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GAMASTAN IMMUNE GLOBULIN (HUMAN) .165 g/mL Injection, Solution — NDC 13533-0635-04 package photo

GAMASTAN IMMUNE GLOBULIN (HUMAN) .165 g/mL Injection, Solution

by GRIFOLS USA, LLC · 1 VIAL in 1 CARTON (13533-635-04) / 2 mL in 1 VIAL (13533-635-40)
NDC 13533-0635-04
🏷️ FDA NDC (as labeled) 13533-635-04 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial Pack sizes2 compare ↓
Also comes in: 10 mL 13533-0635-12
Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 13533-635-04
Product NDC 13533-635
11-digit billing NDC 13533063504
NCPDP billing unit ML — per mL (volume)
Application # BLA101134
SPL Set ID 561f48de-2697-4a35-8233-bd1cdb73438f
Established class (EPC) Human Immunoglobulin G
Mechanism of action Antigen Neutralization
Physiologic effect Passively Acquired Immunity
Chemical class Immunoglobulins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-08-14
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance HUMAN IMMUNOGLOBULIN G
GPI-14 19100020002200
GPI class GamaSTAN
GCN Seq No 030790
GCN 43712
HICL code 041855
Ingredient (HICL) Immune Globul G (Igg)/Glycine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7K
Therapeutic class — specific (HIC3) Antisera
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name GAMASTAN S-D VIAL
FDB brand name Gamastan S-D
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 13533-635-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 13533-0635-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerGRIFOLS USA, LLC
FDA applicationBLA101134 (BLA)
Labeler code13533
First marketedAug 1996
Product typePlasma Derivative
Portfolio52 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GAMASTAN S-D VIAL Ingredient Immune Globul G (Igg)/Glycine
📗 Our plain-language guide HelloPharmacist
  • Think of it as a collection of protective proteins — called antibodies — that healthy donors have built up against many different germs. If your immune system can't make enough of...
  • What exactly is human immunoglobulin G and why do I need it?
  • It depends on the specific product your doctor prescribed. The IV versions — like Privigen, Asceniv, Qivigy, and Gammaplex — are infused into a vein, usually every 3 to 4 weeks. Hi...
  • How is it given, and how often will I need infusions?
📖 Read our full Human Immunoglobulin G guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1460 $48.874 / J1460 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)13533-635-04
11-digit billing NDC13533-0635-04
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1460
DescriptorINJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 1 CC
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gamastan .165 g/mLthis 13533-0635-04 GRIFOLS 1 vial — — FDA listed —
GamaSTAN .165 g/mL 13533-0335-04 GRIFOLS 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
1944
First FDA approval
Jan 1944
📍
2026
Currently FDA-listed
82 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Baygam, Gamastan S/DImmune Globulin (Human)
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gamastan — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Gamastan. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$15.8K
Claims incl. refills
60
Beneficiaries
33
Spend / beneficiary
$478.23
Spend / claim
$263.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for IMMUNE GLOBULIN (HUMAN) — the ingredient across all brands.

Top reported reactions

Expired Product Administered5
Renal Failure4
Liver Function Test Abnormal3
Multi-organ Failure3
Sepsis3
Acute Respiratory Distress Syndrome2
Acute Respiratory Failure2

Reporter sex

51 reports
Male · 58%
Female · 42%

Serious outcomes

Hospitalization17
Death8
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
13533-0635-04 You're viewing this 1 VIAL in 1 CARTON (13533-635-04) / 2 mL in 1 VIAL (13533-635-40) 1996-08-14 Active
13533-0635-12 1 VIAL in 1 CARTON (13533-635-12) / 10 mL in 1 VIAL (13533-635-13) 1996-08-14 Active

Pack size FAQ

What quantity is in NDC 13533-0635-04?
NDC 13533-0635-04 is listed by the FDA — 1 vial in 1 carton / 2 ml in 1 vial.
What NDC number is used to bill for this package of GAMASTAN IMMUNE GLOBULIN (HUMAN) .165 g/mL Injection, Solution?
Bill NDC 13533-0635-04 — the 11-digit billing format is 13533063504. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 13533-635-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 13533-0635-04, written without dashes as 13533063504. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 13533-0635-04, the first segment (13533) is the labeler code FDA assigned to GRIFOLS USA, LLC; the middle segment (0635) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by GRIFOLS USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (13533-0635-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
GRIFOLS USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1460 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Hepatitis A The prophylactic value of Gama STAN S/D is greatest when given before or soon after exposure to hepatitis A. Gama STAN S/D is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously. Measles (Rubeola) Gama STAN S/D should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.

(7) A susceptible person is one who has not been vaccinated and has not had measles previously. Gama STAN S/D may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest. (7) GamaSTAN S/D and measles vaccine should not be given at the same time.

(7) If a child is older than 12 months and has received Gama STAN S/D, he should be given measles vaccine about 3 months later when the measles antibody titer will have disappeared. If a susceptible child exposed to measles is immunocompromised, Gama STAN S/D should be given immediately. (8) Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.

