Gamastan S / D

• Tell all of your health care providers that you take GamaSTAN S/D. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take GamaSTAN S/D.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using GamaSTAN S/D while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where GamaSTAN S/D is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

GamaSTAN 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)

GamaSTAN S/D should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

General

Immune Globulin (Human) should not be administered intravenously because of the potential for serious reactions. Injections should be made intramuscularly, and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.

Skin tests should not be done. In most human beings the intradermal injection of concentrated gamma globulin solution with its buffers causes a localized area of inflammation which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation of a chemical nature. Misinterpretation of the results of such tests can lead the physician to withhold badly needed human immunoglobulin from a patient who is not actually allergic to this material. True allergic responses to human gamma globulin given in the prescribed intramuscular manner are rare.

Although systemic reactions to intramuscularly administered immunoglobulin preparations are rare, epinephrine should be available for treatment of acute allergic symptoms.

Clinical and Laboratory Tests

None required.

Clinically Significant Product Interactions

Antibodies in the globulin preparation may interfere with the response to live viral vaccines such as measles, mumps, polio and rubella. Therefore, use of such vaccines should be deferred until approximately 3 months after Immune Globulin (Human) GamaSTAN™ S/D administration.

No interactions with other products are known.

Pregnancy Category C

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

Pediatric Use

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

GamaSTAN 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

GamaSTAN 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 GamaSTAN S/D are recommended for persons who plan to travel in areas where hepatitis A is common.(3)

Measles (Rubeola)

GamaSTAN 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 GamaSTAN S/D immediately.(8)

Varicella

If Varicella-Zoster Immune Globulin (Human) is unavailable, GamaSTAN 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 GamaSTAN S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN S/D at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.(4)

Immunoglobulin Deficiency

GamaSTAN 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.

Immune
Globulin(Human)

GamaSTAN™ S/D

Solvent/Detergent
Treated

Preservative-free,
latex-free

2 mL

One Single Dose Vial

NDC 13533-635-04

Talecris
BIOTHERAPEUTICS

The patient and physician
should discuss the risks and
benefits of this product.

FOR INTRAMUSCULAR
INJECTION ONLY. DO NOT
GIVE INTRAVENOUSLY

For complete dosage and
administration information,
read enclosed package insert.

Store at 2-8°C (36-46°F).
Do not freeze.

If the shrink band is absent or
shows any sign of tamper-
ing, do not use the product
and notify Talecris Biothera-
peutics, Inc. immediately.

Not returnable for credit or
exchange.

Rx only

CAUTION:  U.S. federal law
prohibits dispensing without
prescription.

Immune Globulin (Human) is
a sterile solution of immuno-
globulin containing 15%-18%
protein stabilized with
0.21-0.32 M glycine.  The
pH is adjusted with sodium
carbonate.

No U.S. standard of potency
for viral hepatitis antibodies.

08938404

Talecris Biotherapeutics, Inc.
Research Triangle Park,
NC 27709 USA
U.S. License No. 1716

Immune Globulin
(Human)

GamaSTAN™ S/D 2 mL

Solvent/Detergent Treated                  The patient and
Talecris                                  physician should discuss
Biotherapeutics, Inc.                  the risks and benefits
RTP, NC 27709 USA              of this product.  Dosage &
U.S. License No. 1716          Administration:  See insert.

Lot

Exp.

08907504

Immune Globulin
(Human)

GamaSTAN™ S/D

Solvent/Detergent Treated

Lot

Exp.

NDC 13533-635-02

The patient and physician should discuss the risks and benefits of this product.
Immune Globulin (Human) is a sterile solution of immunoglobulin containing 15%-18% protein stablilized with
0.21-0.32 M glycine.  The pH is adjusted with sodium carbonate.
No U.S. standard of potency for viral hepatitis antibodies.

For complete dosage and administration information, read enclosed package insert.

For intramuscular injection only.  Do not give intravenously.

No preservative.

If the shrink band is absent or shows any sign of tampering, do not use the product and notify Talecris
Biothreapeutics, Inc. immediately.

Rx only

CAUTION:  U.S. federal law prohibits dispensing without prescription.

Immune Globulin (Human)

GamaSTAN™ S/D 2 mL

Solvent/Detergent Treated       Store at 2-8°C (36-46°F)  Do not freeze
2 mL per Vial                                                                     10 Vials per Carton

Talecris
BIOTHERAPEUTICS

Manufactured by:
Talecris Biotherapeutics, Inc.
Research Triangle Park, NC 27709 USA
U.S. License No. 1716

NDC 13533-635-02