Fluad

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Fluad uses


1 INDICATIONS AND USAGE

Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of Fluad disease caused by Fluad A subtype viruses and type B virus contained in the vaccine.

Fluad is approved for use in persons 65 years of age and older.

Fluad is a vaccine indicated for active immunization for the prevention of Fluad disease caused by Fluad A subtype viruses and type B virus contained in the vaccine. (1)

Fluad is approved for use in persons 65 years of age and older. (1)

2 DOSAGE AND ADMINISTRATION


A single 0.5 mL dose for intramuscular injection in adults 65 years of age and older.

2.1 Dose and Schedule

Fluad should be administered as a single 0.5 mL injection by the intramuscular route in adults 65 years of age and older.

2.2 Administration

Inspect Fluad visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.

Before administering a dose of vaccine, shake the prefilled syringe.

The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

Fluad should not be combined through reconstitution or mixed with any other vaccine.

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3 DOSAGE FORMS AND STRENGTHS

Fluad is a suspension for injection.

Fluad is supplied in prefilled syringes (gray syringe plunger rod), 0.5 mL, for adults 65 years of age and older.

Suspension for injection in prefilled syringe (gray plunger rod), 0.5 mL. (3)

4 CONTRAINDICATIONS

A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11) ], including egg protein, or to a previous dose of any Fluad vaccine is a contraindication to administration of Fluad.

Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any Fluad vaccine. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous Fluad vaccination, the decision to give Fluad should be based on careful consideration of the potential benefits and risks. The 1976 swine Fluad vaccine was associated with an elevated risk of GBS. Evidence for a causal relation of GBS with other Fluad vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.

5.2 Preventing and Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

5.3 Altered Immunocompetence

If Fluad is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

5.4 Limitations of Vaccine Effectiveness

Vaccination with Fluad may not protect all recipients.

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6 ADVERSE REACTIONS


To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.

Two clinical studies have evaluated the safety of Fluad.

Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluad or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluad to those of Fluzone. The safety analysis set included 2573 Fluad recipients and 1260 Fluzone recipients.

Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluad compared to Fluzone.

Fluad (NN is the number of vaccinated participants with available data for the events listed=2569-2572)

Percentage

Fluzone (N=1258-1260)

Percentage

Any ModerateModerate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema and Injection-site swelling: ≥2.5 cm to <5 cm; Fever: >100.4°F to ≤102.2°F; Myalgia, Malaise, and Headache: interferes with daily activities SevereSevere - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injection-site swelling: ≥5 cm; Fever: >102.2°F; Myalgia, Malaise, and Headache: prevents daily activities Any Moderate Severe
Injection-Site Pain 35.6 3.7 0.3 24.3 1.7 0.2
Injection-Site Erythema 14.9 1.9 1.8 10.8 0.8 0.6
Injection-Site Swelling 8.9 1.6 1.5 5.8 1.3 0.6
Myalgia 21.4 4.2 1.6 18.3 3.2 0.2
Malaise 18.0 4.7 1.6 14.0 3.7 0.6
Headache 16.8 3.1 1.1 14.4 2.5 0.3
FeverFever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Fluad; and 98.6% and 1.4%, respectively, for Fluzone (≥99.5°F) 3.6 1.1 0.0 2.3 0.2 0.1

Within 6 months post-vaccination, 156 (6.1%) Fluad recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29 – 180 post-vaccination: 16 (0.6%) among Fluad recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluad.

Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two Fluad seasons. In this study, adults 65 years of age and older were randomized to receive either Fluad or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluad to those of Fluzone. The safety analysis set included 15,992 Fluad recipients and 15,991 Fluzone recipients.

Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluad recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluad recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluad recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluad recipients and 0 (0 %) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluad.

6.2 Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of Fluzone or Fluad. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluad.

Events Reported During Post-Approval Use of Fluzone.


Other Events Reported During Post-Approval Use of Fluad.

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7 DRUG INTERACTIONS

Data evaluating the concomitant administration of Fluad with other vaccines are not available.

8 USE IN SPECIFIC POPULATIONS

Safety and effectiveness of Fluad has not been established in pregnant women.

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Fluad. It is also not known whether Fluad can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluad should be given to a pregnant woman only if clearly needed.

8.4 Pediatric Use

Safety and effectiveness of Fluad in persons <65 years of age have not been established.

8.5 Geriatric Use

Safety, immunogenicity, and efficacy of Fluad have been evaluated in adults 65 years of age and older. [See Adverse Reactions (6.1) and Clinical Studies (14) ]

11 DESCRIPTION

Fluad (Influenza Vaccine) for intramuscular injection is an inactivated Fluad vaccine, prepared from Fluad viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Fluad virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluad process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.

Fluad suspension for injection is clear and slightly opalescent in color.

Neither antibiotics nor preservative are used in the manufacture of Fluad.

