DRUG STUDY

RLE Requirements

Submitted to:
Villarba, Joshua Benjamin S.
BSN 2D

Submitted by:
Mrs. Maria Elizabeth B. Joe, RN, MN
Clinical Instructor
Classification: Anti Rabies
Generic Name: Purified Chick Embryo Cell
Brand Name: RabAvert
Mechanism of Action:
RabAvert Rabies Vaccine produced by
GlaxoSmithKline GmbH is a sterile, freeze-dried
vaccine obtained by growing the fixed-virus
strain Flury Low Egg Passage (LEP) in primary
cultures of chicken fibroblasts.
The growth medium for propagation of the virus
is a synthetic cell culture medium with the
addition of human albumin, polygeline
(processed bovine gelatin), and antibiotics. The
virus is inactivated with β-propiolactone and
further processed by zonal centrifugation in a
sucrose density gradient. The vaccine is
lyophilized after addition of a stabilizer solution
that consists of buffered polygeline and
potassium glutamate.
Dose/Frequency/Route: Contraindications: Nursing Responsibilities:
The individual dose for adults, children, and In view of the almost invariably fatal outcome of The healthcare provider should also question the
infants is 1 mL given intramuscularly. rabies, there is no contraindication to patient, parent, or guardian about
postexposure prophylaxis, including pregnancy.1 (1) the current health status of the vaccinee and
In adults, administer vaccine by IM injection into (2) reactions to a previous dose of RabAvert or a
the deltoid muscle. In small children and infants, Hypersensitivity similar product.
administer vaccine into the anterolateral zone of History of anaphylaxis to the vaccine or any of
the thigh. The gluteal area should be avoided for the vaccine components constitutes a Preexposure vaccination should be postponed in
vaccine injections, since administration in this contraindication to preexposure vaccination with the case of sick and convalescent persons and
area may result in lower neutralizing antibody this vaccine. those considered to be in the incubation stage of
titers. Care should be taken to avoid injection an infectious disease. A separate, sterile syringe
into or near blood vessels and nerves. After In the case of postexposure prophylaxis, if an and needle should be used for each patient.
aspiration, if blood or any suspicious alternative product is not available, the patient Needles must not be recapped and should be
discoloration appears in the syringe, do not should be vaccinated with caution with the properly disposed of. As with any rabies vaccine,
inject but discard contents and repeat procedure necessary medical equipment and emergency vaccination with RabAvert may not protect 100%
using a new dose of vaccine at a different site. supplies available and observed carefully after of susceptible individuals.
vaccination. A patient's risk of acquiring rabies
Indication for Patient: must be carefully considered before deciding to
discontinue vaccination. Advice and assistance
RabAvert is indicated for preexposure on the management of serious adverse reactions
vaccination, in both primary series and booster for persons receiving rabies vaccines may be
dose, and for postexposure prophylaxis against sought from the state health department or CDC.
rabies in all age groups.
Side Effects:
Usually an immunization series is initiated and
completed with 1 vaccine product. No clinical In very rare cases, neurological and
studies have been conducted that document a neuroparalytical events have been reported in
change in efficacy or the frequency of adverse temporal association with administration of
reactions when the series is completed with a RabAvert (see WARNINGS). These include cases of
second vaccine product. However, for booster hypersensitivity
immunization, RabAvert was shown to elicit
protective antibody level responses in persons Adverse Effects:
tested who received a primary series with HDCV.
The most commonly occurring adverse reactions
are injection site reactions, such as injection site
erythema, induration, and pain; flu-like
symptoms, such as asthenia, fatigue, fever,
headache, myalgia, and malaise; arthralgia;
dizziness; lymphadenopathy; nausea; and rash.
Classification: Anti Rabies Dose/Frequency/Route: Contraindications: Nursing Responsibilities:

