Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
TERIPARATIDE (rDNA ORIGIN)
DKSH SINGAPORE PTE. LTD.
H05AA02
750 mcg/3 ml
INJECTION, SOLUTION
TERIPARATIDE (rDNA ORIGIN) 750 mcg/3 ml
SUBCUTANEOUS
Prescription Only
LILLY FRANCE
ACTIVE
2004-09-27
FORTEO ® TERIPARATIDE (RDNA ORIGIN) INJECTION 20 MICROGRAMS/80 MICROLITERS WARNING IN MALE AND FEMALE RATS, TERIPARATIDE CAUSED AN INCREASE IN THE INCIDENCE OF OSTEOSARCOMA (A MALIGNANT BONE TUMOR) THAT WAS DEPENDENT ON DOSE AND TREATMENT DURATION. THE EFFECT WAS OBSERVED AT SYSTEMIC EXPOSURES TO TERIPARATIDE RANGING FROM 3 TO 60 TIMES THE EXPOSURE IN HUMANS GIVEN A 20- MCG DOSE. BECAUSE OF THE UNCERTAIN RELEVANCE OF THE RAT OSTEOSARCOMA FINDING TO HUMANS, TERIPARATIDE SHOULD BE PRESCRIBED ONLY TO PATIENTS FOR WHOM THE POTENTIAL BENEFITS ARE CONSIDERED TO OUTWEIGH THE POTENTIAL RISK. TERIPARATIDE SHOULD NOT BE PRESCRIBED FOR PATIENTS WHO ARE AT INCREASED BASELINE RISK FOR OSTEOSARCOMA (INCLUDING THOSE WITH PAGET’S DISEASE OF BONE OR UNEXPLAINED ELEVATIONS OF ALKALINE PHOSPHATASE, OPEN EPIPHYSES, OR PRIOR EXTERNAL BEAM OR IMPLANT RADIATION THERAPY INVOLVING THE SKELETON) (_SEE _WARNINGS _AND _PRECAUTIONS, CARCINOGENESIS). DESCRIPTION FORTEO ® [teriparatide (rDNA origin) injection] contains recombinant human parathyroid hormone (1- 34), [rhPTH (1-34)], which has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. Teriparatide has a molecular weight of 4117.8 daltons and its amino acid sequence is shown below: Teriparatide (rDNA origin) is manufactured by Eli Lilly and Company using a strain of _Escherichia coli _ modified by recombinant DNA technology. FORTEO is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, Lugege kogu dokumenti
FORTEO ® INJECTION 20MCG/80MCL (TERIPARATIDE) 1 INDICATIONS AND USAGE Forteo is indicated: • For the treatment of postmenopausal women with osteoporosis who are at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, Forteo increases BMD and reduces the risk of vertebral and nonvertebral fractures. • To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, Forteo increases BMD. The effects of Forteo on risk for fracture in men have not been studied. • For the treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fracture. See CLINICAL STUDIES (12.3). . 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE The recommended dosage is 20 mcg given subcutaneously once a day. 2.2 ADMINISTRATION INSTRUCTIONS • Administer Forteo as a subcutaneous injection into the thigh or abdominal region. Forteo is not approved for intravenous or intramuscular use. • Forteo should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see WARNINGS and PRECAUTIONS (4.4)]. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Forteo is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored. Patients and/or caregivers who administer Forteo should receive appropriate training and instruction on the proper use of the Forteo prefilled delivery device (pen) from a qualified health profession Lugege kogu dokumenti