Thursday, 1 March 2012

hepatitis A and hepatitis B vaccine


Generic Name: hepatitis A and hepatitis B vaccine (HEP a TYE tis)

Brand names: Twinrix, Twinrix Preservative-Free


What is hepatitis A and hepatitis B vaccine?

Hepatitis A and B are serious diseases caused by virus.


Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.


Hepatitis B is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected.


Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.


The hepatitis A and hepatitis B vaccine is used to help prevent these diseases. The vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.


Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.


Like any vaccine, the hepatitis A and hepatitis B vaccine may not provide protection from disease in every person.


What is the most important information I should know about this vaccine?


You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have multiple sclerosis, a bleeding or blood clotting disorder, seizures, a weak immune system, if you are taking a blood thinner, or if you are allergic to rubber.


Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has either hepatitis A or B infection.


Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.


You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis if you are already infected with the virus, even if you do not yet show symptoms.


Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.


Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.


What should I discuss with my healthcare provider before receiving this vaccine?


Hepatitis A and hepatitis B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis A or B if you are already infected with the virus, even if you do not yet show symptoms.


You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have:



  • multiple sclerosis;




  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;




  • a history of seizures;




  • an allergy to latex rubber;




  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or




  • if you are taking a blood thinner such as warfarin (Coumadin).



You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.


FDA pregnancy category C. It is not known whether hepatitis A and hepatitis B vaccine is harmful to an unborn baby. Before receiving this vaccine, tell your doctor if you are pregnant. It is not known whether hepatitis A and hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?


This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.


The hepatitis A and hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot.


If you have a high risk of hepatitis infection, you may be given 3 shots within 30 days of each other, and a fourth shot 12 months after the first.


Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.


Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.


It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.


What happens if I miss a dose?


Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.


Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.


What happens if I overdose?


An overdose of this vaccine is unlikely to occur.


What should I avoid before or after receiving this vaccine?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


This vaccine side effects


You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:



  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;




  • fast or pounding heartbeats; or




  • easy bruising or bleeding.



Less serious side effects include:



  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;




  • headache, tired feeling;




  • mild fever;




  • runny or stuffy nose, sore throat, other cold symptoms; or




  • nausea, vomiting, loss of appetite, diarrhea.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.


Hepatitis A and hepatitis B vaccine Dosing Information


Usual Adult Dose for Hepatitis B Prophylaxis:

Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months.
Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.

Usual Adult Dose for Hepatitis A Prophylaxis:

Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months.
Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.


What other drugs will affect hepatitis A and hepatitis B vaccine?


Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have received drugs or treatments in the past 2 weeks that can weaken the immune system, including:



  • an oral, nasal, inhaled, or injectable steroid medicine;




  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or




  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).



This list is not complete and there may be other drugs that can interact with hepatitis A and hepatitis B vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More hepatitis A and hepatitis B vaccine resources


  • Hepatitis A and hepatitis B vaccine Use in Pregnancy & Breastfeeding
  • Hepatitis A and hepatitis B vaccine Drug Interactions
  • Hepatitis A and hepatitis B vaccine Support Group
  • 0 Reviews for Hepatitis A and hepatitis B vaccine - Add your own review/rating


Compare hepatitis A and hepatitis B vaccine with other medications


  • Hepatitis A Prophylaxis
  • Hepatitis B Prevention


Where can I get more information?


  • Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Monday, 27 February 2012

Perrigo Benzoyl Peroxide Gel





Dosage Form: aqueous base gel
BENZOYL PEROXIDE GEL, 2.5%

Benzoyl Peroxide Gel, 2.5% Aqueous Base Acne Gel


Benzoyl Peroxide Gel, 5% Aqueous Base Acne Gel


Benzoyl Peroxide Gel, 10% Aqueous Base Acne Gel



Rx only


For Topical Use Only



Perrigo Benzoyl Peroxide Gel Description


Benzoyl Peroxide Gel, 2.5%, 5%, and 10% Aqueous Base Acne Gels are topical preparations containing benzoyl peroxide as the active ingredient.


Benzoyl Peroxide Gel, 2.5% Aqueous Base Acne Gel contains: 2.5% benzoyl peroxide, in an aqueous gel base formulated with carbomer homopolymer type C, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.


Benzoyl Peroxide Gel, 5% Aqueous Base Acne Gel contains: 5% benzoyl peroxide, in an aqueous gel base formulated with carbomer homopolymer type C, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.


Benzoyl Peroxide Gel, 10% Aqueous Base Acne Gel contains: 10% benzoyl peroxide, in an aqueous gel base formulated with carbomer 940, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, hydrated silica, methylparaben, poloxamer 182, purified water, and sodium hydroxide.


The structural formula of benzoyl peroxide is:




Perrigo Benzoyl Peroxide Gel - Clinical Pharmacology


The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.


Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.



Indications and Usage for Perrigo Benzoyl Peroxide Gel


Benzoyl Peroxide Gel 2.5%, 5%, and 10% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide Gel 2.5%, 5%, and 10% may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.



Contraindications


Benzoyl Peroxide Gel 2.5%, 5%, and 10% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.



Precautions



General -


For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.



Carcinogenesis, Mutagenesis, Impairment of Fertility -


Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.



Pregnancy:


Teratogenic Effects:

Pregnancy Category C -


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



Nursing Mothers -


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.



