Rotarix oral suspension in dosing tube. live rotavirus vaccine

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rotarix oral suspension in dosing tube

live anti-rotavirus vaccine

Read this entire leaflet carefully before your child receives this vaccine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This vaccine has been prescribed for your child only, and must not be given to others.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Rotarix is and what it is used for
2. What you need to know before your child receives Rotarix
3. How Rotarix is administered
4. Possible side effects
5. How to store Rotarix
6. Contents of the pack and other information

1. What Rotarix is and what it is used for

Rotarix is a viral vaccine containing live attenuated human rotaviruses, which helps protect your child from the age of 6 weeks against gastroenteritis (diarrhea and vomiting) caused by rotavirus infection.

How Rotarix works

Rotavirus infection is the most common cause of severe diarrhea in infants and young children. Rotavirus spreads easily through hand-to-mouth contact with the feces of an infected person. Most children with rotavirus diarrhea recover on their own. However, some children become seriously ill with a severe episode of vomiting, diarrhea, and fluid loss that can be life-threatening and may require hospitalization.

When administered to a person, the vaccine stimulates the immune system (the body's natural defense system) to produce antibodies against the most common types of rotavirus. These antibodies protect against disease caused by these rotavirus types.

As with all vaccines, Rotarix may not fully protect all vaccinated individuals against the rotavirus infections it is intended to prevent.

2. What you need to know before your child receives Rotarix

Rotarix must not be given

• if your child has previously had an allergic reaction to rotavirus vaccines or to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, difficulty breathing, or swelling of the face or tongue.
• if your child has previously had intussusception (a bowel obstruction in which one segment of the intestine slides into another).
• if your child was born with an intestinal malformation that could lead to intussusception.
• if your child has a rare inherited immune system disorder called severe combined immunodeficiency (SCID).
• if your child has a serious infection with high fever. Vaccination may need to be postponed until your child has recovered. A minor infection, such as a cold, should not be a problem for vaccination, but inform your doctor first.
• if your child has diarrhoea or vomiting. Vaccination may need to be postponed until your child has recovered.

Warnings and precautions

Talk to your doctor/healthcare professional before your child receives Rotarix if:

• your child has close contact with a family member who has a weakened immune system, e.g. someone with cancer or who is taking medicines that may weaken their immune system.
• your child has any gastrointestinal problems.
• your child has not gained weight or grown as expected.
• your child has any illness or is taking any medicine that reduces resistance to infection, or if your mother took any medicine during pregnancy that may have weakened the immune system.

If, after receiving Rotarix, your child develops severe stomach pain, persistent vomiting, blood in the stools, a swollen abdomen, and/or high fever, contact a doctor/healthcare professional immediately (see also section 4 “Possible side effects”).

As always, please take care to wash your hands thoroughly after changing used diapers.

Use of Rotarix with other medicines

Inform your doctor if your child is taking or has recently taken any other medicines, or might need to take any other medicines, or has recently received any other vaccines.

Rotarix may be given at the same time as other recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough) vaccine, Haemophilus influenzae type b vaccine, oral or inactivated poliomyelitis vaccine, hepatitis B vaccine, as well as pneumococcal and meningococcal serogroup C conjugate vaccines.

Use of Rotarix with food and drink

There are no restrictions on your child eating or drinking, including breastfeeding, either before or after vaccination.

Breastfeeding

Based on evidence from clinical trials, breastfeeding does not reduce the protection against rotavirus gastroenteritis provided by Rotarix. Therefore, breastfeeding can be continued during the vaccination period.

Rotarix contains sucrose, glucose, phenylalanine, and sodium

If your doctor has told you that your child has an intolerance to certain sugars, talk to your doctor before your child receives this vaccine.

This vaccine contains 0.15 micrograms of phenylalanine per dose. Phenylalanine may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This vaccine contains 34 mg of sodium (the main component of table/cooking salt) per dose.

3. How Rotarix is administered

Your child's doctor or nurse will administer the recommended dose of Rotarix. The vaccine (1.5 ml of liquid) is given orally. Under no circumstances should this vaccine be administered by injection.

Your child will receive two doses of the vaccine. Each dose will be given separately, with an interval of at least 4 weeks between doses. The first dose will be administered starting at 6 weeks of age. Both doses of the vaccine should be administered by 24 weeks of age, although they should preferably be given before 16 weeks of age.

Rotarix may be administered to premature infants according to the same vaccination schedule as other newborns, provided that gestation lasted at least 27 weeks.

If your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be administered during the same visit.

When your child receives the first dose of Rotarix, it is recommended that the second dose also be Rotarix (and not another rotavirus vaccine).

It is important to follow the instructions provided by your doctor or nurse regarding follow-up visits. If you missed the scheduled appointment, speak with your doctor.

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur with this vaccine:

• Common (may occur in up to 1 in every 10 doses of the vaccine):

• diarrhoea

• irritability

• Uncommon (may occur in up to 1 in every 100 doses of the vaccine):

• abdominal pain (see also the following paragraph regarding signs of the very rare adverse effect intussusception)

• flatulence

• skin inflammation

Adverse effects reported during the post-marketing use of Rotarix include:

• Very rare: hives (urticaria)
• Very rare: intussusception (a part of the intestine becomes blocked or twisted). Signs may include severe stomach pain, persistent vomiting, blood in the stool, abdominal swelling and/or high fever. Contact a doctor/healthcare professional immediately if your child experiences any of these symptoms
• blood in stool
• in premature infants (born at 28 weeks of gestation or earlier), periods of prolonged breathing pauses may occur more frequently than normal during the first 2–3 days after vaccination
• children with a rare inherited condition called severe combined immunodeficiency (SCID) may develop inflammation of the stomach or intestine (gastroenteritis) and may shed the vaccine virus in their stools. Signs of gastroenteritis may include nausea, vomiting, stomach cramps (colic or colicky pains), or diarrhoea

Reporting of adverse effects

If your child experiences any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rotarix

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep in the original packaging to protect from light.

Once opened, the vaccine must be used immediately.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rotarix

• The active substance is:

Strain of human rotavirus RIX4414 (live, attenuated)* not less than 10^6.0 CCID50

• Produced in Vero cells

• The other components of Rotarix are: sucrose, disodium adipate, Modified Eagle's Medium (MEM) (containing phenylalanine, sodium, glucose and other substances), sterile water (see also section 2, “Rotarix contains sucrose, glucose, phenylalanine and sodium”).

Appearance of the product and pack size

Oral suspension

Rotarix is supplied as a clear, colourless liquid in a single-dose dosing tube (1.5 ml).

Rotarix is available in packs of 1, 10 or 50.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart
Belgium

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: 01/2022

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended for healthcare professionals only:

The vaccine is presented as a clear, colourless liquid, free from visible particles, for oral administration.

The vaccine is ready to use (no reconstitution or dissolution required).

The vaccine must be administered orally without being mixed with other vaccines or solutions.

The vaccine should be inspected visually for any foreign particles and/or changes in physical appearance. If any such changes are observed, the vaccine should be discarded.

Disposal of unused vaccines and all materials that have come into contact with them must be carried out in accordance with local regulations.

Instructions for vaccine administration:

Read the instructions for use in full before beginning vaccine administration.

Dispose of the empty tube and cap in approved biological waste containers according to local regulations.