Instructions Rotarix oral suspension 1.5 ml/1 dose applicator No. 1
Composition
active ingredient: 1 dose (1.5 ml) contains not less than 106.0 TCD50 of human rotavirus, live attenuated strain RIX4414*;
excipients: sucrose (1.073 g), disodium adipate (132.74 mg), Dulbecco's modified Eagle's medium (DMEM) (2.26 mg), water for injection (up to 1.5 ml).
*Grown in Vero cell culture.
Dosage form
Oral suspension.
Main physicochemical properties: the vaccine is a clear colorless liquid.
ROTARIX is a monovalent vaccine for the prevention of rotavirus gastroenteritis, which contains a live attenuated virus derived from a human rotavirus strain.
ROTARIX meets the requirements of the World Health Organization for biological substances and for vaccines against rotavirus infection.
Pharmacotherapeutic group
Vaccines. Antiviral vaccines. Vaccine for the prevention of rotavirus infection, live attenuated. ATX code J07B H01.
Pharmacological properties
Immunological and biological properties.
Pharmacodynamics
Protective efficacy of ROTARIX lyophilisate for oral suspension Clinical trials have demonstrated efficacy against rotavirus gastroenteritis of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8], and against the uncommon rotavirus genotypes G8P[4] (severe gastroenteritis) and G12P[6] (any gastroenteritis). All of these strains circulate worldwide. Clinical trials were conducted in Europe and Latin America, Africa and Asia to assess the protective efficacy of ROTARIX against any, particularly severe, rotavirus gastroenteritis. The severity of gastroenteritis was determined using 2 different criteria: - the 20-point Vesicari scale, which assesses the full clinical picture of rotavirus gastroenteritis, taking into account the severity and duration of diarrhea and vomiting, the severity of fever and dehydration, and the need for treatment - or the World Health Organization (WHO) criteria. Clinical protection was assessed in the Adherent Protocol (ATP) cohort for efficacy, which included all patients in the ATP safety cohort who were included in the appropriate follow-up period for efficacy. Protective efficacy of the vaccine in European studies In a European clinical study, the efficacy of Rotarix was evaluated in 4,000 patients according to the approved schedules in different European countries (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months). After administration of 2 doses of ROTARIX vaccine, protective efficacy was maintained throughout the first and second years of life of the child, as shown in the table below.
1st year of life ROTARIX N = 2572 Placebo N = 1302 | 2nd year of life ROTARIX N = 2554 Placebo N = 1294 | | | |
| Vaccine efficacy (%) against any and severe rotavirus gastroenteritis [95% CI] | | | | |
| Genotype | Rotavirus gastroenteritis of any severity | Severe rotavirus gastroenteritis: | Rotavirus gastroenteritis of any severity | Severe rotavirus gastroenteritis: |
| G1P[8] | 95.6 [87.9; 98.8] | 96.4 [85.7; 99.6] | 82.7 [67.8; 91.3] | 96.5 [86.2; 99.6] |
| G2P[4] | 62.0* [< 0.0; 94.4] | 74.7* [< 0.0; 99.6] | 57.1 [< 0.0; 82.6] | 89.9 [9.4; 99.8] |
| G3P[8] | 89.9 [9.5; 99.8] | 100 [44.8; 100] | 79.7 [< 0.0; 98.1] | 83.1* [< 0.0; 99.7] |
| G4P[8] | 88.3 [57.5; 97.9] | 100 [64.9; 100] | 69.6* [< 0.0; 95.3] | 87.3 [< 0.0; 99.7] |
| G9P[8] | 75.6 [51.1; 88.5] | 94.7 [77.9; 99.4] | 70.5 [50.7; 82.8] | 76.8 [50.8; 89.7] |
| Strains | 88.2 | 96.5 | 75.7 | 87.5 |
| genotype P[8] | [80.8; 93.0] | [90.6; 99.1] | [65.0; 83.4] | [77.8; 93.4] |
| Circulating | 87.1 | 95.8 | 71.9 | 85.6 |
| rotavirus strains | [79.6; 92.1] | [89.6; 98.7] | [61.2; 79.8] | [75.8; 91.9] |
Vaccine effectiveness (%) against rotavirus gastroenteritis requiring medical attention [95% CI] | | | | |
| Circulating | 91.8 | 76.2 | | |
| rotavirus strains | [84; 96.3] | [63.0; 85.0] | | |
Vaccine effectiveness (%) by incidence of hospitalizations due to rotavirus gastroenteritis [95% CI] | | | | |
| Circulating | 100 | 92.2 | | |
| rotavirus strains | [81.8; 100] | [65.6; 99.1] | | |
† A case of gastroenteritis with a score of ≥11 on the Vesicari scale was considered severe.
