Lefebron may be available in the countries listed below.
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Ibuprofen
Ibuprofen is reported as an ingredient of Lefebron in the following countries:
- Peru
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Wednesday, October 26, 2016
Relistor
1. Name Of The Medicinal Product
Relistor 12 mg/0.6 ml solution for injection
2. Qualitative And Quantitative Composition
Each vial of 0.6 ml contains 12 mg methylnaltrexone bromide.
One ml of solution contains 20 mg methylnaltrexone bromide.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
Clear solution, colourless to pale
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of opioid
4.2 Posology And Method Of Administration
Posology
For adults only.
Relistor should be added to induce prompt bowel movements when response to usual laxative therapy has not been sufficient.
The recommended dose of methylnaltrexone bromide is 8 mg (0.4 ml Relistor) (for patients weighing 38
The usual administration schedule is one single dose every other day. Doses may also be given with longer intervals, as per clinical need.
Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg. The injection volume for these patients should be calculated:
Dose (ml) = patient weight (kg) x 0.0075
Renal impairment
In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 ml Relistor) for those weighing 62 to 114 kg, or from 0.15 mg/kg to 0.075 mg/kg for those whose weight falls outside the 62 to 114 kg range (see section 5.2). There are no data available from patients with end-stage renal impairment on dialysis, and Relistor is not recommended in these patients (see section 4.4).
Hepatic impairment
No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).
There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and Relistor is not recommended in these patients (see section 4.4).
Paediatric population
No data are available.There is no experience in children under the age of 18 (see section 5.2). Therefore, methylnaltrexone should not be used in the paediatric age group until further data become available.
Elderly population
No dose adjustment is recommended based on age (see section 5.2).
Method of administration
Relistor is given as a subcutaneous injection.
It is recommended to rotate injection sites. It is not recommended to inject into areas where the skin is tender, bruised, red, or hard. Areas with scars or stretch marks should be avoided.
The three areas of the body recommended for injection of Relistor are upper legs, abdomen, and upper arms.
Relistor can be injected without regard to food.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen is contraindicated.
4.4 Special Warnings And Precautions For Use
Cases of gastrointestinal (GI) perforation have been reported in the postauthorisation period in patients using Relistor. Although patients had medical conditions that may be associated with localised or diffuse reduction of structural integrity in the wall of the GI tract (e.g., cancer, peptic ulcer, pseudo-obstruction), the use of Relistor may have contributed to these events.
Use Relistor with caution in patients with known or suspected lesions of the GI tract.
Advise patients to promptly report severe, persistent, and/or worsening symptoms.
The activity of methylnaltrexone bromide has been studied in patients with constipation induced by opioids. Therefore, Relistor should not be used for treatment of patients with constipation not related to opioid use.
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with Relistor and consult their physician.
Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement.
Methylnaltrexone bromide treatment has not been studied in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.2).
Relistor should only be used in patients who are receiving palliative care. It is added to usual laxative treatment.
Relistor is not recommended in patients with severe hepatic impairment or with end
Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied. Therefore, Relistor should only be administered with caution in these patients.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes. Methylnaltrexone bromide is minimally metabolised by CYP isozymes. In vitro metabolism studies suggest that methylnaltrexone bromide does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate. In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/kg of methylnaltrexone did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone bromide and an OCT inhibitor was studied in 18 healthy subjects by comparing the single-dose pharmacokinetic profiles of methylnaltrexone bromide before and after multiple 400 mg doses of cimetidine. The renal clearance of methylnaltrexone bromide was reduced following multiple-dose administration of cimetidine (from 31 l/h to 18 1/h). However, this resulted in a small reduction in total clearance (from 107 1/h to 95 l/h). Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
4.6 Pregnancy And Lactation
Pregnancy
There are no adequate data with the use of methylnaltrexone bromide in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Relistor should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is unknown whether methylnaltrexone bromide is excreted in human breast milk. Animal studies have shown excretion of methylnaltrexone bromide in breast milk. A decision on whether to continue/discontinue breast
4.7 Effects On Ability To Drive And Use Machines
No studies on the effects on the ability to drive and use machines have been performed. However, as a pure peripherally restricted opioid antagonist, the likelihood that Relistor will affect such activities is low.
