Galvus Met Uses

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Galvus Met indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin (Galvus Met) HCl or Vildagliptin (Galvus Met) alone, or who are already treated with the combination of Vildagliptin (Galvus Met) and Metformin (Galvus Met) HCl as separate tablets.

In combination with a sulphonylurea (SU) (ie, triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with Metformin (Galvus Met) and a sulphonylurea.

As add-on to insulin as an adjunct to diet and exercise to improve glycemic control in patients when stable dose of insulin and Metformin (Galvus Met) alone do not provide adequate glycemic control.

As initial therapy in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled by diet and exercise alone.

Galvus Met description

Galvus Met contains Vildagliptin (Galvus Met) 50 mg and Metformin (Galvus Met) hydrochloride 500, 850 or 1000 mg, respectively.

It also contains the following excipients: Red and yellow ferric oxide, hypromellose, hydroxypropylcellulose, magnesium stearate, polyethylene glycol and talc.

Galvus Met dosage

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The use of antihyperglycaemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability. In using Galvus Met, do not exceed the maximum daily dose of Vildagliptin (Galvus Met) (100 mg).

The recommended starting dose of Galvus Met should be based on the patient’s condition and/or current regimen of Vildagliptin (Galvus Met) and/or Metformin (Galvus Met) hydrochloride. Galvus Met should be given with meals to reduce the gastrointestinal side effects associated with Metformin (Galvus Met) HCl.

Patients Inadequately Controlled on Vildagliptin (Galvus Met) Monotherapy: Based on the usual starting doses of Metformin (Galvus Met) HCl (500 mg twice daily or 850 mg once daily), Galvus Met may be initiated at the 50 mg/500 mg tab strength twice daily and gradually titrated after assessing adequacy of therapeutic response.

Patients Inadequately Controlled on Metformin (Galvus Met) HCl Monotherapy: Based on the patient's current dose of Metformin (Galvus Met) HCl, Galvus Met may be initiated at either 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tab strength twice daily.

Patients Switching from Combination Therapy of Vildagliptin (Galvus Met) plus Metformin (Galvus Met) HCl as Separate Tablets: Galvus Met may be initiated with either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength based on the dose of Vildagliptin (Galvus Met) or Metformin (Galvus Met) already being taken.

Starting Dose for Treatment Naive Patients: In treatment for naive patients, Galvus Met may be initiated at 50 mg/500 mg once daily and gradually titrated to a maximum dose of 50 mg/1000 mg twice daily after assessing adequacy of therapeutic response.

In Combination with SU or Insulin: The dose of Galvus Met should provide Vildagliptin (Galvus Met) dosed as 50 mg twice daily (100 mg total daily dose) and a dose of Metformin (Galvus Met) similar to the dose already being taken.

Elderly: As Metformin (Galvus Met) is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Galvus Met should have their renal function monitored regularly. Galvus Met should only be used in elderly patients with normal renal function.

Patients with Renal Impairment: Galvus Met should not be used in patients with renal failure or renal dysfunction eg, serum creatinine levels ≥1.5 mg/dL (>135 micromol/L) in males and ≥1.4 mg/dL (>110 micromol/L) in females.

Patients with Hepatic Impairment: Galvus Met is not recommended in patients with clinical or laboratory evidence of hepatic impairment including patients with a pre-treatment ALT or AST >2.5 x ULN.

Galvus Met interactions

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Galvus Met: No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (Galvus Met) (100 mg once daily) was co-administered with Metformin (Galvus Met) HCl (1000 mg once daily). Drug interactions for each component of Galvus Met has been extensively studied. However, the concomitant use of Vildagliptin (Galvus Met)/Metformin (Galvus Met) HCl in patients in clinical studies and in widespread clinical use has not resulted in any unexpected interactions.

The following statements reflect the information available on the individual active substances (Vildagliptin (Galvus Met) and Metformin (Galvus Met)).

Vildagliptin (Galvus Met): Vildagliptin (Galvus Met) has a low potential for drug interactions. Since Vildagliptin (Galvus Met) is not a CYP450 enzyme substrate nor does it inhibit, nor induces CYP450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes.

