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Prescribing information: DUKORAL® (oral inactivated cholera vaccine). (Please consult the full Summary of Product Characteristics before prescribing.) Active ingredients: Oral inactivated cholera vaccine – suspension and effervescent granules for oral suspension. Each dose of vaccine suspension (3ml) contains a total of 1x 1011


vaccines The Crucell UK travel vaccine portfolio includes:


O1 Inaba, classical biotype (heat inactivated) 25 x 109 biotype (formalin inactivated) 25 x 109 inactivated) 25 x 109 x 109


bacteria of the following strains:Vibrio cholerae bacteria,Vibrio cholerae O1 Inaba, El Tor


bacteria,Vibrio cholerae O1 Ogawa, classical biotype (heat bacteria,Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 25 bacteria. Recombinant cholera toxin B subunit (rCTB) 1mg. Therapeutic indications: Active


immunisation against disease caused byVibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.Dosage and administration: Standard primary course for adults and children aged over 6 years: 2 doses; Children 2 to 6 years of age should receive 3 doses. Doses are to be administered at intervals of at least 1 week but less than 6 weeks apart. If more than 6 weeks have elapsed between doses, the primary immunisation course should be re-started. Immunisation should be completed at least 1 week prior to potential exposure toVibrio cholerae O1.Contraindications: Hypersensitivity to the active substances or to any of the excipients or formaldehyde. Administration of Dukoral® should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.Warnings and precautions: Dukoral® is not recommended for use in children less than 2 years of age. Formaldehyde is used during the manufacturing process and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde. Dukoral® contains approximately 1.1 g sodium per dose, which should be taken into consideration by patients on a controlled sodium diet. The vaccine does not provide complete protection and it is important to adhere to standard protective measures to avoid cholera. Interactions: The vaccine is acid labile. Food and/or drink will increase acid production in the stomach and the effect of the vaccine may be impaired. Consequently, food and drink should be avoided 1 hour before and 1 hour after vaccination. Oral administration of other vaccines and medicinal products should be avoided 1 hour before and 1 hour after vaccination. Pregnancy and lactation:No animal data on reproduction toxicity are available. Following careful benefit/risk assessment the vaccine may be administered during pregnancy and to lactating women although no specific clinical studies have been performed to address this issue.Undesirable effects:Uncommon (>1/1,000, <1/100): diarrhoea, abdominal pain, abdominal cramps, stomach/ abdominal gurgling (gas), abdominal discomfort, headache. Rare (>1/10,000, <1/1,000): fever, malaise, nausea, vomiting, loss of /or poor appetite, respiratory symptoms (including rhinitis and cough), dizziness. Very rare (<1/10,000): fatigue/drowsiness, dyspepsia, shivers, joint pain, sore throat, reduced sense of taste, sweating, insomnia, dehydration, fainting, rash. Prescribers should consult the Summary of Product Characteristics in relation to other side effects. Special precautions for storage: Store in refrigerator (2°C – 8°C). Do not freeze.Package quantities and basic NHS cost: 2 x 1 dose, basic NHS cost £23.42. Legal category: POM.Marketing authorisation number: EU/1/03/263/001-003.Marketing authorisation holder: Crucell Sweden AB, S-105 21 Stockholm, Sweden.Date of last revision of Prescribing information:March 2009.


Prescribing information: Vivotif®


(Please consult the full Summary of Product Characteristics before prescribing.) Active ingredients: A single dose of Vivotif®


(Live vaccine for active oral immunisation against typhoid fever). contains at least 2 x 109


Salmonella typhi Ty21a in a


lyophilised form. Quantities expressed per capsule. Pharmaceutical form: Enteric-coated capsule. Therapeutic indications: For active oral immunisation against typhoid fever in children aged 6 years and over, adults and elderly.Dosage and administration: One dose of Vivotif®


is to be taken


on days 1, 3 and 5, with lukewarm water at least 1 hour before meals. The protection becomes effective 7–10 days after ingestion of the third dose of vaccine. Under conditions of repeated or continuous exposure to S. typhi protection persists for at least 3 years. In the case of travel from a non-endemic area to an area where typhoid fever is endemic, an annual booster consisting of 3 doses is recommended.Contraindications: Vivotif®


must not be administered: to persons known


Set in your document at a minimum of 100% to be compliant with ABPI guidelines.


to be hypersensitive to any component of the vaccine or the enteric-coated capsule, to persons with congenital or acquired immune deficiency (including patients receiving immunosuppressive or antimitotic drugs), during an acute febrile illness or during an acute gastrointestinal illness. Vaccination should be postponed until after recovery. Warnings and precautions: None known. Interactions with other medicinal products and other forms of interaction: An interval of 3 days should be allowed between the treatment with any antibacterial agents and Vivotif®


vaccination.


