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XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

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About the medicine

How to use XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

Translated with AI

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

Xydalba 500 mg powder for concentrate for solution for infusion

dalbavancin

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

1. What Xydalba is and what it is used for

Xydalba contains the active substance dalbavancin, which is an antibioticof the glycopeptide group.

Xydalba is used to treat skin and soft tissue infections (tissue under theskin) in adults and children from birth.

Xydalba 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 Xydalba.

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 are given Xydalba

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start receiving Xydalba:

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

Diarrhea during or after treatment

If you have diarrhea duringor afteryour treatment, contact your doctor immediately.

Do not take any medicine to treat diarrhea without first talking to your doctor.

Infusion-related reactions

Intravenous infusion with this type of antibiotic can cause redness of the upper body, hives, itching, or skin rashes. 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 a new and different infection to appear. If this happens, your doctor will decide what to do.

Other medicines and Xydalba

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

Pregnancy and breastfeeding

Xydalba is not recommended during pregnancy unless clearly necessary, as it is not known what effect it could have on the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor before you are given this medicine. You and your doctor will decide if you will be given Xydalba.

It is not known if Xydalba passes into breast milk in humans. Talk to your doctor before breastfeeding your baby. You and your doctor will decide if you will be given Xydalba. You should not breastfeed while taking Xydalba.

Driving and using machines

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

Xydalba contains sodium

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

3. How Xydalba is given

Xydalba will be given to you by a doctor or nurse.

  • Adults: Xydalba is given as 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 6to less than 18years: Xydalba is given as a single dose of 18 mg/kg (maximum 1,500 mg).
  • Young children and children from 0to less than 6years: Xydalba is given as a single dose of 22.5 mg/kg (maximum 1,500 mg).

The dose for children from 0 to less than 18 years will be calculated by the doctor based on the child's age and weight.

You will be given Xydalba 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 Xydalba in children with chronic kidney problems.

If you are given more Xydalba than you should

Tell your doctor or nurse immediately if you think you may have been given too much Xydalba.

If you miss a dose of Xydalba

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; severe rash; itching; difficulty swallowing or breathing; low blood pressure.These can be signs of a hypersensitivity reaction and can be life-threatening. This reaction has been reported as a rare side effect.
  • 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 should stoptaking medicines that stop or slow down bowel movements. Intestinal infection has been reported as an uncommon side effect.
  • Changes in hearing. These have been reported with a similar medicine. The frequency is unknown. It is not possible to estimate the frequency from the available data.

Other side effects that have been reported with Xydalba 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, increased eosinophil count, low white blood cell count
  • Changes in other blood tests
  • Loss of 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-glutamyl transferase (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 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 Xydalba

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

Do notuse this medicine after the expiry date which is stated on the vial after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions if kept in the original package.

Do not use the Xydalba solution for infusion if you notice any particles or the solution is cloudy.

Xydalba 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. Container Content and Additional Information

Xydalba Composition

  • The active ingredient is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
  • The other components are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (only for pH adjustment).

Product Appearance and Container Content

Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip-off seal. The vial contains white or off-white to light yellow powder.

It is available in packs containing 1 vial.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate,

Dundalk,

Co. Louth, A91 P9KD, Ireland

Almac Pharma Services Ltd

Seagoe Industrial Estate, Craigavon,

County Armagh BT63 5UA

United Kingdom

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Via Vecchia del Pinocchio, 22

60131 Ancona

Italy

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Belgium/Belgique/Belgien

Advanz Pharma Belgium

Tel: +32 (0)800 78 941

[email protected]

Lithuania

Angelini Pharma S.p.A

Tel: + 39 06 78 0531

Text in Bulgarian language with company name, contact phone number and email address

Luxembourg/Luxemburg

Amdipharm Ltd

Tel: +352 27861461

[email protected]

Czech Republic

Angelini Pharma Ceská republika s.r.o.

Tel: +420 546 123 111

[email protected]

Hungary

Angelini Pharma Magyarország Kft

Tel: + 36 1 336 1614

[email protected]

Denmark

Abcur AB

Sweden

Tel: +45 8082 6022

[email protected]

Malta

Correvio

Tel: +44 (0)208 588 9131

[email protected]

Germany

Advanz Pharma Germany GmbH

Tel: +49 (0)800 1802 091

[email protected]

Netherlands

Amdipharm Ltd

Tel: +31 (0)20 808 32 06

[email protected]

Estonia

Lorenzo Pharma OÜ

Tel: +372 6041669

Norway

Abcur AB

Sweden

Tel: +47 800 16 689

[email protected]

Greece

ANGELINI PHARMA HELLAS A.B.E.E.

Tel: + 30 210 626 9200

[email protected]

Austria

Angelini Pharma Österreich GmbH

Tel: + 43 5 9606 0

[email protected]

Spain

ANGELINI PHARMA ESPAÑA, S.L.

