Rotavirus Vaccine, Live Attenuated (Oral) (Freeze-Dried) Serum Institute of India

Rotavirus Vaccine, Live Attenuated (Oral) (Freeze-Dried) Serum Institute of India

vaccine, rotavirus

Manufacturer:

Serum Institute of India

Distributor:

Masu
Full Prescribing Info
Contents
Live attenuated bovine [human rotavirus reassortant (G1, G2, G3, G4 & G9) ≥ 105.6 FFU/Serotype].
Description
Each dose of 2.5 ml contains Live Attenuated Bovine - Human Rotavirus Reassortant [G1, G2, G3, G4 and G9]* ≥ 105.6 FFU /Serotype, Reconstitute with Diluent for Rotavirus Vaccine.
Diluent is a sterile solution (Citrate Bicarbonate Buffer) prepared using 9.6 mg /ml citric acid monohydrate and 25.6 mg/ml sodium bicarbonate.
*Grown on vero cells.
Rotavirus Vaccine, Live Attenuated (Oral) supplied by Serum Institute of India Pvt. Ltd. is a pentavalent vaccine. The vaccine constitutes five viruses (Human and Bovine reassortant strains) of serotype G1, G2, G3, G4, and G9. All these strains constitute VP7 gene of respective serotype from human strains reassorted with bovine (UK) rotavirus.
Each strain is propagated in VERO cells individually; and all five strains are blended before filling and then freeze-dried. The vaccine is for protection from any severe rotavirus infection.
Rotavirus vaccine is available as a vial of freeze-dried vaccine to be reconstituted with a liquid diluent in a vial containing antacid (Citrate bicarbonate buffer). Vaccine is to be reconstituted with the help of adapter and syringe just prior to oral administration.
The vaccine or diluents contains no preservatives. The vaccine is for oral administration and not for injection.
The vaccine conforms to the World Health Organization (W.H.O.) requirements.
Indications/Uses
Rotavirus Vaccine, Live Attenuated (Oral) is indicated for active immunization of healthy infants from the age of 6 weeks for the prevention of gastroenteritis due to rotavirus infection when administered as a 3-dose series.
Dosage/Direction for Use
Rotavirus Vaccine, Live Attenuated (Oral) is for ORAL ADMINISTRATION ONLY AND MUST NOT BE ADMINISTERED PARENTERALLY.
Dosage: Rotavirus Vaccine, Live Attenuated (Oral) should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. Based on recommendations from the World Health Organization, if the routine childhood immunizations are initiated later than 6 weeks of age and/or at a longer dose interval than 4-weeks, Rotavirus Vaccine, Live Attenuated (Oral) can still be administered, by itself or concomitantly with DTP, inactivated poliovirus vaccine (IPV), oral poliovirus vaccine (OPV), H. influenzae type b conjugate (Hib) vaccine, and hepatitis B vaccine. Because of the typical age distribution of rotavirus gastroenteritis, rotavirus vaccination of children > 24 months of age is not recommended. There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with Rotavirus Vaccine, Live Attenuated (Oral).
It is recommended that infants who receive Rotavirus Vaccine, Live Attenuated (Oral) as the first dose should complete the three dose series with Rotavirus Vaccine, Live Attenuated (Oral). There is no data on safety, immunogenicity or efficacy of Rotavirus Vaccine, Live Attenuated (Oral) when administered interchangeably with other available rotavirus vaccines.
In case that an incomplete dose is administered (the baby spits up or regurgitates most of the vaccine), a single replacement dose may be administered at the same vaccination visit*. The baby may continue to receive the remaining doses as per schedule.
*Physician's discretion is advised.
Dosage administration: Each single oral dose of Rotavirus Vaccine, Live Attenuated (Oral) is 2.5 ml in volume. The administration of a single dose vaccine requires one vial of freeze-dried vaccine, one vial of citrate bicarbonate buffer, one adapter and syringe for vaccine reconstitution and administration. Only the specific buffer diluent provided must be used for reconstitution. If the integrity of either the vaccine or buffer diluent vial has been compromised, that particular vial must be discarded. The content of vial containing buffered diluent should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution. Reconstituted vaccine must be used immediately. If not used immediately, it can be held for a period of maximum 6 hours, provided, a syringe* is used to cap the opening of the vial adapter and the entire assembly is stored at 2 to 8°C.
*Fresh syringe if it is the second dose, else use the syringe used for reconstitution.
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
In the event of either being observed, discard the vaccine. The vaccine must not be mixed with other medicinal products. Any unused vaccine or waste material should be disposed of in accordance with local requirements.
For Reconstitution instructions for Rotavirus Vaccine, Live Attenuated (Oral) refer Instructions for use and handling under Cautions for Usage.
Contraindications
Hypersensitivity to any component of the vaccine is a contraindication to vaccine. Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of Rotavirus Vaccine, Live Attenuated (Oral) should not receive further doses. Infants with a history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant for intussusception should not receive vaccine. Individuals with Severe Combined Immunodeficiency Disease (SCID) should not receive vaccine as cases of gastroenteritis associated with other live rotavirus vaccines have been reported in infants with SCID. History of intussusception (IS) is a contraindication to vaccine administration.
Special Precautions
No safety or efficacy data of Rotavirus Vaccine, Live Attenuated (Oral) is available in immunocompromised infants, infants infected with HIV or infants with chronic gastroenteritis. Administration of Rotavirus Vaccine, Live Attenuated (Oral) may be considered with caution in immunocompromised infants and infants in close contact with immunodeficient persons if in the opinion of the physician the benefit far outweigh the risks of vaccine. Similarly, acute infection or febrile illness may be a reason for delaying the administration of Rotavirus Vaccine, Live Attenuated (Oral). Low-grade fever and mild upper respiratory tract infection are not contraindications to Rotavirus Vaccine, Live Attenuated (Oral).
