Immunoglobulins

Carimune ® nf, nanofiltered

Flebogamma® dif 5% and 10%

Gamastan s/d®

Gammagard liquid®

Carimune ® nf, nanofiltered

DOSAGE FORMS AND STRENGTHS:
Carimune® NF is available as a white lyophilized powder in 3, 6 and 12 g size vials. The only diluents which may be used to reconstitute the product are sterile (0.9%) Sodium Chloride Injection USP, 5% Dextrose, or Sterile Water.

Each product presentation includes a package insert and the following components:

Presentation	Carton NDC Number	Components
3 g	44206-416-03	Carimune NF in a single-use vial [NDC 44206-416-90] One double-ended transfer spike for reconstitution
6 g	44206-417-06	Carimune NF in a single-use vial [NDC 44206-417-91] One double-ended transfer spike for reconstitution
12 g	44206-418-12	Carimune NF in a single-use vial [NDC44206-418-92] One double-ended transfer spike for reconstitution

Storage and Handling
Carimune® NF should be stored at room temperature not exceeding 30°C (86°F).
The preparation should not be used after the expiration date printed on the label.

SOURCE:
FDA:
Proper Name: Immune Globulin Intravenous (Human)
Tradename: Carimune ® NF, Nanofiltered
Manufacturer: CSL Behring AG, License #1766

Package Insert (PDF - 279 KB) - October 2008

Flebogamma® dif 5% and 10%

DOSAGE FORMS AND STRENGTHS:
Flebogamma 5% DIF is supplied in single-use, individually laser etched vials containing the labeled amount of functionally active IgG. The following presentations of Flebogamma 5% DIF are available:

NDC Number	Size	Grams Protein
61953-0004-1	10 mL	0.5 g
61953-0004-2	50 mL	2.5 g
61953-0004-3	100 mL	5.0 g
61953-0004-4	200 mL	10.0 g
61953-0004-5	400 mL	20.0 g

Each vial has an integral suspension band and a label with two peel-off strips showing the product name and lot number.

Flebogamma 5% DIF may be stored at room temperature at 2 to 25 ºC (36 to 77 ºF) for 24 months, as indicated by the expiration date printed on the outer carton and container label. Discard after expiration date. Do not freeze.

Keep Flebogamma 5% DIF in its original carton to protect it from light.

SOURCE:
FDA:
Proper Name: Immune Globulin Intravenous (Human)
Tradename: Flebogamma DIF 5%
Manufacturer: Instituto Grifols, SA, License #1181
Indication: Replacement therapy in primary (inherited) humoral immune deficiency disorders

Product Information

Gamastan s/d®

DOSAGE FORMS AND STRENGTHS:
GamaSTAN S/D is supplied in 2 mL and 10 mL single dose vials. GamaSTAN S/D is preservative-free and latex-free.

NDC Number	Size
13533-635-02	2 mL vial (10 pack)
13533-635-04	2 mL vial
13533-635-10	10 mL vial (10 pack)
13533-635-12	10 mL vial

STORAGE
Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Gammagard liquid®

DOSAGE FORMS AND STRENGTHS:
GAMMAGARD LIQUID is supplied in single use bottles containing the labeled amount of functionally active IgG. The packaging of this product is not made with natural rubber latex.

The following presentations of GAMMAGARD LIQUID are available:

NDC Number	Volume	Grams Protein
0944-2700-02	10 mL	1.0
0944-2700-03	25 mL	2.5
0944-2700-04	50 mL	5.0
0944-2700-05	100 mL	10.0
0944-2700-06	200 mL	20.0
0944-2700-07	300 mL	30.0

Do not freeze.

Refrigeration: 36 months storage at temperature 2°to 8°C (36° - 46°F).

Room Temperature: 12 months storage at room temperature 25°C, (77°F) within the first 24 months of the date of manufacture. See package insert for detailed storage information.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Gammagard s/d®

DOSAGE FORMS AND STRENGTHS:
GAMMAGARD S/D is supplied in single use bottles containing the labeled amount of functionally active IgG. The following presentation of GAMMAGARD S/D is available:

GramsProtein	NDC
5 g	0944-2656-03
10 g	0944-2658-04

Each bottle of GAMMAGARD S/D is furnished with a suitable volume of Sterile Water for Injection, USP, a transfer device and an administration set which contains an integral airway and a 15 micron filter.

GAMMAGARD S/D is to be stored at a temperature not to exceed 25ºC (77ºF) for 24 months.

