Aciclovir 5% 10 g Cream (zovirax)

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SHORT PRODUCT INFORMATION

1. HUMAN MEDICAL PRODUCT NAME

AKLOVIR 5% Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient: 1 g cream each; 50 mg (5% w / w) acyclovir.

Adjuncts: Propylene glycol 4.000 g Cetostearyl alcohol 0.675 g For

auxiliary substances see 6.1.

3. PHARMACEUTICAL FORM Cream White, broken white, characteristic odor, homogeneous cream.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications AKLOVIR is indicated for the treatment of Herpes simplex skin infections, including the first and recurrent genital herpes and herpes labialis.

4.2 Posology and method

of administration Pozology / application frequency and duration: It should be administered at intervals of about 4 hours by skipping doxology 5 times a day, nightly. Acupuncture should be applied to the lesions as soon as possible, preferably on the first signs (erythema or prodrome) to the lesions expected to be delivered to the lesions or after the onset of the infection. The treatment can also be started later (papules or blisters). Treatment should be continued for at least 4 days for herpes labialis and at least 5 days for genital herpes. If there is no recovery, the treatment can be continued for a total of 10 days (5 + 5).

Application type: Used externally.

Additional information on special populations: Kidney / Liver failure: Data not available.

Pediatric population: No data available.

Elderly:

Not available.

4.3 Contraindications Acyclovir is contraindicated in patients with known hypersensitivity to valaciclovir, propylene glycol, or any substance that is clavulanic.

4.4 Special warnings and precautions for use Application of acyclovir cream to mucous areas such as the mouth, eyes or vagina is not recommended as it may be irritating. Particular care should be taken not to accidentally enter the eye.

Oral acyclovir doses should be considered in patients with severe immune deficiency (eg AIDS patients or bone marrow transplant patients). Such patients should be encouraged to seek medical advice for any infection treatment.

Propylene glycol from auxiliary substances can cause irritation. The cetostearyl alcohol in AKLOVIR may cause local skin reactions (eg contact dermatitis).

AKLOVIR should not be used as a part of other medicines or be diluted due to special reasons.

4.5. Interactions with other medicinal products and other forms of interaction Clinically significant interactions have not been identified.

Additional information on special populations No data available.

Pediatric population: No data available.

4.6. Pregnancy and lactation General advice Pregnancy category: B

Women with childbearing potential / Contraception (Contraception) Be cautious when given to women with childbearing potential.

Gestational age The data on the number of cases of pregnancy exposure in limited numbers do not indicate that acyclovir has adverse effects on pregnancy or on the health of the fetus / newborn child. No significant epidemiological data have been obtained until today.

Studies on animals do not show any direct or indirect harmful effects on pregnancy / embryonal / fetal development / birth or postnatal development (see section 5.3).

Pregnancies developed in women who use any acyclovir formulation after the acyclovir fetus has been documented in pregnancy records. These findings obtained from the records, the number of birth defects seen in patients taking acyclovir with the entire population showed an increase compared and any birth defect overall result never seen before to assert showed a property or a consistent pattern. The use of acyclovir should be considered only in cases of severe depression of potential risks with unknown potential benefits. In internationally accepted standard tests, systemic administration of acyclovir did not cause teratogenic or embryotoxic effects in mice, rats or rabbits. In a non-standard study of rats, fetal abnormalities were observed, but maternal toxicity followed only high subcutaneous doses. The clinical evidence of these findings is uncertain.

The lactation period The limited data obtained about humans suggests that the mother of the drug has gone sick when it is systemically taken. However, when used in mothers sucking in acyclovir cream, the dosage that the baby will receive will be ignored.

Reproduction ability / Fertility See Clinical Studies

4.7. Effects on vehicle and machine use No data.

8.4. Unwanted effects The frequency classification is 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 It is unknown (can not be predicted from the given data).

