PRIORIX is indicated for the active immunisation against measles, mumps and rubella in the second year of life. It can also be given as a booster at the age of 4-6 years.
SIDE EFFECTS:
Common:Upper respiratory tract infection
Uncommon: Otitis media
Uncommon: Lymphadenopathy
Rare: Allergic reactions
Uncommon: Anorexia
Uncommon: Nervousness, abnormal crying, insomnia
Rare: Febrile convulsions
Uncommon: Conjunctivitis
Uncommon: Bronchitis, cough
Uncommon: Parotid gland enlargement, diarrhea, vomiting
Common: Rash
Very common: Redness at the injection site, fever >38C (rectal) or >37.5C (axillary/oral)
Common: Pain and swelling at the injection site, fever >39.5C (rectal) or >39C (axillary/oral)
ROTARIX LIQUID ORAL VACCINE is indicated for the prevention of gastro-enteritis caused by Rotavirus. ROTARIX LIQUID ORAL VACCINE is intended for use in infants in the first six months of life.
SIDE EFFECTS:
Common: Diarrhoea
Uncommon: Flatulence, abdominal pain
Uncommon: Dermatitis
Common: Irritability
CERVARIX is indicated from the age of 9 years for the prevention of persistent infection, premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical, vulvar, vaginal and anal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic Human Papillomaviruses (HPV) (see PHARMACOLOGICAL ACTION and WARNINGS AND SPECIAL PRECAUTIONS).
SIDE EFFECTS:
Uncommon: Upper respiratory tract infection
Uncommon: Lymphadenopathy
Very common: Headache
Uncommon: Dizziness
Common: Gastrointestinal including nausea, vomiting, diarrhoea and abdominal pain
Common: Itching/pruritus, rash, urticaria
Very common: Myalgia
Common: Arthralgia
Very common: Injection site reactions including pain, redness, swelling; fatigue
Common: Fever (≥ 38 °C)
Uncommon: Other injection site reactions such as induration, local paraesthesia
HAVRIX is indicated for active immunisation against hepatitis A virus (HAV) infection in subjects at risk of exposure to HAV.
HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low and intermediate prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in subjects who are, or will be, at increased risk of infection such as: Travellers: Persons moving from areas of low endemicity to areas of high endemicity. Armed forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of HAV infection. Active immunisation is indicated for these individuals.
Persons for whom hepatitis A is an occupational hazard or for whom there is an increased risk of transmission.
Contacts of infected persons.
Persons who require protection as part of hepatitis A outbreak control or because of regionally elevated morbidity.
Specific population groups known to have a higher incidence of hepatitis A.
Subjects with chronic liver disease or who are at risk of developing chronic liver disease (e.g. hepatitis B and hepatitis C carriers and alcohol abusers). Hepatitis A tends to compromise the outcome of the chronic liver disease. In areas of intermediate to high prevalence of hepatitis A, susceptible individuals may be considered for active immunisation. These include children and adolescents especially in high socio-economic groups and urban areas.
SIDE EFFECTS:
Uncommon: Upper respiratory tract infection, rhinitis
Common: Appetite lost
Very common: Irritability
Very common: Headache
Common: Drowsiness
Uncommon: Dizziness
Rare: Hypoaesthesia, paraesthesia
Common: Gastrointestinal symptoms (such as diarrhoea, nausea, vomiting)
Uncommon: Rash
Rare: Pruritus
Uncommon: Myalgia, musculoskeletal stiffness
Very common: Pain and redness at the injection site, fatigue
Common: Malaise, fever (³ 37,5 °C), injection site reaction (such as swelling or induration)
Uncommon: Influenza like illness Rare: chills.
Active immunisation of infants and children from 6 weeks up to 5 years of age against disease caused by Streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and against acute otitis media caused by Non-Typeable Haemophilus influenzae.
SIDE EFFECTS:
Rare: Allergic reactions (such as allergic dermatitis, atopic dermatitis, eczema)
Very rare: Angioedema
Very common: Appetite lost
Very common: Rrritability
Uncommon: Crying abnormal
Very common: Drowsiness
Rare: Convulsions (including febrile convulsions)
Very rare: Kawasaki disease
Uncommon: Apnoea (see WARNINGS AND SPECIAL PRECAUTIONS for apnoea in very premature infants (≤ 28 weeks of gestation))
Uncommon: Diarrhoea, vomiting
Uncommon: Rash
Rare: Uticaria
Very common: Pain, redness, swelling at the injection site, fever ≥ 38 °C rectally (age < 2 years) Common: injection site reactions like injection site induration, fever > 39 °C rectally (age < 2 years)
Uncommon: Injection site reactions like injection site haematoma, haemorrhage and nodule The following adverse reactions have additionally been reported after booster vaccination of primary series and/or catch-up vaccination: Nervous system disorders: Uncommon: headache (age 2 to 5 years)
INFANRIX HEXA is indicated for primary and booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b in infants from the age of 6 weeks and may be given to infants who received a first dose of hepatitis B vaccine at birth.
