部份中文SURVANTA处方资料（仅供参考）
商品名 SURVANTA INH 200MG/8ML
中文名 守肺佳氣管吸入懸浮液
類別：抗生素
藥理類別 Other therapeutic products
結構式 
每ml含
總磷脂質   約25mg
游離脂肪酸 1.4至3.5mg
三酸甘油脂 0.5至1.75mg
蛋白質     0.1至1mg 
UpToDate UpToDate 連結 
藥理作用 
內生性的肺部界面活性劑能在呼吸時降低肺泡表面張力，且穩定肺泡以避免其在靜止時的肺間壓力下塌陷。肺部界面活性劑的缺乏對早產兒會產生呼吸窘迫症（RDS）。
Survanta能補充界面活性劑並恢復這些新生兒的肺部表面活性。
適應症 
預防和治療早產兒之呼吸窘迫症(RESPIRATION DISTRESS SYNDROME)。
預防：
出生體重低於1500公克或跡象顯示有缺乏介面活性劑相關之早產兒，應儘速投與Survanta，最好在出生15分鐘內。
治療（援救）：
治療有已X光確認之RDS且需要呼吸器之早產兒，應儘速投與Survanta，最好在出生8小時內。 
用法用量 
僅供氣管內使用。
Survanta的每次劑量為出生體重(4毫升/公克)每公斤給予100mg的磷脂質，詳細參見仿單中Survanta的劑量表。給藥方法：每個劑量分四次給，每1/4劑量都是在不同的姿勢時給予。順序如下：
(1)頭和身體稍為向下傾斜，頭轉向右側
(2)頭和身體稍為向下傾斜，頭轉向左側
(3)頭和身體稍為向上傾斜，頭轉向右側
(4)頭和身體稍為向上傾斜，頭轉向左側。
藥動力學 
Beractant 於氣管內給藥後，約 30 分鐘產生作用，作用可持續 48 至 72 小時。因beractant 是直接使用在目標器官¾肺，並於肺泡表面產生生物物理效應，故大部分的劑量在給藥後數小時內會成為肺的一部份，且脂質成分會進入內生性界面活性劑的再利用與再循環過程。本藥大量由肺部代謝；排除半衰期為 20~36 小時。
副作用 
最常見的不良反應發生在給藥的過程，在多次劑量的臨床試用中見到的副作用為暫時性心跳緩慢(11.9%)、氧飽合量降低(9.8%)；其他副作用發生率不到1%，包括氣管內插管迴流或阻塞、臉色蒼白、血管收縮、低血壓、高血壓、低或高二氧化碳血症及窒息等。
禁忌 
無已知禁忌。 
給付規定 
6.2.1. Surfactant (如Exosurf；Survanta)：(85/1/1)
1.新生兒hyaline membrane disease引起的呼吸窘迫症候群 (respiratory distress syndrome)。
2.治療條件：患有hyaline membrane disease引起呼吸窘迫症候群的新生兒，需使用人工呼吸器，且FIＯ2設定於40 %以上，仍無法維持blood gas PaＯ2大於80 mmHg以上或Ｏ2 artery/Ｏ2 alveoli小於0.2，並排除其他原因，如肺炎所引起的呼吸窘迫情況。
3.使用時機：出生後48小時內最多使用 4劑量，第一劑量建議在出生後8小時內使用。
注意事項 
最常見的不良反應發生在給藥的過程，在多次劑量的臨床試用中見到的副作用為暫時性心跳緩慢(11.9%)、氧飽合量降低(9.8%)；其他副作用發生率不到1%，包括氣管內插管迴流或阻塞、臉色蒼白、血管收縮、低血壓、高血壓、低或高二氧化碳血症及窒息等。
警語 
可快速地影響氧合作用和肺部的順從性。
曾有報導指出，在劑量投予過程中，有短暫的心搏徐緩以及氧飽和量降低的現象。
過量處理 
根據動物試驗數據，投予過量可能發生急性氣道阻塞。應採取治療法與支持性療法。
藥品保存方式 
未開封之小瓶應冷藏於 2 ~ 8 度。需避光。
已準備好要使用時才將小瓶自外盒取出。小瓶僅供單次使用。一旦開封，未用完的部份要丟棄。

 
Survanta 25mg/ml suspension
AbbVie Limited
1. Name of the medicinal product
Survanta 25mg/ml suspension
2. Qualitative and quantitative composition
Each ml contains beractant equivalent to:
Phospholipids  25 mg/ml
(including disaturated phosphatidylcholines 11.0 - 15.5 mg/ml)
Triglycerides
Free Fatty Acids
Protein
0.5 - 1.75 mg/ml
1.4 - 3.5 mg/ml
0.1 - 1.0 mg/ml
Excipient with known effect: 3.54mg/ml Sodium
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Sterile suspension for intratracheal administration
4. Clinical particulars
4.1 Therapeutic indications
Survanta is indicated for treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in new born premature infants with a birth weight of 700g or greater and who are intubated and are receiving mechanical ventilation.
