Revision Year: 2013 Publisher: BB-NCIPD Ltd., 1504 Sofia, 26 Yanko Sakazov Blvd., Tel.: **359 2 9446 191, Fax: 359-2-9433455, e-mail: bulbio@bulbio.com
PPD Tuberculin Mammalian, 5TU/0.1 ml, solution for intradermal injection.
Tuberculin Purified Protein Derivative.
| Pharmaceutical Form |
|---|
|
PPD Tuberculin is an injectable solution ready for intradermal application (I.D.), without dilution. Clear colourless solution. |
The preparation is a cell-free purified protein fraction obtained from a human strain of M. tuberculosis, grown on a protein-free synthetic medium and inactivated at temperature.
The preparation is a sterile isotonic solution of PPD Tuberculin in phosphate buffered saline, containing Tween 80 (0.005%) as stabilizer and phenol (up to 0.25%) as antimicrobial preservative.
Potency is expressed in Tuberculin Units (TU) bio-equivalent to International Units of the International Standard (PPD-S) per test dose (0.1 ml) (9; 33).
The product meets the WHO Requirements for Tuberculins (TRS 745) and European Pharmacopoeia: 0151.
*PPD Tuberculin Mammalian 5 TU/0.1 ml – 1 dose contains:
| Component | Quantity | |
|---|---|---|
| Active ingredient | Tuberculin Purified Protein Derivative | 5 TU* |
| Other ingredients | Tween 80 as stabilizer | 5.0 μg |
| Phenol as preservative | ≤0.25 mg | |
| Isotonic phosphate buffer | pH – 6.5-7.5 | |
| disodium hydrogen phosphate R | 0.76 mg | |
| potassium dihidrogen phosphate R | 0.145 mg | |
| sodium chloride R | 0.48 mg | |
| Water for injection | q.s. 0,1 ml |
* Bio-equivalent to 5 IU of Tuberculin PPD-S (9, 33)
| Active Ingredient | Description | |
|---|---|---|
| Tuberculin |
Tuberculin PPD is indicated for the detection of a delayed hypersensitivity reaction to |
| List of Excipients | ||||||||||||||||||
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Type I glass vials (14):
0,2 ml ( 2 doses) containing 10 TU of PPD = 5 TU/0.1 ml
1 ml (10 doses) containing 50 TU of PPD = 5 TU/0.1 ml
1,5 ml (15 doses) containing 75 TU of PPD = 5 TU/0.1 ml
2 ml (20 doses) containing 100 TU of PPD = 5 TU/0.1 ml
Tuberculin PPD solutions do not require future dilution.
BB-NCIPD Ltd., 1504 Sofia, 26 Yanko Sakazov Blvd., Tel.: **359 2 9446 191, Fax: 359-2-9433455, e-mail: bulbio@bulbio.com
No. II – 11522/13.12.2010
Reg. No. 20000719/19.11.2000
ATC-V04CF01
First registration in Bulgaria: 1977.
Date of last registration in Bulgaria: 19 November 2000
Date of last renewal: 13 December 2010
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