Active ingredient
- diphtheria, tetanus and pertussis vaccine
- poliomyelitis vaccine
- haemophilus influenzae type b conjugated vaccine
- hepatitis b vaccine (rDNA)
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 50692/0001.
Vaxelis suspension for injection in pre-filled syringe
Package leaflet: Information for the user
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).
Read all of this leaflet carefully before your child is vaccinated with this medicine because it contains important information for you.
What is in this leaflet
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
1. What is Vaxelis and what it is used for
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:
Important information about the protection provided
2. What you need to know before Vaxelis is given to your child
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.
Do not use Vaxelis if your child:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before vaccination if your child:
Other medicines or vaccines and Vaxelis
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.
Driving and using machines
It is expected that Vaxelis would have no or negligible influence on the ability to use bicycles and other such machines.
Vaxelis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How Vaxelis is given
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 dose of Vaxelis
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.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Serious allergic reactions
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.
Other side effects
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:
Reporting of side effects
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.
United Kingdom
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.
5. How to store Vaxelis
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.
6. Contents of the pack and other information
What Vaxelis contains
The active substances per dose (0.5 mL):
Diphtheria Toxoid1 not less than 20 IU
Tetanus Toxoid1 not less than 40 IU
Bordetella pertussis antigens1
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 antigen2,3 10 micrograms
Poliovirus (Inactivated)4
Type 1 (Mahoney) 40 D antigen units5
Type 2 (MEF-1) 8 D antigen units5
Type 3 (Saukett) 32 D antigen units5
Haemophilus influenzae type b polysaccharide
(Polyribosylribitol Phosphate) 3 micrograms
Conjugated to meningococcal protein2 50 micrograms
1 adsorbed on aluminium phosphate (0.17 mg Al3+)
2 adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al3+)
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.
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.
What Vaxelis looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
Distributed by:
This leaflet was last revised in 03/2022
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