IBANDRONATE SODIUM injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ibandronate sodium (UNII: J12U072QL0) (ibandronic acid - UNII:UMD7G2653W)

זמין מ:

Sagent Pharmaceuticals

INN (שם בינלאומי):

ibandronate sodium

הרכב:

ibandronic acid 3 mg in 3 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Ibandronate Sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium 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 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 excipients. Cases of a

leaflet_short:

Ibandronate Sodium Injection is supplied in a kit as follows: Each syringe is supplied with a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment. 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.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, DEHP-free. The container and container closure are not made with natural rubber latex. TERUMO and Surflo are registered trademarks of TERUMO CORPORATION.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Sagent Pharmaceuticals
----------
MEDICATION GUIDE
Ibandronate (eye-BAN-dr'oh-nayt) Sodium Injection
for intravenous use
Read the Medication Guide that comes with IBANDRONATE 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.
What is the most important information I should know about
IBANDRONATE?
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 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 may lower the calcium levels in your blood. If you have
low blood calcium
before you start taking IBANDRONATE, it may get worse during
treatment. Your low blood
calcium must be treated before you receive IBANDRONATE. 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. 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 reactions
(anaphylactic reactions) that led to death. Get medical help right
away if you have any of the
symptoms of a serious allergic reaction such as:
•
Swelling of your face, lips, mouth or tongue
•
Trouble

מאפייני מוצר

IBANDRONATE SODIUM- IBANDRONATE SODIUM INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
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 per 3 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 occur.