Consumer medicine information

Tripacel

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine

BRAND INFORMATION

Brand name

Tripacel

Active ingredient

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tripacel.

What is in this leaflet

This leaflet answers some common questions about Tripacel.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of your child having Tripacel against the benefits they expect it will have.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What Tripacel is used for

Tripacel is a combination vaccine used to help prevent three diseases, diphtheria, tetanus and whooping cough (pertussis), in infants and children. These three diseases can each cause severe or life threatening illness in young children.

This vaccine is for use in children up to 7 years of age, and is used in infants from the age of 2 months who are at greatest risk from these diseases.

How Tripacel works

Tripacel works by causing the body to produce its own protection against the bacteria (germs) which cause diphtheria, tetanus and whooping cough. The body makes substances (antibodies) which circulate in the blood and fight diphtheria, tetanus and pertussis germs.

It usually takes several weeks after the full course of vaccination to develop acceptable levels of protection against diphtheria, tetanus and pertussis.

Full protection requires a primary course providing 3 injections at recommended intervals. A fourth and fifth dose (follow-up, or booster doses) are also required.

Most children who receive all five doses will produce enough antibodies to protect against the diseases diphtheria, tetanus and pertussis. However, as with many vaccines, 100% protection cannot be guaranteed.

Tripacel cannot give your child the illnesses diphtheria, tetanus or whooping cough (pertussis).

Before you are given Tripacel

When your child must not be given Tripacel

Do not give Tripacel to a child who has an allergy to:

  • Tripacel or any of the ingredients listed at the end of this leaflet,
  • any other diphtheria, tetanus and/or pertussis vaccine.

Do not give Tripacel to a child who has, or has had, any of the following medical conditions:

  • an immediate severe allergic reaction to a previous dose of Tripacel or any other vaccine containing diphtheria, tetanus and/or pertussis vaccine.
  • an otherwise unidentifiable brain disorder within 7 days of a previous dose of Tripacel or any other diphtheria, tetanus and/or pertussis vaccine. Symptoms of severe, acute brain disorder include: prolonged seizure, fit or convulsion, prolonged unconsciousness, or an abnormality of the nervous system.
  • a progressive nervous system disorder such as infant spasm, uncontrolled epilepsy. The vaccination may be considered only after a treatment has been established and the condition is stabilised.
  • an illness with febrile or acute infection. The vaccination shall be postponed until after the child has recovered.

Do not use Tripacel after the expiry date printed on the pack.

Do not use Tripacel if the packaging is torn or shows signs of tampering.

If you are not sure whether your child should have Tripacel, talk to your doctor or pharmacist.

Before your child is given Tripacel

Tell your doctor if your child has reacted to Tripacel or any other vaccine with any of the following:

  • severe allergic reaction.
  • fits or convulsions within three days.
  • within 2 days, shock-like state or unresponsiveness for a long period of time. Symptoms include shallow breathing, breathing which stops temporarily, skin pale when compared to normal healthy skin colour.
  • within 2 days, high temperature (greater than 40.5°C), without any other identifiable cause.
  • within 2 days, crying or screaming lasting for more than 3 hours.

Tell your doctor if your child has or has had any medical conditions, especially the following:

  • lowered immunity due to diseases (such as HIV/AIDS or cancer) or medicines used to treat cancer including radiation therapy.
  • bleeding disorder.
  • a higher risk of convulsion than the general population. A fever-reducing medication may be given to your child.
  • fainted with a previous injection. Fainting can occur following vaccination. Appropriate measures should be taken to prevent falling injury.

Tell your doctor if your child has allergies to:

  • any other medicines.
  • any other substances, such as foods, preservatives or dyes.

Taking other medicines

Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without prescription.

Having other vaccines

Tell your doctor if your child has had any vaccines in the previous 4 weeks. Your doctor will advise you if Tripacel is to be given at the same visit as another vaccine.

How Tripacel is given

Tripacel is given by a doctor or nurse as an injection into muscle. For infants under the age of 12 months, it is given as an injection into the upper thigh. In older children who have started walking, the vaccine is usually injected into the upper arm.

How much is given and when it is given

The primary immunisation schedule is one 0.5mL dose given at 2, 4 and 6 months of age. A booster dose (0.5 mL) is usually given at 18 months of age. Another booster dose should be given when children are between 4 and 6 years of age (about the time of school entry).