Available published data shows a small increased incidence of intussusception (IS) following other live oral rotavirus vaccines especially after the first dose. The safety data from the clinical trials of Rotavirus Vaccine, Live Attenuated (Oral) did not show any increased risk of IS. However, health care providers should carefully evaluate cases with symptoms suggestive of IS.
Similar to other rotavirus vaccines, vaccination with Rotavirus Vaccine, Live Attenuated (Oral) may not protect all vaccine recipients against rotavirus infection. Also, Rotavirus Vaccine, Live Attenuated (Oral) will not provide protection against gastroenteritis caused by the other pathogens.
Use In Pregnancy & Lactation
Pregnancy: Animal reproduction studies have not been conducted with Rotavirus Vaccine, Live Attenuated (Oral). It is also not known whether Rotavirus Vaccine, Live Attenuated (Oral) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rotavirus Vaccine, Live Attenuated (Oral) is not indicated for adults including women of child-bearing age and should not be administered to pregnant females.
Lactation: Rotavirus Vaccine, Live Attenuated (Oral) is not indicated for use in adults, including nursing women.
Adverse Reactions
In the phase III trial of Rotavirus Vaccine, Live Attenuated (Oral), no differences were detected between Rotavirus Vaccine, Live Attenuated (Oral) and placebo groups in the post-vaccination rates of solicited adverse events within 7 days of each dose of vaccine. These events in decreasing order of frequency were : Fever (68.2% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 69.7% in the placebo group), irritability (42.6% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 36.1% in the placebo group), decreased appetite (20.4% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 20.0% in the placebo group), decreased activity level (18.8% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 17.1% in the placebo group), vomiting (17.0% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 16.9% in the placebo group) and diarrhea (8.4% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 10% in the placebo group). Except for irritability, the incidence of all solicited events was similar in Rotavirus Vaccine, Live Attenuated (Oral) and placebo groups. Most of these events were of short duration and predominately mild (98% of episodes) in severity. It should be noted that in the phase 3 efficacy study, Rotavirus Vaccine, Live Attenuated (Oral) and placebo were administered to all children concomitantly with DTwP vaccine, which is known to cause a level of reactogenicity similar to that observed in this study.
The occurrence of unsolicited adverse events was monitored throughout the phase 3 efficacy trial. The most frequent serious adverse events observed included gastroenteritis, lower respiratory tract infection, bronchiolitis, bronchopneumonia, pyrexia and pneumonia. Except for 11 cases of gastroenteritis that occurred within 7 days post-vaccination, none of the SAEs observed were considered to be related to study products. Of the 11 gastroenteritis cases, 6 participants had received Rotavirus Vaccine, Live Attenuated (Oral) and 5 had received Placebo. However, out of these 11, only one tested positive for rotavirus antigen in stool by ELISA.
A total of seven cases of intussusception occurred until time of primary analysis of which four were in the Rotavirus Vaccine, Live Attenuated (Oral) group and three in the Placebo group. None of the cases occurred within 28 days of receiving a dose of Rotavirus Vaccine, Live Attenuated (Oral) or Placebo. All cases of intussusception were causally unrelated to study vaccination.
Drug Interactions
Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than minimal doses), may reduce the immune response to vaccines.
Rotavirus Vaccine, Live Attenuated (Oral) can be administered concomitantly with other vaccines of the infant immunization programme, including combined diphtheria, tetanus toxoid and pertussis vaccine (DTP), inactivated poliovirus vaccine (IPV), oral polio vaccine (OPV), H. influenzae type b conjugate (Hib) vaccine and hepatitis B vaccine. No interaction studies have been performed with Rotavirus Vaccine, Live Attenuated (Oral) in infants with other medicinal products.
Caution For Usage
Instructions for use and handling: 1. Remove plastic caps from the vials containing diluent and freeze-dried cake.
2. Fit the vial adapter on the diluent vial. Connect the syringe to the vial adapter. Withdraw the entire diluent into the syringe.
3. Disconnect the vial adapter and the attached syringe from the diluent vial.
4. Fit the vial adapter with the syringe on to the vaccine vial. Inject the entire contents of the syringe into the vial containing the freeze-dried cake.
5. While holding the syringe, gently swirl until the solution is clear. Do not shake. The reconstituted vaccine will appear as pinkish to yellowish clear liquid.
6. While holding the plunger down, turn syringe with vial upside down. Pull back the plunger to withdraw single dose (2.5 ml) mixture back into the syringe.
7. Remove the syringe from the vial adapter. The vaccine is ready for administration.
8. Administer the entire content of the syringe orally (on the inside of the cheek). The child should be seated in a reclining position. Do not inject.
Multidose vial: Leave the vial adapter on the reconstituted vaccine vial. Use a fresh syringe for second dose after withdrawal and administration of first dose.
Storage
Rotavirus Vaccine, Live Attenuated (Oral) should be stored at 2-8°C. The diluent should not be frozen, but should be kept cool.
Shelf-Life: 30 months.
ATC Classification
J07BH02 - rota virus, pentavalent, live, reassorted ; Belongs to the class of rota virus diarrhea vaccines.
Presentation/Packing
Oral vaccine (vial) 2.5 mL (w/ diluent + adapter + syringe) x 1 dose x 1's. 5 mL (w/ diluent + adapter + 2 syringe) x 2 dose x 1's.
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