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CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

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About the medicine

How to use CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

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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

Cervarix suspension for injection in a pre-filled syringe

Vaccine against Human Papillomavirus [Types 16, 18]

(Recombinant, adjuvanted, adsorbed)

Read all of this leaflet carefully before you start receiving this vaccine,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.
  • This medicine has been prescribed for you only, and you should not pass it on to others.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

  1. What Cervarix is and what it is used for
  2. What you need to know before you receive Cervarix
  3. How Cervarix is administered
  4. Possible side effects
  5. Storage of Cervarix
  6. Contents of the pack and other information

1. What Cervarix is and what it is used for

Cervarix is a vaccine that is indicated to protect individuals from 9 years of age against diseases caused by Human Papillomavirus (HPV) infection.

These diseases include:

  • cervical cancer (i.e., cancer of the neck of the womb or uterus) and anal cancer,
  • pre-cancerous lesions of the cervix, vulva, vagina, and anus (changes in genital or anal cells that have a risk of turning into cancer).

The types of Human Papillomavirus (HPV) contained in the vaccine (types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of vulvar and vaginal pre-cancerous lesions related to HPV, and 78% of anal pre-cancerous lesions related to HPV. Other types of HPV can also cause anogenital cancers. Cervarix does not protect against all types of HPV.

When a person is vaccinated with Cervarix, the immune system (the body's natural defense system) generates antibodies against HPV types 16 and 18.

Cervarix is not infectious and therefore cannot cause HPV-related diseases.

Cervarix is not used to treat HPV-related diseases that are already present at the time of vaccination.

Cervarix should be used in accordance with official recommendations.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you receive Cervarix

Cervarix must not be administered

  • if you are allergic to any of the active substances or to any of the other components of this vaccine (listed in section 6). The signs of an allergic reaction may include skin rash with itching, difficulty breathing, and swelling of the face or tongue.

Warnings and precautions

Consult your doctor or pharmacist before receiving Cervarix:

  • if you have a bleeding problem or if you bruise easily
  • if you have any disease that reduces your resistance to infection, such as an HIV infection
  • if you have a severe infection with high fever. It may be necessary to postpone vaccination until you recover. A minor infection, such as a cold, should not be a problem for vaccination, but before being vaccinated, discuss it with your doctor.

Before or after any injection, fainting (especially in adolescents) may occur, so you should inform your doctor or nurse if you or your child have fainted after receiving an injection in the past.

Like all vaccines, Cervarix may not fully protect all people who are vaccinated.

Cervarix does not protect against diseases caused by HPV infection if, at the time of vaccination, the subjects are already infected with HPV types 16 or 18.

Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening. You should continue to follow your doctor's advice about having cervical smears/Pap tests (a test to detect changes in the cells of the cervix caused by HPV infection) and using protective measures.

Since Cervarix does not protect against all types of HPV, you should continue to take appropriate precautions to avoid contracting HPV and other sexually transmitted diseases.

Cervarix does not protect against other diseases that are not caused by Human Papillomavirus.

Other medicines and Cervarix

Cervarix can be administered with a combined booster vaccine that contains diphtheria (d), tetanus (T), and pertussis [acellular] (pa), with or without inactivated poliomyelitis (IPV) (dTpa, dTpa-IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix), with a hepatitis B vaccine (Engerix B), or with a conjugate vaccine with tetanus toxoid against meningococcal serogroups A, C, W-135, and Y (MenACWY-TT), in a different injection site (another part of your body, for example, another arm) during the same visit.

Cervarix may not have an optimal effect if you are using medicines that suppress the immune system.

In clinical studies, the use of oral contraceptives (e.g., the pill) did not decrease the protection obtained by Cervarix.

Tell your doctor if you are using, have recently used, or might use any other medicine or if you have recently received any other vaccine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, have become pregnant during the vaccination period, or are planning to become pregnant, it is recommended that you postpone or interrupt vaccination until the end of pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before receiving this vaccine.

Driving and using machines

Cervarix is unlikely to affect your ability to drive or use machines. However, do not drive or use machines if you do not feel well.

Cervarix contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How Cervarix is administered

How the vaccine is administered

Your doctor or nurse will administer Cervarix by injection into the muscle of the upper arm.

How much is administered

Cervarix is indicated for individuals from 9 years of age.

