Advate

Name: Advate

Advate Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • headache;
  • joint pain;
  • sore throat, cough, stuffy nose;
  • weakness, feeling tired;
  • fever; or
  • pain, swelling, itching, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Description

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered CHO cell line. In culture, the CHO cell line expresses rAHF into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against Factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human Antihemophilic Factor [hAHF]. Structurally the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).

ADVATE is formulated as a sterile, non-pyrogenic, white to off-white powder for intravenous injection. When reconstituted with the provided Sterile Water for Injection, USP, the product contains the following stabilizers and excipients in targeted amounts:

Table 5 : Approximate Concentration of Stabilizer and Excipient after Reconstitution

Stabilizer and Excipient 5 mL Reconstitution (for 250, 500, 1000, 1500, 2000, 3000, 4000 IU) Target 2 mL Reconstitution (for 250, 500, 1000, 1500 IU) Target
Tris (hydroxymethyl) aminomethane 10 mM 25 mM
Calcium Chloride 1.7 mM 4.2 mM
Mannitol 3.2% (w/v) 8% (w/v)
Sodium Chloride 90mM 225 mM
α, α-Trehalose 0.8% (w/v) 2% (w/v)
Histidine 10 mM 25 mM
Glutathione (Reduced) 0.08 mg/mL 0.2 mg/mL
Polysorbate 80 0.01% (w/v) 0.025% (w/v)

ADVATE is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000, 3000 or 4000 International Units (IU) per vial. The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. VWF is coexpressed with Factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative.

Each vial of ADVATE is labeled with the rAHF activity expressed in International Units per vial. Biological potency is determined by an in vitro assay, which employs a Factor VIII concentrate standard that is referenced to a WHO International Standard for Factor VIII concentrates. One International Unit, as defined by the WHO standard for blood coagulation Factor VIII, human, is approximately equal to the level of Factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.

Advate Drug Class

Advate is part of the drug class:

  • Blood coagulation factors

Advate Dosage

The dose and duration of treatment of Advate your doctor recommends will be based on the following:

  • your weight
  • your age
  • the severity of factor VIII deficiency
  • the location of the bleeding
  • your overall clinical condition
  • how you respond to this medication

The recommended dose of Advate when being used for control and prevention of bleeding episodes is 10 to 50 IU per kg of body weight, depending on the severity and location of the bleed. The frequency of dosing will be determined by your doctor until the bleeding is resolved.

The recommended dose of Advate when being given during surgery to prevent bleeding is 30 to 60 IU per kg of body weight given as a single dose before surgery. The dose may need to be repeated which will be determined by your doctor.

The recommended dose of Advate when being used for routine prevention of bleeding is 20 to 40 IU per kg body weight every other day (3 to 4 times weekly). 

Your doctor will perform blood tests to measure your level of factor VIII and may adjust your dose or frequency based on the results.

Advate Overdose

If you administer too much Advate, call your doctor or Poison Control Center right away, or get emergency treatment

If Advate is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Uses of Advate

  • It is used to treat hemophilia.
  • It is used to treat or prevent bleeding.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in color of mouth to blue.
  • Chest pain or pressure or a fast heartbeat.
  • Dizziness or passing out.
  • Feeling cold.
  • Fever or chills.
  • Flushing.
  • Pale skin.
  • Restlessness.
  • Shortness of breath.
  • Trouble swallowing.
  • Upset stomach or throwing up.

Drug Interactions

There are no known drug interactions reported with Advate. Drug interaction studies have not been performed.

Advate - Clinical Pharmacology

Mechanism of Action

Advate temporarily replaces the missing clotting Factor VIII that is needed for effective hemostasis.

Pharmacodynamics

The activated partial thromboplastin time (aPTT) is prolonged in patients with hemophilia. Determination of (aPTT) is a conventional in vitro assay for biological activity of Factor VIII. Treatment with Advate normalizes the aPTT over the effective dosing period.

Pharmacokinetics

A randomized, crossover pharmacokinetic study of Advate produced at Orth, Austria (test) and RECOMBINATE [Antihemophilic Factor (Recombinant)] (reference) was conducted in 56 non-bleeding subjects. The subjects received either of the products as an IV infusion (50 ± 5 IU/kg body weight) and there was a washout period of 72 hours to 4 weeks between the two infusions. The pharmacokinetic parameters were calculated from Factor VIII activity measurements in blood samples obtained up to 48 hours following each infusion. Pharmacokinetic parameters for adults for each study preparation in the per-protocol analysis are presented in Table 6.

