Tubersol (Tuberculin PPD)

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Tuberculin purified protein derivative 5 TU/0.1mL

Prieinama:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Tarptautinis Pavadinimas):

Tuberculin purified protein derivative 5 TU/0.1mL

Dozė:

5 TU/0.1mL

Vaisto forma:

Solution for injection

Sudėtis:

Active: Tuberculin purified protein derivative 5 TU/0.1mL Excipient: Phosphate Buffered Saline Polysorbate 80

Vienetai pakuotėje:

Vial, glass, 0.1mL doses, 10 dose units

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Sanofi Pasteur Limited

Terapinės indikacijos:

Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis.

Produkto santrauka:

Package - Contents - Shelf Life: Vial, glass, 0.1mL doses - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 0.1mL doses - 50 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Leidimo data:

1975-02-05

Prekės savybės

tubersol-ccdsv2-dsv4-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
TUBERSOL
® (TUBERCULIN PPD) (5 TU/0.1 ML, SOLUTION FOR
INJECTION)
Tubersol (Tuberculin PPD) 5 TU/0.1 mL Solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tuberculin Purified Protein Derivative (Mantoux) for intradermal
tuberculin testing is prepared by
the Sanofi Pasteur Laboratories Limited from a large Master Batch
Connaught Tuberculin (CT68)
which has been obtained from a human strain of
_Mycobacterium tuberculosis_
grown on a protein-
free synthetic medium. The use of a standard preparation derived from
a single batch (CT68) has
been recommended in order to eliminate batch to batch variation by the
same manufacturer.
It is estimated that this batch is large enough to provide solutions
for many years. From this batch,
Tuberculin PPD at three concentrations is available in sterile
isotonic phosphate buffered saline
containing polysorbate 80 (0.0006%) as a stabiliser. Phenol 0.28% is
added as a preservative.
Independent studies conducted by the US Public Health Service in
humans have determined the
amount of CT68 in stabilised solution necessary to produce
bio-equivalency with Tuberculin
PPD-S (in phosphate buffer without polysorbate 80) using 5 US units
Tuberculin PPD-S as the
standard.
Prior to release, each successive lot is tested for potency in
sensitised guinea pigs in comparison
with a reference standard.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tubersol is a clear, colourless solution for injection.
tubersol-ccdsv2-dsv4-20jun22
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4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tuberculin PPD is indicated as an aid in the detection of infection
with
_Mycobacterium _
_tuberculosis. _
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The Mantoux test is performed by injection intradermally, with a
syringe and needle, 0.1 mL of
Tuberculin PPD. For the intradermal (Mantoux) tuberculin test, the
dose is 5 tuberculin units
(TU) per test dose of 0.1 mL.
METHOD OF ADMINISTRATION
DO NOT