* Not statistically significant (p ³ 0.05). These data should be interpreted with caution.
The increase in vaccine efficacy during the first year of life was directly proportional to the increase in disease severity, reaching 100% (95% CI: 84.7; 100) for Vesicari scores ≥17.
In a clinical trial conducted in Latin America, over 20,000 patients participated in the evaluation of the efficacy of ROTARIX vaccine. The severity of gastroenteritis (GE) was determined according to WHO criteria. Data on the protective efficacy of the vaccine against severe rotavirus (RV) gastroenteritis requiring hospitalization and/or rehydration therapy in medical facilities and the genotype-specific efficacy of the vaccine after the administration of 2 doses of Rotarix vaccine are presented in the table below.
| Genotype | Severe rotavirus gastroenteritis† (1st year of life) ROTARIX N = 9009 Placebo N = 8,858 | Severe rotavirus gastroenteritis† (2nd year of life) ROTARIX N = 7175 Placebo N = 7062 |
Efficiency (%) [95% CI] | Efficiency (%) [95% CI] | |
| All RVGE | 84.7 [71.7; 92.4] | 79.0 [66.4; 87.4] |
| G1P[8] | 91.8 [74.1; 98.4] | 72.4 [34.5; 89.9] |
| G3P[8] | 87.7 [8.3; 99.7] | 71.9* [< 0.0; 97.1] |
| G4P[8] | 50.8#* [< 0.0; 99.2] | 63.1 [0.7; 88.2] |
| G9P[8] | 90.6 [61.7; 98.9] | 87.7 [72.9; 95.3] |
| Strains with genotype P[8] | 90.9 [79.2; 96.8] | 79.5 [67.0; 87.9] |
† A case of gastroenteritis with an episode of diarrhea with or without vomiting that required hospitalization and/or rehydration therapy in a medical facility was considered severe (WHO criteria)
* Not statistically significant (p ³ 0.05). These data should be interpreted with caution.
# The number of cases on which the vaccine efficacy estimates against the G4P genotype[8] were based was small (1 case in the Rotarix group and 2 cases in the placebo group).
A pooled analysis of five efficacy studies* demonstrated 71.4% (95% CI: 20.1; 91.1) efficacy against severe rotavirus gastroenteritis (Vesicari score ≥11) caused by rotavirus genotype G2P[4] during the first year of life.
The point estimates and confidence intervals in these studies were as follows: 100% (95% CI: -1858.0; 100), 100% (95% CI: 21.1; 100), 45.4% (95% CI: -81.5; 86.6), 74.7 (95% CI: -386.2; 99.6). In the latter study, point estimates were not available.
Protective efficacy of the vaccine according to the results of studies conducted in Africa
A clinical trial was conducted in Africa (ROTARIX: N = 2974; placebo: 10
| Genotype | Rotavirus gastroenteritis of any severity ROTARIX N = 2974 Placebo N = 1443 | Severe rotavirus gastroenteritis ROTARIX N = 2974 Placebo N = 1443 |
Efficiency (%) [95% CI] | Efficiency (%) [95% CI] | |
| G1P[8] | 68.3 [53.6; 78.5] | 56.6 [11.8; 78.8] |
| G2P[4] | 49.3 [4.6; 73.0] | 83.8 [9.6; 98.4] |
| G3P[8] | 43.4* [< 0.0; 83.7] | 51.5* [< 0.0; 96.5] |
| G8P[4] | 38.7* [< 0.0; 67.8] | 63.6 [5.9; 86.5] |
| G9P[8] | 41.8* [< 0.0; 72.3] | 56.9* [< 0.0; 85.5] |
| G12P[6] | 48.0 [9.7; 70.0] | 55.5* [< 0.0; 82.2] |
| Strains with genotype P[4] | 39.3 [7.7; 59.9] | 70.9 [37.5; 87.0] |
| Strains with genotype P[6] | 46.6 [9.4; 68.4] | 55.2* [< 0.0; 81.3] |
| Strains with genotype P[8] | 61.0 [47.3; 71.2] | 59.1 [32.8; 75.3] |
† A case of gastroenteritis with a score of ≥11 on the Vesicari scale was considered severe.