Furthermore, Vildagliptin (Galvus Met) does not affect metabolic clearance of co-medications metabolised by CYP 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4/5. Drug-drug interaction studies were conducted with commonly co-prescribed medications for patients with type 2 diabetes or medications with a narrow therapeutic window. As a result of these studies, no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, Metformin (Galvus Met) HCl), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with Vildagliptin (Galvus Met).

Metformin (Galvus Met) HCl: The following is known for Metformin (Galvus Met) component: Furosemide: Furosemide increased Cmax and blood AUC of Metformin (Galvus Met) with no change in renal clearance of Metformin (Galvus Met). Metformin (Galvus Met) decreased Cmax, blood AUC of furosemide, with no change in renal clearance of furosemide.

Nifedipine: Nifedipine increased absorption, Cmax and AUC of Metformin (Galvus Met), and increased excretion of Metformin (Galvus Met) in urine. Metformin (Galvus Met) had minimal effects on nifedipine.

Glyburide: Glyburide produced no changes in Metformin (Galvus Met) pharmacokinetic/pharmacodynamic (PK/PD) parameters. Decreases in Cmax, blood AUC of glyburide were observed, but were highly variable. Therefore, the clinical significance of this finding was unclear.

Cationic Drugs: Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with Metformin (Galvus Met) by competing for common renal tubular transport systems. Thus, with cimetidine increases in Metformin (Galvus Met) plasma/blood concentration and AUC were observed to be 60% and 40%, respectively. Metformin (Galvus Met) had no effect on cimetidine pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful monitoring of patients and doses of Metformin (Galvus Met) and such medications are recommended.

Other: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs and isoniazid. Close monitoring of glycemic control and Metformin (Galvus Met) dose adjustments are recommended when such drugs are administered or withdrawn for these patients.

There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the Metformin (Galvus Met) active substance of Galvus Met. Avoid consumption of alcohol and medicinal products containing alcohol.

Incompatibilities: Not applicable.

Galvus Met side effects

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Summary of the Safety Profile: Galvus Met: The data presented here relate to the administration of Vildagliptin (Galvus Met) and Metformin (Galvus Met) as a free or fixed dose combination.

Rare cases of angioedema have been reported on Vildagliptin (Galvus Met) at a similar rate to controls. A greater proportion of cases were reported when Vildagliptin (Galvus Met) was administered in combination with an angiotensin-converting enzyme (ACE) inhibitor. The majority of events were mild in severity and resolved with ongoing Vildagliptin (Galvus Met) treatment.

Rare cases of hepatic dysfunction (including hepatitis) have been reported with Vildagliptin (Galvus Met). In these cases, the patients were generally asymptomatic without clinical sequelae and LFTs returned to normal after discontinuation of treatment. In data from controlled monotherapy and add-on therapy trials up to 24 weeks in duration, the incidence of ALT or AST elevations ≥3 x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for Vildagliptin (Galvus Met) 50 mg daily, Vildagliptin (Galvus Met) 50 mg twice daily and all comparators, respectively. These elevations in transaminases were generally asymptomatic, nonprogressive in nature and not associated with cholestasis or jaundice.

In clinical trials with the combination of Vildagliptin (Galvus Met) plus Metformin (Galvus Met), 0.4% of patients withdrew due to adverse reactions in the Vildagliptin (Galvus Met) 50 mg once daily plus Metformin (Galvus Met) treatment group and no withdrawal due to adverse reactions was reported in either the Vildagliptin (Galvus Met) 50 mg twice daily plus Metformin (Galvus Met) or the placebo plus Metformin (Galvus Met) treatment groups.

In clinical trials, the incidence of hypoglycemia was uncommon in patients receiving Vildagliptin (Galvus Met) 50 mg once daily in combination with Metformin (Galvus Met) (0.9%), patients receiving Vildagliptin (Galvus Met) 50 mg twice daily in combination with Metformin (Galvus Met) (0.5%) and in patients receiving placebo and Metformin (Galvus Met) (0.4%). No severe hypoglycemic events were reported in the Vildagliptin (Galvus Met) arms.

