Survanta-Vent

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Survanta-Vent uses


Indications and Usage

Survanta-Vent is indicated for prevention andtreatment of Respiratory Distress Syndrome (RDS) (hyalinemembrane disease) in premature infants. Survanta-Vent significantly reducesthe incidence of RDS, mortality due to RDS and air leak complications.

Prevention

In premature infants less than 1250 g birthweight or with evidence of surfactant deficiency, give Survanta-Vent assoon as possible, preferably within 15 minutes of birth.

Rescue

To treat infants with RDS confirmed by x-rayand requiring mechanical ventilation, give Survanta-Vent as soon as possible,preferably by 8 hours of age.

Contraindications

Noneknown.

Warnings

Survanta-Vent is intended for intratracheal useonly.

Survanta-Vent can rapidly affectoxygenation and lung compliance. Therefore, its use should be restrictedto a highly supervised clinical setting with immediate availabilityof clinicians experienced with intubation, ventilator management,and general care of premature infants. Infants receiving SURVANTAshould be frequently monitored with arterial or transcutaneous measurementof systemic oxygen and carbon dioxide.

During the dosing procedure, transient episodes of bradycardiaand decreased oxygen saturation have been reported. If these occur,stop the dosing procedure and initiate appropriate measures to alleviatethe condition. After stabilization, resume the dosing procedure.

Precautions

General

Rales and moistbreath sounds can occur transiently after administration. Endotrachealsuctioning or other remedial action is not necessary unless clear-cutsigns of airway obstruction are present.

Increased probability of post-treatment nosocomial sepsisin SURVANTA-treated infants was observed in the controlled clinicaltrials. The increased risk for sepsis among SURVANTA-treatedinfants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate ofpost-treatment infections other than sepsis.

Use of Survanta-Vent in infants less than 600 g birth weightor greater than 1750 g birth weight has not been evaluated in controlledtrials. There is no controlled experience with use of Survanta-Vent inconjunction with experimental therapies for RDS (eg, high-frequencyventilation or extracorporeal membrane oxygenation).

No information is available on the effects of dosesother than 100 mg phospholipids/kg, more than four doses, dosing morefrequently than every 6 hours, or administration after 48 hours ofage.

Carcinogenesis, Mutagenesis,Impairment of Fertility

Carcinogenicity studies have not been performed with Survanta-Vent. SURVANTAwas negative when tested in the Ames test for mutagenicity. Usingthe maximum feasible dose volume, Survanta-Vent up to 500 mg phospholipids/kg/day(approximately one-third the premature infant dose based on mg/m2/day) was administered subcutaneously to newborn ratsfor 5 days. The rats reproduced normally and there were no observableadverse effects in their offspring.

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Adverse Reactions

Themost commonly reported adverse experiences were associated with thedosing procedure. In the multiple-dose controlled clinical trials,each dose of Survanta-Vent was divided into four quarter-doses which wereinstilled through a catheter inserted into the endotracheal tube bybriefly disconnecting the endotracheal tube from the ventilator. Transientbradycardia occurred with 11.9% of doses. Oxygendesaturation occurred with 9.8% of doses.

Other reactions during the dosing procedureoccurred with fewer than 1% of doses and included endotracheal tubereflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage,hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurredduring the dosing procedure, and all reactions resolved with symptomatictreatment.

The occurrence of concurrentillnesses common in premature infants was evaluated in the controlledtrials. The rates in all controlled studies are in Table 3.

All ControlledStudies
Concurrent Event Survanta-Vent Control (%) P-Valuea
Patent ductus arteriosus 46.9 47.1 0.814
Intracranial hemorrhage 48.1 45.2 0.241
Severe intracranial hemorrhage 24.1 23.3 0.693
Pulmonary air leaks 10.9 24.7 < 0.001
Pulmonary interstitial emphysema 20.2 38.4 < 0.001
Necrotizing enterocolitis 6.1 5.3 0.427
Apnea 65.4 59.6 0.283
Severe apnea 46.1 42.5 0.114
Post-treatment sepsis 20.7 16.1 0.019
Post-treatment infection 10.2 9.1 0.345
Pulmonary hemorrhage 7.2 5.3 0.166
a P-valuecomparing groups in controlled studies
When all controlled studies werepooled, there was no difference in intracranial hemorrhage. However,in one of the single-dose rescue studies and one of the multiple-doseprevention studies, the rate of intracranial hemorrhage was significantlyhigher in Survanta-Vent patients than control patients (63.3% v 30.8%, P = 0.001; and 48.8% v 34.2%, P = 0.047, respectively). The rate in aTreatment IND involving approximately 8100 infants was lower thanin the controlled trials.

