Products

Tb-Ppd Purified Protein Derivative of Tuberculin

China Tb-Ppd Purified Protein Derivative of Tuberculin, Find details about China Tuberculosis Diagnosis, Purified Protein Derivative from Tb-Ppd Purified Protein Derivative of Tuberculin

Model NO.
20IU/ml. Iml/ampoule
Pharmaceutical Technology
Biological
Drug Reg./Approval No.
S10960018
Use
Diagnosis
Trademark
N/A
Transport Package
Box
Specification
5 ampoules/box
Origin
China
Model NO.
20IU/ml. Iml/ampoule
Pharmaceutical Technology
Biological
Drug Reg./Approval No.
S10960018
Use
Diagnosis
Trademark
N/A
Transport Package
Box
Specification
5 ampoules/box
Origin
China
Purified Protein Derivative of Tuberculin (TB-PPD)
Tb-Ppd Purified Protein Derivative of Tuberculin
Component and Characters
It is a diluted preparation containing 0.4μg pure protein derivative of tuberculin per 1ml (that is 20IU per 1ml), which is calibrated by the national standard and PPD RT23 and is completely consistent. 
It is colorless clear liquid, contains phenol as preservative, no insoluble substance or foreign impurities.

Strength
0.1ml for one person, it contains 2IU TB-PPD. 1ml/ampoule. 

Indication and use
For tuberculosis epidemiological investigation and suspected tuberculosis diagnosis in clinical.

User
Infants, children and adults 

Administration and dosage 
Take 0.1ml (2IU) and inject intradermally into the palmar side of forearm by Mantoux method.

Result judgement
Exam the reaction in injection area at 48 ~ 72 hours after injection. Measure and record the transverse and longitudinal diameters of the induration in mm. The positive reaction is that the average diameter of induration should be not less than 6mm. Blisters, necrosis or lymphangitis are regarded as strong positive reactions, which should be specified in details.
Strong positive reaction and the induration diameter are not less than 20mm or the children less than 3 years-old who have not been vaccinated with BCG (according to inoculation history and examination of local BCG marks) and are positive to KCR, even if chest fluoroscopy is normal, they still need to be treated as active tuberculosis. 

Adverse reaction
Adverse events reported in the post-marketing surveillance: dizziness, nausea, weakness, rash and pruritus, etc. The incidence rate and causality with the product is still indefinite since these events are spontaneously reported.
If the object has suffered from excessive tuberculosis or allergic constitution, blister, infiltration or ulcer may occur locally. different degrees of fever may appear in some cases. Generally, they are self-subsiding or self-healing. Occasionally severe symptom should be treated for local anti-inflammatory or antipyretic.

Contraindications
Patients with acute infectious diseases (e.g. Measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, widespread dermatosis and allergic conditions

Precautions 
(1) The syringe and needle should be dedicated used.  
(2) If there are cracks in ampoules or foreign impurities in products, it cannot be used.
(3) It should be used within half an hour after the ampoule is opened

Storage
Store and ship at 2~8ºC, protected from light. 

Packaging
In ampoule, 5 ampoules/box

Shelf life 
24 months from the manufacturing date

Standard
Pharmacopeia of the People's Republic of China, 2015 edition, Volume III 

Approved License No.
NMPA S10960018

Manufacturer 
Company Name: Beijing Sanroad Biological Products Co., Ltd.
Address: No.17, Yanqi North 3rd Street, Yanqi Economic Development Area, Huairou District, Beijing.
Zip code:101407 
 
 
Web site: http://simcere.en.made-in-china.com

 

You Might Also Like