Glaxosmithkline Biologicals Sa

Manufacturer Details

There are currently no manufacturer details available.

Glaxosmithkline Biologicals Sa Drugs

Engerix-b

Engerix-b

For intramuscular administration. See Section 2.2 for subcutaneous administration in persons at risk of hemorrhage.

2.1 Preparation for Administration

Shake well before use. With thorough agitation, ENGERIX-B is a homogeneous, turbid white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

2.2 Administration

ENGERIX-B should be administered by intramuscular injection. The preferred administration site is the anterolateral aspect of the thigh for infants younger than 1 year and the deltoid muscle in older children (whose deltoid is large enough for an intramuscular injection) and adults. ENGERIX-B should not be administered in the gluteal region; such injections may result in suboptimal response.

ENGERIX-B may be administered subcutaneously to persons at risk of hemorrhage (e.g., hemophiliacs). However, hepatitis B vaccines administered subcutaneously are known to result in a lower antibody response. Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, subcutaneous administration should be used only in persons who are at risk of hemorrhage with intramuscular injections.

Do not administer this product intravenously or intradermally.

2.3 Recommended Dose and Schedule

Persons from Birth through 19 Years of Age

Primary immunization for infants (born of hepatitis B surface antigen [HBsAg]-negative or HBsAg-positive mothers), children (birth through 10 years of age), and adolescents (11 through 19 years of age) consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

Persons 20 Years of Age and Older

Primary immunization for persons 20 years of age and older consists of a series of 3 doses (1 mL each) given on a 0-, 1-, and 6-month schedule.

Adults on Hemodialysis

Primary immunization consists of a series of 4 doses (2 mL each) given as a single 2-mL dose or two 1-mL doses on a 0-, 1-, 2-, and 6-month schedule. In hemodialysis patients, antibody response is lower than in healthy persons and protection may persist only as long as antibody levels remain above 10 mIU/mL. Therefore, the need for booster doses should be assessed by annual antibody testing. A 2-mL booster dose (as a single 2-mL dose or two 1-mL doses) should be given when antibody levels decline below 10 mIU/mL.1[See Clinical Studies (14.2).]
Table 1. Recommended Dosage and Administration Schedules
Group

Dosea

Schedules

Infants born of:

HBsAg-negative mothers

0.5 mL

0, 1, 6 months

HBsAg-positive mothersb

0.5 mL

0, 1, 6 months

Children:

Birth through 10 years of age

0.5 mL

0, 1, 6 months

Adolescents:

11 through 19 years of age

0.5 mL

0, 1, 6 months

Adults:

20 years of age and older

1 mL

0, 1, 6 months

Adults on hemodialysis

2 mLc

0, 1, 2, 6 months

HBsAg = Hepatitis B surface antigen.

a 0.5 mL (10 mcg); 1 mL (20 mcg).

b Infants born to HBsAg-positive mothers should receive vaccine and hepatitis B immune globulin (HBIG) within 12 hours after birth [see Dosage and Administration (2.6)].

c Given as a single 2-mL dose or as two 1-mL doses.

2.4 Alternate Dosing Schedules

There are alternate dosing and administration schedules which may be used for specific populations (e.g., neonates born of hepatitis B–infected mothers, persons who have or might have been recently exposed to the virus, and travelers to high-risk areas) (Table 2). For some of these alternate schedules, an additional dose at 12 months is recommended for prolonged maintenance of protective titers.
Table 2. Alternate Dosage and Administration Schedules
Group

Dosea

Schedules

Infants born of:

HBsAg-positive mothersb

0.5 mL

0, 1, 2, 12 months

Children:

Birth through 10 years of age

0.5 mL

0, 1, 2, 12 months

5 through 10 years of age

0.5 mL

0, 12, 24 monthsc

Adolescents:

11 through 16 years of age

0.5 mL

0, 12, 24 monthsc

11 through 19 years of age

1 mL

0, 1, 6 months

11 through 19 years of age

1 mL

0, 1, 2, 12 months

Adults:

20 years of age and older

1 mL

0, 1, 2, 12 months

HBsAg = Hepatitis B surface antigen.

a 0.5 mL (10 mcg); 1 mL (20 mcg).

b Infants born to HBsAg-positive mothers should receive vaccine and hepatitis B immune globulin (HBIG) within 12 hours after birth [see Dosage and Administration (2.6)].

c For children and adolescents for whom an extended administration schedule is acceptable based on risk of exposure.