Generic Name: Purified Chick Embryo Cell Intramuscular
Preexposure prophylaxis against rabies
Adult: Primary immunization: 1 mL on days 0, 7
Brand Name: Rabipur and 28 (3rd dose may be given on day 21 if
needed). Booster: Persons at regular or
Mechanism of Action: continuous risk: 1 mL given 1 year after
completion of primary course, then 1 mL every 3-
Rabies vaccine is an inactivated virus vaccine that 5 years. Persons at intermittent risk: Doses are
is used for active immunization against rabies. It given according to official recommendations.
promotes immunity by inducing an active Child: Same as adult dose.
immune response. It can be used for pre- and
post-exposure immunization. Intramuscular
Postexposure prophylaxis of rabies
For post-exposure immunization, it is often used Adult: Unimmunized or incompletely immunized
in conjunction with rabies immunoglobulins as it persons: 1 mL on days 0, 3, 7, 14, and 28;
takes about 7-10 days for the specific antibodies alternatively, the 5th dose may be given on day
to develop. 30. Fully immunized persons: 1 mL on day 0 and
3.
Child: Same as adult dose.
Indication for Patient:
Adult:
Hypersensitivity (when used for pre-exposure A patient's risk of developing rabies must be
prophylaxis). Severe immunosuppression. carefully considered, before deciding to
discontinue immunization.
Side Effects: Do not administer by intravascular injection.
Headache, dizziness; rash; inj. site reactions, If the vaccine is inadvertently administered
intravascularly (in a blood vessel), there is a risk
malaise, fatigue, asthenia, fever.
of adverse reactions, with shock potentially
occurring in extreme cases. Appropriate
Adverse Effects: emergency measures to prevent shock must be
taken immediately.
Lymphadenopathy; decreased appetite; nausea,
vomiting, diarrhea, abdominal pain/discomfort;
People taking chloroquine for malaria treatment
urticaria; myalgia, arthralgia.
or prophylaxis may have a reduced response to
intradermal rabies vaccination and should
receive the vaccine intramuscularly.
Rabies vaccine must not be given by intra-gluteal
injection or subcutaneously, as the induction of
an adequate immune response may be less
reliable.

IM Preexposure prophylaxis against rabies 1 mL

on days 0, 7 and on day 21 or 28. Booster: Persons
at regular or continuous risk: 1 mL given 1 year
after completion of primary course, then 1 mL
every 3-5 years. Persons at intermittent risk:
Doses are given based on official
recommendations.

Postexposure prophylaxis of rabies

Unimmunised or incompletely immunised
persons: 1 mL on days 0, 3, 7, 14, and on day 28
or 30. Fully immunised persons: 1 mL on day 0
and 3.
Classification: Anti Rabies
Generic Name:
Purified Vero Cell Vaccine (PVRV)
Brand Name: Verorab
Mechanism of Action:
Used in a postexposure prophylaxis regimen that
includes active immunization with rabies vaccine
and passive immunization with RIG. RIG provides
immediate, temporary rabies virus-neutralizing
antibodies until the patient has an immunologic
response to active immunization with rabies
vaccine and produces virus-neutralizing
antibodies
Dose/Frequency/Route: Contraindications: Nursing Responsibilities:
One dose consists in the administration of 0.5 mL Pre-exposure vaccination: Injection-schedule recommendations should be
of vaccine via the intramuscular route. followed scrupulously.
If the patient is allergic to the active substance or
The vaccine is administered by the intramuscular any of the other ingredients of this medicine. To reconstitute the vaccine: Take the cap off the
route, generally in the anterolateral region of the vial of powder.
thigh muscle until the age of 12 months and in the If the patient developed an allergic reaction
deltoid muscle after this age. during a previous injection of this medicine or of Inject the content of the prefilled syringe of
any vaccine with the same composition. solvent into the vial of powder.
Indication for Patient:
If the patient is feverish or if has an acute disease Shake gently in order to obtain a homogenous
VERORAB is indicated for the prevention of rabies (in this case, it is preferable to postpone vaccine suspension.
in children and adults. It can be used before or vaccination).
The reconstituted vaccine appears as a limpid
after exposure to the rabies virus, as a primary
Post-exposure vaccination: homogenous liquid.
vaccination or as a booster dose.
Pre-exposure rabies prevention (pre-exposure Given the fatal outcome of the declared rabies Withdraw 0.5 mL of suspension and inject
vaccination): infection, there are no contraindications to post- immediately.
exposure vaccination.
Pre-exposure vaccination should be offered to Any unused medicinal product or waste material
subjects at high risk of contamination by the Side Effects: should be disposed of in accordance with local
rabies virus. requirements.
Increase in size of lymph nodes, fever, headache,
Post-exposure rabies prevention (post-exposure dizziness, somnolence, Abdominal pain, nausea, This medicinal product is subject to medical
vaccination): diarrhea, vomiting, Muscular pain, joint pain. prescription.
Vaccination should be initiated immediately at Adverse Effects:
the slightest risk of rabies contamination. It must
imperatively be performed in a rabies center Lymphadenopathy; decreased appetite; nausea,
under medical supervision. vomiting, diarrhea, abdominal pain/discomfort;
urticaria; myalgia, arthralgia.
Classification: Anti Rabies Dose/Frequency/Route: Contraindications: Nursing Responsibilities:

