Vaccines, Antisera & Diagnostic agents

Vaccines, Antisera & Diagnostic agents

 

VACCINES & Antisera

 

BCG VACCINE (intradermal):

Indications: Active immunisation against tuberculosis.

Contraindications: Febrile illness, impaired immunity, widespread malignancy, tuberculin positive patients.

Dose and Administration: Adult Dosage: BCG Vaccine (intradermal): 0.1 mL strictly by intradermal injection. Child Dosage: BCG Vaccine (percutaneous): Neonates and young children only, by percutaneous vaccination using multiple puncture technique. BCG Vaccine (intradermal): Under 3 months, 0.05 mL; over 3 months, 0.1 mL. Both strictly by intradermal injection.

 

DTP VACCINE:

Indications: Active immunisation against diphtheria, tetanus and pertussis.

Contraindications: Acute febrile illness. History of convulsions, cerebral irritation or damage in the neonatal period. Severe local or general reaction to a preceding dose. History of familial epilepsy. Neurological familial epilepsy. Neurological disease, developmental neurological defect.

Dose and Administration: Adult Dosage: Not recommended. Child Dosage: Over 2 months, primary immunisation: 3 doses of 0 .5 mL by deep subcutaneous or intramuscular injection at minimum of four week intervals. Reinforcing dose of DIP/TET at 3 years: 0.5 mL by subcutaneous or intramuscular injection. Over 10 years, not recommended.

 

DTP-HAEMOPHILUS B CONJUGATED VACCINE:

Indications: Primary vaccination of infants, at or above the age of two months and as a booster in children up to 7^th birthday against diphtheria, tetanus, pertussis and invasive haemophilus influenza type b infection.

Contraindications: Acute febrile illness. History of convulsions, cerebral irritation or damage in the neonatal period. Severe local or general reaction to a preceding dose. History of familial epilepsy. Neurological familial epilepsy. Neurological disease, developmental neurological defect. History of severe allergy.

Dose and Administration: Adult Dosage: Not recommended. Child Dosage: Over 2 months, primary immunisation: 3 doses of 0 .5 mL by deep subcutaneous or intramuscular injection. Over 7 years, not recommended.

 

DTP-HEPATITIS B VACCINE:

Indications: Active immunisation against diphtheria, tetanus, pertussis & hepatitis B in infants from 6 wk onwards.

Contraindications: Acute severe febrile illness. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis­containing vaccine.

Dose and Administration: Primary vaccination 3 doses of 0.5 mL each w/in the 1st 6 mth of life. Administer each dose at intervals of at least 4 wk. A booster dose can be administered in the 2nd yr of life.

 

DTP-HEPATITIS B-HAEMOPHILUS B VACCINE:

Indications: Active immunisation against diphtheria, tetanus, pertussis, hepatitis B & diseases caused by H. Influenza type B in infants from 6 wk onwards and up to 7 years of age.

Contraindications: Acute severe febrile illness. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis­containing vaccine.

Dose and Administration: Primary vaccination 3 doses of 0.5 mL each w/in the 1st 6 mth of life. Administer each dose at intervals of at least 4 wk. A booster dose can be administered in the 2nd yr of life.

 

HEPATITIS A:

Indications: indicated for active immunisation against HAV infection. The vaccine is particularly indicated for those at increased risk of infection or transmission. It is also indicated for use during outbreaks of hepatitis A infection. Contraindications: Hypersensitivity to any component of the vaccine. Acute severe febrile illness.

Dose and Administration: AVAXIM: 0.5 mL as a single dose; booster dose 0.5 mL 6–12 months after initial dose; child under 16 years, not recommended. HAVRIX: 1 mL as a single dose; booster dose, 1 mL 6–12 months after initial dose; child 1–15 years 0.5 mL; booster dose, 0.5 mL 6–12 months after initial dose.

 

HEPATITIS B:

Indications: indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes in non-immune subjects.

Contraindications: should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown

signs of hypersensitivity after previous administration. As with other vaccines, the administration of the vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication for immunisation.