Vildagliptin (Galvus Met) is weight neutral when administered in combination with Metformin (Galvus Met).

Gastrointestinal adverse reactions including diarrhea and nausea are known to occur very commonly during the introduction of Metformin (Galvus Met) hydrochloride. In the Vildagliptin (Galvus Met) monotherapy clinical program (n=2,264) where Vildagliptin (Galvus Met) was administered 50 mg once daily, 50 mg twice daily or 100 mg once daily, the rate of diarrhea was 1.2%, 3.5% and 0.8%, respectively and the rate of nausea was 1.7%, 3.7% and 1.7%, respectively as compared to 2.9% for both in the placebo group (n=347) and 26.2% and 10.3%, respectively, in the Metformin (Galvus Met) hydrochloride group (n=252).

Overall, gastrointestinal symptoms were reported in 13.2% (50 mg once daily or twice daily) of patients treated with the combination of Vildagliptin (Galvus Met) and Metformin (Galvus Met) hydrochloride compared to 18.1% of patients treated with Metformin (Galvus Met) hydrochloride alone.

Summary of Adverse Drug Reactions from Clinical Trials: Adverse reactions reported in patients who received Vildagliptin (Galvus Met) in double-blind studies as add-on to Metformin (Galvus Met) and as monotherapy, are listed as follows, for each indication, by MedDRA system organ class and absolute frequency. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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).

Long-term clinical trials of up to >2 years did not show any additional safety signal or unforeseen risks when Vildagliptin (Galvus Met) was added-on to Metformin (Galvus Met).

When Vildagliptin (Galvus Met) was studied as initial combination therapy with Metformin (Galvus Met), no additional safety signal or unforeseen risk was observed.

Combination with Insulin: In controlled clinical trials using Vildagliptin (Galvus Met) 50 mg twice daily in combination with insulin, with or without concomitant Metformin (Galvus Met), the overall incidence of withdrawals due to adverse reactions was 0.3% in the Vildagliptin (Galvus Met) treatment group and there were no withdrawals in the placebo group.

The incidence of hypoglycemia was similar in both treatment groups (14% in the Vildagliptin (Galvus Met) group vs 16.4% in the placebo group). Two (2) patients reported severe hypoglycemic events in the Vildagliptin (Galvus Met) group and 6 patients in the placebo group.

At the end of the study, effect on mean body weight was neutral (+0.6 kg change from baseline in the Vildagliptin (Galvus Met) group and no weight change in the placebo group).

Combination with Sulfonylurea: There were no withdrawals reported due to adverse reactions in the Vildagliptin (Galvus Met) plus Metformin (Galvus Met) plus glimepiride treatment group versus 0.6% in the placebo plus Metformin (Galvus Met) plus glimepiride treatment group.

The incidence of hypoglycemia was common in both treatment groups (5.1% for the Vildagliptin (Galvus Met) + Metformin (Galvus Met) + glimepiride vs 1.9 % for the placebo + Metformin (Galvus Met) + glimepiride). One (1) severe hypoglycemic event was reported in the Vildagliptin (Galvus Met) group.

At the end of the study, effect on mean body weight was neutral (+0.6 kg in the Vildagliptin (Galvus Met) group and -0.1 kg in the placebo group).

Vildagliptin (Galvus Met): Adverse reactions for Vildagliptin (Galvus Met) component from monotherapy double-blind studies are presented in Table 4.

None of the adverse reactions reported for the Vildagliptin (Galvus Met) monotherapy were observed at clinically significant higher rates when Vildagliptin (Galvus Met) was administered concomitantly with Metformin (Galvus Met).

The overall incidence of withdrawals from monotherapy trials due to adverse reactions was no greater for patients treated with Vildagliptin (Galvus Met) at a dose of 50 mg once daily (0.2%) or Vildagliptin (Galvus Met) at a dose of 50 mg twice daily (0.1%) than for placebo (0.6%) or comparators (0.5%).

