USA - engelska - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - valacyclovir hydrochloride (unii: g447s0t1vc) (acyclovir - unii:x4hes1o11f) - valacyclovir 500 mg - cold sores (herpes labialis):   valacyclovir tablets, usp are indicated for treatment of cold sores (herpes labialis). the efficacy of valacyclovir tablets, usp initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. genital herpes:   initial episode: valacyclovir tablets, usp are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. the efficacy of treatment with valacyclovir tablets, usp when initiated more than 72 hours after the onset of signs and symptoms has not been established. recurrent episodes:  valacyclovir tablets, usp are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. the efficacy of treatment with valacyclovir tablets, usp when initiated more than 24 hours after the onset of signs and symptoms has not been established. suppressive therapy:   valacyclovir tablets, usp are indicated for chronic suppressive therapy of recurrent epis

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - valaciclovir hydrochloride, quantity: 556 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash.,for the treatment of ophthalmic zoster.,for the treatment of recurrent herpes labialis (cold sores),for the treatment of clinical episodes of genital herpes simplex infections.,for the prevention of recurrent genital herpes.,reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices. ,prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - valaciclovir hydrochloride, quantity: 1112 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; magnesium stearate; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash.,for the treatment of ophthalmic zoster.,for the treatment of recurrent herpes labialis (cold sores),for the treatment of clinical episodes of genital herpes simplex infections.,for the prevention of recurrent genital herpes.,reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices. ,prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - valaciclovir hydrochloride, quantity: 1112 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash.,for the treatment of ophthalmic zoster.,for the treatment of recurrent herpes labialis (cold sores),for the treatment of clinical episodes of genital herpes simplex infections.,for the prevention of recurrent genital herpes.,reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices. ,prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - valaciclovir hydrochloride, quantity: 556.275 mg (equivalent: valaciclovir, qty 500 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. for the treatment of ophthalmic zoster. for the treatment of recurrent herpes labialis (cold sores) for the treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes. reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see section 4.4 special warnings and precautions for use). prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - valaciclovir, quantity: 500 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; crospovidone; microcrystalline cellulose; indigo carmine aluminium lake; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. treatment of ophthalmic zoster. treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. for the reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see precautions). for prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - valaciclovir hydrochloride 556.275mg equivalent to valaciclovir 500 mg - film coated tablet - 500 mg - active: valaciclovir hydrochloride 556.275mg equivalent to valaciclovir 500 mg excipient: crospovidone indigo carmine aluminium lake magnesium stearate microcrystalline cellulose opadry blue 02c50740 povidone - valaciclovir rbx is indicated for the treatment of herpes zoster (shingles) and the reduction of zoster associated pain, which includes acute and post herpetic neuralgia, when given to immunocompetent patients in infection of less than 72 hours duration.

USA - engelska - NLM (National Library of Medicine)

