Registered Tanzania · TMDA

SURVANTA

Beractant 25 mg/ml

TZ 16 H 0201 Suspension, Oral 25 INN generic

What it does

Beractant is a medicine used to help newborns with breathing difficulties, particularly those born prematurely.

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

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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.
TZ 16 H 0201
Registration date
2026-06-05
Expiry date
2031-06-03
Status
Registered/Compliant
Active ingredient
Beractant 25 mg/ml
Dosage form
Suspension, Oral
Strength
25
Pack size
-
Therapeutic class
-
RxNorm RxCUI
46967
Manufacturer / MAH
AbbVie
Applicant / LTR
Abbvie (Pty) Limited
Country of origin
USA

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:42:26 · updated 2026-10-19 03:00:45

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

About this medicine

Beractant is a medicine used to help newborns with breathing difficulties, particularly those born prematurely.

What it treats

  • respiratory distress syndrome (RDS)
  • breathing problems in premature babies

How it works

Beractant works by replacing missing substances in the lungs that help keep the airways open and make breathing easier.

Who it's for

This medicine is specifically for premature infants who have trouble breathing.

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

Clinical monograph: Beractant

BNF-referenced

Beractant is a pulmonary surfactant used to treat and prevent respiratory distress syndrome (RDS) in preterm neonates. It helps reduce surface tension in the alveoli, thus improving lung function and oxygenation.

Indications

  • Treatment of respiratory distress syndrome in preterm neonates
  • Prophylaxis of respiratory distress syndrome in preterm neonates

Dosage

Children: Preterm neonate: 100 mg/kg, preferably administered within 15 minutes of birth; dose may be repeated within 48 hours at intervals of at least 6 hours for up to 4 doses.

Mechanism of action

Beractant acts by reducing the surface tension at the air-liquid interface in the alveoli, thereby preventing alveolar collapse and enhancing lung compliance, which improves gas exchange.

Pharmacodynamics

Beractant is composed of phospholipids, primarily dipalmitoylphosphatidylcholine, which are critical for the formation and maintenance of the alveolar surfactant layer. Its administration leads to improved pulmonary function and gas exchange in neonates with RDS.

Pharmacokinetics

Beractant is administered via an endotracheal tube, where it spreads across the alveolar surface. It is metabolized through pulmonary clearance mechanisms, with a half-life dependent on the clinical condition of the neonate and the extent of surfactant replacement.

Adverse effects

  • Respiratory depression
  • Skin sensitisation
  • Bradycardia
  • Hypotension

Precautions

  • Use under specialist supervision

Pregnancy

Consult product literature for specific advice.

Breast-feeding

Consult product literature for specific advice.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze.

Formulations

  • Beractant 25 mg per 1 ml endotracheopulmonary suspension
BNF for Children 2019-2020 p.215 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.

This drug in other countries

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