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ROTATEQ ORAL SOLUTION

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About the medicine

How to use ROTATEQ ORAL SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

RotaTeq Oral Solution

Rotavirus vaccine (live virus)

Read all of this leaflet carefully before your child is vaccinated because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If your child experiences any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is RotaTeq and what is it used for

RotaTeq is an oral vaccine that helps protect infants and young children from gastroenteritis (diarrhea and vomiting) caused by rotavirus infection and can be given to children from 6 weeks up to 32 weeks (see section 3). The vaccine contains five strains of live rotavirus. When the vaccine is given to a child, the immune system (the body's natural defenses) will create antibodies against the types of rotavirus that occur most frequently. These antibodies help protect against gastroenteritis caused by these types of rotavirus.

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

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 another rotavirus vaccine.
  • your child has had a previous intussusception (a bowel obstruction in which a segment of intestine slides into another segment).
  • your child was born with a gastrointestinal malformation that could predispose to intussusception.
  • your child has any disease that reduces their resistance to infection.
  • your child has a severe infection with high fever. Vaccination may need to be postponed until recovery. A mild infection such as a cold should not be a problem, but consult your doctor first.
  • your child has diarrhea or vomiting. Vaccination may need to be postponed until recovery.

Warnings and precautions

Consult your doctor or pharmacist before starting to use RotaTeq, if your child:

  • has received a blood transfusion or immunoglobulins in the last 6 weeks.
  • has close contact with someone, such as a family member, who has a weakened immune system, for example, a person with cancer or taking medicines that can weaken the immune system.
  • has any gastrointestinal disorder.
  • has not been gaining weight and growing as expected.
  • or the mother has received any medicine during pregnancy that weakens the immune system.

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

As always, be careful to wash your hands thoroughly after changing used diapers.

As with other vaccines, RotaTeq does not guarantee complete protection in all vaccinated children, even after the three doses have been given.

If your child has already been infected with rotavirus but was not yet ill when vaccinated, RotaTeq may not prevent the disease.

RotaTeq does not protect against diarrhea and vomiting due to causes other than rotavirus.

Other medicines and RotaTeq

RotaTeq can be given at the same time as your child receives other vaccinations normally recommended, such as vaccines against diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzaetype b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate vaccine, and meningococcal conjugate vaccine.

Tell your doctor or pharmacist if your child is using, has recently used, or might use any other medicines (or other vaccines).

Using RotaTeq with food and drinks

There are no restrictions on food or drink consumption, including breast milk, before or after vaccination with RotaTeq.

RotaTeq contains sucrose

If your child has been told that they have an intolerance to some sugars, inform your doctor or healthcare professional before the vaccine is given.

RotaTeq contains sodium

This vaccine contains 37.6 mg of sodium (the main component of table/cooking salt) per dose. This is equivalent to 1.88% of the maximum recommended daily sodium intake for an adult.

3. How to use RotaTeq

RotaTeq IS ADMINISTERED ONLY ORALLY.

A doctor or nurse will give your child the recommended doses of RotaTeq. The vaccine will be given by carefully squeezing the tube and administering the vaccine into your child's mouth. The vaccine can be given with or without food, drink, or breast milk. If your child spits up or regurgitates most of the vaccine dose, a single replacement dose can be given at the same vaccination visit.

This vaccine should not be injected under any circumstances.

The first dose (2 ml) of RotaTeq can be given from 6 weeks of age and must be given before 12 weeks of age (about 3 months). RotaTeq can be given to premature infants as long as the pregnancy lasted at least 25 weeks. These children should receive the first dose of the vaccine between 6 and 12 weeks after birth.

Your child will receive 3 doses of RotaTeq, given at least 4 weeks apart. It is essential that your child receives all 3 doses of the vaccine to be protected against rotavirus. It is recommended that the three doses be given before 20-22 weeks of age and no later than 32 weeks of age.

When RotaTeq is given to your child for the first dose, it is recommended to continue with RotaTeq (and not with another rotavirus vaccine) to complete the vaccination regimen.

If you miss a dose of RotaTeq

It is essential that you follow your doctor's/healthcare professional's instructions regarding your child's follow-up visits for the next doses. If you miss or cannot attend your appointment on the scheduled date, consult your doctor/healthcare professional.

Medicine questions

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4. Possible side effects

Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.

Contact a doctor/healthcare professional immediately if your child experiences any of the following symptoms:

  • Allergic reactions (frequency cannot be estimated from the available data), which can be severe (anaphylaxis), and can include: allergic swelling that can affect the face, lips, tongue, or throat.
  • Bronchospasm (rare, may affect up to 1 in 1,000 children): This may present as wheezing, coughing, or difficulty breathing.
  • Severe stomach pain, persistent vomiting, blood in the stool, swollen abdomen, and/or high fever. These could be symptoms of a very rare (may affect up to 1 in 10,000 children) but serious side effect called intussusception (a bowel obstruction in which a segment of intestine slides into another segment).

The following side effects have been reported with the use of RotaTeq:

  • Very common (may affect more than 1 in 10 children): fever, diarrhea, vomiting
  • Common (may affect up to 1 in 10 children): upper respiratory tract infections
  • Uncommon (may affect up to 1 in 100 children): stomach pain (see also the previous paragraph for signs of the very rare side effect intussusception), runny nose and sore throat, ear infection, rash, blood in the stool
  • Rare (may affect up to 1 in 1,000 children): hives
  • Frequency not known (cannot be estimated from the available data): irritability

In children born very prematurely (at 28 weeks of gestation or earlier), longer-than-normal pauses between breaths may occur during the 2 or 3 days following vaccination.

