Product Details

ROTARIX VACCINE ORAL SUS APL 10X1.5 ML

Manufacturer: Glaxo Smith Kline

MFG#: 58160-0740-21

NDC: 58160-0740-21

PID: 302933

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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category -
Drug Category USES: This vaccine is used to prevent a certain virus infection (rotavirus) in infants and young children. Rotavirus can cause fever, vomiting, and diarrhea. Although nearly all children become infected with this virus before they are 5 years old, some severe cases can lead to a dangerous (rarely fatal) loss of body fluids (dehydration). Most severe cases occur in children between 6 to 24 months old. This vaccine contains live virus that has been weakened. It works by causing the body to produce its own protection (antibodies) against rotavirus. Like any vaccine, it may not fully protect your child from rotavirus, and it will not help if your child already has the virus. This vaccine does not prevent fever, vomiting, or diarrhea from other causes.
Drug Type Code COMMON BRAND NAME(S): Rotarix, Rotateq
Drug Type Code -
FDA Approval Date -
FDA Therap Equiv -
HCPCS Rotavirus vacc (human-atten) 2 dose live oral
HCPCS -
Market Entry Date -
Medical Coverage -
Medical Coverage 90681
Termination Date (roe-TUH VYE-russ)
Termination Date -
Unit -
Units Per Pkg -
Active Ingredients 11498 rotavirus vacc,live oral, 89-12 strain,g1p(8) type
Active Ingredients 11498 rotavirus vacc,live oral, 89-12 strain,g1p(8) type
AHFS Class 80120000 VACCINES
AHFS Class 80120000 VACCINES
DEA Class NC
DEA Class NC
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 65226 rotavirus vac,live att, 89-12 ORAL ORAL SUSP 10E6/1.5ML
Gen Code and Des 65226 rotavirus vac,live att, 89-12 ORAL ORAL SUSP 10E6/1.5ML
Inactive Ingredients 11039 sodium bicarbonate 144558; 2598 sucrose 57501; 8921 latex; 915 dextrose 5996101; 9277 pork derived (porcine)
Inactive Ingredients 11039 sodium bicarbonate 144558; 2598 sucrose 57501; 8921 latex; 915 dextrose 5996101; 9277 pork derived (porcine)
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength -
Strength -
Common Brand Name 90681
Common Brand Name COMMON BRAND NAME(S): Rotarix, Rotateq
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this vaccine include: corticosteroids taken by mouth or given by injection (such as dexamethasone), drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy, corticosteroids such as prednisone), recent blood transfusion.
Allocation Period -
Allocation Period -
Case Quantity 14
Case Quantity 14
Drug Form Pack Size 15
Drug Form Pack Size 15
Form APPLICATOR
Form APPLICATOR
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size 10X1.5
Unit Size 10X1.5
How to Use -
How to Use HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional. This vaccine is given by mouth by a health care professional, usually in 2 or 3 separate doses (depending on the brand). The doses are given at least 4 to 10 weeks apart. For the best protection, it is important to receive all scheduled doses. This vaccine is usually given at the same time as other vaccines.
Missed Dose -
Missed Dose MISSED DOSE: It is important that your child receives each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember. If an appointment is missed, contact the health care professional for advice.
Notes -
Notes NOTES: Keep all medical and lab appointments.
Overdose -
Overdose OVERDOSE: Not applicable.
Phonetic Pronunciation (roe-TUH VYE-russ)
Phonetic Pronunciation COVERAGE INFORMATION NOT AVAILABLE
Precautions -
Precautions PRECAUTIONS: Before your child takes this vaccine, tell the health care professional if your child is allergic to it; or if he/she has any other allergies. This product may contain inactive ingredients (such as latex found in the packaging of some products), which can cause allergic reactions or other problems. Talk to your health care professional for more details. Before using this vaccine, tell your health care professional your child's medical history, especially of: current fever/illness, current vomiting/diarrhea, stomach/intestinal problems (such as blockage, intussusception), not gaining weight/growing as expected, blood disorders (such as hemophilia), immune system disorders (such as due to HIV infection, SCID, certain cancers such as leukemia/lymphoma, cancer or radiation treatment). Family or household members with cancer or weakened immune systems may rarely become infected with this virus if they have regular close contact with a child who takes this vaccine. People in close contact with your child should practice good hygiene such as washing hands thoroughly after diaper changes and feedings. Ask the health care professional for more details. This vaccine is not used by adults. It is unlikely to be used during pregnancy or by a mother while breast-feeding. Consult the health care professional if you have any questions about this vaccine.
Side Effects SIDE EFFECTS: Mild fever, diarrhea, or vomiting may occur. If any of these effects last or get worse, tell the health care professional promptly. Remember that this medication has been prescribed because the health care professional has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell the health care professional right away if any of these serious side effects occur: high fever (higher than 102 degrees F/39 degrees C). Rarely, a certain serious intestinal problem (intussusception) has occurred in babies after receiving this vaccine. Intussusception happens when a part of the intestine gets blocked or twisted. The risk may be higher within 21 days after receiving the first dose of rotavirus vaccine, especially in the first 7 days. Get medical help right away if you notice symptoms such as bloody stools or sudden severe abdominal pain/diarrhea. In babies, symptoms may include pulling the knees to the chest and crying, or crying when the abdomen is touched. A very serious allergic reaction to this vaccine is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact the health care professional. Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.
Side Effects -
Storage STORAGE: Store in the refrigerator. Do not freeze. Protect from light. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage -
Uses USES: This vaccine is used to prevent a certain virus infection (rotavirus) in infants and young children. Rotavirus can cause fever, vomiting, and diarrhea. Although nearly all children become infected with this virus before they are 5 years old, some severe cases can lead to a dangerous (rarely fatal) loss of body fluids (dehydration). Most severe cases occur in children between 6 to 24 months old. This vaccine contains live virus that has been weakened. It works by causing the body to produce its own protection (antibodies) against rotavirus. Like any vaccine, it may not fully protect your child from rotavirus, and it will not help if your child already has the virus. This vaccine does not prevent fever, vomiting, or diarrhea from other causes.
Uses Rotavirus vacc (human-atten) 2 dose live oral

Frequently Asked Questions (FAQs)

The cost of ROTARIX VACCINE ORAL SUS APL 10X1.5 ML is $available for registerd members only

ROTARIX VACCINE ORAL SUS APL 10X1.5 ML is manufactured by Glaxo Smith Kline.

You can purchase ROTARIX VACCINE ORAL SUS APL 10X1.5 ML on our website at https://supplies.pipelinemedical.com/product/detail/rotarix-vaccine-oral-sus-apl-10x1-5-ml-302933