Description
Influenza A virus vaccine, H5N1, adjuvanted is used to prevent an infection caused by the H5N1 influenza virus subtype. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
This vaccine is to be given only by or under the supervision of your doctor or other health care professional.
This product is available in the following dosage forms:
- Emulsion
Before Using
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Audenz™ in children younger than 6 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Audenz™ in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
- Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.
- Immune system problems from a disease or medicine—May not work as well in patients with this condition.
Proper Use
A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles, usually in the upper arm. The shot could be given in the thighs for babies 6 to 11 months.
You will need two doses of this vaccine for it to work properly. Make sure you follow your doctor's instructions on when you or your child should come back for the second dose. The second dose is usually given 21 days after the first dose.
Precautions
It is very important that you or your child return to your doctor's office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you receive this vaccine.
This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.
Audenz™ may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.
Tell your doctor if you are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. However, your doctor may still want you to get the vaccine because it can give you some protection.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Fever
Incidence not known
- Cough
- difficulty swallowing
- dizziness
- fast heartbeat
- general feeling of discomfort or illness
- hives, itching, or skin rash
- inability to move the arms and legs
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sudden numbness and weakness in the arms and legs
- tightness in the chest
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty in moving
- headache
- irritability, sleepiness, tenderness, loss of appetite (in children)
- joint pain
- muscle pain or stiffness
- nausea
- redness, pain, or swelling at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