Dizziness may occur, and this may have an effect on driving and use of machines (see section 4.8).
4.8 Undesirable Effects
The most common drug
The adverse reactions are classified as: Very common (
Nervous system disorders
Common: Dizziness
Gastrointestinal disorders
Very common: Abdominal pain, nausea, diarrhoea, flatulence
Skin and subcutaneous tissue disorders
Common: Injection site reactions (e.g. stinging, burning, pain, redness, oedema), hyperhidrosis
Post Marketing Experience
Cases of gastrointestinal perforation have been reported in patients using Relistor (see section 4.4): frequency unknown.
4.9 Overdose
A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.
In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician. Treatment should be initiated as appropriate.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Peripheral opioid receptor antagonists, ATC code: A06AH01.
Mode of action
Methylnaltrexone bromide is a selective antagonist of opioid binding at the muIn vitro studies have shown methylnaltrexone bromide to be a mui] = 28 nM), with 8i = 230 nM) and much reduced affinity for delta opioid receptors.
As a quaternary amine, the ability of methylnaltrexone to cross the blood
Clinical efficacy and safety
The efficacy and safety of methylnaltrexone bromide in the treatment of opioid
Study 301 compared methylnaltrexone bromide given as a single, double
Study 302 compared double
In both studies, there was no evidence to suggest differential effects of age or gender on safety or efficacy. The effect on race could not be analysed because the study population was predominantly Caucasian (88%).
Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2
The efficacy and safety of methylnaltrexone bromide were also demonstrated in open
The rate of laxation response was maintained throughout the extension studies for those patients who continued treatment.
There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide
Effect on cardiac repolarisation
In a double
5.2 Pharmacokinetic Properties
Absorption
Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration. The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a dose-proportional manner. Absolute bioavailability of a 0.30 mg/kg subcutaneous dose versus a 0.30 mg/kg intravenous dose is 82 %.
Distribution
Methylnaltrexone undergoes moderate tissue distribution. The steady
Biotransformation
Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta. Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism. Each of the methyl-6-naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8% of the drug
Elimination
Methylnaltrexone bromide is eliminated primarily as the unchanged active substance. Approximately half of the dose is excreted in the urine and somewhat less in faeces. The terminal disposition half1/2) is approximately 8 hours.
Special populations
Hepatic insufficiency
The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone bromide has been studied in 8 subjects each, with Childmax of methylnaltrexone. The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.
Renal impairment
In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone bromide. The renal clearance of methylnaltrexone decreased with increasing severity of renal impairment. Severe renal impairment decreased the renal clearance of methylnaltrexone bromide by 8max was not significantly changed. No studies were performed in patients with end
Paediatric patients
No studies have been performed in the paediatric population (see section 4.2).
Elderly population
In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone bromide at a dose of 24 mg between healthy, young (18 to 45 years of age n=10) and elderly (65 years of age and over n=10) subjects, the effect of age on exposure to methylnaltrexone bromide was found to be minor. The mean steadymax and AUC for the elderly were 545 ng/ml and 412 ng·h/ml, approximately 8.1 % and 20 %, respectively, greater than those for young subjects. Therefore, no dose adjustment is recommended based on age.
Gender
No meaningful gender differences have been observed.
Weight
An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased. The mean methylnaltrexone bromide exposure at 0.15 mg/kg over a weight range of 38 to 114 kg was 179 (range=139-240) ng·h/ml. This exposure for the 0.15 mg/kg dose can be achieved with a weight-band-based dose adjustment using an 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg, yielding a mean exposure of 187 (range =148-220) ng·h/ml. In addition, the analysis showed that 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg correspond to mean doses of 0.16 (range=0.21
5.3 Preclinical Safety Data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval). The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.
Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats. Doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) did not affect fertility or general reproductive performance.
There was no evidence of teratogenicity in rats or rabbits. Subcutaneous injections of Relistor at 150/100 mg/kg/day to rats resulted in decreased offspring weights; doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) had no effect on labour, delivery, or offspring survival and growth.
Methylnaltrexone bromide is excreted via the milk of lactating rats.
Studies have been conducted in juvenile rats and dogs. Following intravenous injection of methylnaltrexone bromide, juvenile rats were found to be more sensitive that adults rats to methylnaltrexone-related toxicity. In juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs (incidences of convulsions and labored breathing) occurred at dosages (
Following intravenous injection of methylnaltrexone bromide for 13 weeks, similar methynaltrexone related toxicity was observed in both juvenile and adult dogs. In adult and juvenile dogs given methylnaltrexone bromide at 20 mg/kg/day, clinical signs indicative of CNS toxicity and prolongation of QTc interval were observed. No adverse effects occurred in either juvenile or adult dogs at a dose of 5 mg/kg/day (44 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).
Carcinogenicity studies have not been conducted with Relistor.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Sodium calcium edentate
Glycine hydrochloride
Water for injections
Hydrochloric acid (to adjust pH)
Sodium hydroxide (to adjust pH)
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.
After withdrawl in the injection syringe:
Due to light sensitivity, the solution for injection should be used within 24 hours.
6.4 Special Precautions For Storage
This medicinal product does not require any special temperature storage conditions.
Keep the vial in the outer carton in order to protect from light.
For storage of the medicinal product in the syringe, see section 6.3.
6.5 Nature And Contents Of Container
Clear, Type I, flint glass, single
Each vial contains 0.6 ml of solution for injection.
The presentations of Relistor are:
1 vial of solution for injection
2 vials of solution for injection
2 sterile 1 ml injection syringes with retractable injection needle
4 alcohol swabs
7 vials of solution for injection
7 sterile 1 ml injection syringes with retractable injection needle
14 alcohol swabs
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Wyeth Europa Ltd.
Huntercombe Lane South
Taplow, Maidenhead
Berkshire SL6 0PH
UK
Tel: +44 1628 604 377
Fax +44 1628 666 368
8. Marketing Authorisation Number(S)
EU/1/08/463/001
EU/1/08/463/002
EU/1/08/463/003
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 02 July 2008
10. Date Of Revision Of The Text
3 September 2010
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Finocar
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Finasteride
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Eryfer
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Mono Mack Depot
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Florinef
In some countries, this medicine may only be approved for veterinary use.
In the US, Florinef (fludrocortisone systemic) is a member of the drug class mineralocorticoids and is used to treat Addison's Disease, Adrenogenital Syndrome, Dysautonomia and Postural Orthostatic Tachycardia Syndrome.
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Apoven
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Ipratropium
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Clemispray
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Chlorhexidine
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- France
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Thursday, October 20, 2016
Antifungol Hexal
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Bifonazole
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Clotrimazole
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Tetracycline
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Carvasin
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Isosorbide Dinitrate
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Enap-Co
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Enalapril
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Spironolactone
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Catosal
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Butafosfan
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Cyanocobalamin
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Cétrorélix
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Cetrorelix
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| DCF | Dénomination Commune Française |
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Messelxen
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Naproxen
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Procardol Adelco
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Isosorbide Mononitrate
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Losalet
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Hydrochlorothiazide
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- Greece
Losartan
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Cetylpyridinium
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Mini-Pill
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Phenoxymethylpenicillin
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Acyclovir
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Cyclovex
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Acyclovir
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Sunday, October 16, 2016
REPEVAX
1. Name Of The Medicinal Product
REPEVAX®, suspension for injection, in pre-filled syringe
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
2. Qualitative And Quantitative Composition
1 dose (0.5 mL) contains:
Diphtheria Toxoid........................................................... Not less than 2 IU* (2 Lf)
Tetanus Toxoid ........................................................... Not less than 20 IU* (5 Lf)
Pertussis Antigens
Pertussis Toxoid.............................................................................. 2.5 micrograms
Filamentous Haemagglutinin...........................................................5 micrograms
Pertactin.......................................................................................... 3 micrograms
Fimbriae Types 2 and 3................................................................... 5 micrograms
Poliovirus (Inactivated)**
Type 1.......................................................................................... 40 D antigen units
Type 2............................................................................................ 8 D antigen units
Type 3.......................................................................................... 32 D antigen units
Adsorbed on aluminium phosphate....................................................... 1.5 mg (0.33 mg aluminium)
* As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
** Produced in Vero cells.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Suspension for injection in pre-filled syringe
REPEVAX appears as a uniform, cloudy, white suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
REPEVAX is indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization.
