Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rotateq

Document Subject

Generated Narrative: MedicinalProductDefinition mpef95b389907181c6a50441289b7e7a0a

identifier: http://ema.europa.eu/identifier/EU/1/06/348/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: RotaTeq oral solution

type: Full name

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part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-ef95b389907181c6a50441289b7e7a0a

identifier: http://ema.europa.eu/identifier/EU/1/06/348/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rotateq

Attesters

What is in this leaflet

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

RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection and may be given to infants from the age of 6 weeks to 32 weeks (see section 3). The vaccine contains five types of live rotavirus strains. When an infant 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 help protect against gastroenteritis caused by these types of rotavirus.

Do not use RotaTeq if

• your child is allergic to any of the components of this vaccine (see section 6 Contents of the pack and other information).

• your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus vaccine.

• your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).

• your child was born with a malformation of the gastrointestinal system that might predispose for intussusception.

• your child has any disease which reduces his/her resistance to infection.

• 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.

• your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until recovery. Warnings and precautions Talk to your doctor or pharmacist before using RotaTeq if your child:

• has received a blood transfusion or immunoglobulins within the last 6 weeks.

• 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.

• or the mother has taken any medicine during pregnancy that weakens the immune system. After your child has received RotaTeq, contact a 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 (see also section 4 Possible side effects ). As always, please take care to wash your hands thoroughly after changing soiled nappies.
  As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even after all three doses have been given.
  If your child has already been infected with rotavirus but is not yet ill when vaccinated, RotaTeq may not be able to prevent the illness. RotaTeq does not protect against diarrhoea and vomiting due to causes other than rotavirus. Other medicines and RotaTeq RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C conjugate vaccines. Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines (or other vaccines). RotaTeq with food and drink There are no restrictions on taking food or liquid, including breast milk, either before or after vaccination with RotaTeq. RotaTeq contains sucrose If you have been told that your child has an intolerance to some sugars, inform your doctor/health care professional before the vaccine is administered.
  RotaTeq contains sodium This vaccine contains 37.6 mg sodium (main component of cooking/table salt) in each dose. This is equivalent to 1.88% of the recommended maximum daily dietary intake of sodium for an adult.

RotaTeq IS FOR ORAL USE ONLY. A doctor or nurse will administer the recommended doses of RotaTeq to your child. The vaccine will be given by gently squeezing the tube and delivering the vaccine into your child s mouth. The vaccine can be given without regard to food, liquid, or breast milk. 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. Under no circumstance should this vaccine be administered by injection. The first dose (2 ml) of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months). RotaTeq may be given to infants who were born early provided that the pregnancy had lasted at least 25 weeks. These infants should receive the first dose of vaccine between 6 and 12 weeks after birth. Your child will receive 3 doses of RotaTeq given at least four weeks apart. It is important that your child receives all 3 doses of the vaccine for protection against rotavirus. It is preferred that all three doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the age of 32 weeks. When RotaTeq is given to your child for the first dose, it is recommended that your child also receives RotaTeq (and not another rotavirus vaccine) to complete the vaccination course. If you forget an appointment for RotaTeq It is important that you follow the instructions of your doctor/health care professional regarding your child s return visits for the follow-up doses. If you forget or are not able to go back to your doctor/health care professional at the scheduled time, ask him or her for advice.

Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Contact a doctor/health care professional right away if your child experiences one of the following symptoms:

Allergic reactions (frequency cannot be estimated from the available data), which may be severe (anaphylaxis), and may include: allergic swelling that may affect the face, lips, tongue or throat.

Bronchospasm (rare, may affect up to 1 in 1000 infants). This may present as wheezing, coughing or difficulty breathing.

Severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. These could be symptoms of a very rare (may affect up to 1 in 10,000 infants), but serious, side effect called intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment). The following other side effects reported with the use of RotaTeq were: Very common (may affect more than 1 in 10 infants): fever, diarrhoea, vomiting Common (may affect up to 1 in 10 infants): infections of the upper respiratory system Uncommon (may affect up to 1 in 100 infants): stomach pains (see also above for signs of a very rare side effect of intussusception), runny nose and sore throat, ear infection, rash, blood in stool Rare (may affect up to 1 in 1000 infants): hives Not known (frequency cannot be estimated from the available data): irritability 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. Ask your doctor/health care professional if you want more information about side effects for RotaTeq.
Reporting of side effects If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Store and transport refrigerated (2 C to 8 C). Keep the dosing tube in the outer carton in order to protect from light. 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.

What RotaTeq contains The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains: G1 2.2 x 106 Infectious Units G2 2.8 x 106 Infectious Units G3 2.2 x 106 Infectious Units G4 2.0 x 106 Infectious Units P1A[8] 2.3 x 106 Infectious Units The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids and vitamins), and purified water.
What RotaTeq looks like and contents of the pack Oral solution This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink tint. RotaTeq is available in pack size of 1, 10 dosing tubes. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2BN, Haarlem, The Netherlands For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel.: +370.5.2780.msd_lietuva@merck.com

       , 

.: + 359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: + 36.1.888.5hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: + 45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999(+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O Tel.: +372 6144 msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no

MSD . . . . . : +30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel.: +48.22.549.51.msdpolska@merck.com France MSD France T l: +33 (0)1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4msd.slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r.* Tel: +421 2 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: +371.67364.msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com This leaflet was last revised in: Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for health care professionals only: Instructions To administer the vaccine: Tear open the protective bag and remove the dosing tube. Clear the fluid from the dispensing tip by holding tube vertically and tapping the twist-off cap. Open the dosing tube in 2 easy motions:

1. Puncture the dispensing tip by screwing cap clockwise until it becomes tight.
2. Remove cap by turning it counterclockwise.
   Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.)

Discard the empty tube and cap in approved biological waste containers according to local regulations. Any unused product or waste material should be disposed of in accordance with local requirements. See also section 3. How to use RotaTeq.