Dose and  Administration: Adult dosage: The 20 μg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. A 0, 1, 6 months schedule which gives optimal protection at month 7 and produces high antibody titres. Child dosage: 12 years and under: 0 .5 mL by intramuscular injection into the antero-lateral aspect of thigh (infants) or deltoid, repeated 1 month and 6 months later. Rapid immunisation, 0 .5 mL by intramuscular injection, repeated 1 month, 2 months and 12 months later.

 

HUMAN PAPILLOMA VIRUS VACCINE:

Indications: for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of the vaccine should not receive further doses of the vaccine. Administration of the vaccine should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.

Dose and Administration: The primary vaccination series consists of 3 separate 0.5 ml doses administered according to the following schedule: 0, 2, 6 months. If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Cervarix is not recommended for use in girls below 10 years of age due to lack of data on safety and immunogenicity in this age-group. Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy.

 

INFLUENZA VACCINE:

Indications: Prophylaxis of influenza, especially in those who run an increased risk of associated complications. The use of Enzira should be based on official recommendations.

Contraindications: Hypersensitivity to the active substances, to any of the excipients, to eggs and/or chicken proteins. Immunisation shall be postponed in patients with febrile illness or acute infection.

Dose and Administration: Adults and children from 36 months: 0.5 ml. Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used. For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

 

MEASLES VACCINE:

Indications: indicated for vaccination against measles in persons 9 months of age or older.

Contraindications: Hypersensitivity to any component of the vaccine. Do not give Measles vaccine to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Dose and Administration: The dose for any age is 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm. The recommended age for primary vaccination is 9 to 15 months.

 

MEASLES, MUMPS AND RUBELLA (MMR) VACCINE:

Indications: indicated for active immunisation against measles, mumps and rubella.

Contraindications: contraindicated in subjects with known systemic hypersensitivity to any component of the vaccine or to neomycin a history of contact dermatitis to neomycin is not a contraindication. MMR vaccine must not be administered to pregnant women. Furthermore, pregnancy must be avoided for one month after vaccination.

Dose and Administration: 0.5 ml of the reconstituted vaccine constitutes one dose. MMR Vaccine may be used for both primary immunisation and revaccination of children over 9 months of age, adolescents and adults. For infants in their first year of life. The vaccine should be given according to the recommended schedule.

 

MENINGOCOCCAL ACWY VACCINE:

Indications: active immunization against invasive meningococcal disease caused by these serogroups.⁵ Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined may be used to prevent and control outbreaks of serogroup C meningococcal disease.

Contraindications: contraindicated in subjects with known systemic hypersensitivity to any component of the vaccine.

Dose and Administration: For both adults and children, vaccine is administered subcutaneously as a single 0.5 mL dose. Protective antibody levels may be achieved within 7 to 10 days after vaccination.⁵ Revaccination of a single 0.5 mL dose administered subcutaneously may be indicated for individuals at high-risk of infection, particularly children who were first vaccinated when they were less than 4 years of age; such children should be considered for revaccination after 2 or 3 years if they remain at high-risk.

 

PNEUMOCOCCAL POLYSACCHARIDE VACCINE:

Indications: active immunisation against disease caused by the pneumococcal serotypes included in the vaccine. The vaccine is recommended for individuals 2 years of age or older in whom there is an increased risk of morbidity and mortality from pneumococcal disease.

Contraindications: Hypersensitivity to the active substance(s) or to any of the excipients.

Dose and Administration: Adults and children of 2 years of age or older- one single dose of 0.5 millilitres by intramuscular or subcutaneous injection. The vaccine is not recommended for use in children below 2 years of age as the safety and efficacy of the vaccine have not been established and the antibody response may be poor.

 

PNEUMOCOCCAL POLYSACCHARIDE CONJUGATED VACCINE: 

Indications: Active immunisation against invasive disease (including sepsis, meningitis, bacteraemic pneumonia, bacteraemia) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in: – infants and young children from 2 months of age to 2 years of age – previously unvaccinated children aged 2 years to 5 years. For the number of doses to be administered in the different age groups.

