Vancomycin reig jofre

Package leaflet: Information for the user

Vancomycin Reig Jofre, 500 mg, powder for solution for infusion concentrate
Vancomycin Reig Jofre, 1000 mg, powder for solution for infusion concentrate
Vancomycini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Leaflet contents:

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

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

Vancomycin Reig Jofre is an antibiotic belonging to the glycopeptide class of antibiotics.
Vancomycin Reig Jofre works by killing certain bacteria that cause infections.
Vancomycin Reig Jofre in powder form is used to prepare an infusion solution concentrate.
Vancomycin Reig Jofre is administered by infusion in all age groups for the treatment of the following serious infections:

• Skin and soft tissue infections.
• Bone and joint infections.
• Lung infections known as "pneumonia".
• Infections of the inner lining of the heart (endocarditis).

2. Important information before using Vancomycin Reig Jofre

When not to use Vancomycin Reig Jofre

• if the patient is allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting vancomycin, discuss this with the doctor, hospital pharmacist, or nurse if:

• the patient has previously had an allergic reaction to teicoplanin, as this may indicate that the patient is also allergic to vancomycin.

• the patient has hearing problems, particularly if elderly (hearing tests may be necessary during treatment).

• the patient has impaired kidney function (blood tests and liver and kidney function tests will be required during treatment).

• the patient is receiving vancomycin by infusion to treat diarrhoea associated with Clostridium difficile infection instead of oral administration.

• the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after receiving vancomycin.

During treatment with vancomycin, discuss this with the doctor, hospital pharmacist, or nurse if:

• the patient is receiving vancomycin for a prolonged period (blood tests and liver and kidney function tests may be required during treatment).
• the patient develops any skin reaction during treatment.
• the patient develops severe or persistent diarrhoea during or after completion of vancomycin treatment; in such a case, immediate medical advice should be sought. This may be a sign of intestinal inflammation (pseudomembranous colitis), which can occur during antibiotic treatment.

Severe skin reactions have been reported with vancomycin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient notices any of the symptoms described in section 4, vancomycin should be discontinued immediately and medical advice sought without delay. Serious adverse events have occurred when vancomycin has been administered into the eye, potentially leading to vision loss.

Children
Vancomycin will be used with particular caution in premature infants and young infants, as their kidneys are not fully developed, which may lead to accumulation of vancomycin in the blood. In this age group, blood tests may be necessary to monitor vancomycin blood levels.
Concomitant administration of vancomycin and anaesthetic agents in children has been associated with skin redness (flushing) and allergic reactions. Additionally, concurrent use with other medicines such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), or amphotericin B (an antifungal agent) may increase the risk of kidney damage, necessitating more frequent blood and kidney function tests.

Elderly patients
In elderly patients, the doctor will adjust the dose of Vancomycin Reig Jofre, as kidney filtration capacity naturally decreases with age, increasing the risk of elevated drug levels in the blood.

Vancomycin Reig Jofre and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
The following medicines may interact with Vancomycin Reig Jofre or vancomycin may affect their action, potentially leading to adverse effects when used concomitantly:

• anaesthetic agents: concomitant use increases the risk of certain vancomycin adverse effects such as low blood pressure, skin redness, urticaria, cardiac depression, and itching.
• muscle relaxants: simultaneous use of muscle relaxants (e.g. succinylcholine) may enhance or prolong their muscle-relaxing effect.
• oral anticoagulants: when warfarin is used concomitantly, its anticoagulant effect may be enhanced.
• medicines with potential nephrotoxic or ototoxic effects: medicines used to treat bacterial infections (e.g. polymyxin B, colistin, bacitracin, aminoglycosides, piperacillin with tazobactam), antifungal agents (amphotericin B), antituberculosis agents (viomycin), antineoplastic agents (cisplatin), platinum-based chemotherapy agents, certain diuretics. When used concomitantly with vancomycin, these harmful effects may be intensified. In such cases, the doctor will closely monitor and regularly assess the patient's hearing.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning pregnancy, she should consult her doctor or pharmacist before using this medicine.
Vancomycin Reig Jofre should be used during pregnancy and breastfeeding only if absolutely necessary. The doctor may advise discontinuation of breastfeeding.

Driving and operating machinery
Vancomycin Reig Jofre has no effect or negligible effect on the ability to drive or operate machinery.

3. How to use Vancomycin Reig Jofre

Vancomycin Reig Jofre will be administered to the patient by medical personnel during hospitalization. The physician will decide the daily dose required and the duration of treatment.

Dosage
The dose administered will depend on:

• the patient's age,
• the patient's body weight,
• the type of infection,
• kidney function status,
• the patient's hearing status,
• any other medications the patient is taking.

