VECTAVIR CREAM 2G 1%

VECTAVIR 1% CREMA

active ingredients

Each gram of cream contains 10 mg of excipient penciclovir with known effects: 77.2 mg of cetosterial alcohol, 416.8 mg of propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

Solid paraffin, Liquid paraffin, Cetostearilic alcohol, propylene glycol, Cetomacrogol 1000, Purified water.

Therapeutic indications

Vectavir is indicated for the treatment of herpes labialis.

Contraindications

Hypersensitivity to the active ingredient penciclovir, famciclovir or any of the excipients listed in the paragraph 6.1. Children under the age of 12.

Population

Adults (including seniors) and children over 12 years of age: VECTAVIR should be applied at intervals of about 2 hours during the day. Treatment, to be continued for 4 days, should be started as soon as possible, at the first sign of infection. However, even in patients who begin therapy later, VECTAVIR it has proved effective in accelerating the healing of lesions, reducing the pain associated with them, and in shortening the time of viral diffusion. Application instructions: VECTAVIR must be applied, in quantity suitable to the size of the area to be treated, with a clean finger or with a disposable applicator that must be eliminated after use [for packages containing applicators]. Pediatric population . Children under 12 years of age: The use of Vectavir is not recommended in children under 12 years of age due to lack of data on safety and/or effectiveness.

Conservation

Do not store at temperature above 30 °C. Don't freeze.

Warnings

The cream should only be applied on lip lesions and around the mouth. The application on mucous membranes is not recommended (e.g. in the eyes, mouth or nose or genitals). Special attention should be paid to avoid application in the eyes or near the eyes. Severely immunocompromised patients (e.g. AIDS patients or bone marrow transplants) should be encouraged to consult a doctor if an oral therapy is indicated. Vectavir contains cetostearilic alcohol: can cause local skin reactions (e.g. contact dermatitis). Vectavir contains 416 mg of propylene glycol in each gram of cream: it can cause skin irritation.

Interactions

The experience in clinical trials has not identified interactions resulting from the concomitant administration of drugs for topical or systemic use and Vectavir cream.

Effects

Vectavir cream was well tolerated during human studies. The experience from clinical trials showed that there is no difference in the frequency or type of adverse reactions between Vectavir cream and placebo. The most common events are adverse events in the application area. Adverse reactions are listed below by system of organs, classes and frequencies. The frequencies are defined as follows: very common (>1/10); common (>1/100 a non-common (>1/1.000 a rare (>1/10.000 a very rare (not known (frequency cannot be defined on the basis of available data). Within each frequency class, unwanted effects are reported in decreasing order of gravity.

Systemic pathologies and conditions for administration
Town	Reactions to the application site (including skin burning sensation, skin pain, hypoesthesia).

Surveillance after marketing highlighted the following adverse events (all reactions were either localized or general). It is difficult to define a frequency for adverse events after placing on the market and therefore events are listed frequently unknown.

Immune system disorders	Hypersensitivity, hives
Pathologies of skin and subcutaneous tissue	Allergic dermatitis (including rash, itching, bladders and edema)

Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Even after oral ingestion of the entire content of a packaging VECTAVIR cream, no side effects should occur; penciclovir is poorly absorbed after oral administration. However, an irritation of the oral cable can be manifested. In case of accidental ingestion, no specific treatment is required.

Pregnancy: When the cream is used in pregnant women, it is unlikely that there is some cause of concern for adverse effects as systemic absorption of penciclovir after topical application of Vectavir cream has been minimal (see paragraph 5.2). Since the safety of penciclovir has not been established in pregnant women, Vectavir cream should be used, on advice of a doctor, during pregnancy or by mothers who are breastfeeding, only if potential benefits are higher than the potential risks associated with treatment. Nursing: When the cream is used in women who are breastfeeding, it is unlikely that there is some cause of concern for the adverse effects as systemic absorption of penciclovir after topical application of Vectavir cream is result to be minimal (see paragraph 5.2). There is no information on penciclovir excretion in human lact.

Source: Farmadati