The total number of injections you will receive depends on your age at the time of the first injection.

If you are between 9 and 14 years old

You will receive 2 injections:

First injection: on the chosen date.

Second injection: between 5 and 13 months after the first injection.

If you are 15 years old or more

You will receive 3 injections:

First injection: on the chosen date.

Second injection: 1 month after the first injection.

Third injection: 6 months after the first injection.

If necessary, the vaccination schedule can be more flexible. Consult your doctor for more information.

Once the first dose of Cervarix has been administered, it is recommended that Cervarix (and not another HPV vaccine) be used to complete the vaccination schedule.

Cervarix is not recommended for use in individuals under 9 years of age.

The vaccine should never be injected into a vein.

If you miss a dose

It is important to follow the instructions given by your doctor or nurse regarding follow-up visits. If you miss a visit to your doctor, ask your doctor for advice.

If you do not complete the full vaccination cycle (two or three injections, depending on your age at the time of vaccination), you may not obtain the best effect and protection from vaccination.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

The side effects that occurred during clinical trials with Cervarix were:

  • Very common (side effects that occur in more than 1 in 10 doses of vaccine): pain or discomfort at the injection site, redness or swelling at the injection site, headache, muscle pain, muscle tenderness or weakness (not caused by physical exercise), fatigue.
  • Common (side effects that occur in less than 1 in 10 but more than 1 in 100 doses of vaccine): gastrointestinal symptoms including nausea, vomiting, diarrhea, and abdominal pain, itching, skin redness, and rash, hives, joint pain, fever (?38°C).
  • Uncommon (side effects that occur in less than 1 in 100 but more than 1 in 1,000 doses of vaccine): upper respiratory tract infection (infection of the nose, throat, or trachea), dizziness, other reactions at the injection site such as induration, tingling, or numbness of the area.

The side effects observed during the marketing of Cervarix include:

  • allergic reactions. These can be recognized by:
  • skin rash with itching on hands and feet,
  • swelling of the eyes and face,
  • difficulty breathing or swallowing,
  • sudden drop in blood pressure and loss of consciousness.

These reactions usually appear before leaving the doctor's office. However, if your child experiences any of these symptoms, you should contact a doctor urgently.

  • swelling of the neck, armpit, or groin lymph nodes
  • fainting, sometimes accompanied by trembling or stiffness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cervarix

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the pack. The expiry date is the last day of the month stated.

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

Do not freeze.

Store in the original package to protect from light.

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

6. Contents of the pack and other information

Composition ofCervarix

  • The active substances are:

Human Papillomavirus1 type 16 L1 protein 2,3,4 20 micrograms

Human Papillomavirus1 type 18 L1 protein 2,3,4 20 micrograms

1Human Papillomavirus = HPV

2adjuvanted with AS04 which contains:

3-O-desacil-4’-monophosphoryl lipid A (MPL) 3 50 micrograms

3adsorbed on hydrated aluminum hydroxide (Al(OH)3) 0.5 milligrams of Al3+

in total

4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system that uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni.

  • The other ingredients are: sodium chloride (NaCl), disodium phosphate dihydrate (Na2HPO4.2 H2O), and water for injections.

Appearance and pack contents

Suspension for injection in a pre-filled syringe.

Cervarix is a white, turbid suspension.

Cervarix is available in a pre-filled syringe with or without a separate needle; pack sizes of 1 and 10.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

GlaxoSmithKline Biologicals SA

Rue de l'Institut 89

B-1330 Rixensart, Belgium

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Belgium

GlaxoSmithKline Pharmaceuticals SA/NV

Tel: + 32 10 85 52 00

Lithuania

GlaxoSmithKline Biologicals SA

Tel: +370 80000334

Bulgaria

GlaxoSmithKline Biologicals SA

Tel: + 359 80018205

Luxembourg

GlaxoSmithKline Pharmaceuticals SA/NV

Tel: + 32 10 85 52 00

Czech Republic

GlaxoSmithKline, s.r.o.

