Registered Tanzania · TMDA

Xyntha 1000IU

Normal Saline (Sodium Chloride 0.9% w/v) 37.8 mg/6 mL,Water For Injection BP 4.2 ml,moroctocog Alfa 1000 IU

TAN 22 HM 0459 IV Injection 1000 IU

What it does

Alfa is a medication used to treat various health conditions.

Read more in plain English ↓

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

Ask about this medicine

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.
TAN 22 HM 0459
Registration date
2022-10-07
Expiry date
2027-10-06
Status
Registered/Compliant
Active ingredient
Normal Saline (Sodium Chloride 0.9% w/v) 37.8 mg/6 mL,Water For Injection BP 4.2 ml,moroctocog Alfa 1000 IU
Dosage form
IV Injection
Strength
1000 IU
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Wyeth Farma
Applicant / LTR
Pfizer Laboratories Limited
Country of origin
SPAIN
Manufacturer location
Autovía del Norte A1, Km 23, 28700, Madrid, Spain

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:38:35 · updated 2026-10-26 03:00:43

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

About alfa

Alfa is a medication used to treat various health conditions.

How it works

Alfa works by affecting the body's systems to help manage certain conditions.

Who it's for

This medication is suitable for patients with specific health issues as determined by a healthcare professional.

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

About moroctocog

Moroctocog is a medicine used to help control bleeding in people with hemophilia A, a condition where the blood does not clot properly.

What it treats

  • hemophilia A
  • bleeding disorders

How it works

Moroctocog works by replacing a missing protein in the blood that helps it to clot, reducing the risk of bleeding.

Who it's for

This medicine is for individuals diagnosed with hemophilia A who need help managing their bleeding episodes.

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.

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: alfa

Alfa is a pharmacological agent that may refer to a variety of products depending on the context, but lacks a specific chemical or therapeutic classification in this instance. It is essential to clarify the exact nature of 'alfa' to provide comprehensive information, as it could pertain to a range of compounds used in clinical practice.

Dosage

Children: Refer to specific drug information for paediatric dosing guidelines, as this will also vary.

Adults: Refer to specific drug information for dosing guidelines, as this will vary widely.

Mechanism of action

The mechanism of action for 'alfa' cannot be defined without specific identification of the drug. Each compound named 'alfa' will have distinct mechanisms, typically involving receptor interaction, enzyme inhibition, or modulation of physiological pathways.

Pharmacodynamics

Pharmacodynamics will vary widely depending on the specific agent referred to as 'alfa'. Generally, pharmacodynamics describes how a drug affects the body, including its therapeutic effects, side effects, and the relationship between drug concentration and effect.

Pharmacokinetics

The pharmacokinetics of 'alfa' would also depend on the particular drug profile, including absorption, distribution, metabolism, and excretion (ADME). Parameters such as bioavailability, half-life, and clearance rates would need to be defined based on the specific agent.

Pregnancy

Consult healthcare provider for risk assessment.

Breast-feeding

Consult healthcare provider for risk assessment.

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: moroctocog

Moroctocog is a recombinant coagulation factor VIII product used in the management of hemophilia A, a genetic disorder characterized by the deficiency of factor VIII, a crucial protein in the blood coagulation cascade. This medication helps to restore the balance of clotting factors, enabling effective hemostasis and reducing the risk of bleeding episodes in affected patients.

Indications

  • Prophylaxis of bleeding in patients with hemophilia A
  • Management of bleeding episodes in patients with hemophilia A

Dosage

Children: Refer to specific product guidelines for dosing based on severity of hemophilia and individual patient response.

Adults: Refer to specific product guidelines for dosing based on severity of hemophilia and individual patient response.

Mechanism of action

Moroctocog acts as a replacement for the missing or deficient factor VIII in patients with hemophilia A. It binds to factor IXa, forming a complex that activates factor X, which is essential for the conversion of prothrombin to thrombin, ultimately leading to fibrin formation and clot stabilization.

Pharmacodynamics

The pharmacodynamic effects of moroctocog include increased levels of factor VIII activity in the bloodstream, leading to enhanced clotting ability. The peak effect is typically observed within a few hours after infusion, and the duration of action can vary based on individual patient factors, including the presence of inhibitors to factor VIII.

Pharmacokinetics

Moroctocog has a half-life of approximately 12 hours in patients without inhibitors. The pharmacokinetics can be influenced by patient factors such as age, body weight, and the presence of inhibitors. It is administered intravenously, and the bioavailability is effectively 100% since it is given directly into the circulation. The drug is metabolized primarily through proteolytic cleavage and is eliminated through the reticuloendothelial system.

Adverse effects

  • Allergic reactions
  • Headache
  • Nausea
  • Fatigue
  • Dizziness

Precautions

  • Monitor for signs of allergic reactions
  • Use with caution in patients with a history of thromboembolic events
  • Regularly assess for the development of inhibitors

Pregnancy

Limited data available, consult healthcare provider before use.

Breast-feeding

Consult healthcare provider before use.

Storage

Store at 2-8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Lyophilized powder for reconstitution

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.

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.