Table 6. Pharmacokinetic Parameters for Advate and RECOMBINATE (Per-Protocol Analysis, Adult Subjects age > 16 years)
* 56 subjects were enrolled in the clinical study. The per protocol analysis included 30 patients (20 adults and 10 children). The PK parameters in the table are calculated for adult subjects only. † Area under the plasma Factor VIII concentration x time curve from 0 to 48 hours post-infusion ‡ Calculated as (Cmax – baseline Factor VIII) divided by the dose in IU/kg, where Cmax is the maximal post-infusion Factor VIII measurement
Parameter RECOMBINATE Advate
N Mean ± SD N* Mean ± SD
AUC0-48h (IU•h/dL)† 20 1638 ± 357 20 1644 ± 338
In vivo recovery (IU/dL/IU/kg)‡ 20 2.74 ± 0.56 20 2.57 ± 0.53
Half-life (h) 20 11.16± 2.50 20 12.03 ± 4.15
Cmax (IU/dL) 20 136 ± 29 20 128 ± 28
MRT (h) 20 14.68 ± 3.82 20 15.81 ± 5.91
Vss (dL/kg) 20 0.43 ± 0.10 20 0.44 ± 0.10
CL (dL/kg/h) 20 0.03 ± 0.01 20 0.03 ± 0.01

The 90% confidence intervals for the ratios of the mean AUC(0-48h) and in vivo recovery values for the test and control products were within the pre-established limits of 0.80 and 1.25. In addition, in vivo recoveries at the onset of treatment and after 75 exposure days were compared for 62 subjects. Results of this analysis indicated no significant change in the in vivo recovery at the onset of treatment and after ≥ 75 exposure days.

See the description of the clinical study results for a discussion of the effect of long-term exposure on the pharmacokinetic properties of Advate [CLINICAL STUDIES (14.2 )].

In an interim analysis of data from 10 of 25 planned subjects in the Phase 2/3 surgery study, the target Factor VIII level was met or exceeded in all cases following a single loading dose ranging from 48.0 to 69.8 IU/kg.

Pharmacokinetic parameters calculated from interim pharmacokinetic data for 51 subjects ≤ 16 years of age (per-protocol analysis) are available for 0 neonates, 3 infants, 21 children, and 27 adolescents as shown in Table 7. The clearance of Advate in infants, children, older children, and adolescents was 26%, 23%, 42%, and 23% higher than adults (0.031 dL/hr/kg). The half-life of Advate in infants, children, older children, and adolescents was 27%, 15%, 10%, and 3% lower than adults (12.08 hours). Clinical significance of these differences is not known.

Table 7. Pharmacokinetic Parameters (Mean ± Sd) of Advate by Age Group (N = 51; Intent to Treat Analysis)
* Volume of distribution † Incremental recovery at Cmax
Parameters

Infants

(N =3)

(1 month to

<2 yrs)

Children

(N = 8 )

(2 - <5 yrs)

Older Children (N = 13)

(5 - <12 yrs)

Adolescents

(N =27)

(12 - <16 yrs)
AUC (IU*hr/dL) 1385 ± 476 1545 ± 616 1282 ± 509 1447 ± 528
Cmax (IU/dL) 98.0 ± 10.5 104.6 ± 34.5 111.8 ± 25.7 113.3 ± 21.7
CL (dL/hr/kg) 0.039 ± 0.015 0.038 ± 0.016 0.044 ± 0.012 0.038 ± 0.012
Half-life (hrs) 8.86 ± 1.78 10.27 ± 1.94 10.89 ± 1.60 11.70 ± 3.72
Vd (dL/kg)* 0.43 ± 0.08 0.46 ± 0.12 0.54 ± 0.07 0.53 ± 0.08
Recovery† IU/dL/IU/kg 1.96 ± 0.21 2.05 ± 0.62 2.21 ± 0.44 2.26 ± 0.42

