국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Rotavirus reassortant strain G1 2.2e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain G2 2.8e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain G3 2.2e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain G4 2e+006 [iU] (NLT, at expiry); Rotavirus reassortant strain P1 2.3e+006 [iU] (NLT, at expiry)
Merck Sharp & Dohme (New Zealand) Limited
Rotavirus reassortant strain G1 2.2e+006 IU (NLT, at expiry)
2 mL
Oral solution
Active: Rotavirus reassortant strain G1 2.2e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain G2 2.8e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain G3 2.2e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain G4 2e+006 [iU] (NLT, at expiry) Rotavirus reassortant strain P1 2.3e+006 [iU] (NLT, at expiry) Excipient: Rotavirus diluent & LPKM-3 (from actives) to approx 0.3 mL. Includes animal materials as below. Monobasic sodium phosphate monohydrate Polysorbate 80 Purified water Sodium citrate dihydrate Sodium hydroxide Sucrose
Tube, plastic, single dose pack, 2 mL
Prescription
Prescription
Merck Sharp & Dohme Corp
RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1A[8] (e.g., G9). RotaTeq may be administered as early as six weeks of age.
Package - Contents - Shelf Life: Tube, plastic, single dose pack - 2 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours opened stored at or below 25°C - Tube, plastic, 10 x 2mL dose pack - 20 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours opened stored at or below 25°C
2005-07-25
ROTATEQ ® _rotavirus vaccine, live, oral, pentavalent _ Single dose 2 mL unit dosing tube WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RotaTeq. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of your child being given RotaTeq against the benefits they expect it will have for them. If you have any concerns about your child being given this vaccine, ask your doctor. Keep this leaflet with the medicine. You may need to read it again. WHAT ROTATEQ IS USED FOR RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) is a viral vaccine that helps protect your child against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection. RotaTeq works by helping the body develop natural defences against the most common types or “strains” of rotavirus. The doctor has recommended or administered RotaTeq to help protect your child against rotavirus infection, a viral infection of the digestive tract and a major cause of gastroenteritis (inflammation of the stomach and intestines which causes diarrhoea and vomiting). The vaccine is given by mouth and is a series of 3 doses. The first dose is given as early as 6 weeks of age. The next two doses are given one to two months apart. The vaccine course is completed by the time your child is 32 weeks of age. Rotavirus gastroenteritis may cause fever, vomiting, and diarrhoea. These symptoms can lead to the loss of body fluids (dehydration) and even to death. It is the chief cause of severe dehydrating diarrhoea among infants and young children around the world. Before the vaccine was used, the virus was the cause for about 25 million physician visits per year. It also accounted for 2.1 million hospital admissions, and 352,000 to 592,000 deaths per year worldwide. Rotavirus infects the small intestine and usually starts with fever and vomiting, followed by diarrhoea. The diarrhoea can be mild 전체 문서 읽기
RotaTeq® v5.0 Page 1 of 16 WPC-V260-OS-082016 NEW ZEALAND DATA SHEET 1 PRODUCT NAME RotaTeq ® 2 mL Oral solution Rotavirus vaccine, live, oral, pentavalent 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 mL dose contains the following human-bovine rotavirus reassortants: G1, G2, G3, G4, and P1A[8]. The minimum dose levels of the reassortants are as follows: G1 2.2 X 10 6 infectious units G2 2.8 X 10 6 infectious units G3 2.2 X 10 6 infectious units G4 2.0 X 10 6 infectious units P1A[8] 2.3 X 10 6 infectious units The reassortants are propagated in Vero cells using standard tissue culture techniques in the absence of antifungal agents. Excipient with known effect: sucrose For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral solution RotaTeq is a pale yellow clear liquid that may have a pink tint. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1A[8] (e.g. G9). RotaTeq may be administered as early as six weeks of age. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally to infants. The first dose of RotaTeq should be administered at 6 to 12 weeks of age; the subsequent doses should be administered at a minimum interval of 4 weeks between each dose. The vaccination course should be completed by 32 weeks of age. There are no restrictions on the infant’s consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq. RotaTeq may be given to pre-term infants according to their chronological age. If for any reason an incomplete dose is administered (e.g. infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the RotaTeq® v5.0 Page 2 of 16 WPC-V260-OS-082016 clinical trials. The infant should continue to receive 전체 문서 읽기