Contraindications: Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid.

Dose and Administration: The immunisation schedules for Prevenar should be based on official recommendations. Infants aged 2 – 6 months: The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A fourth dose is recommended in the second year of life. The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.

 

POLIOMYELITIS VACCINE, LIVE ORAL (OPV):

Indications: Active immunisation against poliomyelitis.

Contraindications: Acute febrile illness or intercurrent infection, persistent diarrhoea, or vomiting or other gastrointestinal disturbance. Impaired immune reponse, including leukaemia, lymphoma, generalised malignancy or treatment with corticosteroids, cytotoxic drugs or irradiation. Known systemic hypersensitivity to any constituents of the vaccine.

Dose and Administration: Three drops of vaccine from the monodose or ten-dose tube constitute one dose, which may be given with syrup or on a lump of sugar to mask the bitter salty taste of the magnesium chloride.

 

DTP-IPV-HAEMOPHILUS B CONJUGATED VACCINE:

Indications: indicated for the active immunisation of infants against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. the vaccine may also be administered as a single dose to children who have previously completed a primary immunisation series with diphtheria, tetanus, pertussis, polio and Hib antigens, in accordance with the applicable official recommendations.

Contraindications: should not be given to children who: Are known to be hypersensitive to any component of the vaccine (including neomycin, streptomycin and polymyxin B which may be present in trace amounts). Have had a previous severe local or general reaction to this vaccine or to any other vaccine that contains one or more of the antigenic components. Have a fever or acute severe systemic illness. In this case vaccination should be postponed until the child has recovered. Minor infections without fever or systemic upset are not reasons to postpone vaccination.

Dose and Administration: The primary immunisation series in infancy may be commenced from two months of age according to applicable official recommendations. A single 0.5 millilitre dose should be given on three separate occasions with at least one month between doses. Child dosage: Primary Immunisation Series in Infancy The primary immunisation series in infancy may be commenced from two months of age according to applicable official recommendations. A single 0.5 millilitre dose should be given on three separate occasions with at least one month between doses.

 

DTP-IPV-HEPATITIS B- HAEMOPHILUS B VACCINE:

Indications: indicated for the active immunisation of infants against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive infections caused by Haemophilus influenzae type b. the vaccine may also be administered as a single dose to children who have previously completed a primary immunisation series

with diphtheria, tetanus, pertussis, polio and Hib antigens, in accordance with the applicable official recommendations.

Contraindications: should not be given to children who: Are known to be hypersensitive to any component of the vaccine (including neomycin, streptomycin and polymyxin B which may be present in trace amounts). Have had a previous severe local or general reaction to this vaccine or to any other vaccine that contains one or more of the antigenic components. Have a fever or acute severe systemic illness.

Dose and Administration: The primary immunisation series in infancy may be commenced from two months of age according to applicable official recommendations. A single 0.5 millilitre dose should be given on three separate occasions with at least one month between doses. Child dosage: Primary Immunisation Series in Infancy The primary immunisation series in infancy may be commenced from two months of age according to applicable official recommendations. A single 0.5 millilitre dose should be given on three separate occasions with at least one month between doses.

 

RABIES VACCINE:

Indications: For prophylactic immunisation against rabies. Treatment of patients following suspected rabies contact.

Contraindications: Pre Exposure, Known systemic hypersensitivity reaction to any component of Rabies Vaccine BP or after previous administration of the vaccine or a vaccine containing the same components as Rabies Vaccine BP.

Dose and Administration: Three injections each of 1 millilitre given on days 0, 7 and 28. A single reinforcing dose should be given at two or three year intervals to those at continued risk.

 

ROTAVIRUS VACCINE:

Indications: immunisation of infants over 6 weeks of age for protection against gastro-enteritis caused by rotavirus infection.

Contraindications: in individuals with immunodeficiency and in those predisposed to, or with a history of, intussusception. The administration of rotavirus vaccine should be postponed in infants with diarrhoea or vomiting.

