Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dalbavancin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Dalbavancin Baxter contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group. Dalbavancin Baxter is used to treat adults and children from birth with infections of the skin or in the layers of flesh below the skin. This medicine works by killing certain bacteria, which can cause serious infections. It kills these bacteria by interfering with the formation of bacterial cell walls. If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Dalbavancin Baxter.
What you need to know before you take it
Dalbavancin Baxter Do not use Dalbavancin Baxter if you are allergic to 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 being given Dalbavancin Baxter:
- If you have or have had kidney problems. Depending on your age and the condition of your kidney, your doctor may have to reduce your dose.
- If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated with antibiotics.
- If you are allergic to other antibiotics such as vancomycin or teicoplanin. Diarrhoea during or after treatment If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor. Infusion-related reactions Intravenous infusions with these types of antibiotics can cause flushing of the upper body, hives, itching and/or rashes. If you experience these types of reactions your doctor may decide to stop or slow the infusion. Other infections Using antibiotics may sometimes allow a new and different infection to develop. If this happens tell your doctor and they will decide what to do. Other medicines and Dalbavancin Baxter Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding Dalbavancin Baxter is not recommended during pregnancy unless clearly necessary. This is because it is not known what effect it might have on an unborn baby. Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. You and your doctor will decide if you will be given this medicine. It is not known if this medicine passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby. You and your doctor will decide if you will be given Dalbavancin Baxter. You should not breastfeed when given this medicine. Driving and using machines Dalbavancin Baxter may cause dizziness. Take care with driving and using machines after you have been given this medicine. Dalbavancin Baxter contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
How to take it
Dalbavancin Baxter
Dalbavancin Baxter will be given to you by a doctor or nurse. –
Adults: this medicine is given in a single dose of 1 500 mg or in two doses a week apart: 1 000 mg on Day 1 and 500 mg on Day 8. Children and adolescents aged from 6 years to less than 18 years : this medicine is given in a single dose of 18 mg/kg (maximum 1 500 mg). Infants and children aged from birth to less than 6 years : this medicine is given in a single dose of 22.5 mg/kg (maximum 1 500 mg).
The dose for children aged from birth to less than 18 years will be calculated by the doctor based on the age and weight of the child. You will be given this medicine through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes. Patients with chronic kidney problems If you suffer from chronic kidney problems, your doctor may decide to reduce your dose. There is not enough information to recommend the use of Dalbavancin Baxter for children with chronic kidney problems. If you are given more Dalbavancin Baxter than you should Tell your doctor or nurse immediately if you are concerned that you may have been given too much Dalbavancin Baxter. If you miss a dose of Dalbavancin Baxter. Tell your doctor or nurse immediately if you are concerned that you are missing the 2nd dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor straight away if you get any of these symptoms – you may need urgent medical attention:
- Sudden swelling of your lips, face, throat or tongue; severe rash; itchiness; throat tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing. These may all be signs of a hypersensitivity reaction and may be life-threatening. This severe reaction has been reported as a rare side effect. It may affect up to 1 in 1 000 people.
- Abdominal pain (stomach ache) and/or watery diarrhoea. The symptoms may become severe or may not go away and the stools may contain blood or mucus. These may be signs of an infection of the bowel. In this situation, you should not take medicines that stop or slow bowel movement. Infection of the bowel has been reported as an uncommon side effect. It may affect up to 1 in 100 people.
- Changes in hearing. This has been reported as a side effect with a similar medicine. The frequency is not known. The frequency cannot be estimated from the available data. Other side effects reported with Dalbavancin Baxter are listed below. Talk to your doctor, pharmacist or nurse if you get any of the following side effects: Common – may affect up to 1 in 10 people:
- Headache
- Feeling sick (nausea)
- Diarrhoea Uncommon – may affect up to 1 in 100 people:
- Vaginal infections, fungal infections, oral thrush
- Urinary tract infections
- Anaemia (low levels of red blood cells), high blood platelet counts (thrombocytosis), increased blood counts of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cell (leucopenia, neutropenia)
- Changes in other blood tests
- Decreased appetite
- Difficulty sleeping
- Dizziness
- Change in sense of taste
- Inflammation and swelling of surface veins, flushing
- Cough
- Abdominal pain and discomfort, indigestion, constipation
- Abnormal liver function test
- An increase in alkaline phosphatase (an enzyme found in the body)
- Itching, hives
- Genital itching (females)
- Pain, redness or swelling at the place where the infusion was given
- Feeling hot
- Increase in blood levels of gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
- Rash
- Being sick (vomiting) Rare – may affect up to 1 in 1 000 people:
- Difficulty breathing (bronchospasm) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Dalbavancin Baxter
—————————————————————————————————–The following information is intended for healthcare professionals only:
Keep this medicine out of the sight and reach of children.
Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions if kept unopened in the original container. The prepared Dalbavancin Baxter solution for infusion must not be used if there are any particles or the solution is cloudy. Dalbavancin Baxter is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Dalbavancin Baxter contains
- The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
- The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid 1N and/or sodium hydroxide 1N (for pH adjustment only). What Dalbavancin Baxter looks like and contents of the pack Dalbavancin Baxter powder for concentrate for solution for infusion is provided in a single-use 53 ml clear transparent glass vial with a chlorobutyl stopper and a red aluminium flip off seal. The vial contains white to off-white to pale yellow powder. It is available in carton packs containing 1 vial. Marketing Authorisation Holder
Dalbavancin Baxter must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5%) glucose solution for infusion. Dalbavancin Baxter vials are for single-use only. Instructions for reconstitution and dilution Aseptic technique must be used for reconstitution and dilution of Dalbavancin Baxter 1. The content of each vial must be reconstituted by slowly adding 25 ml of water for injections. 2. Do not shake. To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved. The reconstitution time may be up to 5 minutes. 3. The reconstituted concentrate in the vial contains 20 mg /ml dalbavancin. 4. The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles. 5. The reconstituted concentrate must be further diluted with 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 50 mg/ml (5%) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg dalbavancin. 7. After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin 8. The solution for infusion must be clear, colourless to yellow solution with no visible particles. 9. If particulate matter or discoloration is identified, the solution must be discarded. Dalbavancin Baxter must not be mixed with other medicinal products or intravenous solutions. Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution. The compatibility of reconstituted Dalbavancin Baxter concentrate has only been established with 50 mg/ml (5%) glucose solution for infusion. If a common intravenous line is being used to administer other medicinal products in addition to Dalbavancin Baxter,the line should be flushed before and after each Dalbavancin Baxter infusion with 5% glucose solution for infusion.
Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Use in the paediatric population For paediatric patients, the dose of Dalbavancin Baxter will vary according to the age and weight of the child up to a maximum of 1 500 mg. Transfer the required dose of reconstituted dalbavancin solution, according to the instructions above, based on the child's weight, from the vial to an intravenous bag or bottle containing 50 mg/ml (5%) glucose solution for infusion. The diluted solution must have a final dalbavancin concentration of 1 to 5 mg/ml.
Manufacturer Adalvo Limited, Malta Life Science Park, Level 4, Sir Temi Zammit Buildings, Building LS1 San Gwann SGN 3000 Malta Detailed information on this medicine is available on the website of the UK Medicines and Healthcare Products Regulatory Agency This leaflet was last revised in July 2026 07-19-00-0222
Table 1 below provides information to prepare an infusion solution with a final concentration of 2 mg/ ml or 5 mg/ml (sufficient for most scenarios), to be administered by syringe pump, to achieve a dose of 22.5 mg/kg in paediatric patients from birth to 12 months of age weighing from 1 to 12 kg. Alternative concentrations may be prepared, but must have a final concentration range of 1 to 5 mg/ml of dalbavancin. Refer to Table 1 to confirm the calculations. Values shown are approximate. Note that the table is NOT inclusive of all possible calculated doses for every age group but may be utilised to estimate the approximate volume to verify the calculation. Table 1: Preparation of Dalbavancin Baxter (final infusion concentration 2 mg/ml or 5 mg/ml to be administered by syringe pump) in paediatric patients from birth to 12 months (22.5 mg/kg dose) Patient Weight (kg)
Dose (mg) to achieve 22.5 mg/kg
Volume of reconstituted dalbavancin solution (20 mg/ml) to be withdrawn from vial (ml)
Volume of diluent 50 mg/ml (5%) glucose solution to add for mixing (ml)
Final dalbavancin infusion solution concentration
Total Volume Dosed by syringe pump (ml)
1
22.5
11.3
2
45.0
22.5
3
67.5
33.8
4
90.0
5
112.5
6
135.0
67.5
7
157.5
78.8
8
180.0
90.0
9
202.5
40.5
10
225.0
11
247.5
12
270.0
10 ml
20 ml
90 ml
60 ml
2 mg/ml
5 mg/ml
45.0 56.3
45.0 49.5 54.0
Disposal Discard any portion of the reconstituted solution that remains unused. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Frequently asked questions about Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion
How do I take Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion?
Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion comes as infusion containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion?
The active substance in Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion is dalbavancin hydrochloride.
Are there equivalent medicines to Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion?
Medicines with the same active substance, strength and form include: Xydalba 500 mg powder for concentrate for solution for infusion, Dalbavancin 500 mg powder for concentrate for solution for infusion, Dalbavancin 500 mg powder for concentrate for solution for infusion. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dalbavancin hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Dalbavancin Baxter is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Adults
The recommended dose of dalbavancin is 1 500 mg administered as either a single infusion of 1 500 mg or as 1 000 mg followed one week later by 500 mg (see sections 5.1 and 5.2).
Paediatric patients
The recommended dose of dalbavancin is a single dose based on the age and weight of the patient.
Dose of dalbavancin in paediatric patients
Special populations
Elderly
No dose adjustment is necessary (see section 5.2).
Renal impairment
Dose adjustments are not required for adult and paediatric patients with mild or moderate renal impairment (creatinine clearance ≥30 to 79 ml/min). Dose adjustments are not required for adult patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis.
In adult patients with chronic renal impairment whose creatinine clearance is <30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1 000 mg administered as a single infusion or 750 mg followed one week later by 375 mg (see section 5.2).
There is insufficient information to recommend dosage adjustment for patients 3 months to 18 years with creatinine clearance less than 30 ml/min/1.73 m2 and for patients < 3 months old with renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal, or urine output < 0.5 mL/kg/h, or requirement for dialysis. Currently available information is described in section 5.2, but no recommendation on a posology can be made.
Hepatic impairment
No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child‑Pugh A). Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child‑Pugh B and C) as no data are available to determine appropriate dosing (see sections 5.2).
Method of administration
Intravenous use
Dalbavancin Baxter must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30‑minute period. For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Hypersensitivity reactions
Dalbavancin should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur. If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.
Clostridioides (formerly Clostridium) difficile-associated diarrhoea
Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8). In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) difficile should be considered. These patients must never be treated with medicinal products that suppress the peristalsis.
Infusion-related reactions
Dalbavancin Baxter is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions. Rapid intravenous infusions of glycopeptide antibacterial agents can cause reactions including flushing of the upper body, urticaria, pruritus, and/or rash. Stopping or slowing the infusion may result in cessation of these reactions.
Renal impairment
Information on the efficacy and safety of dalbavancin in patients with creatinine clearance <30 ml/min is limited. Based on simulations, dose adjustment is needed for adult patients with chronic renal impairment whose creatinine clearance is <30 ml/min and who are not receiving regular haemodialysis (see sections 4.2 and 5.2). There is insufficient information to recommend dosage adjustment for patients 3 months to 18 years old with creatinine clearance less than 30 ml/min/1.73 m2 and for patients < 3 months old with renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal, or urine output < 0.5 mL/kg/h, or requirement for dialysis.
Mixed infections
In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria (see section 5.1).
Non-susceptible organisms
The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Limitations of the clinical data
There is limited data on safety and efficacy of dalbavancin when administered for more than two doses (one week apart). In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only. There is no experience with dalbavancin in the treatment of severely immunocompromised patients.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium - free'.
4.5. Interaction with other medicinal products and other forms of interaction
Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1).
Clinical drug-drug interaction studies with dalbavancin have not been conducted.
Potential for other medicinal products to affect the pharmacokinetics of dalbavancin
Dalbavancin is not metabolised by CYP enzymes in vitro, therefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of dalbavancin.
It is not known if dalbavancin is a substrate for hepatic uptake and efflux transporters. Co‑administration with inhibitors of these transporters may increase the exposure to dalbavancin. Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine.
