The instruction for medical use
of Norvela® medicine
the Trade name
of Norvela®
the International unlicensed name
Is not present
the Dosage form
of the Tablet, film coated
Structure
One tablet contains
active agent - a wormwood (Artemisiae argyi folium) of 95% the ethanol extract of dry 60 mg (supporting an eupatilin from 0.48 to 1.44 mg and a dzhaseosidin from 0.15 to 0.45 mg),
excipients: calcium silicate, lactoses monohydrate, cellulose microcrystalline, half-oxameasures, sodium of a kroskarmelloz, magnesium stearate, talc, opadray white OY-C-7000A (hydromelloza, titan dioxide (E171), ethyl cellulose, diethyl phthalate), opadray green 80W41066 (polyvinyl alcohol, titan dioxide (E171), talc, tartrazine (E102), blue brilliant FCF (E133), lecithin, indigo carmine (E132), xanthane gum), opadray colourless 97W19196 (sodium carboxymethyl cellulose, Dextrosums monohydrate, sodium citrate, maltodextrin, lecithin).
The description
of the Tablet of an oval form, film coated green color, with the inscription SLT on one party of a tablet and DA on other party
Pharmacotherapeutic group
Other drugs for treatment of the diseases connected with disturbance of acidity
the ATX A02X Code
Pharmacological action
Pharmacokinetics
According to the International convention – when conducting clinical trials of drugs of plant origin – is not required the isolated research of pharmacokinetic parameters
(EMEA – the European Medical Expert Association HMPWG 11/99).
The pharmacodynamics
of Norvela® represents the vegetable drug received from a wormwood of Artemisiae Argyi folium, rendering gastroprotektivny and antierosive effect.
The activity of drug is defined by the sum of flavonoids from which the main substance is eupatilin.
The medical effect in gastritises is carried out by protection of a mucous membrane due to stimulation of production of slime by a stomach epithelium.
The anti-inflammatory activity of drug is implemented at the expense of an eupatilin who shows pronounced antioxidant properties, warning a peroksidation of lipids and blocking formation of bioreactive forms of oxygen.
Норвела® has the healing effect on mucous a stomach in gastritises by strengthening of regenerative processes in the damaged cells of a mucous membrane. Reparative properties of drug are provided with flavonoids which stimulate synthesis of protein and improve local blood supply.
At use of the drug Norvela® there is a reduction and disappearance of manifestations of acute and chronic gastritises in the form of hypostasis and hyperaemia mucous a stomach, erosion, hemorrhages.
Норвела® protects a mucous membrane of a stomach from the damaging action of various ultserogen, such as alcohol and non-steroidal anti-inflammatory drugs (NPVS).
Protection mucous a stomach from the damage caused by alcohol is carried out due to suppression of activity of a xanthineoxidase and an oxidative stress.
Prevention of damage mucous a stomach at use of NPVS is provided at the expense of the increased release of endogenous E2 prostaglandin from peritoneal neutrophils and decrease in production of F1 prostaglandin ɑ, NPVS caused by use.
Drug stimulates slime secretion with a stomach epithelium, at the same time does not affect basal secretion of gastric juice and production of hydrochloric acid.
Indications
- treatment of injuries of a mucous membrane of a stomach (erosion, hemorrhages, hyperaemia, hypostasis) in acute and chronic gastritises
- prevention of the gastropathies caused by intake of non-steroidal anti-inflammatory drugs (NPVS)
the Route of administration and doses
Apply inside, in 20-30 minutes prior to meal.
The adult at treatment and prevention on 1 tablet 3 times a day. Maximum daily dose 3 tablets. In acute and chronic gastritises an average course of treatment 2 weeks, at prevention of gastropathies – 4 weeks.
Side effects
Are received messages about the following side reactions at treatment of acute and chronic gastritis during clinical trials at 386 patients:
- nausea (0.78%), anorexia (0.52%), diarrhea (0.52%), vomiting (0.26), heartburn (0.26%) and pains in epigastric area (0.26%)
- dizziness (0.26%) and a headache (0.26%)
- rash (0.26%) and an itching (0.26%)
- increase in level of a glutamiltranspeptidaza (0.26%)
Post-marketing data
the Frequency of emergence of side effects of 0.15% (loss of appetite, nausea, indigestion, an abdominal pain - 0.03%).