The Fluad prefilled syringe presentation is not made with natural rubber latex.

Fluad is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three Fluad strains recommended for the 2017-2018 Fluad season: A/Michigan/45/2015 X-275 (H1N1), A/Hong Kong/4801/2014 X-263-B(H3N2), and B/Brisbane/60/2008(B Victoria Lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.

Ingredient Quantity

(per dose)

Fluad

0.5 mL Dose

Active Substance: Split Fluad virus, inactivated strains per United States Public Health Service (USPHS) requirement: 180 mcg HA total
A (H1N1) 60 mcg HA
A (H3N2) 60 mcg HA
B 60 mcg HA
Other:
Sodium phosphate-buffered isotonic sodium chloride solution QS Quantity Sufficient to appropriate volume
Formaldehyde ≤100 mcg
Octylphenol ethoxylate ≤250 mcg
Gelatin None
Preservative None
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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fluad illness and its complications follow infection with Fluad viruses. Global surveillance of Fluad identifies yearly antigenic variants. For example, since 1977, antigenic variants of Fluad A (H1N1 and H3N2) viruses and Fluad B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HI) antibody titer post-vaccination with inactivated Fluad virus vaccines have not been correlated with protection from Fluad virus infection. In some human studies, antibody titers ≥1:40 have been associated with protection from Fluad illness in up to 50% of participants.

Antibodies against one Fluad virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of Fluad virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's Fluad vaccine. Therefore, Fluad vaccines are standardized to contain the hemagglutinins of Fluad virus strains representing the Fluad viruses likely to be circulating in the US during the Fluad season.

Annual vaccination with the current vaccine is recommended because immunity during the year after vaccination declines and because circulating strains of Fluad virus change from year to year.

13 NON-CLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluad has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

14 CLINICAL STUDIES

14.1 Immunogenicity of Fluad in Adults 65 Years of Age and Older

Study 1 was a multi-center, double-blind pre-licensure trial conducted in the US in which adults 65 years of age and older were randomized to receive either Fluad or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluad to those of Fluzone. For immunogenicity analyses, 2576 participants were randomized to Fluad and 1275 participants were randomized to Fluzone. Females accounted for 51.3% of participants in the Fluad group and 54.7% of participants in the Fluzone group. In both groups, the mean age was 72.9 years (ranged from 65 through 97 years in the Fluad group and 65 through 94 years in the Fluzone group); 35% of participants in the Fluad group and 36% of participants in the Fluzone group were 75 years of age or older. Most participants in the Fluad and Fluzone groups, respectively, were White (91.7% and 92.9%), followed by Hispanic (4.8% and 3.7%), and Black (2.7% and 2.7%).

The primary endpoints of the study were HI GMTs and seroconversion rates 28 days after vaccination. Pre-specified statistical superiority criteria required that the lower limit (LL) of the 2-sided 95% CI of the GMT ratio (Fluzone High-Dose/Fluzone) be greater than 1.50 for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>0.67), and that the lower limit of the 2-sided 95% CI of the seroconversion rate difference (Fluzone High-Dose minus Fluzone) be greater than 10% for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>-10%). As shown in Table 3, statistically superior HI GMTs and seroconversion rates after vaccination with Fluad compared to Fluzone were demonstrated for Fluad A subtypes, A (H1N1) and A (H3N2), but not for Fluad type B. For strain B, non-inferiority of Fluad compared to Fluzone was demonstrated for both the HI GMTs and seroconversion rates.

Fluad Strain GMT GMT Ratio Seroconversion %Seroconversion: Paired samples with pre-vaccination HI titer <1:10 and post-vaccination (day 28) titer ≥1:40 or a minimum 4-fold increase for participants with pre-vaccination titer ≥1:10 Difference Met Both Pre-defined Superiority Criteria Predefined superiority criterion for seroconversion: the lower limit of the two-sided 95% CI of the difference of the seroconversion rates (Fluzone High-Dose minus Fluzone) is >10%. Predefined superiority criterion for the GMT ratio: the lower limit of the 95% CI of the GMT ratio (Fluzone High-Dose divided by Fluzone) is >1.5
Fluad

N N is the number of vaccinated participants with available data for the immunologic endpoint listed=2542-2544

Fluzone

N=1252

Fluad over Fluzone

(95% CI)

Fluzone

High-Dose

N=2529-2531

Fluzone

N=1248-1249

Fluad minus Fluzone

(95% CI)

A (H1N1) 115.8

67.3

1.7

(1.6; 1.8)

48.6

23.1

25.4

(22.4; 28.5)

Yes
A (H3N2) 608.9

332.5

1.8

(1.7; 2.0)

69.1

50.7

18.4

(15.1; 21.7)

Yes
B 69.1

52.3

1.3

(1.2; 1.4)

41.8

29.9

11.8

(8.6; 15.0)

No

14.2 Efficacy of Fluad in Adults 65 Years of Age and Older

Study 2 (NCT01427309) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada in which adults 65 years of age and older were randomized (1:1) to receive either Fluad or Fluzone. The study was conducted over two Fluad seasons (2011-2012 and 2012-2013); 53% of participants enrolled in the first year of the study were re-enrolled and re-randomized in the second year. The per-protocol analysis set for efficacy assessments included 15,892 Fluad recipients and 15,911 Fluzone recipients. The majority (67%) of participants in the per-protocol analysis set for efficacy had one or more high-risk chronic comorbid conditions.

