Rotarix oral suspensionRotavirus vaccine, live

Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.

Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. Most children with rotavirus diarrhoea recover on their own. However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.

When a person is given the vaccine, the immune system (the body?s natural defences) will make antibodies against the most commonly occurring types of rotavirus. These antibodies protect against disease caused by these types of rotavirus.

As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.

Rotarix should not be given:

• if your child has previously had any allergic reaction to rotavirus vaccines or any component contained in Rotarix. The active substances and other ingredients in Rotarix are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
• if your child was born with a malformation of the gut that could lead to intussusception.
• if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).
• if your child has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
• if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until recovery.

Take special care with Rotarix

Before your child receives Rotarix, inform your doctor/health care professional if he/she:

• has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system.
• has any disorder of the gastrointestinal system.
• has not been gaining weight and growing as expected.
• has any disease or is taking any medicine which reduces his/her resistance to infection.

After your child has received Rotarix, contact your doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.

As always, please take care to wash your hands thoroughly after changing soiled nappies.

Using other vaccines

Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.

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

Using Rotarix with food and drink

There are no restrictions on your child?s consumption of food or liquids, either before or after vaccination.

Breast-feeding

Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule.

Important information about some of the ingredients of Rotarix

If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before receiving this vaccine.

The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1.5 ml liquid) will be given orally. Under no circumstance should this vaccine be administered by injection.

Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.

Rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks.

In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

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

It is important that you follow the instructions of your doctor or nurse regarding return visits. If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.

Like all medicines, Rotarix can cause side effects, although not everybody gets them.

Side effects that occurred during clinical trials with Rotarix were as follows:

Common These may occur with up to 1 in 10 doses of the vaccine diarrhoea irritability

Uncommon These may occur with up to 1 in 100 doses of the vaccine abdominal pain, flatulence inflammation of the skin

Side effects that have been reported during marketed use of Rotarix include:

• blood in stools
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Rotarix after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C ? 8°C).
Do not freeze.
Store in the original package in order to protect from light.

The vaccine should be used immediately after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Rotarix contains

• The active substances are:

Human rotavirus RIX4414 strain live, attenuated not less than 106.0 CCID50

*Produced on Vero cells

• The other ingredients in Rotarix are: sucrose, Di-sodium Adipate, Dulbecco?s Modified Eagle Medium (DMEM), sterile water

What Rotarix looks like and contents of the pack

Oral suspension.

Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml).

Rotarix is available in a pack of 1, 10 or 50.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
B-1330 Rixensart
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34

Malta GlaxoSmithKline Malta Ltd Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal Smith Kline French Portuguesa, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

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

The vaccine is ready to use (no reconstitution or dilution is required).
The vaccine is to be administered orally without mixing with any other vaccines or solutions.

The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Instructions for administration of the vaccine:

1. Pull off the cap from the top of the tube.

2. Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram.

3. Twist the cap to remove the tip seal (do not snap it off) leaving a hole through which the vaccine can be expelled.

4. Ensure that the tip seal has been properly removed. A hole should be clearly visible at the tip of the tube and the tip seal should be inside the top of the tube cap. In the event that the tip seal is accidentally pushed into the tube, discard the vaccine. This is just a precaution, since it is unlikely that the tip seal could be expelled from the tube while administering the vaccine.

5. This vaccine is for oral administration only. The child should be seated in a reclining position. Administer orally (i.e. into the child?s mouth,towards the inner cheek) the entire content of the tube by gently squeezing the tube several times. (A residual drop may remain in the tip of the tube).

Tube Cap Tip seal Tube 1. Pull off the cap from the top of the tube. 2. Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram. Tube tip Tip seal 3. Twist the cap to remove the tip seal do 4. Ensure that the tip seal has been 5. This vaccine is for oral administration not snap it off leaving a hole through properly removed. A hole should be clearly only. The child should be seated in a which the vaccine can be expelled. visible at the tip of the tube and reclining position. Administer orally i.e. the tip seal should be inside the top into the childs mouth, towards the inner of the tube cap. cheek the entire content of the tube by In the event that the tip seal is accidentally gently squeezing the tube several times. pushed into the tube, discard the vaccine. A residual drop may remain in the tip of This is just a precaution, since it is unlikely the tube. that the tip seal could be expelled from the tube while administering the vaccine.

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

ANNEX IV

GROUNDS FOR ONE ADDITIONAL RENEWAL

GROUNDS FOR ONE ADDITIONAL RENEWAL

Based upon the data that have become available since the granting of the Marketing Authorisation, the CHMP considers that the benefit-risk balance of Rotarix remains positive, but considers that its safety profile is to be closely monitored for the following reasons :
Final data from post-authorisation safety studies are still awaited and the CHMP considers that the Rotarix safety profile remains to be closely monitored. Given the remaining questions regarding the risk of intussusception (IS) following administration of Rotarix, the regulatory authorities should be kept updated of the results of the ongoing post-authorisation safety studies to further study IS, as well as analyses of spontaneously reported IS cases. The CHMP considers that more safety experience needs to be gained about IS and recommended that the MAH should continue to submit yearly PSURs. Therefore, based on the safety profile of Rotarix, which requires the submission of yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.