1 message about a face edema is received, but relationship of cause and effect between this reaction and administration of drug is not established.
Side reactions about which it was reported during clinical trials for prevention of gastropathies at reception of NPVS at 266 patients. It is not established whether there is a communication of following side reactions with reception of Norvela® or NPVS.
Sometimes
- a cardiopalmus
- pain in the bottom of a stomach, a constipation, dyspepsia, an eructation, a meteorism, heartburn, vomiting, feeling of hunger
- the increased appetite
- a headache
- insomnia
- a dysuria
- a nasopharyngitis
- increase in level of a laktatdegidrodenaza
- increase in level of bilirubin
Is frequent
- increase in ALT
is Very frequent
- an abdominal distension, pain in epigastriums, heartburn, nausea, diarrhea
Post-marketing data.
Frequency of emergence of adverse reactions: pain in epigastriums of 0.70%, nausea of 0.23%.
Contraindications
- hypersensitivity to any component of drug
- malignant new growths or a heavy course of diseases of digestive tract
- children's and teenage age up to 18 years
- pregnancy and the period of a lactation
- a hereditary lactose intolerance, deficiency of lactase or a syndrome of a malyadsorbtion of lactose galactose
Medicinal interactions
Data on interaction of drug with other medicines are absent.
Special instructions
With care to apply at
- an ischemic stroke, a myocardial infarction, thrombophlebitises
- a serious illness of a liver, heart, kidneys, lungs and blood
- pulmonary bleedings (pulmonary tuberculosis)
- existence in the anamnesis of hypersensitivity or in rash, fever, an itching.
If improvement after 2 weeks of treatment of patients with acute or chronic gastritis is not observed, then reception of Norvely® it is necessary to stop and consult with the doctor.
At daily reception of 3 tablets (180 mg/days) within 2 weeks, the level of aspartate aminotransferase can decrease to limits of admissible norm or raise lactate dehydrogenase level. Increase in a glutamiltranspeptidaza to indicators which exceed norm was seldom noted.
At increase in a daily dose up to 6 tablets in day within 2 weeks, decrease in level of erythrocytes, hemoglobin, neutrophils, crude protein, alkaline phosphatase, aspartate aminotransferase and increase in level of lymphocytes was noted, but all of them remained within normal range.
At daily reception of 3 tablets (180 mg/days) within 4 weeks, for prevention of gastropathies at reception of NPVS, the level of hemoglobin and neutrophils can decrease considerably, and the ALT level, albumine, a laktatdegidrodenaz to increase, but all indicators remain within admissible norms.
Patients of advanced age
of Special instructions on drug use by patients there is no advanced age.
Children should not appoint use in pediatrics In view of lack of experience of use for children, Norvelu® up to 18 years.
Pregnancy and the period of a lactation
do not apply Norvelu® at pregnancy and in the period of a lactation due to the lack of the clinical data confirming safety of use of drug during these periods. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not affect ability to run the vehicle or other potentially dangerous mechanisms.
The overdose
is not revealed. In case of overdose – symptomatic treatment.
The form of release and packing
On 30 tablets place in bank polymeric, corked by a cover.
After 1 bank together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 30ºС, in original packing.
To store out of children's reach!
A period of storage
3 years
not to use drug after the expiry date specified on packing.
Prescription status
Without prescription
ST Dong-A Producer To., Ltd., Korea
64 Cheonho-daero, Dongdaemun-gu, Seoul, Korea
the Owner of the registration certificate
of Seltfar SA, Switzerland
En Reutet, 1868 Collombey, Switzerland
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of Seltfar SA in Republic of Kazakhstan. Almaty, Al-Farabi Ave. 5, Nurla Tau 1A, office 301. Bodies fax +7 (727) 311 16 28.
