at least one examination with ultrasound during pregnancy, Apgar score -6 at 1st minute and -7 at 5th minutes, normal clinical status.

The Committee shall consist of three experts from each Member State, as follows: - one expert from the practising profession of dentistry,

The incubation period in individual animals is about one week to ten days, but under field conditions clinical symptoms may only become evident in a holding two to four weeks after virus introduction or even more if only adult breeding pigs or mild strains of virus are concerned.

Diluted hydrochloric acid: one volume of hydrochloric acid (d 2 0 =1,18 g/ml) plus one volume of water

I.2.2. Suspicion of ISA can be ruled out if continued investigations involving at least one clinical inspection per month for a period of six months reveal no further significant evidence of the presence of ISA.

"geographic number" means a number from the national numbering plan where part of its digit structure contains geographic significance used for routing calls to the physical location of the network termination point (NTP);

"Common channel signalling" (5) is a signalling method in which a single channel between exchanges conveys, by means of labelled messages, signalling information relating to a multiplicity of circuits or calls and other information such as that used for network management.

The development of high fever (more than 40 °C) is usually the first clinical sign of the disease, which is accompanied by depression, loss of appetite, rapid and difficult breathing, and discharges from the nose and eyes. Pigs show uncoordinated movements and huddle together. Sows may abort at all stages of pregnancy. Some pigs may show vomiting and constipation, while others may develop bloody diarrhoea. Congested or haemorrhagic subcutaneous areas become evident, in particular at the extremities and ears. A coma may develop before death, which occurs one to seven days after development of clinical signs. The morbidity and mortality rate within a holding may be 100 %.

If you accidentally turn it too far, go back one click (0.1 mg).

Now turn the black dose knob clockwise (See illustration) by one click (0.1mg).

Any air bubbles will collect at the top of the cartridge • Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture B) • Still with the needle upwards, press the push-button fully down (picture C) • A drop of insulin must appear at the needle tip.

Any air bubbles will collect at the top of the cartridge • Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture C) • Still with the needle upwards, press the push-button fully down (picture D) • A drop of insulin must appear at the needle tip.

Any air bubbles will collect at the top of the cartridge • Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture C) • Still with the needle upwards, press the push-button fully down (picture D) • A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

After a click, there should be one final tightening to ensure that the pump is securely screwed in place.

A coma may develop before death, which occurs one to seven days after development of clinical signs.

In a clinical study with ReFacto in PTPs, 1 inhibitor was observed in 113 patients.

Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle.

A total of 2531 subjects received at least one dose of ADENURIC (10 mg – 300 mg) in clinical studies.

During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.

It is recommended to repeat the clinical examination one month after commencing treatment with Trocoxil and prior to administration of the third dose.

A single case of heart failure related to Paxene was seen in the AIDS-KS clinical study.

The Commission intends further to develop standards such as EN 832 and prEN 13790, also including consideration of air-conditioning systems and lighting.

One patient in clinical trials took ritonavir 1500 mg/day for two days and reported paraesthesia, which resolved after the dose was decreased.

This Directive shall apply to electric mains operated household air-conditioners as defined in the European standards EN 255-1, EN 814-1 or the harmonised standards referred to in Article 2.

Clinical data are too limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast milk.

The highest reported dose ingested was 280 mg per day for one week with no associated clinical symptoms.

A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.

The safety profile of CELSENTRI is based on 1349 HIV-1 infected patients who received at least one dose of CELSENTRI during clinical studies.

In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 94 % of the adults one month after the first dose and in 100 % one month after the third dose (i. e. month 7).

In clinical trials, 99.9 % of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.

In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 89 % of the subjects one month after the first dose and in 100 % one month after the third dose (i. e. month 7). Specific

In pivotal clinical trials, two cases, including one fatality, occurred in MS patients who were being treated with concomitant interferon beta-1a therapy for more than 2 years.

Suspicion of ISA can be ruled out if continued investigations involving at least one clinical inspection per month for a period of six months reveal no further significant evidence of the presence of ISA.

Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.

Virbagen Omega is used to reduce mortality and clinical signs of parvovirosis (a highly contagious viral infection of dogs) in dogs from one month of age.

In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 722 infants, approximately 2 months of age, who had previously received a single dose of hepatitis B vaccine at birth.

In clinical trials with AMMONAPS, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to AMMONAPS.

In two clinical studies performed in healthy adult subjects, cyclosporin A (one 4 mg/ kg dose or two 3 mg/ kg doses 12 hours apart) increased the AUC of caspofungin by approximately 35 %.

"clinically superior" means that a medicinal product is shown to provide a significant therapeutic or diagnostic advantage over and above that provided by an authorised orphan medicinal product in one or more of the following ways:

Elderly A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).

The information provided is based on data generated from clinical trials in which 132 patients (> 1 and < 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine.

In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients

In chronic asthma studies, montelukast has been administered at doses up to 200 mg/ day to adult patients for 22 weeks and in short term studies, up to 900 mg/ day to patients for approximately one week without clinically important adverse experiences.

If it is observed or strongly suspected that an incomplete dose has been swallowed (e. g., infant spits or regurgitates the vaccine), a single replacement dose may be given at the same vaccination visit, however, this has not been studied in clinical trials.

Moreover a study with APTIVUS and low dose ritonavir and another NNRTI (efavirenz) did not show any clinically relevant interaction (see above).

In a clinical trial where Twinrix Adult was administered according to this schedule, 82 % and 85 % of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i. e. at months 1 and 2 after the initial dose).

Serious Adverse Reactions At least one case of the following serious adverse reactions has occurred in at least one patient treated with Herceptin alone or in combination with chemotherapy in clinical trials or has been reported during post marketing experience:

In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1 % one month after the first dose and 100 % after the second dose given at month 6 (i. e month 7).

Immune response after primary vaccination In the pivotal clinical study, all infants (100 %) developed a seroprotective antibody level (equal to or greater than 0.01 IU/ ml) to both diphtheria and tetanus antigens one month after completion of the primary series.

In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % vs.