Do not Freeze.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Gammaked™®

DOSAGE FORMS AND STRENGTHS:
GAMMAKED is supplied in single-use, tamper evident vials (shrink band) containing the labeled amount of functionally active IgG. The three larger vial size labels incorporate integrated hangers. The components used in the packaging for GAMMAKED are latex-free.

GAMMAKED is supplied in the following sizes:

NDC Number	Size	Grams Protein
76125-900-01	10 mL	1.0
76125-900-25	25 mL	2.5
76125-900-50	50 mL	5.0
76125-900-10	100 mL	10.0
76125-900-20	200 mL	20.0

DO NOT FREEZE

GAMMAKED may be stored for 36 months at 2–8°C (36–46°F) from the date of manufacture, AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded. Do not use after expiration date.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Gammaplex®

DOSAGE FORMS AND STRENGTHS:
Gammaplex is supplied in a single use, clear Type II glass bottle, closed with a stopper (13% natural rubber) and oversealed with a tamper-evident cap.

The following presentations of Gammaplex are available:

NDC Number	Grams and Fill Size
64208-8234-1	2.5g in 50 mL
64208-8234-2	5 g in 100 mL
64208-8234-3	10 g in 200 mL

Each vial has a label with a peel-off strip showing the product name and batch number.

When stored between 2 °C [35.6 °F] and 25 °C [77 °F]), Gammaplex has a shelf life of 24 months, as indicated by the expiration date printed on the outer carton and vial label.

Keep Gammaplex in its original carton to protect it from light.

DO NOT FREEZE.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Gamunex®-c

DOSAGE FORMS AND STRENGTHS:
GAMUNEX-C is supplied in single-use, tamper evident vials (shrink band) containing the labeled amount of functionally active IgG. The three larger vial size labels incorporate integrated hangers. The components used in the packaging for GAMUNEX-C are latex-free. GAMUNEX-C is supplied in the following sizes:

NDC Number	Size	Grams Protein
13533-800-12	10 mL	1.0
13533-800-15	25 mL	2.5
13533-800-20	50 mL	5.0
13533-800-71	100 mL	10.0
13533-800-24	200 mL	20.0

DO NOT FREEZE
GAMUNEX-C may be stored for 36 months at 2 - 8°C (36 - 46°F) from the date of manufacture, AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded. Do not use after expiration date.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Hizentra®

DOSAGE FORMS AND STRENGTHS:
Hizentra is supplied in a single-use, tamper-evident vial containing 0.2 grams of protein per mL of preservative-free liquid.

Each product presentation includes a package insert and the following components:

Presentation	Carton NDC Number	Components
5 mL	44206-451-01	Vial containing 1 grams of protein (NDC 44206-451-90)
10 mL	44206-452-02	Vial containing 2 grams of protein (NDC44206-452-91)
20 mL	44206-454-04	Vial containing 4 grams of protein (NDC 44206-454-92)

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Octagam®

DOSAGE FORMS AND STRENGTHS:
Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g, 10 g or 25 g single use bottles.

NDC Number	NDC Number	Size	Grams Protein
Octapharma Pharmazeutika Produktionsges.m.b.H	Octapharma AB
67467 – 843 - 01	68209 – 843 - 01	20 ml	1.0
67467 – 843 – 02	68209 – 843 – 02	50 ml	2.5
67467 – 843 – 03	68209 – 843 – 03	100 ml	5.0
67467 – 843 – 04	68209 – 843 – 04	200 ml	10.0
67467 – 843 – 05		500 ml	25.0

Octagam 5% liquid is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), the filter size must be 0.2 – 200 microns.

Components used in the packaging of Octagam 5% liquid are latex-free.

Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.

Do not use after expiration date.
Do not freeze. Frozen product should not be used.
Any unused product or waste material should be disposed of in accordance with local requirements.

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Privigen®

DOSAGE FORMS AND STRENGTHS:
Privigen is supplied in a single-use, tamper-evident vial containing the labeled amount of functionally active IgG.

Each product presentation includes a package insert and the following components:

Presentation	Carton NDC Number	Components
50 mL	44206-436-05	Vial containing 5 grams of protein (NDC 44206-436-90)
100 mL	44206-437-10	Vial containing 10 grams of protein (NDC44206-437-91)
200 mL	44206-438-20	Vial containing 20 grams of protein (NDC 44206-438-92)
400 mL	44206-439-40	Vial containing 40 grams of protein (NDC 44206-439-93)

SOURCE:
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services

Link to package insert.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.