Vectavir 1% cream 2g

Vectavir 1% cream 2g is a topical treatment specifically formulated to address herpes labialis . Each gram of this cream contains 10 mg of penciclovir , an active ingredient known for its effectiveness in fighting viral infections. The formulation also includes excipients such as cetostearyl alcohol and propylene glycol , which contribute to the consistency and application of the product. Vectavir is designed to be applied directly to the lesions of the lips, offering a targeted approach to reduce symptoms and speed up the healing process. Thanks to its composition, Vectavir 1% cream 2g represents an effective solution for those looking for a quick and localized treatment against herpes labialis.

ACTIVE INGREDIENTS

Active ingredients contained in Vectavir 1% cream 2g - What is the active ingredient of Vectavir 1% cream 2g?

Each gram of cream contains 10 mg of penciclovir Excipients with known effect: 77.2 mg of cetostearyl alcohol, 416.8 mg of propylene glycol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Vectavir 1% cream 2g - What does Vectavir 1% cream 2g contain?

Solid paraffin, Liquid paraffin, Cetostearyl alcohol, Propylene glycol, Cetomacrogol 1000, Purified water.

DIRECTIONS

Therapeutic indications Vectavir 1% cream 2g - Why is Vectavir 1% cream 2g used? What is it used for?

Vectavir is indicated for the treatment of herpes labialis.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Vectavir 1% cream 2g - When should Vectavir 1% cream 2g not be used?

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

DOSAGE

Quantity and method of taking Vectavir 1% cream 2g - How is Vectavir 1% cream 2g taken?

Adults (including the elderly) and children over 12 years of age: VECTAVIR should be applied at approximately 2-hourly intervals throughout the day. Treatment should be started as soon as possible, at the first sign of infection, and should be continued for 4 days. However, even in patients who start therapy later, VECTAVIR has been shown to be effective in accelerating the healing of lesions, reducing the pain associated with them and shortening the time of viral shedding. Application instructions : VECTAVIR should be applied, in an amount appropriate to the size of the area to be treated, with a clean finger or with a disposable applicator that should be discarded after use [ for packs containing applicators ]. Paediatric population : Children (under 12 years of age) : The use of Vectavir is not recommended in children under 12 years of age due to a lack of data on safety and/or efficacy.

CONSERVATION

Storage Vectavir 1% cream 2g - How to store Vectavir 1% cream 2g?

Do not store above 30°C. Do not freeze.

WARNINGS

Warnings Vectavir 1% cream 2g - About Vectavir 1% cream 2g it is important to know that:

The cream should only be applied to lesions on the lips and around the mouth. Application to 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 (e.g. 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 416 mg of propylene glycol in each gram of cream: may cause skin irritation.

INTERACTIONS

Interactions Vectavir 1% cream 2g - Which medicines or foods can modify the effect of Vectavir 1% cream 2g?

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

SIDE EFFECTS

Like all medicines, Vectavir 1% cream 2g can cause side effects - What are the side effects of Vectavir 1% cream 2g?

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 application site adverse events. Adverse reactions are listed below by system organ class, class and frequency. The frequencies are defined as follows: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Systemic disorders and conditions related to the administration site
Common	Application site reactions (including skin burning sensation, skin pain, hypoesthesia).

Post-marketing surveillance has 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 events are listed with unknown frequency.

Immune system disorders	Hypersensitivity, urticaria
Skin and subcutaneous tissue disorders	Allergic dermatitis (including rash, itching, blistering and swelling)

Reporting of suspected adverse reactions . Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

OVERDOSE

Vectavir 1% cream 2g Overdose - What are the risks of Vectavir 1% cream 2g in case of overdose?

Even after oral ingestion of the entire contents of a pack of VECTAVIR cream, no adverse effects should occur; penciclovir is poorly absorbed after oral administration. However, irritation of the oral cavity may occur. In case of accidental ingestion, no specific treatment is necessary.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Vectavir 1% cream 2g.

Pregnancy : When the cream is used in pregnant women, there is unlikely to be any cause for concern about adverse effects as systemic absorption of penciclovir after topical application of Vectavir cream has been shown 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 breast-feeding, only if the potential benefits outweigh the potential risks associated with treatment. Breast-feeding: When the cream is used in women who are breast-feeding, there is unlikely to be any cause for concern about adverse effects as systemic absorption of penciclovir after topical application of Vectavir cream has been shown to be minimal (see section 5.2). There is no information on the excretion of penciclovir in human milk.

DRIVING AND USE OF MACHINERY

Taking Vectavir 1% cream 2g before driving or using machines - Does Vectavir 1% cream 2g affect driving or using machines?

Vectavir does not affect the ability to drive or use machines.