Method of administration
Intravenous infusion means that the medicine flows from an infusion bottle or bag through a tube into one of the patient's veins. The physician or nurse will always administer vancomycin intravenously into the bloodstream, and never into muscle.
Vancomycin will be administered into the vein over at least 60 minutes.
If you have any further questions regarding the use of this medicine, please consult your doctor or healthcare professional.

Intravenous administration
Adults and adolescents (aged 12 years and older)
The dose will be calculated based on the patient's body weight. The usual infusion dose ranges from 15 mg to 20 mg per kg of body weight. This dose is usually given every 8 to 12 hours.
In certain cases, the physician may decide to use an initial dose of up to 30 mg per kilogram of body weight. The maximum daily dose of vancomycin should not exceed 2 g.

Use in children
Children from 1 month of age up to below 12 years
The dose will be calculated based on the patient's body weight. The usual infusion dose ranges from 10 mg to 15 mg per kilogram of body weight. This dose is usually administered every 6 hours.

Preterm neonates and full-term newborns (from 0 to 27 days)
The dose will be calculated based on postconceptional age [the time elapsed from the first day of the mother's last menstrual period to delivery (gestational age) plus the time elapsed since birth (postnatal age)].

Other patient groups
Different dosing may be required for elderly patients, pregnant women, and patients with impaired kidney function, including dialysis patients.

Administration of a higher than recommended dose of Vancomycin Reig Jofre
If the patient suspects having received an excessive dose of Vancomycin Reig Jofre and feels unwell, they should contact their doctor or medical personnel immediately. The physician will assess the amount of Vancomycin Reig Jofre administered. If blood tests and other examinations indicate that there is too much Vancomycin Reig Jofre in the body, the dose will be reduced or treatment will be suspended or discontinued. This will allow the concentration of the medicine remaining in the blood to decrease.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Vancomycin may cause allergic reactions, but severe allergic reactions (anaphylactic reactions) are rare. If the patient suddenly develops a wheezing breath, difficulty breathing, redness of the upper body, rash or itching, inform the doctor immediately.
Treatment with vancomycin should be discontinued and medical advice should be sought immediately if the patient notices any of the following symptoms:

• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

Common adverse reactions (may occur in fewer than 1 in 10 people):

• Decrease in blood pressure
• Shortness of breath, wheezing (a high-pitched sound caused by an obstruction in the airflow in the upper respiratory tract)
• Rash and inflammation of the oral mucosa, itching, itchy rash, urticaria
• Kidney function disorders, usually detected in blood tests
• Redness of the upper body and face, phlebitis

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):

• Transient or permanent hearing loss

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):

• Decreased number of white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting)
• Increased number of certain white blood cells in the blood
• Balance disorders, tinnitus, dizziness
• Vasculitis
• Nausea
• Kidney inflammation and kidney failure
• Chest and back muscle pain
• Fever, chills

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):

• Sudden onset of severe skin allergic reaction involving skin peeling or blistering. This may be accompanied by high fever and joint pain
• Cardiac arrest
• Intestinal inflammation causing abdominal pain and diarrhea, which may contain blood

Frequency not known (frequency cannot be estimated from the available data)

• Vomiting, diarrhea
• Confusion, drowsiness, lack of energy, swelling, fluid retention, reduced urine output
• Rash with swelling and pain behind the ears, neck, groin, under the chin, and under the arms (swelling of lymph nodes), abnormal blood test results and liver function abnormalities
• Rash with blisters and fever

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vancomycin Reig Jofre

The physician will be responsible for the storage of the medicinal product.
The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the outer carton and vial after "EXP". The expiry date refers to the last day of the specified month.

Powder in the retail package:
Do not store above 25°C.

Concentrate after reconstitution:
After reconstitution, the concentrate should be further diluted immediately.

Storage time of the diluted product:
Chemical and physical stability of the product protected from light has been demonstrated for 8 hours at temperatures below 25°C and for 14 days at 2–8°C after dissolution in 9 mg/mL (0.9%) sodium chloride solution or 50 mg/mL (5%) glucose solution.

From a microbiological point of view, the medicinal product should be used immediately.
If the medicinal product is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should generally not exceed 24 hours at a temperature of 2 to 8°C, unless reconstitution and dilution were carried out under controlled and validated aseptic conditions.

Solutions after reconstitution and dilution should be inspected visually for particulate matter and discoloration prior to administration. Only clear, colourless solutions free from visible particles should be used.