To develop
of Norvela® medicine
the Trade name
of Norvela®
the International unlicensed name
Is not present
the Dosage form
of the Tablet, film coated
Structure
One tablet contains
active agent - a wormwood (Artemisiae argyi folium) of 95% the ethanol extract of dry 60 mg (supporting an eupatilin from 0.48 to 1.44 mg and a dzhaseosidin from 0.15 to 0.45 mg),
excipients: calcium silicate, lactoses monohydrate, cellulose microcrystalline, half-oxameasures, sodium of a kroskarmelloz, magnesium stearate, talc, opadray white OY-C-7000A (hydromelloza, titan dioxide (E171), ethyl cellulose, diethyl phthalate), opadray green 80W41066 (polyvinyl alcohol, titan dioxide (E171), talc, tartrazine (E102), blue brilliant FCF (E133), lecithin, indigo carmine (E132), xanthane gum), opadray colourless 97W19196 (sodium carboxymethyl cellulose, Dextrosums monohydrate, sodium citrate, maltodextrin, lecithin).
The description
of the Tablet of an oval form, film coated green color, with the inscription SLT on one party of a tablet and DA on other party
Pharmacotherapeutic group
Other drugs for treatment of the diseases connected with disturbance of acidity
the ATX A02X Code
Pharmacological action
Pharmacokinetics
According to the International convention – when conducting clinical trials of drugs of plant origin – is not required the isolated research of pharmacokinetic parameters
(EMEA – the European Medical Expert Association HMPWG 11/99).
The pharmacodynamics
of Norvela® represents the vegetable drug received from a wormwood of Artemisiae Argyi folium, rendering gastroprotektivny and antierosive effect.
The activity of drug is defined by the sum of flavonoids from which the main substance is eupatilin.
The medical effect in gastritises is carried out by protection of a mucous membrane due to stimulation of production of slime by a stomach epithelium.
The anti-inflammatory activity of drug is implemented at the expense of an eupatilin who shows pronounced antioxidant properties, warning a peroksidation of lipids and blocking formation of bioreactive forms of oxygen.
Норвела® has the healing effect on mucous a stomach in gastritises by strengthening of regenerative processes in the damaged cells of a mucous membrane. Reparative properties of drug are provided with flavonoids which stimulate synthesis of protein and improve local blood supply.
At use of the drug Norvela® there is a reduction and disappearance of manifestations of acute and chronic gastritises in the form of hypostasis and hyperaemia mucous a stomach, erosion, hemorrhages.
Норвела® protects a mucous membrane of a stomach from the damaging action of various ultserogen, such as alcohol and non-steroidal anti-inflammatory drugs (NPVS).
Protection mucous a stomach from the damage caused by alcohol is carried out due to suppression of activity of a xanthineoxidase and an oxidative stress.
Prevention of damage mucous a stomach at use of NPVS is provided at the expense of the increased release of endogenous E2 prostaglandin from peritoneal neutrophils and decrease in production of F1 prostaglandin ɑ, NPVS caused by use.
Drug stimulates slime secretion with a stomach epithelium, at the same time does not affect basal secretion of gastric juice and production of hydrochloric acid.
Indications
- treatment of injuries of a mucous membrane of a stomach (erosion, hemorrhages, hyperaemia, hypostasis) in acute and chronic gastritises
- prevention of the gastropathies caused by intake of non-steroidal anti-inflammatory drugs (NPVS)
the Route of administration and doses
Apply inside, in 20-30 minutes prior to meal.
The adult at treatment and prevention on 1 tablet 3 times a day. Maximum daily dose 3 tablets. In acute and chronic gastritises an average course of treatment 2 weeks, at prevention of gastropathies – 4 weeks.
Side effects
Are received messages about the following side reactions at treatment of acute and chronic gastritis during clinical trials at 386 patients:
- nausea (0.78%), anorexia (0.52%), diarrhea (0.52%), vomiting (0.26), heartburn (0.26%) and pains in epigastric area (0.26%)
- dizziness (0.26%) and a headache (0.26%)
- rash (0.26%) and an itching (0.26%)
- increase in level of a glutamiltranspeptidaza (0.26%)
Post-marketing data
the Frequency of emergence of side effects of 0.15% (loss of appetite, nausea, indigestion, an abdominal pain - 0.03%).
