ZOLEDRONIC ACID- zoledronic acid injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Dr.Reddy's Laboratories Inc

INN (Alþjóðlegt nafn):

ZOLEDRONIC ACID

Samsetning:

ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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) ] . Pregnancy Category D [see Warnings and Precautions (5.

Vörulýsing:

Each bottle contains 5 mg per 100 mL:   NDC 43598-331 -11 Handling After opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.   Storage Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].   Single use vial.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
Dr.Reddy's Laboratories 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. 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
hig

Vara einkenni

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
DR.REDDY'S LABORATORIES INC
----------
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).
_Pregnancy_: Zoledronic acid injection can cause fetal harm. Women of
childbearing potential should be