VibraVenosa 100 mg solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vibravenosa 100 mg solution for injection and infusion

Doxycycline

Read the entire leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Vibravenosa is and what it is used for
2. What you need to know before using Vibravenosa
3. How to use Vibravenosa
4. Possible side effects
5. How to store Vibravenosa
6. Contents of the pack and other information

1. What Vibravenosa is and what it is used for

Vibravenosa contains doxycycline, an antibiotic that belongs to a group of medicines called tetracyclines.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is used in adults, adolescents, and children over 8 years of age for:

• the treatment of the following infections:

• Atypical pneumonia.

• Psittacosis (a disease transmitted by certain birds, presenting as pneumonia accompanied by fever and cough).

• Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), proctitis (inflammation of the rectum), lymphogranuloma venereum (an infection initially characterized by genital ulcers followed by lymph node swelling), granuloma inguinale (purulent ulceration of the genitals), pelvic inflammatory disease, acute purulent orchiepididymitis (inflammation of the testicles, mainly affecting newborns).

• Ocular infections such as: trachoma, inclusion conjunctivitis (eye infection with conjunctival inflammation and irritation).

• Typhus and other infections caused by microorganisms called rickettsiae.

• Q fever.

• Brucellosis (Malta fever).

• Cholera (an infectious disease characterized by severe diarrhea, dehydration, and vomiting).

• Early stages of Lyme disease (transmitted by ticks).

• Relapsing fevers transmitted by lice and ticks.

• Malaria (a febrile infectious disease with chills and sweating, caused by microorganisms that parasitize red blood cells).

• Tularemia (a rodent-borne disease similar to plague).

• Bartonellosis (an infectious disease presenting with severe anemia and fever).

• as an alternative treatment for:

• Anthrax (an infectious disease affecting the skin, intestine, or lungs).

• Listeriosis (a serious infectious disease that may affect the fetus during pregnancy, newborns, and adults).

• Actinomycosis (an infectious disease causing inflammation of lymph nodes in the mouth along with other internal complications).

• Syphilis in patients allergic to penicillin.

• Plague.

• Leptospirosis (an infectious disease causing fever, headache, muscle pain, and yellowing of the skin).

In general, intravenous administration of doxycycline is recommended only for the treatment of severely ill patients (see section 3, How to use Vibravenosa, below).

2. What you need to know before using Vibravenosa

Do not take Vibravenosa

• If you are allergic to doxycycline, to any other tetracycline, or to any of the other ingredients of this medicine (listed in section 6).
• If you have a disease called myasthenia gravis (a condition characterized by muscle weakness).
• If used concomitantly with methoxyflurane (a medicine used for anesthesia), as severe kidney toxicity with fatal outcome may occur.
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• If you have kidney disease. Consult your doctor, as this medicine contains povidone, which may accumulate in your body if your kidneys are not functioning properly (see section 3).

Warnings and precautions

Consult your doctor, pharmacist, or nurse:

• If you experience severe skin reactions such as widespread skin peeling (exfoliative dermatitis), red, raised skin lesions resembling targets (erythema multiforme), inflammation of the skin and mucous membranes that may be severe (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), or drug rash with eosinophilia and systemic symptoms [DRESS, including skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell)]. In such cases, contact your doctor immediately, as they will decide whether doxycycline treatment should be discontinued.
• If during treatment with Vibravenosa you experience unusual headaches accompanied by dizziness, blurred vision, ringing in the ears, nausea, or vomiting, consult your doctor, as these may be symptoms of benign intracranial hypertension (a condition affecting the brain due to increased pressure within the skull).
• If you experience any visual disturbances, seek immediate medical attention from an ophthalmologist.
• If you are taking a medicine called isotretinoin, as concomitant use may cause benign intracranial hypertension.
• If you develop severe and persistent diarrhea while being treated with doxycycline, you may have a type of antibiotic-associated colitis known as pseudomembranous colitis, which can be serious. In such cases, consult your doctor, who will decide whether to discontinue doxycycline and initiate appropriate treatment.
• If an acute anaphylactic-type reaction (characterized by collapse, chest pain, and hypotension) occurs after intravenous injection (see section 4).
• If you have liver disease, consult your doctor. During prolonged treatment, your doctor may need to perform periodic blood tests.
• If you have an autoimmune disease causing joint pain, skin rashes, and fever (systemic lupus erythematosus). This condition may worsen with the use of Vibravenosa.
• If you develop skin redness after exposure to sunlight or ultraviolet radiation. The use of total barrier sunscreens is recommended, and exposure to sunlight or ultraviolet radiation should be avoided.
• If any signs of infection appear. The use of antibiotics may increase the risk of infections caused by microorganisms not sensitive to treatment, including fungi, so your doctor will monitor for any possible signs of infection.
• If you need to undergo urine tests, inform healthcare professionals that you are being treated with this medicine, as doxycycline may interfere with test results.