Pediatric Use -


Safety and effectiveness in children below the age of 12 have not been established.



Adverse Reactions


Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.



Perrigo Benzoyl Peroxide Gel Dosage and Administration


It is recommended that therapy be initiated with Benzoyl Peroxide Gel, 2.5%, applying the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response. Therapy with Benzoyl Peroxide Gel, 5% or Benzoyl Peroxide Gel, 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Gel, 2.5%.


Gentle cleansing of the affected areas prior to application of Benzoyl Peroxide Gel, 2.5%, 5%, or 10% may be beneficial.


Clinically visible improvements will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.



How is Perrigo Benzoyl Peroxide Gel Supplied


Benzoyl Peroxide Gel 2.5%, 5%, and 10% are available as follows:


Benzoyl Peroxide Gel, 2.5%Aqueous Base Acne Gel


60 g tube (NDC 45802-905-96)


Benzoyl Peroxide Gel, 5%Aqueous Base Acne Gel


60 g tube (NDC 45802-910-96)


90 g tube (NDC 45802-910-01)


Benzoyl Peroxide Gel, 10%Aqueous Base Acne Gel


60 g tube (NDC 45802-915-96)


90 g tube (NDC 45802-915-01)



STORAGE


Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].



Manufactured by Stiefel Laboratories, Inc.


Research Triangle Park, NC 27709


Distributed By


Perrigo®


Allegan, MI 49010 • www.perrigo.com


Rev. 12/10


305253


: 0H400 RC J2



Principal Display Panel - Carton


Rx Only


Benzoyl Peroxide Gel, 2.5%


For Topical Use Only


Aqueous Base Acne Gel


Benzoyl Peroxide Gel, 2.5% Carton




Principal Display Panel - Tube


Rx Only


Benzoyl Peroxide Gel, 2.5%


For Topical Use Only


Aqueous Base Acne Gel


Benzoyl Peroxide Gel, 2.5% Tube










BENZOYL PEROXIDE  AQUEOUS BASE
benzoyl peroxide  gel










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)45802-905
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)BENZOYL PEROXIDE2.5 g  in 100 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
145802-905-961 TUBE In 1 CARTONcontains a TUBE
160 g In 1 TUBEThis package is contained within the CARTON (45802-905-96)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/24/2008


Labeler - Perrigo New York Inc (078846912)
Revised: 10/2011Perrigo New York Inc

More Perrigo Benzoyl Peroxide Gel resources


  • Perrigo Benzoyl Peroxide Gel Side Effects (in more detail)
  • Perrigo Benzoyl Peroxide Gel Use in Pregnancy & Breastfeeding
  • Perrigo Benzoyl Peroxide Gel Drug Interactions
  • Perrigo Benzoyl Peroxide Gel Support Group
  • 15 Reviews for Perrigo Benzoyl Peroxide - Add your own review/rating


Compare Perrigo Benzoyl Peroxide Gel with other medications


  • Acne
  • Perioral Dermatitis

Sunday, 25 December 2011

Tiptipot Afalpi




Tiptipot Afalpi may be available in the countries listed below.


Ingredient matches for Tiptipot Afalpi



Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Tiptipot Afalpi in the following countries:


  • Israel

International Drug Name Search

Saturday, 24 December 2011

Gadobenate Dimeglumine




In the US, Gadobenate Dimeglumine (gadobenate dimeglumine systemic) is a member of the drug class magnetic resonance imaging contrast media and is used to treat CNS Magnetic Resonance Imaging.

US matches:

  • Gadobenate Dimeglumine

Ingredient matches for Gadobenate Dimeglumine



Gadobenic Acid

Gadobenate Dimeglumine (USAN) is also known as Gadobenic Acid (Rec.INN)

International Drug Name Search

Glossary

Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Mesigyna




Mesigyna may be available in the countries listed below.


Ingredient matches for Mesigyna



Estradiol

Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Mesigyna in the following countries:


  • Antigua & Barbuda

  • Aruba

  • Bahamas

  • Barbados

  • Belize

  • Bermuda

  • Cayman Islands

  • Colombia

  • Dominican Republic

  • Grenada

  • Guyana

  • Haiti

  • Jamaica

  • Netherlands Antilles

  • Peru

  • Saint Lucia

  • Suriname

  • Trinidad & Tobago

  • Turkey

Norethisterone

Norethisterone enantate (a derivative of Norethisterone) is reported as an ingredient of Mesigyna in the following countries:


  • Antigua & Barbuda

  • Aruba

  • Bahamas

  • Barbados

  • Belize

  • Bermuda

  • Cayman Islands

  • Colombia

  • Dominican Republic

  • Grenada

  • Guyana

  • Haiti

  • Jamaica

  • Netherlands Antilles

  • Peru

  • Saint Lucia

  • Suriname

  • Trinidad & Tobago

  • Turkey

International Drug Name Search

Wednesday, 21 December 2011

Aserin




Aserin may be available in the countries listed below.


Ingredient matches for Aserin



Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Aserin in the following countries:


  • Spain

International Drug Name Search

Vasta




Vasta may be available in the countries listed below.


Ingredient matches for Vasta



Simvastatin

Simvastatin is reported as an ingredient of Vasta in the following countries:


  • Oman

International Drug Name Search