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DRUGS & SUPPLEMENTS
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When are you taking this medicine? |
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.
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.
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 |
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.
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.
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.
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.
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 |
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.
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:
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.
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.
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.
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
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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The information was verified by Dr. Rachana Salvi, MD Pharmacology