Tel: + 420 2 22 00 11 11

[email protected]

Hungary

GlaxoSmithKline Biologicals SA

Tel: + 36 80088309

Denmark

GlaxoSmithKline Pharma A/S

Tel: + 45 36 35 91 00

[email protected]

Malta

GlaxoSmithKline Biologicals SA

Tel: + 356 80065004

Germany

GlaxoSmithKline GmbH & Co. KG

Tel: + 49 (0)89 360448701

[email protected]

Netherlands

GlaxoSmithKline BV

Tel: + 31 (0)30 69 38 100

[email protected]

Estonia

GlaxoSmithKline Biologicals SA

Tel: +372 8002640

Norway

GlaxoSmithKline AS

Tel: + 47 22 70 20 00

Greece

GlaxoSmithKline Μονοπρ?σωπη A.E.B.E

Tel: + 30 210 68 82 100

Austria

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

[email protected]

Spain

GlaxoSmithKline, S.A.

Tel: + 34 900 202 700

[email protected]

Poland

GSK Services Sp. z o.o.

Tel: + 48 (22) 576 9000

France

Laboratoire GlaxoSmithKline

Tel: + 33 (0) 1 39 17 84 44

[email protected]

Croatia

GlaxoSmithKline Biologicals SA

Tel: + 385 800787089

Portugal

GlaxoSmithKline - Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

[email protected]

Romania

GlaxoSmithKline Biologicals SA

Tel: +40 800672524

Ireland

GlaxoSmithKline (Ireland) Ltd

Tel: + 353 (0)1 495 5000

Slovenia

GlaxoSmithKline Biologicals SA

Tel: + 386 80688869

Iceland

Vistor hf.

Tel: +354 535 7000

Slovakia

GlaxoSmithKline Biologicals SA

Tel: + 421 800500589

Italy

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741 111

Finland

GlaxoSmithKline Oy

Tel: + 358 10 30 30 30

Cyprus

GlaxoSmithKline Biologicals SA

Tel: + 357 80070017

Sweden

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

[email protected]

Latvia

GlaxoSmithKline Biologicals SA

Tel: + 371 80205045

United Kingdom (Northern Ireland)

GlaxoSmithKline Biologicals SA

Tel: +44 (0)800 221 441

[email protected]

Date of last revision ofthis leaflet:04/2023

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website (http://www.ema.europa.eu) and on the Spanish Agency for Medicines and Health Products (AEMPS) website (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Once removed from the refrigerator, Cervarix should be administered as soon as possible. However, its stability has been demonstrated when stored outside the refrigerator for up to 3 days at a temperature between 8°C and 25°C or up to 1 day at a temperature between 25°C and 37°C. If not used within this period, discard the vaccine.

During storage of the syringe, a white deposit and a clear supernatant may be observed. This is not a sign of deterioration.

The contents of the syringe should be visually inspected both before and after shaking for any foreign particles and/or changes in physical appearance before administration.

If any of these circumstances are observed, the vaccine should be discarded.

The vaccine should be shaken well before use.

Instructions for the pre-filled syringe

Text that saysVial stopper with large, bold text indicating its functionWhite Luer-Lock adapter with visible threaded connection and top text in blackText that says “Plunger” in black letters on a white backgroundPre-filled syringe with medication showing the retracted plunger and visible needle with transparent protector

Hold the syringe by the body, not by the plunger.

Remove the syringe cap by twisting it in a counterclockwise direction.

Metal needle base with conical shape and sharp tip viewed in detailHands holding an injection device with connected needle showing curved arrows indicating rotation and push

To insert the needle, attach the base to the Luer-Lock adapter and twist it a quarter turn in a clockwise direction until it clicks.

Do not remove the plunger from the syringe body. If this happens, do not administer the vaccine.

Disposal of waste

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

Online doctors for CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Discuss questions about CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE, 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;
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  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders;
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  • medication review and treatment adjustment;
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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
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  • bronchitis and mild asthma flare-ups
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  • rashes, allergic reactions, redness, insect bites
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  • headache, dizziness, migraine symptoms
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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)
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  • 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

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.
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  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
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  • 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.
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  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
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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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Frequently Asked Questions

Is a prescription required for CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 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 CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
The active ingredient in CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE is papillomavirus (human types 16, 18). This information helps identify medicines with the same composition but different brand names.
Who manufactures CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE is manufactured by Glaxosmithkline Biologicals. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 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 CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 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 CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
Other medicines with the same active substance (papillomavirus (human types 16, 18)) include CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE, CERVARIX INJECTABLE SUSPENSION IN VIAL, CERVARIX INJECTABLE SUSPENSION IN VIAL. 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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