Survanta is also indicated for the prophylactic treatment of premature infants <32 weeks gestational age at risk of developing RDS.
4.2 Posology and method of administration
Posology
Paediatric population
100 mg phosholipid/kg birth weight in a volume not exceeding 4ml/kg.
Treatment: Survanta should be administered early in the course of RDS, i.e. preferably less than 8 hours of age. Depending on clinical course, this dose may be repeated within 48 hours at intervals of at least six hours for up to 4 doses.
Prophylaxis: The first dose of Survanta should be administered as soon as possible after birth, preferably within 15 minutes. Depending on clinical course, this dose may be repeated within 48 hours at intervals of at least six hours for up to 4 doses.
Method of Administration
Survanta should be administered by intratracheal administration (i.e. drug should be conducted into the lungs via an endotracheal tube) using a 5 Fr catheter. The tip of the catheter should lie at the end of the endotracheal tube. Infants should not be intubated solely for the administration of Survanta.
Survanta should be warmed to room temperature before administration (see Precautions).
Before administering Survanta to infants on mechanical ventilation, set the respiratory frequency at 60/minute - with inspiration time 0.5s and Fi02 at 1.0. Inspiratory pressure needs no change at this point.
To ensure distribution of Survanta throughout the lungs, each dose is divided into fractional doses. Each dose can be administered as either two half-doses or four quarter-doses. Each fractional dose is administered with the infant in different positions as given below. Between each position the infant should be ventilated for 30 seconds.
For Four quarter-doses, the recommended positions are :
Right Lateral Position with the head lowered (i.e. head and body slanting down at an angle of approximately 15°).
Left Lateral Position with the head lowered (i.e. head and body slanting down at an angle of approximately 15°).
Right Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15°).
Left Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15°).
For administration of each quarter dose, the ventilator is disconnected, the catheter inserted, the dose administered then the ventilator reconnected. Between each quarter dose the infant is ventilated for 30 seconds.
For two half-doses, the recommended positions are :
• With infant supine, the head and body turned approximately 45° to the right.
• With infant supine, the head and body turned approximately 45° to the left.
When two half-doses of Survanta are being administered there are 2 alternative methods of administration:
Installation with disconnection from the ventilator
Each half dose is administered by disconnecting the endotracheal tube from the ventilator, inserting the catheter and administering the half dose. Between the half doses, the ventilator is reconnected for 30 seconds.
Alternatively,
Instillation without disconnection from the ventilator (through a suction port connector).
The first half dose is administered by inserting the catheter through a suction port connector without disconnection from the ventilator. There should be at least 30 seconds between the half doses during which time the catheter is retracted from the endotracheal tube but not removed from the connector. The catheter is then reinserted into the endotracheal tube and the second half dose administered. The catheter is then withdrawn completely.
Dosage in Adults
Not applicable.
Dosage in Older People
Not applicable.
4.3 Contraindications
No specific contraindications for Survanta have been defined by the clinical studies.
4.4 Special warnings and precautions for use
Survanta should only be administered with adequate facilities for ventilation and monitoring of babies with RDS.
Marked improvements in oxygenation may occur within minutes of the administration of Survanta. Therefore, frequent and careful monitoring of systemic oxygenation is essential to avoid hyperoxia. Following Survanta administration, monitoring of the arterial blood gases, the fraction of inspired oxygen and ventilatory change is required to ensure appropriate adjustments.
