VIBRAVENOSA 100 mg INJECTABLE SOLUTION AND PERFUSION SOLUTION

2. What you need to know before starting to use Vibravenosa

Do not take Vibravenosa

• If you are allergic to doxycycline, any other tetracycline, or any of the other components of this medication (listed in section 6).
• If you have a disease called myasthenia gravis (a disease characterized by muscle weakness).
• If you are using methoxyflurane (a medication 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 medication contains povidone, which may accumulate in your body if your kidneys do not function properly (see section 3).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse:

• if you experience severe skin reactions such as widespread skin inflammation with peeling (exfoliative dermatitis), red and swollen skin lesions with a target-like appearance (erythema multiforme), skin and mucous membrane inflammation that can be severe (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), and drug rash with eosinophilia or systemic symptoms [DRESS, which includes skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell)]. In these cases, you should immediately consult your doctor, who will decide whether to discontinue doxycycline administration.
• if you experience abnormal headaches accompanied by dizziness, blurred vision, ringing in the ears, nausea, or vomiting during treatment with Vibravenosa, consult your doctor, as these may be symptoms of benign intracranial hypertension (a process affecting the brain due to increased pressure within the skull).
• if you experience visual disturbances, immediately consult an ophthalmologist.
• if you are taking a medication called isotretinoin, as concurrent use may produce benign intracranial hypertension.
• if you experience severe and prolonged diarrhea while being treated with doxycycline, you may have a type of antibiotic-associated colitis called pseudomembranous colitis, which can be severe. In these cases, you should consult your doctor, who will decide whether to discontinue doxycycline administration and initiate appropriate treatment.
• if an acute anaphylactic reaction (characterized by collapse, chest pain, and hypotension) occurs after intravenous injection (see section 4).
• if you have liver disease, consult your doctor. In prolonged treatments, your doctor may need to perform periodic analytical tests.
• if you have a disease of the immune system that causes joint pain, skin rashes, and fever (systemic lupus erythematosus). The condition may worsen when using Vibravenosa.
• if you experience skin redness after sun exposure or ultraviolet radiation. It is recommended to use total sunblock creams and avoid sun exposure or ultraviolet radiation.
• if any signs of infection appear. The use of antibiotics may increase the risk of developing infections with microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor the appearance of any possible signs of infection.
• if you are going to have any urine tests, inform the healthcare personnel that you are being treated with this medication, as doxycycline may interfere with the test results.

Children and Adolescents

In children from birth 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 diseases) 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 of age and under 12 years of age (up to 45 kg in weight), see section 3.

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

Use of Vibravenosa with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Certain medications may interact with Vibravenosa. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using any of the following medications:

• Penicillin (antibiotic), as doxycycline may interfere with its effect.
• Isotretinoin (for severe acne), as concurrent use with doxycycline may produce benign intracranial hypertension.
• Oral contraceptives, as doxycycline may reduce their effectiveness.
• Anticoagulants (such as warfarin), as doxycycline may alter their effect.
• Antacids (medications used to calm stomach acidity) and other medications containing aluminum, calcium, or magnesium, and medications containing iron or bismuth salts, as they may reduce the effect of doxycycline.
• Antiepileptics and barbiturics (medications for severe insomnia and convulsions), as they may reduce the effect of doxycycline.
• Methoxyflurane (medication used to induce anesthesia), as concurrent use with antibiotics from the tetracycline group, such as doxycycline, may produce severe kidney toxicity.

Use of Vibravenosa with Food, Beverages, and Alcohol

You should avoid consuming alcohol during treatment with this medication, as alcohol reduces the effect of Vibravenosa.

Pregnancy and Breastfeeding

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

Pregnancy

The use of this medication is not recommended during pregnancy, as it may cause developmental disorders in the bones and permanent tooth discoloration in the child. Your doctor will decide whether to use Vibravenosa in these cases.

It is essential to use contraceptive methods during treatment with doxycycline to avoid becoming pregnant. Hormonal oral contraceptives may not be effective, as the use of this medication reduces the contraceptive effect, and therefore, barrier methods are recommended.

Breastfeeding

The use of this medication should be avoided during breastfeeding, as it may cause developmental disorders in the bones and permanent tooth discoloration in the infant.

Driving and Using Machines

There is no evidence that doxycycline alters the ability to drive or use machines.

3. How to use Vibravenosa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the duration of treatment with this medication. Do not discontinue treatment until your doctor indicates it, even if you have already started to improve.

The administration of doxycycline by intravenous route is only recommended for the treatment of seriously ill patients (including the acute phase of pelvic inflammatory disease, in which intravenous treatment is always recommended) or in situations where the oral route cannot be used (for example, in unconscious patients who do not tolerate oral administration or with diseases that compromise 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 in 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 in a single dose or divided into two doses every 12 hours). Treatment should continue for at least 24 to 48 hours after the disappearance of symptoms and fever.

The dose will be established by the doctor based on individual characteristics and the type of infection. As a general rule, the usual dose and frequency of administration are as follows:

(1) Due to the potential severity of the infection, a rapid-acting antimalarial such as quinine should always be administered in combination with doxycycline. Quinine dosage recommendations vary in different geographic areas.

(2) Doxycycline is the treatment of choice.

There are different doses available for different dosing regimens.

