Beractant (Survanta)

Trade Name : Survanta

AbbVie Inc.

SUSPENSION

Strength 25 mg/mL

BERACTANT Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Beractant (Survanta) which is also known as Survanta and Manufactured by AbbVie Inc.. It is available in strength of 25 mg/mL per ml. Read more

Beractant (Survanta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

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About GNH

No data

(beractant)
intratracheal suspension
Sterile Suspension
For Intratracheal Administration Only

SURVANTA (beractant)nIntratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactantnintended for intratracheal use only. It is a natural bovine lung extractncontaining phospholipids, neutral lipids, fatty acids, and surfactant-associatednproteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine),npalmitic acid, and tripalmitin are added to standardize the compositionnand to mimic surface-tension lowering properties of natural lung surfactant.nThe resulting composition provides 25 mg/mL phospholipids (includingn11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides,n1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. nIt is suspended in 0.9% sodium chloride solution, and heat-sterilized.n SURVANTA contains no preservatives. Its protein content consistsnof two hydrophobic, low molecular weight, surfactant-associated proteinsncommonly known as SP-B and SP-C. It does not contain the hydrophilic,nlarge molecular weight surfactant-associated protein known as SP-A.
Each mL of SURVANTA contains 25 mg of phospholipids.n It is an off-white to light brown liquid supplied in single-use glassnvials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).

Endogenous pulmonary surfactant lowers surface tension on alveolarnsurfaces during respiration and stabilizes the alveoli against collapsenat resting transpulmonary pressures. Deficiency of pulmonary surfactantncauses Respiratory Distress Syndrome (RDS) in premature infants. nSURVANTA replenishes surfactant and restores surface activity to thenlungs of these infants.

Clinical effects of SURVANTA were demonstrated in six single-dose and four multiple-dose randomized, multi-center, controlled clinical trials involving approximately 1700 infants. Three open trials, including a Treatment IND, involved more than 8500 infants. Each dose of SURVANTA in all studies was 100 mg phospholipids/kg birth weight and was based on published experience with Surfactant TA, a lyophilized powder dosage form of SURVANTA having the same composition.

SURVANTA is indicated for prevention and treatment (u201crescueu201d) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.

None known.

SURVANTA is intended for intratracheal use only.
SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.
During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.

No data

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of . Oxygen desaturation occurred with 9.8% of .
Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.
The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3.
When all controlled studies were pooled, there was no difference in intracranial hemorrhage. However, in one of the single-dose rescue studies and one of the multiple-dose prevention studies, the rate of intracranial hemorrhage was significantly higher in SURVANTA patients than control patients (63.3% 30.8%, = 0.001; and 48.8% 34.2%, = 0.047, respectively). The rate in a Treatment IND involving approximately 8100 infants was lower than in the controlled trials.
In the controlled clinical trials, there was no effect of SURVANTA on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, and creatinine.
More than 4300 pretreatment and post-treatment serum samples from approximately 1500 patients were tested by Western Blot Immunoassay for antibodies to surfactant-associated proteins SP-B and SP-C. No IgG or IgM antibodies were detected.
Several other complications are known to occur in premature infants. The following conditions were reported in the controlled clinical studies. The rates of the complications were not different in treated and control infants, and none of the complications were attributed to SURVANTA.

Overdosage with SURVANTA has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive.
Rales and moist breath sounds can transiently occur after SURVANTA is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.

No data

SURVANTA (beractant) Intratracheal Suspension is supplied in single-use glass vials containing 4 mL (NDC 0074-1040-04) or 8 mL of SURVANTA (NDC 0074-1040-08). Each milliliter contains 25 mg of phospholipids suspended in 0.9% sodium chloride solution. The color is off-white to light brown.
Store unopened vials at refrigeration temperature (2-8u00b0C). Protect from light. Store vials in carton until ready for use. Vials are for single use only. Upon opening, discard unused drug.
LITHO IN USA
AbbVie Inc.
North Chicago, IL 60064, U.S.A.
03-C072 December, 2019

4 mL Single Use Vial
NDC
SURVANTAn
(beractant)
intratracheal
suspension 4mL
Sterile Suspension
For Intratracheal
Administration Only-
NOT FOR INJECTION
DO NOT SHAKE
STORE AT 2 TO 8 C
PROTECT FROM LIGHT
Rx only
abbvie
4 mL Single Use Vial
NDC 0074u20131040u201304
SURVANTAn
(beractant)
intratracheal suspension 4mL
Sterile Suspension
For Intratracheal
Administration Ony-
NOT FOR INJECTION
Rx only
DO NOT SHAKE
STORE AT 2 to 8 C
PROTECT FROM LIGHT
abbvie

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Beractant (Survanta)

Trade Name : Survanta

SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Beractant (Survanta)

Trade Name : Survanta

SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?