Clinical trial data observed during clinical trials with 3% ophthalmic pomade were used when frequency categories of adverse events were determined. Due to the nature of the observed adverse effects, it is not possible to calculate precisely these effects depend on the mode of administration and the disease. Spontaneous reporting data is a basis for the frequencies allocated for postmarketing effects.

Skin and subcutaneous tissue disorders Uncommon: Transient burning or stinging, followed by acyclovir cream application, slight dryness and scaling, itching Rare: Erythema, contact dermatitis following application. Sensitivity tests have shown that reactive substances are mostly acyclovir-based very creamy substances.

Immune system disorders Very rare: Angioedema, including immediate hypersensitivity reactions

the reporting of suspected adverse reactions

reporting of suspected adverse drug reactions after licensingis of great importance. Reporting allows continuous monitoring of the benefit / risk balance of the drug. Any suspected adverse reactions to health professionals Turkey Pharmacovigilance Center (TÜFAM) What must inform (www.titck.gov.t is; e-mail: [email protected] is; tel: 00 08 0800314; fax: 0 312 218 35 99).

4.9. Overdose and treatment No adverse effects are expected, even if a whole tube containing 500 mg (cream) or 135 mg (ointment) acyclovir is taken orally. However, repeated oral doses of acyclovir for several days resulted in gastrointestinal (nausea and vomiting) and neurological (headache and confusion) effects. Acyclovir can be removed by hemodialysis.

5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties

ATC Code: D06BB03 Pharmacotherapeutic group: Antiviral drugs (Topical dermatologic)

Mechanism of action Asclovir is an antiviral agent highly effective in vitro against Herpes simplex (HSV) type I and II and Varicella zoster virus. Reduce toxicity on mammalian host cells. Acyclovir enters the cell with Herpes infection and then phosphorylates to the active compound acyclovir triphosphate. The first step of this process depends on the presence of the thymidine kinase encoded by the virus. Acyclovir triphosphate, a herb specific DNA polymerase, inhibits the progress of viral DNA synthesis without affecting normal cellular events by acting as an inhibitor and substrate.

Pharmacodynamic effects The randomized clinical trials involving 1,385 patients with recurrent herpes and two cases of double-blind study showed that acyclovir cream remedial action time (p <0.02) and pain relieving time (p <0.03) decreased significantly compared to placebo cream. Approximately 60% of patients have been treated with early treatment lesions (prodrome or erythema) and 40% with a late lesion (papule or blister).

5.2. Pharmacokinetic properties Absorption: Pharmacokinetic studies have shown minimal systemic absorption following external application of acyclovir cream.

Distribution: Data not available.

Biotransformation: No data available.

Elimination: There is no data.

3.5. Preclinical safety data Clinical trials There is no information on the effect of IV infusion or oral formulations on female fertility. In a study of 20 male patients with normal sperm counts, there was no clinically significant effect on sperm count, motility or morphology after 1 g oral acyclovir application every day for 6 months.

Nonclinical information Comprehensive results of in vivo and in vitro mutagenicity tests have shown that acyclovir has no genetic risk role in man. No long-term studies in rats and rats have shown that they are carcinogenic. Most reversible adverse reactions to all toxicity-related spermatogenesis in rats and dogs have been reported only at high systemic doses of acyclovir. The two-generation study in mice did not reveal any effect of acyclovir taken orally on fertility.

6. PHARMACEUTICAL PROPERTIES 6.1. List of adjuvants Polyoxamer 407 Sodium lauryl sulphate Cetostearyl alcohol White petrolatum Mineral oil Propylene glycol

6.2. Incompatibilities have not been reported.

6.3. Shelf life 36 months

6.4. Special precautions for storage should be kept at room temperature below 25 ° C. Do not put it in the fridge.

6.5. The quality and contents of the packaging arealuminum tubes of 2 and 10 g

6.6 in. Disposal of remaining materials and other special precautions for human medical products The products or waste materials used should be disposed of in accordance with the "Control of medical products" and "Packaging Waste Control Regulations". The acyclovir cream contains a specially formulated base and should not be used as a base for undiluted or combined with other medicaments.