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Perfluoropropane-Albumin Microsphere Injection

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Perfluoropropane-Albumin Microsphere Injection

Product Specification

Country	CN
Brand	RunKun
Packing	carton
Payment Term	T/T,Paypal,Western Union

Product Detail

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Perfluoropropane-Albumin Microsphere Injection

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Clinical Value 
 
 The ultrasound contrast agent (UCA) plays an important role in clinical
diagnosis, treatment and clinical research. The internationally approved
echocardiographic contrast agents are used for same clinical
indications: patients with poor left ventricular opacification (LVO) and
left ventricular endocardial border delineation (EBD) in routine
echocardiography in the resting state. 
 
 American Society of Echocardiography (ASE) guidelines recommend: if
imaging quality of the heart is poor in at least two out of the six
stages, ultrasonic contrast should be applied to enhance the image
quality. 
 
 Application of contrast agent in LVO enhances the possibility, accuracy
and repeatability of qualitative and quantitative echocardiographic
assessments of left ventricular structure and function in the resting
state, or during exercise or pharmacological stress, making it easier
for the diagnosis or assessment of intracardiac space occupying lesion,
such as tumors and thrombus. Meanwhile, it improves the visibility of
right ventricle and large vessels and reinforces the Doppler signal
which is used to assess valve function. The UCA can also be used for
echocardiographic study in emergency rooms, intensive care units,
cardiac catheterization rooms and operation rooms. The effective
application of contrast agent in echocardiography will optimize and
improve the cost-effectiveness of examination and may help improve
clinical outcomes. 
 
 In recent years, great progress has been made in the application of
Perfluoropropane-Albumin Microsphere Injection for myocardial blush
grades and ultrasonography of parenchymatous organs, such as liver,
kidneys, mammary glands and pancreatic gland. Clinicians have
established a complete set of methods to qualitatively identify various
masses in parenchymatous organs with Perfluoropropane-Albumin
Microsphere Injection. 
 
 Accurate assessment of ventricular wall motion and wall thickness ratio; 
 Correct measurement of left ventricular ejection fraction; 
 Clear diagnosis of apical hypertrophic cardiomyopathy; 
 Clear diagnosis of intracardiac mural thrombus; 
 
 Potential real-time evaluation of the value of myocardial perfusion; 
 
 Clinical Outcomes 
 
 Clinical experiments in seven hospitals, including Zhongshan Hospital
under Fudan University, Rui Jin Hospital under Shanghai Jiao Tong
University School of Medicine, Changhai Hospital of Shanghai, Chinese
PLA General Hospital, West China Hospital of Sichuan University, Qilu
Hospital of Shandong University and Beijing Chao-Yang Hospital, prove
that 98.6% of intima imaging quality has been enhanced and the
identification of left ventricular endocardial border has been
significantly improved. In the meanwhile, the application of
Perfluoropropane-Albumin Microsphere Injection does not affect the
function of liver or kidneys, or the results of blood and urine routine
examinations and electrocardiogram (ECG) results. Therefore, it is a
safe and effective cardiac ultrasound contrast agent, suitable for
patients with poor imaging quality in routine echocardiography, and can
be promoted for extensive clinical use. 
 
 [Name] 
 
 Generic name: Perfluoropropane-Albumin Microsphere Injection 
 
 [Composition] Main Ingredient: 1% of perfluoropropane-albumin microsphere. Excipient: 0.9% of sodium chloride injection. 
 
 [Description] The bottom layer is transparent liquid without any foreign
matter , turbidity or sedimentation. The top layer is white
microspheres. It becomes even, opaque, white suspension after it's
mixed. 
 
 [Indications] Patients with poor imaging quality in routine
echocardiography; improvement of left ventricular endocardial border
identification; improvement of imaging effect, lesion detection rate and
accuracy of lesion characterization in parenchymatous organs, such as
liver, kidneys and mammary glands. 
 
 [Specification] 3ml/bottle. 
 
 [Usage and dosage] Peripheral intravenous injection; recommended dose: 0.01ml/kg each injection. 
 
 1. Preparation: check the package to make sure it's up to the standard,
mix the drug evenly without shaking it hard to avoid microsphere
rupture or foam. To keep the pressure constant to avoid rupture, insert
another needle into the rubber plug to connect to the outside air while
extracting solution, and then extract the suspension into the syringe. 
 2. Injection: The patient should be in the left recumbent position (for
the convenience of echocardiography). Inject the tee joint scalp needle
into the hand vein or median cubital vein of the right upper limb.
Extract 10ml 0.9% sodium chloride injection with10ml syringe and connect
to one end of the needle. Extract the shaken Perfluoropropane-Albumin
Microsphere Injection with 1ml or 2ml syringe and connect to the other
end of the needle. Start with the dose of 1ml/sec and gradually increase
the dose to 0.02ml/kg, with two injections at maximum in total. 
 