During the dosing procedure, transient episodes of bradycardia and/or oxygen desaturation have been reported. If these occur, dosing should be stopped and appropriate measures to alleviate the condition should be initiated. After stabilisation, the dosing procedure should be resumed.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Paediatric population
Summary of the safety profile
Intracranial haemorrhage has been observed in patients who received either beractant or placebo. The incidence of intracranial haemorrhage in all patients is similar to that reported in the literature in this patient population. Pulmonary haemorrhage has also been reported. Blockage of the endotracheal tube by mucous secretions has been reported. No other serious adverse reactions have been reported.
These are presented in the following table:

System Organ Class	Frequency	Adverse Reactions
Vascular disorders	Very common	Intracranial haemorrhage
Respiratory	Common	Pulmonary haemorrhage
Surgical and Medical Procedures	Uncommon	Blockage of endotracheal tube by mucous secretions

The following frequency categories are used: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100).
No antibody production to Survanta proteins has been observed.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Paediatric Population
If an excessively large dose of Survanta is given, observe the infant for signs of 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 suction or other remedial action is not required unless clear-cut signs of airway obstruction are present.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Lung Surfactant
ATC Code R07AA02
The mode of action of Survanta is biophysical rather than biochemical, i.e. it reduces surface tension and concomitantly increases lung compliance.
Intratracheally administered Survanta distributes rapidly to the alveolar surfaces and stabilises the alveoli against collapse during respiration thereby increasing alveolar ventilation.
In clinical studies of premature infants with Respiratory Distress Syndrome (RDS), a significant improvement in oxygenation was demonstrated after treatment with a single dose of Survanta.
These infants showed a decreased need for supplemental oxygen and an increase in the arterial/alveolar oxygen ratio (a/Ap02). Significantly decreased need for respiratory support, as indicated by a lower mean airway pressure, was also observed. In most cases these effects were maintained for at least 72 hours after the administration of the single dose of Survanta.
5.2 Pharmacokinetic properties
In preclinical studies using radiolabelled phosphatidylcholine, the clearance rate of Survanta in the lung of three day old rabbits has been shown to be similar to that of natural calf and sheep surfactants (approximately 13% within 24 hours). In addition some re-uptake and secretion of Survanta was shown, implying its entry into a metabolically active surfactant pool.
Since an exogenous preparation of Survanta is delivered directly to the lung, classical clinical pharmocokinetic parameters (blood levels, plasma half-life etc.) have not been studied.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloride
Palmitic acid
Dipalmitoyl Phosphatidylcholine
Tripalmitin
Sodium Hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injection
6.2 Incompatibilities
None experienced to date, as product administration is unique.
6.3 Shelf life
18 months
Before administration, Survanta should be warmed by standing at room temperature for 20 minutes or warmed in the hand for 8 minutes. ARTIFICIAL WARMING METHODS SHOULD NOT BE USED. Discard each vial if not used within 8 hours of warming to room temperature. Vials should not be returned to the refrigerator once warmed.
6.4 Special precautions for storage
Store under refrigerated conditions (2-8°C) protected from light. Do not freeze. Any inadvertently frozen product should be discarded. For storage conditions after product is removed from the refrigerator before opening, see section 6.3.
6.5 Nature and contents of container
21ml glass bottle with a 20mm rubber stopper and a 20mm aluminium seal finish containing 8ml of product.
Pack sizes: 1, 3 and 10
6.6 Special precautions for disposal and other handling
Each vial of Survanta is for single use only. Used vials with residual drug should be discarded.
Survanta should be inspected visually for discolouration prior to administration. The colour of Survanta is off-white to light brown. Some settling may occur during storage. If this occurs, gently invert the vial several times (DO NOT SHAKE) to redisperse.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
AbbVie Ltd.
Maidenhead,
SL6 4UB
UK
8. Marketing authorisation number(s)
PL 41042/0003
9. Date of first authorisation/renewal of the authorisation
13th October 1998
10. Date of revision of the text
30 October 2015