International reference: 6 US FDA recalls for this ingredient

Subpotent Drug (lactated)

Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag. (lactated)

Lack of Assurance of Sterility (lactated)

Lack of assurance of sterility. Validation data for decontamination cycles is lacking. (lactated)

Lack of Assurance of Sterility: Product sterility cannot be guaranteed. (lactated)

Subpotent Drug (lactated)

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

Registered Tanzania · TMDA

ABA -RL

Lactated Potassium Saline

TAN 24 HM 0178 Solution for Infusion Each 100 ml contains Sodium Lactate (60%) solution BP 0.533 gm Eq. to Sodium Lactate 0.320gm Sodium Chloride BP 0.600gm Potassium Chloride BP 0.040gm Calcium Chloride BP 0.027gm

What it does

Lactated is a solution often used to help restore the body's fluids and electrolytes.

Commonly used for: dehydration, electrolyte imbalance

Read more in plain English ↓

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

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Registration & product details

Registration no.
TAN 24 HM 0178
Registration date
2024-06-27
Expiry date
2029-06-26
Status
Registered/Compliant
Active ingredient
Lactated Potassium Saline
Dosage form
Solution for Infusion
Strength
Each 100 ml contains Sodium Lactate (60%) solution BP 0.533 gm Eq. to Sodium Lactate 0.320gm Sodium Chloride BP 0.600gm Potassium Chloride BP 0.040gm Calcium Chloride BP 0.027gm
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-06-19 02:01:20 · updated 2026-09-17 03:00:44

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About lactated

Lactated is a solution often used to help restore the body's fluids and electrolytes.

What it treats

  • dehydration
  • electrolyte imbalance

How it works

It helps to rehydrate the body and balance salts in the blood, which is important for many body functions.

Who it's for

This is suitable for individuals who need help with hydration, such as those who are ill or have lost fluids.

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

About saline

Saline is a simple saltwater solution used for various medical purposes.

What it treats

  • dehydration
  • wound cleaning
  • nasal congestion
  • eye wash

How it works

Saline helps to restore body fluids and can also clean and moisturize surfaces.

Who it's for

Saline is suitable for people of all ages needing hydration or cleaning of wounds, eyes, or nasal passages.

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

Clinical monograph: lactated

Lactated Ringer's solution is an intravenous fluid that contains a mixture of sodium lactate, sodium chloride, potassium chloride, and calcium chloride in sterile water. It is used to restore bodily fluids and electrolytes in patients who are dehydrated or have lost fluids due to surgery, trauma, or other medical conditions. The solution helps to maintain electrolyte balance and supports physiological functions. Lactated Ringer's solution is isotonic and mimics the composition of plasma, making it suitable for fluid resuscitation.

Indications

  • Dehydration
  • Electrolyte imbalance
  • Fluid resuscitation
  • Surgical fluid replacement
  • Burn treatment

Dosage

Adults: The dosage of Lactated Ringer's solution varies based on the clinical situation, patient needs, and underlying conditions. It is typically administered intravenously and can be given as a bolus or continuous infusion. Refer to specific clinical guidelines

Mechanism of action

Lactated Ringer's solution acts by providing electrolytes and fluid to the extracellular space, thereby helping to restore blood volume and maintain osmotic balance. The sodium lactate present in the solution is metabolized to bicarbonate, which helps to correct acidosis by providing a source of base that neutralizes excess hydrogen ions in the blood. This metabolic pathway is crucial in patients with lactic acidosis or those undergoing surgical procedures.

Pharmacodynamics

The pharmacodynamics of Lactated Ringer's solution are primarily related to its ability to replace lost fluids and electrolytes. The isotonic nature of the solution ensures that it does not cause significant shifts in fluid balance between compartments. The introduction of lactate helps to buffer acidity, improving the acid-base status of patients. The electrolytes (sodium, potassium, and calcium) play essential roles in cellular functions, nerve conduction, and muscle contraction.

