IBANDRONATE SODIUM injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

TAGI Pharma, Inc.

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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

Produkt oversigt:

Ibandronate Sodium Injection is supplied as a kit containing: The tip cap of the prefilled syringe may contain natural rubber. Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

IBANDRONATE SODIUM- IBANDRONATE SODIUM INJECTION, SOLUTION
TAGI Pharma, Inc.
----------
MEDICATION GUIDE
IBANDRONATE SODIUM
(eye-BAN-droe-nate SOE-dee-um)
Injection for intravenous use
Read the Medication Guide that comes with ibandronate sodium 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.
What is the most important information I should know about ibandronate
sodium?
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 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
•
Low calcium levels in your blood (hypocalcemia). Ibandronate Sodium
may lower the calcium levels
in your blood. If you have low blood calcium before you start taking
ibandronate sodium, it may get
worse during treatment. Your low blood calcium must be treated before
you receive ibandronate
sodium. 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. Take calcium and vitamin D as
your doctor tells you to.
•
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 hav

Produktets egenskaber

IBANDRONATE SODIUM- IBANDRONATE SODIUM INJECTION, SOLUTION
TAGI PHARMA, INC.
----------
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 (1mg/mL) single-dose prefilled syringe
a 25-gauge, 3/4 inch needle with wings, needle-stick protection
device, and a 23 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_ ca