If malaria prophylaxis is also required, the fixed combination of atovaquone and proguanil can be given concomitantly with Vivotif®


. Doses of mefloquine and Vivotif® . It is not known whether Vivotif® least 12 hours. For other antimalarials, there should be an interval of at least 3 days. Vivotif® women or can affect reproduction capacity. Vivotif®


should be separated by at may


be administered concomitantly with the live attenuated vaccines: yellow fever vaccine and oral polio vaccine. Pregnancy and lactation: Animal reproduction studies have not been conducted with Vivotif®


clearly needed. There are no data regarding administration of Vivotif® known if Vivotif®


can cause foetal harm when administered to pregnant should be given to a pregnant woman only if to nursing mothers. It is not


is excreted in human milk.Undesirable effects: The following adverse reactions


were reported commonly (<1/10 but >1/100) in clinical studies: Gastrointestinal disorders: Abdominal pain, nausea, diarrhoea, vomiting. General disorders and administration site conditions: Fever, influenza-like illness. Nervous system disorders: Headache. Skin and subcutaneous tissue disorders: Rash. The following additional adverse reactions have been reported very rarely (approximately <1/10,000) during post-marketing surveillance: Skin reactions such as dermatitis, exanthema, pruritus, urticaria. Anaphylaxis. Asthenia, malaise, tiredness, shivering. Paraesthesiae, dizziness. Arthralgia, myalgia. Overdose: Doses five-fold higher than the recommended dose do not produce vomiting, abdominal distress or fever. However overdosing can increase the possibility of shedding the S. typhi Ty21a organisms in the faeces. Special precautions for storage: Store at 2°C – 8°C. Protect from light. Package quantities and basic NHS cost: 3 x 1 dose, basic NHS cost £14.77. Legal category: POM. Marketing authorisation number: PL 15747/0001.Marketing authorisation holder:Crucell Italy S.r.l, Via Zambeletti 25, I – 20021 Baranzate (MI), ltaly.Date of last revision of Prescribing information: June 2010.


Prescribing information: Epaxal® Hepatitis A vaccine (inactivated, virosome). (Please consult the full Summary of Product Characteristics before prescribing.)Active ingredients: 1 vaccine dose (0.5 ml) contains at least 24 IU of inactivated hepatitis A virus (strain RG-SB). Pharmaceutical form: Suspension for injection in a pre-filled syringe (0.5 ml). Therapeutic indications: Active immunisation against hepatitis A for adults and children from 1 year of age.Method of administration: For basic immunisation: 1 dose is injected intramuscularly. In patients with coagulation disorders, the vaccine may be administered subcutaneously in the upper arm. A second (booster) dose is preferably given between 6–12 months after the first dose but may be given up to 10 years later based on limited experience on healthy volunteers. Epaxal® can be used interchangeably with other hepatitis A vaccines for the first and second (booster) dose. Shake before use.Contraindications: Hypersensitivity to any constituent of the vaccine. Hypersensitivity to eggs, chicken protein or formaldehyde. Postpone vaccination in cases of acute infectious disease with fever.Warnings and precautions: Immunodeficiency disorders may impair the immune response. As with all injectable vaccines, suitable treatment and medical supervision must always be promptly available in case there is a rare anaphylactic reaction following administration of the vaccine. Epaxal® may contain traces of polymyxin B.Undesirable effects: Possible undesirable effects are mild in nature and of short duration. Very common (≥1/10): Injection site pain, fatigue, headache. Common (≥1/100 and <1/10 ): Loss of appetite, diarrhoea, nausea, injection site reactions, injection site induration, injection site erythema, injection site swelling, malaise, fever. Uncommon ((≥1/1000 and <1/100 ): Dizziness, rash, pruritis, vomiting, arthralgia. A transient and mild rise in liver enzymes was observed on single occasions at the time of vaccination. As observed with other vaccines, occasional inflammatory diseases of the central and peripheral nervous system may occur, including ascending paralysis up to respiratory paralysis, e.g. Guillain- Barré syndrome. In very rare cases, anaphylactic shock may occur. Prescribers should consult the Summary of Product Characteristics in relation to other undesirable effects. Pregnancy and lactation: There are no adequate data from the use of Epaxal® in pregnant women. The effect of Epaxal® on foetal development has not been assessed. As with all inactivated vaccines, no harm to the foetus is expected. The vaccine should not be given to pregnant women unless the risk of hepatitis A is increased. Whether the vaccine passes into the milk of a lactating mother is unknown. Breast feeding women should use Epaxal® with caution. Special precautions for storage: Store in refrigerator (2°C – 8°C). Store in the original package in order to protect from light. Do not freeze. Package quantities and basic NHS cost: Single dose pre-filled syringes, basic NHS cost £23.81. Legal category: POM.Marketing authorisation number: PL15747/0003.Marketing authorisation holder: Crucell Italy S.r.I., Via Zambeletti 25, I-20021 Baranzate (MI), Italy.Date of last revision of Prescribing information: 01/04/2011.


Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Crucell at pharmacovigilance@crucell.com


1.Vivotif® Summary of Product Characteristics. June 2010. 2. Monthly Index of Medical Specialities. March 2011. 3. Levine MM et al. Lancet 1987; 8451: 1049–1052. 4. Epaxal® Summary of Product Characteristics. March 2010. 5. Dukoral® Summary of Product Characteristics. March 2009.


www.crucell.co.uk


COR/112/180411/P. 04/11


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