SIDE EFFECTS:
Uncommon: Upper respiratory tract infection
Very common: Appetite loss
Very common: Irritability, crying abnormal, restlessness
Common: Nervousness
Uncommon: Somnolence
Very rare: Convulsions (with or without fever)
Uncommon: Cough*
Rare: Bronchitis
Common: Vomiting, diarrhoea
Common: Pruritus*
Rare: Rash
Very rare: Dermatitis, urticaria*
Very common: Pain, redness, local swelling at the injection site (≤50 mm), fever ≥38 °C, fatigue
Common: Local swelling at the injection site (>50 mm)**, fever >39,5 °C, injection site reactions, including induration
Uncommon: Diffuse swelling of the injected limb, sometimes involving the adjacent joint
SIDE EFFECTS:
Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. (1.1)
Active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A. (1.1)
Active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. (1.2)
In infants and toddlers vaccinated at 2, 4, 6, and 12–15 months of age in US clinical trials, the most commonly reported solicited adverse reactions (>5%) were irritability (>70%), injection site tenderness (>50%), decreased appetite (>40%), decreased sleep (>40%), increased sleep (>40%), fever (>20%), injection site redness (>20%), and injection site swelling (>20%). (6.1)
In children aged 5 through 17 years, the most commonly reported solicited adverse reactions (>5%) were injection site tenderness (>80%), injection site redness (>30%), injection site swelling (>30%), irritability (>20%), decreased appetite (>20%), increased sleep (>20%), fever (>5%), and decreased sleep (>5%). (6.1)
Avaxim is a vaccine. Vaccines are used to protect you against infectious diseases. This vaccine helps to protect against hepatitis A infection in people 16 years of age and older. Hepatitis A infection is due to a virus that attacks the liver. It may be caught from food or drink that contains the virus. Symptoms include yellowing of the skin (jaundice) and feeling generally unwell. When you are given an injection of Avaxim, your body’s natural defences will produce protection against hepatitis A infection.
SIDE EFFECTS:
Mild pain at the injection site
Generally feeling weak (asthenia) Common reactions (reported by less than 1 in 10 but more than 1 in a 100 people):
Headache
Feeling sick (nausea) or being sick (vomiting)
Loss of appetite
Diarrhoea and/or stomach ache (abdominal pain)
Pain in the muscles and joints (myalgia, arthralgia)
Mild fever
Redness (erythema) at the injection site Rare reactions (reported by less than 1 in a 1000 but more than 1 in 10,000 people):
A lump formed at the injection site (injection site nodule)
Mild and temporary changes in blood tests that measure how the liver is working (transaminases increased)
Fainting in response to injection
Rashes that have sometimes been lumpy and itchy (including urticaria)
VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
SIDE EFFECTS:
Fever ≥ (38.9°C) oral: 14.7%
Injection-site complaints: 19.3% (6.1)
Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older include: o fever ≥ (37.8°C)
Varicella-like rash (injection site)
Varicella-like rash (generalized)
Menactra is a vaccine. Vaccines are used to protect you against infectious diseases. Menactra is given to protect persons 9 months through 55 years of age against meningococcal disease caused by four groups of Neisseria meningitidis (A, C, Y and W-135).
The use of this vaccine should be in accordance with official recommendations. It allows the body to produce enough antibodies to provide a defence against the bacteriathat cause meningococcal disease. However, as with all vaccines, 100% protection cannot be guaranteed. Menactra will not prevent meningitis (an infection of the brain and spinal cord coverings) caused by other groups of Neisseria meningitidis or meningitis caused by different kinds of microbes.
SIDE EFFECTS:
Pain, tenderness, redness, hardness and swelling at the injection site
Headache, tiredness (fatigue), feeling unwell (malaise)
Joint pain (arthralgia)
Fever, chills
Loss of appetite, diarrhoea, vomiting
Rash
Irritability, drowsiness, abnormal crying (in children)
BOOSTRIX is a vaccine used for booster vaccination against diphtheria, tetanus and pertussis (whooping cough). The vaccine is sometimes called dTpa vaccine. BOOSTRIX is intended for use in children aged 4 years and older and adults.
Diphtheria, pertussis and tetanus are three life-threatening diseases caused by bacterial infection. The vaccine works by causing the body to produce its own protection (antibodies)against the disease.
SIDE EFFECTS:
Redness, swelling, a hard lump, soreness, bruising or itching around the injection site, or a rash on your skin
Feeling generally unwell, fever (between 38˚C and 40°C), aches and pains
Loss of appetite, or feeling sick (nausea), vomiting, constipation or diarrhoea restlessness, irritability, loss of appetite.
Swelling of limbs, face, eyes, inside of nose, mouth or throat
Shortness of breath, or breathing or swallowing difficulties
Hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
Unusual tiredness or weakness that is sudden and severe, muscular aches and pains
Convulsions/fits, collapse or periods of unconsciousness
Fever over 40°C Those are signs of an allergic reaction. Allergy to BOOSTRIX is rare. Any such severe reactions will usually occur within the first few hours of vaccination.
Hexaxim (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
SIDE EFFECTS:
Crying, somnolence, vomiting, pain redness and swelling at injection site, irritability, Fever (≥38°C
Prolonged crying, diarrhoea, induration
Allergicreaction, lump at injection site, High fever (≥39°C).
Rare side effect (may affect up to 1 in 1,000 people) – Rash, Large injection-site reactions (>5 cm), including extensive limb swelling from the injection site beyond one or both joints, have been reported in children.
These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve within 3-5 days without need of treatment.
Fits (convulsions) with or without fever, Very Rare side effects (may affect up to 1 in 10,000 people) – hypotonic reactions, hypotonic hyporesponsive episodes.