* Not statistically significant (p ³ 0.05). These data should be interpreted with caution.
Duration of protective efficacy of the vaccine in children under 3 years of age, according to the results of a study conducted in Asia
In a clinical study conducted in Hong Kong, Singapore and Taiwan (total cohort of vaccinated patients: ROTARIX: N = 5359; placebo: N = 5349), the efficacy of ROTARIX vaccine was evaluated according to the approved schedules in different European countries (2, 4 months; 3, 4 months).
During the first year of life (from 2 weeks after the 2nd dose to 1 year of age), the incidence of severe rotavirus gastroenteritis due to circulating wild-type RV was significantly lower in the ROTARIX group than in the placebo group (0.0% vs. 0.3%). Vaccine efficacy was 100% (95% CI: 72.2; 100).
Data demonstrating the protective efficacy of two doses of ROTARIX vaccine against severe rotavirus gastroenteritis up to 2 years of age are presented in the table below.
Vaccine effectiveness up to 2 years ROTARIX N = 5263 Placebo N = 5256 | |
| Vaccine efficacy (%) against severe rotavirus gastroenteritis [95% CI] | |
| Genotype | Severe rotavirus gastroenteritis† |
| G1P[8] | 100 [80.8; 100] |
| G2P[4] | 100* [< 0.0; 100] |
| G3P[8] | 94.5 [64.9; 99.9] |
| G9P[8] | 91.7 [43.8; 99.8] |
| Strains with genotype P[8] | 95.8 [83.8; 99.5] |
| 96.1 [85.1; 99.5] |
| Vaccine efficacy (%) against rotavirus gastroenteritis requiring hospitalization and/or rehydration therapy in medical facilities [95% CI] | |
| Circulating rotavirus strains | 94.2 [82.2; 98.8] |
† A case of gastroenteritis with a score of ≥11 on the Vesicari scale was considered severe.
* Not statistically significant (p ³ 0.05). These data should be interpreted with caution.
During the third year of life, no cases of severe RV gastroenteritis were reported in the ROTARIX group (N = 4222) and 13 (0.3%) in the placebo group (N = 4185). Vaccine efficacy was 100% (95% CI: 67.5; 100). Severe RV gastroenteritis was caused by the following RV strains: G1P[8], G2P[4], G3P[8], and G9P[8]. The number of cases of severe RV gastroenteritis caused by individual genotypes was too small to assess efficacy. Vaccine efficacy against severe RV gastroenteritis requiring hospitalization was 100% (95% CI: 72.4; 100).
Protective efficacy of ROTARIX oral suspension vaccine
Since the immune response observed after 2 doses of ROTARIX oral suspension was comparable to the immune response after 2 doses of ROTARIX lyophilisate for oral suspension, the efficacy of the lyophilized vaccine can be extrapolated to the liquid formulation.
Immune response
The immunological mechanism of protection against rotavirus gastroenteritis by ROTARIX vaccine has not been fully understood. The relationship between the humoral immune response to the use of the rotavirus vaccine and protection against rotavirus gastroenteritis has not been established.