Generic Name: IM Post-exposure therapy immunization: 1. Intra-venous injection is prohibited

Purified Vero Cell Vaccine (PVRV) Intra-muscular administration: the 0.5 ml dose 2. The vaccine and anti-rabies immunoglobulin
shall be injected intra-muscularly in the deltoid Because rabies is a fatal disease, there are no must not be administered with the
in antero-lateral region of the thigh in young contraindications for immunization, including same syringe and in the same injection site
Brand Name: Speeda children. Do not inject in the gluteal region. pregnant women. 3. Before use, please carefully check the package,
level, appearance and the
Mechanism of Action: Preventive or pre-exposure vaccination Inj. on Pre-exposure prophylaxis immunization: validity period
days 0, 7, 28 w/ boosters during the 2nd & 6th The person who is pregnant or in the active 4. After reconstitution, the freeze-dried rabies
Speeda can induce immunity against rabies virus yr. of life. period of acute fever is recommended to delay the vaccine should be administered as
in recipient following immunization, it is used to vaccination; the person who has serious chronic soon as possible
protect against rabies. Post-exposure vaccination Adult & children Inj. disease, disease of the nervous system 5. In the event that the dose of vaccine
on days 0, 3, 7, 14 & 28. Previously immunized hypersensitive disease or has an allergic history inadvertently given subcutaneously or
subjects <5 yr. 2 inj. in days 0 & 3. of antibiotic, biological product should avoid use. intramuscularly, a new dose should be
administered intra-dermally immediately
Indication for Patient: Side Effects: 6. For the intra-dermal route, sterile syringe with
fixed needle (insulin type) is
Active immunization against rabies Local reactions like pain, redness, edema, preferred. A sterile needle and syringe must be
pruritus and indurations in the injection site. The used to withdraw and administer
symptoms will be alleviated without treatment each dose of vaccine for each patient to avoid
after injection. cross infection. Correct intradermal injection
should result in a raised papule with a “paeu
d’orange” (orange
Adverse Effects: peal) appurtenance. If the vaccine has been
injected too deeply and a papule is
Systemic reaction: like a little fever, chill,
seen, the needle should be withdrawn and
asphyxia, atony, giddy, arthralgia, muscle pain,
reinserted nearby
gastrointestinal disorder.
7. This vaccine does not contain a preservative,
therefore, grate care must be taken
to avoid contamination of reconstituted vaccine
8. Any reconstituted vaccine should be used as
soon as possible
9. It must be stored in a refrigerator at +2 to +8°C
and used within 8 hours after
reconstitution or discarded
Classification: Anti Rabies Dose/Frequency/Route: Contraindications: Nursing Responsibilities:

