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Alveofact 45mg/ml Powder for Suspension (Each vail contains Alveofact 45mg/ml / 1 Prefilled syringe with 2.4 ml solvent)

Alveofact

FDA/GD.265-010015 Alveofact 45mg/ml

What it does

Alveofact is used to help newborns with breathing difficulties, especially those born prematurely.

Commonly used for: breathing problems in newborns, respiratory distress syndrome (RDS)

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

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Registration & product details

Registration no.
FDA/GD.265-010015
Registration date
2026-01-22
Expiry date
2029-02-01
Status
Valid
Active ingredient
Alveofact
Dosage form
Alveofact
Strength
45mg/ml
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Bag Healthcare
Applicant / LTR
M & G Pharmaceutical
Country of origin
Germany
Manufacturer location
Amtsgerichtsstraße 1-5, 35423 Lich, Germany

Source: Food and Drugs Authority · fetched 2026-05-22 02:35:08 · updated 2026-10-30 04:00:14

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

About this medicine

Alveofact is used to help newborns with breathing difficulties, especially those born prematurely.

What it treats

  • breathing problems in newborns
  • respiratory distress syndrome (RDS)

How it works

It helps to improve the function of the lungs by increasing the amount of a substance that keeps the air sacs in the lungs open.

Who it's for

It is primarily for premature babies or those with lung problems at birth.

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

Clinical monograph: alveofact

Alveofact is a medication primarily used as a surfactant replacement therapy in neonates with respiratory distress syndrome (RDS). It is derived from animal lung extracts and works to reduce surface tension in the alveoli, thereby aiding in respiratory function. By enhancing lung stability and compliance, Alveofact plays a crucial role in the management of preterm infants who are at risk of developing RDS due to surfactant deficiency.

Indications

  • Respiratory distress syndrome in preterm neonates
  • Prevention of RDS in at-risk neonates

Dosage

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

Mechanism of action

Alveofact contains natural surfactant proteins and lipids that mimic the action of endogenous surfactant, reducing surface tension at the air-liquid interface within the alveoli. This action prevents alveolar collapse, thereby improving gas exchange and reducing the work of breathing. The surfactant proteins also have roles in modulating inflammatory responses in the lung.

Pharmacodynamics

The pharmacodynamic properties of Alveofact include its ability to rapidly reduce surface tension in the lungs, leading to improved lung function and oxygenation. The surfactant enhances lung compliance and decreases the risk of atelectasis (lung collapse). The clinical effects of Alveofact can lead to improved outcomes in terms of oxygenation and ventilation in affected neonates.

Pharmacokinetics

Alveofact is administered intratracheally, allowing it to act directly on the lungs. Its effects are seen shortly after administration, with improvements in oxygenation and lung function. The pharmacokinetics of surfactant therapy involve distribution within the alveolar space, where it exerts its effects, and it is gradually metabolized and cleared by alveolar macrophages and epithelial cells. The duration of action is influenced by the infant's lung condition and the presence of respiratory distress.

Adverse effects

  • Hypersensitivity reactions
  • Fever
  • Cough
  • Tachycardia
  • Hypotension

Precautions

  • Use with caution in patients with a history of hypersensitivity to any of the components
  • Monitor for adverse reactions
  • Consider potential for pulmonary complications

Pregnancy

Alveofact should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as safety in pregnancy has not been established.

Breast-feeding

Caution is advised when administering Alveofact to breastfeeding women, as it is unknown whether it is excreted in human milk.

Storage

Store in a refrigerator (2°C to 8°C). Protect from light and do not freeze.

Formulations

  • Inhalation suspension

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