In thecontrolled clinical trials, there was no effect of Survanta-Vent on resultsof common laboratory tests: white blood cell count and serum sodium,potassium, bilirubin, and creatinine.

More than 4300 pretreatment and post-treatment serum samples fromapproximately 1500 patients were tested by Western Blot Immunoassayfor antibodies to surfactant-associated proteins SP-B and SP-C. NoIgG or IgM antibodies were detected.

Several other complications are known to occur in premature infants. The following conditions were reported in the controlled clinicalstudies. The rates of the complications were not different in treatedand control infants, and none of the complications were attributedto Survanta-Vent.

Respiratory

lung consolidation, blood from the endotrachealtube, deterioration after weaning, respiratory decompensation, subglotticstenosis, paralyzed diaphragm, respiratory failure.

Cardiovascular

hypotension, hypertension, tachycardia,ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratoryarrest, increased apical pulse, persistent fetal circulation, airembolism, total anomalous pulmonary venous return.

Gastrointestinal

abdominal distention, hemorrhage, intestinalperforations, volvulus, bowel infarct, feeding intolerance, hepaticfailure, stress ulcer.

Renal

renal failure, hematuria.

Hematologic

coagulopathy, thrombocytopenia, disseminatedintravascular coagulation.

Central Nervous System

seizures

Endocrine/Metabolic

adrenal hemorrhage, inappropriate ADH secretion,hyperphosphatemia.

Musculoskeletal

inguinal hernia.

Systemic

fever, deterioration.

Follow-Up Evaluations

To date, no long-term complications or sequelaeof Survanta-Vent therapy have been found.

Single-Dose Studies

Six-month adjusted-age follow-up evaluations of 232 infants demonstrated no clinically important differences between treatment groups in pulmonary and neurologic sequelae, incidence or severity of retinopathy of prematurity, rehospitalizations, growth, or allergic manifestations.

Multiple-Dose Studies

Six-month adjusted age follow-up evaluationshave been completed in 631 (345 treated) of 916 surviving infants. There were significantly less cerebral palsy and need for supplementaloxygen in Survanta-Vent infants than controls. Wheezing at the time ofexamination was significantly more frequent among Survanta-Vent infants,although there was no difference in bronchodilator therapy.

Final twelve-month follow-up data from themultiple-dose studies are available from 521 (272 treated) of 909surviving infants. There was significantly less wheezing in SURVANTAinfants than controls, in contrast to the six-month results. Therewas no difference in the incidence of cerebral palsy at twelve months.

Twenty-four month adjusted age evaluationswere completed in 429 (226 treated) of 906 surviving infants. Therewere significantly fewer Survanta-Vent infants with rhonchi, wheezing,and tachypnea at the time of examination. No other differences werefound.

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Overdosage

Overdosage with Survanta-Vent 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 occurafter Survanta-Vent is given, and do not indicate overdosage. Endotrachealsuctioning or other remedial action is not required unless clear-cutsigns of airway obstruction are present.

Dosage and Administration

For intratracheal administration only.

Survanta-Vent should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.

Marked improvements in oxygenation may occur within minutes of administration of Survanta-Vent. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.

Review of audiovisual instructional materials describing dosage and administration procedures is recommended before using Survanta-Vent. Materials are available upon request from AbbVie Inc.

Dosage

Each dose of Survanta-Vent is 100 mg of phospholipids/kgbirth weight. The Survanta-Vent Dosing Chart shows the totaldosage for a range of birth weights.