In monotherapy studies, hypoglycemia was uncommon, reported in 0.5% (2 of 409) of patients treated with Vildagliptin (Galvus Met) 50 mg once daily and 0.3% (4 of 1,373) of patients treated with Vildagliptin (Galvus Met) 50 mg twice daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported. Vildagliptin (Galvus Met) is weight neutral when administered as monotherapy.

Long-term clinical trials of up to 2 years did not show any additional safety signals or unforeseen risks with Vildagliptin (Galvus Met) monotherapy.

Adverse Drug Reactions from Spontaneous Reports and Literature Cases: Post-Marketing Experience (Frequency Not Known): The following adverse drug reactions have been derived from post-marketing experience with Galvus Met via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore, categorized as not known.

Hepatitis, reversible upon drug discontinuation. Urticaria, pancreatitis, bullous and exfoliative skin lesions.

Metformin (Galvus Met) Hydrochloride: Known adverse reactions for Metformin (Galvus Met) component are summarized in Table 5.

Gastrointestinal adverse effects occur most frequently during initiation of therapy and resolve spontaneously in most cases.

Galvus Met contraindications

Hypersensitivity to Vildagliptin (Galvus Met) or Metformin (Galvus Met) HCl or to any of the excipients of Galvus Met.

Renal Disease: Patients with renal disease or renal dysfunction [eg, as suggested by serum creatinine levels ≥1.5 mg/dL (>135 micromol/L) in males and ≥1.4 mg/dL (>110 micromol/L) in females or abnormal creatinine clearance], which may also result from conditions eg, cardiovascular collapse (shock), acute myocardial infarction and septicemia.

Congestive Heart Failure: Patients with congestive heart failure requiring pharmacologic treatment.

Diabetic Ketoacidosis: Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Radiologic Studies: Galvus Met should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.



Active ingredient matches for Galvus Met:

Metformin/Vildagliptin in Argentina, Chile, Colombia, Oman, Russian Federation.

Metformin HCl/Vildagliptin in Thailand.


Unit description / dosage (Manufacturer)Price, USD
Tablet, Film-Coated; Oral; Metformin Hydrochloride 1000 mg; Vildagliptin 50 mg
Tablet, Film-Coated; Oral; Metformin Hydrochloride 500 mg; Vildagliptin 50 mg
Tablet, Film-Coated; Oral; Metformin Hydrochloride 850 mg; Vildagliptin 50 mg
Galvus Met 6 x 10's
Galvus Met 30's
Galvus Met 60's
Galvus MET 50+500 Tablet$ 0.31
Galvus Met 50+1000 Tablet$ 0.31
Galvus MET 50+850 Tablet$ 0.31
GALVUS MET 1000 MG/50 MG TABLET 1 strip / 10 tablets each (Novartis India Ltd)$ 4.21
GALVUS MET 500 MG/50 MG TABLET 1 strip / 10 tablets each (Novartis India Ltd)$ 4.10
GALVUS MET 850 MG/50 MG TABLET 1 strip / 10 tablets each (Novartis India Ltd)$ 4.12
Galvus Met FC tab 50 mg/1, 000 mg 6 x 10's (Novartis)
Galvus Met FC tab 50 mg/500 mg 6 x 10's (Novartis)
Galvus Met FC tab 50 mg/850 mg 6 x 10's (Novartis)
Galvus Met 50mg/1000mg Tablet (Novartis India Ltd)$ 0.42
Galvus Met 50mg/500mg Tablet (Novartis India Ltd)$ 0.42
Galvus Met 50mg/850mg Tablet (Novartis India Ltd)$ 0.42

List of Galvus Met substitutes (brand and generic names):

