IBANDRONATE SODIUM injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

IBANDRONATE SODIUM (UNII: J12U072QL0) (IBANDRONIC ACID - UNII:UMD7G2653W)

Commercializzato da:

AuroMedics Pharma LLC

INN (Nome Internazionale):

IBANDRONATE SODIUM

Composizione:

IBANDRONIC ACID 3 mg in 3 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies (14)] . The safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. Ibandronate sodium injection is contraindicated in patients with the following conditions: - Hypocalcemia [see Warnings and Precautions (5.1)] - Known hypersensitivity to ibandronate sodium injection or to any of its ex

Dettagli prodotto:

Ibandronate sodium injection is supplied as a kit containing: 3 mg per 3 mL (1 mg/mL):      3 mL Single-Dose Prefilled Syringes,      Packaged in a carton with 1 needle                                            NDC 55150-191-83 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

IBANDRONATE SODIUM - IBANDRONATE SODIUM INJECTION, SOLUTION
AuroMedics Pharma LLC
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MEDICATION GUIDE
IBANDRONATE SODIUM
(eye ban′ droe nate soe′ dee um)
INJECTION
for intravenous use
Read the Medication Guide that comes with ibandronate sodium 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 ibandronate sodium injection.
What is the most important information I should know about ibandronate
sodium injection?
Ibandronate sodium injection is given in your vein (intravenously) and
only given by a healthcare provider.
Do not give ibandronate sodium injection to yourself.
Ibandronate sodium injection may cause serious side effects including:
1.
Low calcium levels in your blood (hypocalcemia)
2.
Severe allergic reaction (anaphylactic reaction)
3.
Severe kidney problems
4.
Severe jaw bone problems (osteonecrosis)
5.
Bone, joint or muscle pain
6.
Unusual thigh bone fractures
1. Low calcium levels in your blood (hypocalcemia).
Ibandronate sodium injection may lower the calcium levels in your
blood. If you have low blood calcium
before you start taking ibandronate sodium injection, it may get worse
during treatment. Your low blood
calcium must be treated before you receive ibandronate sodium
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 receive ibandronate sodium injection. Take calcium and vitamin D
as your doctor tells you to.
2. Severe allergic reactions.
Some people who received ibandronate sodium injection had severe
allergic rea

Scheda tecnica

IBANDRONATE SODIUM - IBANDRONATE SODIUM INJECTION, SOLUTION
AUROMEDICS PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBANDRONATE SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IBANDRONATE SODIUM
INJECTION.
IBANDRONATE SODIUM INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Ibandronate sodium injection is a bisphosphonate indicated for the
treatment of osteoporosis in
postmenopausal women. (1.1)
Limitations of Use
Optimal duration of use has not been determined. For patients at
low-risk for fracture, consider drug
discontinuation after 3 to 5 years of use (1.2)
DOSAGE AND ADMINISTRATION
3 mg every 3 months administered intravenously over a period of 15 to
30 seconds (2.2)
Dosing Instructions:
Only administer intravenously by a health care professional. (2.1)
Do not mix with calcium-containing solutions or other intravenously
administered drugs. (2.1)
Do not administer more frequently than once every 3 months. (2.2)
Instruct patients to take supplemental calcium and vitamin D if
dietary intake is inadequate
DOSAGE FORMS AND STRENGTHS
Ibandronate sodium injection is supplied as a kit containing:
a 3 mg/3 mL (1 mg/mL) single-dose prefilled syringe.
a 25-gauge, 3/4 inch needle with wings, needle-stick protection
device, and a 9 cm plastic tubing for
attachment (3)
CONTRAINDICATIONS
Hypocalcemia (4)
Hypersensitivity to ibandronate sodium injection (4)
WARNINGS AND PRECAUTIONS
_Hypocalcemia_ can worsen. Correct hypocalcemia prior to use.
Adequately supplement patients with
calcium and vitamin D (5.1)
_Anaphylaxis_, including fatal events, has been reported. (5.2)
_Renal Toxicity _may be greater in patients with underlying renal
impairment. Do not administer
ibandronate sodium injection to patients with severe renal impairment
(creatinine clearance less than
30 mL/min). Monitor serum creatinine prior to each dose. (5.3)
_Tissue Damage with Inappropriate Drug Administration_ can oc