METIOCOLIN
Citicoline (as Citicoline sodium)
Treatment Alzheimer’s disease and other types of dementia
MONINE
Galantamine (as galantamine hydrobromide)
Treatment peripheral neuropathy
MEMOBACK
Galantamine (as galantamine hydrobromide) 4mg/5ml
Treatment peripheral neuropathy
NAUSAZY 4mg
Ondansetron (as Ondansetron hydrochloride dihydrate)
Treatment nausea, vomiting due to chemotherapy and radiotherapy.
Citicoline 100mg/10ml
(as Citicoline sodium)
Liquid solution
Used for Alzheimer's disease and other types of dementia, head trauma, cerebrovascular disease such as stroke, age-related memory loss, Parkinson's disease, attention deficit-hyperactive disorder (ADHD), and glaucoma.
Unless otherwise prescribed by the physician, and depending on the seriousness of the condition to be treated. Somozina oral solution can be used according to the following dosage regimen:
- In case of cognitive impairment:
Adults: 500-1000 mg/day for at least three months.
Children: 500-750 mg/day for at least three months.
- In case of acute and sub-acute and cerebro-vascular accidents and once the patient can swallow:
Adults: 500-2000 mg/day for 6 weeks.
Children: 500-750 mg/day for six weeks.
Form of administration
It can be taken directly from the envelope or dissolved in half a glass of water (120 ml).
Galantamine (as galantamine hydrobromide) 8mg/10ml
Oral solution
Treatment of mild to moderate dementia of the Alzheimer’s type
Posology
Adults/Elderly
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines.
Starting dose
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4 weeks.
Maintenance dose
The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The initial maintenance dose is 16 mg/day (8 mg twice a day) and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day (12 mg twice a day) should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.
In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered.
Treatment withdrawal
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
Renal impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe renal impairment.
For patients with a creatinine clearance ≥9 ml/min, no dosage adjustment is required.
The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/min.
Hepatic impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment.
In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 4 mg once daily, preferably taken in the morning, for at least 1 week. Thereafter, patients should proceed with 4 mg twice daily for at least 4 weeks. In these patients, daily doses should not exceed 8 mg twice daily.
In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated.
No dosage adjustment is required for patients with mild hepatic impairment.
Concomitant treatment
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered.
Paediatric population
There is no relevant use of galantamine in the paediatric population.
Method of administration
Monine oral solution should be administered orally, twice a day, preferably with morning and evening meals. Ensure adequate fluid intake during treatment.
Galantamine (as galantamine hydrobromide) 4mg/5ml
Oral solution
Treatment of mild to moderate dementia of the Alzheimer’s type
Posology
Adults/Elderly
- Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines
- Starting dose
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4 weeks.
- Maintenance dose
The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The initial maintenance dose is 16 mg/day (8 mg twice a day) and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day (12 mg twice a day) should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.
In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered.
- Treatment withdrawal
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
Renal impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe renal impairment
For patients with a creatinine clearance ≥9 ml/min, no dosage adjustment is required.
The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/min
Hepatic impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment
In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 4 mg once daily, preferably taken in the morning, for at least 1 week. Thereafter, patients should proceed with 4 mg twice daily for at least 4 weeks. In these patients, daily doses should not exceed 8 mg twice daily.
In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated
No dosage adjustment is required for patients with mild hepatic impairment.
Concomitant treatment
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see section 4.5).
Paediatric population
There is no relevant use of galantamine in the paediatric population.
Method of administration
Memoback oral solution should be administered orally, twice a day, preferably with morning and evening meals. Ensure adequate fluid intake during treatment
Ondansetron (as Ondansetron hydrochloride dihydrate) 4mg/5ml
Liquid solution
The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting in adults.
Chemotherapy and radiotherapy induced nausea and vomiting.
Adults:
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.
Emetogenic chemotherapy and radiotherapy: Nausazy can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.
For oral administration: 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.
For highly emetogenic chemotherapy: a single dose of up to 24 mg Nausazy taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Nausazy may be continued for up to 5 days after a course of treatment.