2.5 Booster Vaccinations

Whenever administration of a booster dose is appropriate, the dose of ENGERIX-B is 0.5 mL for children 10 years of age and younger and 1 mL for persons 11 years of age and older. Studies have demonstrated a substantial increase in antibody titers after booster vaccination with ENGERIX-B. See Section 2.3 for information on booster vaccination for adults on hemodialysis.

2.6 Known or Presumed Exposure to Hepatitis B Virus

Persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers, persons who experienced percutaneous or permucosal exposure to the virus) should be given hepatitis B immune globulin (HBIG) in addition to ENGERIX-B in accordance with Advisory Committee on Immunization Practices recommendations and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule (0, 1, and 6 months or 0, 1, 2, and 12 months).
Infanrix

Infanrix

2.1 Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5‑mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule

A 0.5-mL dose of INFANRIX is approved for intramuscular administration in infants and children 6 weeks to 7 years of age (prior to the seventh birthday) as a 5-dose series. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. The first dose may be given as early as 6 weeks of age.

The preferred administration site is the anterolateral aspect of the thigh for most infants younger than 12 months of age and the deltoid muscle of the upper arm for most children 12 months of age to 7 years of age.

2.3 Use of INFANRIX With Other DTaP Vaccines

Sufficient data are not available on the safety and effectiveness of interchanging INFANRIX and Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccines from different manufacturers for successive doses of the DTaP vaccination series. Because the pertussis antigen components of INFANRIX and PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] are the same, INFANRIX may be used to complete a DTaP vaccination series initiated with PEDIARIX.

2.4 Additional Dosing Information

If any recommended dose of pertussis vaccine cannot be given [see Contraindications (4.2, 4.3) and Warnings and Precautions (5.5)], Diphtheria and Tetanus Toxoids Adsorbed (DT) For Pediatric Use should be given according to its prescribing information.
Pediarix

Pediarix

2.1 Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Attach a sterile needle and administer intramuscularly.

The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Recommended Dose and Schedule

Immunization with PEDIARIX consists of 3 doses of 0.5 mL each, by intramuscular injection, at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks). The first dose may be given as early as 6 weeks of age. Three doses of PEDIARIX constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis and the complete vaccination course for hepatitis B.

2.3 Modified Schedules in Previously Vaccinated Children

Children Previously Vaccinated With Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP): PEDIARIX may be used to complete the first 3 doses of the DTaP series in children who have received 1 or 2 doses of INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), manufactured by GlaxoSmithKline, identical to the DTaP component of PEDIARIX [see Description (11)] and are also scheduled to receive the other vaccine components of PEDIARIX. Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

Children Previously Vaccinated With Hepatitis B Vaccine: PEDIARIX may be used to complete the hepatitis B vaccination series following 1 or 2 doses of another hepatitis B vaccine (monovalent or as part of a combination vaccine), including vaccines from other manufacturers, in children born of HBsAg-negative mothers who are also scheduled to receive the other vaccine components of PEDIARIX.

A 3-dose series of PEDIARIX may be administered to infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth. However, data are limited regarding the safety of PEDIARIX in such infants [see Adverse Reactions (6.1)]. There are no data to support the use of a 3-dose series of PEDIARIX in infants who have previously received more than one dose of hepatitis B vaccine.

Children Previously Vaccinated With Inactivated Poliovirus Vaccine (IPV): PEDIARIX may be used to complete the first 3 doses of the IPV series in children who have received 1 or 2 doses of IPV from a different manufacturer and are also scheduled to receive the other vaccine components of PEDIARIX.