In the per-protocol analysis set, females accounted for 57.2% of participants in the Fluad group and 56.1% of participants in the Fluzone group. In both groups, the median age was 72.2 years (range 65 through 100 years). Overall, most participants in the study were White (95%); approximately 4% of study participants were Black, and approximately 6% reported Hispanic ethnicity.

The primary endpoint of the study was the occurrence of laboratory-confirmed Fluad (as determined by culture or polymerase chain reaction) caused by any Fluad viral type/subtype in association with influenza-like illness (ILI), defined as the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrent with at least one of the following systemic signs or symptoms: temperature >99.0°F, chills, tiredness, headaches or myalgia. Participants were monitored for the occurrence of a respiratory illness by both active and passive surveillance, starting 2 weeks post-vaccination for approximately 7 months. After an episode of respiratory illness, nasopharyngeal swab samples were collected for analysis; attack rates and vaccine efficacy were calculated.

Fluad

NN is the number of vaccinated participants in the per-protocol analysis set for efficacy assessments=15,892

nn is the number of participants with protocol-defined influenza-like illness with laboratory confirmation (%)

Fluzone

N=15,911

n (%)

Relative Efficacy

% (95% CI)

Any type/subtypePrimary endpoint 227 (1.43) 300 (1.89) 24.2 (9.7; 36.5)The pre-specified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of Fluad relative to Fluzone > 9.1%) was met.
Fluad A 190 (1.20) 249 (1.56) 23.6 (7.4; 37.1)
A (H1N1) 8 (0.05) 9 (0.06) 11.0 (-159.9; 70.1)
A (H3N2) 171 (1.08) 222 (1.40) 22.9 (5.4; 37.2)
Fluad BIn the first year of the study the Fluad B component of the vaccine and the majority of Fluad B cases were of the Victoria lineage; in the second year the Fluad B component of the vaccine and the majority of Fluad B cases were of the Yamagata lineage 37 (0.23) 51 (0.32) 27.4 (-13.1; 53.8)

A secondary endpoint of the study was the occurrence of culture-confirmed Fluad caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modified CDC-defined ILI, defined as the occurrence of a temperature > 99.0°F (> 37.2°C) with cough or sore throat. The efficacy of Fluad relative to Fluzone for this endpoint was 51.1% (95% CI: 16.8; 72.0).

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Single-dose, prefilled syringe, without needle, 0.5 mL (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-401-65).

16.2 Storage and Handling

Store Fluad refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.

Do not use after the expiration date shown on the label.

17 PATIENT COUNSELING INFORMATION


Fluzone is a registered trademark of Sanofi Pasteur Inc.

Manufactured by:

Sanofi Pasteur Inc.

Swiftwater PA 18370 USA

7032

Patient Information Sheet

Fluzone® High-Dose

Fluad Vaccine

Please read this information sheet before getting Fluad vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.

What is Fluad vaccine?

Fluad is a vaccine that helps protect against Fluad illness (flu).

Fluad vaccine is for people 65 years of age and older.

Vaccination with Fluad vaccine may not protect all people who receive the vaccine.

Who should not get Fluad vaccine?

You should not get Fluad vaccine if you:


Tell your healthcare provider if you have or have had:


How is Fluad vaccine given?

Fluad vaccine is a shot given into the muscle of the arm.

What are the possible side effects of Fluad vaccine?

The most common side effects of Fluad vaccine are:


These are not all of the possible side effects of Fluad vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.

Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

Why should I get Fluad vaccine instead of Fluzone vaccine?

An efficacy study in adults 65 years of age and older has demonstrated that Fluad vaccine offers better protection against Fluad than Fluzone vaccine.

What are the ingredients in Fluad vaccine?

Fluad vaccine contains 3 killed flu virus strains.

Inactive ingredients include formaldehyde and octylphenol ethoxylate.

Manufactured by: Sanofi Pasteur Inc.

Swiftwater, PA 18370 USA

Fluad pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Fluad available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Fluad destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Fluad Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Fluad pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."FLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Fluad?

Depending on the reaction of the Fluad after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fluad not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Fluad addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Fluad, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Fluad consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

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One visitor reported doses

What is the dose of Fluad drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
100.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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