The table below shows the proportion of patients who were seronegative for rotavirus (IgA antibody titers < 20 U/ml (enzyme-linked immunosorbent assay)) before vaccination, with a serum IgA antibody titer ≥ 20 U/ml 1 or 2 months after the second dose of vaccine or placebo (based on studies of the lyophilized form of the ROTARIX vaccine).
| Vaccination schedule | Country of study | Vaccine | Placebo | | |
| N | % ³ 20 U/ml [95% CI] | N | % ³ 20 U/ml [95% CI] | | |
| 2, 3 months | France, | 239 | 82.8 | 127 | 8.7 |
| Germany | [77.5; 87.4] | [4.4; 15.0] | | | |
| 2, 4 months | Spain | 186 | 85.5 [79.6; 90.2] | 89 | 12.4 [6.3; 21.0] |
| 3.5 months | Finland, Italy | 180 | 94.4 | 114 | 3.5 |
| [90.0; 97.3] | [1.0; 8.7] | | | | |
| 3, 4 months | Czech | 182 | 84.6 | 90 | 2.2 |
| Republic | [78.5; 89.5] | [0.3; 7.8] | | | |
| From 2, 3 to 4 | Latin | 393 | 77.9% | 341 | 15.1% |
| months | America, 11 countries | [73.8; 81.6] | [11.7; 19.0] | | |
| 10, 14 weeks | South Africa, | 221 | 58.4 | 111 | 22.5 |
| and 6, 10, 14 | Malawi | [51.6; 64.9] | [15.1; 31.4] | | |
| weeks | | | | | |
| (data set) | | | | | |
In three comparative controlled studies, the immune response to the ROTARIX oral suspension vaccine was comparable to the response to the lyophilized form of the vaccine.
Immune response in premature infants
In a clinical study conducted in premature infants (born at or after 27 weeks of gestation), the immunogenicity of ROTARIX was evaluated in a subgroup of 147 subjects. This evaluation showed that ROTARIX is immunogenic in this population. 85.7% (95% CI: 79.0, 90.9) of subjects had serum anti-rotovirus IgA antibody titers ≥20 IU/mL (enzyme-linked immunosorbent assay) 1 month after the second dose of vaccine.
Efficiency
Observational studies have demonstrated vaccine efficacy against severe gastroenteritis caused by rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8], leading to hospitalization, as well as the less common genotypes G9P[4] and G9P[6]. All of these strains circulate worldwide.
Efficacy of two doses of vaccine in preventing RVGE requiring hospitalization
| Country Period | Age range | N(1) (gastroenteritis cases/control patients) | Strain | Efficiency % [95% CI] |
| High-income countries | | | | |
| Belgium 2008–2010(2) | < 4 years 3–11 months | 160/198 | All | 90 [81; 95] 91 [75; 97] |
| < 4 years | 41/53 | G1P[8] | 95 [78; 99] | |
< 4 years 3–11 months | 80/103 | G2P[4] | 85 [64; 94] 83 [22; 96] (3) | |
| < 4 years | 12/13 | G3P[8] | 87* [<0; 98](3) | |
| < 4 years | 16/17 | G4P[8] | 90 [19; 99](3) | |
| Singapore 2008–2010(2) | < 5 years | 136/272 | All | 84 [32; 96] |
| 89/89 | G1P[8] | 91 [30; 99] | | |
| Taiwan 2009–2011 | < 3 years | 184/1623(4) | All G1P[8] | 92 [75; 98] 95 [69; 100] |
USA 2010–2011 | < 2 years | 85/1062(5) | All G1P[8] G2P[4] | 85 [73; 92] 88 [68; 95] 88 [68; 95] |
| 8–11 months | All | 89 [48; 98] | | |
USA 2009–2011 | < 5 years | 74/255(4) | All | 68 [34; 85] |
| Middle-income countries | | | | |
| Bolivia 2010–2011 | < 3 years 6–11 months | 300/974 | All | 77 [65; 84](6) |
| 77 [51; 89] | | | | |
< 3 years 6–11 months | G9P[8] | 85 [69; 93] 90 [65; 97] | | |
| < 3 years | G3P[8] | 93 [70; 98] | | |
| G2P[4] | 69 [14; 89] | | | |
| G9P[6] | 87 [19; 98] | | | |
| Brazil 2008–2011 | < 2 years | 115/1 481 | All | 72 [44; 85](6) |
| G1P[8] | 89 [78; 95] | | | |
| G2P[4] | 76 [64; 84] | | | |
Brazil 2008–2009(2) | < 3 years 3–11 months | 249/249(5) | All | 76 [58; 86] 96 [68; 99] |
< 3 years 3–11 months | 222/222(5) | G2P[4] | 75 [57; 86] 95 [66; 99](3) | |
| El Salvador 2007–2009 | < 2 years 6–11 months | 251/770(5) | All | 76 [64; 84](6) 83 [68; 91] |
Guatemala 2012–2013 | < 4 years | Data not available(7) | All | 63 [23; 82] |
| Mexico 2010 | < 2 years | 9/17(5) | G9P[4] | 94 [16; 100] |
| Low-income countries | | | | |
| Malawi 2012–2014 | < 2 years | 81/286(5) | All | 63 [23; 83] |
* Not statistically significant (P ³ 0.05). These data should be interpreted with caution.