If your child misses a dose

If your child misses a dose, talk to your doctor and arrange another visit as soon as possible.

After having Tripacel

Things you must do

Keep an updated record of your child’s vaccinations.

Keep follow-up appointments with your doctor or clinic. It is important your child has all follow-up doses of Tripacel at the appropriate times to make sure the vaccine has the best chance of providing protection against diphtheria, tetanus and whooping cough (pertussis).

Side effects

Tell your doctor or pharmacist as soon as possible if your child does not feel well after having Tripacel.

Tripacel may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. Your child may need medical treatment if he/she gets some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Allergic reaction

As with all vaccines given by injection, there is a very small risk of a severe allergic reaction.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • sudden onset of signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, difficulty breathing or collapse.

These are very serious side effects. If your child has them, your child may have had a severe allergic reaction to Tripacel. Your child needs urgent medical attention or hospitalisation. Mostly this type of side effect occurs within the first few hours of vaccination.

The following are the more common side effects of Tripacel. Mostly they are mild and short-lived.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • local reaction around the injection site such as redness, tenderness, swelling, rash, whole thigh or upper arm swelling
  • drowsiness
  • decreased activity
  • irritability, fussiness
  • eating and drinking less than usual
  • crying more than usual
  • screaming
  • nausea, vomiting
  • diarrhoea
  • fever greater than 37°C
  • itching, rash.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swollen glands in the neck, armpit or groin
  • abscess or infection at the injection site
  • shock-like state or prolonged unresponsiveness.
  • convulsions with or without high temperature
  • pale skin or bluish appearance to finger nails or lips
  • unusual muscle slackness
  • fainting

All of these side effects are very rare.

Other side effects not listed above may occur in some children.

Tell your doctor or pharmacist if you notice anything that is making your child feel unwell.

Do not be alarmed by this list of possible side effects. Your child may not experience any of them.

Storing Tripacel

Tripacel is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store Tripacel:

  • keep Tripacel where children cannot reach it.
  • keep Tripacel in the original pack until it is time for it to be given.
  • keep Tripacel in the refrigerator, at 2° to 8°C. DO NOT FREEZE Tripacel.
    Freezing destroys the vaccine.

Product description

Tripacel is contained in a single-dose 0.5 mL glass container (vial).

What Tripacel looks like

Tripacel is a white to off-white cloudy suspension for injection.

Ingredients

Active ingredients:

  • 10 micrograms pertussis toxoid
  • 5 micrograms pertussis filamentous haemagglutinin
  • 5 micrograms pertussis fimbriae 2 + 3
  • 3 micrograms pertussis
  • ≥30IU (15 Lf) diphtheria toxoid
  • ≥40IU (5 Lf) tetanus toxoid

Other ingredients:

  • aluminium phosphate
  • phenoxyethanol
  • water for injections
  • residual formaldehyde
  • residual glutaral

The manufacture of this product includes exposure to bovine derive materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

Distributor

Australia:

sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Tel: 1800 818 806

New Zealand:

sanofi-aventis new zealand limited
Level 8
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 283 684

AUST R Number

AUST R 63120

Date of Preparation

23 March 2020

tripacel-ccdsv5-cmiv3-23mar20

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Tripacel

Active ingredient

Diphtheria toxoid; Tetanus toxoid; Pertussis vaccine

Schedule

S4

 

1 Name of Medicine

Pertussis vaccine-acellular, combined with diphtheria and tetanus toxoids (adsorbed).

6.7 Physicochemical Properties

Chemical structure.

Not relevant to vaccines.

CAS number.

Not relevant to vaccines.

2 Qualitative and Quantitative Composition

Tripacel is a sterile, isotonic suspension of purified acellular pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminium phosphate.
Each 0.5 mL dose is formulated to contain:
Diphtheria toxoid (Corynebacterium diphtheriae) ≥ 30 IU (15 Lf);
Tetanus toxoid (Clostridium tetani) ≥ 40 IU (5 Lf);
Pertussis toxoid (PT) 10 micrograms;
Pertussis Filamentous Haemagglutinin (FHA) 5 micrograms;
Pertussis Fimbriae 2 + 3 (FIM) 5 micrograms;
Pertactin (PRN) 3 micrograms;
Adsorbed on aluminium phosphate 1.5 milligrams (0.33 milligrams aluminium).
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
After shaking, Tripacel is a white to off-white cloudy suspension for intramuscular administration.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Pertussis, purified antigens, combinations with toxoids.
ATC code: J07AJ52.

