Sterile Water (Sterile Diluent)

Trade Name : STERILE DILUENT

Merck Sharp & Dohme Corp.

INJECTION, VACCINE

Strength 0.7 mL/.7mL

WATER

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sterile Water (Sterile Diluent) which is also known as STERILE DILUENT and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 0.7 mL/.7mL per ml. Read more

Sterile Water (Sterile Diluent) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

ZOSTAVAXu00ae is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.
Limitations of Use of ZOSTAVAX:
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ()

ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN) ()
ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox) ()

Subcutaneous administration only.
Single 0.65 mL subcutaneous injection ()

ZOSTAVAX is a lyophilized preparation of live, attenuated varicella-zoster virus (Oka/Merck) to be reconstituted with sterile diluent to give a single dose suspension with a minimum of 19,400 PFU (plaque forming units) when stored at room temperature for up to 30 minutes.
Single dose vials with not less than 19,400 plaque-forming units [PFU] per 0.65 mL dose when reconstituted to a suspension. (, , )

No data

History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine. ()
Immunosuppression or Immunodeficiency. ()
Pregnancy. (, )

No data

Hypersensitivity reactions including anaphylaxis have occurred with ZOSTAVAX ()
Transmission of vaccine virus may occur between vaccinees and susceptible contacts ()
Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis ()
Avoid pregnancy for 3 months following vaccination with ZOSTAVAX ()

The most frequent adverse reactions, reported in u22651% of subjects vaccinated with ZOSTAVAX, were headache and injection-site reactions.
The most frequent adverse reactions, reported in u22651% of subjects vaccinated with ZOSTAVAX, were headache and injection-site reactions. ()u00a0
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or .

In a randomized clinical study, a reduced immune response to ZOSTAVAX as measured by gpELISA was observed in individuals who received concurrent administration of PNEUMOVAXu00ae 23 and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks. (, )

Pregnancy: Do not administer ZOSTAVAX to females who are pregnant. Pregnancy should be avoided for 3 months following vaccination with ZOSTAVAX. (, , )

ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a sterile suspension for subcutaneous administration. Each 0.65-mL dose contains a minimum of 19,400u00a0PFU (plaque-forming units) of Oka/Merck strain of VZV when reconstituted and stored at room temperature for up to 30u00a0minutes.
Each dose contains 31.16u00a0mg of sucrose, 15.58u00a0mg of hydrolyzed porcine gelatin, 3.99u00a0mg of sodium chloride, 0.62u00a0mg of monosodium L-glutamate, 0.57u00a0mg of sodium phosphate dibasic, 0.10u00a0mg of potassium phosphate monobasic, 0.10u00a0mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin and bovine calf serum. The product contains no preservatives.

The risk of developing zoster appears to be related to a decline in VZV-specific immunity. ZOSTAVAX was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications. n
Herpes zoster (HZ), commonly known as shingles or zoster, is a manifestation of the reactivation of varicella zoster virus (VZV), which, as a primary infection, produces chickenpox (varicella). Following initial infection, the virus remains latent in the dorsal root or cranial sensory ganglia until it reactivates, producing zoster. Zoster is characterized by a unilateral, painful, vesicular cutaneous eruption with a dermatomal distribution.
Pain associated with zoster may occur during the prodrome, the acute eruptive phase, and the postherpetic phase of the infection. Pain occurring in the postherpetic phase of infection is commonly referred to as postherpetic neuralgia (PHN).
Serious complications, such as PHN, scarring, bacterial superinfection, allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss, and death can occur as the result of zoster.

ZOSTAVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

In two large clinical trials (ZEST and SPS), ZOSTAVAX significantly reduced the risk of developing zoster when compared with placebo (see Table 4 and Table 5).

No data

No. 4963-00 u2014 ZOSTAVAX is supplied as follows: (1)u00a0a package of 1u00a0single-dose vial of lyophilized vaccine, 0006-4963-00 (packageu00a0A); and (2)u00a0a separate package of 10u00a0vials of diluent (packageu00a0B).
No. 4963-41 u2014 ZOSTAVAX is supplied as follows: (1)u00a0a package of 10u00a0single-dose vials of lyophilized vaccine, 0006-4963-41 (packageu00a0A); and (2)u00a0a separate package of 10u00a0vials of diluent (packageu00a0B).
Arrayn- Storage
To maintain potency, ZOSTAVAX must be stored frozen between -58u00b0F and +5u00b0F (-50u00b0C and -15u00b0C). Use of dry ice may subject ZOSTAVAX to temperatures colder than -58u00b0F (-50u00b0C).
Before reconstitution, ZOSTAVAX SHOULD BE STORED FROZEN at a temperature between -58u00b0F and +5u00b0F (-50u00b0C and -15u00b0C) until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature between -58u00b0F and +5u00b0F (-50u00b0C and -15u00b0C) is acceptable for storing ZOSTAVAX. Routine defrost cycling of a frost-free freezer is acceptable.
ZOSTAVAX may be stored and/or transported at refrigerator temperature between 36u00b0F and 46u00b0F (2u00b0C to 8u00b0C) for up to 72u00a0continuous hours prior to reconstitution. Vaccine stored between 36u00b0F and 46u00b0F (2u00b0C to 8u00b0C) that is not used within 72 hours of removal from +5u00b0F (-15u00b0C) storage should be discarded. ZOSTAVAX should be reconstituted immediately upon removal from the freezer. The diluent should be stored separately at room temperature (68u00b0F to 77u00b0F, 20u00b0C to 25u00b0C), or in the refrigerator (36u00b0F to 46u00b0F, 2u00b0C to 8u00b0C).
For information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90.
Before reconstitution, protect from light.
DO NOT FREEZE RECONSTITUTED VACCINE.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