Tel: + 34 93 253 45 00

Poland

Angelini Pharma Polska Sp. z o.o.

Tel.: +48 22 70 28 200

[email protected]

France

Correvio SAS

Tel: +33 (0)1 77 68 89 17

[email protected]

Portugal

AbbVie, Lda.

Tel: +351 (0)21 1908400

Croatia

Angelini Pharma S.p.A

Tel: + 39 06 78 0531

Romania

Angelini Pharmaceuticals România SRL

Tel: + 40 21 331 6767

[email protected]

Ireland

Correvio

Tel: +352 1800 851 119

[email protected]

Slovenia

Angelini Pharma S.p.A

Tel: + 39 06 78 0531

Iceland

Abcur AB

Sweden

Tel: +46 20 088 02 36

[email protected]

Slovakia

Angelini Pharma Slovenská republika s.r.o.

Tel: + 421 2 59 207 320

[email protected]

Italy

Angelini Pharma S.p.A

Tel: +39 06 780531

Finland

Abcur AB

Sweden

Tel: +358 800 416231

[email protected]

Cyprus

ANGELINI PHARMA HELLAS A.B.E.E.

Tel: + 30 210 626 9200

[email protected]

Sweden

Abcur AB

Sweden

Tel: +46 (0)20 088 02 36

[email protected]

Latvia

SIA Livorno Pharma

Tel: +371 67211124

Date of last revision of this leaflet {MM/YYYY}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Important:Consult the summary of product characteristics or package leaflet before prescribing this medicinal product.

Xydalba must be reconstituted with sterile water for injection and subsequently diluted with a 50 mg/ml (5%) glucose solution for infusion.

Xydalba vials are for single use only.

Reconstitution and Dilution Instructions

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

  1. The contents of each vial must be reconstituted by slowly adding 25 ml of water for injectable preparations.
  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 dalbavancin.
  4. The reconstituted concentrate must be a clear, colorless to yellow solution without visible particles.
  5. The reconstituted concentrate must be diluted with a 50 mg/ml (5%) glucose solution for infusion.
  6. To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/ml concentrate must be transferred from the vial to an intravenous bag or bottle containing a 50 mg/ml (5%) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg of dalbavancin.
  7. After dilution, the infusion solution must have a final concentration of 1 to 5 mg/ml of dalbavancin.
  8. The infusion solution must be a clear, colorless to yellow solution without visible particles.
  9. If particles or color changes are identified, the solution must be discarded.

Xydalba must not be mixed with other medicinal products or intravenous solutions. Solutions containing sodium chloride may cause precipitation and MUST NOT be used for reconstitution or dilution. The compatibility of the reconstituted Xydalba concentrate has only been established with a 50 mg/ml (5%) glucose solution for infusion.

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

Use in the Pediatric Population

For pediatric patients, the dose of Xydalba will vary depending on the age and weight of the child up to a maximum of 1,500 mg. Transfer the required dose of the reconstituted dalbavancin solution, according to the instructions above, based on the child's weight, from the vial to an intravenous bag or bottle containing a 50 mg/ml (5%) glucose solution for infusion. The diluted solution must have a final concentration of 1 to 5 mg/ml of dalbavancin.

Table 1 below provides information for preparing 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 from birth to 12 months of age with a weight of 1 to 12 kg. Alternative concentrations can be prepared, but they must have a final concentration range of 1 to 5 mg/ml of dalbavancin.

Refer to Table 1 to confirm 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 Xydalba (final infusion concentration 2 mg/ml or 5 mg/ml for administration via syringe pump) in pediatric patients from birth to 12 months (dose of 22.5 mg/kg)

Patient weight (kg)

Dose (mg) to achieve 22.5 mg/kg

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

Volume of 50 mg/ml (5%) glucose solution to be added for mixing (ml)

Final concentration of dalbavancin infusion solution

Total volume administered via syringe pump (ml)

1

22.5

10 ml

90 ml

2 mg/ml

11.3

2

45.0

22.5

3

67.5

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 unused portion of the reconstituted solution.

Disposal of unused medicinal products and all materials that have come into contact with them must be carried out in accordance with local regulations.

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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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  • 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)
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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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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:

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  • 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.
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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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Alina Tsurkan

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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:

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  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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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.
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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Additional care areas:

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  • 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.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
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Gastroenterology – Digestive health:
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  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION 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 XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
The active ingredient in XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION is dalbavancin. This information helps identify medicines with the same composition but different brand names.
Who manufactures XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION is manufactured by Abbvie Deutschland Gmbh & Co. Kg. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION 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 XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION 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 XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
Other medicines with the same active substance (dalbavancin) include DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, DALBAVANCIN BAXTER 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, DALBAVANCIN SALA 500 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION. 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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