Dalbavancin Reig Iofre

Leaflet attached to the packaging: patient information

Dalbavancin Reig Jofre, 500 mg, powder for concentrate for solution for infusion

Dalbavancin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Dalbavancin Reig Jofre and what is it 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 packaging and other information

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

Dalbavancin Reig Jofre contains the active substance dalbavancin, which is an antibioticfrom the glycopeptide group.
Dalbavancin Reig Jofre is used to treat adults and children from 3 months
and older with skin or soft tissue infections.
The action of Dalbavancin Reig Jofre is based on killing certain bacteria that can cause
severe infections. These bacteria are killed as a result of disrupting the formation of bacterial cell walls.
In the case of an infection caused by other bacteria as well, the doctor may decide to use other antibiotics in addition to Dalbavancin Reig Jofre.

2. Important information before using Dalbavancin Reig Jofre

Do not use Dalbavancin Reig Jofreif the patient is allergicto dalbavancin or
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Dalbavancin Reig Jofre, the following should be discussed with the doctor, pharmacist, or nurse:

• If the patient currently has or has had kidney diseasein the past. Depending on the patient's age and kidney function, the doctor may decide to reduce the dose.
• If the patient has diarrheaor if diarrhea occurred during previous antibiotic treatment.
• If the patient is allergicto other antibiotics, such as vancomycin or teicoplanin.

Diarrhea during or after treatment
If diarrhea occurs duringor aftertreatment, the doctor should be informed immediately. No medication for diarrhea should be taken without prior consultation with the doctor.
Reactions at the infusion site
Infusions of this type of antibiotic can cause sudden redness of the upper body,
hives, itching, and (or) rash. If such a reaction occurs, the doctor may decide to discontinue treatment or reduce the infusion rate.
Other infections
Using antibiotics can sometimes lead to the development of a new, different infection. In such a situation, the doctor should be consulted, who will decide on further action.

Children

This medicine should not be given to children under 3 months of age. There have been no sufficient studies on the use of Dalbavancin Reig Jofre in children under 3 months of age.

Dalbavancin Reig Jofre and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

The use of Dalbavancin Reig Jofre is not recommended during pregnancy, unless it is absolutely necessary. This is because it is not known what effect this medicine may have on the unborn child. If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine. The decision to use Dalbavancin Reig Jofre will be made by the doctor together with the patient.
It is not known whether Dalbavancin Reig Jofre passes into breast milk. Before taking the medicine during breastfeeding, the doctor should be consulted. The decision to administer Dalbavancin Reig Jofre will be made by the doctor together with the patient. Breastfeeding should not be done while taking Dalbavancin Reig Jofre.

Driving and using machines

Dalbavancin Reig Jofre may cause dizziness. After taking this medicine, caution should be exercised when driving vehicles and operating machines.

Dalbavancin Reig Jofre contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means 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 administered in a single dose of 1500 mg or

in two doses at an interval of one week: 1000 mg on day 1 and 500 mg on day 8.

• Children and adolescents from 6 years to less than 18 years:Dalbavancin Reig Jofre is administered in a single dose of 18 mg/kg body weight (maximum 1500 mg).
• Infants and children from 3 months to less than 6 years:Dalbavancin Reig Jofre is administered in 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 will be calculated by the doctor based on the child's age and weight.
Dalbavancin Reig Jofre will be administered intravenously, by infusion directly into the bloodstream, for 30 minutes.

Patients with chronic kidney disease

If the patient has chronic kidney disease, the doctor may decide to reduce the dose. There is a lack of sufficient data to recommend the use of Dalbavancin Reig Jofre in children with chronic kidney disease.

Taking a higher than recommended dose of Dalbavancin Reig Jofre

In case of suspected overdose of Dalbavancin Reig Jofre, the doctor or nurse should be informed immediately.

Missing a dose of Dalbavancin Reig Jofre

In case of suspected missed dose, the doctor or nurse should be informed immediately.
In case of any further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

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

Severe side effects

If any of the following symptoms occur, the doctor should be contacted immediately, as urgent medical attention may be needed:

• Sudden swelling of the lips, face, throat, or tongue; severe rash; itching; throat constriction; blood pressure drop; difficulty swallowing and (or) difficulty breathing.These may be symptoms of an allergic reaction, which can be life-threatening. Such severe reactions have been reported as rare side effects. They may occur less frequently than in 1 in 1000 people.
• Abdominal pain (stomach pain)and (or) watery diarrhea. Symptoms may worsen or may not improve, and stools may contain blood or mucus. These may be symptoms of intestinal infection. In this case, do nottake medications that inhibit or slow down bowel movements (peristalsis). Intestinal infection is a side effect that occurs not very often. It may occur less frequently than in 1 in 100 people.
• Changes in hearing.This side effect has been reported in the case of a similar medicine. The frequency of occurrence is unknown. The frequency cannot be determined based on available data.