Pediatric population

Children from 8 years to less than 12 years of age

Doxycycline should be used for the treatment of acute infections in children from 8 to less than 12 years of age, in situations where other medications are not available or 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 of weight (administered in a single dose or divided into two equal doses every 12 hours).

From the 2nd day onwards: 2.2 mg/kg of weight (in 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 of up to 4.4 mg per kg of body weight may be administered throughout treatment.

There is another presentation, in the form of an oral suspension, which could be more suitable for dose adjustment in children weighing ≤ 45 kg.

• Children weighing more than 45 kg:

The same dose as in adults is recommended, 200 mg on the first day and then 100 mg daily. The duration of treatment will depend on the infection being treated.

Newborns, infants, and children under 8 years of age

Doxycycline should not be used in children under 8 years of age due to the risk of tooth discoloration.

The dosage in pediatric patients for the treatment or prophylaxis of specific infections is:

• Treatment of Rocky Mountain spotted fever: 2.2 mg/kg twice a day. Patients should receive treatment until at least 3 days after the fever disappears 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 every 12 hours intravenously followed by the same dose orally twice a day for 60 days. The duration of treatment should be 60 days, except in the case of cutaneous anthrax without systemic involvement, in which case the duration of treatment may be reduced to 7-10 days. In the case of pulmonary anthrax, the use of two antibiotics in combination 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 altered renal function.

Patients with hepatic impairment

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

Method of administration

Intravenous route. Vibravenosa should not be administered intramuscularly or subcutaneously.

Rapid administration should be avoided.

It is essential that this medication be administered regularly at the same time of day.

In the case of using the intravenous route for extended periods, thrombophlebitis may occur.

If you use more Vibravenosa than you should

This medication will be administered by healthcare personnel, so it is unlikely that you will be administered more Vibravenosa than you should. If you have doubts or think you have been administered more than the dose indicated by your doctor, consult your doctor or another healthcare professional immediately.

Information for healthcare professionals: in case of overdose, administration should be discontinued, symptomatic treatment 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, consult your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Vibravenosa

If you have doubts or think that a dose has been forgotten, consult your doctor or another healthcare professional immediately.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

If you experience any of the adverse effects listed below, consult your doctor as soon as possible:

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

The following adverse effects have been observed in patients who have taken tetracyclines, including doxycycline, ordered by 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, angioedema, exacerbation of systemic lupus erythematosus, pericarditis, serum sickness, Schönlein-Henoch purpura, hypotension, dyspnea, tachycardia, peripheral edema, urticaria, headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular).

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

Gastrointestinal disorders (heartburn/gastritis).

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

Increased destruction of red blood cells (hemolytic anemia), decreased platelet count (thrombocytopenia), alteration of white blood cell count: decreased neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug rash with eosinophilia and systemic symptoms [DRESS, which includes skin rash, lymph node inflammation, 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 skull's unfused space in young children), localized defect in the visual field surrounded by a area of normal vision (scotoma), double vision (diplopia), and possible vision loss, even permanent, ringing in the ears (tinnitus), flushing, pancreatitis, alteration in stool volume or consistency (diarrhea, pseudomembranous colitis), intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, tongue inflammation (glossitis), tooth discoloration, altered liver function, hepatitis, and liver damage, toxic epidermal necrolysis, severe skin and mucous membrane inflammation (Stevens-Johnson syndrome), erythema multiforme, widespread skin inflammation with exfoliation (exfoliative dermatitis), round or oval patches with redness and swelling of the skin, blister formation (urticaria), and itching, which usually reappear in the same places with re-exposure to the medication (fixed drug eruption), darkening of a skin area, nail loss (photo-onycholysis), joint pain (arthralgia), and muscle pain (myalgia), increased blood urea, irritation at the injection site.

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

Tooth discoloration and/or lack of tooth growth.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Vibravenosa

Keep this medication out of sight and reach of children.

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

Before the first opening of the ampoule: Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

If it is not used immediately, the storage times and conditions are the responsibility of the user.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Vibravenosa

• The active ingredient is doxycycline.

• Each 5 ml ampoule 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 (pH adjuster), povidone K-17, nitrogen, and water for injectable preparations.

Appearance of the product and package contents

Package with 1 or 100 ampoules of type I, amber color, with 5 ml of transparent yellowish-brown solution. They are packaged in a cardboard box.

Additional information

It is not compatible with Ringer's lactate solution.

Vibravenosa should not be mixed with any medication or perfused in the same vein or cannula with other medications.

Marketing authorization holder and manufacturer

Marketing authorization holder

Hospira Invicta, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108 Alcobendas (Madrid).

Manufacturer

Fareva Amboise.

Zone Industrielle,

29, Route des Industries.

37530, Poce-sur-Cisse.

France.

You can request more information about this medication by contacting 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 last revision of this leaflet: 06/2024.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

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This information is intended only for healthcare professionals:

Vibravenosa is an injectable solution for intravenous administration.

This medication should not be administered intramuscularly or subcutaneously.

For single use. Discard the remaining solution.

The solution should be examined before injection for particles or turbidity. If foreign particles are observed, the solution should be discarded.

Discoloration indicates a decrease in activity, and the solution should not be administered.

Vibravenosa should be administered slowly, avoiding rapid administration:

BOLUS ADMINISTRATION

When administered by injection, each 100 mg dose should take at least 2 minutes to administer.

INFUSION ADMINISTRATION

The maximum infusion rate is 100 mg/hour.

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

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.