(1) The number of cases of fully vaccinated (2 doses) and unvaccinated patients, as well as the number of patients in the control group, is given.
(2) Studies sponsored by GSK.
(3) Results of retrospective analysis.
(4) Vaccine efficacy was evaluated using control patients without rotavirus (evaluation in Taiwan was performed using a pool of data from control patients without rotavirus and control patients without diarrhea).
(5) The efficacy of the vaccine was assessed using control patients from the same region.
(6) In incompletely vaccinated subjects, vaccine efficacy after a single dose ranged from 51% (95% CI: 26; 67, El Salvador) to 60% (95% CI: 37; 75, Brazil).
(7) The evaluation of vaccine efficacy is based on data from 41 cases of gastroenteritis among fully vaccinated patients and 175 fully vaccinated control patients.
Impact on mortality§
Studies of the effects of the ROTARIX vaccine conducted in Panama, Brazil, and Mexico demonstrated a reduction in all-cause mortality from diarrhea ranging from 17% to 73% in children under 5 years of age, 2–4 years after vaccine administration.
Impact on hospitalization§
In a retrospective database study in Belgium, conducted in children up to and including 5 years of age, the direct and indirect effect of ROTARIX vaccine administration on rotavirus-related hospitalization ranged from 64% (95% CI: 49; 76) to 80% (95% CI: 77; 83) 2 years after vaccine administration. Similar studies in Brazil, Australia, and El Salvador demonstrated a 45–93% reduction in hospitalization rates 2 to 4 years after vaccine administration.
Additionally, 9 studies of the impact on all-cause diarrhea hospitalizations conducted in Africa and Latin America demonstrated a reduction of 14–57% between 2 and 5 years after vaccine introduction.
§NOTE: Impact studies are meant to establish a temporal relationship, not a causal relationship, between disease and vaccination. Fluctuations in incidence rates due to natural causes may also affect the observed temporal relationship.
Pharmacokinetics
Assessment of pharmacokinetic properties is not applicable to vaccines.
Indication
The ROTARIX vaccine is indicated for the prevention of gastroenteritis caused by rotavirus (see sections “Method of administration and dosage”, “Special instructions for use”, “Immunobiological and biological properties”).
Vaccination of children in Ukraine is carried out in accordance with the requirements of current orders of the Ministry of Health of Ukraine.
Contraindication
Hypersensitivity after previous administration of ROTARIX vaccine or to any of the components of the vaccine (see section "Composition").
History of intussusception.
An unresolved congenital malformation of the gastrointestinal tract, which may be a prerequisite for the development of intestinal intussusception.
Severe combined immunodeficiency (SCID) (see section "Adverse reactions").
The administration of ROTARIX vaccine should be postponed in individuals with acute illnesses accompanied by fever. The presence of minor infections, such as the common cold, is not a contraindication to immunization.
The administration of ROTARIX vaccine should be postponed in individuals suffering from diarrhea or vomiting.
When carrying out immunization in Ukraine, contraindications should also be guided by the current orders of the Ministry of Health of Ukraine.
Interaction with other medicinal products and other types of interactions
ROTARIX vaccine can be used in combination with any of the following monovalent and combination vaccines, including the hexavalent DTPa-HBV-IPV/Hib vaccine - a vaccine for the prevention of diphtheria, tetanus, pertussis (acellular), hepatitis B, poliomyelitis and diseases caused by Haemophilus influenzae type b (Hib); with diphtheria, tetanus, and pertussis vaccine (whole cell) (DTPw), with diphtheria, tetanus, and pertussis vaccine (acellular) (DTPa), with Hib vaccine, with inactivated polio vaccine (IPV), with hepatitis B vaccine (HBV), with pneumococcal conjugate vaccine, and with meningococcal serogroup C conjugate vaccine. The results of the studies showed that the simultaneous administration of these vaccines did not affect their immunogenicity and safety.