References

  1. Aledort L: Inhibitors in hemophilia patients: Current status and management. Am J Hematol 1994 47:208-217.
  2. Kessler CM: An introduction to Factor VIII inhibitors: The detection and quantitation. Am J Med 1991 91 (Suppl 5A):1S-5S.
  3. White II GC, Courter S, Bray GL, et al: A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia A. Thromb Haemost 1997 77:660-667.
  4. Abshire TC, Brackmann H-H, Scharrer I, et al: Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost 2000 83:811-816.
  5. Lee CA, Owens D, Bray G, et al: Pharmacokinetics of recombinant factor VIII (Recombinate) using one-stage clotting and chromogenic factor VIII assay. Thromb Haemost 1999 82:1644-1647.
  6. Manco-Johnson MJ, Abshire TC, Shapiro AD et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007; 357:603-5.
  7. Ljung R, Aronis-Vournas S, Kurnik-Auberger K, et al. Treatment of children with haemophilia in Europe: a survey of 20 centres in 16 countries. Haemophilia. 2000; 6:619-24.
  8. Löfqvist T, Nilsson IM, Berntorp E, Pettersson H. Haemophilia prophylaxis in young patients--a long-term follow-up. J Intern Med. 1997; 241:395-400.

Prinicipal display panel

Advate 1000 IU unit carton

Advate

[Antihemophilic Factor (Recombinant)Plasma/Albumin-Free Method]

NDC 0944-2943-10

5 mL size, dried

ACTUAL POTENCY

Rx Only

Includes BAXJECT II Needleless Transfer Device

Refrigeration storage at 36º - 46ºF [2-8ºC].

Room temperature storage up to 86ºF [30ºC].

(Additional storage information on back panel)

Advate 1000 IU vial label

Advate

[Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method]

NDC 0944-2943-01

For intravenous administration only.

Rx Only

See accompanying package insert for full prescribing information.

Baxter Healthcare Corporation

Westlake Village, CA 91362 USA

US License #140

Sterile Water for Injection 5 mL vial label

NDC 0338-0001-56

DIN 02214733

Nonpyrogenic

Single-Dose Container

5 mL

Sterile Water for Injection, USP

for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substance has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion. Rx Only.

Mfd by Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Imported by Baxter Corporation, Mississauga, Ontario, Canada

Advate 
antihemophilic factor, human recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-2941
Packaging
# Item Code Package Description
1 NDC:0944-2941-10 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
Advate 
antihemophilic factor, human recombinant injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 50 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
SODIUM CHLORIDE  
HISTIDINE  
CALCIUM CHLORIDE  
POLYSORBATE 80  
GLUTATHIONE  
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Advate 
antihemophilic factor, human recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-2942
Packaging
# Item Code Package Description
1 NDC:0944-2942-10 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
Advate 
antihemophilic factor, human recombinant powder, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 100 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
SODIUM CHLORIDE  
HISTIDINE  
CALCIUM CHLORIDE  
POLYSORBATE 80  
GLUTATHIONE  
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Advate 
antihemophilic factor, human recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-2943
Packaging
# Item Code Package Description
1 NDC:0944-2943-10 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
Advate 
antihemophilic factor, human recombinant injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 200 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
SODIUM CHLORIDE  
HISTIDINE  
CALCIUM CHLORIDE  
POLYSORBATE 80  
GLUTATHIONE  
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
Water 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Advate 
antihemophilic factor, human recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-2944
Packaging
# Item Code Package Description
1 NDC:0944-2944-10 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
Advate 
antihemophilic factor, human recombinant injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 300 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
SODIUM CHLORIDE  
HISTIDINE  
CALCIUM CHLORIDE  
POLYSORBATE 80  
GLUTATHIONE  
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Advate 
antihemophilic factor, human recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-2945
Packaging
# Item Code Package Description
1 NDC:0944-2945-10 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
Advate 
antihemophilic factor, human recombinant injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 400 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
SODIUM CHLORIDE  
HISTIDINE  
CALCIUM CHLORIDE  
POLYSORBATE 80  
GLUTATHIONE  
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Advate 
antihemophilic factor, human recombinant kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-2946
Packaging
# Item Code Package Description
1 NDC:0944-2946-10 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
Advate 
antihemophilic factor, human recombinant injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 600 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
SODIUM CHLORIDE  
HISTIDINE  
CALCIUM CHLORIDE  
POLYSORBATE 80  
GLUTATHIONE  
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
Water 5 mL  in 5 mL
Packaging
# Item Code Package Description
1 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125063 08/19/2010
Labeler - Baxter Healthcare Corporation (039121363)
Establishment
Name Address ID/FEI Operations
Baxter SA 370191025 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 001728059 MANUFACTURE
Revised: 08/2010   Baxter Healthcare Corporation
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