VECTAVIR 1% CREAM
Vectavir is indicated for the treatment of herpes labialis.
Dosage and method of use
Adults (including the elderly) and children over 12 years of age VECTAVIR should be applied at intervals of approximately 2 hours throughout 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 starting therapy later, VECTAVIR has been shown to be effective in accelerating wound healing, reducing wound pain and shortening the time to viral spread. Application instructions VECTAVIR must be applied, in a quantity suitable for the size of the area to be treated, with a clean finger or with a disposable applicator which must be discarded after use [for packs containing applicators]. Pediatric population Children (under 12 years of age): Vectavir is not recommended for use in children below 12 years of age due to a lack of data on safety and / or efficacy.
Hypersensitivity to the active substance penciclovir, famciclovir or to any of the excipients listed in section 6.1. Children under the age of 12.
Vectavir cream was well tolerated in human studies. Experience from clinical trials has shown 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 organ system, class and frequency. The frequencies are defined as follows: Very common (> 1/10); common (> 1/100 a uncommon (> 1 / 1,000 a rare (> 1 / 10,000 a very rare (not known (cannot be estimated from the available data). Within each frequency class, undesirable effects are reported in order of decreasing severity.
|General disorders and administration site conditions |
|Common ||Application site reactions (including skin burning sensation, skin pain, hypoesthesia). |
Post-marketing surveillance revealed the following adverse events (all reactions were either localized or general). It is difficult to define a frequency for post-marketing adverse events and therefore the events are listed with unknown frequency.
Reporting of suspected adverse reactions
|Disorders of the immune system ||Hypersensitivity, urticaria |
|Skin and subcutaneous tissue disorders ||Allergic dermatitis (including rash, itching, blistering and edema) |
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
The cream should only be applied to the lesions of the lips and around the mouth. Application on mucous membranes (e.g. in the eyes, mouth or nose or on the genitals) is not recommended. Particular care should be taken to avoid application in or near the eyes. Severely immunocompromised patients (eg patients with AIDS or who have undergone a bone marrow transplant) should be encouraged to consult a physician if oral therapy is indicated. Vectavir contains cetostearyl alcohol: may cause local skin reactions (e.g. contact dermatitis). Vectavir contains propylene glycol: may cause skin irritation.
Pregnancy and breastfeeding
Pregnancy When the cream is used in pregnant women, there is unlikely to be any cause for concern for adverse effects as systemic absorption of penciclovir following topical application of Vectavir cream was found to be minimal (see section 5.2). As the safety of penciclovir in pregnant women has not been established, Vectavir cream should be used, on the advice of a physician, during pregnancy or by mothers who are breastfeeding, only if the potential benefits outweigh the potential risks associated with treatment. Feeding time When the cream is used in women who are breastfeeding, there is unlikely to be any cause for concern for adverse effects as systemic absorption of penciclovir following topical application of Vectavir cream has been found to be minimal (see section 5.2). There is no information on the excretion of penciclovir in human milk.
Expiration and retention
Do not store above 30 ° C. Do not freeze.
Interactions with other drugs
Experience in clinical trials has not identified interactions resulting from the concomitant administration of topical or systemic drugs and Vectavir cream.
Even after oral ingestion of the entire contents of a pack of VECTAVIR cream, no undesirable effects should occur; penciclovir is poorly absorbed following oral administration. However, oral irritation may occur. In case of accidental ingestion, no specific treatment is necessary.
Each gram of cream contains 10 mg of penciclovir. Excipients with known effects: 77.2 mg of cetostearyl alcohol, 416.8 mg of propylene glycol. For the full list of excipients, see section 6.1.
Solid paraffin Liquid paraffin Cetostearyl alcohol Propylene glycol Cetomacrogol 1000 Purified water