Potential for dalbavancin to affect the pharmacokinetics of other medicinal products.
The interaction potential of dalbavancin on medicinal products metabolised by CYP enzymes is expected to be low since it is neither an inhibitor nor an inducer of CYP enzymes in vitro. There are no data on dalbavancin as an inhibitor of CYP2C8.
It is not known if dalbavancin is an inhibitor of transporters. Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of dalbavancin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Dalbavancin Baxter is not recommended during pregnancy, unless the potential expected benefit clearly justifies the potential risk to the foetus.
Breast-feeding
It is unknown whether dalbavancin is excreted in human milk. However, dalbavancin is excreted in the milk of lactating rats and may be excreted in human breast milk. Dalbavancin is not well absorbed orally; however, an impact on the gastrointestinal flora or mouth flora of a breast-feeding infant cannot be excluded. A decision must be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Dalbavancin Baxter taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
Studies in animals have shown reduced fertility (see section 5.3). The potential risk for humans is unknown.
4.7. Effects on ability to drive and use machines
Dalbavancin Baxter may have a minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile
In Phase 2/3 clinical studies, 2 473 adult patients received dalbavancin administered as either a single infusion of 1 500 mg or as 1 000 mg followed one week later by 500 mg. The most common adverse reactions occurring in ≥1% of patients treated with dalbavancin were nausea (2.4%), diarrhoea (1.9%), and headache (1.3%) and were generally of mild or moderate severity.
Tabulated list of adverse reactions (Table 1)
The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin. Adverse reactions are classified according to System Organ Class and frequency. Frequency categories are derived according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000).
Table 1: Tabulated list of adverse reactions
System Organ Class
Common
Uncommon
Rare
Infections and infestations
vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis
Blood and lymphatic system disorders
anaemia, thrombocytosis, eosinophilia, leucopenia, neutropenia
Immune system disorders
anaphylactoid reaction
Metabolism and nutrition disorders
decreased appetite
Psychiatric disorders
insomnia
Nervous system disorders
headache
dysgeusia, dizziness
Vascular disorders
flushing, phlebitis
Respiratory, thoracic and mediastinal disorders
cough
bronchospasm
Gastrointestinal disorders
nausea, diarrhoea
constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting
Skin and subcutaneous tissue disorders
pruritus, urticaria, rash
Reproductive system and breast disorders
vulvovaginal pruritus
General disorders and administration site conditions
infusion-related reactions
Investigations
blood lactate dehydrogenase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood uric acid increased, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, platelet count increased, body temperature increased, hepatic enzyme increased, gamma-glutamyl transferase increased
Description of selected adverse reactions
Class adverse reactions
Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic medicinal product, such as an aminoglycoside, may be at increased risk.
Paediatric population
The safety of dalbavancin was evaluated in one Phase 3 clinical trial which included 169 paediatric patients from birth to less than 18 years of age with ABSSSI (or suspected or confirmed sepsis if aged less than 3 months old) treated with dalbavancin (91 patients treated with a single dose of dalbavancin and 78 patients, all of them aged 3 months and older, treated with a two-dose regimen of dalbavancin). Out of these 169 paediatric patients, 58 were adolescents (12 years and older), 49 were children from 6 years to less than 12 years, 35 were 2 years to less than 6 years, 17 were aged 3 months to less than 2 years, and 10 were under 3 months of age. Additionally, in a Phase 1, open-label, pharmacokinetic trial, a single-dose administration of dalbavancin was evaluated in 8 patients under 3 months of age. Across these two clinical studies, 18 children were under 3 months of age, including 3 preterm and 5 term neonates. Overall, the safety findings of dalbavancin in these paediatric patients were similar to those observed in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No specific information is available on the treatment of overdose with dalbavancin, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered single doses of up to 1 500 mg, and cumulative doses up to 4 500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern. In Phase 3 studies, patients have been administered single doses of up to 1 500 mg.
Treatment of overdose with dalbavancin should consist of observation and general supportive measures. Although no information is available specifically regarding the use of haemodialysis to treat overdose, it should be noted that in a Phase 1 study in patients with renal impairment, less than 6% of the recommended dalbavancin dose was removed after 3 hours of haemodialysis.
💬 Ask about this leaflet
Ask anything about Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.