Concomitant administration of ROTARIX and oral polio vaccine (OPV) had no effect on the immune response to polioviruses. Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe gastroenteritis caused by rotaviruses is maintained, as demonstrated in a clinical study involving more than 4,200 patients who received ROTARIX concomitantly with oral polio vaccine (OPV).
There are no restrictions on the infant's food or liquid intake either before or after vaccination.
Application features
According to the requirements of medical practice, vaccination should be preceded by a history taking, especially regarding contraindications, and a medical examination.
There are no data on the safety and efficacy of ROTARIX in infants with gastrointestinal diseases or growth retardation. Therefore, ROTARIX should be administered to such infants with caution, weighing the risks and benefits of vaccination.
As a precautionary measure, healthcare professionals should monitor for any symptoms suggestive of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal distension and/or fever) in the post-vaccination period, as data from observational safety studies indicate an increased risk of intussusception, predominantly within 7 days after rotavirus vaccination (see section 4.8). Parents or guardians should be advised to promptly report any such symptoms.
For individuals prone to intussusception, see the Contraindications section.
Asymptomatic and mildly symptomatic HIV infection is not expected to affect the safety and efficacy of Rotarix. A clinical study in a limited number of asymptomatic or mildly symptomatic HIV-positive infants did not reveal any apparent safety concerns (see section 4.8). The use of Rotarix in infants with known or suspected immunodeficiency, including in utero exposure to immunosuppressive therapy, should be based on careful consideration of the potential benefits and risks of administering Rotarix.
As is known, excretion of the vaccine virus with feces appears after vaccination and lasts on average up to 10 days with a peak excretion on the 7th day. Viral antigen particles detected using the ELISA method were detected in 50% of feces after the first dose of Rotarix vaccine in the form of a lyophilisate for the preparation of an oral suspension.
and in 4% of stools after the second dose. When these stools were tested for the presence of the live vaccine strain, only 17% were positive. In two comparative controlled studies, vaccine excretion after administration of Rotarix oral suspension was comparable to that observed after vaccination with Rotarix lyophilisate for oral suspension.
Cases of transmission of the vaccine virus to seronegative contacts have been observed, but without the appearance of any clinical symptoms.
ROTARIX should be used with caution in individuals who have close contact with immunocompromised patients, particularly those with malignancies, or those receiving immunosuppressive therapy.
Persons in contact with recently vaccinated children should practice careful hygiene (including washing hands after changing the child's diapers).
When primary immunization is performed in very premature infants (born ≤ 28 weeks of gestation), respiratory monitoring is required for 48 to 72 hours after vaccination due to the potential risk of apnea, and especially in infants with a history of respiratory immaturity.
Because the benefits of vaccination are high for this group of infants, vaccination should not be delayed or canceled.
A protective immune response may not be obtained in all vaccinated children.
It is currently unknown to what extent ROTARIX vaccine may provide protection against rotavirus strains that were not circulating in the clinical trials. Clinical trials from which efficacy data were obtained were conducted in Europe, Central and South America, Africa and Asia (see section “Immunological and biological properties”)
The ROTARIX vaccine does not protect against gastroenteritis of non-rotavirus etiology.
The ROTARIX vaccine MUST NOT BE ADMINISTERED BY INJECTION UNDER ANY CIRCUMSTANCES!
Excipients
This vaccine contains sucrose and glucose as excipients. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
This vaccine contains 0.15 micrograms of phenylalanine in each dose. Phenylalanine may be harmful to patients with phenylketonuria (PKU).
This vaccine contains 34 mg of sodium in each dose.
Traceability
In order to improve the traceability of medical immunobiological preparations, in the relevant forms of medical record documentation regarding vaccination, the healthcare professional must clearly indicate the trade name and batch number of the medical immunobiological preparation that was used.