1 message about a face edema is received, but relationship of cause and effect between this reaction and administration of drug is not established.
Side reactions about which it was reported during clinical trials for prevention of gastropathies at reception of NPVS at 266 patients. It is not established whether there is a communication of following side reactions with reception of Norvela® or NPVS.
Sometimes
- a cardiopalmus
- pain in the bottom of a stomach, a constipation, dyspepsia, an eructation, a meteorism, heartburn, vomiting, feeling of hunger
- the increased appetite
- a headache
- insomnia
- a dysuria
- a nasopharyngitis
- increase in level of a laktatdegidrodenaza
- increase in level of bilirubin
Is frequent
- increase in ALT
is Very frequent
- an abdominal distension, pain in epigastriums, heartburn, nausea, diarrhea
Post-marketing data.
Frequency of emergence of adverse reactions: pain in epigastriums of 0.70%, nausea of 0.23%.
Contraindications
- hypersensitivity to any component of drug
- malignant new growths or a heavy course of diseases of digestive tract
- children's and teenage age up to 18 years
- pregnancy and the period of a lactation
- a hereditary lactose intolerance, deficiency of lactase or a syndrome of a malyadsorbtion of lactose galactose
Medicinal interactions
Data on interaction of drug with other medicines are absent.
Special instructions
With care to apply at
- an ischemic stroke, a myocardial infarction, thrombophlebitises
- a serious illness of a liver, heart, kidneys, lungs and blood
- pulmonary bleedings (pulmonary tuberculosis)
- existence in the anamnesis of hypersensitivity or in rash, fever, an itching.
If improvement after 2 weeks of treatment of patients with acute or chronic gastritis is not observed, then reception of Norvely® it is necessary to stop and consult with the doctor.
At daily reception of 3 tablets (180 mg/days) within 2 weeks, the level of aspartate aminotransferase can decrease to limits of admissible norm or raise lactate dehydrogenase level. Increase in a glutamiltranspeptidaza to indicators which exceed norm was seldom noted.
At increase in a daily dose up to 6 tablets in day within 2 weeks, decrease in level of erythrocytes, hemoglobin, neutrophils, crude protein, alkaline phosphatase, aspartate aminotransferase and increase in level of lymphocytes was noted, but all of them remained within normal range.
At daily reception of 3 tablets (180 mg/days) within 4 weeks, for prevention of gastropathies at reception of NPVS, the level of hemoglobin and neutrophils can decrease considerably, and the ALT level, albumine, a laktatdegidrodenaz to increase, but all indicators remain within admissible norms.
Patients of advanced age
of Special instructions on drug use by patients there is no advanced age.
Children should not appoint use in pediatrics In view of lack of experience of use for children, Norvelu® up to 18 years.
Pregnancy and the period of a lactation
do not apply Norvelu® at pregnancy and in the period of a lactation due to the lack of the clinical data confirming safety of use of drug during these periods. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not affect ability to run the vehicle or other potentially dangerous mechanisms.
The overdose
is not revealed. In case of overdose – symptomatic treatment.
The form of release and packing
On 30 tablets place in bank polymeric, corked by a cover.
After 1 bank together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 30ºС, in original packing.
To store out of children's reach!
A period of storage
3 years
not to use drug after the expiry date specified on packing.
Prescription status
Without prescription
ST Dong-A Producer To., Ltd., Korea
64 Cheonho-daero, Dongdaemun-gu, Seoul, Korea
the Owner of the registration certificate
of Seltfar SA, Switzerland
En Reutet, 1868 Collombey, Switzerland
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of Seltfar SA in Republic of Kazakhstan. Almaty, Al-Farabi Ave. 5, Nurla Tau 1A, office 301. Bodies fax +7 (727) 311 16 28.
To develop
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