Company
Product List
Offer to buy
Offer to sell
Sign In
Join
Help
Languages
English
繁體中文
簡體中文
HunanRunkunPharmaceuticalCo.,Ltd.
Home
Company Profile
Products
Video
Inquiry
Contact Us
Recommended Results
Perfluoropropane-Albumin Microsphere Injection
Category :
Chemicals->Chemical->aspalthic products
View Larger Picture
View Larger Picture
View Larger Picture
Product Specification
Country
CN
Brand
RunKun
Packing
carton
Payment Term
T/T,Paypal,Western Union
Product Detail
<div align="left">
<blockquote>
<blockquote>
<blockquote>
<p>
<strong><span style="font-family:Verdana;font-size:14px;">Perfluoropropane-Albumin Microsphere Injection</span></strong>
</p>
</blockquote>
</blockquote>
</blockquote>
</div>
<p>
<span style="font-family:Verdana;font-size:12px;">Clinical Value</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><span><span></span></span><span></span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 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. </span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> Accurate assessment of ventricular wall motion and wall thickness ratio;</span><br />
<span style="font-family:Verdana;font-size:12px;"> Correct measurement of left ventricular ejection fraction;</span><br />
<span style="font-family:Verdana;font-size:12px;"> Clear diagnosis of apical hypertrophic cardiomyopathy;</span><br />
<span style="font-family:Verdana;font-size:12px;"> Clear diagnosis of intracardiac mural thrombus;</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> Potential real-time evaluation of the value of myocardial perfusion;</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> Clinical Outcomes</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Name]</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> Generic name: Perfluoropropane-Albumin Microsphere Injection</span><span style="font-family:Verdana;font-size:12px;"></span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Composition] Main Ingredient: 1% of perfluoropropane-albumin microsphere. Excipient: 0.9% of sodium chloride injection.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Specification] 3ml/bottle.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Usage and dosage] Peripheral intravenous injection; recommended dose: 0.01ml/kg each injection.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 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. </span><br />
<span style="font-family:Verdana;font-size:12px;"> 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. </span><br />
<span style="font-family:Verdana;font-size:12px;"></span><br />
<span style="font-family:Verdana;font-size:12px;"> [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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Contraindications] </span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 1. The product should not be used in patients with a history of allergy to food, drug, albumin and other blood products.</span><br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><br />
<span style="font-family:Verdana;font-size:12px;"> 3. The product must not be used in patients with heart functional class IV and severe arrhythmia.</span><br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><br />
<span style="font-family:Verdana;font-size:12px;"> 5. The product should be used with caution in patients with liver and kidney dysfunction.</span><br />
<span style="font-family:Verdana;font-size:12px;"> 6. The product should be used with caution in patients with psychosis and epilepsy.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Precautions]</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> 1. The product must be used in strict accordance with the package insert
and physician must fully master the operating procedures and safety.</span><br />
<span style="font-family:Verdana;font-size:12px;"> 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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Administration for children] For there is no safe and effective
information, the product should be used with caution in children. </span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Administration for elderly patients] For there is no safe and effective
information, the product should be used with caution in elderly
patients.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Drug Interaction] Data unavailable yet.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Overdose] In case of drug overdose, start symptomatic treatment immediately and monitor vital signs periodically.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [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).</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [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.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [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-∞).</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Storage Conditions] Store at 2-8℃. Protect from freezing and light. Do not invert or shake vigorously.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Package] Penicillin bottle, 3ml/bottle.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Shelf Life] 24 months.</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Standard] YBSO1672006 Perfluoropropane-Albumin Microsphere Injection Manufacturing and Verification Procedures (Trial).</span><br />
<br />
<span style="font-family:Verdana;font-size:12px;"> [Registered number of approval] S20083098</span>
</p>runkun-med.com
More Products from this Supplier
Hepatitis C Virus Core Antigen Detection Kit
Hepatitis C Virus Antibody Diagnostic Kit
[ Back Products Catalog ]
Commerce Member:
Please log in your ID and password, we will later fill in relating info.
ID:
Password:
Remember my ID on this computer
Complete this form below to send out your enquiries.
All enquiries will be automatically sent to the company you want to develop.
Subject
Content
(Don't input Company Name, E-Mail, Phone Number, Fax Number, and URL)
Company Profile:
*
Company Name
*
E-mail
*
Country
Please Select Your Country
United States
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaidjan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Cook Islands
Costa Rica
Croatia
Cuba
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
East Timor
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
Former Czechoslovakia
Former USSR
France
France (European Territory)
French Guyana
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Great Britain
Greece
Greenland
Grenada
Guadeloupe (French)
Guam (USA)
Guatemala
Guinea
Guinea Bissau
Guyana
Haiti
Heard and McDonald Islands
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Ivory Coast
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Kiribati
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique (French)
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldavia
Monaco
Mongolia
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
Neutral Zone
New Caledonia (French)
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Korea
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Island
Poland
Polynesia (French)
Portugal
Puerto Rico
Qatar
Reunion (French)
Romania
Russian Federation
Rwanda
S. Georgia & S. Sandwich Isls.
Saint Helena
Saint Kitts & Nevis Anguilla
Saint Lucia
Saint Pierre and Miquelon
Saint Tome (Sao Tome) and Principe
Saint Vincent & Grenadines
Samoa
San Marino
Saudi Arabia
Senegal
Seychelles
Sierra Leone
Singapore
Slovak Republic
Slovenia
Solomon Islands
Somalia
South Africa
South Korea
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen Islands
Swaziland
Sweden
Switzerland
Syria
Tajikistan
Taiwan
Tanzania
Thailand
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Vanuatu
Vatican City State
Venezuela
Vietnam
Virgin Islands (British)
Virgin Islands (USA)
Wallis and Futuna Islands
Western Sahara
Yemen
Yugoslavia
Zaire
Zambia
Zimbabwe
*
Contact Person
URL
*
Phone
-
-
Fax
-
-
*
Postal code
*
City
*
Street Address
*
Business Nature
Distributor
Exporter
Importer
Manufacturer
Whole Sale
Retailer
Reseller
Retrofitter
User
Others, please specify:
*
Security Code
Enter the security code.
Site Map l
Privacy Policy l
Company Profile l
Corporate Proposal l
Contact Us l
Help l
Advertise With Us l
World Trade Link
.