

Pregnancy

The safety of emulsions during pregnancy depends on the specific type and formulation. Consult relevant guidelines and specific product information.

Breast-feeding

Emulsions may be used while breastfeeding, but specific product information should be consulted to ensure safety.

Storage

Store at room temperature, away from light and moisture. Specific formulations may have unique storage requirements.

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: lipid

Lipids are a diverse group of hydrophobic organic compounds, including fats, oils, waxes, and steroids, that play crucial roles in biological systems. They are essential components of cell membranes, serve as energy storage molecules, and are involved in signaling pathways. Lipids can be classified into several categories, including triglycerides, phospholipids, and cholesterol, each with distinct functions in metabolism and cellular structure.

Indications

  • Hyperlipidemia
  • Atherosclerosis
  • Pancreatitis
  • Fatty liver disease
  • Obesity
  • Cardiovascular disease

Dosage

Children: Refer to paediatric guidelines for dosing; specific dosages depend on the lipid-lowering medication used and the child's condition.

Adults: Refer to specific treatment guidelines for dosing based on the type of lipid-lowering therapy or condition being addressed.

Mechanism of action

Lipids perform various roles depending on their type. Triglycerides provide energy through oxidation; phospholipids form bilayers that make up cellular membranes, facilitating membrane fluidity and the function of membrane proteins. Cholesterol stabilizes cell membranes and is a precursor for steroid hormones, bile acids, and vitamin D. Lipid signaling molecules, such as eicosanoids, are derived from polyunsaturated fatty acids and play pivotal roles in inflammation and immune responses.

Pharmacodynamics

Lipids influence numerous physiological processes, including energy metabolism, cell membrane integrity, and the synthesis of bioactive molecules. They modulate enzyme activity, hormone production, and gene expression. The balance of different lipid types is crucial for maintaining cellular functions and overall health.

Pharmacokinetics

Lipids are absorbed in the gastrointestinal tract and transported in the bloodstream primarily as lipoproteins. They undergo processes of hydrolysis by lipases to yield free fatty acids and glycerol, which can be utilized for energy or re-esterified for storage. The metabolism of lipids occurs in the liver, where they can be synthesized or converted into other metabolites. The elimination of lipid metabolism products primarily occurs through the liver and kidneys.

Contra-indications

  • Hypersensitivity to any component of the formulation
  • Severe liver disease
  • Active pancreatitis

Adverse effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Dyspepsia
  • Elevated liver enzymes
  • Rash
  • Myopathy or rhabdomyolysis (particularly with certain lipid-lowering agents)

Interactions

  • Certain anticoagulants may have altered effects
  • Caution with other medications that can affect liver function
  • Some drugs may increase the risk of myopathy when used in combination

Precautions

  • Monitor liver function tests regularly during therapy
  • Consider potential drug-drug interactions before initiating therapy
  • Use with caution in patients with a history of muscle disorders

Pregnancy

Lipid-lowering therapies are generally avoided during pregnancy due to potential risks to the fetus. Consult relevant guidelines for specifics.

Breast-feeding

Caution is advised, as some lipid-lowering agents may pass into breast milk. Consult healthcare professionals for specific recommendations.

Storage

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

Formulations

  • Oral tablets
  • Capsules
  • Injectable forms (for certain lipid formulations)

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

Molecular reference: Glucose

PubChem CID 5793

Molecular formula: C6H12O6

Mechanism of action

Glucose supplies most of the energy to all tissues by generating energy molecules ATP and NADH during a series of metabolism reactions called glycolysis. Glycolysis can be divided into two main phases where the preparatory phase is initiated by the phosphorylation of glucose by hexokinase to form glucose 6-phosphate. The addition of the high-energy phosphate group activates glucose for the subsequent breakdown in later steps of glycolysis and is the rate-limiting step. Products end up as substrates for following reactions, to ultimately convert C6 glucose molecule into two C3 sugar molecules. These products enter the energy-releasing phase where the total of 4ATP and 2NADH molecules are generated per one glucose molecule. The total aerobic metabolism of glucose can produce up to 36 ATP molecules. These energy-producing reactions of glucose are limited to D-glucose as L-glucose cannot be phosphorylated by hexokinase. Glucose can act as precursors to generate other biomolecules such as vitamin C. It plays a role as a signaling molecule to control glucose and energy homeostasis. Glucose can regulate gene transcription, enzyme activity, hormone secretion, and the activity of glucoregulatory neurons. The types, number, and kinetics of glucose transporters expressed depends on the tissues and fine-tunes glucose uptake, metabolism, and signal generation to preserve cellular and whole body metabolic integrity. Vascular calcification is a hallmark of type 2 diabetes. Glucose stimulates calcification in culture of vascular smooth muscle cells (VSMCs) but the underlying mechanisms remain obscure. We observed that high glucose levels stimulated mouse and human VSMC trans-differentiation into chondrocytes, with increased levels of Sox9, type II collagen, glycosaminoglycan and Runx2 expression, and increased alkaline phosphatase activity and mineralization. These effects were associated with increased expression of IL-1beta, which stimulated alkaline phosphatase and calcification, suggesting that glucose induces chondrocyte differentiation of VSMCs, possibly through IL-1beta activation.

Pharmacodynamics

Blood glucose is an obligatory energy source for humans involved in various cellular activities, and it also acts as a signaling molecule for diverse glucose-sensing molecules and proteins. Glucose undergoes oxidation into carbon dioxide, water, and yields energy molecules in the process of glycolysis and subsequent citric cycle and oxidative phosphorylation. Glucose is readily converted into fat in the body which can be used as a source of energy as required. Under a similar conversion into storage of energy, glucose is stored in the liver and muscles as glycogen. Glucose stores are mobilized in a regulated manner, depending on the tissues' metabolic demands. Oral glucose tablets or injections serve to increase the supply of glucose and oral glucose administration is more effective in stimulating insulin secretion because it stimulates the incretin hormones from the gut, which promotes insulin secretion.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

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