2.4 Booster Immunization Following PEDIARIX

Children who have received a 3-dose series with PEDIARIX should complete the DTaP and IPV series according to the recommended schedule.1 Because the pertussis antigens contained in INFANRIX and KINRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine), manufactured by GlaxoSmithKline, are the same as those in PEDIARIX, these children should receive INFANRIX as their fourth dose of DTaP and either INFANRIX or KINRIX as their fifth dose of DTaP, according to the respective prescribing information for these vaccines. KINRIX or another manufacturer’s IPV may be used to complete the 4-dose IPV series according to the respective prescribing information.
Quillivant Xr

Quillivant Xr

2.1 Preparation for Administration

Shake well before use. With thorough agitation, TWINRIX is a slightly turbid white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 1-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

2.2 Administration

TWINRIX should be administered by intramuscular injection only as a 1-mL dose. Administer in the deltoid region. Do not administer in the gluteal region; such injections may result in a suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.3 Recommended Dose and Schedule

Standard dosing schedule consists of 3 doses (1 mL each), given intramuscularly at 0, 1, and 6 months. Alternatively, an accelerated schedule of 4 doses (1 mL each), given intramuscularly on days 0, 7, and 21 to 30 followed by a booster dose at month 12 may be used.
Menhibrix

Menhibrix

2.1 Reconstitution

MENHIBRIX is to be reconstituted only with the accompanying saline diluent. The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Figure 1. Cleanse both vial stoppers. Withdraw 0.6 mL of saline from diluent vial.

Figure 2. Transfer saline diluent into the lyophilized vaccine vial.

Figure 3. Shake the vial well.

Figure 4. After reconstitution, withdraw 0.5 mL of reconstituted vaccine and administer intramuscularly.

2.2 Administration

For intramuscular use only. Do not administer this product intravenously, intradermally, or subcutaneously.

After reconstitution, administer MENHIBRIX immediately.

Use a separate sterile needle and sterile syringe for each individual. The preferred administration site is the anterolateral aspect of the thigh for most infants younger than 1 year of age. In older children, the deltoid muscle is usually large enough for an intramuscular injection.

2.3 Dose and Schedule

A 4-dose series, with each 0.5-mL dose given by intramuscular injection at 2, 4, 6, and 12 through 15 months of age. The first dose may be given as early as 6 weeks of age. The fourth dose may be given as late as 18 months of age.
4life Enummi Protective...

4life Enummi Protective Day Moisturizer Spf-15

2.1 Preparation for Administration

Shake syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. With thorough agitation, CERVARIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise.

Attach a sterile needle and administer intramuscularly.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule

Immunization with CERVARIX consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm.
Hiberix

Hiberix

2.1 Reconstitution Instructions

HIBERIX is to be reconstituted only with the accompanying saline diluent. The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Figure 1. Cleanse vial stopper. Attach appropriate needle to accompanying prefilled syringe of saline diluent and insert into vial.

Figure 2. Transfer entire contents of prefilled syringe into vial. With needle still inserted, vigorously shake the vial.

Figure 3. After reconstitution, withdraw entire contents of vial (approximately 0.5 mL) and administer by intramuscular injection.

After reconstitution, HIBERIX should be administered promptly or stored refrigerated between 2° and 8°C and administered within 24 hours. If the vaccine is not administered promptly, shake the solution vigorously again before injection.

2.2 Dose and Administration

HIBERIX is administered as a single dose (approximately 0.5 mL) by intramuscular injection into the anterolateral aspect of the thigh or deltoid.

Do not administer this product intravenously, intradermally, or subcutaneously.

HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization [see Indications and Usage (1)].
Havrix

Havrix

2.1 Preparation for Administration

Shake well before use. With thorough agitation, HAVRIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

2.2 Administration

HAVRIX should be administered by intramuscular injection only. HAVRIX should not be administered in the gluteal region; such injections may result in suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.3 Recommended Dose and Schedule

Children and Adolescents: Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children.

Adults: Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later. In adults, the injection should be given in the deltoid region.
Boostrix

Boostrix

2.1 Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5‑mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule

BOOSTRIX is administered as a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.

