País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Pneumococcal polysaccharide serotype 1 1ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 14 1ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 18C 3ug (conjugated with Tetanus Toxoid); ; ; Pneumococcal polysaccharide serotype 19F 3ug (conjugated with Diptheria Toxoid); ; ; Pneumococcal polysaccharide serotype 23F 1ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 4 3ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 5 1ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 6B 1ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 7F 1ug (conjugated with NTHi protein D); ; ; Pneumococcal polysaccharide serotype 9V 1ug (conjugated with NTHi protein D); ;
GlaxoSmithKline NZ Limited
Pneumococcal polysaccharide type 1 1 µg (conjugated with NTHi protein D)
Suspension for injection
Active: Pneumococcal polysaccharide serotype 1 1ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 14 1ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 18C 3ug (conjugated with Tetanus Toxoid) Pneumococcal polysaccharide serotype 19F 3ug (conjugated with Diptheria Toxoid) Pneumococcal polysaccharide serotype 23F 1ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 4 3ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 5 1ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 6B 1ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 7F 1ug (conjugated with NTHi protein D) Pneumococcal polysaccharide serotype 9V 1ug (conjugated with NTHi protein D) Excipient: Aluminium phosphate Diphtheria toxoid, adsorbed Haemophilus influenzae protein D Sodium chloride Tetanus toxoid Water for injection
Syringe, glass, Pre-filled Type 1 with rubber butyl plunger stopper, 0.5mL, 1 dose unit
Prescription
Prescription
GlaxoSmithKline Biologicals SA
Synflorix is indicated for the active immunisation of infants and children from the age of 6 weeks up to 5 years against disease caused by Streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including invasive disease, pneumonia and acute otitis media).
Package - Contents - Shelf Life: Syringe, glass, Pre-filled Type 1 with rubber butyl plunger stopper, 0.5mL - 1 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Pre-filled Type 1 with rubber butyl plunger stopper, 0.5mL - 10 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber butyl plunger stopper, 0.5mL - 1 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber butyl plunger stopper 0.5mL - 10 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2009-04-15
1 SYNFLORIX _Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use SYNFLORIX. This leaflet answers some common questions about SYNFLORIX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of your child having SYNFLORIX against the possible risks. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD RECEIVING SYNFLORIX, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE VACCINE. You may need to read it again. WHAT IS SYNFLORIX USED FOR? SYNFLORIX is a pneumococcal vaccine. SYNFLORIX helps protect your child against diseases such as: meningitis, blood infection, pneumonia and ear infection caused by ten types of the bacteria _Streptococcus _ _pneumoniae_. The vaccine works by helping the body to make its own antibodies, which protect your child against these diseases. As with all vaccines, SYNFLORIX may not fully protect all children who are vaccinated. SYNFLORIX will only protect against infections caused by the groups of _Streptococcus _ _pneumoniae_ for which the vaccine has been developed. Children with a weakened immune system, for example due to human immunodeficiency virus (HIV) infection, may not get the full benefit from SYNFLORIX. BEFORE YOUR CHILD RECEIVES SYNFLORIX _ _ _SYNFLORIX SHOULD NOT BE _ _GIVEN IF YOUR CHILD: _ • has previously had any allergic reaction to SYNFLORIX, or any ingredient contained in SYNFLORIX. The active substances and other ingredients in SYNFLORIX are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. BEFORE YOUR CHILD IS VACCINATED, MAKE SURE YOUR DOCTOR KNOWS IF ANY OF THE FOLLOWING APPLY TO YOUR CHILD • has a severe infection Leia o documento completo
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SYNFLORIX pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. Suspension for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 mL) contains: Pneumococcal polysaccharide serotype 1 1,2 1 microgram Pneumococcal polysaccharide serotype 4 1,2 3 micrograms Pneumococcal polysaccharide serotype 5 1,2 1 microgram Pneumococcal polysaccharide serotype 6B 1,2 1 microgram Pneumococcal polysaccharide serotype 7F 1,2 1 microgram Pneumococcal polysaccharide serotype 9V 1,2 1 microgram Pneumococcal polysaccharide serotype 14 1,2 1 microgram Pneumococcal polysaccharide serotype 18C 1,3 3 micrograms Pneumococcal polysaccharide serotype 19F 1,4 3 micrograms Pneumococcal polysaccharide serotype 23F 1,2 1 microgram 1 adsorbed on aluminium phosphate 0.5 milligram Al 3+ 2 conjugated to protein D (derived from Non-Typeable _Haemophilus influenza (NTHi)_) carrier protein 9-16 micrograms 3 conjugated to tetanus toxoid carrier protein 5-10 micrograms 4 conjugated to diphtheria toxoid carrier protein 3-6 micrograms For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection. SYNFLORIX is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation of infants and children from the age of 6 weeks up to 5 years against disease caused by _Streptococcus pneumoniae_ vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including invasive disease, pneumonia and acute otitis media). 4.2 DOSE AND METHOD OF ADMINISTRATION Dose Official recommendations should be taken into account when immunising with SYNFLORIX. It is recommended that subjects who receive a first dose of SYNFLORIX complete the full vaccination course with SYNFLORIX. 2 _VACCINATION OF INFANTS FROM 6 WEEKS TO 6 MONTHS OF AGE: _ _Three-dose primary series_ The recommended immunisation series to ensure optimal protection consists of a total of four doses, each of 0.5 ml. The primary infan Leia o documento completo