Other side effects that occur when using Dalbavancin Reig Jofre are listed below.

In case of any of the following side effects, the doctor, pharmacist, or nurse should be informed:

Common- may occur less frequently than in 1 in 10 people:

• Headache
• Nausea
• Diarrhea

Uncommon- may occur less frequently than in 1 in 100 people

• Vaginal infections, fungal infections, oral thrush
• Urinary tract infections
• Anemia (low red blood cell count), high platelet count (thrombocytosis), increased count of white blood cells called eosinophils (eosinophilia), low count of other types of white blood cells (leukopenia, neutropenia)
• Changes in blood test results
• Decreased appetite
• Sleeping difficulties
• Dizziness
• Taste changes
• Phlebitis and swelling of superficial veins, redness
• Cough
• Abdominal pain, discomfort in the abdomen, indigestion, constipation
• Abnormal liver function test results
• Increased activity of alkaline phosphatase (an enzyme found in the body)
• Itching, hives
• Genital itching (in women)
• Pain, redness, or swelling at the infusion site
• Feeling of heat
• Increased activity of gamma-glutamyltransferase (an enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

Rare- may occur less frequently than in 1 in 1000 people:

• Breathing difficulties (bronchospasm).

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa; tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dalbavancin Reig Jofre

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the vial after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storing this medicine, provided it is stored in the original packaging.
The prepared infusion solution of Dalbavancin Reig Jofre should not be used if it contains solid particles or is cloudy.
Dalbavancin Reig Jofre is intended for single use.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dalbavancin Reig Jofre contains

• The active substance of the medicine is dalbavancin. Each vial of powder 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 be between 1 mg/mL and 5 mg/mL.
• The other ingredients are: mannitol, lactose monohydrate, hydrochloric acid, and (or) sodium hydroxide (to adjust pH).

What Dalbavancin Reig Jofre looks like and what the pack contains

Dalbavancin Reig Jofre is available as a powder for concentrate for solution for infusion 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 authorization holder and manufacturer

Marketing authorization holder

Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warszawa
e-mail: biuro@reigjofre.com
Phone: +48 22 487 88 49

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

France:
Dalbavancine Reig Jofre 500 mg powder for solution for infusion
Spain: Dalbavancina Sala 500 mg powder for concentrate for solution for infusion EFG
Poland:
Dalbavancin Reig Jofre
Sweden:
Dalbavancin Bioglan

Date of last revision of the leaflet:

Other sources of information

Detailed information about this medicine is available on the website of URPL: www.urpl.gov.pl.
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Information intended for healthcare professionals only:

Important:before prescribing the medicine, the Summary of Product Characteristics (SmPC) should be consulted.
Dalbavancin Reig Jofre should be reconstituted in sterile water for injections and then diluted with a 5% glucose solution for infusion.
The vials of Dalbavancin Reig Jofre are for single use only.
Instructions for reconstitution and dilution
During reconstitution and dilution of Dalbavancin Reig Jofre, aseptic technique should be used.

• 1. The contents of each vial should be reconstituted by slowly adding 25 mL of water for injections.
• 2. Do not shake.To avoid foaming, the vial should be slowly and gently rotated and inverted until the contents are completely dissolved. Reconstitution may take up to 5 minutes.
• 3. The concentrate in the vial after reconstitution contains 20 mg/mL of dalbavancin.
• 4. After reconstitution, the concentrate should be a clear, colorless to yellow solution without visible particles.
• 5. The reconstituted concentrate should be diluted with a 5% glucose solution for infusion.
• 6. To dilute the reconstituted concentrate, the required volume of dalbavancin solution should be transferred from the vial to an infusion bag or bottle containing a 5% glucose solution for infusion. 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, colorless to yellow solution without visible particles.
• 9. If particles or discoloration are visible, the solution should be discarded.

Disposal
Any unused reconstituted solution should be discarded.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

Table 1. Preparation of Dalbavancin Reig Jofre (final infusion solution concentration 2 mg/mL or 5 mg/mL for administration via a syringe pump) in children and adolescents from 3 to 12 months (dose 22.5 mg/kg body weight).

Disposal
All unused reconstituted solution should be discarded.
Any unused medicine or waste material should be disposed of in accordance with local regulations.