The use of REPEVAX should be determined on the basis of official recommendations.
4.2 Posology And Method Of Administration
Posology
A single injection of one (0.5 mL) dose is recommended in all indicated age groups.
REPEVAX may be administered from the age of three years onwards. The use of REPEVAX in children aged 3 to 5 years is based upon studies in which REPEVAX was given as the fourth dose (first booster) of diphtheria, tetanus, pertussis and poliomyelitis vaccines.
REPEVAX is a vaccine containing low-dose diphtheria toxoid plus tetanus toxoid in combination with pertussis and polio antigens for booster vaccinations. When administering the vaccine, indications and dosing intervals according to the official recommendations should be considered for all antigens contained in the vaccine.
Individuals with an incomplete, or no history of a primary series of diphtheria and tetanus toxoids or polio vaccine should not be vaccinated with REPEVAX.
REPEVAX is not precluded in persons with an incomplete, or no history of previous pertussis vaccination. However, a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection.
There are currently no data upon which to base a recommendation for the optimal interval for administering subsequent booster doses with REPEVAX.
Method of Administration
A single injection of one dose (0.5 mL) of REPEVAX should be administered intramuscularly. The preferred site is into the deltoid muscle.
Do not administer REPEVAX intravascularly. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.
REPEVAX should not be administered into the gluteal area; intradermal or subcutaneous routes should not be used (in exceptional cases the subcutaneous route may be considered, see section 4.4).
4.3 Contraindications
• REPEVAX should not be administered to persons with known hypersensitivity
- to diphtheria, tetanus, pertussis or poliomyelitis vaccines
- to any other component of the vaccine (see Section 6.1)
- to any residual substances carried over from manufacture (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin), which may be present in undetectable trace amounts.
• REPEVAX should not be administered to persons who experienced an encephalopathy of unknown origin within 7 days of previous immunization with a pertussis-containing vaccine.
• As with other vaccines, administration of REPEVAX should be postponed in persons suffering from an acute severe febrile illness. The presence of a minor infection (e.g., mild upper respiratory infection) is not a contraindication.
4.4 Special Warnings And Precautions For Use
REPEVAX should not be used for primary immunization.
Regarding the interval between a booster dose of REPEVAX and preceding booster doses of diphtheria and/or tetanus containing vaccines, the official recommendations should generally be followed. Clinical data in adults have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of REPEVAX as early as 4 weeks, compared to at least 5 years after a preceding dose of tetanus and diphtheria-containing vaccine.
Prior to Immunization
Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of REPEVAX vaccine must be carefully considered.
As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine.
If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
REPEVAX should not be administered to individuals with a progressive or unstable neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
The rates and severity of adverse events in recipients of tetanus toxoid antigen are influenced by the number of prior doses and level of pre-existing antitoxins.
The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. It is recommended to postpone the vaccination until the end of such disease or treatment if practical. Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited.
Administration Precautions
Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. In these situations and following official recommendations the administration of REPEVAX by deep subcutaneous injection may be considered, although there is a risk of increased local reactions.
Other Considerations
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).
