ZOLEDRONIC ACID injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)

Pieejams no:

Hospira, Inc.

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Zoledronic acid 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 is contraindicated in patients with the following conditions: Risk Summary Available data on the use of zoledronic acid in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue zoledronic acid when pregnancy is recognized. In animal reproduction studies, daily subcutaneous administration of zoledronic acid to pregnant rats during organogenesis resulted in increases in fetal skeletal, visceral, and external malformations, decreases in postimplantation survival, and decreases in viable fetuses and fetal weight starting at doses equivalent t

Produktu pārskats:

Zoledronic Acid Injection is available in single-dose sterile Non-PVC flexible containers. Each bag contains 5 mg/100 mL. Handling If refrigerated, allow the refrigerated solution to reach room temperature before administration. Storage Store at temperature not exceeding 30°C (86°F). Protect from freezing. This container closure is not made with natural rubber latex.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

ZOLEDRONIC ACID- zoledronic acid injection, solution
Hospira, Inc.
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MEDICATION GUIDE
Zoledronic Acid Injection (ZOE-le-DRON-ik AS-id)
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.
Unusual thigh bone fractures
5.
Bone, joint or muscle pain
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:
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Produkta apraksts

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
HOSPIRA, INC.
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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 is a bisphosphonate indicated for:
•
DOSAGE AND ADMINISTRATION
Infusion given intravenously over no less than 15 minutes:
•
DOSAGE FORMS AND STRENGTHS
5 mg in a 100 mL ready-to-infuse solution (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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ADVERSE REACTIONS
The most common adverse reactions (greater than 10%) were pyrexia,
myalgia, headache, arthralgia,
pain in extremity (6.1). Other important adverse reactions were
flu-like illness, nausea, vomiting, diarrhea
(6.2), and eye inflammation (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HOSPIRA, INC. AT
1-800-441-4100, OR FDA
AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
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•
•
•
Treatment of Paget's disease of bone in men and women (1.5)
Treatment of Paget's disease of bone: a single 5 mg infusion. Patients
should receive 1,500 mg
elemental calcium and 800 international units vitamin D daily (2.6)
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)
_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 dehydrat