Survanta-Vent DOSINGCHART
Weight (grams) Total Dose (mL) Weight (grams) Total Dose (mL)
600-650 2.6 1301-1350 5.4
651-700 2.8 1351-1400 5.6
701-750 3.0 1401-1450 5.8
751-800 3.2 1451-1500 6.0
801-850 3.4 1501-1550 6.2
851-900 3.6 1551-1600 6.4
901-950 3.8 1601-1650 6.6
951-1000 4.0 1651-1700 6.8
1001-1050 4.2 1701-1750 7.0
1051-1100 4.4 1751-1800 7.2
1101-1150 4.6 1801-1850 7.4
1151-1200 4.8 1851-1900 7.6
1201-1250 5.0 1901-1950 7.8
1251-1300 5.2 1951-2000 8.0
Four doses of Survanta-Vent can be administeredin the first 48 hours of life. Doses should be given no more frequentlythan every 6 hours.

Directions for Use

Survanta-Vent should be inspected visually for discoloration prior to administration. The color of Survanta-Vent is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.

Survanta-Vent is stored refrigerated (2-8°C). Date and time need to be recorded in the box on front of the carton or vial, whenever Survanta-Vent is removed from the refrigerator. Before administration, Survanta-Vent should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. Artificial warming methods should not be used. If a prevention dose is to be given, preparation of Survanta-Vent should begin before the infant’s birth.

Unopened, unused vials of Survanta-Vent that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming, and stored for future use. Survanta-Vent SHOULD NOT BE REMOVED FROM THE REFRIGERATOR FOR MORE THAN 24 HOURS. Survanta-Vent SHOULD NOT BE WARMED AND RETURNED TO THE REFRIGERATOR MORE THAN ONCE. Each single-use vial of Survanta-Vent should be entered only once. Used vials with residual drug should be discarded.

Survanta-Vent does not require reconstitution or sonication before use.

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Dosing Procedures

General

Survanta-Vent is administered intratracheallyby instillation through a 5 French end-hole catheter. The cathetercan be inserted into the infant’s endotracheal tube without interruptingventilation by passing the catheter through a neonatal suction valveattached to the endotracheal tube. Alternatively, Survanta-Vent can beinstilled through the catheter by briefly disconnecting the endotrachealtube from the ventilator.

Theneonatal suction valve used for administering Survanta-Vent should be atype that allows entry of the catheter into the endotracheal tubewithout interrupting ventilation and also maintains a closed airwaycircuit system by sealing the valve around the catheter.

If the neonatal suction valve is used, thecatheter should be rigid enough to pass easily into the endotrachealtube. A very soft and pliable catheter may twist or curl within theneonatal suction valve. The length of the catheter should be shortenedso that the tip of the catheter protrudes just beyond the end of theendotracheal tube above the infant’s carina. Survanta-Vent should not beinstilled into a mainstem bronchus.

To ensure homogenous distribution of Survanta-Vent throughout the lungs,each dose is divided into four quarter-doses.

Each quarter-dose is administered with theinfant in a different position. The recommended positions are:

The dosing procedure is facilitatedif one person administers the dose while another person positionsand monitors the infant.

First Dose

Determine the total dose of Survanta-Vent fromthe Survanta-Vent dosing chart based on the infant’s birth weight. Slowlywithdraw the entire contents of the vial into a plastic syringe througha large-gauge needle. Do not filter SURVANTAand avoid shaking.

Attach thepremeasured 5 French end-hole catheter to the syringe. Fill the catheterwith Survanta-Vent. Discard excess Survanta-Vent through the catheter so thatonly the total dose to be given remains in the syringe.

Before administering Survanta-Vent, assure properplacement and patency of the endotracheal tube. At the discretionof the clinician, the endotracheal tube may be suctioned before administeringSURVANTA. The infant should be allowed to stabilize before proceedingwith dosing.

In the preventionstrategy, weigh, intubate and stabilize the infant. Administer thedose as soon as possible after birth, preferably within 15 minutes. Position the infant appropriately and gently inject the first quarter-dosethrough the catheter over 2-3 seconds.

After administration of the first quarter-dose, removethe catheter from the endotracheal tube. Manually ventilate witha hand-bag with sufficient oxygen to prevent cyanosis, at a rate of60 breaths/minute, and sufficient positive pressure to provide adequateair exchange and chest wall excursion.