The recommended dose for oral administration is 8 mg to be taken twice daily.
Paediatric Population:
CINV in children aged ≥ 6 months and adolescents:
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluid and infused over not less than 15 minutes.
Weight-based dosing results in higher total daily doses compared to BSA-based dosing.
There are no data from controlled clinical trials on the use of Nausazy in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Nausazy for radiotherapy-induced nausea and vomiting in children.
Dosing by BSA:
Nausazy should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m2. The single intravenous dose must not exceed 8 mg.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 1). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 1: BSA-based dosing for Chemotherapy - Children aged ≥6 months and adolescents
|
BSA |
Day 1 (a,b) |
Days 2-6(b) |
|
< 0.6 m2 |
5 mg/m2 IV plus 2 mg syrup after 12 hours |
2 mg syrup every 12 hours |
|
≥ 0.6 m2 to ≤ 1.2 m2 |
5 mg/m2 IV plus 4 mg syrup or tablet after 12 hours |
4 mg syrup or tablet every 12 hours |
|
> 1.2 m2 |
5 mg/m2 or 8 mg IV plus 8 mg syrup or tablet after 12 hours |
8 mg syrup or tablet every 12 hours |
a The intravenous dose must not exceed 8 mg.
b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg
Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to BSA-based dosing.
Nausazy should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg.
Two further intravenous doses may be given in 4-hourly intervals.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 2). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 2: Weight-based dosing for Chemotherapy - Children aged ≥6 months and adolescents
|
Weight |
Day 1 (a,b) |
Days 2-6(b) |
|
≤ 10 kg |
Up to 3 doses of 0.15 mg/kg IV every 4 hours |
2 mg syrup every 12 hours |
|
> 10 kg |
Up to 3 doses of 0.15 mg/kg IV every 4 hours |
4 mg syrup or tablet every 12 hours |
a The intravenous dose must not exceed 8 mg.
b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Elderly:
No alteration of oral dose or frequency of administration is required.
Post operative nausea and vomiting (PONV).
Adults:
For the prevention of PONV: Nausazy can be administered orally or by intravenous or intramuscular injection.
For oral administration: 16 mg one hour prior to anaesthesia.
For the treatment of established PONV: Intravenous or intramuscular administration is recommended.
Paediatric population:
PONV in children aged ≥ 1 month and adolescents
Oral formulation:
No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose.
Injection:
For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.
For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Nausazy may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg.
There are no data on the use of Nausazy in the treatment of PONV in children below 2 years of age.
Elderly:
There is limited experience in the use of Nausazy in the prevention and treatment of PONV in the elderly, however Nausazy is well tolerated in patients over 65 years receiving chemotherapy.
For both indications:
Patients with Renal impairment:
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with Hepatic impairment:
Clearance of Nausazy is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.
Patients with poor Sparteine/Debrisoquine Metabolism:
The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
CONIPA PURE
Zinc (as zinc gluconate)
Treatment and prevention of zinc deficiency and its consequences
Beejuvit subtilis
Bacillus subtilis
Treatment and prevention intestinal bacterial flora disorders.
NIMOVASO SOL
Nimodipine
Indicated for the improvement of neurological outcome
AMBROXEN
Ambroxol hydrochloride
Treatment of bronchial secretions acute bronchial disease, chronic bronchopulmonary disease
Zinc gluconate 70mg/10ml
Oral solution
Additional zinc in case p- regnancy, lactation,dwarf children, stunted children, immunodeficiency case.
- Treatment and prevention of zinc deficiency and its consequences, including stunted growth and acute diarrhea in children, and slow wound healing.
- Boosting the immune system, treating the common cold and recurrent ear infections, and preventing lower respiratory infections.
Wilson disease:
- Children 1-6 years: 25 mg zinc/day.
- Children 6-16 years old, weigh less than 57 kg: 25 mg zinc/day.
- Persons aged 16 and over, or with a body weight of over 57 kg: 50 mg of zinc/day.
- Pregnant women: 25 mg of zinc/day. Divide 3 times/day.