If you want more information about the side effects of RotaTeq, talk to your doctor or healthcare professional.

Reporting of side effects

If your child experiences 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of RotaTeq

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. (CAD). The expiry date is the last day of the month stated.

Store and transport refrigerated (between 2°C and 8°C). Keep the dosing tube in the outer packaging to protect it from light.

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 protect the environment.

6. Contents of the pack and other information

What is in RotaTeq

The active substances in RotaTeq are 5 strains of human-bovine rotavirus reassortants:

G1 2.2 x 10^6 Infectious Units

G2 2.8 x 10^6 Infectious Units

G3 2.2 x 10^6 Infectious Units

G4 2.0 x 10^6 Infectious Units

P1A[8] 2.3 x 10^6 Infectious Units

The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture medium (which contains inorganic salts, amino acids, and vitamins) and purified water.

Appearance and packaging

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 packs of 1 and 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, Netherlands

Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, Netherlands

You can get more information on this medicine by contacting the local representative of the marketing authorisation holder.

Belgium

MSD Belgium

Tel: +32(0)27766211

[email protected]

Lithuania

UAB Merck Sharp & Dohme

Tel: +370 5 2780 247

[email protected]

Text in Bulgarian language with contact information for Merck Sharp and Dohme Bulgaria, including phone and email

Luxembourg

MSD Belgium

Tel: +32(0)27766211

[email protected]

Czech Republic

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

[email protected]

Hungary

MSD Pharma Hungary Kft.

Tel.: + 36 1 888 5300

[email protected]

Denmark

MSD Danmark ApS

Tlf.: + 45 4482 4000

[email protected]

Malta

Merck Sharp & Dohme Cyprus Limited.

Tel: 8007 4433 (+356 99917558)

[email protected]

Germany

MSD Sharp & Dohme GmbH

Tel.: +49 (0) 89 20 300 4500

[email protected]

Netherlands

Merck Sharp & Dohme B.V.

Tel: 0800 9999000

(+31 23 5153153)

[email protected]

Estonia

Merck Sharp & Dohme OÜ

Tel: +372 614 4200

[email protected]

Norway

MSD (Norge) AS

Tlf: +47 32 20 73 00

[email protected]

Greece

MSD Α.Φ.Ε.Ε.

Τηλ: +30 210 98 97 300

[email protected]

Austria

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

[email protected]

Spain

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

[email protected]

Poland

MSD Polska Sp. z o.o.

Tel.: +48 22 549 51 00

[email protected]

France

MSD France

Tél: + 33 (0)1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

[email protected]

Croatia

Merck Sharp & Dohme d.o.o.

Tel: +385 1 66 11 333

[email protected]

Romania

Merck Sharp & Dohme Romania S.R.L.

Tel: + 40 21 529 29 00

[email protected]

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

[email protected]

Slovenia

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 520 4201

[email protected]

Iceland

Vistor ehf.

Sími: + 354 535 7000

Slovakia

Merck Sharp & Dohme, s. r. o.

Tel: +421 2 58282010

[email protected]

Italy

MSD Italia S.r.l.

Tel: 800 23 99 89 (+39 06 361911)

[email protected]

Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650

[email protected]

Cyprus

Merck Sharp & Dohme Cyprus Limited

Τηλ: 800 00 673 (+357 22866700)

[email protected]

Sweden

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

Latvia

SIA Merck Sharp & Dohme Latvija

Tel.: + 371 67025300

[email protected]

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Instructions

To administer the vaccine:

Hand placing a cotton swab soaked with liquid over the injection site on the skin, gently pressing with the fingers

Tear the protective bag and remove the dosing tube.

Hand holding an auto-injector with the viewing window facing up and pressing the activation button

Remove the liquid from the dispensing tip by holding the tube vertically and tapping the cap.

Administration device with arrow indicating rotational movement and hand holding the applicator with the button pressed

Open the dosing tube with 2 simple movements:

  1. Puncture the dispensing tip by screwing the cap clockwise until it is tight.

Hand holding an auto-injector with curved arrows indicating rotation and a straight arrow showing the direction of injection

  1. Remove the cap by twisting it counterclockwise.

Hand holding a syringe with the needle inserted into the skin, showing the angle of injection and the formation of a skin fold

Administer the dose by carefully pouring the liquid into the inside of the child's mouth towards the inner cheek until the 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 in accordance with local requirements.

The unused medicine and all materials that have come into contact with it should be disposed of in accordance with local regulations.

See also section 3. How to use RotaTeq.

Online doctors for ROTATEQ ORAL SOLUTION

Discuss questions about ROTATEQ ORAL SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55

Frequently Asked Questions

Is a prescription required for ROTATEQ ORAL SOLUTION?
ROTATEQ ORAL SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ROTATEQ ORAL SOLUTION?
The active ingredient in ROTATEQ ORAL SOLUTION is rota virus, pentavalent, live, reassorted. This information helps identify medicines with the same composition but different brand names.
Who manufactures ROTATEQ ORAL SOLUTION?
ROTATEQ ORAL SOLUTION is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ROTATEQ ORAL SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ROTATEQ ORAL SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ROTATEQ ORAL SOLUTION?
Other medicines with the same active substance (rota virus, pentavalent, live, reassorted) include ROTARIX ORAL SUSPENSION IN PRE-FILLED ORAL APPLICATOR. LIVE ANTIRROTAVIRUS VACCINE, ROTARIX ORAL SUSPENSION IN A DOSING TUBE. LIVE ANTI-ROTAVIRUS VACCINE, ROTARIX ORAL SUSPENSION IN A DOSING TUBE. LIVE ANTI-ROTAVIRUS VACCINE. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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