Dalbavancin reig jofre

Package leaflet: Information for the patient

Dalbavancin Reig Jofre, 500 mg, powder for solution for infusion concentrate
Dalbavancinum
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Dalbavancin Reig Jofre is and what it is used for
2. Important information before using Dalbavancin Reig Jofre
3. How to use Dalbavancin Reig Jofre
4. Possible side effects
5. How to store Dalbavancin Reig Jofre
6. Contents of the pack and other information

1. What Dalbavancin Reig Jofre is and what it is used for

Dalbavancin Reig Jofre contains the active substance called dalbavancin, which is an
antibiotic belonging to the glycopeptide class.
Dalbavancin Reig Jofre is used in the treatment of adults and children aged 3 months and older
with skin infections or soft tissue infections under the skin.
Dalbavancin Reig Jofre works by killing certain bacteria that may cause serious infections. These bacteria are killed by interfering with the formation of their bacterial cell walls.
If the infection is caused by other types of bacteria as well, your doctor may decide to use additional antibiotics alongside Dalbavancin Reig Jofre.

2. Important information before using Dalbavancin Reig Jofre

Do not use Dalbavancin Reig Jofre if the patient is allergic to dalbavancin or
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Dalbavancin Reig Jofre, discuss this with the doctor,
pharmacist, or nurse:

• If the patient currently has or has had kidney disease in the past. Depending on the patient's age and kidney function, the doctor may decide to reduce the dose.
• If the patient has diarrhoea or has previously experienced diarrhoea during antibiotic treatment.
• If the patient is allergic to other antibiotics, such as vancomycin or teicoplanin.

Diarrhoea during or after treatment
If diarrhoea occurs during or after completion of treatment, the patient must immediately inform
the doctor. Do not take any anti-diarrhoeal medicines without first consulting
a doctor.

Reactions at the infusion site
Intravenous infusions of this type of antibiotic may cause sudden redness of the upper body,
urticaria, itching, and/or rash. If such a reaction occurs, the doctor may decide
to discontinue treatment or reduce the infusion rate.

Other infections
Antibiotic use may sometimes lead to the development of a new, different infection. In such
a case, the patient should consult the doctor, who will decide on further management.

Children
This medicine must not be given to children under 3 months of age. There have been
insufficient studies on the use of Dalbavancin Reig Jofre in children under 3 months of age.

Dalbavancin Reig Jofre and other medicines
Inform the doctor or pharmacist about all medicines currently being taken, recently taken, or
planned to be taken.

Pregnancy and breastfeeding
Use of Dalbavancin Reig Jofre during pregnancy is not recommended unless absolutely
necessary. This is because it is unknown what effect this medicine may have on the unborn
child. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to
become pregnant, she should consult a doctor before using this medicine. The decision on using
Dalbavancin Reig Jofre will be made jointly by the doctor and the patient.

It is unknown whether Dalbavancin Reig Jofre passes into human milk. Before using
this medicine during breastfeeding, the patient should consult a doctor. The decision on
administering Dalbavancin Reig Jofre will be made jointly by the doctor and the patient. Breastfeeding
must not be continued during treatment with Dalbavancin Reig Jofre.

Driving and operating machinery
Dalbavancin Reig Jofre may cause dizziness. After receiving this medicine, caution should be
exercised when driving or operating machinery.

Dalbavancin Reig Jofre contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Dalbavancin Reig Jofre

Dalbavancin Reig Jofre will be administered by a doctor or nurse.

• Adults: Dalbavancin Reig Jofre is given as a single dose of 1500 mg or
  in two doses one week apart: 1000 mg on day 1 and 500 mg on day 8.

• Children and adolescents from 6 years to less than 18 years of age: Dalbavancin Reig Jofre is given as a single dose of 18 mg/kg body weight (maximum 1500 mg).

• Infants and children from 3 months to less than 6 years of age: Dalbavancin Reig Jofre is given as a single dose of 22.5 mg/kg body weight (maximum 1500 mg).

