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DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

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About the medicine

How to use DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION 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 Patient

Dalbavancina Accord 500 mg powder for concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine 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, pharmacist, or nurse.
  • If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Dalbavancina Accord and what is it used for

Dalbavancina Accord contains the active substance dalbavancina, which is an antibioticof the glycopeptide group.

  • Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.
  • It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.
  • Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Dalbavancina is used to treat skin and soft tissue infections (tissue under the skin) in adults and children 3 months or older.

Dalbavancina works by killing certain bacteria that can cause serious infections. It kills bacteria by interfering with the formation of bacterial cell walls.

If you also have other bacteria that cause the infection, your doctor may decide to treat you with other antibiotics in addition to dalbavancina.

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 use Dalbavancina Accord

Do not use Dalbavancina Accordif you are allergicto dalbavancina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to receive dalbavancina:

  • If you have or have had kidney problems. Depending on your age and kidney condition, your doctor may need to reduce your dose.
  • If you suffer from diarrhea, or have previously had diarrhea when treated with antibiotics.
  • If you are allergicto other antibiotics such as vancomycin or teicoplanin.

Diarrhea during or after treatment

If you develop diarrhea duringor afteryour treatment, contact your doctor immediately. Do not take any medicine to treat diarrhea without consulting your doctor first.

Infusion-related reactions

Intravenous infusion with this type of antibiotic can cause redness of the upper body, hives, itching, or skin rash. If you experience this type of reaction, your doctor may decide to interrupt or slow down the infusion.

Other infections

The use of antibiotics can sometimes cause the development of a new and different infection. If this happens, your doctor will decide what to do.

Children

Do not give this medicine to children under 3 months. The effects of using dalbavancina in children under 3 months have not been sufficiently studied.

Using Dalbavancina Accord with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

Dalbavancina is not recommended during pregnancy unless clearly necessary, because it is not known what effect it could have on an unborn baby. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You and your doctor will decide if you should be given dalbavancina.

It is not known whether dalbavancina passes into human breast milk. Ask your doctor for advice before breastfeeding your baby. You and your doctor will decide if you should be given dalbavancina. You should not breastfeed while taking dalbavancina.

Driving and using machines

Dalbavancina may cause dizziness. Be careful when driving vehicles or using machines after you have been given this medicine.

Dalbavancina Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to use Dalbavancina Accord

Dalbavancina will be administered to you by a doctor or nurse.

  • Adults:dalbavancina is administered in a single dose of 1,500 mg or in two doses with a week's difference: 1,000 mg on day 1 and 500 mg on day 8.
  • Children and adolescents from 6 to less than 18 years:dalbavancina is administered in a single dose of 18 mg/kg (maximum 1,500 mg).
  • Young children and children from 3 months to less than 6 years:dalbavancina is administered in a single dose of 22.5 mg/kg (maximum 1,500 mg).

The dose for children from 3 months to less than 18 years will be calculated by the doctor based on the child's age and weight.

You will be given dalbavancina through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.

Patients with chronic kidney problems

If you have chronic kidney problems, your doctor may decide to reduce your dose. There is not enough information to recommend the use of dalbavancina in children with chronic kidney problems.

If you are given more Dalbavancina Accord than you should

Tell your doctor or nurse immediately if you think you may have received too much dalbavancina.

If you miss a dose of Dalbavancina Accord

Tell your doctor or nurse immediately if you are concerned that you may miss the 2nd dose.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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 medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you have any of these symptoms - you may need urgent medical attention:

  • Sudden swelling of the lips, face, throat, or tongue; intense rash; itching; throat tightness; low blood pressure; difficulty swallowing and/or difficulty breathing.These can be signs of a hypersensitivity reaction and can be life-threatening. This reaction has been reported as a rare side effect.It can affect 1 in 1,000 people.
  • Abdominal pain (stomach)or watery diarrhea. The symptoms can be severe or may not go away, and the stools may contain blood or mucus. These can be signs of an intestinal infection. In this situation, you must stop takingmedicines that stop or reduce bowel movement. Intestinal infection has been reported as an uncommon side effect. It can affect 1 in 100 people.

Other side effects that have been reported due to the use of dalbavancina are listed below.

Talk to your doctor, pharmacist, or nurse if you have any of the following side effects:

Common -may affect up to 1 in 10 people:

  • Headache
  • Feeling sick (nausea)
  • Diarrhea

Uncommon -may affect up to 1 in 100 people:

  • Vaginal infections, fungal infections, oral thrush
  • Urinary tract infections
  • Anemia (low red blood cell count), high platelet count in blood (thrombocytosis), increased count of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cells (leucopenia, neutropenia)
  • Changes in other blood tests
  • Decreased appetite
  • Difficulty sleeping
  • Dizziness
  • Change in taste
  • Inflammation and swelling of superficial veins, flushing
  • Cough
  • Abdominal pain and discomfort, indigestion, constipation
  • Abnormal liver function tests
  • Increased alkaline phosphatase (an enzyme found in the body)
  • Itching, hives
  • Genital itching (women)
  • Pain, redness, or swelling at the infusion site
  • Feeling of warmth
  • Increased gamma-glutamyltransferase (an enzyme produced by the liver and other body tissues)
  • Rash
  • Vomiting

Rare -may affect up to 1 in 1,000 people:

  • Difficulty breathing (bronchospasm)

Reporting of side effects

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

5. Storage of Dalbavancina Accord

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

Do not use this medicine after the expiry date which is stated on the vial after EXP/CAD. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions if it is kept in its original packaging.

