Package Insert: Information for the Patient

Vibravenosa100 mg Injectable Solution and for Infusion

Doxycycline

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

This medication is usedin 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 that presents 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 characterized by ulcers on the genitals followed by lymph node inflammation), genital granuloma (purulent ulceration of the genitals), pelvic inflammatory disease, acute epididymo-orchitis (inflammation of the testicles, purulent, and primarily affecting newborns).
• Eye infections such as trachoma, inclusion conjunctivitis (eye infection with conjunctival inflammation and irritation).
• Typhus and other infections caused by microorganisms called rickettsias.
• Q fever.
• Brucellosis (Malta fever).
• Cholera (an infectious disease that presents with severe diarrhea, dehydration, and vomiting).
• Early stages of Lyme disease (transmitted by ticks).
• Recurring fevers transmitted by lice and ticks.
• Malaria (an infectious disease presenting with fever, chills, and sweating, caused by microorganisms that parasitize red blood cells).
• Tularemia (a disease of rodents similar to the plague).
• Bartonellosis (an infectious disease presenting with severe anemia and fever).

• alternative treatment for:

• Carbuncle (an infectious disease affecting the skin, intestines, or lungs).
• Listeriosis (a severe infectious disease that can affect the fetus during pregnancy, the newborn, and the adult).
• Actinomycosis (an infectious disease causing lymph node inflammation in the mouth and other internal complications).
• Syphilis in patients allergic to penicillin.
• The plague.
• Leptospirosis (an infectious disease causing fever, headache, muscle pain, and yellow discoloration of the skin).

In general, doxycycline is only recommended for intravenous administration in severely ill patients (see section 3, How to use Vibravenosa for further information).

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 condition called myasthenia gravis (a disease that manifests with muscle weakness).
• If you are using it together with methoxyflurane (a medication used to anesthetize), as it can cause severe kidney toxicity with fatal results.
• 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 that can 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 (dermatitis exfoliativa), red and swollen skin lesions in the shape of a target (erythema multiforme), severe skin and mucous membrane inflammation (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), and drug-induced 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 during treatment with Vibravenosa you experience abnormal 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 process affecting the brain due to increased pressure within the skull).
• If you experience visual disturbances, seek immediate attention from an ophthalmologist.
• If you are taking a medication called isotretinoin, as taking it together with doxycycline can cause benign intracranial hypertension.
• If you experience intense and prolonged diarrhea while taking 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 you experience an acute anaphylactic reaction (characterized by collapse, chest pain, and hypotension) 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 controls.
• If you have a condition that causes joint pain, skin rashes, and fever (systemic lupus erythematosus). The condition may worsen when using Vibravenosa.
• If you experience skin redness after exposure to the sun or ultraviolet radiation. It is recommended to use sunscreen with a total sunblock and avoid exposure to the sun or ultraviolet radiation.
• If you experience any signs of infection. The use of antibiotics can increase the risk of developing infections caused by microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor for the appearance of any possible signs of infection.
• If you need to undergo urine analysis, inform the healthcare staff that you are taking this medication, as doxycycline can interfere with the results.

Children and adolescents

In children from birth to 8 years of age, the use of Vibravenosa is not recommended because it can cause permanent tooth discoloration, as well as delayed bone development. However, there may be situations (for example, severe or potentially fatal diseases) in which your doctor may decide that the benefits outweigh this risk in children under 8 years old and doxycycline should be prescribed.

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

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

Use of Vibracina with other medications

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

Certain medications can 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 can interfere with its effect.
• Isotretinoin (for severe acne), as taking it together with doxycycline can cause benign intracranial hypertension.
• Oral contraceptives, as doxycycline can reduce their effectiveness.
• Anticoagulants (such as warfarin), as doxycycline can alter their effect.
• Antacids (medications used to calm stomach acid) and other medications containing aluminum, calcium, or magnesium, and medications containing iron or bismuth salts, as they can reduce the effect of doxycycline.
• Antiepileptics and barbiturates (medications for severe insomnia and seizures), as they can reduce the effect of doxycycline.
• Methoxyflurane (anesthesia medication), as when used together with antibiotics from the tetracycline group, such as doxycycline, it can cause severe kidney toxicity.

Use of Vibracina with food, drinks, 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 or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of this medication during pregnancy is not recommended, as it can cause bone development disorders 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 to avoid pregnancy during treatment with doxycycline. Oral contraceptives (hormonal) may not be effective, as the use of this medication reduces their effectiveness, and barrier methods are recommended.

Breastfeeding

The use of this medication during breastfeeding is not recommended, as it can cause bone development disorders and permanent tooth discoloration in the infant.

Driving and operating machinery

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

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

This medication is only recommended for intravenous administration for the treatment of severely ill patients (including the acute phase of pelvic inflammatory disease, in which intravenous treatment is always recommended) or in situations where oral administration cannot be used (e.g., in unconscious patients who cannot tolerate oral administration or with diseases that compromise absorption).

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

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

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

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

(2)Doxycycline is the treatment of choice

There are different doses available for the various dosing regimens.

