IBANDRONATE SODIUM (Page 8 of 8)

Manufactured for: TAGI Pharma, Inc.
South Beloit, IL 61080

Manufactured by: Nang Kuang Pharmaceutical Co. Ltd.
No. 1001, Zhongshan Rd., Xinhua Dist, Tainan City 71243, Taiwan.

01/2022

Reference ID: 2620000000U535

TERUMO ® Surshield™ Safety Winged Infusion Set —

Instructions for Use: IV Administration

Aseptic technique, proper skin preparation and continued protection of the site are essential. Observe Universal Precautions on all patients.

Caution: Keep hands behind the needle at all times during use and disposal.

Instructions for Device Assembly

  1. Open the package.
  2. Remove the rubber cap from the tip of the syringe containing the ibandronate sodium injection and the protective SV cap from hub at the end of the tubing opposite the butterfly needle.
  3. Insert the tip of the syringe into the hub and twist as firm pressure is applied to assure a tight connection.
  4. Proceed with priming and confirm that administration fluid comes from the needle.

Venipuncture and Administration

  1. Flip the safety shield back away from the needle towards the tubing. Grasp wings securely.
  2. Remove the needle protector. Caution: Care should be taken not to touch the needle.
  3. Perform venipuncture and confirm proper positioning of the needle in the vein.
  4. Carefully allow wings to return to starting position and conform to the shape of the skin.
  5. Further secure the position of the winged infusion set per facility protocol.

After Use

  1. Remove tape, if present, from wings.
  2. Flip the safety shield forward toward the needle. Grasp a wing and the safety shield between your thumb and index finger. Completely remove the needle from the puncture site and apply digital pressure to the site using a sterile gauze pad held in the opposite hand (Fig. 1).
  3. With the wing and shield between your thumb and index finger pinch together (or press the safety shield against a hard surface such as a bedside table) until an audible click is heard (Fig. 2).
  4. Visually confirm activation of the safety feature (Fig. 3).
  5. Dispose of used needles and materials following the policies and procedures of your facility, as well as federal and local regulations for “Sharps Disposal.”
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® Registered Trademark. Surshield is a trademark of TERUMO CORPORATION.

07/2021
2620000000U535

PRINCIPAL DISPLAY PANEL — 3 mL Single Use Syringe Label and Carton

Rx only

NDC 51224-008-01

Sterile. For I.V. Use Only.

Ibandronate Sodium Injection
3 mg*/3 mL (1mg/mL)

*Each syringe delivers 3 mL solution containing 3.375 mg ibandronate sodium monohydrate, equivalent to 3 mg ibandronate free acid; sodium chloride, 25.8 mg; glacial acetic acid, 1.53 mg; sodium acetate, 0.612 mg and water for injection, quantity sufficient to 3 mL

Usual Dosage: For intravenous administration over a period of 15 to 30 seconds. See accompanying prescribing information.
Storage: Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
The tip cap of the prefilled syringe may contain natural rubber.

Pharmacist: Dispense the enclosed Medication Guide to each patient

Package contains:
One 3 mL Single Use Syringe,
Ibandronate Sodium 3 mg/3 mL
1 Needle
Precribing Information, Medication Guide and Instructions for Use

Manufactured for:
TAGI Pharma, Inc.
South Beloit, IL 61080

Manufactured by:
Nang Kuang Pharmaceutical Co., Ltd.
No. 1001, Zhongshan Rd., Xinhua Dist.,
Tainan City 71243, Taiwan.

I04/2018
2630003000U535 (on Syringe Label) 2660003001U535 (on Carton)

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IBANDRONATE SODIUM ibandronate sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51224-008
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibandronate sodium (ibandronic acid) ibandronic acid 3 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
acetic acid
sodium acetate
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51224-008-01 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
1 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (51224-008-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204329 06/30/2022
Labeler — TAGI Pharma, Inc. (963322560)
Establishment
Name Address ID/FEI Operations
Nang Kuang Pharmaceutical Co. Ltd. 656118783 MANUFACTURE (51224-008), ANALYSIS (51224-008)

Revised: 01/2022 TAGI Pharma, Inc.

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