PAMIDRONATE DISODIUM injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

PAMIDRONATE DISODIUM (UNII: 8742T8ZQZA) (PAMIDRONIC ACID - UNII:OYY3447OMC)

Διαθέσιμο από:

GeneraMedix, Inc.

INN (Διεθνής Όνομα):

pamidronate disodium

Φαρμακοτεχνική μορφή:

INJECTION, SOLUTION

Σύνθεση:

3 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Pamidronate disodium in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions ha

Περίληψη προϊόντος:

Pamidronate Disodium Injection is supplied as follows: 30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL.  NDC 10139-306-10 , individually boxed. 90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL.  NDC 10139-307-10 , individually boxed. Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature]. *Zometa ® is a registered trademark of Novartis Pharmaceuticals Corporation. Manufactured for: GeneraMedix Inc. 150 Allen Road Liberty Corner, NJ  07938 Manufactured by: Mustafa Nevzat İlaç Sanayii A.Ş. Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/1 34349 Gayrettepe / İstanbul -Turkey January 2009 PI30600.01

Αρχείο Π.Χ.Π.

PAMIDRONATE DISODIUM- PAMIDRONATE DISODIUM INJECTION, SOLUTION
GENERAMEDIX, INC.
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DESCRIPTION
Pamidronate Disodium Injection is a bone resorption inhibitor
available in 30 mg and 90 mg sterile vials
for intravenous administration.
Each mL of the 30 mg vials contains 3 mg of pamidronate disodium; 47
mg of mannitol USP and water
for injection q.s.; phosphoric acid and/or sodium hydroxide have been
added to adjust pH 6 to 7.
Each mL of the 90 mg vials contains 9 mg of pamidronate disodium; 37.5
mg of mannitol USP and water
for injection q.s.; phosphoric acid and/or sodium hydroxide have been
added to adjust pH 6 to 7.
The pH of a 1% solution of pamidronate disodium in distilled water is
approximately 8.3. Pamidronate
disodium, a member of the group of chemical compounds known as
bisphosphonates, is an analog of
pyrophosphate. Pamidronate disodium is designated chemically as
disodium dihydrogen (3-amino-1-
hydroxypropylidene) diphosphonate, and its structural formula is:
Pamidronate disodium is a white-to-practically-white powder. It is
soluble in water and in 2N sodium
hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N
acetic acid, and practically
insoluble in organic solvents. Its molecular formula is C H NO P Na
and its molecular weight is
279.1.
CLINICAL PHARMACOLOGY
The principal pharmacologic action of pamidronate disodium is
inhibition of bone resorption. Although
the mechanism of antiresorptive action is not completely understood,
several factors are thought to
contribute to this action. Pamidronate disodium adsorbs to calcium
phosphate (hydroxyapatite) crystals
in bone and may directly block dissolution of this mineral component
of bone. In vitro studies also
suggest that inhibition of osteoclast activity contributes to
inhibition of bone resorption. In animal
studies, at doses recommended for the treatment of hypercalcemia,
pamidronate disodium inhibits bone
resorption apparently without inhibiting bone formation and
mineralization. Of relevance to the treatment
of hypercalcemia of