Cases of zinc deficiency (Diarrhea, poor nutrition, pregnant women): The dose can be up to 50 mg zinc/day, divided 3 times/day
Bacillus subtilis 2 x 10^9cfu/5ml.
Oral suspension.
Supplements intestinal beneficial bacteria, helps balance intestinal microflora, supports to prevent digestive disorders in cases of diarrhea, constipation, and flatulence.
Supports to protect intestinal health.
Adults: Take 1 – 2 ampoules/time, 1 – 2 times per day.
Children: Take 1 ampoule/time, 1 – 2 times per day.
Nimodipine 30mg/10ml
Oral solution
Indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients withsubarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V)
Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes.
Give one hour before a meal or two hours after a meal.
Start dosing within 96 hours of the SAH.
Recommended dose is 20 mL (60 mg) every 4 hours for 21 consecutive days.
Nasogastric or Gastric Tube Administration: Administer 20 mL (60 mg) every 4 hours with supplied oral syringe. Refill syringe with 20 mL of 0.9% saline water solution; flush remaining contents from nasogastric or gastric tube into stomach.
Patients with Cirrhosis: Reduce dosage to 10 mL (30 mg) every 4 hours
Ambroxol hydrochloride 30mg/10ml
Oral solution
All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma
- Adult and children above 10 years old: 10 ml x 3 times a day. After that, twice a day if taking for a long time
- Children 5 – 10 years old: 5 ml x 3 times a day. After that, twice a day if taking for a long time.
- Children 2 – 5 years old: 2.5 ml x 3 times a day. After that, twice a day if taking for a long time
- Children under 2 years old: 2.5 ml x twice a day.
METIOCOLIN
Citicoline
Treatment conscious disorders, Alzheimer, Parkinson and support recover movement
NOVOTHYM
Thyme Extract/ Elderberry Extract/ Althea officinalis Extract/ Bromelain
Protection the upper respiratory and prevents the infection of the upper respiratory tract
BROMETIC
Bromhexin
Sputum dilution in acute and chronic bronchopulmonary disease by abnormal mucus secretion
BOMINITY
Vitamin C
Prevention and treatment of Vitamin C deficiency and enhance the body's resistance
Each plastic ampoule (10 ml) contains:
Citicoline (formed citicoline sodium):.....................100mg
Oral solution
- Conscious disorders caused by injury or after brain surgery
- Support recovery of movement with patients with hemiplegia after stroke
- Parkinson's disease has a severe tremor
- Old age dementia (including Alzheimer's disease)
PHARMACODYNEMIC:
Citicoline stimulates the biosynthesis of structural phospholipids of the neuronal membrane as it is demonstrated in the magnetic resonance spectroscopy studies. Citicoline, through its action, improves the function of the membrane mechanisms, such as the functioning of the ionic exchange pumps and receptors inserted in the latter, the modulation of which is indispensable in the neurotransmission.
Citicoline due to its membrane stabilizing activity has properties which favour brain oedema reabsorption.
Experimental studies have shown that citicoline inhibits the activation of some phospholipases (A1, A2, C and D), reducing the formation of free radicals, avoiding the destruction of membranous systems and preserving antioxidant defence systems as glutathione.
Citicoline preserves the neuronal energetic reserve, inhibits apoptosis and stimulates acetylcholine synthesis.
It has been experimentally shown that citicoline also exerts a prophylactic neuroprotective effect in focal brain ischemic models.
Clinical trials have shown that citicoline significantly increases the functional evolution of patients with acute ischemic cerebrovascular accident, coinciding with a lower growth of the brain ischemic injury in neuroimaging tests.
In patients with craniocerebral traumatisms, citicoline speeds up their recuperation and reduces duration and intensity of the post-concussional syndrome.
Citicoline improves the level of attention and consciousness and acts favourably over amnesia and cognitive and neurological disorders associated to brain ischemia.
DOSAGE AND USAGE
Dose
Acute brain disease recovery phase
Adults: 2 ampoules 10 ml x 3 times/day
Children: 1 ampoules 10 ml x 2-3 times/day
Chronic brain disease
Use oral dose as recovery phase
Elderly: No need to adjust the dose.
