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Vaxelis suspension for injection in pre-filled syringe
Vaxelis suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
1. What Vaxelis is and what it is used for
2. What you need to know before Vaxelis is given to your child
3. How to use Vaxelis
4. Possible side effects
5. How to store Vaxelis
6. Contents of the pack and other information
Vaxelis is a vaccine, which helps to protect your child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Vaxelis is given to children from the age of six weeks.
The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause the following diseases:
To make sure that Vaxelis is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child. If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain.
Talk to your doctor, pharmacist or nurse before vaccination if your child:
Tell your doctor or nurse if your child is taking or has recently taken or might take any other medicines or vaccines.
Vaxelis can be given at the same time as other vaccines such as pneumococcal vaccines, measles- mumps-rubella-varicella (MMRV) vaccines, rotavirus vaccines or meningococcal C vaccines.
Your doctor or nurse will give these injections at different sites and will use different syringes and needles for each injection.
It is expected that Vaxelis will have no or negligible influence on the ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Vaxelis will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Your doctor or nurse will inject Vaxelis into your child’s thigh (in infants from the age of 6 weeks) or arm (in children older than one year).
The recommended dose is as follows:
First course of vaccination (primary vaccination)
Your child will receive two or three injections given at least one month apart. Your doctor or nurse will tell you when your child should come back for their next injection as per the local vaccination program.
Additional injection (booster)
After the first course of injections, your child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course. Your doctor will tell you when this dose should be given.
If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.
It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections. If not, your child may not be fully protected against the diseases.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY:
When these signs or symptoms occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor’s surgery.
Serious allergic reactions are very rare (may affect up to 1 in 10,000 people) and can occur after receiving any vaccine.
If your child experiences any of the following side effects, please tell your doctor, nurse or pharmacist.
Other side effects not listed above have been reported with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines:
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at https://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep this vaccine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vaccine in the outer carton in order to protect from light.
Do not use this vaccine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substances per dose (0.5 mL):
Diphtheria Toxoid1 not less than 20 IU 6
Tetanus Toxoid 1 not less than 40 IU 6
Bordetella pertussis antigens 1
Pertussis Toxoid (PT) 20 micrograms
Filamentous Haemagglutinin (FHA) 20 micrograms
Pertactin (PRN) 3 micrograms
Fimbriae Types 2 and 3 (FIM) 5 micrograms
Hepatitis B surface antigen 2,3 10 micrograms
Poliovirus (Inactivated) 4
Type 1 (Mahoney) 40 D antigen units 5
Type 2 (MEF-1) 8 D antigen units 5
Type 3 (Saukett) 32 D antigen units 5
Haemophilus influenzae type b polysaccharide
(Polyribosylribitol Phosphate) 3 micrograms
Conjugated to meningococcal protein 2 50 micrograms
1 adsorbed on aluminium phosphate (0.17 mg Al 3+)
2 adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3+)
3 produced in yeast ( Saccharomyces cerevisiae) by recombinant DNA technology
4 produced in Vero cells
5 or equivalent antigenic quantity determined by a suitable immunochemical method
6 or equivalent activity determined by an immunogenicity evaluation.
Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants. Adjuvants are included to improve the immune response of vaccines.
The other ingredients are:
Sodium phosphate, water for injections
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin.
The normal appearance of the vaccine is a uniform, cloudy, white to off-white suspension, which may settle down during storage.
Vaxelis is provided as a suspension for injection in pre-filled syringe.
Pack size of 1 or 10 pre-filled syringes, without attached needle, with 1 separate needle or with 2 separate needles.
Multipack of 5 packs of 10 pre-filled syringes with no needle.
Not all pack sizes may be marketed.
This leaflet was last revised in February 2023.