Mechanism of action.

The acellular pertussis component of the vaccine contains five pertussis antigens which are thought to be related to protection against pertussis. The diphtheria and tetanus toxoids, as well as the acellular pertussis components, are adsorbed on to aluminium phosphate as an adjuvant.
The diphtheria and tetanus toxoids, which are obtained from cultures of C. diphtheriae and C. tetani, are detoxified and purified. The acellular pertussis components PT, FHA, PRN and FIM are manufactured by culturing B. pertussis, from which the components are extracted and purified. The PT and FHA components are detoxified.

Clinical trials.

This product has been shown to be less reactogenic than whole-cell pertussis vaccines. Protective antibody levels against diphtheria and tetanus can be demonstrated one month following the third dose of a three dose primary series given at 2, 4, and 6 months of age. In a randomized controlled efficacy study conducted in Sweden where 2,551 infants received Tripacel and 2,539 received a control vaccine containing diphtheria and tetanus toxoids at 2, 4, and 6 months of age, Tripacel was shown to have an absolute vaccine efficacy of 85% (95% CI 81-89) against pertussis disease (defined as at least 21 days of paroxysmal cough with culture, serologic, or epidemiologic confirmation of infection with Bordetella pertussis). The incidence of local and systemic reactions after administration of Tripacel was comparable to the Diphtheria Tetanus Vaccine (DT) control group.
Tripacel has been administered to 92 children (see Table 4) in 3 different clinical trials as an 18-month booster following primary immunisation with a whole-cell pertussis-containing vaccine. Control groups in two of these trials received 4 doses of whole-cell DTP.
Tripacel has also been administered to 324 children as an 18 month booster, following primary immunisation with Tripacel. Strong booster responses for all antigens were achieved.
Tripacel has been given as a booster at 4-6 years of age as follows:
To 21 children following four doses (primary plus 18 month booster) of whole-cell pertussis-containing vaccine. Over 77% of children had a four-fold or greater rise in antibody titre for all pertussis components;
To 11 children following a three dose primary immunisation with whole-cell pertussis-containing vaccine and an 18-month booster of Tripacel. Post fifth dose antibodies were substantially higher than pre-fifth dose levels;
To 13 children following four doses (primary plus 18 month booster) of Tripacel. Antibody levels increased significantly after the fifth dose of Tripacel when compared with pre-fifth dose levels.

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

Tripacel has not been tested for genotoxic potential.

Carcinogenicity.

Tripacel has not been tested for carcinogenetic potential.

4 Clinical Particulars

4.1 Therapeutic Indications

Tripacel is indicated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age.
Tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell or acellular) vaccines.

4.3 Contraindications

Hypersensitivity.

Known systemic hypersensitivity reaction or life-threatening reaction to any component of Tripacel after previous administration of the vaccine or a vaccine containing the same components.

Febrile or acute disease.

Vaccination should be postponed in case of an acute or febrile disease; however a disease with low-grade fever should not usually be a reason to postpone vaccination.

Acute neurological disorders.

The following events are contraindications to administration of any pertussis-containing vaccine, including Tripacel:
Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regime has been established and the condition has stabilised.

4.4 Special Warnings and Precautions for Use

General.

Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Before the injection of any biological, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine.
As a precautionary measure adrenaline (epinephrine) injection must be immediately available in case of unexpected anaphylactic or serious allergic reactions.
Syncope (fainting) has been reported following vaccination with Tripacel. Vaccinees should be observed for 15 minutes after vaccine administration, and procedures should be in place to prevent and manage syncopal reactions.

Hypersensitivity.

Anaphylaxis has been reported after receiving preparations containing diphtheria toxoids, tetanus toxoids, and/or pertussis antigens.

Serious and severe adverse event-related precautions.

A few cases of peripheral neuropathy have been reported following tetanus toxoid administration, although a causal relationship has not been established.
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to administer Tripacel should be based on careful consideration of potential benefits and possible risks. When a decision is made to withhold any recommended dose of pertussis vaccine, immunisation with DT (for paediatric use) vaccine should be continued.
Temperature of ≥ 40.5°C within 48 hours not attributable to another identifiable cause;
Collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours;
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours;
Convulsions, with or without fever, occurring within 3 days.

Bleeding disorders.