A persistent nodule at the site of injection may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
REPEVAX may be administered concurrently with a dose of hepatitis B vaccine.
REPEVAX may be administered concurrently with a dose of recombinant Human Papillomavirus with no significant interference with antibody response to any of the components of either vaccine. However, a trend of lower anti-HPV GMTs was observed in the concomitant group. The clinical significance of this observation is not known. This is based on the results from a clinical trial in which REPEVAX was administered concomitantly with the first dose of Gardasil (see section 4.8).
Separate limbs must be used for the site of injection. Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. However, in accordance with commonly accepted immunization guidelines, since REPEVAX is an inactivated product it may be administered concomitantly with other vaccines or immunoglobulins at separate injection sites.
In the case of immunosuppressive therapy please refer to Section 4.4.
4.6 Pregnancy And Lactation
The effect of REPEVAX on embryo-foetal development has not been assessed. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. Data on the use of vaccines containing acellular pertussis antigens in pregnant women are not available.
The use of this combined vaccine is not recommended during pregnancy.
It is not known whether the active substances included in REPEVAX are excreted in human milk. The effect on breast-fed infants of the administration of REPEVAX to their mothers has not been studied.
The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.
The effect of administration of REPEVAX during lactation has not been assessed. Nevertheless, as REPEVAX contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers.
4.7 Effects On Ability To Drive And Use Machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable Effects
Clinical Trials
In clinical trials REPEVAX was given to a total of 1,384 children, adolescent and adults. Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling). These signs and symptoms usually were mild in intensity and occurred within 48 hours following vaccination. They all resolved without sequelae.
Adverse reactions are ranked under headings of frequency using the following convention:
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Children
In a clinical study, 240 children were primed at 3, 5 and 12 months of age with a DTaP vaccine with no additional dose in the second year of life. These children received REPEVAX at 5 to 6 years of age.
The rates of general symptoms after the first day but within 10 days after vaccination were low; only fever (
One hundred and fifty children primed at 2, 3, and 4 months of age with a DTwP vaccine (with no additional dose in the second year of life) received REPEVAX at 3 to 5 years of age
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**Fever was measured as temperature
NR: Not Reported
Adolescents (11 years of age and older) and Adults
There was a trend for higher rates of local and systemic reactions in adolescents than in adults. In both age groups, injection site pain was the most common adverse reaction.
Late-onset local adverse reactions (i.e. a local adverse reaction which had an onset or increase in severity 3 to 14 days post-immunization), such as injection site pain, erythema and swelling occurred in less than 1.2%. Most of the reported adverse reactions occurred within 24 hours after the vaccination.
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In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Gardasil concomitantly with REPEVAX showed that there was more injection-site swelling and headache reported following concomitant administration. The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity.
Data from Post-Marketing Experience
The following additional adverse events have been spontaneously reported during the post-marketing use of REPEVAX worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Therefore, the frequency category “Not Known” is assigned to these adverse events.
Blood and Lymphatic Disorders
Lymphadenopathy
Immune System Disorders
Anaphylactic reactions, such as urticaria, face oedema and dyspnea
Nervous System Disorders
Convulsions, vasovagal syncope, Guillain-Barré syndrome, facial palsy, myelitis, brachial neuritis, transient paresthesia / hypoesthesia of vaccinated limb, dizziness.
Musculoskeletal and Connective Tissue Disorders
Pain in vaccinated limb
General Disorders and Administrative Site Conditions
Extensive limb swelling which may extend from the injection site beyond one or both joints and is frequently associated with erythema, and sometimes with blisters has been reported following administration of REPEVAX. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae.
The risk appears to be dependent on the number of prior doses of d/DtaP vaccine, with a greater risk following the 4th and 5th doses.
Malaise, pallor, injection site induration
4.9 Overdose
Not-applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic Group: Vaccine against diphtheria, tetanus, pertussis and poliomyelitis
ATC Code: J07CA02
Clinical Trials
The immune responses of adults, adolescents and children 3 to 6 years of age one-month after vaccination with REPEVAX are shown in the table below.
