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Eranfu

Eranfu Dosage/Direction for Use

fulvestrant

Manufacturer:

Dr Reddy's Lab

Distributor:

Dr Reddy's Lab
Full Prescribing Info
Dosage/Direction for Use
Posology: Adult females (including Elderly): The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
Special population: Renal impairment: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 mL/min), and therefore caution is recommended in these patients.
Hepatic impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, fulvestrant should be used in caution in these patients. There are no data in patients with severe hepatic impairment.
Pediatric population: The safety and efficacy of fulvestrant in children from birth to 18 years of age have not been established.
Method of administration: Fulvestrant should be administered as two consecutive 5 mL injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area). Caution should be taken if injecting fulvestrant at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Instructions for administration: Administer the injection according to the local guidelines for performing large volume intramuscular injections.
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering fulvestrant at the dorsogluteal injection site.
Warning - Do not autoclave safety needle (SurGuard3 Safety Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.
For each syringe: Remove glass syringe barrel from tray and check that it is not damaged.
Peel open the safety needle outer packaging.
Parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Hold the syringe upright on the ribbed part. With the other hand, take hold of the cap and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist.
Remove the cap in a straight upward direction. To maintain sterility do not touch the syringe tip.
Step 1: Tighten the syringe to the needle using aseptic technic. Grip the base of the needle, not the safety sheath, push and turn the syringe clockwise.
Step 2: Move the safety sheath away from the needle and toward the syringe barrel to the angle, prior to removing the needle cap. Perform injection procedure according to established technic.
(Note: The needle "bevel up" position is oriented to the position of the safety sheath.)
Step 3: After the injection procedure, use a one-handed technic to activate the safety mechanism using any of the three (3) methods: Finger Activation or Thumb Activation or Surface Activation.
(Activation is verified by an audible and/or tactile "click", and can be visually confirmed.)
Step 4: Visually confirm that the safety sheath is fully engaged.
Pre-filled syringes are for single use only.
Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.
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