 [Adverse reactions] According to domestic and foreign clinical studies,
the adverse reactions with the occurrence rate higher than 0.5% include:
headache (5.4%), nausea and vomiting (4.3%), hot flashes or flushing
sensation (3.6%) and dizziness (2.5%). Other adverse reactions include:
chills, flu-like symptoms, discomfort, weakness, fatigue, chest pain,
dyspnea, diarrhea, discomfort at the injection site, erythema, taste
alteration and slight changes in the heart rate and blood pressure. The
adverse reactions with the occurrence rate lower than 0.5% include:
joint pain, back pain, physical or muscle pain or sclerosis, rubella,
dry mouth, heart palpitations, paresthesia, photophobia, ventricular
premature beats, pruritus, rash, irritability, allergy, tinnitus tremor,
blurred vision, asthma, cough, color changes at the injection site and
the sense of burning in the eyes. 
 
 [Contraindications] 
 
 1. The product should not be used in patients with a history of allergy to food, drug, albumin and other blood products. 
 2. The product should be used with caution in patients with mitral
stenosis and congenital heart disease with intracardiac shunt. This
product can enter the arterial circulation directly without lung
filtration, so it should be used with extreme caution in patients with
congenital heart disease. 
 3. The product must not be used in patients with heart functional class IV and severe arrhythmia. 
 4. The product must not be used in patients with severe pulmonary
hypertension, pulmonary emphysema, pulmonary vasculitis, pulmonary
embolism, asthma, adult respiratory distress syndrome and respiratory
failure. 
 5. The product should be used with caution in patients with liver and kidney dysfunction. 
 6. The product should be used with caution in patients with psychosis and epilepsy. 
 
 [Precautions] 
 
 1. The product must be used in strict accordance with the package insert
and physician must fully master the operating procedures and safety. 
 2. Whenever a protein-containing product is applied to human body, it
might cause allergic reaction. Therefore, drugs for emergency treatment
of allergy, such as epinephrine, antihistamine drugs and
glucocorticoids, should be prepared. 
 
 [Administration for pregnant and lactating women]Animal reproductive
toxicity test did not show that the product would impair fertility or
cause harm to fetus. However, there is no data of strictly controlled
clinical research conducted on pregnant women at present. Therefore, the
product should not be used in pregnant women unless it is necessary and
should be used with caution in lactating women. 
 
 [Administration for children] For there is no safe and effective
information, the product should be used with caution in children. 
 
 [Administration for elderly patients] For there is no safe and effective
information, the product should be used with caution in elderly
patients. 
 
 [Drug Interaction] Data unavailable yet. 
 
 [Overdose] In case of drug overdose, start symptomatic treatment immediately and monitor vital signs periodically. 
 
 [Clinical trial] A multicenter self controlled blind evaluation phase
III clinical study was conducted to evaluate the efficacy and safety of
clinical use of Perfluoropropane-Albumin Microsphere Injection. Three
hundred and two patients (64.2% male, 35.8% female) with unclear border
visualization of left ventricle in two (or more) out of the six stages
were selected. Patients were intravenously injected with the contrast
agent (0.01ml/kg) and then real-time contrast echocardiography was
conducted. Evaluation indexes of the contrast effect are the
identification effect of left ventricular and right ventricular
endocardial border. The results showed that, Perfluoropropane-Albumin
Microsphere Injection can improve the quality of 98.6% of unclear border
imaging, with the occurrence rate of adverse reaction being 0.3%,
including mild nausea and diarrhea (see Adverse Reactions for more
details). 
 
 [Pharmacology and toxicology] Perfluoropropane-Albumin Microsphere
Injection is gas-filled microsphere preparation and can significantly
strengthen the acoustic reflection signal in ultrasound diagnostic
instrument. After peripheral intravenous injection, it can enhance the
left cardiac ultrasound contrast effect without causing adverse effect
on hemodynamics or electrocardiogram. 
 
 [Pharmacokinetics] Pharmacokinetics study on this product has not been
conducted. The following kinetic data are obtained from using the same
type of Perfluoropropane-Albumin Microsphere Injection in Chinese
patients. After intravenous administration, perfluoropropane will be
immediately released and exhaled out of the human body. When the dosages
of administration reaches 0.02ml/kg, 0.03ml/kg and 0.04ml/kg,
respectively, Tmzx of perfluoropropane in breath is 0.42±0.14 (min),
0.39±0.13 (min) and 0.44±0.17 (min), respectively; T1/2 is 1.84±0.2
(min), 1.95±0.73 (min) and 2.22±0.53 (min). The call-out volume of
perfluoropropane in one minute after the administration (AUCO-1min)
accounts for 0.49 (49%)±0.02 (2%) of the total call-out volume (AUCO-∞)
on average. The call-out volume of perfluoropropane in 15 minute after
administration accounts for 0.96 (96%)±0.02 (2%) of the total (AUCO-∞). 
 
 [Storage Conditions] Store at 2-8℃. Protect from freezing and light. Do not invert or shake vigorously. 
 
 [Package] Penicillin bottle, 3ml/bottle. 
 
 [Shelf Life] 24 months. 
 
 [Standard] YBSO1672006 Perfluoropropane-Albumin Microsphere Injection Manufacturing and Verification Procedures (Trial). 
 
 [Registered number of approval] S20083098
runkun-med.com

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