Method of administration
It may be taken directly or dissolved in half glass of water (120 ml)
Each ampoule contains:
Thyme Extract:.............................40 mg
Elderberry Extract:......................500 mg
Althea officinalis Extract:.............275 mg
Bromelain:................................31.25 mg
Oral solution
- Respiratory protection for children at high risk of upper respiratory tract infection in the case of :
+ Children under 1-year-old
+ Malnourished children, postoperative children
+Immunocompromised children
+ Children often exposed to the polluted living environment, winter-spring changing weather
- Prevents the infection of the upper respiratory tract
- Children with mild upper respiratory tract infection, do not have to take antibiotics.
Take 1 ampoule, twice a day, reduce the inflammation of the upper respiratory tract, prevent the progression of upper respiratory tract infection from the beginning.
- Children with severe upper respiratory tract infection, have taken antibiotics.
Taking 1 ampoule twice a day that helps increases the effectiveness of antibiotics.
- Prophylaxis of upper respiratory
Bromhexine (as bromhexine hydrochloride): 2mg/10ml
Oral solution
Sputum dilution in acute and chronic bronchopulmonary diseases accompanied by abnormal mucus secretion and impaired mucus transport
Children below 2 years old: 5 ml x 3 times/day.
Children from 2 – 6 years old: 10 ml x 3 times/day.
Children from 6-12 years old: 20 ml x three times/day
Chilldren above 12 years old: 40 ml x three times/day.
Vitamin C 100mg/10ml
Oral solution
- Prevention of Vitamin C deficiency can occur when dietary imbalance or deficiency.
- Enhancing the body's resistance to infections, colds, flu, sickness period.
Preventive dose:
- Children from 2 to 6 years old (including infants and young children): 1 ampoule once a day.
- Children over 6 years and adults: 1 ampoule x 1-2 times/day.
Treatment dose: Use continuously for at least 2 weeks.
- Children 2 - 6 years: 1 ampoule x 2-3 times/day.
- Children 7-15 years: 1 ampoule x 2-3 times/day.
METIOCOLIN
Citicoline (as Citicoline sodium)
Treatment Alzheimer’s disease and other types of dementia
MONINE
Galantamine (as galantamine hydrobromide)
Treatment peripheral neuropathy
Citicoline 100mg/10ml
(as Citicoline sodium)
Liquid solution
Used for Alzheimer's disease and other types of dementia, head trauma, cerebrovascular disease such as stroke, age-related memory loss, Parkinson's disease, attention deficit-hyperactive disorder (ADHD), and glaucoma.
Unless otherwise prescribed by the physician, and depending on the seriousness of the condition to be treated. Somozina oral solution can be used according to the following dosage regimen:
- In case of cognitive impairment:
Adults: 500-1000 mg/day for at least three months.
Children: 500-750 mg/day for at least three months.
- In case of acute and sub-acute and cerebro-vascular accidents and once the patient can swallow:
Adults: 500-2000 mg/day for 6 weeks.
Children: 500-750 mg/day for six weeks.
Form of administration
It can be taken directly from the envelope or dissolved in half a glass of water (120 ml).
Galantamine (as galantamine hydrobromide) 8mg/10ml
Oral solution
Treatment of mild to moderate dementia of the Alzheimer’s type
Posology
Adults/Elderly
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines.
Starting dose
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4 weeks.
Maintenance dose
The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The initial maintenance dose is 16 mg/day (8 mg twice a day) and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day (12 mg twice a day) should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.
In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered.
Treatment withdrawal
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
Renal impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe renal impairment.
For patients with a creatinine clearance ≥9 ml/min, no dosage adjustment is required.
The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/min.
Hepatic impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment.
In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 4 mg once daily, preferably taken in the morning, for at least 1 week. Thereafter, patients should proceed with 4 mg twice daily for at least 4 weeks. In these patients, daily doses should not exceed 8 mg twice daily.
In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated.
No dosage adjustment is required for patients with mild hepatic impairment.
Concomitant treatment
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered.
Paediatric population
There is no relevant use of galantamine in the paediatric population.