Table 1: Immune Responses 4 Weeks after Vaccination
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* From the age of 10 years onwards
† Primed with DTaP at 3 and 5 months with a booster at 12 months of age
‡ Primed with DTwP at 2, 3 and 4 months of age
§ Measured by ELISA
** EU = ELISA units: Antibody levels of>5 EU/mL were postulated as possible surrogate markers for protection against pertussis by Storsaeter J. et al, Vaccine 1998; 16:1907-16.
The safety and immunogenicity of REPEVAX in adults and adolescents was shown to be comparable to that observed with a single booster dose of Td adsorbed or Td Polio adsorbed vaccines containing a similar amount of tetanus and diphtheria toxoids and inactivated poliovirus types 1, 2 and 3.
The lower response to diphtheria toxoid in adults probably reflected the inclusion of some participants with an uncertain or incomplete immunization history.
Serological correlates for protection against pertussis have not been established. On comparison with data from the Sweden I pertussis efficacy trials conducted between 1992 and 1996, where primary immunization with Sanofi Pasteur Limited's acellular pertussis infant DTaP formulation confirmed a protective efficacy of 85% against pertussis disease, it is considered that REPEVAX had elicited protective immune responses.
In a subsequent study, robust immune responses were observed following a single dose of REPEVAX in UK children 3.5 to 4.0 years of age previously primed with either an acellular pertussis combination vaccine (DTaP-IPV-Hib) or whole cell pertussis combination vaccine (DTwP//Hib) and OPV.
Serology follow-up studies were conducted in children adolescents and adults immunized with a single booster dose of REPEVAX.
At the 5-year follow-up time point, seroprotective antibody levels (
For poliovirus, the seroprotective levels (
GMTs for all pertussis antigens at 5 years remained several fold higher than pre-immunization levels, indicating a sustained long-term immune response for all age groups.
5.2 Pharmacokinetic Properties
Evaluation of pharmacokinetic properties is not required for vaccines.
5.3 Preclinical Safety Data
Non-clinical data revealed no special hazard for humans based on conventional studies of repeated doses toxicity.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Phenoxyethanol
Polysorbate 80
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store in a refrigerator at 2°C to 8°C.
Do not freeze. Discard the vaccine if it has been frozen.
Keep the container in the outer carton in order to protect from light.
6.5 Nature And Contents Of Container
0.5 mL of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl elastomer), without attached needle, with a tip-cap (chlorobromobutyl elastomer) - pack size of 1, 10 or 20.
0.5 mL of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl elastomer), without attached needle, with a tip-cap (chlorobromobutyl elastomer) and 1 or 2 separate needles - pack size of 1 or 10.
0.5 mL of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl elastomer) with attached needle and needle guard (elastomer) - pack size of 1, 10 or 20.
0.5 mL of suspension in pre-filled syringe (type I glass) with a plunger stopper (chlorobromobutyl elastomer) with attached needle and needle guard (translucent polypropylene rigid safeshield and polyisoprene) - pack size of 1, 10 or 20.
The stoppers, plunger stoppers and caps for all presentations of REPEVAX are latex-free.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Instructions for Use
Parenteral products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. In the event of either being observed, discard the medicinal product.
The normal appearance of the vaccine is a uniform cloudy, white suspension which may sediment during storage. Shake the prefilled syringe well to uniformly distribute the suspension before administering the vaccine.
For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
Needles should not be recapped.
7. Marketing Authorisation Holder
Sanofi Pasteur MSD Ltd
Mallards Reach
Bridge Avenue
Maidenhead, Berkshire
SL6 1QP
8. Marketing Authorisation Number(S)
PL 06745/121
9. Date Of First Authorisation/Renewal Of The Authorisation
02 November 2001 / 15 December 2006
10. Date Of Revision Of The Text
06 /2011
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