STERITALC 4G- talc powder STERITALC 2G- talc powder STERITALC 3G- talc powder

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)

Inapatikana kutoka:

Novatech SA

Njia ya uendeshaji:

INTRAPLEURAL

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

New Drug Application

Tabia za bidhaa

STERITALC 4G- TALC POWDER
STERITALC 2G- TALC POWDER
STERITALC 3G- TALC POWDER
NOVATECH SA
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STERITALC
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
STERITALC® safely and
effectively. See full prescribing information for STERITALC®.
STERITALC® (talc), powder, for intrapleural use
Initial U.S. Approval: 2003
___________ INDICATIONS AND USAGE____________
STERITALC® is a sclerosing agent indicated:
To decrease the recurrence of malignant pleural effusions in
symptomatic patients
following maximal drainage of the pleural effusion. (1.1)
In adults to decrease the recurrence of pneumothorax..(1.2)
________DOSAGE AND ADMINISTRATION ________
Malignant Pleural Effusion: The recommended dose is 2 to 5 grams
administered
intrapleurally. (2.2)
Pneumothorax: The recommended dose is 2 grams administered
intrapleurally.
Do not exceed a total cumulative dosage of 10 grams per procedure.
(2.3)
Prepare and administer as recommended. (, 2.5)
_______ DOSAGE FORMS AND STRENGTHS________
Powder: 2 grams, in a 50 mL single-dose vial (3)
Powder: 4 grams, in a 50 mL single-dose vial (3)
Powder: 3 grams, in a 10 mL single-dose vial (3)
_____________CONTRAINDICATIONS _____________
Pregnancy. (4, 5.3, 8.1)
________ WARNINGS AND PRECAUTIONS _________
Pneumonitis and Acute Respiratory Distress Syndrome (ARDS): Acute
Pneumonitis
and ARDS, , have been reported with intrapleural use of various talc
products. (5.1)
Interference with Future Procedures: Sclerosis of the pleural space
may preclude or
complicate subsequent ipsilateral surgery and diagnostic procedures.
(5.2)
Lead Content: STERITALC® contains lead as an impurity. May cause lead
toxicity,
especially in children. (5.3)
_____________ADVERSE REACTIONS _____________
Common adverse reactions are fever and pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Boston Medical Product
Inc., at
508-898-9300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
--------------USE IN SPECIFIC