Generic Name: Recommended dose of rabies immunoglobulin is Because of the life-threatening risk due to rabies, Human rabies immunoglobulin should be
Human Rabies Immunoglobin 20 IU Berirab P per kg body weight (bw). Because there are no contraindications to the administered via the intramuscular route.
of the risk of interference with antibody administration of rabies immunoglobulin.
production related to vaccination, neither the Do not use solutions which are cloudy or contain
Brand Name: Berirab dose should be increased nor repeat rabies residues (deposits/particles).
Side Effects:
immunoglobulin be given even if the onset of the
Mechanism of Action: simultaneous prophylaxis is delayed. Local reactions like pain, redness, edema, Berirab is a ready-for-use solution and should be
pruritus and indurations in the injection site. The administered at body temperature.
A medication made up of antibodies against the It is advisable to administer them in divided doses
symptoms will be alleviated without treatment
rabies virus. It is used to prevent rabies following at different sites. This applies in the case of doses Do not inject intravenously.
after injection.
exposure. above 2 mL for children up to 20 kg bw and doses
above 5 mL for persons above 20 kg bw.
Adverse Effects:
Indication for Patient: In rare cases the following adverse reactions may
occur:
Post-exposure prophylaxis of rabies infection ● allergic reactions including fall in blood
after exposure to scratches, bites or other injuries pressure, dyspnea, cutaneous
caused by a suspected rabid animal; mucous reactions (flush, urticaria), in isolated cases
membrane contamination with infectious tissue reaching as far as anaphylactic shock,
or saliva of a suspected rabid animal; contact of even when the patient has shown no
mucous membranes or newly skin in jury with hypersensitivity to previous administration of
rabies live attenuated vaccine e.g. vaccination immunoglobulins.
baits.
● generalized reactions such as chills, fever,
Human rabies immunoglobulin must always be headache, malaise, nausea, vomiting,
used in combination with a rabies vaccine. arthralgia and moderate back pain.
cardio-vascular reactions particularly if the
product is inadvertently injected
intravascularly (e.g. tachycardia, bradycardia,
sweating, hypotension, vertigo)
Classification: Anti Rabies
Generic Name:
Equine Rabies Immunoglobin
Brand Name: Equirab
Mechanism of Action:
Passive immunization against rabies.
Dose/Frequency/Route: Contraindications: Nursing Responsibilities:
IM/SC 40 IU/kg. As much as possible infiltrate the Anti-Rabies Serum (Equine) should be used with Inform the doctor or pharmacist if the patient
dose around the wounds & the remainder should extreme caution in subjects with a history of experiences any undesirable effects.
be administered in a single dose. allergic or hypersensitivity.
It is recommended to perform a skin test before
administering Anti-Rabies Serum (Equine). The
Indication for Patient: Side Effects:
skin test consists of an intradermal injection 1:10
Prevention of rabies in patients at risk of being Immediate or delayed hypersensitive type dilution of Anti-Rabies Serum (Equine) (0.1 mL) on
exposed to rabies after contact with a reactions may be developed on administration of the outside of the forearm so as to obtain an
rabid/presumed to be rabid animal. Use in Anti-Rabies Serum (Equine). The observed orange peel type appearance (3 mm diameter
conjunction with rabies vaccine. immediate reactions are anaphylactoid reactions induration).
with hypotension, dyspnea, urticaria.
The safety of Anti-Rabies Serum (Equine) when
used during pregnancy has not been established
Adverse Effects: in clinical trials in human beings. Considering the
lethal risk associated with rabies, pregnancy is
Delayed reactions consist of anti-inflammatory
not a contra-indication to the administration of
reaction, fever, pruritus, rash or urticaria,
Anti-Rabies Serum (Equine) subsequent to
adenopathy and arthralgia.
exposure.
Classification: Antisera, Immunologicals Dose/Frequency/Route: Contraindications: Nursing Responsibilities:

Generic Name: After the initial immunization series is completed, Hypersensitivity to any component of the vaccine, As part of the child's or adult's immunization
Anti-Tetanus Toxoids a booster dose of 0.5 mL of Tetanus Toxoid including thimerosal, a mercury derivative, is a record, the date, lot number and manufacturer of
(tetanus (tetanus toxoid) toxoid) should be given contraindication for further use of this vaccine. the vaccine administered MUST be recorded.
Brand Name: Imatet, Adacel, Boostrix, intramuscularly
adequate immunity.
every 10 years to maintain
It is a contraindication to use this or any other Patients should be fully informed of the benefits
Easyfive TT
related vaccine after a serious adverse event and risks of immunization with Tetanus (tetanus
Indication for Patient: temporally associated with a previous dose toxoid) Toxoid vaccine.
Mechanism of Action: including an anaphylactic reaction.
Tetanus (tetanus toxoid) Toxoid is indicated for The health-care provider should inform the
This vaccine is NOT indicated for primary parent, guardian, or adult patient of the
booster injection only for persons 7 years of age Side Effects:
immunization. If passive immunization is importance of completing the immunization
or older against tetanus (tetanus toxoid).
required, Tetanus (tetanus toxoid) Immune
Adverse reactions may be local and include series, unless a contraindication to further
Globulin (TIG) (Human) should be used
This vaccine is NOT to be used for the treatment of redness, warmth, edema, induration with or immunization exists.
tetanus (tetanus toxoid) infection. without tenderness as well as urticaria, and rash.
Malaise, transient fever, pain, hypotension,
nausea and arthralgia may develop in some
patients after the injection. Arthus-type
hypersensitivity reactions, characterized by
severe local reactions (generally starting 2 to 8
hours after an injection) may occur, particularly
in persons who have received multiple prior
boosters.

Adverse Effects:
Reportable events include those listed in the Act
for each vaccine and events such as anaphylaxis
or anaphylactic shock within 7 days, brachial
neuritis within 28 days; any acute complication or
sequela (including death) of an illness, disability,
injury, or condition referred to above, or any
events that would contraindicate further doses of
vaccine.