The dose for children from 3 months to less than 18 years of age will be calculated by the doctor based on the child's age and body weight.
Dalbavancin Reig Jofre will be administered intravenously, as an infusion directly into the bloodstream, over 30 minutes.

Patients with chronic kidney disease
If the patient has chronic kidney disease, the doctor may decide to reduce the dose. There are insufficient data to recommend the use of Dalbavancin Reig Jofre in children with chronic kidney disease.

If more Dalbavancin Reig Jofre has been administered than recommended
If an overdose of Dalbavancin Reig Jofre is suspected, immediately inform the doctor or nurse.

If a dose of Dalbavancin Reig Jofre has been missed
If there is suspicion that the second dose of the medicine was not administered, immediately inform the doctor or nurse.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following symptoms occur, contact your doctor immediately,
as urgent medical attention may be required:

• Sudden swelling of the lips, face, throat or tongue; severe rash; itching; tightness in the throat; drop in blood pressure; difficulty swallowing and/or difficulty breathing. These may be symptoms of a hypersensitivity reaction, which could be life-threatening. Such serious reactions have been reported as a rare adverse reaction. They may occur in fewer than 1 in 1,000 people.
• Abdominal pain (stomach pain) and/or watery diarrhoea. Symptoms may worsen or persist, and stools may contain blood or mucus. These may be symptoms of intestinal infection. In this case, do not take medicines that inhibit or slow down intestinal motility (peristalsis). Intestinal infection is an adverse reaction that occurs uncommonly. It may occur in fewer than 1 in 100 people.
• Changes in hearing. This adverse reaction has been reported with use of a similar medicine. The frequency is unknown. Frequency cannot be estimated from available data.

Other adverse reactions occurring during treatment with Dalbavancin Reig Jofre
are listed below.
If any of the following adverse reactions occur, inform your doctor, pharmacist or nurse:
Common – may occur in fewer than 1 in 10 people:

• Headache
• Nausea
• Diarrhoea

Uncommon – may occur in fewer than 1 in 00 people:

• Vaginal infections, fungal infections, oral candidiasis
• Urinary tract infections
• Anaemia (low red blood cell count), increased platelet count (thrombocytosis), increased number of white blood cells called eosinophils (eosinophilia), low count of other types of white blood cells (leukopenia, neutropenia)
• Changes in results of other blood tests
• Decreased appetite
• Difficulty sleeping
• Dizziness
• Altered taste sensation
• Inflammation and swelling of superficial veins, redness
• Cough
• Abdominal pain, abdominal discomfort, indigestion, constipation
• Abnormal liver function test results
• Increased alkaline phosphatase activity (an enzyme present in the body)
• Itching, urticaria
• Genital itching (in women)
• Pain, redness or swelling at the infusion site
• Feeling of warmth
• Increased gamma-glutamyl transferase (GGT) activity (an enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

Rare – may occur in fewer than 1 in 1,000 people:

• Breathing difficulties (bronchospasm).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dalbavancin Reig Jofre

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine, provided it is stored in the original closed packaging.
Do not use the prepared infusion solution of Dalbavancin Reig Jofre if solid particles are present or if the solution is cloudy.
Dalbavancin Reig Jofre is intended 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Dalbavancin Reig Jofre contains

• The active substance is dalbavancin. Each vial contains 500 mg of dalbavancin in the form of dalbavancin hydrochloride. After reconstitution, each mL of concentrate contains 20 mg of dalbavancin. After dilution, the final concentration of dalbavancin in the infusion solution should range from 1 mg/mL to 5 mg/mL.
• Other ingredients are: mannitol, lactose monohydrate, hydrochloric acid, concentrated, and/or sodium hydroxide (for pH adjustment).

What Dalbavancin Reig Jofre looks like and contents of the pack
Dalbavancin Reig Jofre, as a powder for concentrate solution for infusion,
is available in a 50 mL glass vial with a green flip-off cap. The vial contains
a white or almost white to pale yellow powder.
The medicine is available in packs containing 1 vial, in a cardboard box.

Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw
e-mail: [email protected]
Telephone: +48 22 487 88 49

Manufacturer
Laboratorio Reig Jofre, S.A.
Gran Capitan, 10
08970 Sant Joan Despí, Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Dalbavancine Reig Jofre 500 mg poudre pour solution à diluer pour perfusion
Spain: Dalbavancina Sala 500 mg polvo para concentrado para solución para perfusión EFG
Poland: Dalbavancin Reig Jofre
Sweden: Dalbavancin Bioglan

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL): www.urpl.gov.pl.

Information intended exclusively for healthcare professionals:

Important: Before prescribing the medicinal product, refer to the Summary of Product Characteristics (SmPC).
The medicinal product Dalbavancin Reig Jofre must be reconstituted with sterile water for injections and subsequently diluted with 5% glucose infusion solution (50 mg/mL).
Vials of the medicinal product Dalbavancin Reig Jofre are for single use only.

Instructions for reconstitution and dilution
Aseptic technique must be used during reconstitution and dilution of the medicinal product Dalbavancin Reig Jofre.

1. Reconstitute the contents of each vial by slowly adding 25 mL of water for injections.
2. Do not shake. To avoid foaming, gently rotate and invert the vial alternately until the contents are completely dissolved. Reconstitution may take up to 5 minutes.
3. The reconstituted concentrate in the vial contains 20 mg/mL of dalbavancin.
4. After reconstitution, the concentrate should be a clear, colourless to yellow solution, free from visible particles.
5. The reconstituted concentrate must be diluted with 5% glucose infusion solution (50 mg/mL).
6. To dilute the reconstituted concentrate, transfer the appropriate volume of the 20 mg/mL concentrate from the vial into an infusion bag or bottle containing 5% glucose infusion solution (50 mg/mL). For example: 25 mL of concentrate contains 500 mg of dalbavancin.
7. After dilution, the final concentration of dalbavancin in the infusion solution should be between 1 mg/mL and 5 mg/mL.
8. The infusion solution should be a clear, colourless to yellow solution, free from visible particles.
9. If visible particulate matter or discoloration is present, the solution must be discarded.

The medicinal product Dalbavancin Reig Jofre must not be mixed with other medicinal products or intravenous infusion solutions. Solutions containing sodium chloride may cause precipitation and MUST NOT be used for reconstitution or dilution of the medicinal product.
Compatibility of the reconstituted concentrate of the medicinal product Dalbavancin Reig Jofre has been confirmed only with 5% glucose infusion solution (50 mg/mL).
When using a common intravenous line to administer Dalbavancin Reig Jofre and other medicinal products, the line must be flushed with 5% glucose infusion solution before and after each Dalbavancin Reig Jofre infusion.

Use in children and adolescents
In children and adolescents, the dose of the medicinal product Dalbavancin Reig Jofre will vary depending on the age and body weight of the child, with a maximum dose of 1500 mg. The required dose of reconstituted dalbavancin solution, calculated based on the child's body weight, should be transferred from the vial to an infusion bag or bottle containing 5% glucose infusion solution (50 mg/mL), according to the instructions above. After dilution, the final concentration of dalbavancin in the solution should be between 1 mg/mL and 5 mg/mL.

Table 1 below provides information on the preparation of an infusion solution with a final concentration of 2 mg/mL or 5 mg/mL (sufficient for most scenarios) for administration via syringe pump, to achieve a dose of 22.5 mg/kg body weight in children and adolescents aged 3 to 12 months and weighing 3 to 12 kg. Alternative concentrations may be prepared, but the final concentration of dalbavancin must be within the range of 1 mg/mL to 5 mg/mL. Refer to Table 1 to verify calculations. The values provided are approximate. Note that the table does NOT include all possible calculated doses for each age group, but may be used to estimate approximate volume for verification of calculations.

Table 1. Preparation of the medicinal product Dalbavancin Reig Jofre (final infusion solution concentration 2 mg/mL or 5 mg/mL for administration via syringe pump) in children and adolescents aged 3 to 12 months (dose 22.5 mg/kg b.w.).

Disposal
All unused portions of the reconstituted solution must be discarded.
Any unused remnants of the medicinal product or its waste must be disposed of in accordance with local regulations.