Children and adolescents

In children from birth up to 8 years of age, the use of Vibravenosa is not recommended because it may cause permanent tooth discoloration and delayed bone development. However, there may be situations (e.g., severe or potentially life-threatening conditions) in which your doctor may decide that the benefits outweigh this risk in children under 8 years of age, and doxycycline may be prescribed.

In children over 8 years and under 12 years of age (weighing up to 45 kg), see section 3.

In children over 12 years of age (weighing more than 45 kg), the same dose as in adults is recommended (see section 3).

Using Vibravenosa with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Certain medicines may interact with Vibravenosa. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are taking any of the following medicines:

• Penicillin (an antibiotic), as doxycycline may interfere with its effect.
• Isotretinoin (used to treat severe acne), as concomitant use with doxycycline may cause benign intracranial hypertension.
• Oral contraceptives, as doxycycline may reduce their effectiveness.
• Anticoagulants (such as warfarin), as doxycycline may alter their effect.
• Antacids (medicines used to relieve stomach acidity) and other medicines containing aluminum, calcium, or magnesium, and medicines containing iron salts or bismuth salts, as they may reduce the effect of doxycycline.
• Antiepileptic drugs and barbiturates (medicines for severe insomnia and seizures), as they may reduce the effect of doxycycline.
• Methoxyflurane (a medicine used to induce anesthesia), as concomitant use with tetracycline antibiotics such as doxycycline may cause severe kidney toxicity.

Use of Vibravenosa with food, drinks, and alcohol

You should avoid alcohol consumption during treatment with this medicine, as alcohol reduces the effectiveness of Vibravenosa.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of this medicine during pregnancy is not recommended, as it may cause disturbances in bone development and permanent tooth discoloration in the child. Your doctor will decide whether the use of Vibravenosa is appropriate in such cases.

It is important to use contraceptive methods during treatment with doxycycline to avoid pregnancy. Oral hormonal contraceptives may not be effective, as this medicine reduces contraceptive efficacy; therefore, barrier methods are recommended.

Breastfeeding

The use of this medicine should be avoided during breastfeeding, as it may cause disturbances in bone development and permanent tooth discoloration in the infant.

Driving and using machines

There is no evidence that doxycycline impairs the ability to drive or operate machinery.

3. How to use Vibravenosa

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the duration of treatment with this medicine. Do not stop treatment before being instructed to do so by your doctor, even if you have started to feel better.

Intravenous administration of doxycycline is recommended only for the treatment of seriously ill patients (including the acute phase of pelvic inflammatory disease, in which intravenous treatment is always recommended initially) or in situations where oral administration cannot be used (for example, in unconscious patients who do not tolerate oral administration or in patients with diseases that impair absorption).

Adults and adolescents (over 12 years to 18 years of age)

The usual dose of doxycycline is 200 mg on the first day of treatment (administered as a single dose or divided into two doses every 12 hours), followed by a maintenance dose of 100 to 200 mg/day depending on the severity of the infection (administered as a single dose or divided into two doses every 12 hours). Treatment should be continued for at least 24 to 48 hours after the disappearance of symptoms and fever.

