Iprivask (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Iprivask (desirudin for injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6 mL of Mannitol USP (3%) in Water for Injection].

Each Iprivask Vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP.

Each carton (NDC 0187-0011-10) of Iprivask (desirudin for injection) contains 10 individual doses of Iprivask, each in a separate tray.

Each tray of Iprivask (desirudin for injection) contains:

  • One (1) x 15.75 mg Single Dose Vial
  • One (1) x 0.6 mL Prefilled syringe of Diluent
  • One (1) Eclipse™ needle
  • One (1) Vial Adapter

Each prefilled syringe of diluent contains 0.6 mL Mannitol USP (3% w/v) in Water for Injection provided for reconstitution of the desirudin lyophilized powder.

Storage: Protect from light.

Unopened vials or prefilled syringes: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)[See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise patients to watch carefully for any signs of bleeding or bruising and to report these to their health care provider immediately. Inform patients that it might take them longer than usual to stop bleeding, and that they may bruise and/or bleed more easily when they are treated with Iprivask. If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence. If any of these symptoms occur, advise the patient to contact his or her physician immediately.

Advise patients that allergic reactions, including anaphylaxis, can occur during treatment with Iprivask. Inform patients to immediately notify their health care provider if the patient experiences symptoms of an allergic reaction while taking Iprivask.

Advise patients to discuss with their health care provider their use of any other medications, including over-the-counter medications or herbal products, prior to Iprivask use. Examples of other medications that should not be taken with Iprivask are aspirin, non-steroidal anti-inflammatory drugs including ketorolac, acetylsalicylic acid ticlopidine, dipyridamole, sulfinpyrazone, clopidogrel, abciximab and other glycoprotein IIb/IIIa antagonists.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Made in Germany

Rev. 06/15

9469400

Patient Package Insert

Product Assembly Iprivask®
Instructions for Use (desirudin for injection)

Patients are encouraged to refer to complete Patient Instruction Sheet for additional information on Iprivask assembly and administration.

Reconstitution should be carried out under sterile conditions.

Step 1:

Remove plastic flip-top cap from Iprivask Vial. Remove back cover of Vial Adapter package. Attach Vial Adapter to Vial by using the outer package to handle Adapter. Push Adapter down onto Vial until spike pierces rubber stopper and snaps into place. Discard Vial Adapter package.

Step 1:
Remove plastic flip-top cap from Iprivask Vial. Remove back cover of Vial Adapter package. Attach Vial Adapter to Vial by using the outer package to handle Adapter. Push Adapter down onto Vial

Step 2:

Remove Syringe cap by twisting and pulling gently. Attach Syringe to Adapter on Vial by twisting. Slowly push plunger down to completely transfer solution into Vial. Leaving Syringe connected to Vial, gently swirl; lyophilized powder in Vial will dissolve within 10 seconds.

Step 2:
Remove Syringe cap by twisting and pulling gently. Attach Syringe to Adapter on Vial by twisting. Slowly push plunger down to completely transfer solution into Vial. Leaving Syringe connected

Step 3:

With Syringe still connected to Vial, turn Vial upside down and withdraw entire contents of Vial back into Syringe. Remove Syringe from Vial and hold it with plunger-end down.

Step 3:
With Syringe still connected to Vial, turn Vial upside down and withdraw entire contents of Vial back into Syringe. Remove Syringe from Vial and hold it with plunger-end down.

Step 4:

You must use enclosed Eclipse™ needle. Attach Needle to Syringe by twisting. Pull pink lever down and uncap needle. You are ready to inject Iprivask.

After injection, flip up pink lever to cover needle until it snaps into place. Dispose of the used Syringe in a Sharps® container.

Step 4:
You must use enclosed Eclipse™ needle. Attach Needle to Syringe by twisting. Pull pink lever down and uncap needle. You are ready to inject Iprivask.
After injection, flip up pink lever to c

Eclipse is a registered trademark of Becton, Dickinson and Company. Sharps is a registered trademark of Sharps Compliance Corporation.

Iprivask is a trademark of Valeat Pharmaceuticals International, Inc. or its affiliates.

© Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

9469300

Rev. 06/15

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Carton image
(click image for full-size original)
IPRIVASK desirudin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0011
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0011-10 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 0.5 mL
Part 2 1 SYRINGE 0.6 mL
Part 1 of 2
IPRIVASK desirudin injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESIRUDIN (DESIRUDIN) DESIRUDIN 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM CHLORIDE ANHYDROUS
SODIUM HYDROXIDE
MANNITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 10 TRAY in 1 PACKAGE contains a TRAY
1 1 VIAL, SINGLE-DOSE in 1 TRAY This package is contained within the PACKAGE and contains a VIAL, SINGLE-DOSE
1 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within a TRAY and a PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021271 12/31/2013
Part 2 of 2
MANNITOL mannitol injection
Product Information
Item Code (Source) NDC:0187-0012
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
MANNITOL 3 mg in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0012-01 0.6 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021271 12/31/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021271 12/31/2013
Labeler — Valeant Pharmaceuticals North America LLC (042230623)
Registrant — Valeant Pharmaceuticals North America LLC (042230623)
Establishment
Name Address ID/FEI Operations
Wasserburger Arzneimittel Werk, GMBH 326482247 manufacture (0187-0011), manufacture (0187-0012)

Revised: 06/2015 Valeant Pharmaceuticals North America LLC

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