Pediatric population

Children under 12years of age

Doxycycline should be used for the treatment of acute infections in children under 12years of age in situations where other medications are not available or may not be effective or contraindicated.

In these cases, the usual doses are:

• Children weighing 45 kg or less:

First day: 4.4mg/kg of body weight (administered as a single dose or divided into two equal doses every 12hours)

From the 2nd day: 2.2mg/kg of body weight (as a single dose or divided into two equal doses). The treatment duration will depend on the infection being treated.

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

There is another presentation, in the form of an oral suspension, which may be more suitable for adjusting doses for children weighing ≤45 kg.

• Children weighing more than 45 kg:

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

Newborns, infants, and children under 8years of age

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

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

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

• Treatment of cutaneous, intestinal, or pulmonary carbuncle: 2.2mg/kg every 12hours administered intravenously followed by the same dose orally twice daily for 60 days. The treatment duration should be 60 days, except in the case of cutaneous carbuncle without systemic involvement, in which case the treatment duration can be reduced to 7-10days. In the case of pulmonary carbuncle, the use of two antibiotics in combination (see section 4.4) should be considered.

Geriatric patients

No dose adjustment is necessary.

Patients with renal impairment

Doxycycline does not require dose adjustment in patients with renal impairment.

Patients with hepatic impairment

Doxycycline should be administered with caution in patients with hepatic impairment.

Administration form

Intravenous administration.Subcutaneous or intramuscular administration is not recommended.

Administration should be avoided.

It is essential to administer this medication regularly at the same time of day.

In the case of intravenous administration over prolonged periods, thrombophlebitis may occur.

If you use more Vibravenosathan you should

This medication will be administered by healthcare personnel, making it unlikely that you will receive more Vibravenosa than you should. If you have doubts or think you have received 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 interrupted, 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 or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forget to use Vibravenosa

If you have doubts or think you have forgotten to administer a dose, consult your doctor or another healthcare professional immediately.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the side effects listed below, speak with your doctor as soon as possible:

- Jarisch-Herxheimer reaction, which is characterized by 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 side effects have been observed in patients taking tetracyclines, including doxycycline, listed in order of their frequency of occurrence:

Frequent side 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 disease, Schönlein-Henoch purpura, hypotension, dyspnea, tachycardia, peripheral edema, urticaria, headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, and skin eruption (including erythematous and maculopapular types).

Less frequent side effects (may affect up to 1 in 100 people):

Digestive disturbances (gastritis).

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

Severe destruction of red blood cells (hemolytic anemia), decreased platelet count (thrombocytopenia), alteration in white blood cell count: decreased neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug eruption with eosinophilia or systemic symptoms [DRESS, including skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell)], decreased appetite, possible symptoms of benign intracranial hypertension that include headache, nausea, vomiting, visual disturbances (including blurred vision), and dizziness, transient bulging of the fontanelle in infants, localized visual field defect surrounded by a normal visual field (scotoma), double vision (diplopia), and possible permanent vision loss, tinnitus in the ears, facial redness (rubefaction), pancreatitis, alteration in stool volume or consistency (diarrhea, pseudomembranous colitis), intestinal inflammation, anogenital inflammatory lesions, difficulty swallowing (dysphagia), abdominal pain, tongue inflammation (glossitis), tooth discoloration, liver dysfunction, hepatitis, and liver damage, toxic epidermal necrolysis, severe skin and mucous membrane inflammation that may be life-threatening (Stevens-Johnson syndrome), multiform erythema, widespread skin inflammation with desquamation (exfoliative dermatitis), round or oval skin lesions with redness and swelling, urticaria, and pruritus that usually recur in the same locations with re-exposure to the medication (fixed drug eruption), skin darkening, nail loss (photoonycholysis), joint pain (arthralgia), and muscle pain (myalgia), increased blood urea, injection site irritation.

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

Teeth discoloration and/or failure to grow.

Reporting side effects

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

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

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

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

Before the first opening of the ampule: 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 the ampule opening:from a microbiological point of view, unless the opening method excludes the risk of microbial contamination, the product must be used immediately.

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

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of Vibravenosa

• The active principle 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 (to adjust pH), povidone K-17, nitrogen and water for injection preparations.

Appearance of the product and contents of the package

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

Additional information

Not compatiblewith Ringer lactate solution.

Do not mix Vibravenosa with any other medication or infuse in the same vein or cannula with other medications.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Hospira Invicta, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108 Alcobendas (Madrid).

Responsible 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.

Last review date of this leaflet:06/2024.

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.

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This information is intended solely for healthcare professionals:

Vibravenosa is an injectable solution for administration byintravenous route

This medication should not be administered by intramuscular or subcutaneous route.

For single use. Dispose of any remaining solution.

The solution should be examined before injecting for the presence of 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:

ADMINISTRATION IN BOLUS

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

ADMINISTRATION BY INFUSION

The maximum infusion rate is 100 mg/hour.

The following sterile solutions are compatible with this medication: physiological saline, glucose-saline solution and glucose solutions 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.