a-s medication solutions - valacyclovir hydrochloride (unii: g447s0t1vc) (acyclovir - unii:x4hes1o11f) - valacyclovir 500 mg - cold sores (herpes labialis): valacyclovir tablets, usp are indicated for treatment of cold sores (herpes labialis). the efficacy of valacyclovir tablets, usp initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. genital herpes: initial episode: valacyclovir tablets, usp are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. the efficacy of treatment with valacyclovir tablets, usp when initiated more than 72 hours after the onset of signs and symptoms has not been established. recurrent episodes: valacyclovir tablets, usp are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. the efficacy of treatment with valacyclovir tablets, usp when initiated more than 24 hours after the onset of signs and symptoms has not been established. suppressive therapy: valacyclovir tablets, usp are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in hiv-infected adults. the efficacy and safety of valacyclovir tablets, usp for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in hiv-infected patients have not been established. reduction of transmission: valacyclovir tablets, usp are indicated for the reduction of transmission of genital herpes in immunocompetent adults. the efficacy of valacyclovir tablets, usp for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. the efficacy of valacyclovir tablets, usp for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. safer sex practices should be used with suppressive therapy (see current centers for disease control and prevention [cdc] sexually transmitted diseases treatment guidelines ). herpes zoster: valacyclovir tablets, usp are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. the efficacy of valacyclovir tablets, usp when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets, usp for treatment of disseminated herpes zoster have not been established. cold sores (herpes labialis): valacyclovir tablets, usp are indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age. the efficacy of valacyclovir tablets, usp initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. chickenpox: valacyclovir tablets, usp are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age. based on efficacy data from clinical studies with oral acyclovir, treatment with valacyclovir tablets, usp  should be initiated within 24 hours after the onset of rash [see clinical studies (14.4)].   the efficacy and safety of valacyclovir tablets, usp have not been established in: •   immunocompromised patients other than for the suppression of genital herpes in hiv-infected patients with a cd4+ cell count ≥100 cells/mm 3 . •   patients <12 years of age with cold sores (herpes labialis). •   patients <2 years of age or ≥18 years of age with chickenpox. •   patients <18 years of age with genital herpes. •   patients <18 years of age with herpes zoster. •   neonates and infants as suppressive therapy following neonatal herpes simplex virus (hsv) infection. valacyclovir hydrochloride tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see adverse reactions (6.3)]. pregnancy category b. there are no adequate and well-controlled studies of valacyclovir hydrochloride or acyclovir in pregnant women. based on prospective pregnancy registry data on 749 pregnancies, the overall rate of birth defects in infants exposed to acyclovir in-utero appears similar to the rate for infants in the general population. valacyclovir hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. a prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in april 1999. there were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. the occurrence rate of birth defects approximates that found in the general population. however, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. animal reproduction studies performed at oral doses that provided up to 10 and 7 times the human plasma levels during the period of major organogenesis in rats and rabbits, respectively, revealed no evidence of teratogenicity. following oral administration of a 500 mg dose of valacyclovir hydrochloride to 5 nursing mothers, peak acyclovir concentrations (c max ) in breast milk ranged from 0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum concentrations. the acyclovir breast milk auc ranged from 1.4 to 2.6 times (median 2.2) maternal serum auc. a 500 mg maternal dosage of valacyclovir hydrochloride twice daily would provide a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day. this would result in less than 2% of the exposure obtained after administration of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir to the nursing infant. unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. caution should be exercised when valacyclovir hydrochloride is administered to a nursing woman. valacyclovir hydrochloride is indicated for treatment of cold sores in pediatric patients ≥12 years of age and for treatment of chickenpox in pediatric patients 2 to <18 years of age [see indications and usage(1.2, dosage and administration (2.2)]. the use of valacyclovir hydrochloride for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents (≥12 years of age) with a history of recurrent cold sores [see clinical studies (14.1)]. the use of valacyclovir hydrochloride for treatment of chickenpox in pediatric patients 2 to <18 years of age is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by efficacy and safety data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox [see dosage and administration (2.2), adverse reactions (6.2), clinical pharmacology (12.3), clinical studies (14.4)]. the efficacy and safety of valacyclovir have not been established in pediatric patients: • <12 years of age with cold sores • <18 years of age with genital herpes • <18 years of age with herpes zoster • <2 years of age with chickenpox • for suppressive therapy following neonatal hsv infection. the pharmacokinetic profile and safety of valacyclovir oral suspension in children <12 years of age were studied in 3 open-label studies. no efficacy evaluations were conducted in any of the  3 studies. study 1 was a single-dose pharmacokinetic, multiple-dose safety study in 27 pediatric patients 1 to <12 years of age with clinically suspected varicella-zoster virus (vzv) infection [see dosage and administration (2.2), adverse reactions (6.2), clinical pharmacology (12.3), clinical studies (14.4)]. study 2 was a single-dose pharmacokinetic and safety study in pediatric patients 1 month to <6 years of age who had an active herpes virus infection or who were at risk for herpes virus infection. fifty-seven subjects were enrolled and received a single dose of 25 mg/kg valacyclovir oral suspension. in infants and children 3 months to <6 years of age, this dose provided comparable systemic acyclovir exposures to that from a 1 gram dose of valacyclovir in adults (historical data). in infants 1 month to <3 months of age, mean acyclovir exposures resulting from a 25 mg/kg dose were higher (cmax: ↑30%, auc: ↑60%) than acyclovir exposures following a 1 gram dose of valacyclovir in adults. acyclovir is not approved for suppressive therapy in infants and children following neonatal hsv infections; therefore valacyclovir is not recommended for this indication because efficacy cannot be extrapolated from acyclovir. study 3 was a single-dose pharmacokinetic, multiple-dose safety study in 28 pediatric patients 1 to <12 years of age with clinically suspected hsv infection. none of the children enrolled in this study had genital herpes. each subject was dosed with valacyclovir oral suspension, 10 mg/kg twice daily for 3 to 5 days. acyclovir systemic exposures in pediatric patients following valacyclovir oral suspension were compared with historical acyclovir systemic exposures in immunocompetent adults receiving the solid oral dosage form of valacyclovir or acyclovir for the treatment of recurrent genital herpes. the mean projected daily acyclovir systemic exposures in pediatric patients across all age-groups (1 to <12 years of age) were lower (cmax: ↓20%, auc: ↓33%) compared with the acyclovir systemic exposures in adults receiving valacyclovir 500 mg twice daily, but were higher (daily auc: ↑16%) than systemic exposures in adults receiving acyclovir 200 mg 5 times daily. insufficient data are available to support valacyclovir for the treatment of recurrent genital herpes in this age-group because clinical information on recurrent genital herpes in young children is limited; therefore, extrapolating efficacy data from adults to this population is not possible. moreover, valacyclovir has not been studied in children 1 to <12 years of age with recurrent genital herpes. of the total number of subjects in clinical studies of valacyclovir hydrochloride, 906 were 65 and over, and 352 were 75 and over. in a clinical study of herpes zoster, the duration of pain after healing (post-herpetic neuralgia) was longer in patients 65 and older compared with younger adults. elderly patients are more likely to have reduced renal function and require dose reduction. elderly patients are also more likely to have renal or cns adverse events [see dosage and administration (2.4), warnings and precautions (5.2, 5.3), clinical pharmacology (12.3)]. dosage reduction is recommended when administering valacyclovir hydrochloride to patients with renal impairment [see dosage and administration (2.4), warnings and precautions (5.2, 5.3)].

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - valaciclovir hydrochloride monohydrate, quantity: 611.7 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; magnesium stearate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. for the treatment of opthalmic zoster. for the treatment of recurrent herpes labialis (cold sores). for the treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes. reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with vaciclor, it is recommended that patients use safer sex practices (see precautions). prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - valaciclovir hydrochloride -