1. Name Of The Medicinal Product
Typherix, solution for injection in a pre-filled syringe
Typhoid Polysaccharide vaccine.
2. Qualitative And Quantitative Composition
Each 0.5 ml dose of vaccine contains:
Vi polysaccharide of Salmonella typhi (Ty2 strain) 25 micrograms
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection in a pre-filled syringe.
Clear isotonic colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Typherix is indicated for active immunisation against typhoid fever for both adults and children two years of age and older.
4.2 Posology And Method Of Administration
Posology
A single dose of 0.5 ml is recommended for both adults and children two years of age and older.
The vaccine should be administered at least two weeks prior to risk of exposure to typhoid fever.
Subjects who remain at risk of typhoid fever should be revaccinated using a single dose of vaccine with an interval of not more than 3 years.
Method of administration
Typherix is for intramuscular injection.
Typherix should under no circumstances be administered intravascularly.
4.3 Contraindications
Typherix 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 Typherix should be postponed in subjects suffering from acute febrile illness. The presence of a minor infection, however, is not a contraindication for vaccination.
4.4 Special Warnings And Precautions For Use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following administration of the vaccine.
The vaccine protects against typhoid fever caused by Salmonella typhi. Protection is not conferred against disease caused by Salmonella paratyphi and other non-typhoidal Salmonellae.
Typherix has not been evaluated in children under 2 years of age. Polysaccharide vaccines in general have lower immunogenicity under this age.
Different injectable vaccines should always be administered at different injection sites.
Typherix should be administered with caution to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects: following injection, firm pressure should be applied to the site (without rubbing) for at least two minutes.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In clinical studies in adults aged over 18 years, Typherix has been administered concomitantly in opposite arms with Havrix Monodose (1440), GlaxoSmithKline's inactivated hepatitis A vaccine.
There was no adverse impact on either the reactogenicity or immunogenicity of the vaccines when they were administered simultaneously in opposite arms.
No interaction studies with other vaccines have been performed.
4.6 Pregnancy And Lactation
Pregnancy
The effect of Typherix on fetal development has not been assessed.
Typherix should only be used during pregnancy when there is a high risk of infection.
Lactation
The effect on breastfed infants of the administration of Typherix to their mothers has not been evaluated.
Typherix should therefore only be used in breastfeeding women when there is a high risk of infection.
4.7 Effects On Ability To Drive And Use Machines
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
4.8 Undesirable Effects
During clinical studies, the most commonly reported adverse events after the first dose were reactions at the injection site, including soreness, redness and swelling.
Frequencies are reported as:
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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
General reactions that may occur in temporal association with Typherix vaccination include:
Clinical studies
Nervous system disorders:
Common: headache
Gastrointestinal disorders:
Common: nausea
Skin and subcutaneous tissue disorders:
Common: itching
General disorders and administration site conditions:
Common: fever, general aches, malaise
Following a second dose, there was an increased incidence of redness and soreness (>10%).
Local reactions were usually reported during the first 48 hours and systemic reactions were also transient.
Post-marketing
The following reactions have been reported in post-marketing experience:
Skin and subcutaneous tissue disorders:
Very rare: urticaria
Immune system disorders:
Very rare: anaphylaxis, allergic reactions, including anaphylactoid reactions
4.9 Overdose
Occasional reports of overdose have been received. The symptoms reported in these cases are not different from those reported following normal dosage.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Bacterial vaccine, ATC code: J07AP03
In comparative clinical studies, the immune response to Typherix was shown to be equivalent to a licensed comparator Vi polysaccharide vaccine. Seroconversion was observed in >95% of Typherix recipients when measured at two weeks after administration. Two years after vaccination 61% were seropositive, and at three years 46%.
The protective efficacy of Typherix has not been investigated in clinical trials.
For individuals who remain at - or who may be reexposed to - risk of typhoid fever, it is recommended that they be revaccinated using a single dose of vaccine with an interval of not more than 3 years.
5.2 Pharmacokinetic Properties
Evaluation of pharmacokinetic properties is not required for vaccines and formal pharmacokinetic studies have not been performed.
5.3 Preclinical Safety Data
No preclinical safety testing with the vaccine has been conducted.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Sodium chloride
Phenol
Water for injection
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store in a refrigerator (2°C
Do not freeze.
Store in the original package, in order to protect from light.
6.5 Nature And Contents Of Container
0.5 ml of solution in a pre-filled syringe (Type I glass) with a plunger stopper (elastomer rubber butyl) in pack sizes of 1, 10, 50 or 100.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Vaccines should be inspected for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the vaccine.
Shake before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9BD
Trading as:
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex, UB11 1BT
8. Marketing Authorisation Number(S)
PL 10592/0126
9. Date Of First Authorisation/Renewal Of The Authorisation
05/07/2008
10. Date Of Revision Of The Text
3/11/09
POM
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