ZOLEDRONIC ACID injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

zoledronic acid (UNII: 6XC1PAD3KF) (zoledronic acid anhydrous - UNII:70HZ18PH24)

Tillgänglig från:

Sagent Pharmaceuticals

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Zoledronic Acid Injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5)] . Zoledronic Acid Injection is contraindicated in patients with the following conditions: - Hypocalcemia [see Warnings and Precautions (5.2)] . - Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3)] . - Known hypersensitivity to zoledronic acid or any components of Zoledronic Acid Injection. Hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Adverse Reactions (6.2)] . Risk Summary Available data on the use of Zoledronic Acid

Produktsammanfattning:

Zoledronic Acid Injection is supplied as follows: Handling After entering the IV administration port, the solution is stable for 24 hours at 2° to 8°C (36° to 46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration. Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Single-use only. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, DEHP-free, PVC-free. The container closure is not made with natural rubber latex.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Sagent Pharmaceuticals
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MEDICATION GUIDE
Zoledronic Acid (ZOE-le-DRON-ik AS-id) Injection
Read the Medication Guide that comes with Zoledronic Acid Injection
before you start taking it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking with your doctor about your medical condition or treatment.
Talk to your doctor if you have any
questions about Zoledronic Acid Injection.
What is the most important information I should know about Zoledronic
Acid Injection?
You should not receive Zoledronic Acid Injection if you are already
receiving Zometa. Both Zoledronic
Acid
Injection
and
Zometa
contain
zoledronic
acid.
Zoledronic Acid Injection can cause serious side effects including:
1.
Low calcium levels in your blood (hypocalcemia)
2.
Severe kidney problems
3.
Severe jaw bone problems (osteonecrosis)
4.
Bone, joint or muscle pain
5.
Unusual thigh bone fractures
1.
Low calcium levels in your blood (hypocalcemia).Zoledronic Acid
Injection may lower the
calcium levels in your blood. If you have low blood calcium before you
start taking Zoledronic
Acid Injection, it may get worse during treatment. Your low blood
calcium must be treated before
you take Zoledronic Acid Injection. Most people with low blood calcium
levels do not have
symptoms, but some people may have symptoms. Call your doctor right
away if you have
symptoms of low blood calcium such as:
•
Spasms, twitches, or cramps in your muscles
•
Numbness or tingling in your fingers, toes, or around your mouth
Your doctor may prescribe calcium and vitamin D to help prevent low
calcium levels in your
blood, while you take Zoledronic Acid Injection. Take calcium and
vitamin D as your doctor tells
you to.
2.
Severe kidney problems.Severe kidney problems may happen when you take
Zoledronic Acid
Injection. Severe kidney problems may lead to hospitalization or
kidney dialysis and can be life-
threatening. Your risk of kidney problems is higher if you:
•
already have kidney problems
•
take a diu

Produktens egenskaper

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLEDRONIC ACID INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID
INJECTION.
ZOLEDRONIC ACID INJECTION, FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Zoledronic Acid Injection is a bisphosphonate indicated for:
Treatment of Paget's disease of bone in men and women (1.5)
DOSAGE AND ADMINISTRATION
Infusion given intravenously over no less than 15 minutes:
Treatment of Paget's disease of bone: a single 5 mg infusion. Patients
should receive 1500 mg elemental calcium and
800 international units vitamin D daily (2.6)
DOSAGE FORMS AND STRENGTHS
5 mg in a 100 mL ready-to-infuse solution (3)
CONTRAINDICATIONS
Hypocalcemia (4)
Patients with creatinine clearance less than 35 mL/min and in those
with evidence of acute renal impairment (4, 5.3)
Hypersensitivity to any component of Zoledronic Acid Injection (4,
6.2)
WARNINGS AND PRECAUTIONS
_Products Containing Same Active Ingredient:_ Patients receiving
Zometa should not receive Zoledronic Acid Injection
(5.1)
_Hypocalcemia_ may worsen during treatment. Patients must be
adequately supplemented with calcium and vitamin D
(5.2)
_Renal Impairment:_ A single dose should not exceed 5 mg and the
duration of infusion should be no less than 15
minutes. Renal toxicity may be greater in patients with underlying
renal impairment or with other risk factors, including
advanced age or dehydration. Monitor creatinine clearance before each
dose (2.7, 5.3)
_Osteonecrosis of the Jaw (ONJ)_ has been reported. All patients
should have a routine oral exam by the prescriber prior
to treatment (5.4)
_Atypical Femur Fractures_ have been reported. Patients with thigh or
groin pain should be evaluated to rule out a femoral
fracture (5.5)
_Severe Bone, Joint, and Muscle Pain_ may occur. Withhold future doses
of Zoledronic Acid Injection if severe sy