There are no data to support repeat administration of BOOSTRIX.

Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine and the administration of BOOSTRIX.

2.3 Additional Dosing Information

Primary Series: The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied.

Wound Management: If tetanus prophylaxis is needed for wound management, BOOSTRIX may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.
Fluarix 20132014

Fluarix 20132014

For intramuscular injection only.

2.1 Dosage and Schedule

The dose and schedule for FLUARIX are presented in Table 1.
Table 1. FLUARIX: Dosing
Age

Vaccination Status

Dose and Schedule

3 through 8 years of age

Not previously vaccinated with influenza vaccine

Two doses (0.5‑mL each) at least 4 weeks apart

Vaccinated with influenza vaccine in a previous season

One or two dosesa (0.5‑mL each)

9 years of age and older

Not applicable

One 0.5‑mL dose

a One dose or two doses (0.5‑ mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of influenza with vaccines. If two doses, administer each 0.5‑ mL dose at least 4 weeks apart.

2.2 Administration Instructions

Shake well before administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Attach a sterile needle to the prefilled syringe and administer intramuscularly.

The preferred site for intramuscular injection is the deltoid muscle of the upper arm. Do not inject in the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously, intradermally, or subcutaneously.
Irinotecan Hydrochlorid...

Irinotecan Hydrochloride

For intramuscular injection only.

2.1 Dosage and Schedule

The dose and schedule for FLUARIX QUADRIVALENT are presented in Table 1.
Table 1. FLUARIX QUADRIVALENT: Dosing
Age

Vaccination Status

Dose and Schedule

Aged 3 through 8 years

Not previously vaccinated with influenza vaccine

Two doses (0.5‑mL each) at least 4 weeks apart

Vaccinated with influenza vaccine in a previous season

One or two dosesa (0.5‑mL each)

Aged 9 years and older

Not applicable

One 0.5‑mL dose

a One dose or two doses (0.5‑mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of influenza with vaccines. If two doses, administer each 0.5‑mL dose at least 4 weeks apart.

2.2 Administration Instructions

Shake well before administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Attach a sterile needle to the prefilled syringe and administer intramuscularly.

The preferred site for intramuscular injection is the deltoid muscle of the upper arm. Do not inject in the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously, intradermally, or subcutaneously.
Kinrix

Kinrix

2.1 Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5‑mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Recommended Dose and Schedule

KINRIX is to be administered as a 0.5-mL dose by intramuscular injection. The preferred site of administration is the deltoid muscle of the upper arm.

KINRIX may be used for the fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children 4 through 6 years of age (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose [see Indications and Usage (1)].
Rotarix

Rotarix

2.1 Reconstitution Instructions for Oral Administration

For oral use only. Not for injection.

Reconstitute only with accompanying diluent. Do not mix ROTARIX with other vaccines or solutions.

Remove vial cap and push transfer adapter onto vial (lyophilized vaccine).

Shake diluent in oral applicator (white, turbid suspension). Connect oral applicator to transfer adapter.

Push plunger of oral applicator to transfer diluent into vial. Suspension will appear white and turbid.

Withdraw vaccine into oral applicator.

Twist and remove the oral applicator.

Ready for oral administration.

Do not use a needle with ROTARIX.

Not for injection.

2.2 Recommended Dose and Schedule

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age.

Safety and effectiveness have not been evaluated if ROTARIX were administered for the first dose and another rotavirus vaccine were administered for the second dose or vice versa.

In the event that the infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be considered at the same vaccination visit.

2.3 Infant Feeding

Breast-feeding was permitted in clinical studies. There was no evidence to suggest that breast-feeding reduced the protection against rotavirus gastroenteritis afforded by ROTARIX. There are no restrictions on the infant’s liquid consumption, including breast-milk, either before or after vaccination with ROTARIX.

Glaxosmithkline Biologicals Sa

Manufacturer Details

Share This Page

Glaxosmithkline Biologicals Sa Drugs