Because any intramuscular injection can cause an injection site haematoma in persons with any bleeding disorders, such as haemophilia or thrombocytopenia, or in persons on anticoagulant therapy, intramuscular injections with Tripacel should not be administered to such persons unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such persons, it should be given with caution, with steps taken to avoid the risk of haematoma formation following injection.

Altered immune status.

Immunocompromised persons (whether due to a medical condition or immunosuppressive therapy) may not obtain the expected immune response. If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment. Nevertheless, vaccination of persons with chronic immunodeficiency such as human immunodeficiency virus infection is recommended even if the antibody response might be limited.

Neurological disorders.

A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give Tripacel or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
For infants or children at higher risk for seizures than the general population, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (such as Tripacel) and for 24 hours following immunisation, to reduce the possibility of post-vaccination fever. Caregivers should be aware that antipyretic therapy could also obscure fever caused by concomitant, unrelated infection.

Protection.

As with many vaccines, immunisation with Tripacel may not protect 100% of vaccinated individuals.

Use in the elderly.

Tripacel should not be used in adults.

Paediatric use.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Effects on laboratory tests.

Interference of Tripacel with laboratory and/or diagnostic tests has not been studied.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Administration of the vaccine during treatment with immunosuppressive drugs may cause a decreased response to the vaccine. While interactions with other vaccine antigens were not measured, the safety and efficacy of Tripacel was demonstrated in 2,551 infants in Sweden in a randomised controlled trial where they also received simultaneous administration with Haemophilus b conjugate vaccine (tetanus protein-conjugate) and inactivated poliomyelitis vaccine at separate sites. In clinical trials conducted in Canada, Tripacel was administered simultaneously with Haemophilus influenzae type b (Hib) conjugate vaccine given at a separate site and oral poliomyelitis vaccine (OPV). Although the interactions with the OPV and Hib vaccines were not studied, the safety and immunogenicity of the Tripacel was shown to be satisfactory.
In cases where Tripacel and Menactra are to be administered at 4 to 6 years of age, preference should be given to simultaneous administration of the two vaccines, or administration of Menactra prior to Tripacel.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Tripacel has not been evaluated for the effects on fertility.
This vaccine is not intended for administration to women of child-bearing age.
This vaccine is not intended for administration to women of child-bearing age.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data section.

In a clinical study conducted in Canada, 324 children received Tripacel and 108 children received whole cell DTP* adsorbed at 2, 4, 6 and 18 months of age. The following rates of reactions were observed in this trial (see Table 1):
Most reactions were described as mild and resolved spontaneously within 24-72 hours. Seizures and hypotonic/hyporesponsive episodes were not observed in this study.
In a clinical trial in Sweden comparing two acellular pertussis vaccines, DT, and a whole-cell DTP vaccine, 2,587 infants received Tripacel at 2, 4 and 6 months of age. Rates of reactions following Tripacel administration were similar to those following DT and significantly lower than following whole-cell DTP. There were two reports of fever > 40°C and one report of a hypotonic-hyporesponsive episode following Tripacel administration. There were seven reports of convulsions, but none were within 7 days of vaccination.
In another clinical trial conducted in Sweden comparing three acellular pertussis vaccines and one whole-cell DTP vaccine, 20,745 infants received an acellular pertussis DTP vaccine similar to Tripacel but containing twice the amount of PT and four times the amount of FHA per dose at 2, 4 and 6 or 3, 5 and 12 months of age. Rates of adverse events were less than or comparable to the rates in the other acellular pertussis vaccine and whole-cell DTP groups in this study. The rates of reports of fever > 40.5°C and seizures or suspected seizures were significantly higher following whole-cell DTP than following acellular pertussis vaccines. Rates of hypotonic/hyporesponsive episodes were comparable, with 29 reports following administration of Tripacel-related vaccine. No deaths or cases of encephalitis/acute encephalopathy, invasive bacterial infection, infantile spasms or anaphylactic reactions were reported within 48 hours of vaccination.
In clinical studies conducted in Canada, children who had received 3 or 4 doses of a whole-cell DTP vaccine received Tripacel. Tables 2 and 3 show adverse reactions reported in the above 3 studies.
Now that there has been significant experience with acellular pertussis-containing vaccines at the fourth and fifth doses, the occurrence of large local reactions, consisting of redness and/or swelling > 50 mm, some circumferential swelling of the injected limb, has been identified. These local reactions are usually not associated with significant pain and resolve spontaneously.
In a study conducted by the U.S. National Institutes of Health (NIH) to evaluate safety and immunogenicity of six formulations of acellular pertussis vaccines combined with diphtheria and tetanus toxoids (DTaP), it was found that large injection site reactions occurred more frequently after the fifth dose of DTaP than after the previous fourth dose. This formulation of Tripacel vaccine was not used in the NIH study.
In a review by NIH of 1015 children who received 4 consecutive doses of the same DTaP, circumferential thigh swelling was reported in 20 children (2%). No reports were received for circumferential swelling of the upper arm in 121 children who received a fifth dose of the same DTaP. In 146 recipients who received 5 doses of a mixed schedule of DTaP vaccines, 4 (2.7%) children were reported to have such swelling. There was a significant linear association between the rates of entire thigh swelling after dose 4 and diphtheria toxoid content in the DTaP products. In all reports the swelling subsided spontaneously and completely, without sequelae.
Other adverse reactions have been reported with diphtheria, tetanus and/or pertussis vaccines (see Section 4.4 Special Warnings and Precautions for Use).