Galvus Met 50 mg/850 mg film-coated tab 60's (Novartis)
GalvusMet 60's (Novartis Healthcare)
Galvusmet 50 mg/850 mg x 30's (Novartis Healthcare)$ 18.79
Galvusmet 50 mg/1000 mg x 30's (Novartis Healthcare)$ 18.79
Galvusmet 50 mg/500 mg x 30's (Novartis Healthcare)$ 18.79
10's (Novartis Healthcare)$ 3.14
Galvusmet 50 mg/500 mg x 10's (Novartis Healthcare)
Galvusmet 50 mg/850 mg x 10's (Novartis Healthcare)
Galvusmet 50 mg/1000 mg x 10's (Novartis Healthcare)
Galvusmet 50 mg/500 mg x 3 x 10's (Novartis Healthcare)$ 19.16
Galvusmet 50 mg/850 mg x 3 x 10's (Novartis Healthcare)$ 19.16
Galvusmet 50 mg/1000 mg x 3 x 10's (Novartis Healthcare)$ 19.16
Galvusmet Vildagliptin 50mg, Metformin500mg TAB / 10 (Novartis Healthcare)$ 3.14
Galvusmet Vildagliptin 50mg, Metformin850mg TAB / 10 (Novartis Healthcare)$ 3.14
Galvusmet Vildagliptin 50mg, Metformin1000mg TAB / 10 (Novartis Healthcare)$ 3.14
Galvusmet 50 mg/1000 mg FC tab 30's (Novartis Healthcare)$ 20.71
Galvusmet 50 mg/500 mg FC tab 30's (Novartis Healthcare)$ 20.71
Galvusmet 50 mg/850 mg FC tab 30's (Novartis Healthcare)$ 20.71
Galvusmet Vildagliptin 50mg, Metformin500mg TAB / 10 (Novartis Healthcare)$ 3.14
Galvusmet Vildagliptin 50mg, Metformin850mg TAB / 10 (Novartis Healthcare)$ 3.14
Galvusmet Vildagliptin 50mg, Metformin1000mg TAB / 10 (Novartis Healthcare)$ 3.14
Tablet, Film-Coated; Oral; Metformin 1000 mg; Vildagliptin 50 mg
Tablet, Film-Coated; Oral; Metformin 850 mg; Vildagliptin 50 mg
Jalra M 50+1000 Tablet (USV Limited.)$ 0.31
Jalra M 500+50 Tablet (USV Limited.)$ 0.31
JALRA M 1000 MG/50 MG TABLET 1 strip / 10 tablets each (USV Limited.)$ 4.21
JALRA M 500 MG/50 MG TABLET 1 strip / 10 tablets each (USV Limited.)$ 4.10
JALRA M 850 MG/50 MG TABLET 1 strip / 10 tablets each (USV Limited.)$ 4.12
10's (USV)$ 3.14
Jalra-M Vildagliptin 50mg, Metformin500mg TAB / 10 (USV)$ 3.14
Jalra-M Vildagliptin 50 mg, Metforminhydrochloride 850 mg. TAB / 10 (USV)$ 3.14
Jalra-M Vildagliptin 50 mg, metforminhydrochloride 1000 mg. TAB / 10 (USV)$ 3.14
JALRA-M tab 10's (USV)$ 3.67
Jalra-M Vildagliptin 50mg, Metformin500mg TAB / 10 (USV)$ 3.14
Jalra-M Vildagliptin 50 mg, Metforminhydrochloride 850 mg. TAB / 10 (USV)$ 3.14
Jalra-M Vildagliptin 50 mg, metforminhydrochloride 1000 mg. TAB / 10 (USV)$ 3.14
Jalra-M 50mg/1000mg Tablet (USV)$ 0.42
Jalra-M 50mg/500mg Tablet (USV)$ 0.41

References

  1. PubChem. "Vildagliptin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. PubChem. "metformin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Vildagliptin". http://www.drugbank.ca/drugs/DB04876 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Galvus Met are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Galvus Met. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

2 consumers reported useful

Was the Galvus Met drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful2
100.0%


3 consumers reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Galvus Met drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Expensive2
66.7%
Not expensive1
33.3%


4 consumers reported time for results

To what extent do I have to use Galvus Met before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes > 3 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Galvus Met. To get the time effectiveness of using Galvus Met drug by other patients, please click here.
Users%
> 3 month1
25.0%
1 day1
25.0%
1 week1
25.0%
2 days1
25.0%


21 consumers reported age

Users%
46-6012
57.1%
> 607
33.3%
30-451
4.8%
1-51
4.8%


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