Varicella Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZIG]. If VZIG is unavailable, Gama STAN S/D, promptly given, may also modify varicella. (5) Rubella The routine use of Gama STAN S/D for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.

(6) Some studies suggest that the use of Gama STAN S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, Gama STAN S/D may benefit those women who will not consider a therapeutic abortion. (4) Immunoglobulin Deficiency In patients with immunoglobulin deficiencies, Gama STAN S/D may prevent serious infection. However, Gama STAN S/D may not prevent chronic infections of the external secretory tissues such as the respiratory and gastrointestinal tract.

Prophylactic therapy, especially against infections due to encapsulated bacteria, is effective in Bruton-type, sex-linked, congenital agammaglobulinemia, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Gama STAN S/D is administered intramuscularly (see PRECAUTIONS ), preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. (10) Doses over 10 mL should be divided and injected into several muscle sites to reduce local pain and discomfort.

An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A number of factors could reduce the efficacy of this product or even result in an ill effect following its use.

These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use. Hepatitis A Gama STAN S/D in a dose of 0.01 mL/lb (0.02 mL/kg) is recommended for household and institutional hepatitis A case contacts.

The following doses of Gama STAN S/D are recommended for persons who plan to travel in areas where hepatitis A is common. (3) Length of Stay Dose Volume Less than 3 months 0.02 mL/kg 3 months or longer 0.06 mL/kg (repeat every 4–6 months) Measles (Rubeola) Gama STAN S/D should be given in a dose of 0.11 mL/lb (0.25 mL/kg) to prevent or modify measles in a susceptible person exposed fewer than 6 days previously. (7) A susceptible child who is exposed to measles and who is immunocompromised should receive a dose of 0.5 mL/kg (maximum dose, 15 mL) of Gama STAN S/D immediately.

(8) Varicella If Varicella-Zoster Immune Globulin (Human) is unavailable, Gama STAN S/D at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella. (5) Rubella Some studies suggest that the use of Gama STAN S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, Gama STAN S/D at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion. (4) Immunoglobulin Deficiency Gama STAN S/D may prevent serious infection in patients with immunoglobulin deficiencies if circulating IgG levels of approximately 200 mg/100 mL plasma are maintained.

The recommended dosage is 0.66 mL/kg (at least 100 mg/kg) given every 3 to 4 weeks. (6) A double dose is given at onset of therapy; some patients may require more frequent injections.

⛔ Contraindications 63 words ▾

CONTRAINDICATIONS Gama STAN S/D should not be given to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA. (9) Gama STAN S/D should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

⚠️ Warnings 194 words ▾

WARNINGS GamaSTAN S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.

ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. Gama STAN S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

(9)

🤒 Adverse Reactions 53 words ▾

ADVERSE REACTIONS Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. (6,9) Anaphylaxis is more likely to occur if Gama STAN S/D is given intravenously; therefore, Gama STAN S/D must be administered only intramuscularly.

🤰 Pregnancy 52 words ▾

Pregnancy Category C Animal reproduction studies have not been conducted with Gama STAN S/D. It is also not known whether Gama STAN S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gama STAN S/D should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 13 words ▾

Pediatric Use Safety and effectiveness in the pediatric population have not been established.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Peak levels of immunoglobulin G are obtained approximately 2 days after intramuscular injection of Gama STAN S/D. (1) The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days. (2) Passive immunization with Gama STAN S/D modifies hepatitis A, prevents or modifies measles, and provides replacement therapy in persons with hypogammaglobulinemia or agammaglobulinemia.

Gama STAN S/D is not standardized with respect to antibody titers against hepatitis B surface antigen (HBsAg) and should not be used for prophylaxis of viral hepatitis type B. Prophylactic treatment to prevent hepatitis B can best be accomplished with use of Hepatitis B Immune Globulin (Human), often in combination with Hepatitis B Vaccine. (3) Gama STAN S/D may be of benefit in women who have been exposed to rubella in the first trimester of pregnancy and who will not consider a therapeutic abortion.

(4) Gama STAN S/D may also be considered for use in immunocompromised patients for passive immunization against varicella if Varicella-Zoster Immune Globulin (Human) is not available. (5) Immune Globulin (Human) is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella. It is not indicated for allergy or asthma in patients who have normal levels of immunoglobulin.

(6) In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), Hyper RAB ™ S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Gama STAN S/D is supplied in 2 mL and 10 mL single dose vials. Gama STAN 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 and Handling 14 words ▾

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

📋 Description ~2 min read ▾

DESCRIPTION Immune Globulin (Human) — Gama STAN ™ S/D treated with solvent/detergent is a sterile solution of immune globulin for intramuscular administration; it is preservative-free and latex-free. Gama STAN S/D is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn fraction II.

The fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration.

Gama STAN S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. Gama STAN S/D is then incubated in the final container for 21–28 days at 20–27°C. The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Gama STAN S/D has been validated in laboratory studies.

Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.

Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. (11-14) Studies of the Gama STAN S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log 10 ).

These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 13533-0634-02 · GRIFOLS 13533-0636-01 · GRIFOLS →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.