MERCK & CO., INC.,
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2006-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-v211-i-fro-1909r029

Arrayn- Arrayn- u00ae
You should read this summary of information about ZOSTAVAX before you are vaccinated. If you have any questions about ZOSTAVAX after reading this leaflet, you should ask your health care provider. This information does not take the place of talking about ZOSTAVAX with your doctor, nurse, or other health care provider. Only your health care provider can decide if ZOSTAVAX is right for you.
Arrayn- What is ZOSTAVAX and how does it work?
ZOSTAVAX is a vaccine that is used for adults 50 years of age or older to prevent shingles (also known as zoster).
ZOSTAVAX contains a weakened chickenpox virus (varicella-zoster virus).
ZOSTAVAX works by helping your immune system protect you from getting shingles.
If you do get shingles even though you have been vaccinated, ZOSTAVAX may help prevent the nerve pain that can follow shingles in some people. ZOSTAVAX does not protect everyone, so some people who get the vaccine may still get shingles.
ZOSTAVAX cannot be used to treat shingles, or the nerve pain that may follow shingles, once you have it.
Arrayn- What do I need to know about shingles and the virus that causes it?
Shingles is caused by the same virus that causes chickenpox. Once you have had chickenpox, the virus can stay in your nervous system for many years. For reasons that are not fully understood, the virus may become active again and give you shingles. Age and problems with the immune system may increase your chances of getting shingles.
Shingles is a rash that is usually on one side of the body. The rash begins as a cluster of small red spots that often blister. The rash can be painful. Shingles rashes usually last up to 30 days and, for most people, the pain associated with the rash lessens as it heals.
Arrayn- Who should not get ZOSTAVAX?
You should not get ZOSTAVAX if you:
You should not get ZOSTAVAX to prevent chickenpox.
Children should not get ZOSTAVAX.
Arrayn- How is ZOSTAVAX given?
ZOSTAVAX is given as a single dose by injection under the skin.
Arrayn- What should I tell my health care provider before I get ZOSTAVAX?
You should tell your health care provider if you:
Tell your health care provider if you expect to be in close contact (including household contact) with newborn infants, someone who may be pregnant and has not had chickenpox or been vaccinated against chickenpox, or someone who has problems with their immune system. Your health care provider can tell you what situations you may need to avoid.
Arrayn- Can I get ZOSTAVAX with other vaccines?
ZOSTAVAX can be given at the same time as inactivated flu vaccine.
Talk to your health care provider if you plan to get ZOSTAVAX at the same time as PNEUMOVAXu00ae 23 because it may be better to get these vaccines at least 4 weeks apart.
Arrayn- What are the possible side effects of ZOSTAVAX?
The most common side effects that people in the clinical studies reported after receiving the vaccine include:
The following additional side effects have been reported with ZOSTAVAX:
Tell your healthcare provider if you have any new or unusual symptoms after you receive ZOSTAVAX. For a complete list of side effects, ask your health care provider.
Report the following to your doctor or your child's doctor:
Arrayn- What are the ingredients of ZOSTAVAX?
Active Ingredient: a weakened form of the varicella-zoster virus.
Inactive Ingredients: sucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride.
This leaflet summarizes important information about ZOSTAVAX. If you would like more information, talk to your health care provider or visit the website at or call 1-800-622-4477.

Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2006-2018 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 08/2018
usppi-v211-i-fro-1808r019

A
NDC 0006-4963-001 Single-dose Vial (0.65 mL)
Zoster Vaccine Live
STORE FROZEN
Oka/Merck strain. Humandiploid cell (MRC-5) cultureorigin. Each 0.65-mLdose contains aminimum of 19,400 PFU(plaque-forming units).
Contains no preservative.Contains trace quantitiesof neomycin.
Rx only

NDC 0006-4309-00
10 Single-Dose0.7-mL Vials
STERILE DILUENT
FOR MERCK SHARP & DOHME CORP.LIVE VIRUS VACCINES(Sterile Water)
Rx onlyB
CONTAINS NO PRESERVATIVE
This carton contains 10 diluent-containing vials. Use one diluent vialfor reconstitution of one single-dose vial of live virus vaccine.

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Sterile Water (Sterile Diluent)

Trade Name : STERILE DILUENT

INJECTION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Sterile Water (Sterile Diluent)

Trade Name : STERILE DILUENT

INJECTION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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