Use during pregnancy or breastfeeding
ROTARIX is not intended for use in adults. Therefore, there are no data on the use of the vaccine in women during pregnancy or breastfeeding.
Based on evidence from clinical trials, breastfeeding does not reduce the protection against rotavirus gastroenteritis following (resulting from) the administration of ROTARIX. Therefore, breastfeeding can be continued during vaccination.
Method of administration and doses
ROTARIX vaccine is for oral use only.
The ROTARIX vaccine CANNOT BE ADMINISTERED BY INJECTION UNDER ANY CIRCUMSTANCES!
Instructions for using the vaccine are given below.
Technique of application/handling the drug.
Special precautions for use and handling of the drug.
The vaccine is a clear, colorless liquid, free from any foreign particles, for oral administration.
The vaccine is ready to use (no need to dissolve or dilute it).
The vaccine should be administered orally without mixing it with any other vaccines or solutions.
The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical appearance prior to administration. If any of the above are observed, the vaccine should not be used.
Any unused product or waste material should be disposed of in accordance with local requirements.
Vaccine administration technique in an oral applicator
| 3. Do not administer by injection. |
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| 1. Remove the protective cap from the oral applicator. |
| | 2. This vaccine is for oral use only. The child should be in a supine position. Administer the entire contents of the oral applicator onto the inside of the child’s cheek ORALLY. |
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Dispose of the empty oral applicator and protective cap according to local requirements.
Technique for administering the vaccine in a tube
A What you should do before you inject ROTARIX™ - Check the expiration date.
- Check the tube for damage or opening.
- Check that the liquid is clear and colorless, without any particles.
If you notice anything unusual, do not use the vaccine. - This vaccine is administered orally - directly from the tube.
- The vaccine is ready to use - there is no need to mix it with anything else.
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B Prepare the tube for use 1. Remove the protective cap - Don't throw away the protective cap - you will need it to pierce the membrane.
- Hold the tube vertically.
2. Tap the top of the tube to free it of any liquid. - Remove the liquid from the thin part of the tube by tapping just below the membrane.
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3. Position of the protective cap for opening the tube - Hold the tube in an upright position.
- Hold the tube by the sides.
- Inside the top of the protective cap there is a small spike - in the center.
- Turn the protective cap with the spike facing down (180°).
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4. To open the tube - You don't need to twist the protective cap. Press it to pierce the membrane.
- Then remove the protective cap.
| | Press the protective cap down. | |
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C Check that the tube is opened correctly 1. Check that the membrane is punctured - There should be a hole in the top of the tube.
2. What to do if the membrane has not been punctured - If the membrane is not punctured, return to point B and repeat steps 2, 3 and 4.
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D Administer the vaccine - After opening the tube, check that the liquid is clear and free of any foreign particles.
If you notice anything unusual, do not use the vaccine. - Administer the vaccine immediately.
1. Position the child correctly to administer the vaccine - Place your child in a slightly tilted back position.
2. Administer the vaccine - While pressing on the tube, carefully introduce all the liquid into the mouth (on the inner surface of the child's cheek).
- It may take several presses on the tube to squeeze out all the vaccine - it is normal if a drop remains at the tip of the tube.
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Dispose of the empty tube and protective cap according to local requirements.
Children
ROTARIX vaccine should not be used in children older than 24 weeks of age.
Overdose
Some cases of overdose have been reported. In general, the adverse reactions reported were similar to those observed after the recommended dose of ROTARIX.
Side effects
The safety profile of the vaccine presented below is based on data from clinical trials conducted with both the lyophilized form of the ROTARIX vaccine and the reconstituted oral suspension.
A total of 1900 infants were immunized in 4 clinical trials with ROTARIX suspension, receiving approximately 3800 doses of vaccine. These trials showed that the safety profile of the suspension vaccine was comparable to that of the lyophilized powder vaccine.
A total of approximately 106,000 doses of ROTARIX vaccine (as lyophilized powder or suspension) were administered to approximately 51,000 infants in 23 clinical trials.
In three placebo-controlled clinical trials (conducted in Finland, India and Bangladesh) in which ROTARIX was administered alone (other routine paediatric vaccines were administered as scheduled), the frequency and severity of these expected adverse reactions were similar.