The prepared Dalbavancina Accord solution for infusion should not be used if there are any particles or if the solution is cloudy.

Dalbavancina Accord is for single use only.

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 of Dalbavancina Accord

  • The active substance is dalbavancina. Each vial of powder contains dalbavancina hydrochloride equivalent to 500 mg of dalbavancina.

After reconstitution, each ml of the concentrate contains 20 mg of dalbavancina.

The diluted solution for infusion should have a final concentration of 1 to 5 mg/ml of dalbavancina.

  • The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid, and/or sodium hydroxide (only for pH adjustment).

Appearance of the product and pack contents

Dalbavancina Accord powder for concentrate for solution for infusion is provided in a 50 ml glass vial with a green closure cap. The vial contains a white to off-white or pale yellow powder.

It is available in packs containing 1 vial.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitan, 10

08970 Sant Joan Despí, Barcelona,

Spain

Date of last revision of this leaflet: March 2024

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

This information is intended only for healthcare professionals:

Important:Consult the technical data sheet of the product before prescribing this medicine.

Dalbavancina Accord must be reconstituted with sterile water for injections and subsequently diluted with a 5% glucose solution for infusion.

The vials of Dalbavancina Accord are for single use only.

Instructions for reconstitution and dilution

Aseptic technique must be used for the reconstitution and dilution of dalbavancina.

  1. The contents of each vial should be reconstituted by slowly adding 25 ml of water for injections.
  2. Do not shake.To avoid foam formation, gently swirl and invert the vial until the contents are completely dissolved. The reconstitution time may be up to 5 minutes.
  3. The reconstituted concentrate in the vial contains 20 mg/ml of dalbavancina.
  4. The reconstituted concentrate must be a clear solution, colorless to yellow, without visible particles.
  5. The reconstituted concentrate must be diluted with a 5% glucose solution for infusion.
  6. To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/ml concentrate should be transferred from the vial to an intravenous bag or bottle containing the 5% glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg of dalbavancina.
  7. After dilution, the infusion solution should have a final concentration of 1 to 5 mg/ml of dalbavancina.
  8. The infusion solution must be a clear solution, colorless to yellow, without visible particles.
  9. If particles or discoloration are identified, the solution should be discarded.

Dalbavancina must not be mixed with other medicines or intravenous solutions. Solutions containing sodium chloride may cause precipitation and MUST NOT be used for reconstitution or dilution. The compatibility of the reconstituted dalbavancina concentrate has only been established with a 5% glucose solution for infusion.

If a common intravenous line is used to administer other medicines in addition to dalbavancina, the line should be flushed before and after each dalbavancina infusion with a 5% glucose solution for infusion.

Use in the pediatric population

For pediatric patients, the dose of dalbavancina will vary based on the child's age and weight, up to a maximum of 1,500 mg. Transfer the required dose of the reconstituted dalbavancina solution, according to the instructions above, based on the child's weight, from the vial to an intravenous bag or bottle containing a 5% glucose solution for infusion. The diluted solution should have a final concentration of 1 to 5 mg/ml of dalbavancina.

The table below provides information to prepare an infusion solution with a final concentration of 2 mg/ml or 5 mg/ml (sufficient in most cases), to be administered via a syringe pump, to achieve a dose of 22.5 mg/kg in pediatric patients 3 to 12 months of age with a weight of 3 to 12 kg. Alternative concentrations can be prepared, but they must have a final concentration range of 1 to 5 mg/ml of dalbavancina.

Consult the table to confirm the calculations. The values shown are approximate. Note that the table does NOT include all possible calculated doses in each age group, but it can be used to estimate the approximate volume for verification of the calculation.

Table 1. Preparation of dalbavancina (final infusion concentration 2 mg/ml or 5 mg/ml for administration via syringe pump) in pediatric patients 3 to 12 months (dose 22.5 mg/kg)

Patient weight (kg)

Dose (mg) to achieve 22.5 mg/kg

Volume of reconstituted dalbavancina solution (20 mg/ml) to be withdrawn from the vial (ml)

Volume of diluent 5% glucose solution to be added for mixing (ml)

Final concentration of dalbavancina infusion solution

Total volume to be administered via syringe pump (ml)

3

67.5

10 ml

90 ml

2 mg/ml

33.8

4

90.0

45.0

5

112.5

56.3

6

135.0

67.5

7

157.5

78.8

8

180.0

90.0

9

202.5

20 ml

60 ml

5 mg/ml

40.5

10

225.0

45.0

11

247.5

49.5

12

270.0

54.0

Disposal

Discard any remaining reconstituted solution that is not used.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

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Томаш Гжеловський

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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Даниэль Чики

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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;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders;
  • 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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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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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.

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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 DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION?
DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION 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 DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION?
The active ingredient in DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION is dalbavancin. This information helps identify medicines with the same composition but different brand names.
Who manufactures DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION?
DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION is manufactured by Accord Healthcare S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION 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 DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION 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 DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION?
Other medicines with the same active substance (dalbavancin) include DALBAVANCIN BAXTER 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, DALBAVANCIN SALA 500 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION, DALBAVANCIN TEVA 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION. 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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