Method of administration
Monine oral solution should be administered orally, twice a day, preferably with morning and evening meals. Ensure adequate fluid intake during treatment.
MEMOBACK
Galantamine (as galantamine hydrobromide) 4mg/5ml
Treatment peripheral neuropathy
NAUSAZY 4mg
Ondansetron (as Ondansetron hydrochloride dihydrate)
Treatment nausea, vomiting due to chemotherapy and radiotherapy.
Galantamine (as galantamine hydrobromide) 4mg/5ml
Oral solution
Treatment of mild to moderate dementia of the Alzheimer’s type
Posology
Adults/Elderly
- Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines
- Starting dose
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4 weeks.
- Maintenance dose
The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The initial maintenance dose is 16 mg/day (8 mg twice a day) and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day (12 mg twice a day) should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.
In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered.
- Treatment withdrawal
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
Renal impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe renal impairment
For patients with a creatinine clearance ≥9 ml/min, no dosage adjustment is required.
The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/min
Hepatic impairment
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment
In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 4 mg once daily, preferably taken in the morning, for at least 1 week. Thereafter, patients should proceed with 4 mg twice daily for at least 4 weeks. In these patients, daily doses should not exceed 8 mg twice daily.
In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated
No dosage adjustment is required for patients with mild hepatic impairment.
Concomitant treatment
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see section 4.5).
Paediatric population
There is no relevant use of galantamine in the paediatric population.
Method of administration
Memoback oral solution should be administered orally, twice a day, preferably with morning and evening meals. Ensure adequate fluid intake during treatment
Ondansetron (as Ondansetron hydrochloride dihydrate) 4mg/5ml
Liquid solution
The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting in adults.
Chemotherapy and radiotherapy induced nausea and vomiting.
Adults:
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.
Emetogenic chemotherapy and radiotherapy: Nausazy can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.
For oral administration: 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.
For highly emetogenic chemotherapy: a single dose of up to 24 mg Nausazy taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Nausazy may be continued for up to 5 days after a course of treatment.
The recommended dose for oral administration is 8 mg to be taken twice daily.
Paediatric Population:
CINV in children aged ≥ 6 months and adolescents:
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluid and infused over not less than 15 minutes.
Weight-based dosing results in higher total daily doses compared to BSA-based dosing.
There are no data from controlled clinical trials on the use of Nausazy in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Nausazy for radiotherapy-induced nausea and vomiting in children.
Dosing by BSA:
Nausazy should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m2. The single intravenous dose must not exceed 8 mg.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 1). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 1: BSA-based dosing for Chemotherapy - Children aged ≥6 months and adolescents
|
BSA |
Day 1 (a,b) |
Days 2-6(b) |
|
< 0.6 m2 |
5 mg/m2 IV plus 2 mg syrup after 12 hours |
2 mg syrup every 12 hours |
|
≥ 0.6 m2 to ≤ 1.2 m2 |
5 mg/m2 IV plus 4 mg syrup or tablet after 12 hours |
4 mg syrup or tablet every 12 hours |
|
> 1.2 m2 |
5 mg/m2 or 8 mg IV plus 8 mg syrup or tablet after 12 hours |
8 mg syrup or tablet every 12 hours |
a The intravenous dose must not exceed 8 mg.
b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg
Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to BSA-based dosing.
Nausazy should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg.
Two further intravenous doses may be given in 4-hourly intervals.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 2). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 2: Weight-based dosing for Chemotherapy - Children aged ≥6 months and adolescents
|
Weight |
Day 1 (a,b) |
Days 2-6(b) |
|
≤ 10 kg |
Up to 3 doses of 0.15 mg/kg IV every 4 hours |
2 mg syrup every 12 hours |
|
> 10 kg |
Up to 3 doses of 0.15 mg/kg IV every 4 hours |
4 mg syrup or tablet every 12 hours |
a The intravenous dose must not exceed 8 mg.
b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Elderly:
No alteration of oral dose or frequency of administration is required.
Post operative nausea and vomiting (PONV).