Pharmacokinetics

The pharmacokinetics of Lactated Ringer's solution involves its distribution, metabolism, and excretion. Upon administration, the solution is distributed rapidly into the extracellular fluid compartment. The sodium and chloride are excreted primarily through the kidneys. Lactate is metabolized in the liver to bicarbonate and other metabolites, contributing to the correction of metabolic acidosis. The rate of elimination depends on renal function and fluid status, with normal renal function allowing for effective clearance of excess electrolytes.

Adverse effects

  • Hypernatremia
  • Hyperkalemia
  • Metabolic alkalosis
  • Hypophosphatemia

Precautions

  • Caution in patients with renal impairment
  • Monitor electrolytes closely during use
  • Use with caution in patients with congestive heart failure

Pregnancy

Lactated Ringer's solution is generally considered safe during pregnancy; however, electrolyte balance should be monitored.

Breast-feeding

Lactated Ringer's solution is not absorbed systemically and is considered safe during breastfeeding.

Storage

Store at room temperature, away from light. Do not freeze.

Formulations

  • Lactated Ringer's solution 1000 mL
  • Lactated Ringer's solution 500 mL

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: saline

BNF-referenced

Saline, a solution of sodium chloride (NaCl) in water, is primarily used for fluid and electrolyte replenishment. It is a critical component in various medical treatments, including rehydration, as a diluent for medications, and in surgical procedures. The solution can come in various concentrations, with isotonic saline (0.9% NaCl) being the most common for general use. Hypertonic saline solutions (e.g., 3% or 20% NaCl) are often used in specific clinical scenarios such as hyponatremia treatment or to induce uterine contractions in abortion procedures.

Indications

  • Fluid replacement therapy in dehydration
  • Electrolyte replenishment
  • As a diluent for intravenous medications
  • Wound irrigation
  • Intra-amniotic instillation for abortion procedures

Dosage

Children: Paediatric dosing of saline is dependent

Adults: The dosage of saline varies depending on the clinical indication. For fluid resuscitation, isotonic saline (0.9% NaCl) is typically administered at a rate determined by the patient's condition and response to therapy. Refer to specific clinical guidelines for detailed dosing.

Mechanism of action

Sodium and chloride, the major electrolytes in extracellular fluid, control extracellular volume and blood pressure. Changes in sodium concentrations are linked to water balance disorders. Intra-amniotic instillation of hypertonic sodium chloride injection may induce abortion, potentially mediated by prostaglandins released from damaged decidual cells, resulting in uterine contractions that lead to evacuation of the fetus and placenta.

Pharmacodynamics

Sodium, as the principal cation in extracellular fluid, regulates water distribution, fluid balance, and osmotic pressure. It plays a crucial role in maintaining acid-base equilibrium in conjunction with chloride and bicarbonate. Chloride, the major extracellular anion, closely follows sodium metabolism, with fluctuations in acid-base balance reflected in chloride concentrations.

Pharmacokinetics

Saline is administered intravenously or through other routes depending on clinical needs. Once in the body, sodium and chloride are distributed in the extracellular fluid compartment. The elimination of sodium occurs primarily through renal excretion, while chloride follows similar pathways. The pharmacokinetic properties can vary based on the concentration of the saline solution and the physiological state of the patient.

Pregnancy

Saline is generally considered safe for use during pregnancy, but its use should be justified based on the clinical situation.

Breast-feeding

Saline is considered safe to use during breastfeeding, as it is not expected to affect the milk or nursing infant.

Storage

Store at room temperature, away from light and moisture. Do not freeze.

Formulations

  • 0.9% Sodium Chloride Injection
  • 20% Sodium Chloride Injection

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: saline

PubChem CID 5234

Molecular formula: ClNa

Mechanism of action

Sodium and chloride - major electrolytes of the fluid compartment outside of cells (i.e., extracellular) - work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance. Intra-amniotic instillation of 20% sodium chloride injection induces abortion and fetal death. Although the mechanism has not been conclusively determined, some studies indicate that the drug's abortifacient activity may be mediated by prostaglandins released from decidual cells damaged by hypertonic solutions of sodium chloride. Hypertonic sodium chloride-induced uterine contractions are usually sufficient to cause evacuation of both the fetus and placenta; however, abortion may be incomplete in 25-40% of patients. /20% injection/

Pharmacodynamics

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

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

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.