The dose will be determined by your doctor according to your individual characteristics and the type of infection. As a general rule, the usual dose and frequency of administration is as follows:

(1) Due to the potential severity of the infection, a rapidly acting antimalarial such as quinine should always be administered in combination with doxycycline. Quinine dosing recommendations vary across different geographic regions.

(2) Doxycycline is the treatment of choice.

Various dosage strengths are available for different dosing regimens.

Paediatric population

Children from 8 years to less than 12 years of age

Doxycycline may be used for the treatment of acute infections in children aged 8 years and under 12 years of age, in situations where other medications are unavailable, may not be effective, or are contraindicated.

In these cases, the usual doses are:

• Children weighing 45 kg or less:

First day: 4.4 mg/kg (administered as a single dose or divided into two equal doses every 12 hours)
From day 2 onwards: 2.2 mg/kg (as a single dose or divided into two equal doses). The duration of treatment will depend on the infection being treated.

In more severe infections, a dose up to 4.4 mg per kg of body weight may be administered throughout the entire treatment.

An alternative formulation, as an oral suspension, may be more suitable for dose adjustment in children weighing ≤ 45 kg.

• Children weighing more than 45 kg:

The adult dose should be used: 200 mg on the first day, followed by 100 mg daily. The duration of treatment will depend on the infection being treated.

Newborns, infants, and children under 8 years of age

Doxycycline must not be used in children aged 8 years or younger due to the risk of tooth discoloration.

Dosage recommendations in paediatric patients for the treatment or prophylaxis of specific infections are:

• Treatment of Rocky Mountain spotted fever: 2.2 mg/kg twice daily. Patients should be treated for at least 3 days after defervescence and until there is evidence of clinical improvement. The duration of treatment should be at least 5–7 days.

• Treatment of cutaneous, intestinal, or pulmonary anthrax: 2.2 mg/kg intravenously every 12 hours, followed by the same dose orally twice daily for 60 days. The treatment duration should be 60 days, except in cases of cutaneous anthrax without systemic involvement, where treatment duration may be reduced to 7–10 days. In cases of pulmonary anthrax, combination therapy with two antibiotics should be considered (see section 4.4).

Elderly patients

No dose adjustment is necessary.

Patients with renal impairment

Doxycycline does not require dose adjustment in patients with impaired renal function.

Patients with hepatic impairment

Doxycycline should be administered with caution in patients with impaired hepatic function.

Method of administration

Intravenous route. Vibravenosamust not be administered intramuscularly or subcutaneously.

Rapid administration should be avoided.

It is important that this medicine is administered regularly at the same time each day.

When the intravenous route is used for prolonged periods, thrombophlebitis may occur.

If you use more Vibravenosathan you should

This medicine will be administered by healthcare professionals, so it is unlikely that you will receive more Vibravenosathan prescribed. If you have any doubts or think you have been given more than your doctor prescribed, consult your doctor or other healthcare professional immediately.

Information for healthcare professionals: in case of overdose, administration should be discontinued and symptomatic and supportive measures should be initiated.

Peritoneal dialysis does not alter the plasma elimination half-life and therefore would not be beneficial in the treatment of overdose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to use Vibravenosa

If you have any doubts or think a dose has been missed, consult your doctor or other healthcare professional immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, speak with your doctor as soon as possible:

• Jarisch-Herxheimer reaction, characterized by fever, chills, headache, muscle pain, and skin rash, which usually resolves spontaneously. This reaction occurs shortly after starting doxycycline treatment for spirochetal infections, such as Lyme disease.

The following adverse effects have been observed in patients taking tetracyclines, including doxycycline, listed according to their frequency of occurrence:

Common adverse effects (may affect up to 1 in 10 people):

Hypersensitivity, allergic reactions (including anaphylactic shock, anaphylactic and anaphylactoid reactions, skin and mucosal swelling (angioedema), exacerbation of systemic lupus erythematosus, inflammation of the tissue surrounding the heart (pericarditis), serum sickness, Schönlein-Henoch purpura, low blood pressure (hypotension), difficulty breathing (dyspnea), rapid heartbeat (tachycardia), fluid retention in the limbs (peripheral edema), red, raised, itchy skin lesions (urticaria), headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular types).