Adults:
For the prevention of PONV: Nausazy can be administered orally or by intravenous or intramuscular injection.
For oral administration: 16 mg one hour prior to anaesthesia.
For the treatment of established PONV: Intravenous or intramuscular administration is recommended.
Paediatric population:
PONV in children aged ≥ 1 month and adolescents
Oral formulation:
No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose.
Injection:
For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.
For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Nausazy may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg.
There are no data on the use of Nausazy in the treatment of PONV in children below 2 years of age.
Elderly:
There is limited experience in the use of Nausazy in the prevention and treatment of PONV in the elderly, however Nausazy is well tolerated in patients over 65 years receiving chemotherapy.
For both indications:
Patients with Renal impairment:
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with Hepatic impairment:
Clearance of Nausazy is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.
Patients with poor Sparteine/Debrisoquine Metabolism:
The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
CONIPA PURE
Zinc (as zinc gluconate)
Treatment and prevention of zinc deficiency and its consequences
Beejuvit subtilis
Bacillus subtilis
Treatment and prevention intestinal bacterial flora disorders.
Zinc gluconate 70mg/10ml
Oral solution
Additional zinc in case p- regnancy, lactation,dwarf children, stunted children, immunodeficiency case.
- Treatment and prevention of zinc deficiency and its consequences, including stunted growth and acute diarrhea in children, and slow wound healing.
- Boosting the immune system, treating the common cold and recurrent ear infections, and preventing lower respiratory infections.
Wilson disease:
- Children 1-6 years: 25 mg zinc/day.
- Children 6-16 years old, weigh less than 57 kg: 25 mg zinc/day.
- Persons aged 16 and over, or with a body weight of over 57 kg: 50 mg of zinc/day.
- Pregnant women: 25 mg of zinc/day. Divide 3 times/day.
Cases of zinc deficiency (Diarrhea, poor nutrition, pregnant women): The dose can be up to 50 mg zinc/day, divided 3 times/day
Bacillus subtilis 2 x 10^9cfu/5ml.
Oral suspension.
Supplements intestinal beneficial bacteria, helps balance intestinal microflora, supports to prevent digestive disorders in cases of diarrhea, constipation, and flatulence.
Supports to protect intestinal health.
Adults: Take 1 – 2 ampoules/time, 1 – 2 times per day.
Children: Take 1 ampoule/time, 1 – 2 times per day.
NIMOVASO SOL
Nimodipine
Indicated for the improvement of neurological outcome
AMBROXEN
Ambroxol hydrochloride
Treatment of bronchial secretions acute bronchial disease, chronic bronchopulmonary disease
Nimodipine 30mg/10ml
Oral solution
Indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients withsubarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V)
Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes.
Give one hour before a meal or two hours after a meal.
Start dosing within 96 hours of the SAH.
Recommended dose is 20 mL (60 mg) every 4 hours for 21 consecutive days.
Nasogastric or Gastric Tube Administration: Administer 20 mL (60 mg) every 4 hours with supplied oral syringe. Refill syringe with 20 mL of 0.9% saline water solution; flush remaining contents from nasogastric or gastric tube into stomach.
Patients with Cirrhosis: Reduce dosage to 10 mL (30 mg) every 4 hours
Ambroxol hydrochloride 30mg/10ml
Oral solution
All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma
- Adult and children above 10 years old: 10 ml x 3 times a day. After that, twice a day if taking for a long time
- Children 5 – 10 years old: 5 ml x 3 times a day. After that, twice a day if taking for a long time.
- Children 2 – 5 years old: 2.5 ml x 3 times a day. After that, twice a day if taking for a long time
- Children under 2 years old: 2.5 ml x twice a day.