Post-marketing experience.

The following adverse events have been spontaneously reported during the post-marketing use of Tripacel. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The following adverse events were included based on severity, frequency of reporting or the strength of causal association to Tripacel.

Blood and lymphatic disorders.

Lymphadenopathy.

Cardiac disorders.

Cyanosis.

Gastro-intestinal disorders.

Nausea, diarrhoea.

General disorders and administration site conditions.

Injection site reactions: injection site pain, injection site rash, injection site nodule, injection site mass.
Large injection site reactions (> 50 mm), including extensive limb swelling that may extend from the injection site beyond one or both joints have been reported in children following Tripacel administration. These reactions usually start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site, and resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.

Immune system disorders.

Hypersensitivity, allergic reaction, anaphylactic reaction (oedema, face oedema).
Pruritus, generalised rash and other types of rash (erythematous, macular, maculo-papular).

Infections and infestations.

Injection site cellulitis, cellulitis, injection site abscess.

Nervous system disorders.

Convulsions: febrile convulsion, grand mal convulsion, partial seizures.
Hypotonic-hyporesponsive episode, hypotonia, somnolence, syncope.

Psychiatric disorders.

Screaming.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.2 Dose and Method of Administration

For primary immunisation of infants, the following routine Tripacel immunisation schedule is recommended: one 0.5 mL dose administered at 2, 4 and 6 months of age.
A booster dose of 0.5 mL should be administered at 18 months of age. Tripacel may be used irrespective of whether a whole-cell DTP or Tripacel was used for the primary immunisation.
A booster dose of 0.5 mL should be administered between four and six years of age (i.e. at the time of school entry). Tripacel may be used irrespective of whether a whole-cell DTP or Tripacel was used for the primary immunisation and 18-month booster dose.
Infants born prematurely whose clinical condition is satisfactory should be vaccinated according to their chronological age from birth.
Parenteral biological products should be inspected visually for extraneous particulate matter and/or discolouration prior to administration. If these conditions exist, the product should not be administered.
Shake the vial well to distribute uniformly the suspension before withdrawing dose. When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Once the vial has been opened, any of its contents not used immediately should be discarded. Aseptic technique must be used for withdrawal of the dose.
Administer the vaccine intramuscularly. The preferred site is into the anterolateral aspect of the mid thigh in infants younger than 1 year or into the deltoid muscle in children over 1 year of age.
Do not administer the product intravascularly or subcutaneously.
Fractional doses (doses < 0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined.
The product must not be mixed with other vaccines in the same syringe.
Product is for single use only and must not be used in more than one individual. Discard any remaining unused contents.

4.7 Effects on Ability to Drive and Use Machines

Not applicable - for paediatric use only.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Tripacel contains the excipients: aluminium phosphate, phenoxyethanol, water for injections, other ingredients per dose include ≤ 5 micrograms residual formaldehyde and < 50 nanogram residual glutaral.

6.2 Incompatibilities

This vaccine must not be mixed with other medicinal products except those mentioned above.

6.3 Shelf Life

36 months at 2°C to 8°C.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate. Do not freeze. Vaccine that has been frozen must not be used. Do not use after expiry date.

6.5 Nature and Contents of Container

Tripacel is available as single dose vials containing 0.5 mL of vaccine. The vial stopper for this product does not contain latex (natural rubber).

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely according to locally agreed procedures.

Summary Table of Changes