Medicinal products must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Vancomycin Reig Jofre contains
The active substance is vancomycin hydrochloride.
Vancomycin Reig Jofre, 500 mg, powder for solution for concentrate for infusion:
Each vial contains 500 mg vancomycin (as vancomycin hydrochloride), equivalent to
500,000 I.U. of vancomycin.
After reconstitution with 10 mL of water for injections, the prepared concentrate solution for infusion contains
50 mg/mL vancomycin hydrochloride.
Vancomycin Reig Jofre, 1000 mg, powder for solution for concentrate for infusion:
Each vial contains 1000 mg vancomycin (as vancomycin hydrochloride), equivalent to
1,000,000 I.U. of vancomycin.
After reconstitution with 20 mL of water for injections, the prepared concentrate solution for infusion contains
50 mg/mL vancomycin hydrochloride.

What Vancomycin Reig Jofre looks like and contents of the pack
Vancomycin Reig Jofre 500 mg:

• White or almost white powder, contained in a clear glass vial with a white flip-off cap, packed in a cardboard box.

Pack sizes: 1 or 10 vials.
Vancomycin Reig Jofre 1000 mg:

• White or almost white powder, contained in a clear glass vial with a blue flip-off cap, packed in a cardboard box.

Pack sizes: 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warszawa
e-mail: [email protected]
Tel.: +48 22 487 88 49
{logo of the marketing authorisation holder}

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

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark Vancomycin Reig Jofre 500mg, powder for concentrate for infusion solution
Vancomycin Reig Jofre 1000mg, powder for concentrate for infusion solution
Finland Vancomycin Reig Jofre 500mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Vancomycin Reig Jofre 1000mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
France Vancomycine Reig Jofre 500mg, poudre pour solution à diluer pour perfusion
Vancomycine Reig Jofre 1000mg, poudre pour solution à diluer pour perfusion
Norway Vancomycin Reig Jofre
Poland Vancomycin Reig Jofre
Portugal Vancomicina Reig Jofre 500mg pó para concentrado para solução para perfusão
Vancomicina Reig Jofre 1000mg pó para concentrado para solução para perfusão
Sweden Vancomycin Reig Jofre 500mg pulver till koncentrat till infusionsvätska, lösning
Vancomycin Reig Jofre 1000mg pulver till koncentrat till infusionsvätska, lösning
Italy Vancomicina Reig Jofre

Information intended exclusively for healthcare professionals

500 mg:
Reconstitute the contents of each vial with 10 mL of sterile water for injection. The reconstituted solution should be further diluted in at least 100 mL of 9 mg/mL (0.9%) sodium chloride solution for injection or 50 mg/mL (5%) glucose solution for injection.
1000 mg:
Reconstitute the contents of each vial with 20 mL of sterile water for injection. The reconstituted solution should be further diluted in at least 200 mL of 9 mg/mL (0.9%) sodium chloride solution for injection or 50 mg/mL (5%) glucose solution for injection.
The vancomycin concentration in the final infusion solution should not exceed 5 mg/mL.
In patients with restricted fluid intake, a solution with a concentration up to 10 mg/mL may be used.
The use of such high concentrations may increase the risk of adverse reactions associated with infusion administration.
After reconstitution and dilution, solutions should be inspected visually for particulate matter and discoloration prior to administration. Only clear, colorless or pale yellow solutions, free from visible particles, should be used.
The infusion solution must not be mixed with other medicinal products.

Infusion
Administer via slow intravenous infusion over at least 60 minutes, at a maximum rate of 10 mg/min, corresponding to 2 mL/min for a solution with a concentration of 5 mg/mL.

Dosage
Adults and children over 12 years of age
The recommended intravenous dose is 2000 mg (2 g) per day, administered as 500 mg every 6 hours or 1000 mg (1 g) every 12 hours. Recovery usually occurs within 48–72 hours. The total duration of treatment depends on the type and severity of infection and the individual clinical response of the patient.

Children and adolescents

• Children from 1 month of age to 12 years: 40 mg/kg body weight/day: usually divided into four doses (e.g., 10 mg/kg body weight every 6 hours).
  Each dose should be administered over at least 60 minutes.

• Newborns (full-term): Days 0–7: initial dose 15 mg/kg body weight, followed by 10 mg/kg body weight every 12 hours. Days 7–30: initial dose 15 mg/kg body weight, followed by 10 mg/kg body weight every 8 hours. Each dose should be administered over at least 60 minutes. In these patients, close monitoring of serum vancomycin concentrations may be necessary.

Elderly patients
Due to age-related decline in renal function, reduced maintenance doses may be required.

Pregnancy
It has been reported that to achieve therapeutic serum concentrations, a significant dose increase may be necessary.

Storage
Do not store Vancomycin Reig Jofre above 25°C.
Do not use Vancomycin Reig Jofre after the expiry date stated on the cardboard package.
Storage conditions after reconstitution and further dilution are described in section 5.