METIOCOLIN
Citicoline
Treatment conscious disorders, Alzheimer, Parkinson and support recover movement
NOVOTHYM
Thyme Extract/ Elderberry Extract/ Althea officinalis Extract/ Bromelain
Protection the upper respiratory and prevents the infection of the upper respiratory tract
Each plastic ampoule (10 ml) contains:
Citicoline (formed citicoline sodium):.....................100mg
Oral solution
- Conscious disorders caused by injury or after brain surgery
- Support recovery of movement with patients with hemiplegia after stroke
- Parkinson's disease has a severe tremor
- Old age dementia (including Alzheimer's disease)
PHARMACODYNEMIC:
Citicoline stimulates the biosynthesis of structural phospholipids of the neuronal membrane as it is demonstrated in the magnetic resonance spectroscopy studies. Citicoline, through its action, improves the function of the membrane mechanisms, such as the functioning of the ionic exchange pumps and receptors inserted in the latter, the modulation of which is indispensable in the neurotransmission.
Citicoline due to its membrane stabilizing activity has properties which favour brain oedema reabsorption.
Experimental studies have shown that citicoline inhibits the activation of some phospholipases (A1, A2, C and D), reducing the formation of free radicals, avoiding the destruction of membranous systems and preserving antioxidant defence systems as glutathione.
Citicoline preserves the neuronal energetic reserve, inhibits apoptosis and stimulates acetylcholine synthesis.
It has been experimentally shown that citicoline also exerts a prophylactic neuroprotective effect in focal brain ischemic models.
Clinical trials have shown that citicoline significantly increases the functional evolution of patients with acute ischemic cerebrovascular accident, coinciding with a lower growth of the brain ischemic injury in neuroimaging tests.
In patients with craniocerebral traumatisms, citicoline speeds up their recuperation and reduces duration and intensity of the post-concussional syndrome.
Citicoline improves the level of attention and consciousness and acts favourably over amnesia and cognitive and neurological disorders associated to brain ischemia.
DOSAGE AND USAGE
Dose
Acute brain disease recovery phase
Adults: 2 ampoules 10 ml x 3 times/day
Children: 1 ampoules 10 ml x 2-3 times/day
Chronic brain disease
Use oral dose as recovery phase
Elderly: No need to adjust the dose.
Method of administration
It may be taken directly or dissolved in half glass of water (120 ml)
Each ampoule contains:
Thyme Extract:.............................40 mg
Elderberry Extract:......................500 mg
Althea officinalis Extract:.............275 mg
Bromelain:................................31.25 mg
Oral solution
- Respiratory protection for children at high risk of upper respiratory tract infection in the case of :
+ Children under 1-year-old
+ Malnourished children, postoperative children
+Immunocompromised children
+ Children often exposed to the polluted living environment, winter-spring changing weather
- Prevents the infection of the upper respiratory tract
- Children with mild upper respiratory tract infection, do not have to take antibiotics.
Take 1 ampoule, twice a day, reduce the inflammation of the upper respiratory tract, prevent the progression of upper respiratory tract infection from the beginning.
- Children with severe upper respiratory tract infection, have taken antibiotics.
Taking 1 ampoule twice a day that helps increases the effectiveness of antibiotics.
- Prophylaxis of upper respiratory
BROMETIC
Bromhexin
Sputum dilution in acute and chronic bronchopulmonary disease by abnormal mucus secretion
BOMINITY
Vitamin C
Prevention and treatment of Vitamin C deficiency and enhance the body's resistance
Bromhexine (as bromhexine hydrochloride): 2mg/10ml
Oral solution
Sputum dilution in acute and chronic bronchopulmonary diseases accompanied by abnormal mucus secretion and impaired mucus transport
Children below 2 years old: 5 ml x 3 times/day.
Children from 2 – 6 years old: 10 ml x 3 times/day.
Children from 6-12 years old: 20 ml x three times/day
Chilldren above 12 years old: 40 ml x three times/day.
Vitamin C 100mg/10ml
Oral solution
- Prevention of Vitamin C deficiency can occur when dietary imbalance or deficiency.
- Enhancing the body's resistance to infections, colds, flu, sickness period.
Preventive dose:
- Children from 2 to 6 years old (including infants and young children): 1 ampoule once a day.
- Children over 6 years and adults: 1 ampoule x 1-2 times/day.
Treatment dose: Use continuously for at least 2 weeks.
- Children 2 - 6 years: 1 ampoule x 2-3 times/day.
- Children 7-15 years: 1 ampoule x 2-3 times/day.