SURVANTA 25 MG
BERACTANT : 25 MG · DIN 02016109 · ABBVIE CORPORATION
Health Canada status: MARKETED
What is SURVANTA?
SURVANTA 25 MG contains BERACTANT : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02016109, held by ABBVIE CORPORATION, supplied as SUSPENSION for INTRATRACHEAL administration. Health Canada currently lists it as marketed, status dated 30-Jun-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is SURVANTA used for?
Prevention (prophylaxis) and treatment (rescue) of Respiratory Distress Syndrome (RDS/Hyaline Membrane Disease) in premature infants.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02016109 |
|---|---|
| Brand name | SURVANTA |
| Generic / active ingredient | BERACTANT : 25 MG |
| Manufacturer | ABBVIE CORPORATION |
| Strength | 25 MG |
| Dosage form | SUSPENSION |
| Route of administration | INTRATRACHEAL |
| Schedule | Prescription |
| ATC code | R07AA02 NATURAL PHOSPHOLIPIDS |
| AHFS class | 48:36.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 30-Jun-2014 |
| Original market date | 1993-12-31 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02016109 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2016109 |
| Brand name | SURVANTA |
| Active ingredient / INN | BERACTANT : 25 MG |
| ATC code | R07AA02 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R07 |
| AHFS class | 48:36.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | ABBVIE CORPORATION |
How is it administered?
Intratracheal use only. 100 mg phospholipids/kg birth weight (4 mL/kg). Administered in 2 half-doses or 4 quarter-doses. Up to 4 doses in first 48 hours, no more frequently than every 6 hours.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store refrigerated (2 to 8°C). Protect from light. Unopened vials warmed to room temperature may be returned to refrigerator once within 24 hours.
How is it supplied?
Single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).
Which pack is which?
| Strength on the label | 25 MG |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRATRACHEAL |
| Packaging as described in the monograph | Single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). |
| Storage | Store refrigerated (2 to 8°C). Protect from light. Unopened vials warmed to room temperature may be returned to refrigerator once within 24 hours. |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Contraindications
There are no known contraindications to treatment with SURVANTA.
Warnings and precautions
Administer in highly supervised setting. Can rapidly affect oxygenation and lung compliance; monitor systemic oxygenation to avoid hyperoxia. Risk of bradycardia and oxygen desaturation during dosing.
What can be used instead?
Other Canadian products sharing ATC code R07AA02 NATURAL PHOSPHOLIPIDS. 3 of 4 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| BLES | 27 MG | SUSPENSION | BLES BIOCHEMICALS INC | MARKETED | DIN 02245464 |
| CUROSURF | 80 MG | SUSPENSION | CHIESI FARMACEUTICI S.P.A. | MARKETED | DIN 02241551 |
| NEOSURF | 27 MG | SUSPENSION | CIPLA LTD | CANCELLED (UNRETURNED ANNUAL) | DIN 02288621 |
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.