Uncommon adverse effects (may affect up to 1 in 100 people):

Digestive disturbances (heartburn/gastritis).

Rare adverse effects (may affect up to 1 in 1,000 people):

Excessive destruction of red blood cells (hemolytic anemia), reduced platelet count (thrombocytopenia), changes in white blood cell count: reduced neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug reaction with eosinophilia and systemic symptoms [DRESS, including skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell)], decreased appetite, possible symptoms of benign intracranial hypertension (increased pressure inside the skull), including headache, nausea, vomiting, visual disturbances (including blurred vision), and dizziness, bulging fontanelle (transient bulging of the unfused skull area in young children), localized defect in the visual field surrounded by a normal visual area (scotoma), double vision (diplopia), and possible vision loss, in some cases even permanent, ringing in the ears (tinnitus), facial redness (rubefaction), inflammation of the pancreas (pancreatitis), changes in stool volume or consistency (diarrhea, pseudomembranous colitis), intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, inflammation of the tongue (glossitis), tooth discoloration, impaired liver function, inflammation of the liver (hepatitis) and liver damage, skin inflammation with blistering (toxic epidermal necrolysis), skin and mucous membrane inflammation that may be very severe (Stevens-Johnson syndrome), red, raised skin lesions with target-like appearance (erythema multiforme), widespread skin inflammation with peeling (exfoliative dermatitis), round or oval spots with redness and swelling of the skin, blister formation (urticaria) and itching, which typically recur in the same locations upon re-exposure to the medication (fixed drug eruption), darkening of an area of skin, nail loss (photo-onycholysis), joint pain (arthralgia) and muscle pain (myalgia), increased blood urea, irritation at the injection site.

Adverse effects with unknown frequency (cannot be estimated from available data):

Tooth discoloration and/or lack of tooth development.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vibravenosa

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

Store in a refrigerator (between 2°C and 8°C).

Before first opening of the ampoule: Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After opening the ampoule: From a microbiological standpoint, unless the opening method excludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, the times and conditions of storage during use are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vibravenosa

• The active substance is doxycycline.

• Each 5 ml vial of solution contains 100 mg of doxycycline (as hyclate).

• Each ml of solution contains 20 mg of doxycycline (as hyclate).

• The other components are: magnesium chloride hexahydrate, ethanolamine (for pH adjustment), povidone K-17, nitrogen, and water for injections.

Appearance of the product and contents of the pack

Pack containing 1 or 100 Type I amber-colored vials, each containing 5 ml of a clear yellowish-brown solution. Packaged in a cardboard box.

Additional information

Not compatible with Ringer lactate solution.

Vibravenosa must not be mixed with any other medicinal product, nor administered through the same intravenous line or cannula as other drugs.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Hospira Invicta, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108 Alcobendas (Madrid), Spain.

Manufacturer

Fareva Amboise.

Zone Industrielle,

29, Route des Industries.

37530, Poce-sur-Cisse, France.

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder

Pfizer, S.L. Avda. de Europa, 20-B. Parque Empresarial La Moraleja. 28108, Alcobendas, Spain.

Date of the most recent revision of this leaflet: 06/2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

This information is intended for healthcare professionals only:

Vibravenosa is an injectable solution for intravenous administration.

This medicinal product must not be administered by intramuscular or subcutaneous route.

For single use only. Any unused solution must be discarded.

The solution should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is observed, the solution must be discarded.

Discoloration indicates reduced potency and the solution must not be administered.

Vibravenosa must be administered slowly; rapid administration must be avoided.

INTRAVENOUS BOLUS ADMINISTRATION

When administered by injection, at least 2 minutes should be taken to deliver each 100 mg dose.

INFUSION ADMINISTRATION

The maximum infusion rate is 100 mg/hour.

The following sterile solutions are compatible with this medicinal product: physiological saline, glucose-saline solution, and glucose solutions 5%, 10%, and 20%.

Any unused medicinal product and all materials that have come into contact with it must be disposed of in accordance with local regulations.