Dose and Administration: By mouth infant over 6 weeks, 2 doses of 1 mL separated by an interval of at least 4 weeks; course should be completed before 24 weeks of age (preferably before 16 weeks)

 

TETANUS VACCINE:

Indications: Active immunisation against tetanus. Reinforcement of immunity to tetanus.

Contraindications: Acute infectious disease except in tetanus prone wounds.

Dose and Administration: Primary immunisation: 3 doses of 0.5 mL at minimum 4-week intervals. Normally, use triple vaccine in children. Reinforcing doses: 0 .5 ml 10 years after primary immunisation with a further 0.5 mL 10 years later. Injuries: 0 .5 mL unless a booster has been given in the preceding year. All by deep subcutaneous or intramuscular injection. intramuscular injection.

 

TYPHOID VACCINE: 

Indications: indicated for active immunisation against typhoid fever for both adults and children two years of age and older.

Contraindications: should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration. As with other vaccines, the administration of Typhoid vaccine should be postponed in subjects suffering from acute febrile illness. The presence of a minor infection, however, is not a contraindication for vaccination.

Dose and Administration: A single dose of 0.5 ml is recommended for both adults and children two years of age and older.

 

VARICELLA-ZOSTER VACCINE:

Indications: Varicella vaccine is used to prevent infection by the varicella-zoster virus, which causes chickenpox.

Contraindications: Varicella vaccine should not be used by anyone who: is sensitive or allergic to any of the components of the vaccine (including gelatin). Is pregnant or planning to become pregnant within 3 months of receiving the vaccine.is receiving mmunosuppressive therapy (e.g., some medications used for the treatment of cancer or for transplant recipients).

Dose and Administration: Adults and adolescents 13 years of age and older receive a dose of 0.5 mL followed by a second 0.5 mL dose 4 to 8 weeks later. Children 12 months of age receive a single dose of 0.5 mL and 2^nd dose at the school age.

 

POLYVALENT SNAKE ANTIVENOM: 

Indications: For the treatment of snakebite.

Contraindications: Significant allergic disease, or a history of an adverse reaction to the injection of serum.

Dose and Administration: For fast effect, the Anti Snkae Venom Serum should be injected intravenously as soon as possible after the bite. As a first dose, at least 20 ml. of the reconstituted serum should be injected intravenously very gradually (for every 1 ml per minute). The second dose should be repeated two hours after the first dose or even earlier.

SCORPION ANTIVENOM:

Indications: Used for treatment of the sting of the parabuthus scorpion.

Contraindications: Should be used with great caution if patient is subject to allergic diseases such as asthma or infantile eczema, or was allergic to any previous antiserum injection.

Dose and Administration: Local symptoms may be relieved by the subcutaneous injection of serum around the site of the sting. For serious parabuthus stings, inject 5 mL intravenously or intramuscularly, and repeat injection after 1 to 2 hours if improvement has not occurred.

 

Diagnostic Agents

 

TUBERCULIN PURIFIED PROTEIN DERIVATIVE (PPD):

Indications: The intradermal (Mantoux) skin test employing PPD RT/23 is used as an aid in the diagnosis of tuberculosis infection. Reactivity to the test may be depressed or suppressed if the individual is suffering from advanced tuberculosis disease, acute viral infection (including immunisation with live viral vaccine during past 14 days), or overwhelming bacterial infection. Patients receiving corticosteroids or other immunosuppressive agents, or who are suffering from malignant conditions, may also react poorly to the tuberculin test.

Contraindications: Known hypersensitivity to the test, such as may occur in individuals who are known tuberculin reactors and who have been repeatedly tested with tuberculin, or in persons who have previously suffered from tuberculosis.

Dose and Administration: By intradermal injection, for Mantoux test, 2 units (0.1 mL of 20 units/mL strength) for routine Mantoux test; if first test is negative and a further test is considered appropriate 10 units (0.1 mL of 100 units/mL strength)