In the rescue strategy, the first dose should be givenas soon as possible after the infant is placed on a ventilator formanagement of RDS. In the clinical trials, immediately before instillingthe first quarter-dose, the infant’s ventilator settings were changedto rate 60/minute, inspiratory time 0.5 second, and FiO2 1.0.

Position theinfant appropriately and gently inject the first quarter-dose throughthe catheter over 2-3 seconds. After administration of the firstquarter-dose, remove the catheter from the endotracheal tube and continuemechanical ventilation.

In bothstrategies, ventilate the infant for at least 30 seconds or untilstable. Reposition the infant for instillation of the next quarter-dose.

Instill the remaining quarter-doses usingthe same procedures. After instillation of each quarter-dose, removethe catheter and ventilate for at least

30 seconds or until the infant is stabilized. Afterinstillation of the final quarter-dose, remove the catheter withoutflushing it. Do not suction the infant for 1 hour after dosing unlesssigns of significant airway obstruction occur.

After completion of the dosing procedure, resume usualventilator management and clinical care.

Repeat Doses

The dosage of Survanta-Vent for repeat dosesis also 100 mg phospholipids/kg and is based on the infant’s birthweight. The infant should not be reweighed for determination of theSURVANTA dosage. Use the Survanta-Vent Dosing Chart to determine the totaldosage.

The need for additionaldoses of Survanta-Vent is determined by evidence of continuing respiratorydistress. Using the following criteria for redosing, significantreductions in mortality due to RDS were observed in the multiple-doseclinical trials with Survanta-Vent.

Dose no sooner than 6 hours after the preceding dose if the infantremains intubated and requires at least 30% inspired oxygen to maintaina PaO2 less than or equal to 80 torr.

Radiographic confirmation of RDS shouldbe obtained before administering additional doses to those who receiveda prevention dose.

Prepare SURVANTAand position the infant for administration of each quarter-dose aspreviously described. After instillation of each quarter-dose, removethe dosing catheter from the endotracheal tube and ventilate the infantfor at least 30 seconds or until stable.

In the clinical studies, ventilator settings used toadminister repeat doses were different than those used for the firstdose. For repeat doses, the FiO2 was increasedby 0.20 or an amount sufficient to prevent cyanosis. The ventilatordelivered a rate of 30/minute with an inspiratory time less than

1.0 second. If the infant’s pretreatmentrate was 30 or greater, it was left unchanged during Survanta-Vent instillation.

Manual hand-bag ventilation should not beused to administer repeat doses. During the dosing procedure, ventilatorsettings may be adjusted at the discretion of the clinician to maintainappropriate oxygenation and ventilation.

After completion of the dosing procedure, resume usualventilator management and clinical care.

Dosing Precautions

If an infant experiences bradycardia or oxygen desaturation during the dosing procedure, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After the infant has stabilized, resume the dosing procedure.

Rales and moist breath sounds can occur transiently after administration of Survanta-Vent. Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.

How Supplied

Survanta-Vent (beractant) Intratracheal Suspension is supplied in single-use glass vials containing 4 mL (NDC 0074-1040-04) or 8 mL of Survanta-Vent (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 (2-8°C). 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-A683 December, 2012

NDC 0074–1040–04

4 mL Single Use Vial

Survanta-Vent® (beractant) intratracheal suspension 4mL

Sterile Suspension For Intratracheal Administration Only- NOT FOR INJECTION

DO NOT SHAKE STORE AT 2º TO 8º C PROTECT FROM LIGHT

Rx only abbvie

NDC 0074–1040–04

4 mL Single Use Vial

Survanta-Vent® (beractant) intratracheal suspension 4mL

Sterile Suspension For Intratracheal Administration Ony-NOT FOR INJECTION

DO NOT SHAKE

STORE AT 2º to 8º C PROTECT FROM LIGHT

Rx only abbvie

Survanta-Vent 4mL single use vial Survanta-Vent 4mL single use vial

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Survanta-Vent pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Survanta-Vent available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Survanta-Vent destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Survanta-Vent Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Survanta-Vent pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Beractant". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Beractant - DrugBank". http://www.drugbank.ca/drugs/DB0676... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Survanta-Vent?

Depending on the reaction of the Survanta-Vent after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Survanta-Vent not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Survanta-Vent addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Survanta-Vent, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Survanta-Vent consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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